nctId stringlengths 11 11 | briefTitle stringlengths 7 300 | briefSummary stringlengths 2 5.11k ⌀ | detailedDescription stringlengths 0 32.3k ⌀ | eligibilityCriteria stringlengths 0 20.1k ⌀ |
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NCT00424944 | Safety of Recombinant Hybrid GMZ 2 [GLURP + MSP 3] Blood Stage Malaria Vaccine | The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies. 40 adult male Gabonese volunteers will be enrolled and randomly allocated to receive either malaria vaccine or rabies vaccine without the investigator or the participants knowing what they rece... | Background. GMZ2 is a recombinant hybrid of the Glutamate Rich Protein (GLURP) and the Merozoite Surface Protein 3 (MSP 3).This product has been developed at Sate Serum Institute in Denmark and Bacth released by Henogen of Belgium. The phase Ia trial in malaria naive volunteers is currently ongoing in Germany, at Tuebi... | Inclusion Criteria:
* Adult male Gabonese 18-45 years inclusive at the time of screening
* Residing in Lambarene for the duration of the study
* Separate written informed consent obtained before screening and study start respectively
* Available to participate in follow-up for the duration of study (13 months)
* Gener... |
NCT04776785 | Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries | The aim of this randomized controlled, double-blinded, split-mouth clinical trial was to evaluate the efficacy of self-assembling peptide P11-4 solution (Curodont™ Repair) with fluoride varnish on the progression of non-cavitated proximal caries compared to casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) wi... | First, the subjects were randomly allocated to three main groups with 50 individuals in each. Then the carious lesions belonging to each subject were randomly assigned to two subgroups based on different treatment agents used: Group 1; P11-4+NaF/NaF, Group 2; P11-4+NaF/CPP-ACP+NaF, Group 3; CPP-ACP+NaF/NaF. Accordingly... | Inclusion Criteria:
* Children who had two permanent molars with non-cavitated proximal carious lesions that included one in the right jaw and the other one in the left jaw, and in contact with neighboring teeth,
* Non-cavitated proximal carious lesions which is radiographically extending into either the outer half of... |
NCT04339062 | Cemiplimab in AlloSCT/SOT Recipients With CSCC | In this research study, Cemiplimab is being evaluated as a treatment for advanced cutaneous squamous cell carcinoma in participants who have previously received an allogeneic hematopoietic stem cell transplant or kidney transplant.
- This research study involves the following drug(s):
* Cemiplimab
* Everolimus or Sir... | * This an open-label, two cohort, phase I/II research study to evaluate the safety and effectiveness of Cemiplimab as a treatment for advanced cutaneous squamous cell carcinoma in participants who have received allogeneic hematopoietic stem cell or kidney transplants.
* The research study procedures include screening f... | Inclusion Criteria:
* Patients must have histologically confirmed, advanced or metastatic cutaneous squamous cell carcinoma (cSCC) with 1 or more measurable lesions (greater than or equal to 1 cm).
* A history of either (Cohort 1) allogeneic hematopoietic stem cell transplant (alloHSCT) and ≥ 2 years or 730 days from ... |
NCT01799941 | Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA) | The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 wee... | This will be an Open-label, Multicenter, study in patients with PBA and dementia, stroke or TBI. Patients with a clinical diagnosis of PBA and who meet all other inclusion and exclusion criteria will be eligible to participate and receive NUEDEXTA for 12 weeks.
Males and females patients with a minimum age of 18 years... | Inclusion Criteria:
* Center for Neurologic Study-Lability Scale (CNS-LS)score of 13 or greater
* Clinical diagnosis of Pseudobulbar Affect (PBA)
* Documentation of Neurologic disease or brain injury
Exclusion Criteria:
* Unstable neurologic disease
* Severe dementia
* Stroke within 3 months
* Penetrating TBI
* Cont... |
NCT06223672 | Essential Fats for Enhancing Cognitive Thinking (EFFECT) Study | The proposed research is a randomized crossover trial designed to assess changes in postprandial cognitive function and the gut-brain axis in adults with subjective cognitive complaints who consume 1 study snack per day for 1 week. | Study objective including
1. To measure the impact of dietary fats on postprandial cognitive function in adults who report subjective cognitive complaints.
2. To assess the effect of dietary fat consumption on the gut-brain axis in relationship to cognitive function. | Inclusion Criteria:
* Subjective cognitive impairment
* BMI ≥30 kg/m2
* HbA1C \<6.5%
Exclusion Criteria:
* Diagnosis og cognitive impairment or dementia
* Montreal Cognitive Assessment (MoCA) score of \<26
* Current or previous diagnosis of Diabetes or use of diabetes medications
* Current diagnosis of or current tr... |
NCT03593824 | The Visual Plasticity During Adversity and Prosperity in Infants With Congenital Cataracts | Phenotypic plasticity is the ability of individuals to change their phenotypic status when exposed to environmental variations. However, whether the plastic changes show differential susceptibility in adversity and prosperity is debated and the specific pattern of plasticity remains elusive.
Here the investigators add... | Inclusion Criteria:
* Diagnosis with dense or non-dense nuclear congenital cataract
Exclusion Criteria:
* no metabolic diseases, mental retardation or central nervous diseases
* had no history of inherited diseases | |
NCT02242149 | Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects | This study is conducted to test the hypothesis that in uncontrolled type 2 diabetic adults treatment with diacerein will improve glycemic control and will reduce liver fat within a 24 month period. | Background: Recently, knowledge about diacerhein, an anthraquinone drug with powerful anti-inflammatory properties, revealed that this drug improves insulin sensitivity, mediated by the reversal of chronic subclinical inflammation. Amongst the numerous pathogenetic factors, oxidative stress and apoptosis of hepatocytes... | Inclusion Criteria:
* Type 2 diabetes.
* Presence of liver steatosis diagnosed by ultrasound or transient elastography (Fibroscan®)
* Age 30-75 years.
* HbA1c 7.5- 9.5 for at least 8 weeks prior to screening.
* Stable diabetes therapeutic regimen consisting of either diet, oral hypoglycemic agents with or without insu... |
NCT04660799 | A Study on Pharmacokinetics (PK), Efficacy and Safety of Subcutaneous (SC) Versus Intravenous (IV) Rituximab, in Combination With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) in Previously Untreated Participants With CD20 Positive Diffuse Large B-Cell Lymphoma (DLBCL) | This is a multicenter China-only study to investigate the PK, efficacy and safety of SC rituximab versus IV rituximab, both in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in previously untreated participants with CD20 positive DLBCL. Participants will be randomized to receive eight cy... | Inclusion Criteria:
* Previously untreated CD20 positive diffuse large B-cell lymphoma (DLBCL)
* Participants with an International Prognostic Index (IPI) score of 1 to 5 or IPI score of 0 with bulky disease, defined as one lesion \>/=7.5 cm
* At least one bi-dimensionally measurable lesion defined as \>/=1.5 cm in it... | |
NCT03799497 | Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa Mental | Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neura... | Patients suffering from Anorexia Nervosa and control subjects (matched by age and study level) are recruited in medical care facilities in Lille's Metropolis. They are asked to identify their body shape when being presented with 3 different stimuli, i.e.real (RBS), estimated (EBS) and neutral body shape (NBS), in a fun... | Inclusion Criteria:
* Providing informed, dated and signed consent (for minors, consent must be signed by both parents)
* With medical insurance
* With normal vision
* Only for the AN Group : Diagnosis of Anorexia Nervosa (AN) restrictive for at least one year and with a Body Masse index (BMI) between 14 and 18
* Only... |
NCT04290130 | Dynamic Neural Mechanisms of Audiovisual Speech Perception | Understanding speech is one of the most important functions of the human brain. We use information from both the auditory modality (the voice the of person we are talking to) and the visual modality (the facial movements of the person we are talking to) to understand speech. We will use intracranial encephalography to ... | Inclusion Criteria:
* must be undergoing neurosurgery for the treatment of a brain disorder
Exclusion Criteria:
* must have corrected-to-normal vision and hearing | |
NCT05780385 | Nasotracheal Intubation in Critically Ill. | The aim of this prospective randomized trail is to compare nasotracheal versus orotracheal intubation in critically ill patients. We aim to study:
* required sedation depth
* rate of spontaneous breathing
* extend and possibility of physiotherapy
* vasopressor and sedative drug doses
Participants are randomized 1:1 t... | In the intensive care unit endotracheal intubation and consecutive mechanical ventilation are required for different surgical procedures, examinations and interventions in the ICU or due to respiratory insufficiency. Commonly, intubation is performed orotracheally by direct laryngoscopy after preoxygenation and adminis... | Inclusion Criteria:
* Age ≥ 18
* Patients requiring tracheal intubation during their intensive care stay.
Exclusion Criteria:
* orotracheal or nasotracheal route of intubation technically not possible (e.g. confirmed indication for awake fiberoptic intubation due to expected difficult airway)
* tracheal intubation i... |
NCT01407237 | Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV | The purpose of this study is to see if individuals with HIV-infection, particularly those with increased belly fat, have abnormalities in the renin angiotensin aldosterone axis. Renin, angiotensin, and aldosterone are hormones that regulate salt and water balance in the body, and they may also have effects on sugar met... | Inclusion Criteria:
1. Stable use of antiretroviral therapy for at least 3 months (HIV group)
2. Age ≥ 18 and ≤ 65 years of age
Exclusion Criteria:
1. Antihypertensive use, including angiotensin converting enzyme inhibitors or angiotensin II receptor blocker use, diuretics, beta-blockers, calcium-channel blockers, p... | |
NCT04554407 | Study to Evaluate the Performance of a Sustained Vacuum System | The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections. | Inclusion Criteria:
* Aged 21 years or older;
* Undergoing mastectomy (uni or bilateral), axillary node resection, or inguinal node resection;
* Capable of providing informed consent.
Exclusion Criteria:
* Pregnant or lactating females;
* Patients on steroids or other immune modulators known to impact healing;
* Pat... | |
NCT04870775 | Effectiveness of a Mindfulness Training Program for Hospital Workers During the Pandemic. | The aim of this study is to reduce the negative psychological impact of the pandemic on hospital workers through mindfulness training. | In the face of the recent health crisis, one group vulnerable to psychological consequences has been the hospital workers who have worked on the front line during the COVID-19 pandemic.
It is expected that subjects participating in Mindfulness training will decrease their psychopathological symptoms more than the cont... | Inclusion Criteria:
* Working in a hospital
* Proficiency in the Spanish language
Exclusion Criteria:
* Have severe mental disorders. |
NCT02820688 | Concentration-Volume Relationship in Infraclavicular Block | This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomized into three groups. Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be use... | Although ultrasound guided infraclavicular nerve block is routinely used to provide anesthesia for almost all of the upper extremity surgeries, optimal volume and concentration of locak anesthetic to be administered is still a subject of debate. This prospective, randomized, double blind study aims to determine the opt... | Inclusion Criteria:
* Scheduled for upper extremity surgery with infraclavicular nerve block
Exclusion Criteria:
* Patient Refusal
* Patients younger than 18
* Patients with known local anesthetic allergies
* Patients with a BMI\>30
* Diabetic Patients
* Uncooperated Patients
* Patients with coagulopathy or recievin... |
NCT00266188 | Follow up of Post-repair Tetralogy of Fallot | Tetralogy of Fallot is the most frequent complex congenital heart malformation. Over the past five decades, surgical repair has been performed with respectable results. However, relevant postoperative residues frequently remain. Pulmonary insufficiency, in particular, has been identified as a factor limiting the right ... | In the repair of tetralogy of Fallot, pulmonary insufficiency used to be tacitly accepted as a result of extensive transannular patching (TAP) and considered unobjectionable. In fact, this is well tolerated during the first postoperative years, but today there is increasing evidence that the resulting chronic volume st... | Inclusion Criteria:
* Written consent of the patient and/or the patient's legal representative
* Patients with tetralogy of Fallot (including pulmonary atresia with extreme form of VSD ) after corrective operation
* The corrective intervention has to date back to at least one year before study inclusion
* Ergospiromet... |
NCT02621047 | Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib | This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by age, gender, and body weight to assess the effect of hepatic impairment on the pharmacokineti... | Inclusion Criteria:
All Participants
* Body mass index between 18 to 35 kilograms per square meter (kg/m\^2) inclusive and weight greater than (\>) 50 kilograms (kg)
* Female participants must be surgically sterile or post-menopausal
* Male participants and their partners of child-bearing potential must be willing to... | |
NCT01291680 | Assessment of Central Pain in the Peripartum Period | Chronic pain is common. Up to 10% of the Population has been estimated to suffer from chronic pain and up to 5% of the female population has been estimated to suffer from widespread, chronic pain and tenderness, thus fulfilling American College of Rheumatology (ACR) criteria for classification of fibromyalgia syndrome ... | Chronic pain is common. Up to 10% of the Population has been estimated to suffer from chronic pain and up to 5% of the female population has been estimated to suffer from widespread, chronic pain and tenderness, thus fulfilling American College of Rheumatology (ACR) criteria for classification of fibromyalgia syndrome ... | Inclusion Criteria:
* Pregnant women, week 39-41
* Ability to give written informed consent
Exclusion Criteria:
* Age under 18
* High risk pregnancy
* Not able to give written informed consent |
NCT06185335 | A Trial of the Safety and Efficacy of Single-Dose Administration of ANB-010 in Subjects With Hemophilia A | The goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of ANB-010 in subjects with hemophilia A. The study will have a dose-escalation design with elements of phase I/II seamless adaptive design. | The study will be conducted in 2 stages:
Stage 1: pilot efficacy and safety study of different doses to select a potentially therapeutic dose for further study.
Stage 2: study of the efficacy and safety of ANB-010 at the selected potentially therapeutic dose.
The stage 1 design is typical of phase I clinical trials ... | Inclusion Criteria:
1. Male subjects aged ≥18 years at the time of signing the informed consent form.
3. Established diagnosis of hemophilia A with a documented history of endogenous FVIII activity ≤1% AND ≤2% at screening.
4. Therapy with FVIII concentrates for at least 150 exposure days.
Exclusion Criteria:
1. H... |
NCT04929717 | Social Media and Breastfeeding Self Efficacy | This study aimed to determine the effect of breastfeeding support on women's breastfeeding self-efficacy via social media. This study was conducted maternity unit at a state hospital in Turkey. Education and consulting about breastfeeding were given via WhatsApp application to women in the intervention group. Women in ... | The research was conducted as a randomized controlled trial. The stratified and permutation block randomization methods were used in the study. The personal information form and BSES-SF were administered to women in the hospital before the intervention. Breastfeeding education and counseling were provided via social me... | Inclusion Criteria:
* being primipara
* being 18 years of age or older
* using the WhatsApp social media application
* having a newborn with a weight of 2500 grams and above
* agreeing to participate in the study
Exclusion Criteria:
* being multiparity
* having a physical or mental health problem that would prevent ... |
NCT03369197 | Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy | This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be ... | This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be ... | Inclusion Criteria:
* Adult patients (≥ 18 years of age) undergoing colonoscopy, endoscopic gastroduodenoscopy, and endoscopic gastroduodenoscopy with biopsy and/or ultrasound, or combined upper and lower endoscopy procedure anticipated to last longer than 10 minutes in the Endoscopy Suite at the Johns Hopkins Hospita... |
NCT04614883 | Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in the Context of Suspicion of COVID-19 Infection | In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients.
The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory disease... | Inclusion Criteria:
1. Patients
* Patents anaged at the Foch Hospital for suspected COVID-19 and any other patient whose management requires diagnosis of SARS-CoV-2 infection
* Patients aged 18 or over;
* Patients Fluent in French ;
* Patients with a signed consent form;
* Patients with a health insura... | |
NCT03508349 | Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda | The main aim of this study is to test the primary hypothesis that the addition of intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will reduce malaria prevalence among pregnant women when c... | More specifically, the primary objective is to understand the effect of ISTp in a context where routine antenatal care does not include malaria chemoprohylaxis and whether this intervention is protective against malaria during pregnancy. The secondary objective is to determine whether this intervention results in an im... | Inclusion Criteria:
* Pregnant women age 18 or older who have their first ANC visit during the study recruitment period
* Willing to participate
Exclusion Criteria:
* • Pregnant women below the age of 18
* Not willing to participate |
NCT03755102 | A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib. | The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers. | Inclusion Criteria:
* Written informed consent
* Advanced biopsy-proven metastatic non-small cell lung cancer
* Somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy
* Prior treatment with osimertinib with response followed by disease progression
* No prior first or second generation EGFR... | |
NCT00255216 | Policosanol for the Treatment of Hypercholesterolemia | Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba.
This study will asses... | Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Policosanol has been used in Cuba since 1991 to treat high cholesterol. Virtually all of the published medical literature on policosa... | Inclusion Criteria
* Age ≥ 18 years
* Males, or females who are not pregnant and have a highly reliable contraception method (i.e. hormonal or surgical contraception)
* Baseline LDL-C between 130 and 200
Exclusion Criteria
* History of Coronary Artery Disease - Patients will be excluded if they have been told at any... |
NCT04621955 | Observational Study of Home Administration of Carfilzomib | The purpose of this study is to evaluate the feasibility of an at home administration program for carfilzomib patients. | In this observational study, the feasibility of an at home administration program for carfilzomib will be evaluated in patients with relapsed and/or refractory multiple myeloma having already received a minimum of 2 and a maximum of 6 full cycles of KRd (carfilzomib - lenalidomide - dexamethasone) in the hospital.
One... | Inclusion Criteria:
* Age ≥ 18 years
* Ability to understand the informed consent and willingness to provide an informed consent signature
* Signed and dated written informed consent available (for participation in the home administration program or for agreement on data-collection in case of refusal to participate (r... |
NCT05948241 | Online Psychological Support Group for Patients With Heart Failure and Depression | Heart failure is a chronic disease, being the second cause of death in Brazil. Currently, it is estimated that 6.4 million Brazilians suffer from this disease. The higher number of rehospitalization, lower survival of these individuals. There are recommendations from Societies of Cardiology for the inclusion of effecti... | Inclusion Criteria:
* Patients diagnosed with heart failure
* Age between 18 and 79 years B)
* After hospital discharge
* Depression (BDI-II score above 14 points)
* Acceptance of the Term of Consent;
Exclusion Criteria:
* Patients with dementia
* Communication barriers
* Octogenarians
* People unable to access the ... | |
NCT06851923 | Study of Visual Mecanisms Involved in Face Recognition | Since the 19th century, perception has been regarded as an inferential process in which sensory input is compared with prior knowledge, namely the internalised representation of the visual environment. This notion is central to the understanding of everyday perception and cognition in general, and is attracting much at... | Inclusion Criteria:
Participants will be screened (see annex 2) to ascertain they fit with all these inclusion criteria:
* Be between 18 and 50 years old,
* have normal eyesight or eyesight corrected with contact lenses,
* Have no neurological disorder,
* Not have had a skull fracture or head surgery,
* Have no chron... | |
NCT00630708 | Safety of Dual Blockage of Rennin-angiotensin System in Patients With Advanced Renal Insufficiency | The primary aim of the present study is to assess the safety of combined treatment of benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced renal insufficiency. | Interruption of the renin-angiotensin systerm (RAS) with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) slows the progression of chronic renal insufficiency in the presence or absence of diabetes. Even for advanced chronic renal insufficiency (stage 4 CKD), ACE inhibitors a... | Inclusion Criteria:
1. Serum creatinine concentration of 3.0 to 5.0 mg per deciliter (265 to 442 µmol/L)
2. Creatinine clearance of 15 to 30 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation
3. non-diabetic renal disease
4. Persistent heavier proteinuria ... |
NCT05729724 | Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept) | SynABPM 2 proof-of-efficacy is a retrospective, multicentre, observational study performed in patients affected by hypotensive reflex syncope who had performed two ABPMs, one before and another after any therapeutical intervention aimed to increase arterial blood pressure | 24-hour ambulatory blood pressure monitoring (ABPM) is able to detect systolic blood pressure (SBP) drops that allow to discriminate patients with reflex syncope from controls. One episode of daytime SBP \<90 mmHg or one episode of daytime SBP \<100 mmHg, if mean 24-hour SBP is \<125 mmHg, is the best cut-off for the i... | Inclusion Criteria:
Eligible patients were those who fulfilled all the following criteria:
* had received a diagnosis of reflex syncope
* had undergone an ABPM as part of the routine work-up of syncope in use in these hospitals that had shown one or more daytime SBP drop \<90 mmHg or one or more daytime drops \<100 m... |
NCT06771544 | Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma | This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma. | Inclusion Criteria:
* Age ≥18 years at the time of signing informed consent form (ICF)
* Patients must have unresectable Stage III or Stage IV non-ocular melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria not amenable to local therapy
* Participants must have measurable disease by RECIST v1.1... | |
NCT02050672 | Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome | In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI) treatment is able to improve IVF outcomes.
In particular, retrieved oocytes will be randomly divided in two groups, one group will be inseminated with MI treated semen while the other will be inseminated with untreated semen. | Myo is synthesized from glucose-6-phosphate, it is a precursor of second messengers in the cell signaling pathways and it is involved in the regulation of intracellular calcium.
Literature data have demonstrated the MI play a crucial role in reproduction, indeed, oocyte and spematozoa are nursed in a medium congaing h... | Inclusion Criteria:
* couple counselled for IVF
Exclusion Criteria:
* cryopreserved sample |
NCT04652544 | Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury | The main objective of this placebo-controlled randomized double-blinded study is to investigate the effect of vitamin D supplementation on vitamin D status (25(OH)D concentration in the blood) among individuals with a chronic spinal cord injury (SCI). Further, the effects of vitamin D supplementation on several other p... | The purpose of this study is to evaluate the influence of vitamin D supplementation among individuals with chronic SCI. The primary aim is to study whether different dosages (24'000 IU/month or 48'000 IU/month) of vitamin D supplementation over 12 months will lead to differences in vitamin D status as well as differenc... | Inclusion Criteria:
* Informed Consent to the present study as documented by a signature
* Chronic (\> 3 years) traumatic or non-traumatic spinal cord injury with a sub-C4-level lesion
* Wheelchair dependency during activities of daily living
* vitamin D status \<75nmol/L
Exclusion Criteria:
* Contraindications to t... |
NCT01341483 | Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study | The purpose of this study is to determine the proportion of men with known or suspected coronary artery disease (CAD) and/or peripheral arterial disease (PAD) that have angiographic identifiable erectile related artery (ERA) atherosclerotic disease defined as at least one ERA stenosis greater than or equal to 50% (per ... | Vascular insufficiency is a commonly cited cause of Erectile Dysfunction (ED) and the most common treatments of ED target aspects of the penile vasculature. Initial pharmacotherapy typically focuses on the penile microvasculature; however, surgical revascularization has also been used to treat ED caused by lesions in t... | Inclusion Criteria:
* Subject must be undergoing coronary or peripheral angiography for suspected or known coronary or peripheral atherosclerotic disease
* Subject must be male ≥ 35 and ≤ 70 years old
* Subject must provide written informed consent before any study-related procedures are performed
* Subject must agree... |
NCT05033587 | Study of AK105 With Anlotinib and Radiotherapy Adjuvant Therapy in MGMT Unmethylated Newly Diagnosed Glioblastoma. | This is a prospective, open-label single-arm, exploratory, two-stage design trial, aiming to investigate safety and efficacy of AK105 with anlotinib and radiotherapy adjuvant therapy in MGMT unmethylated newly diagnosed glioblastoma. | Glioblastoma is the most common and aggressive primary brain tumor in adults. Treatment usually involves surgery, after which chemotherapy and radiation therapy are used. The Central Brain Tumor Registry of the United States (CBTRUS) Statistical Report primary brain and other central nervous system tumors diagnosed in ... | Inclusion Criteria:
* The patient voluntarily joined the study and signed a written informed consent;
* Pathologically confirmed treatment-naïve glioblastoma with PCR tested MGMT unmethylated;
* The interval between the last biopsy or surgery is 4-6 weeks, and the surgical incision is healed well;
* According to Rano ... |
NCT00656799 | Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773) | The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment. | The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hem... | Inclusion Criteria:
* At least 18 years of age
* American Society of Anesthesiologists (ASA) Class \>=4
* Creatinine clearance (CLCR) \< 30 mL/min and clinical indication for dialysis
* Hospitalization at Intensive Care Unit (ICU) and scheduled for a (surgical) procedure under general anesthesia requiring neuromuscula... |
NCT05195099 | Respiratory Physiotherapy and Neurorehabilitation in Patients With Post-covid19 Sequelae. | The objectives are to reduce dyspnoea, increase exertional capacity, increase vital capacity and respiratory muscle strength.
vital capacity and respiratory muscle strength. In addition to increasing the sensibility of smell and taste, observing if there is a relationship between the decrease of these senses with the ... | Inclusion Criteria:
* age range between 18 and 42 years.
* patients with respiratory sequelae post Covid-19.
* patients with smell and taste sequelae post Covid-19.
Exclusion Criteria:
* Under 18 years old.
* Over 42 years old.
* Patients not diagnosed with Covid-19 (PCR positive). | |
NCT04417790 | Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population | Increased extravascular lung water (EVLW) may increase mortality and morbidity in cardiopulmonary pathology. Many factors can cause increased extravascular lung water and pulmonary edema after cardiac surgery. This includes left ventricular failure, acute mitral regurgitation; systemic inflammatory response post-cardio... | Inclusion Criteria:
* aged under 12 years,
* undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease,
* Aristotle score ≤9,
* with prior written informed consent
Exclusion Criteria:
* Neonates,
* Children with any chest wall deformity,
* children with known lung disease, active infecti... | |
NCT00081965 | Acupuncture in Treating Hot Flashes in Women With Breast Cancer | RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer
PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in... | OBJECTIVES:
Primary
* Determine whether acupuncture, compared to placebo, reduces the incidence of hot flashes in women with breast cancer.
Secondary
* Determine the long-term effects of acupuncture on hot flashes.
OUTLINE: This a randomized, placebo-controlled, multicenter study. Patients are stratified according... | DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer (including in situ disease)
* Must be receiving treatment for breast cancer at Memorial Sloan Kettering Cancer Center (MSKCC) or its regional site (Commack)
* Has an average of 3 or more hot flashes a day during 1 week of baseline diary recording
* Hormone receptor... |
NCT03680092 | Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation | The purpose of this study is to investigate whether the combination of cyclophosphamide and abatacept versus the treatment used in standard of care will reduce the incidence of moderate and severe chronic graft-versus-host disease (GVHD) following hematopoietic stem cell transplantation. GVHD occurs when the cells from... | The experimental GVHD prophylaxis arm consists of cyclophosphamide and abatacept. Cyclophosphamide induces apoptosis of activated T cells and abatacept (CTLA4Ig) blocks activation of T cells by inhibiting the co-stimulatory signal.
Compared to the standard-of-care control arm, the experimental arm is much more conveni... | Inclusion Criteria:
* High risk hematologic malignancy justifying the need for an allogeneic hematopoetic stem cell transplantation: AML, ALL, CML in accelerated or blast phase, MDS/MPN, NHL, Hodgkin lymphoma, and multiple myeloma
* Creatinine clearance \> 40
* Adequate hepatic function
* Normal cardiac function (EF \... |
NCT05252013 | The Impact of Broad Bean Hull on Blood Glucose Control and Gut Health | This study aims to assess the effects of broad bean hull (BBH) consumption on blood glucose and gut health. Broad bean (Vicia faba) is widely cultivated in Scotland, with the UK being the most significant European producer. The seed coat (hull or testa) is removed during broad bean processing. This is a significant sec... | The study aims to confirm in vivo the effects of consuming broad bean hull on blood glucose control and gut health. Although in vitro evidence is promising, its benefits remain confirmed in vivo in humans. No studies have previously attempted to assess the impact of broad bean hull consumption on glycaemic and gut heal... | Inclusion Criteria:
* Healthy males and females
* Aged 18-75 years old.
* BMI 23-35 kg/m2
* HbA1c \<6.5%
* Total cholesterol ≤ 7 mmol/l
Exclusion Criteria:
* Glucose 6 Phosphate Dehydrogenase deficiency
* Diagnosed for chronic diseases; thyroid disorders, metabolic/genetic diseases, diabetes and disorders of glycaem... |
NCT04750291 | Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy | Double-blinded randomized controlled trial with 20 people of whom 10 will receive a placebo infiltration and 10 an infiltration with botulinum toxin type A for cramping pain after arthroscopic tenotomy of the long head of the biceps tendon. | Title: Management of Popeye sign with botulinum toxin after tenotomy of the long head of the biceps tendon: a double-blinded randomized controlled trial Précis: Double-blinded randomized controlled trial with 20 people. Randomization in 2 arms of 10 people. 3 visits will be planned with a meantime of 3 months after the... | Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Have had arthroscopic tenotomy of the long head of the biceps tendon without rotator cuff repair, acromioclavicular joint resection or glen... |
NCT04173845 | Double Randomized and Placebo Controlled Trail of Tianqi Pingchan Granule to Prevent Levodopa-Induced Dyskinesia | A randomized, double-blind, placebo-controlled multicenter clinical trial was used to observe the effectiveness, safety and side effects of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia, so as to determine the clinical efficacy of Tianqi Pingzhan Granule in the prevention of levodopa induced ... | The aim of this clinical trail is to evaluate the effect of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia in adults. All patients included in the study should meet the inclusion criteria. Half of participants will receive Tianqi Pingzhan Granule, while the other half will receive a placebo of... | Inclusion Criteria:
Patients with PD aged 30-85，have at least the following two conditions:
1. Dosage of Levodopa ≥ 400mg/d;
2. Grade of H\&Y≥3;
3. risk score of dyskinesia\>4;
Exclusion Criteria:
1. PD patients with dyskinesia;
2. Taking other Chinese medicines against Parkinson's disease;
3. pregnant and lactatin... |
NCT01546428 | A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors | INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280 | Inclusion Criteria:
* Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
* Good organ (hepatic, kidney, BM) function at screening/baseline visit.
Exclusion criteria:
* Symptoma... | |
NCT01980927 | Changes in Intracranial Compliance in Migraine Subjects Following a National Upper Cervical Chiropractic Association Atlas Correction | A small number of chiropractors, who align only the atlas C-1, or "top" vertebra in the spine, practice the National Upper Cervical Chiropractic Association (NUCCA) atlas correction procedure. This procedure uses a precise, non-invasive, gentle touch technique to correct misalignment of the atlas. Although NUCCA practi... | Inclusion Criteria:
* Patients must be 18-65 years of age.
* Be naive to Upper Cervical Chiropractic care. Other forms of chiropractic care in the past are permitted.
* Have migraine with or without aura.
* Have between 10-26 headache days per month over the last 4 months.
* Have at least 4 separate headache episodes ... | |
NCT04561635 | Effects of Multiple-micronutrients Supplementation on Growth and Iron Status of Indigenous Children in Malaysia | Child undernutrition is largely attributed to inadequate nutrition including micronutrient deficiency. Undernutrition is prevalent among indigenous children as compared to the general population. This cluster randomized controlled trial aimed to determine the effect of multiple-micronutrients supplement (MMS) on growth... | 1. Study Objectives This study was undertaken to determine the effect of Multiple micronutrients supplement (MMS) on the nutritional status of Orang Asli (indigenous people in Peninsular Malaysia) children (6 to 24 months) in Selangor. This study assessed growth (weight, length, WAZ, LAZ, WLZ) and iron status (haemoglo... | Inclusion Criteria:
* Aged between 6 to 24 months old; and
* Normal weight-for-age (WAZ \> -2SD), length-for-age (LAZ \> -2SD) and weight-for-length (WLZ \> -2SD); and
* Normal haemoglobin level (\> 11.0g/dL).
Exclusion Criteria:
* Has/ had history of chronic diseases e.g. failure to thrive and/or metabolic or endoc... |
NCT01712048 | Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps | The aim of this study is to compare the efficacy and safety of two standard methods of polypectomy (polyp removal), submucosal injection-assisted endoscopic mucosal resection (EMR) and full water emersion (without submucosal injection) EMR, for large colorectal polyps. | The endoscopic resection of benign colon polyps (polypectomy) plays a vital role in the prevention of colo-rectal cancer. While, small pedunculated polyps are removed with ease, large flat lesions pose a greater challenge. As a result, special techniques have been developed to assist in the removal of these difficult p... | Inclusion Criteria:
* Patients age \>18 years that are scheduled for endoscopic resection of large colo-rectal lesions who consent to this study.
Exclusion Criteria:
* Patients unable to provide informed consent.
* Patients with lesions showing adenoma invasion into the muscularis propria on EUS.
* Patients without ... |
NCT05062226 | GMP Case Studies of Tolerance, Safety and Acceptability in PKU and TYR | Three new protein substitutes have been developed to help with compliance in PKU and TYR patients, which are powdered protein substitutes, low in Phe and, low in Phe and Tyr respectively, with a mixed balance of glycomacropeptide (GMP), essential and non-essential amino acids, carbohydrates, fats and micronutrients for... | Phenylketonuria (PKU) and Tyrosinaemia (TYR) are rare inherited metabolic disorders of amino acid metabolism requiring dietary management. PKU is characterised by an inability to metabolise the essential dietary amino acid phenylalanine (Phe) into tyrosine (Tyr). As such, without appropriate management, PKU can lead to... | Inclusion Criteria:
* Male or female
* Over 3 years of age
* Diagnosed with classical or variant type phenylketonuria, or tyrosinaemia (as appropriate)
* Have been compliant in taking at least one protein substitute, providing at least 10g protein equivalents, for at least 1 month prior to trial commencement
* Have a ... |
NCT01465633 | Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 50 μg/ 75 μg Tablets | The purpose of this study is to measure the area under the curve (AUC0-48h; extent of systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as tablets also containing iodine supple-ments vs. th... | Inclusion Criteria:
* Euthyroid men
* Age: 18 - 50
* Normal values for fT4 und TSH
* Good state of health
Exclusion Criteria:
* Thyroid function disorders in terms of subclinical or overt hyper- or hypothyroidism
* History of thyroid function disorders
* Focal or diffuse autonomies of the thyroid gland
* Thyroid nod... | |
NCT00801957 | Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis | Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were considered to benefit from vaccination to prevent invasive disease caused by Neisseria meningitides serogroup C. | At the week 1 visit, the patients were vaccinated with a protein-conjugated vaccine against meningitis. All patients received a challenge at the month 6 visit with a low dose of meningo polysaccharide vaccine. A control group of healthy subjects (not suffering from atopic dermatitis) received only the vaccination and t... | Inclusion Criteria:
* Patients with moderate to severe atopic dermatitis and in need for treatment
* Patients require vaccination to prevent invasive disease caused by Neisseria meningitidis serogroup C
Exclusion Criteria:
* Patients have known hypersensitivity to macrolides, tacrolimus and any component of the vacc... |
NCT06757179 | The ELYAR (Elysium Against Rhinitis) Project | Acute rhinitis is an inflammatory process that primarily affects the nasal mucosa, with a high incidence in the pediatric population and a morbidity rate of 6-8 episodes annually during the first two years of schooling (1). It is one of the most common conditions causing discomfort and debilitation in children, comprom... | Inclusion Criteria:
* Caucasian subjects of both sexes,
* aged between 4 and 14 years;
* diagnosis of acute rhinitis based on the presence of ≥3 of the following symptoms that had onset within the last 24 hours: rhinorrhea, nasal congestion, nasal obstruction, sneezing, pharyngodynia, cough;
* in addition to ≥1 of the... | |
NCT03235960 | Efficacy of Glass-ionomer Fissure Sealants | Despite numerous techniques for enamel protection, occlusal caries still remains a problem. Sealing pits and fissures is considered to be an effective way of preventing caries development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moi... | Despite numerous techniques for enamel protection, such as topical fluorides, calcium phosphate-based remineralization systems, xylitol, etc., occlusal caries still remains a problem. A carious lesion occurs in pits and fissures of occlusal surfaces primarily due to their specific anatomy, which is considered to be an ... | Inclusion Criteria:
* at least one recently erupted permanent molar with sound pits and fissures
* healthy patients
* possibility to perform a dental treatment
* willing to participate in the study
Exclusion Criteria:
* teeth with an obvious cavity, with a restoration or a sealant completely or partially presented i... |
NCT03976583 | Remineralization Potential of Pearl Powder Compared to CPP-ACP on Enamel White Spot Lesions | The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate. | The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate. The remineralisation potential will be assessed both visually and by standardised photographic image analys... | Inclusion Criteria:
* Males or females.
* Age: 12-25 years old.
* Patients with good oral hygiene.
* Co-operative patients who show interest to participate in the study.
Exclusion Criteria:
* Patients with bad oral hygiene.
* Lack of patient's approval and compliance.
* Presence of abnormal oral, medical, or mental ... |
NCT04449679 | Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study | This trial tests new methods and materials for the real-time chemotherapy-associated side effects monitoring support system (RT-CAMSS) in patients with gastrointestinal cancers undergoing chemotherapy. RT-CAMSS is a monitoring support system that provides patients with evidence-based information and side-effect managem... | PRIMARY OBJECTIVES:
I. Develop and refine a real-time chemo-associated side effects monitoring support system (RT-CAMSS) using interactive text messaging (TXT) for patients with gastric, esophageal, pancreatic and colorectal cancer during chemotherapy.
II. Assess the feasibility and engagement of the RT-CAMSS in a 2-... | Inclusion Criteria:
* Patients diagnosed with gastric, esophageal, pancreatic or colorectal cancer
* Scheduled to start intravenous (IV) chemotherapy or has started IV chemotherapy
* Able to read and understand English
* Able to provide signed and dated informed consent form
* Have a mobile device with text message ca... |
NCT04779008 | Long-term Remote Ischemic Preconditioning Improves Myocardial Perfusion and Prognosis of Patients After CABG | Remote Ischemic preconditioning (RIPC) has been reported to improve myocardial microcirculation, promote collateral circulation recruitment, and improve myocardial perfusion in patients.Two large randomized controlled trials demonstrated a perioperative cardioprotective effect of RIPC (reduced troponin levels), but did... | A total of 210 patients were randomly divided into three groups according to the inclusion and exclusion criteria, with 70 patients in each group.
Experimental Group 1:
The patient underwent one RIPC (Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff air vehicle t... | Inclusion Criteria:
* Three coronary artery lesions, CABG surgery was planned
Exclusion Criteria:
* The patients could not tolerate ripc;
* peripheral vascular disease affecting upper limbs
* Acute myocardial infarction complicated with cardiogenic shock，in recent 30 days,
* Emergency cases
* Severe structural heart... |
NCT05013645 | Evaluation of Skin Hydration in Adults With Dry Skin Using a Moisturizer With an Added Sterilized Probiotic | Double-blind placebo-controlled clinical trial to evaluate the effectiveness of a sterilized probiotic on skin health and hydration in adults with dry skin.
The goal of the study is to determine if the addition of a skin-conditioning probiotic to a standard gel product will moisturize the skin, support a healthy skin ... | Inclusion Criteria:
1. Provision of a signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability to attend study visits for the duration of the study
3. English-speaking
4. 18-90 years of age
5. Score of a 2 or higher in one of the four areas assessed on the Dry S... | |
NCT03079895 | Thrive Care: Internet CBT for Depression | This project will study the effectiveness of computerized cognitive behavioral therapy (CBT) in reducing depression symptoms. The design is a two-arm randomized controlled trial comparing (i) control arm, which is treatment as usual with (ii) treatment arm, which is treatment as usual plus computerized CBT. The primary... | Population:
* As identified in Epic, Kaiser Permanente Southern California (KPSC) Fontana Family Medicine patients with a depression diagnosis recorded during the prior week (rolling basis).
* Target study enrollment: 150 participants per arm (300 total)
Recruitment:
* Kaiser Permanente (KP) will send eligible patie... | Inclusion Criteria:
* Per EPIC (or other system) records, clinical depression was addressed during the prior week by a KPSC Fontana Family Medicine physician , reflected by an ICD-9 or ICD-10 diagnosis of Depression, Major Depressive Disorder, Dysthymia, Adjustment Disorder with Depressed Mood, and Depression Not Othe... |
NCT01221779 | Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation | The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the out of intensive language therapy in chronic aphasia | Stroke is the leading cause of death and disability worldwide. Given the increasing average lifespan worldwide, the incidence and prevalence of patients with stroke will dramatically increase in the future. One of the most frequent and devastating conditions after stroke is aphasia, which affects language production an... | Inclusion Criteria:
* right-handedness
* single first time left-hemisphere stroke
* fluent- or non-fluent chronic aphasia (more than six months post-stroke)
* anomia (PR\>10 and PR\<60 Aachen Aphasia Naming Subtest)
* native German Speaker
Exclusion Criteria:
* more than one stroke
* alcoholism, severe psychiatric c... |
NCT06087731 | Efficacy and Safety of Tocilizumab for TAO | This study aims to evaluate the efficacy and safety of tocilizumab treating Thyroid Associated Ophthalmopathy. | Thyroid Associated Ophthalmopathy(TAO) is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. In TAO pathogenesis, orbital fibroblasts are activated by autoantibod... | Inclusion criteria:
Age 18-70 years old
* Clinical diagnosis of Thyroid-associated ophthalmopathy
* Euthyroid status at least 1 months before baseline.
* No previous specific therapy for TAO, except for local measures
* Written informed consent is obtained
Exclusion criteria:
* Uncontrolled diabetes or hypertension... |
NCT02236481 | Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes | The TRACK \[Treatment of Rheumatoid Arthritis and Comorbidities with Kineret (anakinra)\]-study: a randomized, open-label multicenter study assessing the efficacy of anakinra in lowering HbA1c (glycated hemoglobin) as well as changes in DAS28 in Rheumatoid Arthritis (R.A.) patients with type 2 diabetes (T2D) Authors: R... | Inclusion Criteria:
* male and female patients aged ≥ 18 years;
* previous diagnosis of RA with criteria of the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR);
* Diagnosis of Diabetes Mellitus type II according to the American Diabetes Association (ADA) criteria since at least 6 mo... | |
NCT04552483 | Effects of Early Use of Nitazoxanide in Patients With COVID-19 | Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms.
Population: 392 Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease.
Experimental group: 196 pat... | SARITA-2 is a multicenter, randomized, placebo-controlled, parallel, -blinded, interventional, treatment clinical trial with two arms, which aims to study the impact of nitazoxanide in the early phase of the COVID-19 (Coronavirus Disease-19).
Experimental group: 196 patients received nitazoxanide 500mg 8 / 8 hours for... | Inclusion Criteria:
* Clinical scenario compatible with infection by the SARS-CoV-2 \[Characteristic symptoms of COVID-19 (fever and / or cough and / or fatigue)
* Beginning 1 to 3 days before inclusion in the study
* Age equal or superior to 18 years
* Willingness to receive study treatment
* Providing written and in... |
NCT04884724 | Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Cerebral Palsy | The human body needs a system to control and coordinate its action plan in order to perform an effective action. This system works irregularly or inappropriately in people with Cerebral Palsy (CP). An alternative to controlling these disorders is automatic movement modulation such as dance. Dance, whose main purpose is... | Inclusion Criteria:
* Diagnosed with Cerebral Palsy
* Volunteer
* Ages between of 6-18 years
* Gross Motor Function Classification System (GMFCS) Level 1 and Level 2
* To have cognitive skills to understand and apply adaptive dance exercises to be given.
Exclusion Criteria:
* Participants diagnosed with Cerebral Pal... | |
NCT06379867 | A Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects | Assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization for healthy subjects. | Inclusion Criteria:
1. Ability to understand and comply with protocol requirements and is willing voluntarily sign written ICF.
2. Healthy participants at age from 18 to 45 years old (inclusive) at Screening.
3. Male body weight ≥50 kg, female body weight ≥45 kg, with a body mass index BMI of 19\~28 kg/m2 (inclusive).... | |
NCT00412932 | An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension | This 14 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients 65 years of age or older with high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure. | Inclusion Criteria:
1. Males or Females greater than 65 years of age
2. Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 150 mmHg but less than 200 mm Hg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 2-3 week single blind placebo run-i... | |
NCT02236949 | Sustainability of a Knowledge Translation Intervention to Improve Paediatric Pain | The purpose of this research study is to evaluate the effectiveness of short refresher sessions. "Pain Practice Change Boosters" given at regular intervals to sustain improved pain process (assessment and management) and clinical outcomes (pain intensity) achieved during a 15 month knowledge translation intervention, E... | This is an 8 hospital repeated measures Randomized Controlled Trial design using a centrally controlled cluster random allocation of units with stratification by hospital. The sample consisted of the 16 hospital units that implemented the EPIQ intervention in the CIHR Team in Children's Pain study. Randomization was re... | Inclusion Criteria:
Hospitals met the following inclusion criteria in at least four patient care units:
* distinct geographic location and administrative structure;
* minimum of 15 beds per unit;
* care for children exposed to painful procedures for diagnostic or therapeutic purposes; and
* implementation of pharmaco... |
NCT05739760 | Impact of Cuddle and Calm Booklets on Parent-Child Emotional Connection a Nurture-based Children's Book | Children's social and emotional development is affected by their relationship with their parents. The goal of the study is to test an intervention that guides parents and children to strengthen their relational health and navigate difficult situations. This study will begin in the well-child visit in the pediatric depa... | The parent-child relationship affects the child's socio-emotional development and the parent's stress. The purpose of this study is to test a behavioral intervention designed to guide parents and children on how to strengthen their relational health and navigate challenging interactions. This intervention will involve ... | Inclusion Criteria:
* Children between 18 months and 6 years old and their mothers or grandmothers, if primary caregiver, scheduled for a well visit.
Exclusion Criteria:
* Refusal to consent
* Inability to access internet; not having an email address. |
NCT06420388 | 2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy | The study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. 222 patients undergoing Ferguson haemorrhoidectomy will be randomly assigned to receive either 2% lidocaine gel or a non-anaesthetic lub... | Title: Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial Objective: To assess the effect of 2% lidocaine gel on postoperative pain intensity and analgesic consumption following haemorrhoidectomy.
Study Design:... | Inclusion Criteria:
* Age 18 years or older
* Diagnosed with Grade III or IV hemorrhoids
* Candidate for Ferguson haemorrhoidectomy
Exclusion Criteria:
* Not a candidate for Ferguson haemorrhoidectomy
* Recurrent hemorrhoidal disease
* Concurrent anal pathology diagnosed preoperatively, including:
* Anal fistula
* A... |
NCT01972061 | Foot/Hand Neuromodulation for Overactive Bladder (OAB) | The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions. | Foot neuromodulation is designed to treat OAB conditions by electrically stimulating the somatic afferent nerves in the foot using skin surface electrodes. The foot stimulation is non-invasive, can be performed at home, and has no adverse effects. Foot neuromodulation therapy will likely be accepted by more patients an... | Inclusion Criteria:
1. 18 year old men and women and older
2. Currently having overactive bladder (OAB) symptoms, i.e. urgency, frequency, or incontinence
3. No evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as idiopathic OAB
Exclusion Criteria:
1. Pregnant women in their lat... |
NCT06068881 | A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic Mutation | The purpose of this research study is to learn about the effectiveness and safety of the study drug, tazemetostat, in adults with relapsed/refractory follicular lymphoma whose tumours do not have an "EZH2 gain-of-function" genetic mutation. Follicular lymphoma is a blood cancer. It affects white blood cells called lymp... | Inclusion Criteria:
* At least 18 years of age, inclusive, at the time of signing the informed consent form
* Histologically confirmed follicular lymphoma (FL) grades 1, 2, or 3A
* Previously treated with ≥1 prior systemic chemotherapy, immunotherapy, or chemo-immunotherapy consistent with those used in a US populatio... | |
NCT06604000 | Goal Management Training (GMT) for Improvement of Cognitive Control Function After Acquired Brain Injury | The goal of this clinical trial is to investigate predictors of treatment outcome, and the effect of individual treatment components of Goal Management Training (GMT) for improvement of cognitive control function in people with acquired brain injury (ABI).
Primary aim: To identify demographic, clinical and cognitive p... | The Global Executive Composite (GEC) score derived from BRIEF-A will be used as the primary outcome measure. A selection of other included measures will be used as secondary outcome measures. Data will be analyzed based on an intention-to-treat approach. Penalized linear regression by the elastic net approach (a combin... | Inclusion Criteria:
* Patients aged 18-65 with acquired brain injury with no concomitant diseases minimum 12 months' post-injury/surgery, reporting cognitive control problems by structured interview or clinical performance measures.
Exclusion Criteria:
* Non-fluency in Norwegian Language
* Major psychiatric disorder... |
NCT00918671 | Medication-overuse Headache: 4 Years Follow up | From 1 January 2004 to 31 December 2006 64 individuals with probable medication overuse headache were included in a randomized, 1-year open-labeled, multicentre study to evaluate the effect of early introduction of prophylactic treatment compared to abrupt withdrawal and with a control group (ClinicalTrials.gov number ... | The participants will be interviewed by telephone or consult the study doctor completing a headache diary for at least 1 month before attending the visit. | Inclusion Criteria:
* Randomized during the initial trial during 2004-2006. |
NCT05501548 | Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer | This is a study to evaluate the safety and clinical activity of the combination of olaparib and high-dose IV ascorbate, as second or later line of therapy, in castration resistant prostate cancer patients with no known DNA repair gene mutations (DDRm). In brief, the primary endpoint is PSA50 response , defined by a 50%... | Inclusion Criteria:
* Have metastatic castration-resistant prostate cancer (prostate cancer progressing by PSA (rise by 25% on prior therapy) or imaging despite castrate levels of testosterone \[\<50 ng/dL\] using standard measures of progression defined by Prostate Cancer Working Group3)
* Have a minimum PSA of 1 ng/... | |
NCT06777082 | Role of RPL8 Protein Alterations in High-grade Serous Ovarian Carcinoma | Background and rationale of the study:
From our preliminary analyses of a dataset on patients with high-grade serous ovarian carcinoma (HGSOC), available in the online database The Cancer Genome Atlas, we found that the gene encoding ribosomal protein L8 (RPL8) is amplified at a high frequency (\~30%) in HGSOC. Moreov... | Background and rationale of the study:
From our preliminary analyses of a dataset on patients with high-grade serous ovarian carcinoma (HGSOC), available in the online database The Cancer Genome Atlas, we found that the gene encoding ribosomal protein L8 (RPL8) is amplified at a high frequency (\~30%) in HGSOC. Moreov... | Inclusion Criteria:
* Age ≥ 18 years.
* Diagnosis of high-grade (3 or 4) serous ovarian carcinoma, either at onset or recurrence.
* Signed informed consent to participate in the study.
Exclusion Criteria:
* Ovarian tumors of histological types other than serous.
* Other primary tumor types. |
NCT04086901 | Dose Escalated Adaptive RadioTherapy in Definitive Chemo-radiotherapy for Esophageal Cancer | In Denmark, 1000 new cases of esophageal and gastro-esophageal junction cancer occur every year. Surgery is the primary treatment for patients with localized disease who are considered medically and technically operable. For patients deemed non-resectable, definitive chemoradiotherapy is the treatment of choice, but de... | In Denmark, there are almost 900 new cases of oesphageal and gastro-esophageal junction (GEJ) cancer per year, with a 5-year survival rate below 20% for the entire group and a 5-year survival rate of approximately 40% for the curatively treated patients.
Surgery is the primary treatment for patients with localized dis... | Inclusion Criteria:
The patients must meet all of the following inclusion criteria to be included in the study:
* Patients with histologically verified squamous cell or adenocarcinoma (including signet cell carcinoma) of the oesophagus or GEJ.
* Multi-Disciplinary Team (MDT) assessment and treatment recommendation; d... |
NCT04168775 | Peak Inspiratory Flow Rates in Patients With COPD | Recent studies have reported that some Chronic Obstructive Pulmonary Disease (COPD) patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these pa... | Recent studies have reported that some COPD patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these patients in the home setting, whether clin... | Inclusion Criteria:
* Age \> 50 years-old
* Spirometry-confirmed diagnosis of COPD (FEV1/FVC \<0.70)
* Global initiative for Chronic Obstructive Lung Disease (GOLD) II-IV based on spirometry results
* COPD Assessment Test (CAT) score \> 10
* For high resistance DPI, baseline PIFR \< 90 L/min (InCheck DIAL®) and \>=30 ... |
NCT01927978 | Using "PET Response Criteria in Solid Tumors (PERCIST)" in Evaluating Response to Neoadjuvant Chemoradiotherpy for Esophageal Cancer | This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.
Purpose:
1. The incremental staging information by using 18F-FDG PET
2. The impact of the PET results on the patients' subsequent therapy plann... | Background: Esophageal cancer is one of the leading malignancies in Taiwan. Accuracy tumor staging can direct to appropriate therapy planning and provide prognostic implications. Positron emission tomography (PET) with \[18F\]-fluoro-2-deoxy-D-glucose (FDG) has been shown to have better N staging and prognostic stratif... | Inclusion Criteria:
1. Age：20-90 years old
2. Histological proved esophageal cancer
3. ECOG performance status 0-2
4. written informed consent signed
Exclusion Criteria:
1. prior chemotherapy or treatment for other systemic anti-cancer agent(s)
2. pregnant or intend to be pregnant
3. other malignancies known
4. othe... |
NCT03300362 | Improved Novel VaccIne CombinaTion InflUenza Study | A Phase IIb randomised, participant-blinded, placebo-controlled, multi-centre phase IIb efficacy study in 2030 volunteers aged 65 and over. The study will assess the safety and efficacy of the co-administration of a viral vectored vaccine, MVA- NP+M1, and the annual recommended licensed inactivated influenza vaccine (I... | The efficacy of current seasonal influenza vaccines is limited in the face of antigenic mismatch between circulating viral strains and those in the given vaccine. Additionally vaccination in older adults, a major target group for vaccination, prevents laboratory-confirmed influenza in only 30-40% compared to 70-90% in ... | Inclusion Criteria:
* Volunteer is willing and has capacity to provide written informed consent for participation in the trial (in the Investigator's opinion).
* Male or female adults, aged 65 years and above
* Able and willing (in the Investigator's opinion) to comply with all study requirements
* Willing to allow th... |
NCT02927730 | The Correlation Between Clinical Diagnosis of Retained Placenta And Histology | The main purpose is to evaluate the correlation in qualitative and quantitative manner between clinical diagnosis of retained placenta and histology. Secondly, to assess different clinical parameters that are likely related to accuracy of the diagnosis of RPOC | Background:
Retained products of conception (RPOC) are a common and treatable complication after delivery or termination of pregnancy. The reported incidence in the literature is around 1% of all pregnancies. Most often, diagnoses are made on clinical basis and there is only scarce information available related to the... | Inclusion Criteria:
* Women who diagnosed clinically with RPOC
* women who prefomed therapeutic hysteroscopy under the diagnosis of RPOC
Exclusion Criteria:
* Women who underwent hysteroscopy presumptive diagnosis of RPOC without documentation of pathological results were excluded.
* Women who have not performed / r... |
NCT04400890 | Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19 | Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help fight coronavirus as well as help protect the body from the effects of disease (COVID-19) caused by the infection. In this proof-of-concept pilot study we will compare the effects of resveratrol to placebo to assess the safety... | This randomized placebo-controlled trial is for the outpatient treatment of (Coronavirus Disease 2019) COVID-19. The purpose of this trial is to evaluate the safety and explore the effectiveness of resveratrol, a plant polyphenol, being re-purposed for patients with early COVID-19. Published in vitro data supports that... | Inclusion Criteria:
* Outpatients who test positive for infection with SARS-CoV-2.
* Age ≥45 years
* Mild COVID-19 based on World Health Organization (WHO) Baseline Severity Categorization
* Symptom duration ≤ 10 days, or \<72 hours of new respiratory symptoms.
* Patient must have access to the internet or a smartphon... |
NCT00415948 | Myeloperoxidase and Multi-Markers In the Diagnosis of Diagnoses of Acute Coronary Syndrome (MIDAS) - Sample Procurement | The purpose of the study is to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome). | This is a prospective, multi-center, observational, and sample procurement study of adult subjects presenting to an Emergency Department (ED) in whom ACS is in the differential diagnosis. Subjects must present to one of the participating EDs within 6 hours or less from the time of symptom onset, and must have experienc... | Inclusion Criteria:
* Age 18 years or older at time of enrollment
* Patient presenting to the ED within 6 hours or less from symptom (chest discomfort consistent with possible ACS) onset
* Patient experiencing at least 30 minutes of chest discomfort, consistent with possible ACS, from time of symptom onset; patients w... |
NCT05801861 | Modulating Goal-directed Navigation Using Noninvasive Brain Stimulation | Our specific aim is to examine the effects of TMS on spatial processing during goal-directed navigation. In these experiments the investigators will utilize a scalp-recorded brain oscillation called right posterior theta that is believed to index the sensitivity of the parahippocampal cortex to spatial context. Here th... | The design is primarily a randomized control-trial design (3 sessions), testing the effects of 10-Hz rTMS and single-pulse TMS on spatial processing during goal-directed navigation tasks. Subjects will be randomly assigned to an active or sham group. All participants will be asked to complete two TMS sessions within tw... | Inclusion Criteria:
1. Be between the ages of 18 and 55 years old.
2. Not received substance abuse treatment within the previous 30 days.
3. Be in stable mental and physical health.
4. If female, test non-pregnant.
5. No evidence of focal or diffuse brain lesion on MRI.
6. Be willing to provide informed consent.
7. Be... |
NCT03285373 | This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain | The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation. | Inclusion Criteria:
* The patient is willing and provides written informed consent to participate in this study
* The patient is at least 18 years of age
* The patient has a diagnosis of non-valvular atrial fibrillation (NVAF)
* The patient is on treatment with NOAC according to its approved local SmPC and has initiat... | |
NCT05558007 | Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients | To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo. | Prostate cancer remains one of the most prevalent cancer in men. For its treatment, recent technological advances demonstrate that the most effective treatment is the Radical Prostatectomy (RP) procedure. However, although curative for Prostate Cancer, can result in damage to the cavernosal nerves.
The cavernosal auto... | Inclusion Criteria:
1. Men between the ages of 40 and 65 years;
2. Exclusive heterosexual men, regardless of race or social class.
3. RP due to prostate cancer without metastasis;
4. RP performed less than 60 days before the screening visit;
5. Erectile function prior to normal RP, defined as IIEF questionnaire with m... |
NCT05349032 | Assessing the Bioavailability of Leading Phytonutrient Products | This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. The study will secondarily look at inflammatory markers in the urine to determine any change. | This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. 120 mg of curcumin from brands Meriva, CurcElite, Lonvida, UltraCur, NovaSol. The study will secondarily look at inflammatory markers in the urine to determine any change. | Inclusion Criteria:
* Age and gender
Exclusion Criteria:
* Cannot take any phytonutrient or curcumin supplement five days prior to commencement. |
NCT04091477 | Impact of Neuropsychological Alteration of Patients With Eating Disorders | Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability factors have been found in eating disorders... | The investigators will recruit a total of 200 patients with an eating disorder in the university hospital of Montpellier.
Participation consists of a one-day visit with a multidisciplinary assessment. No action is specific to research. This is the usual management of patients with eating disorders addressed to our dep... | Inclusion criteria :
* Patient with an eating disorder according to DSM-V criteria
* Patient aged from 15 to 65 years
* Patient who performs the day-hospital evaluation
* Patient affiliated to a French social security system
* Patient able to understand the nature, the aim and the methodology of the study For minor on... |
NCT00462579 | Risk Factors for Carbapenem-resistant Acinetobacter Baumannii | It has been demonstrated that panresistant strains of Acinetobacter species may be selected by antibiotic use \[4\], may be transmitted from person to person \[5\], and may be passed via environmental contamination \[6\]. Surveillance for panresistant Acinetobacter species should be a priority, given the lack of antibi... | The elucidation of potential risk factors for resistant strains of Acinetobacter is therefore an important task, and the use of alternative antibiotics should be considered in ICUs where these strains are endemic.he following information will be collected: age, sex, occupation, hospital location at the time of positive... | Inclusion Criteria:
* Positive cultures of carbapenem-resistant acinetobacter baumannii
Exclusion Criteria:
* Not meeting inclusion criteria |
NCT05298917 | Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity | Soft contact lens wear reduces the amount of oxygen reaching the eye, which may have an influence on corneal sensitivity. The aim of this study is to measure corneal sensitivity with means of liquid jet esthesiometry at baseline and after 6 days of continuous, extended contact lens wear. | Contact lens wear may have an influence on corneal sensitivity, by three mechanisms: hypoxic, mechanical and inflammatory. Extended silicone hydrogel contact lens wear increases the risk of infections. A change in corneal sensitivity may be considered as an indicator for change in corneal physiology. It is there the ai... | Inclusion Criteria:
* no contact lens wear three days before first visit
* corneal radius between 7.4 and 8.0; if corneal radius \>8.0, corneal diameter must be at least 12 mm; if corneal radius \< 7.4, corneal diameter must be \< 12.0
* OSDI score no higher than 13 points
Exclusion Criteria:
* systemic disease that... |
NCT00036647 | OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer | The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that h... | * Clinical diagnosis of stage IIIB or IV non-small cell lung cancer.
* Must have evidence of disease (clinical or radiological).
* Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days.
* If the patient has had surgery, ... | |
NCT00918983 | Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) | This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo. | Inclusion Criteria:
1. Provide signed informed consent prior to enrolment in the study
2. IPSS ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax \< 15 mL/sec based on a minimum void of 125 mL
5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study
Exclusion Criteria:
1. Hi... | |
NCT03087903 | A Study of Grape Seed Extract in Asymptomatic Non-Metastatic Prostate Cancer Patients with Rising PSA | Patients will take 150 mg of GSE product by mouth twice daily and will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. | Patients will take 150 mg of GSE product by mouth twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation; total oral dosage is 300 mg GSE per day for one year. Patients will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. PSA measurements will be obtain... | Inclusion Criteria:
1. Written informed consent has been obtained.
2. Adults \> or = 18 years of age.
3. Histologically confirmed prostate adenocarcinoma.
4. Evidence of rising PSA, on 2 separate occasions, at least one week apart. Baseline PSA must be ≥ 0.2 ng/mL at the time of screening. Radiographic evidence of dis... |
NCT03315286 | Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure | This study will evaluate the safety and effectiveness of Shade for the management of UV-induced skin complications and data collected from this study will be used to support the proposed indications for use. | The incidence of non-melanoma skin cancers, due to increased ultraviolet (UV) exposure, has increased by 300% over the past 2 decades. The innovative UV sensor, Shade, is designed to help people manage their UV exposure by quantifying their UV exposure levels through a linked smartphone application. In order to validat... | Inclusion Criteria:
* between 18-80 years of age
* given a diagnosis of actinic keratosis in the past year and/or has had a history of \>5 actinic keratosis over the past 5 years
* has a compatible smartphone ((Apple version \>= 7, Android version \>= 4.4.2; no Jitterbug or Samsung Galaxy J3)
* willing to commit to de... |
NCT06801665 | FMT+ QL1706+bevacizumab+ XELOX As First-line Treatment for Advanced MSS-type Colon Cancer with Liver Metastasis | The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 30 patients with advanced colon cancer patients with liver metastasis who have not received prior treatment. This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine with ... | This is a prospective, single-arm, multi-center, exploratory clinical study. Patients with previously untreated, newly diagnosed advanced colon cancer with liver metastasis, who could be diagnosed by histological or cytological means, ECOG PS 0-1, excluded Ras, Raf wild type left colon and rectum, excluded dMMR/MSI-H. ... | Inclusion Criteria:
1. Histological or cytological confirmed advanced colon cancer with liver metastasis.
2. Signed written informed consent.
3. Have not received anti-tumor treatment.
4. According to the investigators assessment, at least one measurable target lesion defined by RECIST v1.1.
5. Patients of both sexes,... |
NCT01430962 | Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Performed Under General Anesthesia Versus Moderate Sedation | The purpose of the study is to determine if there are any differences in yield or safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) (a type of bronchoscopy with biopsy) performed under general anesthesia versus moderate sedation. | Inclusion Criteria:
* All patients over the age of 18, evaluated by pulmonary physician that require EBUS TBNA for sampling of hilar and/or mediastinal lymphadenopathies or masses
* Patients should be considered eligible to undergo either CS or GA, without contraindications for either one of them, based on the assessm... | |
NCT04723251 | The Gratitude Gallery - A Positive Psychology Intervention | This study will assess the feasibility and acceptability of a positive psychology intervention, The Gratitude Gallery, for increasing gratitude in adults.
The study hypothesizes that participants will find the activity feasible and acceptable and complete the intervention as directed. The project also hypothesizes tha... | Inclusion Criteria:
* Able to read/understand English and give consent
* Owns a smart phone capable of taking pictures
* Willing and able to comply with all aspects of study procedures
* PHQ-9 score greater or equal to 5 but less or equal to 14 with no suicidal ideation
* Generalized anxiety disorder (GAD-7) score gre... | |
NCT00699920 | Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks | Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient.
Secondary objectives:
For the first attack:
To compare the 2 groups of treatment... | Inclusion Criteria:
Specific inclusion criteria for initial enrollment:
* Confirmed mono infection with Plasmodium falciparum, with parasite density ≥2000 asexual forms per µl of blood,
Inclusion criteria for each attacks:
* Body weight ≥5 kg
* Able to be treated by oral route
* Fever (axillary temperatur ≥37.5 deg... | |
NCT04494438 | Rituximab for Idiopathic Nephrotic Syndrome | Open-label, randomized, controlled trial due to value whether the monoclonal antibody rituximab is non-inferior to steroids in maintaining remission in juvenile forms of SDNS.
The investigators will enroll 30 pediatric patients affected by idiopathic nephrotic syndrome, who have been in treatment with steroids for at ... | Inclusion Criteria:
* Age between 1 and 16 years.
* Steroid-dependent idiopatic nephrotic syndrome for a minimum of 6 to a maximum of 12 months at the time of study entry, regardless of disease duration.
* Low-dose steroid dependence (between 0.4 and 0.7 mg/ kg/ day)
Exclusion Criteria:
* Positivity of autoimmunity ... | |
NCT04088123 | Impact of Anti-platelet Drug Exposure on Platelet mRNA Splicing in Healthy Subjects | The purpose of this pilot study is to determine how the anti-platelet drug, ticagrelor, impacts platelet mRNA splicing after a single loading dose in 10 healthy participants. These results will be valuable in that they will help inform our analysis of platelet RNA splicing after a thrombotic event. | There is nothing known on how differential splicing in platelets is impacted by of P2Y12 inhibition by anti-platelet agents. Consequently, the focus of this longitudinal pilot study will be to determine the impact of a single ticagrelor loading dose (180 mg), our "model" anti-platelet drug, on platelet RNA splicing in ... | Inclusion Criteria:
* 18 - 70 years-old
* Speak and understand English
Exclusion Criteria:
* History of blood clotting/bleeding disorders
* Current medications that are CYP3A4 inhibitors/inducers
* Current medications that their pharmacokinetics is impacted by ticagrelor (i.e. simvastatin, lovastatin, digoxin) per F... |
NCT00792610 | The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines | At the time of the present study, the necessity for booster vaccinations for the prevention of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become seronegative for HB markers after complete neonatal HB vaccination was in question. A booster vaccination strategy may lead to a significa... | This cohort study was conducted between October 2007 and Jan 2009. The target population was subjects aged 18-23 years who were born after 1984 when the Taiwanese national HB vaccination program was launched. Their vaccination records must have shown a completed neonatal HB vaccination, and they were seronegative for a... | Inclusion Criteria:
1. aged 18-23 years
2. the youth born after July 1984 who have received a hepatitis B virus markers checkup within 2 years including HBsAg, core antibody against hepatitis B(anti-HBc), and surface antibody against hepatitis B (anti-HBs) and the results are all negative for these 3 viral markers.
3.... |
NCT01869036 | Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery | The aim of this study is to test an efficacy and safety of supplemented by Morphine caudal anesthesia in children who undergo renal surgery in our department. | The kidney surgery is a significant part of surgical armamentarium in pediatric urology. The common operations are open and laparoscopic pyeloplasty, partial nephrectomy open and laparoscopic and laparoscopic nephrectomy.
One of the main goals in the postoperative period is to provide a painless recovery following by ... | Inclusion Criteria:
* children who are scheduled for renal surgery from two months age to puberty
* operations are open and laparoscopic pyeloplasty, partial nephrectomy open and laparoscopic and laparoscopic nephrectomy
Exclusion Criteria:
* malignancy |
NCT02206503 | Cyclophosphamide With Biochemical Progression During Lenalidomide-Dexamethasone Treatment for Relapsed/Refractory Multiple Myeloma (MM) | This study evaluates the efficacy of the addiction of Cyclophosphamide to Revlimid-low dose dexamethasone (Rd) in relapsed/refractory Multiple Myeloma patients, who experienced a biochemical progression, without CRAB, during Rd treatment. | This protocol is a phase II multicenter, open label study designed to determine whether the addiction of Cyclophosphamide to Rd (CRd) treatment significantly increases response rates and prolonged the outcome (PFS, OS) in patients who experienced a biochemical relapse, without CRAB under Rd treatment. Patients will be ... | Inclusion Criteria:
* Patient with relapse/refractory multiple myeloma who experienced biochemical progression, without CRAB, during treatment with Rd. CRAB means the presence of organ damage, multiple myeloma related (renal impairment and/or anemia and/or new bone lesions and/or hypercalcemia). It is sufficient one o... |
Subsets and Splits
Clinical Trials Eligibility Criteria
Returns the eligibility criteria for different clinical trial studies by their nctId, providing basic information but limited analytical value.