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NCT05004103
Cosmetic Products and Facial Skin Microbiome
The skin microbiome diversity in female healthy volunteers will be studied along with cosmetic products application in 1 month period. This study is also aimed to investigate the efficacy of cosmetic products on skin rejuvenation. .
The study is conducted in COVID-19 pandemic era, thus every person involved in this study must follow health protocol for COVID-19. The study procedure, consist of screening visit (D -7), 7-day wash out, baseline visit (D 0), first follow up ( D 14), and second follow up (D 28). 1. Screening visit: obtained Informed ...
Inclusion Criteria: 1. female 18-35 years old 2. signed the informed consent Exclusion Criteria: 1. infected by COVID-19 2. females with skin diseases on face and neck such as atopic dermatitis, skin allergy, acne with moderate and severe degree, seborrheic dermatitis, malignancy 3. females with ongoing skin treatme...
NCT02491125
The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism
The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.
A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.
Inclusion Criteria: * Overweight to obese men and women (BMI ≥ 25 kg/m2 \<35 kg/m2) * Aged 20-50 years * Caucasian * Normal fasting glucose (\<6.1 mmol/L.) * Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg) * Weight stable in last 3 months (±2 kg) * A low defecation fre...
NCT05314530
The ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare Sector
The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with ps...
The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with ps...
Inclusion Criteria: * currently on sick leave for burnout * employed in the Swedish healthcare services as a nurse or as a physician Exclusion Criteria: -
NCT01672385
Improving Transition Outcomes Through Accessible Health IT and Caregiver Support
Background: Older hospitalized adults frequently experience preventable short-term readmissions due to inadequate transition support. Although proactive telephone follow-up improves transition outcomes, these services often are unsystematic and of low intensity. Informal caregivers are invaluable for ensuring successfu...
Methods: 846 older adults with complex chronic conditions will be identified upon admission to two community-based acute care medical services. Patients will be asked to identify a CarePartner (CP) living outside their household, i.e., an adult child or other social network member willing to play an active role in thei...
Inclusion Criteria: * Being discharged from study site with any diagnoses that indicate a chronic condition with a high risk of short-term readmission, for example: stroke, heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, peripheral vascular disease, deep venous throm...
NCT06519331
Development of a New Method for Liver Stiffness Measurement Using FibroScan
This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 114 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.
Inclusion Criteria: * Adult patients (≥ 18 years of age) followed in the hepatology or endocrinology department for liver disease, suspected liver disease or consequences of liver disease, all etiologies combined. * Adult patient able to give his written consent * Patient affiliated to the French Social Security syste...
NCT03200366
Comparing Interventions to Increase Colorectal Cancer Screening
The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers to screening so they can make informed decisions about CRC screening. Participants will be randomly assigned to one of three groups...
Colorectal cancer (CRC) often can be prevented through regular screening and although multiple screening tests are available, colonoscopy is often the only screening test offered to patients. Unfortunately, up to half of people in some hospitals who receive a recommendation and are scheduled for colonoscopy do not comp...
Inclusion Criteria: * Referred for a screening colonoscopy that was not done (i.e, canceled or no show) Exclusion Criteria: * Unable to speak, read, and write English * Personal history of CRC or polyps * Personal history of conditions that place participants at high risk for CRC such as ulcerative colitis, Crohn's ...
NCT03163745
Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis
Spontaneous bacterial peritonitis is defined as the presence of an infection in a previously sterile ascites in the absence of an intra-abdominal source of infection or malignancy . The variants of Spontaneous bacterial peritonitis includes - (i) Classic Spontaneous bacterial peritonitis: -ascitic fluid polymorphonucl...
Spontaneous bacterial peritonitis is a serious complication in patient with decompensated liver cirrhosis . The incidence in ascetic patients varies between 7-30 % as a consequence result of impaired defense mechanism and increased susceptibility to bacterial infection in cirrhotic patients with ascites Spontaneous bac...
Inclusion Criteria: Patients diagnosed with decompensated liver cirrhosis with ascites (Child B and C) regardless of the etiology of liver cirrhosis Exclusion Criteria: 1. Symptomatic spontaneous bacterial peritonitis (patients with fever, abdominal pain or tenderness, leucocytosis, hepatic encephalopathy, impaired ...
NCT01748019
ST1968 Intravenous (Weekly) in Solid Tumors
ST1968 is a novel camptothecin derivative which interacts with topoisomerase I-DNA complex, inducing S-Phase specific cytotoxicity. It is endowed with a potent antitumor activity and an increased Therapeutic Index with respect to the clinically used analogues (i.e.irinotecan and topotecan) in some xenograft models (ova...
Multicenter, open label, uncontrolled Phase I pharmacokinetic trial to determine the Maximum Tolerated Dose (MTD) of ST1968 given intravenously (I.V.) once every week for 2 consecutive weeks every 3 weeks and the MTD of ST1968 given I.V. once every 3 weeks. A starting dose of 1.5mg/m2 given as a flat dose of 2.5mg is d...
Inclusion Criteria: * Histological/cytological diagnosis of solid tumors for which therapy of proven efficacy does not exist. * Preferably measurable disease * ECOG performance status ≤ 1. * Age ≥ 18 years. * Ongoing toxicity associated with prior anticancer therapy ≤ grade 1 (NCI-CTCAE V3.0). * Maximum of 2 prior che...
NCT00179985
The Impact of Implementing NIDCAP on the Developmental Sensitivity of Nurses Caring for Preterm Infants
The purpose of this study is to determine whether implementing the Newborn Individualized Developmental Care and Assessment Program increases NICU nurses' sensitivity in meeting the developmental care needs of preterm infants.
Therapies that have brought about sharp decreases in neonatal mortality have not brought about similar decreases in neurodevelopmental morbidity for preterm infants. Developmentally supportive care is NICU (Neonatal Intensive Care Unit) care that seeks to optimize the developmental course and outcomes for preterm infan...
Inclusion Criteria: * be an RN, * be an employee of the NICU at the study site, * have completed the NICU nursing orientation at the study site, * work at least 0.4 FTE in the NICU at the study site, and * be observed while caring for a preterm infant born at less than or equal to 36 weeks gestation and at less than o...
NCT06651905
Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation.
This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients.
Inclusion Criteria: * Age range ≥ 18 or ≤60. * Both sexes. * American Society of Anesthesiologists (ASA) II-III. * Body mass index:18.5 to 30 kg/m2. * Hemimandibulectomy patients with an anticipated difficult airway \[El-Ganzouri Risk Index (EGRI)\>3\]. Exclusion Criteria: * Patient's refusal. * Known allergy to dru...
NCT02689102
Confocal Laser Endomicroscopy and Optical Coherence Tomography for Diagnosing ILD.
Often, assessing a classifying diagnosis in patients with interstitial lung disease provides a diagnostic challenge. Currently HRCT, endoscopic or surgical video assisted thoracoscopic surgery(VATS) assessment including lung biopsies are diagnostic tools for patients with suspected ILD. However, tissue acquisition is a...
Novel probe based optical techniques such as Confocal laser endomicroscopy (pCLE) and Optical coherence tomography (pOCT) are non-invasive optical techniques, compatible with conventional diagnostic bronchoscopes and provide non-invasive, real-time information on the airway wall and the alveolar compartment. Therefore,...
Inclusion Criteria: * 18 years of age * Supected ILD and referred for diagnostic bronchoscopic procedure with cryobiopsy Exclusion Criteria: * Smoked in the last 6 months * Inability and willingness to provide informed consent * Inability to comply with the study protocol
NCT00000614
Prevention of Recurrent Venous Thromboembolism (PREVENT)
A multicenter randomized, double blind placebo controlled trial to determine the efficacy of long-term, low dose warfarin in the secondary prevention of venous thromboembolism.
BACKGROUND: Venous thromboembolism is associated with more than 300,000 hospitalizations and results in thousands of deaths annually. Conventional therapy consists of intravenous heparin followed by oral anticoagulants usually given for three to six months. The recommended intensity of oral anticoagulants (warfarin) h...
Patients with venous thromboembolism, including patients with factor V Leiden. Patients had completed prescribed anticoagulation therapy within the last two years before the trial and were not currently on anticoagulation therapy.
NCT01997450
A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age
This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.
This post-marketing study will enroll approximately 5,200 subjects 2-17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness. This study will begin in the fall of 2013 and will be completed after 4 influenza seasons (i.e.after the 2016-2017 influenza season). No investigation...
Inclusion Criteria: * Community-dwelling children and adolescents 2 to 17 years of age. * Written Informed Consent or Assent. * Acute respiratory illness documented at study visit or at home with fever (oral temperature ≥ 100.0° Fahrenheit at study visit, or history of fever reported by parents, or use of antipyretic ...
NCT01590017
Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving cisplatin together with radiation therapy may be an effective treatment...
OBJECTIVES: Primary * To determine if it is feasible to administer a regimen of cisplatin/radiotherapy in HIV-infected women with locally advanced cervical cancer (LACC) on antiretroviral therapy (ART). * To evaluate the safety and tolerability of concomitant chemoradiotherapy with cisplatin in HIV-infected women wit...
DISEASE CHARACTERISTICS: * Participants (who have been adequately clinically staged by standard clinical guidelines) with primary, untreated, histologically confirmed, documented invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, stages IB2, IIA, IIB, IIIA, IIIB, and IV...
NCT03184896
Services Mapping Among Older Adults With Hip Fracture
Hip fracture is a osteoporosis-related fracture with higher mortality, and is a major public health issue in China. The British Orthopedic Association and the British Geriatric Society have published the UK Blue Book, which summarizes current evidence and best practice in the hip fracture care and secondary prevention,...
Inclusion Criteria: * Adults aged 65 years old or over; * Hip fracture with X-ray-confirmed femoral neck, trochanteric or sub-trochanteric fracture; * Within 21 days of a hip fracture; * Willingness to sign informed consent form; Exclusion Criteria: * Patients with pathological fractures; * With terminal malignancie...
NCT03969524
Functional MRI in Predicting Response to Chemotherapy
• Address the accuracy of functional MRI techniques to predict response to neoadjuvant chemotherapy given to local advanced breast cancer patients with correlation with pathology thus allowing early chemotherapy regimen modification to increase number of patients achieving pathological complete response or save patient...
patient selection: Selection of patients diagnosed with of biopsy proven breast cancer (BIRAD VI ) : • Inclusion criteria: patient in different age groups with local advanced breast cancer who are eligible for neoadjuvant chemotherapy and breast conservative surgery and in need for clip placement for tumor localizati...
Inclusion Criteria: * patient in different age groups with local advanced breast cancer who are eligible for neoadjuvant chemotherapy and breast conservative surgery and in need for clip placement for tumor localization Exclusion Criteria: * Patient with breast cancer who are not eligible for NAC (pregnant patients,...
NCT04334616
POST: Comparison of Macintosh Laryngoscope vs Video Laryngoscope in Patients Intubated by Anaesthesia Trainee
OBJECTIVES The objective of this study is to compare the frequency of POST in patients intubated by trainee anaesthetist using Video LaryngoscopeTM(VDL) versus Conventional Macintosh Laryngoscope (CL) at a tertiary care hospital in Karachi, Pakistan OPERATIONAL DEFINITIONS 1. Sore Throat: A sore throat is pain, scrat...
MATERIAL AND METHODS SETTING: The study will be conducted at main Operating Room, Department of Anaesthesiology, Aga Khan University Hospital Karachi. DURATION OF STUDY: This study will be conducted for a period of one year or till the completion of sample size after approval of synopsis by ERC and CPSP. SAMPLE SIZE...
Inclusion Criteria: 1. All adult patient of age between 20-60 year 2. American society of Anesthesiologist grade I and II 3. Scheduled for elective laparoscopic cholecystectomy 4. Both male and female genders Exclusion Criteria: 1. Anticipated difficult airway as assessed by limited mouth opening (\< 2 finger breadt...
NCT03496948
Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease
Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with over 200 million people affected. Most prominent symptom is leg pain while walking known as intermittent claudication. Based on the currently existing gaps in the management of intermittent claudication, the objective of ...
Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide and has become a serious public health issue, with over 200 million people affected. Smoking and diabetes are the strongest risk factors for the development of peripheral artery disease, but also high cholesterol, high blood pr...
Inclusion Criteria: * Insured with one of the three participating health insurance companies * Sufficient German language skills to follow the telephone-based health coaching * Access to a telephone (landline or mobile); * Primary or secondary diagnosis of PAD at Fontaine stage IIa or IIb within the last 36 months, bu...
NCT00761787
Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY
The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test. Sensitive detection of cardiac allograft rejection and dysfunction is the basis for successful recipient management. The CARGO II Study...
Inclusion Criteria: * New and existing allograft recipients * All patients (age ≥ 18years) receiving post-transplant care at the enrolling centers Exclusion Criteria: * Concurrent enrollment in a double-blind drug trial (immunosuppressive drugs).
NCT02873585
Conventional Bite Wing Radiography Versus Stationary Intraoral Tomosynthesis, a Comparison Study
A comparison of caries detection rates between conventional intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source array. The secondary objective is to assess participants experience with the s-IOT device.
The primary purpose of this study is to compare caries detection rates between conventional intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source array. Patient experience with the s-IOT device will be assess using a short questionnaire. Fifty adul...
Inclusion Criteria: * 18 years and older * Scheduled for horizontal BW or Full (FMX) with horizontal BWs * Patients who have in the right and left maxilla and mandible at least a canine and two posterior teeth that are in contact * At least one proximal caries lesion in a surface of a posterior tooth (premolar or mola...
NCT02547740
Macular Damage in Early Glaucoma and Progression
Glaucoma is the leading cause of irreversible blindness worldwide. This study aims to test a new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is getting worse. There is scientific evidence that the macula, the central part of the retina, can be involved in very early stages of gl...
There is compelling evidence that glaucomatous damage to the macula occurs even in early stages of the disease. The macula comprises about 30% of all retinal ganglion cells and its information corresponds to over 50% of the visual cortex. However, glaucomatous damage to the macula is often missed in clinical practice. ...
Glaucoma Group: Inclusion Criteria: * glaucomatous optic neuropathy (as defined in the American Academy of Ophthalmology Preferred Practice Pattern criteria) Exclusion Criteria: * late functional glaucomatous damage * significant cataract * previous ocular surgery (aside from uncomplicated cataract extraction with ...
NCT00910715
Duration of Antibiotic Treatment of Erythema Migrans
The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.
Inclusion Criteria: * solitary erythema migrans in patients \> 15 years Exclusion Criteria: * a history of Lyme borreliosis in the past * pregnancy or lactation * immunocompromised status * serious adverse event to doxycycline * taking antibiotic with antiborrelial activity within 10 days * multiple erythema migrans...
NCT06307210
Is Inpatient Rehabilitation Effective for Very Old Patients?
The goal of this retrospective longitudinal observational study is to compare the effects of physical and mental performance as well as quality of life in patients with neurological and musculoskeletal disorders. The main question it aims to answer is: Do very old patients benefit in a similar way from inpatient rehab...
Inpatient rehabilitation has been shown to improve exercise capacity and quality of life in patients with neurological and musculoskeletal disorders. Rehabilitation in Valens includes intensive strength and endurance training. Expectedly improvements in physical and mental performance measured by Functional Independen...
Inclusion Criteria: * german speaking * age \>74 * patients with neurological and musculoskeletal disorders Exclusion Criteria: * age \<75 * patients with pulmonological and internal disorders
NCT00778622
Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients
The purpose of this study is to investigate the effect of the baseline body mass index (BMI) on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with newly diagnosed type 2 diabetes
Inclusion Criteria: * Signed Written Informed Consent * Age≥ 17 and \<80 years, * Newly diagnosed T2DM (defined as T2DM diagnosed within 6 months prior to enrollment) * Oral antidiabetic agents naïve (defined as without receiving any anti-diabetic medication therapy before, or having received anti-diabetic medication ...
NCT04402788
Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial
This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of t...
PRIMARY OBJECTIVES: I. To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase II) II. To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase III) SECONDARY OBJECTIVES: I. To assess the toxi...
Inclusion Criteria: * Any confirmation (cytologic, histologic, or pathologic) of extensive stage small cell lung cancer at any site, either primary or metastases * Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab by re-staging scans (positron emission ...
NCT03702400
Norepinephrine or Phenylephrine in Bolus for Hypotension in Cesarean Delivery
This study evaluate the ability of phenylephrine and of noradrenaline to maintain normal systemic arterial blood pressure and heart rate in healthy pregnant women submitted to cesarean section with spinal anesthesia. Half of participants will receive bolus of phenylephrine while the other half will receive bolus of nor...
This is a prospective, randomized, double-blind, comparative two-group clinical study to observe two vasopressor drugs, phenylephrine and noradrenaline, in the ability to maintain systemic arterial pressure in pregnant women after spinal anesthesia for cesarean section; based on the hypothesis that, since noradrenaline...
Inclusion Criteria: * Pregnant women, with single gestation, with cesarean programming to be performed under spinal anesthesia; * Age above 18 years; * Physical State American Society of Anesthesiologists (ASA) II and III; * Weight between 50kg and 120kg; * Height between 140cm and 180cm. Exclusion Criteria: * Refus...
NCT03961308
A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
The purpose of this study is to compare the PK of single dose of Vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device.
The drug being tested in this study is called vedolizumab SC. The study will compare the PK of a vedolizumab SC in a PFS to an investigational device. This study will include 2 different device delivery presentations in 2 treatment groups. Participants in each treatment group will be randomized to one of the three adm...
Inclusion Criteria: 1. Weighs greater than (\>) 50 kilogram (kg) and less than (\<) 90 kg or has a body mass index (BMI) from 18 to 28 kilogram per square meter (kg/m\^2), inclusive, at the time of informed consent. Exclusion Criteria: 1. Has had previous exposure to approved or investigational anti-integrins (examp...
NCT01102907
Effect of Food Form on Satiety and Gastric Emptying
Our objective is to determine whether food form (liquid vs. solid) alters gastric emptying, satiety, and food intake, when all macronutrients and fiber are controlled. The study population will include 10 healthy women, who have a normal body mass index. We have chosen to evaluate only women because this is a small pil...
Inclusion Criteria: * Healthy women * Age 18 - 35 * Body mass index in the healthy range between 18.5 and 25 * Proficient English speakers * Non-smoking * Not taking medications * Non-dieting (weight stable over last 3 months) * Able to swallow a large capsule Exclusion Criteria: * Irregular or erratic breakfast eat...
NCT06591364
Prevalence and Predictive Factors of Difficult Biliary Cannulation
The main purpose of the study is to evaluate the prevalence of difficult biliary cannulation using endoscopic retrograde cholangiopancreatography (ERCP) according to the criteria defined by the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE), as well ...
All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study. They will be informed by one of the investigators from each center and will sign an informed consent form. A data collection sheet will be completed to record demographic data, the ind...
Inclusion Criteria: * Age \>18 years * Signed informed consent * Patients indicated for ERCP Exclusion Criteria: * INR \> 1.5 * Platelets \< 50,000/mm³ * Patients with a prior endoscopic sphincterotomy * Papilla of Vater not accessible via duodenoscope (gastric or duodenal stenosis due to neoplasm) or gastric surger...
NCT06553625
Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS
The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.
The objective of this study is to compile real-world outcomes of Boston Scientific Corporation commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery.
Inclusion Criteria: * Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain or for CNS applications per local Directions for Use (DFU) * Signed a valid, IRB/EC/REB-approved informed consent form Exclusion Criteria: * Meets any contraindications per locally appli...
NCT06756828
Effects of 3-Month Melatonin Treatment on Regional Cerebellar Structure and Blood Biomarkers in Alzheimer's Disease Spectrum
The goal of this clinical trial is to explore and verify the preventive effects of melatonin on the progression of Alzheimer's disease. The study aims to analyze the changes in blood biomarkers (phosphorylated tau, glial fibrillary acidic protein, neurofilament chain), various sleep-related subjective report questionna...
Inclusion Criteria: * Male and female participants aged 60 to 90 years * Individuals presenting with cognitive impairment as their chief complaint at the Department of Psychiatry, St. Vincent's Hospital * Those capable of undergoing imaging studies, including Brain MRI and Amyloid PET CT * Individuals able to complete...
NCT01580891
Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis
The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of...
Inclusion Criteria: * Male or non-pregnant, non-lactating females 18 years of age or older. * Signed informed consent form, which meets all criteria of current FDA regulations. * If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual interco...
NCT05115149
The Study of a Neural Interface and a Neurostimulation in the Rehabilitation of Upper Limb Movement Impairments.
The aim of the study is to investigate the effectiveness of a new rehabilitation technology for paralysis that occurs after stroke or spinal cord injury. The research will jointly use a prototype neurorehabilitation orthosis, in which a robotic device moves a paralyzed arm at the command of a non-invasive brain-compute...
The aim of the study is to investigate the effectiveness of a new rehabilitation technology for paralysis that occurs after stroke or spinal cord injury. The research will jointly use a prototype neurorehabilitation orthosis, in which a robotic device moves a paralyzed arm at the command of a non-invasive brain-compute...
Criteria for inclusion in the study of patients: 1. Signed written informed consent. 2. Men or women aged 18 to 60 years after a first occurred acute cerebrovascular accident or in the recovery period after injury of the cervical and upper thoracic spinal cord. 3. Early or late rehabilitation period of acute cerebrova...
NCT06433518
BEst Size for Ovulation Triggering in Poseidon 4 Patients (BEST 4 Study)
This observational clinical study aims to determine the optimal timing of ovulation triggering in women aged 35 and above with poor ovarian reserve. For this purpose, cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups: ...
The timing of final oocyte maturation in assisted reproductive techniques is critically important. If serum steroid hormone levels are appropriate during the late follicular phase, ovulation triggering can be performed using various agents. There are numerous comparative studies in the literature on this topic. Howeve...
Inclusion Criteria: Women age \&gt;35 years Women with low serum AMH (\&lt;1,2 ng/ml), low AFC (\&lt;5) Undergoing assisted reproduction with Short antagonist protocol Max daily gonadotropin dose of 300 IU Exclusion Criteria: * women with uterine and/or endometrial abnormality, women with endometrioma(s), short or l...
NCT06023810
The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers
The rise in diabetes incidence has led to a corresponding increase in diabetes-related complications. Diabetic foot ulcers, a severe consequence of diabetes, have substantial impacts on patients, the social environment, overall well-being, and nursing procedures. Given this context, there is a clear necessity for inter...
According to the International Diabetes Federation (IDF) data, there are currently 425 million adults worldwide affected by diabetes, and it is projected to increase to 578 million by 2030 and 700 million by 2045. The increasing prevalence of diabetes has led to a rise in the frequency of complications arising from dia...
Inclusion Criteria: * Individuals with clear consciousness, * No communication problems, * Diagnosed with type 1 or type 2 diabetes, * Grade 1 diabetic foot ulcer according to the Wagner classification, * Receiving standard wound care, * Residing in the Kocaeli province, * No musculoskeletal or neurological disorders ...
NCT00001061
Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS
To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL 109 and efficacy and virologic markers. Therapeutic a...
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients. Patients ...
Inclusion Criteria Concurrent Medication: Allowed: * G-CSF and GM-CSF. * Antiretroviral therapy. Patients must have: * HIV infection. * First episode of CMV retinitis. * No prior end-organ CMV disease - PER AMENDMENT 4/25/96: No prior end organ CMV disease within the past 6 months. Subjects who have been prophylax...
NCT03969615
SuperNO2VA™ and General Anesthesia Postoperative Care
The purpose of the study is to randomly and prospectively evaluate the differences in outcomes between the control group (closed full facemask immediate post-extubation with standard oxygenating device used post-operatively in PACU) and the SuperNO2VA™ group (SuperNO2VA™ immediate post-extubation and post-operatively i...
Inclusion Criteria: 1. Age 18 years of age or older 2. Patients scheduled for general anesthesia with a supraglottic device or ETT 3. American Society of Anesthesiology (ASA) Physical Status I-IV (E) 4. Has provided written informed consent 5. BMI \> 35 kg/m2 or documented Obstructive Sleep Apnea Exclusion Criteria: ...
NCT00483925
Cardiovascular Risk Factors and LCH in Adults
Langerhans-cell histiocytosis (LCH) is a rare disease with features of chronic inflammation and hypopituitarism, conditions associated with increased risk of cardiovascular diseases. Objective: To investigate glucose and lipid metabolism, insulin resistance, structural arterial and functional endothelial properties in...
CARDIOVASCULAR RISK FACTORS IN ADULT PATIENTS WITH MULTISYSTEM LANGERHANS-CELL HISTIOCYTOSIS: EVIDENCE OF ABNORMALITIES OF CARBOHYDRATE METABOLISM Langerhans cell histiocytosis (LCH) is a rare disease, usually affecting children although it has recently increasingly been recognized in adults with a prevalence of appro...
Inclusion Criteria: * diagnostic criteria for "definitive diagnosis" of LCH Exclusion Criteria: * not participate in strenuous physical activities, on a balanced isocaloric diet for at least 4 weeks prior to the study
NCT02531516
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival based on conventional or prostate speci...
This is a randomized, double-blind, placebo-controlled, multicenter study of apalutamide plus GnRH agonist compared with GnRH agonist among participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT). The study will include a Screening Phase, Treatment Phase, a Po...
Inclusion Criteria: * Age \>= 18 years * Indicated and planned to receive primary radiation therapy for prostate cancer * Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score \>=8 and \>=cT2c, 2) Gleason score \>=7, PSA \>=20 nanogram per milliliters (ng/...
NCT00803374
Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma
The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable
Inclusion Criteria: * Histologically or cytologically confirmed malignant melanoma * Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens * Willing to undergo up to 3 biopsies of an accessible lesion Exclusion Cr...
NCT06690073
The Effect of Motor Relearning Program on Functional Mobility in Stroke Rehabilitation.
1. To find out the effectiveness of conventional physiotherapy on improving functional mobility of lower extremity among chronic hemiplegic subjects. 2. To find out the effcctiveness of motor relearning program along with conventional physical therapy treatment on improving functional mobility of lower extremity among ...
After a careful monitor of inclusion and exclusion criteria and obtaining the institutional review board approval, the study was conducted by convenience sampling to select the suitable subjects, explaining the procedure to them, and got the written \& oral informed consent. The study included two groups, each with 16 ...
Inclusion criteria: The following subjects were included: * Right or left-sided chronic hemiplegic subjects. * More than six months after the onset of stroke. * Age group between 45-65 years of both genders. * Scored minimally 24/30 on the Mini-Mental State Exam (MMSE). * Motor assessment scale of sitting to standing ...
NCT04535505
Pathogenic Bordetella Rapid Detection
A CPA platform based on the CRISPR technology is going to established to achieve the goal of detecting pathogenic bordetella and drug resistance genes in one step. The accuracy of this platform will be checked through prospective diagnostic test evaluation methods. Bordetella pertussis isolation culture and identificat...
Pertussis is an acute respiratory infectious disease caused by bordetella pertussis. Although it is a vaccine-preventable disease, outbreaks and epidemic cases of whooping cough worldwide have been reported from time to time. Bordella parapertussis, Bodella bronchiseptica, and bordetella hosei can cause pertussis-like ...
Inclusion Criteria: * Patients with continuous cough (paroxysmal cough) for more than 1 week, peripheral white blood cell 18×109/L (infants and young children), or\> 15×109/L (children), ineffective use of cephalosporin antibacterial drugs,and these patients whose nasopharyngeal swabs are collected for routine bordete...
NCT05203679
Evaluation of the Safety and Efficacy of Hemophilia B Gene Therapy Drug
This is a multi-center, single-arm, open-label, single-dose treatment clinical study to evaluate the safety, tolerability and efficacy of BBM-H901 injection in Hemophilia B subjects with ≤2 International unit per deciliter (IU/dl) residual factor IX (FIX) levels. BBM-H901 is an adeno-associated virus (AAV) vector deri...
Inclusion Criteria: 1. Males ≥ 18 years of age; 2. Have hemophilia B with ≤2 IU/dL (≤2 %) endogenous FIX activity levels; 3. Have had ≥100 prior exposure days (EDs) to any recombinant and/or plasma-derived FIX protein products based on historical data from the subjects' records/histories; 4. Have had bleeding events a...
NCT03093597
Skin Barrier Biophysical Properties and Clinical Appearance After Moisturizer in Dry Skin
The purpose of the study is to compare the changes in the appearance of dry skin after the use various moisturizers: white petrolatum ointment, coconut oil, jojoba oil, and almond oil in patients with dry skin.
The goal of this study is to compare how the appearance of dry skin changes before and after the use of following moisturizers: white petrolatum, coconut oil, jojoba oil and almond oil). Up to 40 subjects from Banner-University Medical Center/University of Arizona dermatology clinics and University of California, Davis...
Inclusion Criteria: 1. Male and female, at least 18 years of age 2. Subject must receive a diagnosis of dry skin by a dermatologist. 3. Subject must be able to comprehend and read the English language. Exclusion Criteria: 1. Subjects who do not fit the inclusion criteria. 2. Subjects unable to or unwilling to comply...
NCT03139292
Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway
Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway.
The study aims to compare the two devices with respect to: Time taken for insertion. Insertion attempts or failed attempt. Oropharyngeal leak pressure Air leak Time taken to pass an orogastric tube Attempts to pass an orogastric tube or failed attempt. Haemodynamic variation Incidence of adverse events like failed ins...
Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) Physical Status I \& II 2. Patients undergoing limb or breast surgery 3. Patients undergoing elective surgery under general anesthesia and spontaneous ventilation. 4. Patients with expected duration of surgery of less than 2 hours. Exclusion Criteria:...
NCT06791070
A Study of RC48-ADC Combined With JS001 for Advanced Extramammary Paget Disease of the Scrotum
The goal of this clinical trial is to learn if Disitamab Vedotin combined with Toripalimab works to treat advanced HER2-positive extramammary Paget disease of the scrotum. It will also learn about the safety of this combination. The main questions it aims to answer are: Does this combination reduce tumor volume and del...
This study is a multiple-center, phase II clinical trial. Participants with HER2-positive advanced scrotal extramammary Paget's disease who met the eligibility criteria were enrolled after signing an informed consent form. All patients received treatment with 2mg/kg of Disitamab Vedotin and 3mg/kg of Toripalimab intrav...
Inclusion Criteria: Voluntarily sign the informed consent form and comply with the requirements of the protocol. Age ≥ 18 years old. Confirmed diagnosis by histological examination, combined with imaging assessment for scrotal extramammary Paget's disease; pathologically confirmed as HER2 positive, i.e., immunohistoc...
NCT02741232
Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block for Breast Cancer Surgery
In this study, the investigators will compare the intraoperative opioid consumption for patients undergoing breast cancer surgery. The patients will be divided in two groups, the first one will receive a pectoral nerve block right after induction of anesthesia and the second one, the control group, will not receive the...
After induction of general anesthesia with propofol, remifentanil and succinylcholine, the patients will be divided either in the pectoral block group or the control group (sham block). Both groups will receive the same perioperative and postoperative anesthetic protocol. The investigator in charge of the patient will ...
Inclusion Criteria: * ASA 1 to 3 inclusively * breast cancer surgery with or without axillary dissection Exclusion Criteria: * any contraindication to the pectoral nerve block (coagulopathy, infection, pre- existing neuropathy, local anesthetic allergy and refusal of local anesthesia) * refusal to participate in the...
NCT01789788
A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus
This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO6811135 or placebo daily for 2 weeks, with a follow-up ex...
Inclusion Criteria: * Adult patients, 18 to 65 years of age, inclusive * Type 2 diabetes mellitus according to WHO criteria diagnosed for at least 3 months prior to screening * On stable dose of metformin for at least 2 months prior to screening * Fasting plasma glucose during the screening period \</= 240 mg/dL * Hem...
NCT04228484
The Insulin Response to the Gut Hormone GIP After Near-normalisation of Plasma Glucose in Patients With Type 2 Diabetes
The investigators hypothesise that the insulinotropic effect of endogenous GIP is improvable in patients with type 2 diabetes after three weeks of near-normalisation of plasma glucose. To test this hypothesis, a randomised, placebo-controlled, double-blinded, crossover study employing a GIP receptor antagonist, will be...
Glucose-dependent insulinotropic polypeptide (GIP) exerts a strong insulinotropic effect in healthy individuals following meal ingestion. Studies in patients with type 2 diabetes have shown that the insulinotropic effect of exogenous GIP is severely reduced and recent data from the investigators' group suggest that the...
Inclusion Criteria: 1. Type 2 diabetes 2. Metformin treatment 3. Haemoglobin A1c (HbA1c) I. \>/= 59 mmol/mol in case the diabetes treatment is only metformin II. 53-75 mmol/mol in case the diabetes treatment is metformin and add-on therapy 4. Body Mass Index (BMI) \> 25 kg/m2 5. Age \> 18 years 6. Caucasian 7. Normal ...
NCT06193798
Diagnostic Laparoscopy for Unexplained Abdominal Pain
To evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories in general surgery depatment Assuit university hospital
Abdominal pain may be a simple thing or it may be a dangerous and life threatening one.It is very difficult to come to a correct diagnosis(1).Diagnostic laparoscopy gives many advantages in the management of many intra-abdominal conditions where the correct diagnosis could not establish clinically or even with the help...
Inclusion Criteria: * Patients with obscure abdominal pain * Age from 18 years old up to 70 years old Exclusion Criteria: 1. Current use of narcotics 2. patients have uncontrolled coagulopathy 3. Patients are Haemodynamically unstable 4. patients have Cardiopulmonary problems 5. Patients refusing the diagnostic lapa...
NCT06800690
Impact of Menstrual Phase on Oral Glucose Sensitivity
In this study we are determining whether the hormones associated with the phases of the menstrual cycle (menstruation \& ovulation) influence taste sensitivity to glucose. We hypothesized that women would be more sensitive to oral glucose as assessed by absolute detection threshold during ovulation than when assessed d...
Participants: The participants consisted of 15 healthy, non-obese, cycling females between the ages of 18-46 years. All participants completed informed consent and the study protocol was approved by the Rutgers University Institutional Review Board. 30 participants were screened for eligibility requirements. Inclusion ...
Inclusion Criteria: * regular menstrual cycle of 21-35 days Exclusion Criteria: * hormonal contraceptives or other hormonal treatments * a history of polycystic ovarian syndrome (PCOS) * menstrual irregularities * pregnancy * diabetes mellitus * thyroid conditions * recent COVID-19 infection * alterations in taste o...
NCT01278550
Prevention of Recurrent Ulcer Bleeding in High-risk Users of Low-dose Aspirin
Low-dose aspirin is the mainstay of treatment for patients with coronary heart disease and stroke. However, low-dose aspirin increases the risk of ulcer bleeding. Current evidence indicates that 80 - 100 mg of aspirin daily provides good protection against vascular events and the risk of ulcer bleeding is low (about 1%...
Low-dose aspirin is increasingly used for the prophylaxis against coronary heart disease and stroke. However, it is also an important cause of peptic ulcer bleeding worldwide. In England and Wales, low-dose aspirin is estimated to account for about 10% of ulcer bleeding in people aged 60 and over \[Weil 1995\]. The pro...
High-risk cohort Inclusion criteria: Patients must fulfill ALL of the following: 1. History of endoscopically confirmed ulcer bleeding 2. Need long-term aspirin for cardiovascular or cerebrovascular prophylaxis 3. Successful eradication of H. pylori based on histology Exclusion criteria: 1. Concomitant use of anti...
NCT01449487
Investigation of Efficacy and Safety of PPC-5650 to Experimental Induced Sensation and Pain in the Rectosigmoid
Irritable Bowel Syndrome (IBS) is a gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. Patients with IBS visit the doctor more frequently, use more diagnostic tests, consume more medications, miss more workdays, and consume more overall direct...
Clinical pain and especially visceral pain is diffuse and widespread, and normally associated with many autonomic symptoms that may blur the characterization of disease in clinical practice. When treating clinical pain analgesic effects are difficult to evaluate due to a number of factors other than the pain intensity....
Inclusion Criteria: * Signed informed consent * Postmenopausal women or women who have undergone hysterectomy, and males between 18 and 70 years of age * Pain intensity during pain attack should be \>5 on the GSRS questionnaire * Hypersensitivity within the last 2 years measured with the barostat * Patients able to co...
NCT06183307
Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia
The study aims to evaluate the effect of the nattokinase enzyme on inflammation and markers of cardiovascular risk in participants with dyslipidemia. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants with dyslipidemia for two months.
Nattokinase has potent fibrinolytic/antithrombotic, antihypertensive, antiatherosclerotic, lipid-lowering, antiplatelet/anticoagulant and neuroprotective activities. Nattokinase is capable of inhibiting platelet aggregation by blocking the formation of thromboxane and inactivating the type 1 plasminogen activator inhib...
Inclusion Criteria: * Both sexes; * Over 18 years of age; * Isolated increase in LDL-c (LDL-c ≥ 160 mg/dL); * Isolated increase in triglycerides (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting); * increased LDL-c (LDL-c ≥ 160 mg/dL) * TG (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting); * Reduction in HDL-c (men \< 40...
NCT00966030
Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974 (0974-042)
This study will demonstrate the definitive bioequivalence of a solid dose formulation of MK0974 to the liquid filled capsule formulation of MK0974.
Inclusion Criteria: * Subject is in good health * Subject is a nonsmoker * Subject is willing to comply with the study restrictions Exclusion Criteria: * Subject has history of stroke, chronic seizures, or any major neurological disorder * Subject has a history of cancer * Subject is a nursing mother * Subject has u...
NCT02085369
Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle
Obesity bariatric surgery patients usually lose more than 50% of their former obesity within a relatively short time (\~ 2 years). There is still a lack of knowledge about underlying psychological and biological mechanisms of decline in body weight. The intention of this project is to investigate whether bariatric surg...
Inclusion Criteria: * First bariatric surgery Exclusion Criteria: * More than one surgery
NCT05049889
Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema
Immersion Pulmonary Edema (IPE) is a relatively new form of hemodynamic pulmonary edema. The number of cases has been increasing over the last ten years and it has become the second most common cause of hospitalization for military divers, after decompression sickness. The pathophysiological mechanisms of IPE are not c...
Inclusion Criteria: * Military or civilian diver with at least 100 dives * Between the ages of 18 and 60 * Good physical condition (able to run/swim for 30 minutes at a constant pace). Exclusion Criteria: * Divers with a current temporary medical incapacity to dive * Persons with contraindications to physical exerci...
NCT00277017
Combination Therapy With 5-Fluorouracil, Interferon-an Interleukin-2, & Thalidomide for Metastatic, Advanced or Recurrent Renal Cell Carcinoma
The purpose of this study is to evaluate a therapy combining the established FUNIL regimen with Thalidomide. We want to see how well the therapy works, if it can be easily done, and how well the body handles the treatment. We also wish to see if the addition of Thalidomide will increase the effectiveness of the already...
Eligible patients who agree to take part in the study will receive oral dosages of Thalidomide at 200mg/day to start, with dosage gradually increasing up to a maximum of 1200mg/day. This will be taken in combination with: 5-fluorouracil, given by continuous IV infusion over 24 hours (Day 1) every week for 4 weeks. In...
Inclusion Criteria: * All patients must have histologically proven renal cell carcinoma which is metastatic, non-resectable and/or recurrent. * Patients must have bidimensionally measurable disease as defined in Section 10.1a documented within 28 days prior to registration. X-rays, scans, or physical exam of all non-m...
NCT05364515
Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
Lichen sclerosus is a chronic dermatosis of the skin and semimucous membranes, characterized by the presence of well-defined atrophic white papules or plaques, which appear mainly on the skin of the anogenital region of both sexes, and less frequently on the skin of the trunk. , mainly affecting postmenopausal women. T...
Inclusion Criteria: * Age \>18 years * Woman with symptoms associated with LEA confirmed by histological study * Being 1 month without prior treatment in the affected area as a washing period * Availability of observation during the treatment period * Signature of the informed consent Exclusion Criteria: * Acute som...
NCT05286684
Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis (Exo-LCR)
The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metasta...
The primary objective is to describe on an exploratory basis the association between the type of proteomic profile from cerebrospinal fluid (CSF) microvesicles (from unsupervised bioinformatics analysis) and CSF cytology analysis (positive, negative, equivocal) in breast cancer patients with suspected leptomeningeal me...
Inclusion Criteria: * Patient with histologically proven breast cancer; * Patient with suspected metastatic leptomeningeal involvement; * Age ≥ 18 ans ; * WHO performance status ≤ 2 ; * Affiliation to the National Social Security System ; * With informed and signed consent Exclusion Criteria: * History of another ca...
NCT02106754
Alcohol Screening & Brief Lntervention in Juvenile Justice: Filling the Gap
This proposal is in response to RFA-AA-12-008, Evaluation of NIAAA's Alcohol Screening Guide for Children and Adolescents. Of particular interest to the agency are evaluation of the Screener in clinical and/or other settings to predict alcohol-related consequences including use disorder; its use as an initial screen fo...
1. A) To evaluate SN, SP, PP and NP of the 2-question Alcohol Screener to detect: a) alcohol problems (academic, social, injuries, intoxicated driving, unprotected sex), b) abuse/dependence, c) past 4 week binge drinking. 1B) This will be repeated to predict risk prospectively over 12 months. Classification rates will ...
Inclusion Criteria: * Youths 9-18 years old Exclusion Criteria: * Age (\< 9, \>18 years) * Prior enrollment in a behavioral intervention study * PO previously engaging them with Screener
NCT03910439
Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma
Background: Multiple myeloma is a cancer that forms from plasma cells which normally produce important immune response antibodies. It cannot be cured. Researchers hope the combination of radiation combined with the drug avelumab causes the immune system to kill myeloma cells more effectively. Objective: To see if av...
Background: * Multiple Myeloma (MM) is a hematologic neoplasm of the plasma cells defined by an M- protein greater than or equal to 3.0 g/dL or bone marrow plasma cells greater than or equal to 10% and presence of end-organ disease. * Although significant advances in treatment have been made in the past decade, MM rem...
* INCLUSION CRITERIA: * Patients must have a documented diagnosis of multiple myeloma defined by the International Myeloma Working Group Criteria (IMWG)(3). Patients at initial diagnosis must have had a serum M-protein greater than or equal to 3 g/dL and/or bone marrow plasma cells greater than or equal to 10%, and at ...
NCT04810624
Relapse Prevention and Changing Habits in Anorexia Nervosa
This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package. In the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after acute hospita...
While many approaches to reducing relapse after hospital care have been tried, there is little information about which treatment elements confer benefit. This trial, Relapse Prevention and Changing Habits (REACH+), targets the habitual control of maladaptive behavior to support patients with AN in the 6 months after ac...
Inclusion Criteria: * Diagnosis of Anorexia Nervosa at hospital admission * Medically Stable * Internet capability with videoconferencing * Weight restored (BMI \> 19 kg/m2) at New York State Psychiatric Institute Exclusion Criteria: * Current substance use or other comorbid disorder requiring specialized treatment ...
NCT04202913
Building Resilience for Healthy Kids
School based, mental-health intervention focused on improving self-efficacy and coping skills in children aged 9-13 years. The overall premise of our intervention is that by teaching children these skills they will in-turn become more resilient when faced with life-stressors and/or adverse events.
Healthy Kids is a 1:1 health coaching intervention delivered in school-settings. Students meet weekly with their assigned health coach and together they identify both strengths and areas for improvement with respect to resilience, developing resilience skills, and setting resilience goals. Topics discussed include copi...
Inclusion Criteria: * All children in participating school Exclusion Criteria: * None.
NCT06384417
Using an End-of-life Conversation Game to Engage Patients with Cancer in Advance Care Planning: Phase 2
The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness of end-of-life conversation game "Hello" as a tool to help individuals with various solid cancer types (including: breast, gastro-intestinal, lung, melanoma, head and neck, and/or genito-urinary cancers) treated at Penn State He...
Previous studies conducted by the investigators have shown that the Hello game demonstrates successful advance care planning (ACP) engagement in general populations, but has yet to be tailored to meet the unique needs of patients with advanced cancer and their caregivers. Outlining their care preferences by engaging in...
Inclusion Criteria Patient with Cancer: * Adults (\> 18 years old) * Able to speak and read English and/or Spanish * Be an individual diagnosed with a solid tumor cancer (e.g., breast, colon, lung, melanoma, head and neck, or genitourinary/prostate cancer) as verified by primary oncologist or is the chosen caregiver f...
NCT03611374
Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study
The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. The goals of this study are to determine if bilateral erector spinae plane blocks (ESPB) after sternotomy for congenital heart repair in high risk children and adult...
Inclusion Criteria: i) Ages 0-99 ii) Give consent/parental consent to participate in study iii) Patients undergoing sternotomy for congenital heart repair surgeries Exclusion Criteria: i) Participants who do not consent or have parental consent ii) Patients who are clinically unstable or require urgent/emergent inte...
NCT01270503
Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines. Primary Objective: To describe the serious adverse events occurring within 30 days among particip...
Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.
Inclusion Criteria: * Aged 2 to 11 years of age on the day of inclusion (Group 1) * Aged 12 to 17 years of age on the day of inclusion (Group 2) * Aged 18 to 55 years of age on the day of inclusion (Group 3) * Provision of informed consent form signed by the parent(s) or legal representative (Group 1) * Provision of a...
NCT04729855
Association of Autophagy-related Genes ,LncRNA and SNPs With Colorectal Cancer in Egyptian Population
1. Determination of expression level of HOTTIP and EIF4EBP1(Eukaryotic translation initiation factor 4E-binding protein 1) . 2. Investigation of the SNP HOTTIP rs1859168 and it's association with CRC susceptibility. 3. Correlation of the expression of these genes with various stages of CRC to determine the prognostic v...
Colorectal cancer (CRC) is a common digestive tract tumor 1.It is the third leading cause of death in the world. Overall 5-year survival rate is less than 40%, and the occurrence is rising 2. However, the prognosis and therapy have not been significantly improved. Therefore, a proper selection of patients for aggressiv...
Inclusion Criteria: * No sex predilection. * Age (25-65 yr). * Colorectal carcinoma confirmed by histopathological examination Exclusion Criteria: * -patients who received any treatment. * Cases with other organ cancers. * History of chemotherapy and radiotherapy. * Systemic diseases such as renal failure, diabetes ...
NCT03078543
Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System
The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature
The ANTHEM PS Study is a prospective, multicentre, cohort study to collect relevant patient reported, clinical, surgical and radiological data from 143 subjects implanted with the ANTHEM™PS Knee System for degenerative joint disease in up to 6 clinical sites globally. Total study duration for study participants will be...
Inclusion Criteria: 1. Subject is a candidate for primary total knee arthroplasty due to degenerative joint disease 2. Subject is willing to sign and date an EC-approved consent form 3. Subject is male or female between the ages of 18 and 75 years of age 4. Subject plans to be available through ten (10) years post-ope...
NCT01972802
International Cancer of the Head and Neck, Genetics and Environment (InterCHANGE) Study
Our overall objective is to understand the role of lifestyle factors, genetics and HPV infection in the development and prognosis of head and neck cancer particularly in Asia.
Inclusion Criteria: Age 18\~80 Incident head and neck cancer patients * Oral, oropharynx and hypopharynx (C00-C14) * Laryngreal cancer (C32) * \*Esophageal cancer if possible (C15) Exclusion Criteria: * Salivary gland (C07-C08) * Nasopharynx (C11) * Thyroid (C79.3)
NCT02507271
Speed of Processing Training in Traumatic Brain Injury
The purpose of this project is to test the hypothesis that Speed of Information Processing (SIP) deficits in acquired brain injury (ABI) can be remediated. The majority of individuals with acquired brain injuries have speed of information processing deficits as part of the cognitive sequelae of the brain injury. Empiri...
The specific aims of the current research protocol are as follows: Aim 1: To test the hypothesis that SIP training of individuals with ABI will improve processing speed. This study is expected to demonstrate that individuals with ABI that receive SIP training will improve on neurocognitive measures of processing speed....
Inclusion Criteria: * Mild, moderate and severe traumatic brain injury or a cerebral vascular accident (Stroke) * All subjects will be between the ages of 18 and 70 years * Free from significant psychiatric history (such as schizophrenia or bipolar disorder), due to the potential influence of such disorders on cogniti...
NCT06955117
McKenzie vs Manual Therapy for Low Back Pain
A comparative study evaluating the effectiveness of the McKenzie technique versus manual therapy in patients with nonspecific low back pain. The study aims to assess which intervention is more effective in reducing pain and improving functional mobility.
The study compares McKenzie Method, a directional preference-based approach involving repeated movements and posture correction, against Manual Therapy, which includes hands-on techniques such as mobilizations and manipulations. Patients with nonspecific low back pain will be randomly assigned to one of the two groups ...
Inclusion Criteria: Diagnosis of nonspecific low back pain lasting \>4 weeks Age 35-45 years Willing to participate and follow protocol Exclusion Criteria: History of lumbar spine surgery Spinal fracture, tumor, or infection Pregnant women Severe osteoporosis or deformity
NCT00412724
Development and Validation of the Food Acceptability Questionnaire
The Food Acceptability Questionnaire (FAQ) is a self-report measure of palatability, ease of preparation, satisfaction, and perceived benefits and adverse effects related to a prescribed or self-selected diet. This study intends to develop a reliable and valid food acceptability questionnaire for use in clinical studie...
Two hundred adult participants who follow a therapeutic diet will be recruited from the Washington DC area. Participants will be asked to rate their impression on the foods that they were eating in the past two weeks. Fifty participants will be chosen at random and asked to complete the questionnaire a second time, thr...
Inclusion Criteria: * Participants must be older than 18 years and follow any kind of therapeutic diet. Exclusion Criteria: * Those who have difficulty eating by themselves will be excluded. No vulnerable subjects will be included.
NCT03310333
Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes
The objective is to demonstrate the superiority of the strategy of labor induction by Cook® cervical ripening balloon between recommended strategy by dinoprostone (propess®) on the reduction of the time between cervical ripening and delivery in case of unfavorable cervix after 12 hours of PROM in term pregnant women.
The inclusion begins after 12 hours of PROM for a pregnant woman who has an unfavourable cervix and no B streptococcus. The case is discussed during the obstetric staff every morning. If the cervix is unfavourable (cervical Bishop's score \<6), the information of the study is given to the patient and the consent colle...
Inclusion Criteria: * Pregnant women * 18 years old With a singleton live cephalic pregnancy ≥ 37+0 weeks Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation) PROM without spontaneous labour in the 12 hours after the rupture. The diagnostic of PROM is clini...
NCT02820961
Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer
The purpose of this study is to determine the effect of exemestane on the pharmacokinetics (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer. Additionally, this study will evaluate the safe...
SNDX-275-0130 is a Phase 1, two-cohort, open-label, drug-drug interaction study of entinostat and exemestane. All patients will be enrolled into one of two cohorts to receive either entinostat monotherapy followed by entinostat plus exemestane (Cohort 1), or exemestane monotherapy followed by exemestane plus entinostat...
Inclusion Criteria: * Postmenopausal female patients * Histologically or cytologically confirmed ER+ breast cancer at initial diagnosis and have locally recurrent or metastatic disease that has progressed to where the patient is a candidate to receive exemestane as determined by the Investigator * Patients receiving p...
NCT03584126
Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation
The main objective of the present project is to develop an imaging-based tool to determine the origin and cause of persistent atrial fibrillation (AF). The result of the study is a diagnostic method which aids the medical work-up of patients suffering from this disease.
Atrial fibrillation (AF) is the most common arrhythmia associated with substantial morbidity and mortality in humans. Histopathological studies of persistent AF have reported extracellular matrix remodeling with fibrotic infiltration which may cause atrial dilation. The degree of the fibrosis might have a significant i...
Inclusion Criteria: * age: 20-80 years * weight: 50-120 kg * persistent, permanent or paroxysmal atrial fibrillation * clinically stable patients: outside of an acute cardiac event with constant chronic medication * optimum echographic window Exclusion Criteria: * patients with: rheumatic mitral disease; acute myoca...
NCT01487915
Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma
Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma. But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice. Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb) with MCAVI (Methotrexate, Carboplatin, Vinblastine...
Inclusion Criteria: * Cytologically of histologically confirmed urothelial carcinoma * Locally advanced or metastatic disease * Measurable disease according to RECIST v.1.1 * ECOG PS 0-2 * Cisplatin-unfit condition (any of the followings: NYHA functional class 3, creatinine clearance 30-60 ml/min, and ECOG PS=2) * Ade...
NCT06709066
Muscle Relaxant Effect and Safety of Mivacurium Chloride and Succinylcholine for Bronchoscopy
The goal of this clinical trial is to evaluate whether mivacurium chloride and succinylcholine can provide effective and safe muscle relaxation in adult patients aged 18-60 years undergoing bronchoscopy who require muscle relaxants during anesthesia. The main questions it aims to answer are: * Is the recovery of spont...
Inclusion Criteria: 1. Patients scheduled for painless bronchoscopy who require muscle relaxants during anesthesia. 2. Aged between 18 and 60 years. 3. Classified as Grade I-III according to the American Society of Anesthesiologists (ASA) Physical Status Classification. 4. Patients voluntarily participate and sign an ...
NCT00394550
Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty
This is a research study of the effect of treating laryngomalacia (floppiness of tissue on top of the voice box that can possibly block breathing) found in association with obstructive sleep apnea (blockage of breathing while sleeping). The purpose of this study is to determine which is the best treatment for children...
If you agree to have your child be in the study, you will do the following things: you are consenting to your child having the adenoid (tissue similar to lymph nodes, found in the back of the throat) and tonsils removed (if not previously performed), direct laryngoscopy (looking in the throat) and bronchoscopy (inspec...
Inclusion Criteria: * 1 year old to 18 years of age, clinical signs or symptoms of obstructive sleep apnea (snoring, witnessed apneas, daytime somnolence, restless sleeping, or cyanosis), abnormal polysomnogram (mild, moderate, or severe OSA) including CO2 measures, failed or refused trial of CPAP, or not recommended ...
NCT02693106
Evaluation of the Ketogenic Potential of Different Diet Supplements
Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults.
The aim of this study is to evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate, carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which multiple blood samples are taken in order to measu...
Inclusion Criteria: * Healthy adults aged of 18 years old or older. * Non-smoking. Exclusion Criteria: * Diabetes or prediabetes * Uncontrolled hypertension * Uncontrolled thyroid function * Taking medication that will affect lipid/glucose metabolism * Severe infection or inflammation * Pregnancy
NCT04591756
Effectiveness of Respiratory Protection During Simulated Resuscitation: a Prospective Cohort Study
The study hypothesizes that EHMRs with P100 filters will provide superior respiratory protection during simulated CPR compared to disposable N95 FFRs as measured by qualitative fit testing. To this end, the study is a prospective observational cohort to evaluate the effectiveness of disposable FFRs and EHMR during sim...
Inclusion Criteria: * Current use of respirator within last 7 days * Completed fit test with respirator within last 2 years Exclusion Criteria: * Previous adverse reaction to fit testing or testing agent * Development of any health problem that precludes use of a respirator since last occupational health evaluation
NCT00204256
Intravenous Iron in Patients With Anemia of Chronic Kidney Disease
The objective of this study is the evaluation of the efficacy and safety of intravenous iron sucrose in anemic patients with chronic kidney disease not on renal replacement therapy.
This is a randomized, open label, phase IV study in anemic predialysis patients (Hb between 8 and 11.5 g/dl) who require iron supplementation. The duration of the study for each patient will be approximately 6 months. Patients will be randomized to one of two treatment arms and admitted to the anemia correction phase (...
Inclusion Criteria: Chronic kidney disease Anemia (Hb 8 - 11.5 g/dl) Age above 18 years Signed informed consent Exclusion Criteria: Rapid progression of kidney disease Need for dialysis Uncontrolled hypertension
NCT00673062
Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED)
This study is to evaluate the effectiveness of a new drug on congestion in subjects with seasonal allergic rhinitis. This effect will be compared to placebo and to the decongestant, pseudoephedrine.
Inclusion Criteria: * Subjects must be 18 to 65 years of age, of either sex, and of any race. * Subjects must have a history of SAR due to ragweed for the last two consecutive ragweed seasons. * Subjects must be skin-test positive for the ragweed pollen allergen used in the Environmental Exposure Unit (pollen chamber ...
NCT06097546
Serum Retinoic Acid Induced Protein 14 (RAI14) and Metastasis Associated Cancer Colon -1 (MACC-1) in Breast Cancer
1. Measurement of serum levels of Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) as biomarkers for diagnosis of breast cancer. 2. Study their relationship to disease stages and clinicopathological features of BC. 3. Compare the diagnostic performance of serum RAI14 and serum MACC-1 ...
Breast cancer (BC) is one of the most prevalent Neoplasms and the second leading reason of death from cancer in women. Every year approximately 2.3 million new cases of BC are diagnosed worldwide. Due to the high impact of this type of cancer, the early detection, early diagnosis and effective treatment, will improve t...
Inclusion Criteria: 1. Patients with benign breast lesions. 2. Patients with breast cancer who were confirmed by histopathological studies and did not receive any treatment. Exclusion Criteria: 1- Patients who received chemotherapy or radiotherapy. 2- Patients with known other organ malignancy.
NCT06578416
The Development of Stuttering in Young Children
The goal of this longitudinal research is to learn why some children "grow out" of stuttering, while others persist. Children who do and do not stutter aged 3-6 years are eligible to participate in our study. During the study, children's speech and language abilities will be assessed with standardized assessments, and ...
The length of participation in our study depends on the subset of activities completed. Families in the longitudinal study will take part in three visits each lasting approximately 2 hrs for up to 5 years. Parents and caregivers will complete parent questionnaires (1 x each year for up to 5 years) and a 5-minute, onli...
Inclusion Criteria for controls: * English as first/primary language * No history of neurological disease * Normal or corrected visual acuity * No medications expected to affect performance * No intellectual impairment, autism spectrum disorder, ADHD * Age-appropriate scores on speech and language assessment battery *...
NCT03278171
Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit
Post-traumatic stress disorder (PTSD) is a psychiatric pathology noticed in the DSM-5, in troubles due to a traumatism or a stress factor and appearing at least 1 month after confrontation with trauma. This trouble can become chronic, and be the source of psychiatric and somatic comorbidities, which themselves have per...
Inclusion Criteria: * Patient over 18 years old leaving an intensive care unit after a stay of more than 72 hours, in one of the medical and surgical intensive care units of the E Herriot Hospital * Patient having given his agreement to participate in this study Exclusion Criteria: * Patient not understanding French...
NCT05940532
A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC
The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.
Inclusion Criteria: 1.18 to 75 years old, both male and female; 2.ECOG score: 0-1; 3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer; 4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy; 5.Measurable le...
NCT04768205
The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus
Globus pharyngeus or sensation may be defined as a feeling of something a lump in the throat without dysphagia. Kinesio tex tape is a medical tap developed by Dr. Kase for therapeutic purposes and has been widely used in physical therapy applications in recent years. Although it is not a treatment with full consensus, ...
We conducted a therapy program with kinesio taping on patients who diagnosed with globus pharyngeus for 8 session with sham kinesio taping controlled group. This study aimed to assess of efficacy of the kinesio taping with therapy on patients patients who diagnosed with globus pharyngeus.
Inclusion Criteria: * diagnosed with globus pharyngeus * 18 -65 years * give a consent form Exclusion Criteria: * patients with dysphagia or odynophagia * laryngeal organic pathologies * pharyngeal organic pathologies * epiglottic retroversion * malignancy * pregnancy * mental disorders * neurological disorders * ma...
NCT03936348
Effects of an Exercise Rehabilitation Programme With a Nasal Inspiratory Restriction Device in COPD Patients
This study evaluates the effects of a nasal restriction device for inspiratory muscle training (FeelBreathe) after 8 weeks of exercise intervention on exercise capacity, quality of life, dyspnea and inspitarotory muscle strength in patients with stable COPD. Participants were divided in three groups: 1) exercise interv...
The Feelbreathe® device, tested in the investigator's study can be used in static and dynamic situations and is a nasal ventilatory flow restriction device made by a strip of hypoallergenic material (3M Spain, S.A. Medical Specialties / O.E.M.) that is placed and adhered under the nostrils impairing the free pass of ai...
Inclusion Criteria: * men with diagnosis of COPD according to guidelines criteria * with moderate or severe airflow obstruction (GOLD 2 or 3) * dyspnea grade 2 or greater by mMRC scale * stable clinical condition for at least 2 months. Exclusion Criteria: * poor compliance * treatment with oxygen therapy or non-inva...
NCT00685516
Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery
RATIONALE: Green tea contains ingredients that may prevent or slow the growth of certain cancers. It is not yet known whether green tea is more effective than black tea or water in treating prostate cancer. PURPOSE: This randomized phase II trial is studying green tea to see how well it works compared with black tea a...
OBJECTIVES: * to determine the effect of GT and BT consumption on apoptosis (TUNEL, ratio Bax:Bcl-2), proliferation, oxidation, and inflammation in malignant radical prostatectomy tissue compared to water control using immunohistochemistry. * to examine levels of tea polyphenols and methylated tea polyphenol metabolit...
Inclusion Criteria: * subject consents to participate in the trial. * subject is 40-75 years of age and has a diagnosis of adenocarcinoma of the prostate. * Scheduled to undergo radical prostatectomy. * The subject agrees to stop consumption of tea or tea-containing products throughout the entire intervention period e...
NCT03100994
Post-operative Analgesia Efficacy Using Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Ultrasound-guided Quadratus Lumborum Type II Block.
Post-operative analgesia efficacy using ultrasound-guided transmuscular quadratus lumborum block versus ultrasound-guided quadratus lumborum type II block
The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics between the quadratus lumborum muscle and latissimus dorsi muscle, which is called quadratus lumborum type II block. 〝 Transmu...
Inclusion Criteria: * American Society of Anesthesiologists classification (ASA) 1\~3 * adequate communication skills * Body mass index \< 32 Exclusion Criteria: chronic pain neurological illness/ neuropathy contraindication against local anesthetics
NCT03536897
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identifi...
Inclusion Criteria: * Female * ECOG performance status 0-1 * Age 65 years or older * cT1 or cT2 (≤3.0 cm) * Invasive ductal carcinoma histology * Estrogen receptor positive (ER+) * Grade 1 or Grade 2 * Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling * Suitable for breast conserving ...
NCT03879720
Comparison of Standard and Endoscope Assisted Endotracheal Intubation
Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation
Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures are typically performed using general anesthesia. During anesthesia, the anesthesiologist inserts a breathing tube (endotracheal tube) into the patient's wind pipe (trachea) and a machine helps the patient breathe (mechanical ventilation) while they are u...
Inclusion Criteria: * Patients undergoing ERCP at Stanford University Medical Center Exclusion Criteria: * Unable to consent * Contra-indication to general anesthesia
NCT05037838
Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation
Mycocardial systolic function (contractility) is an essential element of cardio-circulatory physiology during major visceral surgery, in particular during liver transplantation during which several factors are likely to be at the origin of a ventricular dysfunction: acute hemorrhage, major volume changes, acute pulmona...
Inclusion Criteria: * Age of 18 years old and more * Patients undergoing a liver transplantation Exclusion Criteria: * Contraindication to transesophageal ultrasound * Refusal to participate * Age \<18 years old
NCT02460263
The EvAluation of TaBlo In-CLinic and In-HOme
The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects.
Inclusion Criteria: * Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist. * Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ...
NCT04727333
[Trial of device that is not approved or cleared by the U.S. FDA]
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NCT01481948
Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation
The purpose of this project is to reduce health disparities in obesity risk among 8-10 year old African American girls using a culturally sensitive and developmentally appropriate internet-based program with no face-to-face interaction. This study will conduct an outcome evaluation to test short and longer term effects...
This research will conduct an outcome evaluation on a promising web based obesity prevention program for 8-10 year old African American girls. A pilot study with 80 girls established its feasibility: recruitment goals were met; attrition rates were \< 10%; logon rates to the online program were 74.5%; and statistically...
Inclusion Criteria: * 8-10 years old * healthy * African American * parent willing to participate in data collection * internet access * personal email address Exclusion Criteria: * mental, physical, or medical conditions that limit fruit-vegetable consumption, physical activity, or ability to fully participate in t...
NCT01591824
Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain
Through this research is to conduct a pilot clinical trial in the treatment of chronic nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that will apply a technique of physiotherapy by passive movement of the column with oscillations in axial rotation at a frequency of 1.5 to 2 cps (...
Type of study: This is an analytical study, the experimental group clinical trial type, controlled, randomized with complete randomization and single blind. Two groups, the study to which the POLD treatment shall apply, and the control group with conventional treatment will be formed by complete randomization system ...
Inclusion Criteria: * Having a diagnosis instrumental prior to treatment to rule out pathologies pollutants, neurological or structural malformations. * No previous trauma. * Age between 25 and 65. * With similar clinical characteristics to have a homogenous group: * Low back pain (\> 3 months) and that at the time...
NCT01948752
Clinical Trial of Menu Labeling
The current study sought to examine the effect of menu labeling on food ordering and food consumption, including the effect of displaying calories along with other nutrients, such as sodium, fat, and sugar, as well as in different formats, such as traffic lights. The investigators hypothesize significant differences i...
Inclusion Criteria: * 18 years of age or older, * able to speak and read English Exclusion Criteria: - no food allergies to gluten or other grain products
NCT03571828
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g., recommended phase 2 dose \[RP2D\])
Inclusion Criteria: * Subject has provided informed consent prior to initiation of any study-specific activities/procedures * Age ≥ 18 at the time of informed consent. * Biopsy proven B-NHL including: * DLBCL, which also includes DLBCL that represents transformation of indolent NHL (including follicular, marginal z...