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Participants will be given bottles of heavy water to drink at home on a schedule for 21 days. Each bottle holds about 3.5 tablespoons. Heavy water is odorless, colorless, and tasteless, like normal drinking water. It is safe to drink and has been used in research for many years.
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Participants will have tests during study visits, including:
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Imaging scans of a leg.
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Exercise on a treadmill.
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Biopsies of muscle, skin, and fat: Small samples of tissue will be cut from the calf and abdomen.
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Resting metabolic rate: Participants will lie still and breathe into a mask for 20 minutes.
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Knee/grip strength: Participants will do strength tests with their legs. They will squeeze a device with their hands.
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D3-Creatine: Participants will take 1 pill of D3-Creatine, which occurs naturally in muscle. conditions: Healthy Volunteers studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 75 type: ESTIMATED measure: Measure the turnover proteins in humans across tissues, age, and sex. measure: Test the hypothesis that older age is associated with diminished protein turnover. sex: ALL minimumAge: 20 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Aging, Clinical Research Unit status: RECRUITING city: Baltimore state: Maryland zip: 21224 country: United States name: Luigi Ferrucci, M.D. role: CONTACT phone: 410-558-8110 email: ferruccilu@grc.nia.nih.gov lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06269640 id: 10001640 id: 001640-H briefTitle: NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Early Feasibility Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-10-01 date: 2027-10-01 date: 2024-02-21 date: 2024-04-26 name: National Heart, Lung, and Blood Institute (NHLBI) class: NIH briefSummary: Background:
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Some people have a condition in which the wall (septum) that separates the two main pumping chambers of the heart is too thick. This thick septum causes a condition called "left ventricular outflow tract obstruction" (LVOTO), which reduces blood flow out of the heart. LVOTO can cause serious heart disease; symptoms may include shortness of breath, chest pain, heart failure, or death. Researchers want to find better ways to treat LVOTO.
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Objective:
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To test a new procedure where excess tissue is sliced away from the septum in people with LVOTO. This procedure is called "septal scoring along midline endocardium" (SESAME).
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Eligibility:
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Adults aged 21 years with LVOTO.
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Design:
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Participants will have baseline tests. They will have imaging scans and tests of their heart structure and function. They will take a walking test and answer questions about how their heart condition affects their life.
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Participants will stay in the hospital 2 to 6 days for the SESAME procedure.
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They will be completely or partially asleep for the procedure. A tube will be inserted into the mouth and down the throat to take pictures of the heart. Pictures may also be taken with a tube inserted inside the heart.
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Next, tubes will be inserted into the groin and guided through the blood vessels up to the heart. Guidewires will be inserted into the heart. Doctors will watch the path the wires take with x-rays and ultrasound. When the wire is in the correct place, it will be electrified to slice excess tissue away from the septum.
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Participants will have 3 follow-up visits within 1 year. conditions: Hypertrophic Cardiomyopathy conditions: Left Ventricular Septal Hypertrophy conditions: Mitral Valve Disease conditions: Aortic Valve Stenosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Septal Scoring Along Midline Endocardium measure: Technical success measure: Safety measure: Complete heart block requiring permanent pacemaker sex: ALL minimumAge: 21 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Emory University Hospital city: Atlanta state: Georgia zip: 30322 country: United States name: Robert Lederman, M.D. role: CONTACT phone: 301-402-6769 email: lederman@nih.gov lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06269627 id: 10001644 id: 001644-AA briefTitle: Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-12-31 date: 2024-02-21 date: 2024-04-26 name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) class: NIH briefSummary: Background:
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Chronic heavy drinking can cause alcohol use disorder (AUD). AUD changes how the brain works. People with AUD may drink compulsively or feel like they cannot control their alcohol use. Acamprosate is an FDA-approved drug that reduces anxiety and craving in some, but not all, people with AUD.
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Objective:
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To learn more about how acamprosate affects brain function in people with AUD.
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Eligibility:
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People aged 21 to 65 years with moderate to severe AUD.
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Design:
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Participants will stay in the clinic for 21 days after a detoxification period of approximately 7 days.
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Acamprosate is a capsule taken by mouth. Half of participants will take this drug 3 times a day with meals. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which capsules they are taking.
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Participants will have a procedure called electroencephalography (EEG): A gel will be applied to certain locations on their scalp, and a snug cap will be placed on their head. The cap has sensors with wires. The sensors detect electrical activity in the brain. Participants will lie still and perform 2 tasks: they will look at different shapes and press a button when they see a specific one; and they will listen to tones and press dedicated buttons when they hear the corresponding tones.
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Participants will have 2 EEGs: 1 on day 2 and 1 on day 23 of their study participation. They may opt to have up to 4 more EEG studies (one on day 13 and one on each of the three follow-up visits) and 2 sleep studies, in which they would have sensors attached to their scalp while they sleep.
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Participants may have up to three follow-up visits for 6 months. conditions: Alcohol Use Disorder studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 48 type: ESTIMATED name: Acamprosate calcium name: Placebo measure: Reduction of beta power measure: Promotion of alpha power in active group compared to placebo group. measure: No change in slow band (delta and theta) power in active group compared to placebo group. measure: Reduction of theta event-related synchronization in active group compared to placebo group. measure: Amplification and hastening of P300 in active group compared to placebo group. measure: Correlation of EEG markers of acamprosate treatment with clinical measures of anxiety and alcohol craving measure: Correlation of EEG markers of acamprosate treatment with polysomnography markers measure: Correlation of polysomnography markers of acamprosate treatment with clinical measures of anxiety and alcohol craving sex: ALL minimumAge: 21 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: NIH Clinical Center Office of Patient Recruitment (OPR) role: CONTACT phone: 800-411-1222 phoneExt: TTY dial 711 email: ccopr@nih.gov lat: 38.98067 lon: -77.10026 hasResults: False
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<|newrecord|> nctId: NCT06269614 id: QOL334829 briefTitle: Assessing the Gut Microbiome and Its Association With Pediatric Stress and Cognition overallStatus: RECRUITING date: 2023-01-12 date: 2025-12-31 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Nova Southeastern University class: OTHER briefSummary: Using a metabolomics approach in combination with eye-tracking data, this research study proposes to gather evidence from two interrelated body systems (gut and brain) in order to assess how the microbiome is involved in stress modulated symptoms in children with autism and children exposed to repeated stress in comparison to a control group. conditions: Autism Spectrum Disorder conditions: Adverse Childhood Experiences conditions: Stress Reaction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SCREENING masking: NONE count: 75 type: ESTIMATED name: Probiotic measure: Enteric Microbiome abundance measure: Enteric Microbiome diversity measure: Improved response to stressor measure: Improved physiological response to stressor sex: ALL minimumAge: 4 Years maximumAge: 95 Months stdAges: CHILD facility: Nova Southeastern University College of Nursing status: RECRUITING city: Davie state: Florida zip: 33314 country: United States name: Gesulla Cavanaugh, PhD role: CONTACT phone: 954-262-1980 email: gcavanaugh@nova.edu lat: 26.06287 lon: -80.2331 hasResults: False
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<|newrecord|> nctId: NCT06269601 id: HÜ- FTR- BD- 02 briefTitle: The Reliability of the Upper Limb Rotation Test in Adolescent Male Basketball Players overallStatus: COMPLETED date: 2023-08-10 date: 2023-09-15 date: 2023-09-15 date: 2024-02-21 date: 2024-02-28 name: Hacettepe University class: OTHER briefSummary: The objective of the study is to examine the reliability of the Upper Limb Rotation Test in adolescent male basketball players aged between 14 and 16. According to the sample size calculation for the study, 51 athletes were included. The Upper Limb Rotation Test was administered to the athletes twice, with a one-week interval. The athlete was positioned in a plank stance with shoulder, elbow lateral epicondyle, greater trochanter, and ankle lateral malleolus making contact with the wall. The athletes were instructed to perform a 90° abduction and 90° external rotation of the shoulder, accompanied by trunk rotation for a duration of 15 seconds. The number of repetitions was recorded. The tested side was the upper extremity in which the closed kinetic chain position was maintained. The test was repeated three times, and the average of the results was calculated. The Upper Extremity Rotation Test is a reliable assessment tool for evaluating performance in adolescent basketball players aged 14-16, particularly in relation to shooting skills. conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 14-18 years basketball players primaryPurpose: OTHER masking: NONE count: 51 type: ACTUAL name: Upper Limb Rotation Test measure: The Reliability of the Upper Limb Rotation Test sex: MALE minimumAge: 14 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Hacettepe University city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06269588 id: NBM-NP004 briefTitle: Efficacy and Safety of Nexpowder™ for Non-variceal, Upper Gastrointestinal Bleeding overallStatus: RECRUITING date: 2024-02 date: 2024-12 date: 2024-12 date: 2024-02-21 date: 2024-02-21 name: Changi General Hospital class: OTHER name: Next Biomedical Co., Ltd. name: Tan Tock Seng Hospital name: National University Hospital, Singapore briefSummary: The purpose of this pilot clinical trial is to confirm the efficacy and safety of Nexpowder™ for hemostasis in pilot cohort of patients with NVUGIB in Singapore conditions: Gastrointestinal Hemorrhage conditions: Hematemesis; With Ulcer conditions: Endoscopy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: prospective single arm intervention cohort primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: Nexpowder measure: endoscopic hemostasis measure: recurrent bleeding rate on second-look endoscopy measure: hydrogel persistence rate at the bleeding site measure: Recurrent bleeding within 30 days after endoscopic therapy sex: ALL minimumAge: 21 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changi General Hospital status: RECRUITING city: Singapore zip: 529889 country: Singapore name: Tiing Ang, MRCP (UK) role: CONTACT phone: 69365737 email: ang.tiing.leong@singhealth.com.sg lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06269575 id: Dysphagia briefTitle: Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia overallStatus: COMPLETED date: 2020-10-05 date: 2023-08-15 date: 2023-12-15 date: 2024-02-21 date: 2024-02-21 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: It was planned in a quasi-experimental design with a non-randomized control group. The study was planned to be completed in three stages: control, preparation and intervention periods.
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Question 1: Does a safe nutrition program prevent aspiration pneumonia, dehydration and malnutrition in acute stroke patients with dysphagia? Question 2: Is the safe nutrition program effective on addiction level, quality of life and depression in acute stroke patients with dysphagia? Question 3: Does a safe nutrition program shorten the hospital stay and NG tube duration in acute stroke patients with dysphagia? conditions: DYSPHAGIA studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: non-randomized controlled primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 78 type: ACTUAL name: SAFE NUTRITION PROGRAM measure: Complications of dysphagia measure: Complications of dysphagia measure: Complications of dysphagia measure: Stroke-Specific Quality of Life Scale (SS-QOL) measure: Swallowing Anxiety Scale (YKÖ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istanbul Universitesi-Cerrahpasa city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06269562 id: clavicle briefTitle: SPSIPB and CPB on Clavicle Surgeries overallStatus: COMPLETED date: 2023-06-20 date: 2023-12-20 date: 2024-02-04 date: 2024-02-21 date: 2024-02-21 name: Cumhuriyet University class: OTHER briefSummary: Clavicular fractures represent a common occurrence often necessitating effective pain management strategies, particularly following surgical interventions. This study involved a cohort of five patients who underwent clavicular fracture surgery under general anesthesia. A novel analgesic approach combining two distinct nerve block techniques-Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Clavipectoral Plane Block (CPB)-was employed for postoperative pain control. The procedural methodology encompassed the administration of SPSIPB preceding anesthesia induction, followed by CPB subsequent to induction. SPSIPB targeted specific neural regions responsible for sensory blockade within the innervation of the clavicular skin, whereas CPB focused on the clavipectoral fascia. Standard anesthesia protocols were utilized, and postoperative pain levels were evaluated using Numeric Rating Scores (NRS). conditions: Clavicle Fracture conditions: Postoperative Pain conditions: Analgesia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: Serratus posterior superior intercostal plane block and clavipectoral plane block measure: Numerical Rating Scale measure: tramadol consumption sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sivas Cumhuriyet University city: Sivas zip: 58050 country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False
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<|newrecord|> nctId: NCT06269549 id: KDS_KOA briefTitle: Kinesiological / Dietary Supplement Intervention in Knee Osteoarthritis acronym: KDSKOA overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-09-30 date: 2025-12-31 date: 2024-02-21 date: 2024-02-26 name: University of Primorska class: OTHER name: Community Healthcare Center dr. Adolf Drolc Maribor (HCM) briefSummary: The goal of this clinical trial is to assess the effectiveness of dietary supplement combined with exercise in managing knee osteoarthritis (KOA). The main questions it aims to answer are:
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* Is adding a dietary supplement to exercise additionally effective in managing KOA?
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* Is adding exercise to the dietary supplement additionally effective in managing KOA?
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Participants will be given in three groups:
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1. Real dietary supplement alone
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2. Real dietary supplement with exercise
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3. Placebo dietary supplement with exercise
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Investigators will compare groups 1 and 2, or 2 and 3, to answer the research questions.
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The hypothesis is that participants who receive the dietary supplement along with exercise will experience greater reduction in pain level, improved physical function, and enhanced quality of life compared to those who receive a placebo combined with exercise or dietary supplement alone. conditions: Osteoarthritis, Knee studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL interventionModelDescription: The differences between groups will be tested using a two-way analysis of variance for repeated measures (factor 1 = group, factor 2 = time) primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE maskingDescription: Placebo blinding / masked for dietary supplement whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Non-training Real Dietary Supplement (G1) name: Training Placebo Dietary Supplement (G2) name: Training Real Dietary Supplement (G3) measure: Change from baseline in severity grading of knee osteoarthritis from X-ray Images at week 12 measure: Change from baseline in thickness of the articular cartilage and cross-section of muscles around knee joint at week 12 measure: Change from baseline in self-assessment pain, stiffness, and physical function (WOMAC questionaire) at week 12 measure: Change from baseline in self-assessment quality of life (SF-36 questionaire) at week 12 measure: Change from baseline in time spent sleeping, awake/sedentary, and physical activity within 24 hour (DAB-Q) at week 12 measure: Change from baseline in knee pain on visual analogue scale at week 12 measure: Change from baseline in static balance time at week 12 measure: Change from baseline in direction-specific amplitude from the center of pressure in static balance at week 12 measure: Change from baseline in direction-specific velocity from the center of pressure in static balance at week 12 measure: Change from baseline in direction-specific frequency from the center of pressure in static balance at week 12 measure: Change from baseline in number of repetitions in Chair Stand Test at week 12 measure: Change from baseline in time for Five Times Sit to Stand Test at week 12 measure: Change from baseline in number of repetitions in Arm Curl Test at week 12 measure: Change from baseline in lower body flexibility at week 12 measure: Change from baseline in upper body flexibility at week 12 measure: Change from baseline in 6-minute walk distance at week 12 measure: Change from baseline in maximal isometric voluntary contraction of knee flexor and extensor at week 12 measure: Change from baseline in explosive strength of knee extensor at week 12 measure: Change from baseline in 24-hour time use at week 12 measure: Change from baseline in presence of inflammatory markers in blood sample at week 12 sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Primorska, Faculty of Health Sciences city: Izola zip: 6310 country: Slovenia name: Nejc Šarabon, PhD role: CONTACT phone: 05 662 64 66 phoneExt: +386 email: nejc.sarabon@fvz.upr.si name: Tina Čeh, MSc role: SUB_INVESTIGATOR lat: 45.53694 lon: 13.66194 facility: Community Healthcare Center dr. Adolf Drolc city: Maribor zip: 2000 country: Slovenia name: Jernej Završnik, PhD role: CONTACT phone: 02 2286 257 phoneExt: +386 email: jernej.zavrsnik@zd-mb.si name: Tina Čeh, MSc role: SUB_INVESTIGATOR lat: 46.55472 lon: 15.64667 hasResults: False
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<|newrecord|> nctId: NCT06269536 id: UC-SK004 briefTitle: Stress-reducing Intervention in Urothelial Carcinoma overallStatus: RECRUITING date: 2024-02-15 date: 2027-02-15 date: 2029-02-15 date: 2024-02-21 date: 2024-02-21 name: Comenius University class: OTHER briefSummary: The aim of this interventional study is to test the heart-rate variability biofeedback intervention (HRV BI) in patients with muscle-infiltrating bladder carcinoma (MIBC) treated with chemotherapy based on cisplatin in neoadjuvant setting followed by local therapy (standard of care, SOC) compared to SOC alone. conditions: Bladder Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 50 type: ESTIMATED name: HRV biofeedback measure: Primary Objective: Inflammation measure: Primary Objective: Heart Rate Variability (HRV) measure: Primary Objective: Quality of Life (QoL) measure: Primary Objective: Working memory measure: Primary objective: Executive function measure: Primary objective: Salivary Cortisol Slopes measure: Primary objective: Sleep Quality measure: Secondary objective: Serious Adverse Events measure: Secondary objective: Disease-Free Survival (DFS) measure: Secondary objective: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Institute status: RECRUITING city: Bratislava zip: 83310 country: Slovakia name: Katarina Rejlekova role: CONTACT email: katarina.rejlekova@nou.sk name: Patrik Palacka role: PRINCIPAL_INVESTIGATOR lat: 48.14816 lon: 17.10674 hasResults: False
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<|newrecord|> nctId: NCT06269523 id: MFR032024 briefTitle: Effects of Rehabilitation and Kinesio Taping to Prevent Axillary Web Syndrome After Breast Cancer Surgery overallStatus: COMPLETED date: 2021-07-21 date: 2023-01-31 date: 2024-01-31 date: 2024-02-21 date: 2024-02-21 name: University of Palermo class: OTHER briefSummary: Axillary web syndrome (AWS) is a complication associated with breast cancer surgery, characterized by pain, functional limitation of the shoulder and decreased quality of life. There are several physical treatment options to reduce pain and improve the functionality of the upper limb in women with AWS. This study evaluates the effectiveness of an early rehabilitation approach to prevent axillary web syndrome consisting in functional and proprioceptive re-education, manual lymphatic drainage and kinesio taping after breast cancer surgery. conditions: Axillary Web Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 18 type: ACTUAL name: Kinesio taping, Lymphatic drainage name: Lymphatic drainage measure: NRS Scale measure: Joint excursion shoulder measure: Muscular strength of the upper limbs measure: Constant Murley Score measure: upper limbs circumferenze (cyrtometry) sex: FEMALE minimumAge: 45 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Functional Recovery and Rehabilitation Unit of the A.O.U.P. Paolo Giaccone city: Palermo zip: 90127 country: Italy lat: 38.13205 lon: 13.33561 hasResults: False
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<|newrecord|> nctId: NCT06269510 id: HUM00242997 id: 1R01AA030748-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01AA030748-01 briefTitle: Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients overallStatus: NOT_YET_RECRUITING date: 2025-04 date: 2027-07 date: 2027-07 date: 2024-02-21 date: 2024-03-26 name: University of Michigan class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The purpose of this trial is to see if providing patients with alcohol-related liver disease with tailored alcohol use treatment options will increase engagement with treatment and correct possible misconceptions. conditions: Alcohol-related Liver Disease conditions: Liver Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Computer-generated urn randomization will ensure balanced groups based on stage of ALD (advanced ALD and non-advanced ALD) and inpatient versus outpatient status at time of recruitment. Second stage randomization to 3-month intervention conditions will be stratified based on response and non-response status. Urn randomization using stage of ALD and inpatient versus outpatient recruitment will also be used at the second stage randomization. Re-randomization of non-responders will be computerized and stratified by stage of ALD and inpatient vs outpatient status. primaryPurpose: TREATMENT masking: NONE count: 268 type: ESTIMATED name: ENGAGE-ALD Application (APP) name: Treatment Facilitation bundle name: Enhanced Usual Care measure: Alcohol treatment engagement measure: Alcohol Use Frequency as Measured by a 30-day alcohol recall calendar method measure: Percent heavy drinking days (PHDD) measure: Change in Liver health based on liver laboratory values (aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase) for all participants measure: Change in Liver health based on liver laboratory values (total bilirubin) for all participants measure: Change in Liver health based on The Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis or alcoholic hepatitis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States name: Haila Asefa role: CONTACT phone: 734-232-0284 email: asefah@umich.edu name: Jessica Mellinger, MD, MSc role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
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<|newrecord|> nctId: NCT06269497 id: 2018/2300 briefTitle: TiO2-scaffolds for Alveolar Ridge Preservation acronym: TIOSCAFF overallStatus: COMPLETED date: 2021-11-09 date: 2022-06-20 date: 2023-08-10 date: 2024-02-21 date: 2024-02-21 name: University of Oslo class: OTHER briefSummary: The goal of this clinical trial is to evaluate the safety of placing TiO2 scaffolds in alveolar ridge and to evaluate if the scaffold material contributes to maintain the anatomy and the volume of the alveolar process after tooth extraction. conditions: Alveolar Bone Resorption studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Observational study / clinical trial primaryPurpose: OTHER masking: NONE count: 10 type: ACTUAL name: Scaffold placement name: CBCT measure: Adverse reactions measure: Anatomy measure: Inflammation measure: Mineralization sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Dentistry, University of Oslo city: Oslo zip: Postboks 1142 Blindern country: Norway lat: 59.91273 lon: 10.74609 hasResults: False
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<|newrecord|> nctId: NCT06269484 id: D4326C00004 briefTitle: A Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Participants With Cirrhosis-ZEAL-UNLOCK acronym: ZEAL UNLOCK overallStatus: RECRUITING date: 2024-02-15 date: 2025-01-17 date: 2025-01-17 date: 2024-02-21 date: 2024-03-25 name: AstraZeneca class: INDUSTRY briefSummary: This is a Phase IIb multicentre, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the safety of zibotentan/dapagliflozin in combination as compared to zibotentan monotherapy as well as zibotentan/dapagliflozin and zibotentan monotherapy as compared to placebo in patients with cirrhosis. conditions: Liver Cirrhosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 66 type: ESTIMATED name: Placebo (placebo matching zibotentan capsule and placebo matching dapagliflozin tablet) name: Zibotentan + placebo (placebo matching dapagliflozin tablet) name: Zibotentan + dapagliflozin measure: Occurence of any of the following components of this composite endpoint: >2kg increase in body weight (office-based), >2 L increase in total body water, increase in 2 or more loop-diuretic equivalents, fluid retention adverse event (AE) measure: Occurence of any of the following components of this composite endpoint: >2kg increase in body weight (office-based), >2 L increase in total body water, increase in 2 or more loop-diuretic equivalents, fluid retention adverse event (AE) measure: Change in body weight (kg) over time course of study measure: Change in body weight (kg) over time course of study measure: Change in total dosage of loop-diuretic equivalents use measure: Change in total dosage of loop-diuretic equivalents use measure: Occurence of either of the two components of this composite: 1. >3 L increase in total body water volume from baseline to Week 6 2. Increase in 3 or more loop-diuretics equivalents use measure: Occurence of either of the two components of this composite: 1. >3 L increase in total body water volume from baseline to Week 6 2. Increase in 3 or more loop-diuretics equivalents use measure: Absolute change in systolic and diastolic blood pressure measure: Absolute change in systolic and diastolic blood pressure measure: Change from baseline in body weight measure: Change from baseline in total body water measure: Change from baseline in extracellular water volume measure: Change from baseline in intracellular water volume measure: Change from baseline in body fat mass measure: Change from baseline in body weight measure: Change from baseline in total body water measure: Change from baseline in extracellular water volume measure: Change from baseline in intracellular water volume measure: Change from baseline in body fat mass sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Englewood state: Colorado zip: 80113 country: United States lat: 39.64777 lon: -104.98776 facility: Research Site status: NOT_YET_RECRUITING city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 facility: Research Site status: RECRUITING city: San Antonio state: Texas zip: 78215 country: United States lat: 29.42412 lon: -98.49363 facility: Research Site status: NOT_YET_RECRUITING city: Adelaide zip: 5000 country: Australia lat: -34.92866 lon: 138.59863 facility: Research Site status: NOT_YET_RECRUITING city: Kogarah zip: 2217 country: Australia lat: -33.98333 lon: 151.11667 facility: Research Site status: NOT_YET_RECRUITING city: Mitcham zip: 3132 country: Australia lat: -37.81667 lon: 145.2 facility: Research Site status: NOT_YET_RECRUITING city: Edegem zip: 2650 country: Belgium lat: 51.15662 lon: 4.44504 facility: Research Site status: NOT_YET_RECRUITING city: Mechelen zip: 2800 country: Belgium lat: 51.02574 lon: 4.47762 facility: Research Site status: NOT_YET_RECRUITING city: Liberec zip: 460 63 country: Czechia lat: 50.76711 lon: 15.05619 facility: Research Site status: NOT_YET_RECRUITING city: Mladá Boleslav zip: 293 01 country: Czechia lat: 50.41135 lon: 14.90318 facility: Research Site status: NOT_YET_RECRUITING city: Plzeň zip: 323 00 country: Czechia lat: 49.74747 lon: 13.37759 facility: Research Site status: NOT_YET_RECRUITING city: Praha 4 zip: 140 21 country: Czechia lat: 50.08804 lon: 14.42076 facility: Research Site status: NOT_YET_RECRUITING city: Aachen zip: 52074 country: Germany lat: 50.77664 lon: 6.08342 facility: Research Site status: NOT_YET_RECRUITING city: Kiel zip: 24146 country: Germany lat: 54.32133 lon: 10.13489 facility: Research Site status: NOT_YET_RECRUITING city: Leipzig zip: 04103 country: Germany lat: 51.33962 lon: 12.37129 facility: Research Site status: NOT_YET_RECRUITING city: Tuebingen zip: 72076 country: Germany lat: 48.52266 lon: 9.05222 facility: Research Site status: NOT_YET_RECRUITING city: Milano zip: 20122 country: Italy lat: 45.46427 lon: 9.18951 facility: Research Site status: NOT_YET_RECRUITING city: Padova zip: 35128 country: Italy lat: 45.40797 lon: 11.88586 facility: Research Site status: NOT_YET_RECRUITING city: Roma zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 facility: Research Site status: NOT_YET_RECRUITING city: Gifu-shi zip: 500-8513 country: Japan lat: 35.42291 lon: 136.76039 facility: Research Site status: RECRUITING city: Iizuka-shi zip: 820-8505 country: Japan lat: 33.63654 lon: 130.68678 facility: Research Site status: NOT_YET_RECRUITING city: Kawasaki-shi zip: 215-0026 country: Japan lat: 35.52056 lon: 139.71722 facility: Research Site status: NOT_YET_RECRUITING city: Kitakyusyu-shi zip: 806-8501 country: Japan facility: Research Site status: RECRUITING city: Nagaoka-shi zip: 940-2085 country: Japan lat: 37.45 lon: 138.85 facility: Research Site status: RECRUITING city: Niigata-shi zip: 951-8520 country: Japan lat: 37.88637 lon: 139.00589 facility: Research Site status: NOT_YET_RECRUITING city: Sapporo-shi zip: 006-8555 country: Japan lat: 43.06667 lon: 141.35 facility: Research Site status: NOT_YET_RECRUITING city: Yokohama-shi zip: 236-0004 country: Japan lat: 35.43333 lon: 139.65 facility: Research Site status: NOT_YET_RECRUITING city: Bydgoszcz zip: 85-794 country: Poland lat: 53.1235 lon: 18.00762 facility: Research Site status: NOT_YET_RECRUITING city: Katowice zip: 40-081 country: Poland lat: 50.25841 lon: 19.02754 facility: Research Site status: NOT_YET_RECRUITING city: Kraków zip: 31-513 country: Poland lat: 50.06143 lon: 19.93658 facility: Research Site status: NOT_YET_RECRUITING city: Mysłowice zip: 41-400 country: Poland lat: 50.20745 lon: 19.16668 facility: Research Site status: NOT_YET_RECRUITING city: Poznań zip: 61-848 country: Poland lat: 52.40692 lon: 16.92993 facility: Research Site status: NOT_YET_RECRUITING city: Wrocław zip: 52-210 country: Poland lat: 51.1 lon: 17.03333 facility: Research Site status: NOT_YET_RECRUITING city: Bratislava zip: 83104 country: Slovakia lat: 48.14816 lon: 17.10674 facility: Research Site status: NOT_YET_RECRUITING city: Nitra zip: 950 01 country: Slovakia lat: 48.30763 lon: 18.08453 facility: Research Site status: NOT_YET_RECRUITING city: Trnava zip: 91702 country: Slovakia lat: 48.37741 lon: 17.58723 facility: Research Site status: NOT_YET_RECRUITING city: Aberdeen zip: AB25 2ZN country: United Kingdom lat: 57.14369 lon: -2.09814 facility: Research Site status: NOT_YET_RECRUITING city: Hull zip: HU3 2KZ country: United Kingdom lat: 53.7446 lon: -0.33525 facility: Research Site status: NOT_YET_RECRUITING city: Ipswich zip: IP4 5PD country: United Kingdom lat: 52.05917 lon: 1.15545 facility: Research Site status: NOT_YET_RECRUITING city: London zip: SE5 9RS country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: Nottingham zip: NG7 2UH country: United Kingdom lat: 52.9536 lon: -1.15047 hasResults: False
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<|newrecord|> nctId: NCT06269471 id: 2023-A02039-36 briefTitle: On the ICC's Path: a Prevalence Study acronym: SSICC overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-30 date: 2024-07-30 date: 2024-02-21 date: 2024-02-21 name: University Hospital, Grenoble class: OTHER briefSummary: The number of trailers is growing all the time, and TRu seems to be a risky activity for the ankle joint. Ankle sprains can lead to significant health consequences, as in the case of chronic ankle instability.
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However, there are no studies informing of the prevalence of chronic ankle instability in trail running. The aim of this study is therefore to take stock of chronic ankle instability in trail running in France. conditions: Chronic Ankle Instability studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 385 type: ESTIMATED measure: Prevalence of chronic ankle instability in trailers measure: Socio-demographic data (1/4) measure: Socio-demographic data (2/4) measure: Socio-demographic data (3/4) measure: Socio-demographic data (4/4) measure: Trail running and prevalence reports (1/11) measure: Trail running and prevalence reports (2/11) measure: Trail running and prevalence reports (3/11) measure: Trail running and prevalence reports (4/11) measure: Trail running and prevalence reports (5/11) measure: Trail running and prevalence reports (6/11) measure: Trail running and prevalence reports (7/11) measure: Trail running and prevalence reports (8/11) measure: Trail running and prevalence reports (9/11) measure: Trail running and prevalence reports (10/11) measure: Trail running and prevalence reports (11/11) measure: Associated pathologies (1/2) measure: Associated pathologies (2/2) measure: Medical care (1/3) measure: Medical care (2/3) measure: Medical care (3/3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Grenoble Alpes city: Grenoble zip: 38000 country: France name: Leo Druart role: CONTACT email: leo.druart@univ-grenoble-alpes.fr name: Audrey Milon role: PRINCIPAL_INVESTIGATOR name: Massamba M'Baye role: SUB_INVESTIGATOR name: Thomas Lathière role: SUB_INVESTIGATOR name: Maïa Dolopogoloff role: SUB_INVESTIGATOR name: Guillaume Néron role: SUB_INVESTIGATOR lat: 45.16667 lon: 5.71667 hasResults: False
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<|newrecord|> nctId: NCT06269458 id: ABU-001 briefTitle: The Effects of Mother-Baby Yoga and Baby Massage on Attachment and Sleep overallStatus: COMPLETED date: 2023-01-01 date: 2023-11-25 date: 2023-12-26 date: 2024-02-21 date: 2024-02-21 name: Antalya Bilim University class: OTHER briefSummary: Purpose: This study was conducted to examine the effects of mother-baby yoga and massage on mother-baby bonding and the baby's sleep.
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Method: A randomised, crossover pilot study was conducted in the postpartum service of a hospital between January and November 2023, with 60 mothers and their babies in the postpartum period, 30 in each group. To the mothers and their babies included in the research, baby massage was applied to one group and mother-baby yoga was applied to the other. After four weeks, the groups' practices were changed. In the results of the research, characteristics related to attachment and sleep were evaluated. conditions: Newborn conditions: Yoga conditions: Mother-Infant Interaction conditions: Sleep studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: Baby Massage name: Monther-Baby Yoga measure: Attachment measure: Weight and Sleep sex: ALL minimumAge: 0 Days maximumAge: 5 Days stdAges: CHILD facility: Antalya Bilim Üniversitesi city: Antalya country: Turkey lat: 36.90812 lon: 30.69556 hasResults: False
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<|newrecord|> nctId: NCT06269445 id: 2023-942-01 briefTitle: The Efficacy and Safety of Lcaritin Combined With Bevacizumab and FOLFIRI in Treatment of Liver Metastases From Colorectal Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2025-02-01 date: 2026-02-01 date: 2024-02-21 date: 2024-02-21 name: Sir Run Run Shaw Hospital class: OTHER briefSummary: To evaluate the efficacy and safety of the combination regimen of Icaritin with bevacizumab + FOLFIRI in patients with liver metastases from advanced colorectal cancer. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Icaritin Combined With Bevacizumab and FOLFIRI measure: Progression-free survival(PFS) measure: Objective remission rate (ORR) measure: Overall survival (OS) measure: Disease Control Rate (DCR) measure: Duration of ongoing remission (DOR) measure: TRAEs measure: Quality of life of the patients sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang zip: 310000 country: China name: Fei Wang role: CONTACT phone: 13732236150 email: 21418531@zju.edu.cn lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06269432 id: 2023YFS0042 briefTitle: Precise Antiplatelet THerapy Guided by Platelet Aggregation Function in Acute Ischemic STROKE(PATH-STROKE) acronym: PATH-STROKE overallStatus: RECRUITING date: 2023-01-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-21 date: 2024-02-21 name: Sichuan Provincial People's Hospital class: OTHER briefSummary: Objectives of Study:To explore the efficacy and safety of antiplatelet therapy in patients with non-cardiogenic cerebral infarction under the guidance of platelet aggregation function. conditions: Ischemic Stroke conditions: Antiplatelet Drug studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 3524 type: ESTIMATED name: Precision Antiplatelet Therapy Trial Group name: Traditional Antiplatelet Therapy Control Group measure: 3-month major ischemic events and major bleeding events measure: disability measure: Cardiovascular or cerebrovascular mortality sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Provincial People's Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610072 country: China name: Jie Yang, doctor role: CONTACT phone: +86 13678130516 email: yangjie1126@163.com lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06269419 id: 2023-KY295 briefTitle: Study of Natural Course Progression of Diabetic Retinopathy overallStatus: RECRUITING date: 2024-02-25 date: 2029-01-01 date: 2029-01-01 date: 2024-02-21 date: 2024-03-12 name: Jie Li class: OTHER briefSummary: The goal of this observational study is to observe the formation and development of the non-perfusion area of diabetic retinopathy in the posterior area of the retina in type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.The main questions it aims to answer are whether posterior retinal non-perfusion area occurs earlier than peripheral non-perfusion area and whether the rate of non-perfusion area expansion is a risk factor for the progression of diabetic retinopathy.
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Participants will have protocol-specific follow-up examinations at 1, 2, 3, 4, and 5 years (± 3 months). Additional visits are made as required by the study and the patient's condition.
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