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no effect on the infant's growth parameters and nutrient absorption levels by the infant.
Hypothesis 1 (H1): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the weight of the infants.
Hypothesis 2 (H2): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the height of the infants.
Hypothesis 3 (H3): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the head circumference of the infants.
Hypothesis 4 (H4): Feeding preterm newborns with breast milk according to the circadian rhythm has an effect on the absorption levels of vitamins and trace elements measured in the infants' breast milk. conditions: Breast Feeding conditions: Breast Milk Collection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized Controlled Trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Single (participant) blinding was used in the study. For this purpose, it was not stated which group the participating mothers were in the research, but they were informed about the procedure to be performed. Therefore, a separate informed consent form was prepared for each group. Statistician blinding will also be applied. While coding the research data, the research group will be coded as A and B, and the statistician will be prevented from knowing which letter represents which group. whoMasked: OUTCOMES_ASSESSOR count: 44 type: ESTIMATED name: Giving breast milk to the newborn according to the circadian rhythm name: Usual care measure: Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups Evaluation of the newborn's body weight in the study and control groups measure: Evaluation of the baby's height measurements in the study and control groups measure: Evaluation of the baby's head circumference in the study and control groups measure: Evaluation of nutritional absorption of infants in the study and control groups sex: ALL minimumAge: 32 Weeks maximumAge: 34 Weeks stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06342661 id: 2022IIT205 briefTitle: Study On the Expression Level and Clinical Significance of VISTA in Patients With Vascular Cognitive Impairment overallStatus: RECRUITING date: 2023-03-01 date: 2028-11 date: 2028-11 date: 2024-04-02 date: 2024-04-02 name: First Affiliated Hospital of Harbin Medical University class: OTHER briefSummary: 1. Explore the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors; 2. Discuss the correlation between different risk factors (mainly hypertension, diabetes, smoking, hyperlipidemia, hyperhomocysteinemia, etc.) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cerebrovascular diseases and immune-inflammatory related diseases of the nervous system; 3. Explore the correlation between different immune inflammatory factors (IL1, IL6, IL10, INFγ, TNFα) and the expression level of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients; 4. Track and explore the dynamic changes of immune checkpoint VISTA in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors in 3 months, 1 year, 3 years, and 5 years. conditions: Cerebrovascular Disease Small Vessel studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Neuropsychological testing measure: Patient characteristics measure: VISTA expression in PBMCs in the VCI and control groups sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: First Affiliated Hospital of Harbin Medical University status: RECRUITING city: Harbin state: Heilongjiang zip: 150010 country: China name: LiJun Chi role: CONTACT phone: 13895783757 email: clj3757@163.com lat: 45.75 lon: 126.65 hasResults: False
<\|newrecord\|> nctId: NCT06342648 id: Cutaneous water in renal colic briefTitle: Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-02 name: Suez Canal University class: OTHER briefSummary: Renal colic is a serious and excruciatingly painful condition that frequently presents itself in the emergency department. In this trial, patients with renal colic who have received intramuscular diclofenac sodium injection or intracutaneous sterile water injection will have their Visual Analogue Scale (VAS) measured and compared. conditions: Renal Colic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 570 type: ESTIMATED name: Sterile Water Injection name: Diclofenac Sodium injection measure: Visual Analogue Scale (VAS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342635 id: HYD/DENMARK-001/2023 briefTitle: Hydra Single-centre Experience - Copenhagen, Denmark overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-09-30 date: 2026-10-31 date: 2024-04-02 date: 2024-04-02 name: Sahajanand Medical Technologies Limited class: INDUSTRY name: Qmed Consulting A/S briefSummary: The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series. conditions: Aortic Valve Stenosis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Hydra Transcatheter Aortic Valve (THV) Series measure: Primary safety endpoint measure: Primary performance endpoint measure: Technical success measure: Cardiovascular mortality measure: All-cause mortality measure: All stroke measure: Disabling stroke measure: Myocardial infarction measure: Major vascular complication measure: Acute kidney injury measure: New permanent pacemaker implantation due to procedure related conduction abnormalities measure: New-onset atrial fibrillation measure: Coronary artery obstruction requiring intervention measure: Re-hospitalization for procedure- or valve-related causes measure: Mean aortic valve gradient measure: Effective Orifice Area (EOA) measure: Paravalvular leak measure: New York Heart Association (NYHA) functional class measure: Quality-of-life evaluation measure: Bioprosthetic Valve Failure (BVF) measure: Bioprosthetic valve dysfunction (BVD) measure: Stroke or peripheral embolism measure: VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns measure: Rates of Hypoattenuated Leaflet Thickening (HALT) measure: Rates of Reduced leaflet motion (RLM) measure: Commissural alignment sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Copenhagen University Hospital, Rigshospitalet city: Copenhagen country: Denmark name: Dr. Ole De Backer role: CONTACT name: Dr. Ole De Backer, Copenhagen University Hospital, Rigshospitalet role: PRINCIPAL_INVESTIGATOR lat: 55.67594 lon: 12.56553 hasResults: False
<\|newrecord\|> nctId: NCT06342622 id: Weiguo Dong briefTitle: Young-onset Colorectal Cancer Screening Based on Artificial Intelligence overallStatus: COMPLETED date: 2023-12-01 date: 2024-01-10 date: 2024-01-25 date: 2024-04-02 date: 2024-04-02 name: Renmin Hospital of Wuhan University class: OTHER briefSummary: In this study, we aimed to develop, internally and temporally validate the machine learning models to help screen YOCRC bansed on the retrospective extracted Electronic Medical Records (EMR) data. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 11000 type: ACTUAL name: Using routine clinical data and machine learning models. measure: The performance of machine learning screening models sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Renmin Hospital of Wuhan University city: Wuhan state: Hubei zip: 430060 country: China lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06342609 id: 32857-01-EKSTROM briefTitle: Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease acronym: EKSTROM overallStatus: ACTIVE_NOT_RECRUITING date: 2023-03-15 date: 2024-09-07 date: 2024-09-07 date: 2024-04-02 date: 2024-04-02 name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center class: OTHER briefSummary: This is a randomized double-blind, placebo-controlled, investigator-initiated trial that compares Colchicine 0.5mg/day with placebo, among patients with stable CAD. Subjects will be educated to maintain medication compliance with other prescribed medications. conditions: Coronary Artery Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double blind Placebo controlled primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 84 type: ACTUAL name: Colchicine 0.5 MG measure: Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography measure: Effect of Colchicine on markers of inflammation using laboratory tests measure: Effects of Colchicine on Pericoronary Adipose Tissue (PCAT) volume using CTA measure: Effects of Colchicine on Epicardial Adipose Tissue (EAT) volume using CTA measure: Effect of Colchicine on the markers of Endothelial Function using Flow-mediated dilation (FMD) sex: ALL minimumAge: 30 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center city: Torrance state: California zip: 90502 country: United States lat: 33.83585 lon: -118.34063 hasResults: False
<\|newrecord\|> nctId: NCT06342596 id: 18597 id: J2O-MC-EKBD type: OTHER domain: Eli Lilly and Company briefTitle: A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-05 date: 2024-04 date: 2024-04 date: 2024-04-02 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY briefSummary: The main purpose of this study is to evaluate how much of the study drug (LY3473329), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 16 type: ESTIMATED name: [14C]-LY3473329 name: [14C]-LY3473329 name: LY3473329 measure: Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered measure: Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered measure: Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329 measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329 measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329 measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity measure: Part 1: PK: Maximum Concentration (Cmax) of LY3473329 measure: Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity measure: Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) measure: Part 1: Total Number of Metabolites of LY3473329 measure: Part 2: PK: AUC (0-∞) of LY3473329 measure: Part 2: PK: AUC (0-∞) of [14C]-LY3473329 measure: Part 2: PK: AUC (0-∞) of Total Radioactivity measure: Part 2: PK: Cmax of LY3473329 measure: Part 2: PK: Cmax of [14C]-LY3473329 measure: Part 2: PK: Cmax of Total Radioactivity measure: Part 2: Total Radioactivity Recovered in Urine and Feces sex: MALE minimumAge: 35 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea Clinical Research Unit city: Holbeck state: Leeds zip: LS11 9EH country: United Kingdom lat: 53.25 lon: -1.18333 hasResults: False
<\|newrecord\|> nctId: NCT06342583 id: CNR-IRIB-PRO-2024-004 briefTitle: Advanced Social Relations Training overallStatus: RECRUITING date: 2024-03-01 date: 2025-03-17 date: 2026-02-10 date: 2024-04-02 date: 2024-04-02 name: Istituto per la Ricerca e l'Innovazione Biomedica class: OTHER name: Messina, Italy briefSummary: Advanced social relations protocol is aimed at young people with autism aged 9-12 years with an intelligence quotient (IQ) ≥ 80. There will be an experimental group in which technology will be used and a control group in which activities will be carried out in the traditional way. The protocol will be carried out once a week for a duration of 45 minutes. The aim is to enhance communication and social skills within the group. A total of 23 sessions are planned. From the first to the third session the participants will acquire skills for communicating and conversing in an appropriate way. Thereafter from the fourth to the eleventh session social stories illustrating scenes from everyday life will be shown, with the aim of learning and managing the dynamics in which they find themselves on a daily basis. At the end of each story shown they will be asked to impersonate the protagonists depicted in the stories, each participant involved in turn will play all the roles shown in the stories, thus working in the mode of role playing.
The last part, which includes sessions from the twelfth to the twenty-third, will be dedicated to the correct and conscious use of social networks with a focus on the risks that can be encountered and the correct ways to make good use of them. conditions: Autism conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 30 type: ESTIMATED name: Advanced social relations training with technical device name: Advanced social relations training without technical device measure: Vineland-II (Vineland Adaptive Behavior Scales-II - Survey Intervention Form) measure: Eye contact measure: Smile in relation to group members' expressions measure: Greeting measure: Asking a question measure: Proposing an idea or activity to be carried out measure: Answering a question measure: Taking verbal initiative measure: Approval/sharing gestures sex: ALL minimumAge: 9 Years maximumAge: 12 Years stdAges: CHILD facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) status: RECRUITING city: Messina zip: 98164 country: Italy name: Flavia Marino role: CONTACT phone: +393395798263 email: flavia.marino@irib.cnr.it name: Maria Valeria Maiorana role: CONTACT phone: +393285856656 email: mariavaleria.maiorana@irib.cnr.it name: Flavia Marino role: PRINCIPAL_INVESTIGATOR name: Giovanni Pioggia role: SUB_INVESTIGATOR name: Paola Chilà role: SUB_INVESTIGATOR name: Roberta Minutoli role: SUB_INVESTIGATOR name: Noemi Vetrano role: SUB_INVESTIGATOR name: Chiara Failla role: SUB_INVESTIGATOR name: Germana Doria role: SUB_INVESTIGATOR name: Ileana Scarcella role: SUB_INVESTIGATOR name: Cinzia Grasso role: SUB_INVESTIGATOR name: Mariaelena Franchina role: SUB_INVESTIGATOR lat: 38.19394 lon: 15.55256 hasResults: False
<\|newrecord\|> nctId: NCT06342570 id: 3-2023-0462 briefTitle: Quantitative Analysis of EEG Changes in Response to Nociception overallStatus: RECRUITING date: 2024-04-18 date: 2026-12-30 date: 2026-12-30 date: 2024-04-02 date: 2024-04-17 name: Gangnam Severance Hospital class: OTHER briefSummary: This study will quantify the nociception using Analgesia Nociception Index (ANI) during general anesthesia and analyze the differences in EEG depending on the degree of nociception. Additionally, the investigators will quantify the nociception during recovery and analyze the differences in EEG depending on the degree of nociception. conditions: Patients Undergoing Laparoscopic Surgery studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 109 type: ESTIMATED name: There is no Intervention name to describe. measure: Correlation between changes in ANI and EEG band power in response to surgical stimulation. measure: Correlation between changes in ANI and EEG band power in response to tracheal intubation measure: Correlation between changes in ANI and EEG connectivity in response to surgical stimulation measure: Correlation between changes in ANI and EEG connectivity in response to tracheal intubation measure: Correlation between changes in ANI, EEG band power and NRS in response to analgesic administration measure: Correlation between changes in ANI, EEG connectivity and NRS in response to analgesic administration measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during surgery between groups with large and small changes in ANI measure: Differences in EEG connectivity during surgery between groups with large and small changes in ANI measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) during recovery between groups with large and small changes in ANI measure: Differences in EEG connectivity during recovery between groups with large and small changes in ANI measure: Differences in EEG band power(Delta, Theta, Alpha, Beta, Gamma) depending on the type of inhaled anesthetic measure: Differences in EEG connectivity depending on the type of inhaled anesthetic measure: Differences in ANI depending on the type of inhaled anesthetic sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GangnamSeverance Hospital status: RECRUITING city: Seoul country: Korea, Republic of name: Myung Il Bae role: CONTACT phone: 82-2-2019-6611 email: BMI87@yuhs.ac lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06342557 id: FROM briefTitle: Transitional ePRO Diary Liver acronym: MACROLIVER overallStatus: RECRUITING date: 2024-03-28 date: 2034-02-21 date: 2034-02-21 date: 2024-04-02 date: 2024-04-16 name: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS class: OTHER briefSummary: The study is part of the MACROLIVER Project, whose main objective is to create a digital tool for patients and caregivers for the management of liver disease that allows the optimization of therapy and/or the treatment process, even remotely. Such a tool not only reduces the movement of patients who are by definition fragile, but also enables the optimization of access and care by a multidisciplinary team. This tool is intended to support doctors and patients, but in no way replaces normal clinical practice. This study aims to explore the specificities of patients experiencing the transition from the pediatric ward to the adult ward in order to identify risk and protective factors that influence psychological well-being at both an individual and relational level. In order to gather all the information about the patients attending the transitional clinic and to obtain a more complete and truthful clinical-psychological picture, the study also includes the collection of retrospective data of the transplanted patients. conditions: Liver Transplant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 250 type: ESTIMATED measure: four-item Morisky Medication Adherence Scale (MGLS) sex: ALL minimumAge: 14 Years maximumAge: 20 Years stdAges: CHILD stdAges: ADULT facility: ASST-Papa Giovanni XXIII status: RECRUITING city: Bergamo state: Milano zip: 24127 country: Italy name: Stefano Fagiuoli, MD role: CONTACT phone: 035.2674259 email: sfagiuoli@asst-pg23.it lat: 45.69601 lon: 9.66721 hasResults: False
<\|newrecord\|> nctId: NCT06342544 id: AGN_2023_14 briefTitle: Immediate Corticosteroid Therapy and Rituximab to Prevent Generalization in Ocular Myasthenia: a PROBE Multicenter Open-label Randomized Controlled Trial. acronym: IMCOMG overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-06 date: 2029-06 date: 2024-04-02 date: 2024-04-02 name: Fondation Ophtalmologique Adolphe de Rothschild class: NETWORK briefSummary: Myasthenia is an autoimmune disease causing dysfunction of the neuromuscular junction, resulting in fluctuating and variable muscle weakness.
In the initial phase of the disease, 70% of patients present with ocular onset myasthenia (OMG), i.e. weakness limited to the oculomotor muscles. Generalization to skeletal, bulbar and axial muscles occurs in 20-40% of cases, with a higher frequency in the first and second years, respectively 46% and 60% of generalizations. This reflects the maturation of the autoimmune response in the early years of the disease, and represents a therapeutic window of opportunity to modify the course of the disease.
Generalization is a critical event, putting the patient at risk of admission to an intensive care unit and necessitating the use of long-term immunosuppressants.
There is currently no validated strategy for preventing generalization. On the one hand, a preventive role for corticosteroid therapy in ocular-onset myasthenia has been observed in some studies, but not confirmed by others. These contradictory results may be explained by the bias of retrospective observational studies and the use of different corticosteroid administration regimens.
On the other hand, recent data on the use of low-dose Rituximab in the early phase of the disease shows greater efficacy than later use, enabling prolonged remission of the disease with a very good tolerability profile.
We propose to compare in a randomized controlled trial the usual practice with a proactive strategy with a standardized corticosteroid regimen immediate at diagnosis.
Patients with ocular myasthenia are usually treated symptomatically with acetylcholinesterase inhibitors. The introduction of corticosteroids is delayed and limited to patients with persistent disabling diplopia or ptosis with occlusion. When corticosteroids are tapered off, ocular symptoms may recur. This level of corticosteroid dependence observed in patients treated for ocular myasthenia has not been specifically studied. In order to reduce the levels of corticosteroids administered and avoid recurrence of ocular symptoms and their delayed generalization, it is usually proposed to introduce another immunosuppressant.
The aim of this study is to evaluate the efficacy of a standardized proactive prevention strategy on the generalization of ocular onset myasthenias during the first 2 years. It will combine immediate treatment with corticosteroids at the time of diagnosis, with the addition of rituximab in the event of recurrence of ocular symptoms as corticosteroids are tapered off. conditions: Ocular Myasthenia Gravis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 128 type: ESTIMATED name: immediate treatment with corticosteroids name: addition of rituximab if recurrence measure: proportion of patients who progressed to generalized myasthenia within 2 years of follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342531 id: 210324 briefTitle: More Effective Violence Risk Management - eDASA+APP FI acronym: eDASA+APP FI overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-12 date: 2026-12 date: 2024-04-02 date: 2024-04-02 name: University of Turku class: OTHER name: Helsinki University Central Hospital briefSummary: The main goal of this study is to evaluate if the Finnish version of eDASA+APP (electronic Dynamic Appraisal of Situational Aggression + Aggression Prevention Protocol), a clinical decision support system (CDSS), has an impact on reducing workplace violence, use of coercive measures and increasing nurses' job satisfaction in adult psychiatric inpatient care. conditions: Violence studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: A pre-post design (quasi-experimental), a cluster design primaryPurpose: SCREENING masking: NONE count: 26 type: ESTIMATED name: eDASA+APP FI measure: Workplace violence measure: Coercive measures measure: Job satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342518 id: MU ESWT briefTitle: ESWT in Lateral Epicondylitis: Clinical,Ultrasonographic Evaluation overallStatus: COMPLETED date: 2020-12-01 date: 2021-09-01 date: 2021-12-01 date: 2024-04-02 date: 2024-04-02 name: Istanbul Medeniyet University class: OTHER briefSummary: This study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound. conditions: Lateral Epicondylitis conditions: Tennis Elbow studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 42 type: ACTUAL name: Extracorporeal Shock Wave Therapy (ESWT) name: Sham ESWT name: Resting Splint , Exercises and ice measure: Hand Grip Strength measure: Pain severity measure: Functionality measure: Quality of life score measure: deep muscular tissue sensitivity measure: thickness of the common extensor tendon (CET) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department city: Istanbul zip: 34732 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06342505 id: MEC-2022-0037 briefTitle: Tacrolimus in CD3+ T Lymphocytes acronym: INTACT overallStatus: COMPLETED date: 2022-05-30 date: 2022-10-10 date: 2022-11-10 date: 2024-04-02 date: 2024-04-02 name: Erasmus Medical Center class: OTHER briefSummary: The goal of this study is to measure concentrations of the drug tacrolimus in both whole blood and within T lymphocytes. It will also learn on the correlation between the concentration in T lymphocytes and the effects of the drug. The main questions are:
(i) What is the ratio between the tacrolimus concentration within T lymphocytes and in whole blood?; (ii) What is the correlation between tacrolimus concentrations and the effects of the drug?
Participants will:
* Receive standard clinical care;
* Undergo two extra venipunctures for the collection of blood. conditions: Immunosuppression studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 28 type: ACTUAL name: Venipunctures measure: The intracellular tacrolimus concentration in CD3+ T lymphocytes measure: Intracellular cytokine production sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus MC city: Rotterdam zip: 3015 GD country: Netherlands lat: 51.9225 lon: 4.47917 hasResults: False
<\|newrecord\|> nctId: NCT06342492 id: KCHRRF_CS Lead Failure_0025 briefTitle: Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2024-12 date: 2024-04-02 date: 2024-04-02 name: Kansas City Heart Rhythm Research Foundation class: OTHER briefSummary: This a single-center, retrospective, observational study of patients that undergo coronary sinus(CS) lead revision, comparing epicardial lead placement to coronary sinus pacing(CSP) in those that had lead failure. conditions: Heart Failure With Reduced Ejection Fraction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Coronary Sinus Lead Revision measure: Need for lead revision measure: Electrocardiography characteristics - QRS Interval sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Menorah Medical Center city: Overland Park state: Kansas zip: 66209 country: United States lat: 38.98223 lon: -94.67079 facility: Kansas City Heart Rhythm Institute - Roe Clinic city: Overland Park state: Kansas zip: 66211 country: United States lat: 38.98223 lon: -94.67079 facility: Overland Park Regional Medical Center city: Overland Park state: Kansas zip: 66215 country: United States lat: 38.98223 lon: -94.67079 facility: Centerpoint Medical Center Clinic city: Independence state: Missouri zip: 64057 country: United States lat: 39.09112 lon: -94.41551 facility: Centerpoint Medical Center city: Independence state: Missouri zip: 64057 country: United States lat: 39.09112 lon: -94.41551 facility: Research Medical Center Clinic city: Kansas City state: Missouri zip: 64032 country: United States lat: 39.09973 lon: -94.57857 facility: Research Medical Center city: Kansas City state: Missouri zip: 64032 country: United States lat: 39.09973 lon: -94.57857 hasResults: False
<\|newrecord\|> nctId: NCT06342479 id: NM: 04.20.ND:30.03.2023 briefTitle: Discharge Training for Patients With Intertrochanteric Fracture overallStatus: RECRUITING date: 2023-09-01 date: 2024-06-01 date: 2024-07-01 date: 2024-04-02 date: 2024-04-02 name: Erzurum Technical University class: OTHER briefSummary: This study examines the effect of discharge training given to patients with intertrochanteric femur fractures on the wound healing process and readiness for discharge. In the study, patients were provided with certain educational content before and after discharge. The effect of training on wound healing, readiness for discharge and post-discharge recovery process will be evaluated statistically. conditions: Surgical Wound studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Discharge Education measure: Toronto Wound Symptom Assessment System measure: Discharge readiness scale sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erzurum Technical University Faculty of Health Sciences status: RECRUITING city: Erzurum zip: 25000 country: Turkey name: Yasemin Erden role: CONTACT phone: 05303461516 email: yasemin.erden@erzurum.edu.tr lat: 39.90861 lon: 41.27694 hasResults: False
<\|newrecord\|> nctId: NCT06342466 id: 2023-358-02 briefTitle: Bortezomib, Pomalidomide, Dexamethasone For Systemic AL Amyloidosis overallStatus: RECRUITING date: 2024-04 date: 2026-12 date: 2026-12 date: 2024-04-02 date: 2024-04-02 name: Jin Lu, MD class: OTHER briefSummary: This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months. conditions: Systemic Amyloidosis studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Bortezomib, pomalidomide, dexamethasone primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Bortezomib name: Pomalidomide name: Dexamethasone measure: Hematologic VGPR + CR rate at 6 months measure: Overall Hematologic response rate at 6 months measure: At least one organ response at 6 months measure: TTNT at 2 years measure: Estimated PFS at 2 years measure: Estimated OS at 2 years measure: TRAE sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing zip: 100044 country: China name: Yang Liu role: CONTACT phone: +8613716926210 email: pkuphliuyang@bjmu.edu.cn name: Jin Lu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06342453 id: STUDY00026814 id: NCI-2024-01534 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: STUDY00026814 type: OTHER domain: OHSU Knight Cancer Institute briefTitle: Examining Arts as Therapy in Children With Cancer, CREATe Trial overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-03-30 date: 2026-03-30 date: 2024-04-02 date: 2024-04-02 name: OHSU Knight Cancer Institute class: OTHER name: Oregon Health and Science University name: National Center for Complementary and Integrative Health (NCCIH) briefSummary: This clinical trial is being done to develop and test how well creative arts interventions (drawing, painting, making sculptures) compared to watching videos can affect symptoms and impact the quality of life in children with cancer. Creative arts mind-body interventions (CrA) are one type of complementary health interventions which have been associated with improved quality of life and reduced symptom burden among children with cancer. CrA is an ideal intervention for children with cancer due to the long hours spent in the hospital setting for treatments, the creativity and developmental focus of children, and their potential ability to communicate more easily through art than words. Researchers want to develop and test a CrA intervention to help improve symptoms and the quality of life of children with cancer. conditions: Hematopoietic and Lymphatic System Neoplasm conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 72 type: ESTIMATED name: Art Therapy name: Discussion name: Media Intervention name: Survey Administration measure: Number of participants that complete all interventions and data collection time points measure: Number of eligible participants that enroll in the study (feasibility threshold of 60%) measure: Number of participants that complete all interventions and all surveys in the study. measure: Number of intervenor fidelity surveys that obtain at least 95% score. measure: Comparison of scores on the PRO-CTCAE between intervention arms measure: Comparison of scores on the PROMIS between intervention arms measure: Comparison of scores on the Faces between intervention arms sex: ALL minimumAge: 8 Years maximumAge: 13 Years stdAges: CHILD facility: OHSU Knight Cancer Institute city: Portland state: Oregon zip: 97239 country: United States name: Jennifer L. Raybin role: CONTACT phone: 503-418-5150 email: raybin@ohsu.edu name: Jennifer L. Raybin role: PRINCIPAL_INVESTIGATOR lat: 45.52345 lon: -122.67621 hasResults: False
<\|newrecord\|> nctId: NCT06342440 id: 23228/AACRC briefTitle: Early Detection of Advanced Adenomas and Colorectal Cancer acronym: AACRC overallStatus: RECRUITING date: 2020-03-15 date: 2025-12-15 date: 2025-12-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: This study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses. conditions: Colorectal Cancer conditions: Colorectal Neoplasms conditions: Colorectal Polyp conditions: Colorectal Adenocarcinoma conditions: Colorectal Disorders conditions: Colorectal Dysplasia conditions: Colorectal Cancer Stage I conditions: Colorectal Cancer Stage II conditions: Colorectal Cancer Stage III conditions: Colorectal Cancer Stage IV conditions: Colorectal Neoplasms Malignant conditions: Colorectal Serrated Adenocarcinoma conditions: Colorectal Adenoma With Severe Dysplasia conditions: Colorectal Adenoma With Mild Dysplasia conditions: Colorectal Adenoma With Moderate Dysplasia conditions: Colorectal Adenoma and Carcinoma 1 conditions: Colorectal Adenomatous Polyp conditions: Colorectal Adenocarcinoma Metastatic in the Liver studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 2000 type: ESTIMATED name: DENEB measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Monrovia state: California zip: 91016 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: AJGOEL@COH.ORG name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR name: Alessandro Mannucci role: SUB_INVESTIGATOR name: James Lin role: SUB_INVESTIGATOR name: Gregory Idos role: SUB_INVESTIGATOR name: Trilokesh Kadambi role: SUB_INVESTIGATOR lat: 34.14806 lon: -117.99895 facility: University of California San Diego status: RECRUITING city: San Diego state: California zip: 92093 country: United States name: C Richard Boland, MD, PhD role: CONTACT name: C Richard Boland, MD, PhD role: SUB_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: The First Affiliated Hospital of Dalian Medical University status: RECRUITING city: Dalian country: China name: Jing Zhang role: CONTACT name: Jing Zhang role: SUB_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR lat: 38.91222 lon: 121.60222 facility: IRCCS San Raffaele status: RECRUITING city: Milan country: Italy name: Giulia Martina Cavestro, MD, PhD role: CONTACT email: cavestro.giuliamartina@hsr.it name: Giulia Martina Cavestro role: SUB_INVESTIGATOR name: Alessandro Mannucci role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Mie University status: RECRUITING city: Mie country: Japan name: Yuji Toiyama role: CONTACT name: Yuji Toiyama role: SUB_INVESTIGATOR name: Yoshinaga Okugawa role: SUB_INVESTIGATOR name: Tadanobu Shimura role: SUB_INVESTIGATOR facility: Barcelona University status: RECRUITING city: Barcelona country: Spain name: Francesc Balaguer, MD, PhD role: CONTACT email: fprunes@clinic.cat name: Francesc Balaguer role: SUB_INVESTIGATOR name: Miguel Pera role: SUB_INVESTIGATOR name: Lorena Moreno role: SUB_INVESTIGATOR name: Luis Bujanda role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06342427 id: 23228/DESTINEX briefTitle: Stomach Cancer Exosome-based Detection acronym: DESTINEX overallStatus: RECRUITING date: 2023-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer. conditions: Gastric Cancer conditions: Gastric Adenocarcinoma conditions: Gastric Cancer Stage conditions: Gastric Neoplasm conditions: Gastric Lesion conditions: Gastric Cancer in Situ conditions: Gastric Cancer Stage IV conditions: Gastric Cancer Stage IIIB conditions: Gastric Cancer Stage III conditions: Gastric Cancer Stage IB conditions: Gastric Cancer Stage IA conditions: Gastric Cancer, Stage 0 conditions: Gastric Cancer Stage IIIA conditions: Gastric Cancer Stage II conditions: Gastric Cancer TNM Staging conditions: Gastric Cancer Metastatic to Lung conditions: Gastric Cancer Metastatic to Liver conditions: Gastric Cancer Stage I conditions: Gastric Cancer TNM Staging Primary Tumor (T) T2B studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 800 type: ESTIMATED name: DESTINEX measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: AJGOEL@COH.ORG name: Silei Sui role: PRINCIPAL_INVESTIGATOR name: Caiming Xu role: SUB_INVESTIGATOR name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Nagoya University status: RECRUITING city: Nagoya country: Japan name: Yasuhiro Kodera role: CONTACT name: Yasuhiro Kodera role: SUB_INVESTIGATOR name: Mitsuo Kanda role: SUB_INVESTIGATOR lat: 35.18147 lon: 136.90641 facility: Mie University status: RECRUITING city: Tsu country: Japan name: Yuji Toiyama role: CONTACT name: Yuji Toiyama role: SUB_INVESTIGATOR name: Yoshinaga Okugawa role: SUB_INVESTIGATOR lat: 34.73333 lon: 136.51667 hasResults: False
<\|newrecord\|> nctId: NCT06342414 id: 23228/ELUCIDATE briefTitle: An Exosome-Based Liquid Biopsy for the Differential Diagnosis of Primary Liver Cancer acronym: ELUCIDATE overallStatus: RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-03-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: It is sometimes difficult to precisely understand whether a primary liver cancer is a hepatocellular carcinoma or a cholangiocarcinoma. The researchers will develop and validate a liquid biopsy, based on exosomal content analysis and powered by machine learning, to help clinicians differentiate these two cancers before surgery. conditions: Hepatocellular Carcinoma conditions: Intrahepatic Cholangiocarcinoma conditions: Cholangiocarcinoma conditions: Primary Liver Cancer conditions: Primary Liver Carcinoma conditions: Hepatic Cancer conditions: Hepatic Carcinoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: ELUCIDATE measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total number of cases (i.e., accuracy) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: AJGOEL@COH.ORG name: Caiming Xu, MD, PhD role: SUB_INVESTIGATOR name: Yoh Asahi, MD role: PRINCIPAL_INVESTIGATOR name: Ajay Goel, PhD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: Graduate School of Medical Sciences, Kyushu University status: RECRUITING city: Fukuoka country: Japan name: Tomoharu Yoshizumi role: CONTACT name: Tomoharu Yoshizumi role: SUB_INVESTIGATOR name: Takeo Toshima role: SUB_INVESTIGATOR lat: 33.6 lon: 130.41667 facility: Graduate School of Medical Sciences, Kumamoto University status: RECRUITING city: Kumamoto country: Japan name: Hideo Baba role: CONTACT name: Hideo Baba role: SUB_INVESTIGATOR lat: 32.80589 lon: 130.69182 facility: Hokkaido University Graduate School of Medicine status: RECRUITING city: Sapporo country: Japan name: Akinobu Taketomi role: CONTACT name: Akinobu Taketomi role: PRINCIPAL_INVESTIGATOR name: Yoh Asahi role: PRINCIPAL_INVESTIGATOR name: Tatsuhiko Kakisaka role: SUB_INVESTIGATOR lat: 43.06667 lon: 141.35 facility: Tokushima University status: RECRUITING city: Tokushima country: Japan name: Mitsuo Shimada role: CONTACT name: Mitsuo Shimada role: SUB_INVESTIGATOR name: Katsuki Miyazaki role: SUB_INVESTIGATOR lat: 34.06667 lon: 134.56667 hasResults: False
<\|newrecord\|> nctId: NCT06342401 id: 23228/ENCODE briefTitle: Early Onset Colorectal Cancer Detection acronym: ENCODE overallStatus: RECRUITING date: 2023-04-15 date: 2025-04-15 date: 2025-10-15 date: 2024-04-02 date: 2024-04-02 name: City of Hope Medical Center class: OTHER briefSummary: Colorectal cancer (CRC) once predominantly affected older individuals, but in recent years has witnessed a progressive increase in incidence among young adults. Once rare, early-onset colorectal cancer (EOCRC, that is, a CRC diagnosed before the age of 50) now constitutes 10-15% of all newly diagnosed CRC cases and it stands as the first cause of cancer-related death in young men and the second for young women.
This study aims to detect EOCRC with a non-invasive test, using a blood-based molecular assay based on microRNA (ribonucleic acid) conditions: Colorectal Cancer conditions: Colorectal Neoplasms conditions: Colorectal Adenocarcinoma conditions: Colorectal Cancer Stage I conditions: Colorectal Cancer Stage IV conditions: Colorectal Cancer Stage II conditions: Colorectal Cancer Stage III conditions: Colorectal Neoplasms Malignant studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: ENCODE measure: Sensitivity measure: Specificity measure: Proportion of correct predictions (true positives and true negatives) among the total cases (i.e., accuracy) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: City of Hope Medical Center status: RECRUITING city: Duarte state: California zip: 91010 country: United States name: Ajay Goel, PhD role: CONTACT phone: 626-218-3452 email: AJGOEL@COH.ORG name: Alessandro Mannucci, MD role: PRINCIPAL_INVESTIGATOR lat: 34.13945 lon: -117.97729 facility: IRCCS San Raffaele status: RECRUITING city: Milan country: Italy name: Giulia Martina Cavestro, MD, PhD role: CONTACT email: cavestro.giuliamartina@hsr.it name: Alessandro Mannucci, MD role: PRINCIPAL_INVESTIGATOR name: Giulia Martina Cavestro, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 45.46427 lon: 9.18951 facility: Kawasaki University status: RECRUITING city: Kawasaki country: Japan lat: 35.52056 lon: 139.71722 facility: Mie University status: RECRUITING city: Mie country: Japan facility: National Cancer Center Hospital status: RECRUITING city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 facility: Tokyo Medical and Dental University status: RECRUITING city: Tokyo country: Japan lat: 35.6895 lon: 139.69171 facility: Yamagata University status: RECRUITING city: Yamagata country: Japan lat: 38.23333 lon: 140.36667 facility: Barcelona University status: RECRUITING city: Barcelona country: Spain name: Francesc Balaguer, MD, PhD role: CONTACT email: fprunes@clinic.cat lat: 41.38879 lon: 2.15899 facility: University of La Laguna status: RECRUITING city: La Laguna country: Spain lat: 28.4853 lon: -16.32014 facility: Salamanca Biomedical Research Institute status: RECRUITING city: Madrid country: Spain name: Jose Perea, MD role: CONTACT email: josepereag@hotmail.com name: Jose Perea, MD role: SUB_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
<\|newrecord\|> nctId: NCT06342388 id: 2024-0427 id: A538500 type: OTHER domain: UW- Madison id: Protocol Version 3/20/2024 type: OTHER domain: UW- Madison id: SMPH/POP HEALTH SCI/POP HLTH type: OTHER domain: UW- Madison briefTitle: Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage overallStatus: WITHDRAWN date: 2024-07 date: 2026-03 date: 2026-06 date: 2024-04-02 date: 2024-04-09 name: University of Wisconsin, Madison class: OTHER name: Covering Wisconsin briefSummary: The goal of this study is to try new outreach methods to improve access to Medicaid for those who lost Medicaid for procedural reasons. The main questions it aims to answer are:
1. How does a live phone call from a Navigator impact Medicaid enrollment among people who lost Medicaid coverage for procedural reasons?
2. What is the effectiveness of outreach using a live call rather than a pre-recorded call? conditions: No Medicaid Coverage studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 0 type: ACTUAL measure: Number of people who successfully renew their Medicaid coverage within 3 months of receiving the live outbound call measure: Duration of coverage gaps measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the live outbound call measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the pre-recorded outbound call sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342375 id: 2024-0434 id: A538500 type: OTHER domain: UW- Madison id: Protocol Version 3/20/2024 type: OTHER domain: UW- Madison id: SMPH/POP HEALTH SCI/POP HLTH type: OTHER domain: UW- Madison briefTitle: Enrollment Barriers, Procedural Denials, and Loss of Medicaid Coverage overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-03 date: 2026-06 date: 2024-04-02 date: 2024-04-05 name: University of Wisconsin, Madison class: OTHER name: Covering Wisconsin briefSummary: The goal of this study is to try new outreach methods to improve access to Medicaid for those who lost Medicaid for procedural reasons. The main questions it aims to answer are:
1. How does a live phone call from a Navigator impact Medicaid enrollment among people who lost Medicaid coverage for procedural reasons?
2. What is the effectiveness of outreach using a live call rather than a pre-recorded call? conditions: No Medicaid Coverage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 425000 type: ESTIMATED name: Outbound phone call measure: Number of people who successfully renew their Medicaid coverage within 3 months of receiving the live outbound call measure: Duration of coverage gaps measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the live outbound call measure: Number of people who successfully renew their Medicaid coverage within 6 months of receiving the pre-recorded outbound call sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342362 id: SICHN/IRB-001/2024 briefTitle: Magnesium Sulfate in Neonatal HIE" overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2024-10-02 date: 2024-12-02 date: 2024-04-02 date: 2024-04-02 name: Sindh Institute of Child Health and Neonatology class: OTHER briefSummary: The study will investigates the neuroprotective effects of intravenous magnesium sulfate in neonates with hypoxic-ischemic encephalopathy (HIE) at a Karachi tertiary care hospital. Using a randomized clinical trial design, the study targets term and near-term newborns with moderate to severe HIE. Data collection involves obtaining informed consent, preparing and administering magnesium sulfate, and assessing outcomes including mortality and morbidity. The study aims to provide insights into improving patient outcomes and clinical practice for neonatal HIE management. conditions: Neonates With HIE studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 102 type: ESTIMATED name: Magnesium sulfate name: placebo or standard treatment) measure: Neuroprotective effects sex: ALL minimumAge: 1 Day maximumAge: 30 Days stdAges: CHILD facility: SICHN city: Karachi state: Sindh zip: 74201 country: Pakistan name: Naseem Ahmed, FCPS role: CONTACT phone: 03003145554 email: drnaseemkubar@gmail.com lat: 24.8608 lon: 67.0104 hasResults: False
<\|newrecord\|> nctId: NCT06342349 id: SIBP-V03-I briefTitle: A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above. overallStatus: NOT_YET_RECRUITING date: 2024-03-31 date: 2024-12-30 date: 2024-12-30 date: 2024-04-02 date: 2024-04-02 name: Shanghai Institute Of Biological Products class: INDUSTRY name: Shaanxi Provincial Center for Disease Control and Prevention briefSummary: To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above. conditions: Influenza studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a single center, randomized, double-blind, controlled phase I clinical trial. primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Quadrivalent influenza virus split vaccine (MDCK cells) name: Quadrivalent influenza virus split vaccine (Chicken embryo) name: Phosphate buffer solution measure: Solicited Adverse Events (AEs) measure: Unsolicited Adverse Events measure: Serious Adverse Events (SAE) measure: Seroconversion rate measure: Ratio of ≥1:40 measure: Geometric mean increase (GMI) sex: ALL minimumAge: 6 Months stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342336 id: HS-IT101ST01-I briefTitle: HS-IT101 Injection in the Treatment of Advanced Solid Tumors overallStatus: RECRUITING date: 2024-01-18 date: 2026-03-31 date: 2028-03-31 date: 2024-04-02 date: 2024-04-02 name: Qingdao Sino-Cell Biomedicine Co., Ltd. class: INDUSTRY name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences name: The First Hospital of Jilin University name: West China Hospital briefSummary: Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 44 type: ESTIMATED name: HS-IT101 Injection measure: Adverse Events (AE) measure: Serious Adverse Events (SAE) measure: Objective Response Rate (ORR) measure: Time-to-response (TTR) measure: Duration of Response (DOR) measure: Disease Control Rate (DCR) measure: Progression-Free-Survival (PFS) measure: Overall Survival (OS) measure: Lymphocyte subpopulation measure: TCR repertoire sex: ALL minimumAge: 18 Days maximumAge: 75 Days stdAges: CHILD facility: Cancer Hospital, Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Ning Li, MD role: CONTACT phone: 86-010-87788713 email: lining@cicams.ac.cn lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06342323 id: IRB00006761-M2023235 id: ONFM-SBRT type: OTHER domain: Peking university third hospital briefTitle: The Optimal Number of Fiducial Marker for Stereotactic Body Radiotherapy acronym: ONFM-SBRT overallStatus: RECRUITING date: 2023-10-08 date: 2024-10-07 date: 2025-10-07 date: 2024-04-02 date: 2024-04-02 name: Peking University Third Hospital class: OTHER briefSummary: This is a clinical study focused on the use of fiducial marker-guided stereotactic body radiotherapy (SBRT) for treating malignant tumors, including lung, liver, pancreatic, and kidney/adrenal cancers. Here's a breakdown of the key components of the study:
Study Design: Prospective, single-center, exploratory clinical study.
Patient Enrollment: The study intends to enroll patients diagnosed with malignant tumors requiring fiducial marker-guided SBRT. Each tumor type (lung, liver, pancreatic, kidney/adrenal) aims to include 15 cases.
Informed Consent: Patients are required to sign informed consent before participating in the study, indicating their understanding of the procedures, risks, and benefits involved.
Intervention: Enrolled patients will undergo stereotactic radiotherapy for their respective malignant tumors. During this process, fiducial markers will be implanted according to the study protocol.
Monitoring: Following implantation of fiducial markers, the study will monitor adverse events associated with the procedure. This includes any complications or side effects resulting from the marker implantation process.
Success Rate: The study will assess the success rate of fiducial marker implantation. This likely involves evaluating the accuracy and reliability of marker placement for guiding SBRT treatment.
SBRT Treatment Error: The study will also monitor SBRT treatment errors. This involves tracking any deviations or inaccuracies in the delivery of stereotactic radiotherapy, potentially caused by issues such as improper fiducial marker placement or technical errors in treatment administration.
Overall, the study aims to explore the feasibility and effectiveness of using fiducial marker-guided SBRT for treating various types of malignant tumors to assess both the safety and the efficacy with a focus on patient outcomes and treatment accuracy. conditions: Lung Cancer conditions: Liver Cancer conditions: Pancreatic Cancer conditions: Renal Cell Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 57 type: ESTIMATED name: SBRT measure: success rate measure: Treatment error sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing zip: 100191 country: China name: Qiu Bin role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06342310 id: RE104-201-PPD briefTitle: RE104 Safety and Efficacy Study in Postpartum Depression overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-06 date: 2024-04-02 date: 2024-04-03 name: Reunion Neuroscience Inc class: INDUSTRY briefSummary: The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo. conditions: Postpartum Depression studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 72 type: ESTIMATED name: RE104 for Injection measure: RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score measure: RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score measure: RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS response (≥ 50 percent reduction in score from baseline) measure: RE104 30 mg versus RE104 1.5 mg percentage of patients with MADRS remission (score ≤ to 10) measure: RE104 30 mg versus RE104 1.5 mg Clinical Global Impression-Improvement (CGI-I) measure: RE104 30 mg versus RE104 1.5 mg change from baseline in CGI-Severity (CGI-S) measure: RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A) measure: RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness. sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342297 id: OLL-1003043 briefTitle: Dermatoscopy Guided Resection for Skin Cancer overallStatus: RECRUITING date: 2024-01-14 date: 2025-12-15 date: 2026-01-14 date: 2024-04-02 date: 2024-04-02 name: Region Örebro County class: OTHER briefSummary: In this randomizid controlled trial the aim is to use dermatoscopy in deciding the resection margin for patients with suspected or verified basal cell carcinoma or cutaneous squamous cell carcinoma. The outcome is radical/non radical resection of the lateral margins in the pathology report. conditions: Basal Cell Carcinoma conditions: Cutaneous Squamous Cell Carcinoma conditions: Surgical Margin studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 400 type: ESTIMATED name: Dermatoscopy measure: Pathology resection side margin (radical/not radical) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Örebro University Hospital status: RECRUITING city: Örebro zip: 70375 country: Sweden name: Örebro U Hospital role: CONTACT phone: 0729655663 email: fredrik.landstrom@regionorebrolan.se lat: 59.27412 lon: 15.2066 hasResults: False
<\|newrecord\|> nctId: NCT06342284 id: NYPC ERC# 2021-030 briefTitle: Patient-Generated Health Data Collection During Chemoradiotherapy for Lung Cancer acronym: PGHD overallStatus: RECRUITING date: 2024-03-22 date: 2026-03-21 date: 2031-03-21 date: 2024-04-02 date: 2024-04-02 name: The New York Proton Center class: OTHER briefSummary: This is an observational study involving the collection of patient-generated health data using an Apple Watch, a home pulse oximeter, and a smartphone during a course of proton beam radiotherapy for lung cancer. The study period over which this information is collected will range from the day of study enrollment until two weeks after radiotherapy completion. Subjects will complete a short satisfaction survey at the end of the study period. Other information that is collected as part of routine care for this patient population will be extracted from subjects' medical records during the study period and afterwards. conditions: Thoracic Cancer studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Proton Beam Radiation with or without concurrent chemotherapy measure: Demonstrate the feasibility of patient-generated health data collection during thoracic proton beam radiotherapy for lung cancer, based on the quantity of data collected from the day of radiotherapy initiation to the day of radiotherapy completion. measure: Demonstrate the face validity of physical activity and vital sign data collected in this trial by reviewing the distribution of values obtained for each measure quantitatively using descriptive statistics. measure: Assess associations between radiotherapy treatment parameters, wearable device data, patient-reported outcomes, adverse events, and long-term clinical outcomes using inferential statistical analyses. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New York Proton Center status: RECRUITING city: New York state: New York zip: 10035 country: United States name: Ryan Holder, BS role: CONTACT phone: 646-968-9055 email: rholder@nyproton.com name: Thomas Mistretta, MS role: CONTACT phone: 646-568-5675 email: tmistretta@nyproton.com name: Nitin Ohri, MD role: PRINCIPAL_INVESTIGATOR name: Charles Simone, MD role: SUB_INVESTIGATOR name: Annemarie Shepherd, MD role: SUB_INVESTIGATOR name: Stanislav Lazarev, MD role: SUB_INVESTIGATOR name: Alexandra Hanlon, PhD role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06342271 id: 24-2023 briefTitle: Effects of Nordic Walking and Free Walking on Arm Swing Parameters and Gait in Parkinson's Disease overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-03-30 date: 2025-06-30 date: 2024-04-02 date: 2024-04-02 name: University of Talca class: OTHER briefSummary: People with Parkinson's Disease(PD) present a series of alterations such as muscle stiffness and motor slowing, which gradually affect the swinging movement of the arms and legs, altering the ability to walk, increasing the risk of falling, and reducing functionality. This implies a higher energy cost and a greater probability of developing freezing of the gait.
Nordic walking (NW) is a form of physical exercise characterized by the use of walking poles, which could contribute positively to arm swing movement and, thus, gait.
This clinical trial aims to compare Nordic Walking with free walking (FW) protocol training and investigate their effects on arm swing and gait parameters in people with PD.
The study hypothesizes that NW training will reduce asymmetry and increase arm swing amplitudes during gait to a greater extent than FW. Also, improvements in arm swing could positively influence lower limb performance during regular gait, increasing gait speed, stride length, functional mobility, and quality of life.
People with PD will complete 24 supervised NW or FW training sessions for 12 weeks. Both trainings will be identical in volume and intensity, the only difference will be the use of poles in the NW group. Blinded researchers will conduct evaluations at baseline (T0), post-intervention (T1), and in one-month follow-up (T2). conditions: Parkinson Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 28 type: ESTIMATED name: Nordic walking training name: Free Walking training measure: Change in the amplitude of arm swing measure: Change in the arm swing asymmetry measure: Change in the temporospatial measurements during walking including measurements of Gait speed [m/s] and step length [m]. measure: Change in the functional mobility will be measured through the Timed up and go (TUG). measure: Change in the quality of life sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342258 id: HS-23-00611 briefTitle: COES: Curing Order Effects on Sealants acronym: COES overallStatus: RECRUITING date: 2024-02-23 date: 2026-06-30 date: 2026-06-30 date: 2024-04-02 date: 2024-04-11 name: University of Southern California class: OTHER briefSummary: Background: Sealants are a great tool in the prevention of caries in the pediatric population. It has been shown that up to 71% of occlusal decay is preventable after a single sealant application in a fissure, and thus is the standard of care due to difficulty for pediatric patients in hygiene, diet, and overall home care until manual dexterity increases.
Purpose: This prospective randomized case control study aims to look at the longevity of sealants with bonding agent cured prior to sealant placement vs those with uncured bond. The study will be performed by USC graduate pediatric personnel.
Methods: A split mouth prospective randomized control study will be performed on pediatric dental patients at Long Beach Memorial's Children's Dental Health Clinic and USC Pediatric Dental Clinic, placing sealants with cured bond on half of a mouth and sealants with uncured bond on the contralateral half. Intraoral photos will be obtained at the initial visit and recalls to evaluate the overall retention/longevity of the sealant placement. The goal of this study is determine which sealant has higher longevity and to provide recommendations for future pediatric dentists regarding sealant procedures. conditions: Dental Sealant conditions: Sealant Retention studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: After baseline examination, a randomized generator, will be used in order to issue which side will bonding agent cured prior to sealant placement. Randomization will be a simple randomization, and will be determined by the provider flipping a coin. Randomization will be performed to ensure graders of sealants will be blinded to which side of bond is cured prior to sealant placement.
Heads indicates the RIGHT side of mouth WILL be cured prior to sealant placement. The left side of the mouth will have bond and sealant cured together after.
Tails indicates the LEFT side of the mouth WILL be cured prior to sealant placement. The right side of the mouth will not have bond cured prior to sealant placement. primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 217 type: ESTIMATED name: Ultradent Ultra Seal XT Plus measure: Sealant Longevity measure: Caries measure: Molar hypomineralization sex: ALL minimumAge: 5 Years maximumAge: 14 Years stdAges: CHILD facility: Herman Ostrow School of Dentistry of USC status: RECRUITING city: Los Angeles state: California zip: 90089 country: United States name: Catherine Pham, DDS, MPH role: CONTACT phone: 213-740-0412 email: cmpham@usc.edu lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06342245 id: 2023.568 briefTitle: Low-temperature Radiofrequency Coblation Micro-tenotomy for the Treatment of Achilles Tendinopathy acronym: AT RCT overallStatus: NOT_YET_RECRUITING date: 2024-06-11 date: 2027-06-10 date: 2027-06-11 date: 2024-04-02 date: 2024-04-02 name: Chinese University of Hong Kong class: OTHER briefSummary: This is a prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only). Adults (age \>18) with clinically diagnosed midportion Achilles tendinopathy will be recruited and scheduled for ultrasound screening. All participants will undergo a 12-week eccentric exercise program taught by a registered physiotherapist / athletic trainer. Undergo Endoscopic Achilles debridement and Radiofrequency coblation micro-tenotomy intervention. Criteria for discontinuing or modifying allocated interventions, Strategies to improve adherence to interventions, Relevant concomitant care permitted or prohibited during the trial and Provisions for post-trial care. Outocme measure will use VISA-A, pain scores, ultrasound measurement of thickness and vascularity, calf muscle strength, and ankle range of motion. conditions: Achilles Tendinopathy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a multicentre prospective randomized, double-blinded, placebo-controlled superiority trial with two parallel groups and a 1:1 allocation ratio to investigate the effectiveness of radiofrequency coblation micro-tenotomy for patients with Achilles tendinopathy. All participants will be randomized into two groups: the intervention group (n=24; radiofrequency coblation micro-tenotomy + endoscopic Achilles debridement) and the control group (n=24; endoscopic Achilles debridement only).
Investigators will obtain written consent from all participants before the commencement of this study. primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 48 type: ESTIMATED name: Radiofrequency coblation micro-tenotomy measure: Victorian Institute of Sports Assessment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342232 id: BEH1986 id: 423629 type: OTHER_GRANT domain: Saskatchewan Health Research Foundation briefTitle: The Efficacy of Neurofeedback Mindfulness in Migraine Management overallStatus: COMPLETED date: 2021-09-09 date: 2022-12-24 date: 2023-03-01 date: 2024-04-02 date: 2024-04-02 name: University of Saskatchewan class: OTHER name: Saskatchewan Health Research Foundation briefSummary: This longitudinal randomized controlled trial explored how long-term practice of neurofeedback mindfulness would be helpful for migraine management when compare dot a similar controlled intervention. All the participants went through assigned 10 minutes practices on a daily basis for 8 weeks. Behavioural reports and migraine characteristics were compared before and after the intervention. conditions: Migraine Headaches studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 101 type: ACTUAL name: Neurofeedback mindfulness name: Simple attention controlled task measure: Migraine Disability measure: Migraine Severity measure: Headache Management Self-efficacy measure: Anxiety measure: Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Saskatchewan city: Saskatoon state: Saskatchewan zip: S7N5A2 country: Canada lat: 52.13238 lon: -106.66892 hasResults: False
<\|newrecord\|> nctId: NCT06342219 id: 423629 briefTitle: Chronic Migraines and Neurofdeeback Mindfulness overallStatus: NOT_YET_RECRUITING date: 2024-12 date: 2025-12 date: 2026-06 date: 2024-04-02 date: 2024-04-02 name: University of Saskatchewan class: OTHER name: Saskatchewan Health Research Foundation briefSummary: As the second phase of our study on migraine headaches and neurofeedback mindfulness, we will explore how chronic migraineurs will benefit from a long term practice (8 weeks) of neurofeedback mindfulness compared to a similar attention group and a waitlisted group. This randomized controlled trial will also explore if migrianuers could decrease their dependence on medicine intake after completion of the study. conditions: Chronic Migraine, Headache studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 135 type: ESTIMATED name: Neurofeedback Mindfulness name: Attention Task measure: Migraine Disability measure: Migraine Severity measure: Headache management self-efficacy measure: Dependence on medicine measure: Anxiety measure: Depression sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Saskatchewan city: Saskatoon state: Saskatchewan zip: S7N5A2 country: Canada lat: 52.13238 lon: -106.66892 hasResults: False
<\|newrecord\|> nctId: NCT06342206 id: CMUH111-REC2-144 briefTitle: The Assessment of Acute /Chronic Phase in Patients With Ischemic Cerebral Stroke Using TCM Diagnostic Tools overallStatus: RECRUITING date: 2022-09-08 date: 2022-09-21 date: 2024-09-07 date: 2024-04-02 date: 2024-04-02 name: China Medical University Hospital class: OTHER briefSummary: Cerebral infarction is the second cause of death and the third cause of disability. More than 13.7 million patients worldwide are diagnosed with stroke every year, and the number of deaths is 5.5 million, of which ischemic stroke is the major type, accounting for 87%. Sequelae of stroke are problems that require long-term medical care. If we can intervene and assist with Traditional Chinese Medicine (TCM) at early stage, it will be a great boon for patients. In clinical practice, TCM collects data as the basis for diagnosis through the four diagnostic methods-look, listen, question, and feel the pulse. Among these, tongue diagnosis and pulse diagnosis belong to the categories of look and feel the pulse. At present, the objective examination instruments of TCM developed are mainly tongue diagnostic instruments and pulse diagnostic instruments. Therefore, we hope to utilize tongue and pulse diagnoses as the main reference to analyze the changes in ischemic stroke stages. The data of this study are collected from China Medical University Hospital and YuanRung Hospital-for further statistical analysis. Ischemic stroke patients (ICD-10: I63) who were hospitalized within 1 week from the date of diagnosis were eligible to join this research project. Tongue and pulse examinations were collected once per week within 1 month. A total of 4 tongue-pulse examinations were collected in each case, which were categorized into acute stage (24 hours to 1 week), subacute stage (1 to 3 weeks) and chronic stage (more than 3 weeks). \[30\] This research is to study the changes of tongue and pulse diagnoses in acute, subacute and chronic stages among ischemic patients who receive TCM diagnosis and treatment. Through utilizing objective evaluation of Chinese and Western medical examination instruments, we hope to establish clear diagnostic standards for TCM syndrome types, so as to evaluate the efficacy of clinical diagnosis and treatment. The goal is to improve the quality of TCM care and to provide Chinese and Western integrated treatment for stroke patients in the future. This research can also serve as a reference for related TCM research and development. conditions: Stroke, Ischemic studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 24 type: ESTIMATED measure: Differences between tongue diagnosis and pulse diagnosis in acute and chronic stroke patients sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: YuanRung Hospital status: RECRUITING city: Changhua zip: 510 country: Taiwan name: LI-CHI TSAI role: CONTACT phone: 0919688481 name: YEN-HUA YANG role: CONTACT phone: 0912587467 lat: 24.07327 lon: 120.56276 hasResults: False
<\|newrecord\|> nctId: NCT06342193 id: virtual reality briefTitle: Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial overallStatus: RECRUITING date: 2024-03-14 date: 2024-06-15 date: 2024-06-15 date: 2024-04-02 date: 2024-04-02 name: Uşak University class: OTHER briefSummary: The aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia. conditions: Cystoscopy conditions: Virtual Reality conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 54 type: ESTIMATED name: virtual reality group measure: anxiety sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Usak Training and Research Hospital status: RECRUITING city: Uşak state: Center zip: 64100 country: Turkey name: Yucel Can Danisman role: CONTACT phone: +905532864569 email: 202201023@ogr.usak.edu.tr name: Fatma Susam, PhD role: SUB_INVESTIGATOR name: Yucel Can Danisman role: PRINCIPAL_INVESTIGATOR name: Ozan Ozavci role: SUB_INVESTIGATOR name: Shahnaza Mahmudova role: SUB_INVESTIGATOR name: Erkan Arslan, MD role: SUB_INVESTIGATOR name: Adem Tuncekin, MD role: SUB_INVESTIGATOR name: Bilgen Arikan, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.67351 lon: 29.4058 hasResults: False
<\|newrecord\|> nctId: NCT06342180 id: Usakupcos1 briefTitle: Metabolic Differences Between Subtypes of Polycystic Ovary Syndrome overallStatus: COMPLETED date: 2022-01-01 date: 2022-09-01 date: 2023-07-20 date: 2024-04-02 date: 2024-04-02 name: Uşak University class: OTHER briefSummary: We aimed to investigate serum uric acid levels in patients with different phenotype of policystic ovary syndrome and to compare healthy controls. conditions: Uric Acid Concentration, Serum, Quantitative Trait Locus 7 conditions: Polycystic Ovary Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 300 type: ACTUAL name: Serum uric acid level measure: Uric acid levels in PCOS subtypes sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Usak Egitim Ve Araştırma Hastanesi city: Uşak zip: 64100 country: Turkey lat: 38.67351 lon: 29.4058 hasResults: False
<\|newrecord\|> nctId: NCT06342167 id: NCC4409 briefTitle: Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-14 date: 2026-07-01 date: 2026-12-01 date: 2024-04-02 date: 2024-04-03 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: At present, concurrent chemoradiotherapy (cCRT) with platin-based dual-drug regimen is the standard treatment for inoperable, locally advanced esophageal cancer in patients with a good performance status. However, cCRT has substantial toxic effects, and a large number of patients with older age, malnutrition and other morbidities, cannot tolerate cCRT. Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma (LA-ESCC).
Therefore, this single-arm, multicenter, phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT. conditions: Locally Advanced Esophageal Squamous Cell Carcinoma conditions: Sintilimab conditions: Radiotherapy conditions: Concurrent Chemoradiotherapy conditions: Immunonutrition studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 57 type: ESTIMATED name: Radiotherapy name: Programmed Cell Death Protein 1 Inhibitor name: Immunonutrition support measure: 1-year Progression-free survival rate (PFS) measure: Objective response rate measure: Progression-free survival measure: Overall survival rate measure: Overall survival measure: Incidence of adverse events sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College city: Beijing state: Beijing zip: 100021 country: China lat: 39.9075 lon: 116.39723 facility: Department of Radiation Oncology，Clinical Oncology School of Fujian Medical University，Fujian Cancer Hospital city: Fujian state: Fujian country: China facility: Department of Oncology, Affiliated Hospital, Hebei University of Engineering city: Handan state: Hebei country: China lat: 36.60056 lon: 114.46778 facility: Department 1st of Radiation Oncology, Anyang Tumor Hospital city: Anyang state: Henan country: China lat: 36.096 lon: 114.38278 facility: Department of Radiation Oncology the first affiliated hospital of Xinxiang Medical University city: Xinxiang state: Henan country: China lat: 35.19033 lon: 113.80151 facility: Department of Radiation Oncology, General Hospital of Ningxia Medical University city: Yinchuan state: Ningxia country: China lat: 38.46806 lon: 106.27306 facility: Department of Radiation Oncology，Fei County People's Hospital city: Feixian state: Shandong country: China facility: Department of Radiation Oncology, Affiliated hospital of Jining Medical University city: Jining state: Shandong country: China lat: 35.405 lon: 116.58139 facility: Taizhou hospital of Wenzhou Medical University city: Taizhou state: Zhejiang zip: 317000 country: China lat: 32.49069 lon: 119.90812 hasResults: False
<\|newrecord\|> nctId: NCT06342154 id: MCBU-SBF-YC-03 briefTitle: Does Endorphin Massage Reduce the Anxiety of Pregnant Women? overallStatus: RECRUITING date: 2023-10-09 date: 2024-10-09 date: 2024-12-10 date: 2024-04-02 date: 2024-04-02 name: Celal Bayar University class: OTHER briefSummary: Before cesarean section surgery, researchers will demonstrate endorphin massage to the husbands of pregnant women, and they will be asked to apply the massage before the surgery. The stress levels and pain levels of women will be compared before and after the massage. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized study with experimental and control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 68 type: ESTIMATED name: Endorphin Massage measure: visual analog scale (VAS) measure: State and Trait Anxiety Scales measure: cortisol level sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi status: RECRUITING city: Manisa zip: 45060 country: Turkey lat: 38.61202 lon: 27.42647 hasResults: False
<\|newrecord\|> nctId: NCT06342141 id: 24-1423 briefTitle: Empagliflozin for No-reflow Phenomenon in PCI for STEMI acronym: EMPA-PCI overallStatus: NOT_YET_RECRUITING date: 2024-05-15 date: 2025-01-15 date: 2025-03-15 date: 2024-04-02 date: 2024-04-02 name: Instituto Nacional de Cardiologia Ignacio Chavez class: OTHER briefSummary: Myocardial infarction remains, in our current era, a leading cause of morbidity and mortality both domestically and globally. A significant contributor to this issue is reperfusion injury, which enlarges the infarction, deteriorates ventricular function, leads to poorer outcomes, and currently has no specific treatment. Originally developed as an antidiabetic, empagliflozin has shown significant benefits in other organs and systems. Recent years have seen the demonstration of its cellular and vascular effects in animal models, potentially contributing to the reduction of reperfusion damage. However, no human studies have yet confirmed these effects.
Consequently, this double-blind, randomized, parallel-arm clinical trial was designed to evaluate the effect of empagliflozin treatment, administered from the pre-intervention period through to 3 days post-intervention, on the incidence of the no-reflow phenomenon in patients with ST-segment elevation myocardial infarction (STEMI) undergoing coronary angioplasty compared to a placebo.
Before entering the hemodynamics room, participants in the intervention group will receive a loading dose of 25 mg of empagliflozin or a placebo. In-hospital treatment will continue with 10 mg empagliflozin daily for 3 days for the intervention group, while the control group will receive a placebo. Patients will be monitored weekly during the first month and bi-weekly during the second and third months.
The primary outcome will be the incidence of the no-reflow phenomenon, measured through the Thrombolysis in Myocardial infarction (TIMI) flow scale in the coronary angiography performed to treat the infarction. Secondary outcomes will include the reduction of ST segment on the electrocardiogram, troponin levels, differences in the longitudinal strain by echocardiogram, and infarct size by magnetic resonance imaging. conditions: STEMI conditions: No-Reflow Phenomenon studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 162 type: ESTIMATED name: Empagliflozin 25 milgrams (Mg) name: Empagliflozin 10 Mg name: Placebo 25 Mg name: Placebo 10 Mg measure: Non-Reflow Phenomenon measure: Infract size measure: Longitudinal Strain measure: High-sensitivity Troponin Clearance measure: Creatine Kinase-myocardial band Clearance measure: Adverse Cardiovascular Events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342128 id: MVI_Kidney_001 briefTitle: Molecular Landscape of Microvascular Inflammation in Kidney Allografts overallStatus: RECRUITING date: 2022-01-01 date: 2024-06 date: 2024-12 date: 2024-04-02 date: 2024-04-03 name: Paris Translational Research Center for Organ Transplantation class: OTHER briefSummary: Microvascular inflammation in kidney allografts has been widely reappraised in the recent update of Banff classification. There is a critical need to better understand the pathophysiological mechanisms associated with the various phenotypes of microvascular inflammation that are observed in kidney transplants, particularly in order to develop targeted therapeutic approaches. conditions: Kidney Rejection Transplant studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 600 type: ESTIMATED name: No intervention measure: RNA-based molecular signatures assessed using bulk and spatial transcriptomics measure: Probability of graft survival based on outcome data measure: Probability of patient survival on outcome data sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris status: RECRUITING city: Paris zip: 75010 country: France name: Carmen Lefaucheur, MD PhD role: CONTACT email: carmen.lefaucheur@aphp.fr lat: 48.85341 lon: 2.3488 facility: Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris status: RECRUITING city: Paris zip: 75015 country: France name: Alexandre Loupy, MD PhD role: CONTACT phone: +33612491082 email: alexandreloupy@inserm.fr lat: 48.85341 lon: 2.3488 facility: Bichat Hospital, Assistance Publique - Hôpitaux de Paris status: RECRUITING city: Paris zip: 75018 country: France name: Aurélie Sannier, MD PhD role: CONTACT email: aurelie.sannier@aphp.fr lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06342115 id: CLEMENT TRIAL briefTitle: Ceftolozane/Tazobactam Versus Meropenem for Febrile Neutropenia on Patients Colonized With or at Risk for Infection With Extended Spectrum Beta Lactamase - Producing Pathogens acronym: CLEMENT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-04 date: 2025-04 date: 2024-04-02 date: 2024-04-02 name: Beneficência Portuguesa de São Paulo class: OTHER name: Merck Sharp & Dohme LLC briefSummary: The study proposes a planned, double-blind, non-inferiority clinical trial involving patients with febrile neutropenia and risk of extended-spectrum beta-lactamase (ESBL) infection. The goal is:
- Analyze the efficacy and tolerability of Ceftolozane/tazobactam (CEF/TAZ) compared to the current standard of care (meropenem) in patients with febrile neutropenia and risk of ESBL infection.
Patients will be randomly assigned to receive CEF/TAZ or meropenem, with assessment of clinical response, toxicity and microbiological evolution. Stool samples will be collected before, during and after treatment for intestinal microbiota analysis and intestinal microbiome analysis to evaluate possible effects on GVHD. Analysis of the results will include the taxonomic classification of the organisms present. Data will be analyzed to assess non-inferiority in clinical response, incidence of GVHD, antimicrobial resistance and other outcomes. conditions: Febrile Neutropenia studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 176 type: ESTIMATED name: Ceftolozane-Tazobactam name: Meropenem measure: Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Intent-to-Treat (ITT) Population measure: Percentage of Participants With Clinical Response of Clinical Cure at the End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population measure: Percentage of Participants With Clinical Response of Clinical Cure at the Test-of-Cure (TOC) Visit in the Intent-to-Treat (ITT) Population measure: Incidence of microbiologically documented infections and identification of causative organisms in culture measure: In-hospital mortality measure: Occurrence of graft versus host disease (GVHD) measure: Frequency of multidrug resistant-pathogen infections or colonization measure: Faecal microbiota analysis measure: Percentage of Participants Who Report 1 or More Adverse Event (AE) measure: Percentage of Participants With Any Serious Adverse Event (SAE) measure: Percentage of Participants Discontinuing Study Drug Due to an Adverse Event (AE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: A Beneficência Portuguesa de São Paulo city: São Paulo country: Brazil name: João Prats, MD role: CONTACT phone: +55 11 3505 5031 lat: -23.5475 lon: -46.63611 hasResults: False
<\|newrecord\|> nctId: NCT06342102 id: ID 4286 briefTitle: PENG and LFCN Block Versus FIC Block for Multimodal Analgesia After Total Hip Replacement Surgery: a Retrospective Analysis Focused on Movement (Retro-PvF) acronym: Retro-PvF overallStatus: NOT_YET_RECRUITING date: 2024-03-26 date: 2024-03-26 date: 2024-04-30 date: 2024-04-02 date: 2024-04-04 name: Ospedale Edoardo Bassini class: OTHER briefSummary: Total hip arthroplasty is a major surgical procedure performed on a growing number of patients. Optimal pain control with limited muscle weakness is paramount for a swift initiation of physical therapy and ambulation, thus expediting hospital discharge. Amongst the many peripheral nerve blocks, FIB (fascia iliaca block) has been recommended as the block of choice by many international guidelines since it offers the best pain control with a relatively low risk of motor block. PENG (pericapsular nerve group) and its association with LFCN (lateral femoral cutaneous nerve) has been proposed as an effective alternative that offers comparable, If not better, pain control with a considerably lower risk for motor block compared to FIB. Given the novelty of this block, there are few published papers on the subject, mostly case series or case reports thus justifying the need for retrospective study. conditions: Regional Anesthesia Block conditions: Regional Anesthesia conditions: Total Hip Replacement Surgery conditions: Total Hip Arthroplasty \(THA\) studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 80 type: ESTIMATED name: PENG + LFCN block name: FIC block measure: Movement of the lower limb affected by surgery measure: pain control measure: pain control measure: pain control measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses measure: Morphine Milligram Equivalents (MME) of "pro re nata" (PRN) opioid doses measure: time to first opioid request measure: time to first postoperative ambulation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06342089 id: NCT06342089 briefTitle: Association Between Molar Incisor Hypomineralization And Type I Diabetes Milletus. overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2024-11 date: 2025-05 date: 2024-04-02 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: * Determine the association between molar incisor hypomineralization and type I diabetes millutes, its severity and treatment need via clinical examination of children with type I diabetes millutes .
* Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth.
* Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken.
* The severity and treatment needs of each case with MIH will be recorded in patient's chart.
* The results of the study will be regularly monitored by the supervisors who will have full access to these results. conditions: Molar Incisor Hypomineralization studyType: OBSERVATIONAL observationalModel: ECOLOGIC_OR_COMMUNITY timePerspective: RETROSPECTIVE count: 238 type: ESTIMATED name: Type I diabetes milletus measure: Association between molar incisor Hypomineralization and type I diabetes milletus measure: Severity of molar incisor Hypomineralization among among a group of children with type I diabetes milletus. measure: Treatment need sex: ALL minimumAge: 8 Years maximumAge: 14 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06342076 id: 2023-596 briefTitle: Comparison of the Efficacy of Peripheral Nerve Blocks in Major Open Gynaecological Cancer Surgery overallStatus: COMPLETED date: 2024-01-01 date: 2024-03-01 date: 2024-03-01 date: 2024-04-02 date: 2024-04-02 name: Bakirkoy Dr. Sadi Konuk Research and Training Hospital class: OTHER_GOV briefSummary: The aim of this prospective randomized study was to compare the effectiveness of subcostal transversus abdominis plane block or rectus sheath block applied in addition to posterior transversus abdominis plane block for postoperative analgesia in major gynecological cancer surgeries.
The main question(s) it aims to answer are:
\[Is subcostal transversus abdominis plane block more effective in postoperative analgesia? \] \[Is there a difference in pain scores at 24 hours after surgery? \] Since pain scores within the first 24 hours after surgery will be evaluated, participants will be asked to give a value between 0 and 10 at certain time periods. conditions: Postoperative Pain conditions: Postoperative Complications conditions: Analgesia conditions: Regional Anesthesia Morbidity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective randomize study primaryPurpose: SUPPORTIVE_CARE masking: NONE maskingDescription: Prospective randomize study count: 50 type: ACTUAL name: Patients undergoing subcostal transversus abdominis plane block and posterior transversus abdominis plane block name: Patients undergoing rectus sheat block and posterior transversus abdominis plane block measure: visuel analog scale measure: amount of opioid used sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Başakşehir Çam and Sakura City Hospital city: Istanbul state: Basaksehir country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06342063 id: 20-0070-E briefTitle: The Effects of Preoperative Blood Flow Restriction Training in Patients Undergoing ACL Reconstruction acronym: BFRACL overallStatus: COMPLETED date: 2021-04-01 date: 2023-10-31 date: 2024-01-31 date: 2024-04-02 date: 2024-04-02 name: Women's College Hospital class: OTHER briefSummary: This prospective feasibility study is designed to assess pre-operative BFR in patients awaiting ACL reconstruction. This study will serve the following: (1) to determine if BFR improves strength testing prior to surgery and (2) to determine if BFR reduces QF muscle group atrophy prior to surgery. Additionally, preliminary results on pre-operative clinical and quality of life scores will be collected. If this study shows encouraging results, it will serve as a template for a more comprehensive randomized control trial. conditions: ACL Injury conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patients were recruited and randomized to one of the two treatment arms. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Outcome measurement was blinded to participant intervention. whoMasked: OUTCOMES_ASSESSOR count: 32 type: ACTUAL name: Blood Flow Restriction Therapy name: Blood Flow Restriction Therapy Sham measure: Biodex Strength Testing measure: Short Form Health Survey 12 (SF-12) measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Mount Sinai Hospital city: Toronto state: Ontario zip: M5G 1X5 country: Canada lat: 43.70011 lon: -79.4163 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2022-10-28 uploadDate: 2024-03-07T20:51 filename: Prot_000.pdf size: 303762 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2022-10-28 uploadDate: 2024-03-23T13:30 filename: ICF_001.pdf size: 892575 hasResults: False
<\|newrecord\|> nctId: NCT06342050 id: STU-2023-0548 id: R01MD011686 type: NIH link: https://reporter.nih.gov/quickSearch/R01MD011686 briefTitle: Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-02 date: 2025-08 date: 2024-04-02 date: 2024-04-02 name: University of Texas Southwestern Medical Center class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The goal of this cross-sectional observational study is to examine potential relationships between the blood and gut microbiota of patients with obesity before and after weight loss surgery (WLS) and evaluate potential ethnic differences in the blood and gut microbiotas before and after the WLS.
The main aims / objectives of this sub-study are:

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