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<|newrecord|> nctId: NCT06269705 id: 006-C-301 briefTitle: ZILRETTA in Subjects With Glenohumeral Osteoarthritis overallStatus: RECRUITING date: 2024-02-05 date: 2025-08 date: 2025-08 date: 2024-02-21 date: 2024-04-03 name: Pacira Pharmaceuticals, Inc class: INDUSTRY briefSummary: Primary Objective: To assess the efficacy of ZILRETTA on pain following an intra-articular (IA) injection in subjects with glenohumeral osteoarthritis (OA) relative to normal saline placebo
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Secondary Objective:
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* To assess the efficacy of ZILRETTA on pain following an IA injection in subjects with glenohumeral OA relative to triamcinolone acetonide injectable suspension, immediate release (TCA-IR) and normal saline placebo
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* To assess the safety of ZILRETTA in subjects with glenohumeral OA relative to normal saline placebo and TCA-IR conditions: Glenohumeral Osteoarthritis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Only unblinded team (pharmacist, unblinded coordinator, drug administrator) will know the treatment assignment. A site-specific blinding plan will be developed to ensure blinding. Unblinded team will only interact with the subject at treatment and will not have any blinded roles on the study (only exception- informed consent). The subject and the assessor responsible for assessments/safety monitoring will be blinded. Site and Sponsor personnel/representatives will be blinded, with the following Sponsor/representative exceptions: unblinded monitors for performing drug accountability, unblinded clinical manager for reviewing unblinded monitoring visit reports and escalation of site unblinded issues, inventory manager for addressing product-related issues, and regulatory personnel for safety reporting. Information regarding treatment assignments will be kept securely at Sponsor. whoMasked: INVESTIGATOR count: 250 type: ESTIMATED name: ZILRETTA name: TCA-IR name: Placebo measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to placebo measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to TCA-IR measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 18 for ZILRETTA relative to TCA-IR measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 2 for ZILRETTA relative to placebo measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 4 for ZILRETTA relative to placebo measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 8 for ZILRETTA relative to placebo measure: Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to placebo measure: Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to TCA-IR sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Alabama Orthopaedic Center- Research status: RECRUITING city: Birmingham state: Alabama zip: 35243 country: United States name: Robert Sorrell, MD role: CONTACT lat: 33.52066 lon: -86.80249 hasResults: False
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<|newrecord|> nctId: NCT06269692 id: 2023-A01353-42 briefTitle: MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators acronym: SMART-DEF overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2030-04-01 date: 2030-04-01 date: 2024-02-21 date: 2024-02-21 name: Central Hospital, Nancy, France class: OTHER briefSummary: Implantable cardioverter-defibrillators (ICD) are currently recommended for the primary prevention of sudden cardiac death (SCD) in patients with a remote (\>6 weeks) myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF).
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Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Hence, the use of LVEF as a unique risk-stratifier of SCD results in a low proportion (17 to 31%) of appropriate ICD device therapy at 2 years. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. Therefore, the current implantation strategy of prophylactic ICDs, based on LVEF only, needs to be improved in post-MI patients. conditions: Myocardial Infarction conditions: Ventricular Tachycardia conditions: Ventricular Fibrillation conditions: Sudden Cardiac Death studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 1812 type: ESTIMATED name: MRI screening name: Implantable Loop Recorder name: Implantable Cardioverter Defibrillator measure: Occurrence of Sudden Cardiac Death (SCD) during the follow-up period measure: Total number of deaths during the follow-up period measure: Total number of deaths from cardiovascular cause during the follow-up period measure: Total number of SCD due to ventricular arrhythmia during the follow-up period measure: Total number (per patient) of sustained VT episodes treated by the ICD or recorded by the ILR during the follow-up period measure: Total number (per patient) of VF episodes treated by the ICD or recorded by the ILR during the follow-up period measure: Total number of hospitalizations due to cardiovascular causes during the follow-up period measure: Duration of hospitalizations due to cardiovascular causes during the follow-up period measure: Total number of hospitalizations from any cause during the follow-up period measure: Duration of hospitalizations from any cause during the follow-up period measure: Quality of life assessed by the scoring obtained from EuroQol questionnaires (EQ-5D-5L) during the follow-up period measure: Measurements of the estimated costs measure: Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences measure: Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences measure: Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar measure: Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHRU Nancy city: Vandœuvre-lès-Nancy zip: 54511 country: France name: Christian de CHILLOU, MD, PhD role: CONTACT email: [email protected] name: Guillaume DROUOT, PhD role: CONTACT email: [email protected] lat: 48.65 lon: 6.18333 hasResults: False
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<|newrecord|> nctId: NCT06269679 id: RC23_0336 briefTitle: CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis. acronym: 3D STARS overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-05-01 date: 2024-02-21 date: 2024-02-21 name: Nantes University Hospital class: OTHER briefSummary: 1. Infective Endocarditis (IE) is a rare and serious disease with high morbidity and mortality; 2. Streptoccoci of oral origin are the second more frequent microorganisms responsible for IE; 3. Oral Infectious Foci (OIF) are underdetected using the current recommended clinical examination/Orthopantomogram (OPT) approach; 4. Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF than OPT; 5. To date, no study has been performed to assess the potential benefit of a clinical examination/CBCT approach on the oral health status in IE patients.
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Thus, conducting a randomized controlled trial is highly desirable to assess the potential impact of a clinical examination/CBCT approach on the oral health status of patients hospitalized for IE and potentially to reduce IE new episodes. conditions: Infective Endocarditis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 170 type: ESTIMATED name: CBCT measure: Superiority of CBCT measure: Superiority of CBCT measure: Superiority of CBCT measure: Diagnostic at inclusion measure: Incident symptomatic OIF measure: Incident asymptomatic OIF measure: Oral hygiene measure: Follow-up habits measure: Follow-up habits measure: Oral health quality of life measure: Premature end of study sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Bordeaux - Site Pellegrin city: Bordeaux country: France name: Elise ARRIVE role: CONTACT phone: +33/5 56 79 56 79 email: [email protected] lat: 44.84044 lon: -0.5805 facility: CHU Grenoble city: Grenoble country: France name: Cécile CHATEL role: CONTACT phone: +33/4 76 76 50 26 email: [email protected] lat: 45.16667 lon: 5.71667 facility: CHRU Nancy city: Nancy country: France name: Vanessa MOBY role: CONTACT phone: +33/3 83 39 18 00 email: [email protected] lat: 48.68439 lon: 6.18496 facility: CHU Nantes city: Nantes country: France name: Philippe LESCLOUS role: CONTACT phone: +33/2.40.41.29.40 email: [email protected] name: Astrid GARREAU role: CONTACT email: [email protected] lat: 47.21725 lon: -1.55336 facility: AP-HP - Site Bretonneau city: Paris country: France name: MESSECA Clément role: CONTACT phone: +33/1 53 11 18 00 email: [email protected] lat: 48.85341 lon: 2.3488 facility: CHU Toulouse city: Toulouse country: France name: Sarah COUSTY role: CONTACT phone: +33/5.61.32.20.30 email: [email protected] lat: 43.60426 lon: 1.44367 facility: CHRU Tours city: Tours country: France name: Frédéric DENIS role: CONTACT phone: +33/2 47 47 47 47 email: [email protected] lat: 47.38333 lon: 0.68333 hasResults: False
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<|newrecord|> nctId: NCT06269666 id: OPT1100 briefTitle: P200TxE Diseased Eye Image Collection overallStatus: RECRUITING date: 2024-01-31 date: 2024-06-30 date: 2024-06-30 date: 2024-02-21 date: 2024-02-21 name: Optos, PLC class: INDUSTRY briefSummary: The primary objective is to collect images on the P200TxE device in diseased eyes. conditions: Retinal Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: P200TxE measure: Number of images sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bennett and Bloom Eye Centers status: RECRUITING city: Louisville state: Kentucky zip: 40215 country: United States name: Megan Kingdon role: CONTACT phone: 513-305-8654 email: [email protected] lat: 38.25424 lon: -85.75941 hasResults: False
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<|newrecord|> nctId: NCT06269653 id: 10001944 id: 001944-AG briefTitle: Measuring Protein Turnover in Humans Across the Lifespan by Metabolic Labeling With Deuterium Oxide overallStatus: RECRUITING date: 2024-05-01 date: 2026-03-01 date: 2026-03-01 date: 2024-02-21 date: 2024-04-26 name: National Institute on Aging (NIA) class: NIH briefSummary: Background:
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Proteins are essential to the health and structure of the cells that make up body tissues. Most proteins become damaged over time and are replaced with new ones. This process is called "protein turnover." Stress, disease, and aging can affect this process. Researchers want to better understand how aging affects protein turnover.
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Objective:
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To measure rates of protein turnover in healthy adults.
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Eligibility:
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Healthy people aged 20 years and older with a body mass index between 20 and 30.
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Design:
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Participants will have 6 study visits over 4 to 6 weeks. They will fast 12 hours before each visit.
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Participants will be screened. They will have a physical exam, with blood and urine tests and tests of their heart function. They will lie down while blood pressure cuffs are used on their arms and legs.
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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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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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The contents of follow-up examinations are:
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History of other diseases, medications being used, eye diseases, surgeries, treatments, height, weight, and blood pressure.
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Best corrected vision, logarithmic visual acuity chart. Tupai OCTA, 24×20mm range, 6×6mm range scan. Optos fundus imaging, color and no red light images. Fundus fluorescence angiography (only preliminary examination for the first time found mild to moderate NPDR patients, who have been angiographed in the past, only at the 5th year, or as required by the condition).
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Glycosylated hemoglobin. Creatinine, urea, glomerular filtration rate. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol.
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Urinary microalbumin/urinary creatinine ACR. Microvisual field. conditions: Biomarkers of Diabetic Retinopathy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 200 type: ESTIMATED measure: Observation and follow-up of biomarkers of diabetic retinopathy measure: Level of Glycosylated hemoglobin measure: Creatinine measure: Total cholesterol measure: Urinary microalbumin measure: Urea measure: Glomerular filtration rate measure: Triglycerides measure: Low-density lipoprotein cholesterol measure: High-density lipoprotein cholesterol measure: Urinary creatinine ACR sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Academy of Medical Science Sichuan Provincial Hosptial status: RECRUITING city: Chendu state: Sichuan zip: 610014 country: China name: Jie Li, doctor role: CONTACT phone: +86 13908094675 email: [email protected] hasResults: False
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<|newrecord|> nctId: NCT06269406 id: SW008 briefTitle: A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults acronym: ICLID overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-07-10 date: 2024-09-10 date: 2024-02-21 date: 2024-02-21 name: S.LAB (SOLOWAYS) class: OTHER name: NMSI DENTMASTER briefSummary: Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy. conditions: Dental Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 264 type: ESTIMATED name: ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg name: ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg name: The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure measure: Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points) measure: Total pain relief (TOTPAR) % measure: Time to pain half pain gone (in minutes) measure: Duration of pain half gone (in minutes) measure: Any adverse events (facial swelling, nausea, vomiting, headache) (%) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nmsi Dentmaster city: Novosibirsk state: Novosibirsk Region zip: 630090 country: Russian Federation name: Gatilova A Tatyana, MD role: CONTACT phone: 9529399919 phoneExt: +7 lat: 55.0415 lon: 82.9346 hasResults: False
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<|newrecord|> nctId: NCT06269393 id: CIBI311Y101 briefTitle: A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-01 date: 2025-06-01 date: 2026-02-01 date: 2024-02-21 date: 2024-02-21 name: Peking University People's Hospital class: OTHER briefSummary: This is an exploratory study of the efficacy and safety of IBI311, a modified anti-IGF-1R antibody, in patients with steroid-resistant, thyroid associated ophthalmopathy (TAO). This study includes two stages. Stage I is a single-center, single-arm, open-label clinical study designed to evaluate the safety and tolerability of IBI311 in subjects with TAO. Approximately 10 subjects meeting the study eligibility criteria will be enrolled. Stage II is a single-center, randomized, double-masked, placebo-controlled clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with steroid-resistant TAO. Approximately 54 subjects meeting the study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by disease activity. conditions: Thyroid Associated Ophthalmopathy studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 54 type: ESTIMATED name: Placebo name: IBI311 measure: The proptosis responder rate (defined as percentage of subjects with a ≥ 2mm reduction from baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye) of the study eye. measure: Overall responder rate in proptosis of the study eye. measure: Percentage of subjects with a CAS value of 0 or 1 measure: Diplopia responder rate (defined as percentage of subjects with a ≥ 1-grade improvement in diplopia) measure: Safety and tolerability of intravenous IBI311 in subjects with TAO sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100034 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06269380 id: 30.01.2024-4274 briefTitle: Evaluation of Antral Biopsies Obtained in Normal Esophagogastroduodenoscopy overallStatus: COMPLETED date: 2024-02-13 date: 2024-02-20 date: 2024-02-21 date: 2024-02-21 date: 2024-02-23 name: Sisli Hamidiye Etfal Training and Research Hospital class: OTHER briefSummary: Esophagogastroduodenoscopy (EGD) is commonly performed in patients presenting with abdominal pain and dyspeptic symptoms, serving as a valuable diagnostic and therapeutic tool. While various methods are available for biopsy sampling when mucosal pathology is observed during EGD, the practice of obtaining biopsies from endoscopically normal mucosa remains controversial. Although there is literature suggesting that routine biopsies from the antrum and duodenum for surveillance purposes increase costs, pathological findings can sometimes be detected in areas that appear normal on mucosal examination, leading to potential changes in treatment approach if biopsies are obtained.
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In this study, a retrospective evaluation of the prevalence of various pathologies detected in biopsies obtained from endoscopically normal mucosa in patients who underwent EGD was reported as normal. conditions: Gastritis H Pylori conditions: Gastritis Chronic conditions: Intestinal Metaplasia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The biopsies obtained from patients who underwent esophagogastroduodenoscopy and were found to have normal endoscopic findings will be evaluated. The histopathological findings and their frequencies in these biopsies will be examined to assess the necessity of routine biopsy during esophagogastroduodenoscopy. primaryPurpose: DIAGNOSTIC masking: NONE count: 671 type: ACTUAL name: Esophagogastroduodenoscopy name: Endoscopic biopsy sampling measure: Rate of abnormal histopathologic findings measure: Rate of intestinal metaplasia measure: Rates of gastritis severity and activity measure: Rate of Helicobacter Pylori positivity sex: ALL minimumAge: 18 Years maximumAge: 95 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sisli Hamidiye Etfal Research and Training Hospital city: Istanbul country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06269367 id: HUM00226149 id: 1R41HD111289-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R41HD111289-01 briefTitle: NewGait: A Low-Cost Rehabilitation System to Improve Post-Stroke Gait (Biomechanical Adaptations) overallStatus: RECRUITING date: 2024-04-01 date: 2024-12 date: 2024-12 date: 2024-02-21 date: 2024-04-03 name: University of Michigan class: OTHER name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) briefSummary: An affordable and easy to use gait-assistive device for stroke survivors to use at home is yet to be developed. This study is intended to modify the current design of the NewGait device to specifically work for stroke survivors based on feedback from patients and clinicians. Consequently, conducting a short-term biomechanical gait study is planned to determine the usability and functionality of the NewGait device compared to other comparative devices. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Participants will be randomly assigned to the two device interventions but will receive both interventions. primaryPurpose: TREATMENT masking: NONE count: 18 type: ESTIMATED name: NewGait name: Control wearable limb orthotic device measure: Gait speed measure: Ankle Muscle Activation measure: Changes in paretic leg propulsive force measure: Changes in paretic leg loading (i.e., vertical ground reaction force) measure: Changes in other lower extremity muscle activation measure: Muscle Coordination sex: ALL minimumAge: 40 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Physical Medicine & Rehabilitation 325 E Eisenhower Pkwy Suite 3011 status: RECRUITING city: Ann Arbor state: Michigan zip: 48108 country: United States name: Chanramouli Krishnan, PT, PhD role: CONTACT phone: 734-936-4031 email: [email protected] lat: 42.27756 lon: -83.74088 hasResults: False
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<|newrecord|> nctId: NCT06269354 id: 20231121-71479 briefTitle: Multi-center Study on Comprehensive Diagnosis and Treatment of Lower Limb Bone Defect Based on Three-dimensional Printing Technology overallStatus: RECRUITING date: 2023-11-01 date: 2026-06-01 date: 2026-12-31 date: 2024-02-21 date: 2024-02-21 name: Peking University Third Hospital class: OTHER briefSummary: The clinical diagnosis and treatment of lower limb bone defect is a difficult problem in orthopedics. The traditional treatment has the shortcomings of long treatment period, no weight bearing in the early stage of the limb, weak mechanical strength, many complications, and difficulty in repairing deformed and large segment bone defects around the joint. The Orthopedics Department of Peking University Third Hospital, the lead unit of this study, developed the TCBridge system based on three-dimensional (3D) printing technology in the early stage, which is the first approved 3D printing lower limb long bone defect repair system in China. The system can achieve personalized and accurate repair of lower limb bone defects, and ensure patients to carry out limb weight and functional exercise safely in the early stage after surgery. On this basis, this study will establish a multi-center clinical case cohort to achieve accurate comprehensive diagnosis and treatment of lower limb bone defects, benefiting patients and contributing to society. conditions: Bone Defects studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED name: 3D printed prostheses measure: Evaluation of implant stability, new bone growth- limb length measure: Evaluation of bone healing measure: Pain assessment measure: Evaluation of life quality and health status. measure: Evaluation of knee function measure: Evaluation of hip function measure: Evaluation of ankle function sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Haidian country: China name: Bingchuan Liu role: CONTACT phone: +86 18310188678 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06269341 id: SCCH-TS2208 briefTitle: Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy acronym: OSinEC overallStatus: RECRUITING date: 2010-02-01 date: 2024-07-30 date: 2024-08-30 date: 2024-02-21 date: 2024-02-21 name: Sichuan Cancer Hospital and Research Institute class: OTHER briefSummary: Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking, and those who only smoked or drank conditions: Outcomes of Smoker and Drinker After Esophagectomy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 2957 type: ESTIMATED name: No intervention measure: Overall Survival sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Cancer Hospital and Research Institute status: RECRUITING city: Chengdu state: Sichuan zip: 610041 country: China name: Lin Peng, M.D. role: CONTACT phone: +8618908190013 email: [email protected] name: Wenwu He, M.D. role: CONTACT phone: +8613350055340 email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06269328 id: 2011-KAEK-26/463 briefTitle: Measuring Sleep Quality In Patients That Posterior Spinal Instrumentatıon Plannıng overallStatus: COMPLETED date: 2022-07-01 date: 2023-09-01 date: 2024-01-01 date: 2024-02-21 date: 2024-02-28 name: Uludag University class: OTHER briefSummary: Postoperative sleep disorders have serious problems with cognition, pain perception, sustained circadian rhythm, psychomotor function, metabolic function, catabolic responses, and continuity. The relationship between general anesthesia and sleep disturbances following surgery is still unclear. Since the risk of sleep disorders after surgery is high, it is important to determine the efficiency of the interval with automatic sleep disorders. By evaluating how major orthopedic surgery and general anesthesia applied to posterior spinal instrumentation divides sleep quality, risk management allows determining the factors involved in the peroperative period and thus facilitating surgical results and patient comfort. conditions: Sleep Disorder conditions: Sleep, Inadequate conditions: Total ıntravenous Anesthesia conditions: Inhalation Anesthesia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 39 type: ACTUAL name: Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance name: Inhalation anesthesia with sevoflurane for anesthetic maintenance measure: Subjective sleep quality (evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale) measure: Subjective anxiety level measure: Subjective pain level sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Elifgül Ulutaş city: Bursa state: Nilüfer zip: 16240 country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False
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<|newrecord|> nctId: NCT06269315 id: SBDDCP briefTitle: Assessment of Skin Barrier Disruption Due to Daily Use of Cleaning Products and Hand Disinfectants acronym: SBDDCP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-31 date: 2025-04-01 date: 2024-02-21 date: 2024-02-21 name: Swiss Institute of Allergy and Asthma Research class: OTHER name: University Hospital, Zürich briefSummary: The goal of this clinical trial is to assess the effects of household detergents and hand disinfectants on human skin barrier integrity among healthy adult volunteers.
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The main questions it aims to answer are:
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* How does exposure to household detergents and hand disinfectants impact skin barrier function?
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* Are there differences in skin barrier disruption between various types of cleaning agents and disinfectants?
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Participants will:
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Undergo patch testing with controlled amounts of household detergents and hand disinfectants on a small area of their skin.
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Be monitored for adverse reactions during and after exposure. Have their skin barrier integrity assessed using electrical impedance spectroscopy at multiple time points post-exposure.
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If there is a comparison group:
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Researchers will compare the effects of different types of cleaning agents, hand disinfectants, and their ingredients on skin barrier integrity to determine variations in their impact. conditions: Control Condition (PBS) conditions: Household Detergent Exposure conditions: Hand Disinfectant Exposure conditions: Surfactant Exposure conditions: Other Ingredients Exposure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 1. Skin Cleansing and Testing Patch Preparation:
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