Datasets:
hackint0sh
/
Text-Clinical-Records

Dataset card Data Studio Files Community
text
stringlengths
0
197k
1. Evaluation of restoration quality based on the glass ionomer restoration criteria (simplified FDI criteria)
2. Evaluation of restoration wear based on comparison of digital impressions
Safety Endpoint:
1. Evaluation of potential adverse events NULL HYPOTHESIS There is no statistically significant difference between both glass ionomers
* regarding overall survival
* regarding restoration quality parameters TEST GROUP Ketac Universal Aplicap Glass Ionomer Restorative (3M) CONTROL GROUP Ketac Molar Quick Aplicap Glass Ionomer Restorative (3M)
* regarding restoration wear METHODS AND MATERIALS A total of 39 subjects were enrolled and treated. The study was originally planned with 80 patients. Due to slow recruitment, it was decided to decrease the number of patients.
Treatment:
After signing informed consent, test and control product were randomly assigned to the two study teeth (randomization letter). Restoration extension (e.g. mod) and reason for restoration placement (e.g. secondary caries, tooth fracture) were recorded in the CRF. Two teeth per subject were included. Each product was used strictly according to respective Instructions for Use without using the optional protective coating. Restorations were placed in combination with sectional matrix system (Palodent system) and according to best practice (especially with regards to moisture control). Finishing and polishing was done with the Sof-Lex system. Areas in close proximity to the pulp were covered with local application of a calcium hydroxide material in both study materials. Study teeth were excluded from study if pulp exposure had occurred or if only a repair restoration was required instead of a full Class II restoration.
Evaluation periods:
All subjects were evaluated by two independent evaluators according to Performance Criteria for Posterior Glass Ionomer Restorations (simplified FDI criteria)
* at baseline at day of restoration placement or up to 1 month after restoration placement
* after 6 months (± 1 months)
* after 1 year (± 1 months)
* after 2 years (± 1 months) In addition, photos (at least occlusal view) were taken of every study tooth prior to restoration placement and at every evaluation.
In order to further assess the wear of both restorative materials, full arch digital impressions (both upper and lower jaw) were taken at baseline evaluation and at every following evaluation using 3M True Definition Scanner. STL files were digitally compared to those taken at baseline. conditions: Tooth Wear conditions: Glass Ionomer Cements studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Blinded evaluation whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 39 type: ACTUAL name: Ketac Universal Aplicap Glass Ionomer Restorative (3M) (test group) name: Ketac Molar Quick Aplicap Glass Ionomer Restorative (control group) measure: Restoration survival over time based on the glass ionomer restoration criteria measure: Evaluation of restoration quality based on the glass ionomer restoration criteria measure: Evaluation of restoration wear based on comparison of digital impressions measure: Safety Endpoint: The safety endpoint is the incidence of Adverse Events. sex: ALL minimumAge: 18 Years maximumAge: 66 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Dental Health Clinic at Universidad Europea de Madrid (UEM) Department of Prosthodontics city: Madrid zip: 28045 country: Spain lat: 40.4165 lon: -3.70256 hasResults: False
<|newrecord|> nctId: NCT06275568 id: HSC-SPH-23-0655 briefTitle: Accelerating Healthcare Engagement in Healthy Food Interventions - Food Rx in High Risk Pregnant Mothers With About Fresh and Texas Children's Health Plan overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-11-15 date: 2024-11-15 date: 2024-02-23 date: 2024-02-23 name: The University of Texas Health Science Center, Houston class: OTHER briefSummary: The purpose of the study is to assess if the Fresh Connect food prescription (Fresh Connect Food Rx) program that provides consistent access to healthy fresh produce through purchases at the grocery store plus nutrition education impacts gestational weight gain, other pregnancy and birth outcomes, and food and nutrition security in low-income, ethnically diverse, at-risk women residing in Houston, Texas. Enrollment of participants will begin in pregnancy at the time of the first prenatal visit (as long as the first visit occurs before the end of the first trimester); each participant will be followed until 60 days post-partum (up to 11 months follow-up per participant). conditions: Nutrition in High-Risk Pregnancy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 620 type: ESTIMATED name: Usual Care Fresh Connect cardholder engagement name: Enhanced engagement communication measure: Absolute gestational weight gain (GWG) in pounds measure: Absolute gestational weight gain (GWG) in pounds measure: Absolute gestational weight gain (GWG) in pounds measure: Excess gestational weight gain (EGWG) in pounds measure: Excess gestational weight gain (EGWG) in pounds measure: Excess gestational weight gain (EGWG) in pounds measure: Number of participants diagnosed with pregnancy-induced hypertension measure: Number of participants diagnosed with gestational diabetes measure: Number of participants with pre-term birth (<37 weeks) measure: Infant birth weight sex: FEMALE minimumAge: 18 Years maximumAge: 44 Years stdAges: ADULT facility: The University of Texas Health Science Center at Houston city: Houston state: Texas zip: 77030 country: United States name: Shreela Sharma, PhD role: CONTACT phone: 713-500-9344 email: Shreela.V.Sharma@uth.tmc.edu name: Naomi Tice, MPH role: CONTACT phone: (713) 500-9000 email: Naomi.Tice@uth.tmc.edu lat: 29.76328 lon: -95.36327 hasResults: False
<|newrecord|> nctId: NCT06275555 id: 2023-101 briefTitle: Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane Oxygenation overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-12-31 date: 2024-02-23 date: 2024-02-26 name: Xiaotong Hou class: OTHER briefSummary: The purpose of this study was to evaluate the efficacy and safety of bivalirudin in anticoagulation therapy in patients with extracorporeal membrane oxygenation (ECMO) compared with unfractionated heparin. conditions: Extracorporeal Membrane Oxygenation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 154 type: ESTIMATED name: bivalirudin name: unfractionated heparin measure: thrombotic complications measure: bleeding complications measure: Hospitalization mortality measure: Loop replacement measure: Infusion volume of blood products measure: Acute renal failure measure: Heparin-induced thrombocytopenia measure: the time of reaching the target anticoagulant level for the first time measure: Percentage of time during ECMO within the target anticoagulant level sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Anzhen Hospital city: Beijing state: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<|newrecord|> nctId: NCT06275542 id: USurabaya briefTitle: Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criteria Without TOF Monitoring Equipment overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2026-01-01 date: 2024-02-23 date: 2024-02-23 name: University of Surabaya class: OTHER name: Department of Anesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Gadjah Mada name: Sardjito General Hospital, Yogyakarta briefSummary: Patients undergoing general anesthesia will have an endotracheal tube inserted. Adequate muscle strength recovery in the recovery room is crucial to ensure before extubation. One of the criteria we use to determine the recovery of muscle strength post-use of muscle relaxants in conditions without specific monitoring devices is the ability to maintain body oxygen levels without oxygen assistance for 3 minutes. This study aims to determine the muscle strength value in the recovery room using extubation strategies without muscle strength monitoring compared to extubation strategies with muscle strength monitoring. conditions: Anesthesia Intubation Complication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was conducted through a randomized clinical trial with blinding of observers. Two parallel groups were selected to compare the incidence of paralysis in the recovery room. The research samples were collected using non-probability sampling method through consecutive enrollment over a specific period. This study consisted of 3 comparisons distinguished based on the type of volatile anesthetic gas maintenance and neuromuscular blockade agent, namely:
* Comparison 1: The volatile anesthetic gas used was sevoflurane and the muscular blockade agent used was rocuronium.
* Comparison 2: The volatile anesthetic gas used was isoflurane and the muscular blockade agent used was rocuronium.
* Comparison 3: The volatile anesthetic gas used was sevoflurane and the muscular blockade agent used was atracurium. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Upon arrival in the recovery room, all subjects were fitted with SpO2, EKG, NIBP monitors, and the TOF monitoring device. TOF values were measured by a second researcher who was unaware of the type of intervention. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 240 type: ESTIMATED name: Train of four monitoring device intraoperative name: Neostigmine name: Air chalenge prior to extubation name: Train of Four monitoring device in recovery room measure: Residual paralysis in recovery room measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06275529 id: 27.12.2023.685 briefTitle: Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2024-06-15 date: 2024-08-15 date: 2024-02-23 date: 2024-02-23 name: Başakşehir Çam & Sakura City Hospital class: OTHER_GOV briefSummary: Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes.
The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification. conditions: Radiculopathy Lumbar conditions: Low Back Pain conditions: Disc Herniation conditions: Injections, Epidural studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: Transforaminal Epidural Steroid Injection measure: Change of the pain severity score measure: Change of the disability score sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06275516 id: 2024-208 briefTitle: Safety and Efficacy of Multisensory Stimulation Virtual Reality for Stroke Patients. overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2024-06-20 date: 2024-09-20 date: 2024-02-23 date: 2024-02-23 name: First Affiliated Hospital of Chongqing Medical University class: OTHER briefSummary: This was a single-blind randomized controlled trial of multisensory stimulation virtual reality to improve motor and cognitive dysfunction in stroke patients. conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: multi-sensory stimulation immersive VR+ treadmill training name: treadmill training measure: Fugl-Meyer scale measure: Berg balance scale measure: three-dimensional gait detection measure: Fall incidents measure: Dizzy incidents sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06275503 id: STROKESTOP III briefTitle: STROKESTOP III - Optimized Method for Atrial Fibrillation Screening overallStatus: NOT_YET_RECRUITING date: 2024-02-20 date: 2025-02-28 date: 2026-06-30 date: 2024-02-23 date: 2024-02-23 name: Danderyd Hospital class: OTHER name: Karolinska Institutet name: Landstinget i Värmland briefSummary: Atrial fibrillation is the most common sustained cardiac arrhythmia affecting more than 3% of the adult population. The symptoms of atrial fibrillation can range from asymptomatic to debilitating. It can be permanent in its nature, but also paroxysmal with only short bursts of atrial fibrillation randomly occurring and can therefore remain unnoticed. Atrial fibrillation increases the risk of stroke five fold if left untreated.
Screening for atrial fibrillation in elderly populations above age 65 years can result in detection of new atrial fibrillation cases ranging from 0,5% new AF with a single time-point ECG, up to 30% AF if an implantable loop recorder is inserted for 3 years.
Currently opportunistic screening using pulse palpation, or a single time-point ECG is recommended by the European Society of Cardiology guidelines. Systematic screening in individuals aged 75 or above, or at a high stroke risk should be considered.
Overall, participation in systematic atrial fibrillation screening trials has been shown to be relatively low with almost 50% non-participants. Participants are generally healthier, with higher socioeconomic status, hence the ones who would potentially benefit the most remain absent.
Opportunistic screening has shown promising results with higher participation rates and the possibility of better outreach. There is a lack of data from randomized trials on the difference in participation rates in systematic and opportunistic screening approaches when screening with prolonged ECG monitoring. conditions: Atrial Fibrillation conditions: Atrial Fibrillation New Onset studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Cluster randomized trial primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 2200 type: ESTIMATED name: Screening invitation mode measure: Participation in screening measure: AF detection in opportunistic compared to systematic screening measure: OAC treatment after AF detection measure: Compliance to OAC treatment 1 year after initiation measure: Health economy measure: Composite endpoint of stroke, death and severe bleeding measure: Reminder strategy effect on participation measure: Comparison of automatic ECG analysis (using AI) for detection of AF in a (by AI algorithm classified) high- compared to a low-risk group measure: Application of the FIND-AF algorithm sex: ALL minimumAge: 75 Years maximumAge: 76 Years stdAges: OLDER_ADULT facility: Karolinska Institutet, Dept Med H city: Stockholm zip: 141 86 country: Sweden name: Emma Svennberg, MD PhD role: CONTACT phone: +46739584822 email: emma.svennberg@regionstockholm.se name: MD PhD role: CONTACT lat: 59.33258 lon: 18.0649 facility: Region Värmland city: Värmland country: Sweden name: Fredrik Carlstedt role: CONTACT lat: 60.83333 lon: 16.5 hasResults: False
<|newrecord|> nctId: NCT06275490 id: 181123PER6_3_1 briefTitle: Post Extraction Changes Following Ridge Preservation Using Partially Demineralized Dentin Block Versus L- PRF Block overallStatus: RECRUITING date: 2024-01-01 date: 2024-05-01 date: 2024-11-15 date: 2024-02-23 date: 2024-02-23 name: Cairo University class: OTHER briefSummary: * The aim is to evaluate post extraction hard tissue changes following ridge preservation using partially demineralized dentin block versus L-PRF block in intact socket in the esthetic zone.
* The main question: In patients with un restorable tooth, Will ridge preservation using partially demineralized dentin block be more effective than L-PRF block in managing the post extraction hard tissue alterations?
* After enrolment, periodontal and radiographic examination and patients with badly un-restorative tooth in the esthetic zone will be identified. These patients will undergo to mesio-distal distance between adjacent teeth, corono-apical height of bone, presence of labial undercut, dehiscence, or fenestration and Relation to adjacent teeth measurements using trans gingival probing technique, and preapical radiograph or CBCT .
* In both groups, the desired tooth will be extracted under local anesthesia using peritomies and surgical forceps.
* In intervention group: the teeth will be cleaned and dried, and then the dentin will be ground to obtain particles of a certain size then partially demineralize dentin will obtained by using a tooth transformer machine. At the same time, blood samples are collected and processed to obtain fibrin membranes rich in platelets and leukocytes. This tissue is then mixed with partially demineralized dentin to create a solid mass called a "dentin block". During the process of preserving the alveolar bumps after extraction, this solid mass "dentin mass" is placed inside the dental pockets and covered with fibrin membranes rich in platelets and white blood cells, then 5/0 proline suture are used to fix the fibrin membranes and dentin mass in place. After the recovery period "4-6 months", a biopsy is taken for some cases from the site of the operation for histological evaluation during implant placement.
* In control group: the same steps as the first group will be used, but by replacing the partially demineralized dental graft with a xenograft.
* Outcomes: Radiographic vertical buccal bone changes, vertical Palatal bone changes, horizontal bone changes, Percentage of new vital bone formation, Percentage of residual bone graft, Implant Primary Stability. The results directly postoperative and 4-6 months postoperatively. conditions: Socket Preservation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized Controlled Pilot Trial primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Partially Demineralized Dentin Block name: L-PRF block measure: Radiographic vertical bone changes measure: Radiographic horizontal bone changes measure: Percentage of new vital bone formation and residual graft measure: Implant Primary Stability sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of dentistry Cairo University status: RECRUITING city: Cairo state: Elmanil zip: 4240101 country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
<|newrecord|> nctId: NCT06275477 id: 29BRC23.0029 briefTitle: 68Gallium-FAPI PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases acronym: PARADISE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-21 date: 2026-04-21 date: 2024-02-23 date: 2024-02-23 name: University Hospital, Brest class: OTHER briefSummary: This single-center pilot study is designed to explore the preliminary utility of the \[68Ga\] Ga-FAPI imaging agent in positron emission tomography (PET) combined with computed tomography (CT) for a range of chronic inflammatory and fibrosing diseases. The study focuses on the potential of \[68Ga\] Ga-FAPI, a novel radiotracer targeting Fibroblast Activation Protein (FAP), to improve diagnostic accuracy in various medical conditions. Thirteen distinct clinical situations have been selected for this investigation, including rheumatoid arthritis, liver fibrosis, and systemic lupus, among others. This approach aims to ascertain the value of further clinical development in each area and refine the use of this imaging modality in routine care for both initial evaluation and ongoing monitoring of these diseases. conditions: Inflammatory Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a single-center, descriptive and analytical pilot study, which will be implemented in 13 distinct and independent populations of patients with chronic inflammatory and/or fibrosing disease. primaryPurpose: DIAGNOSTIC masking: NONE count: 390 type: ESTIMATED name: 68Ga-FAPI46 measure: PET uptake intensity measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Others pathology evaluation correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Biomarkers correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Functional parameters correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga]Ga-FAPI PET/CT - Imaging characteristics correlation measure: [68Ga] Ga-FAPI PET/CT parameters evolution measure: [68Ga] Ga-FAPI PET/CT parameters evolution measure: [68Ga] Ga-FAPI PET/CT / [18F] F-FDG PET/CT comparison measure: [68Ga] Ga-FAPI PET/CT kinetic measure: [68Ga] Ga-FAPI PET/CT kinetic measure: [68Ga] Ga-FAPI PET/CT kinetic sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06275464 id: BT-600-101 briefTitle: BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects overallStatus: RECRUITING date: 2024-01-11 date: 2024-04 date: 2024-06 date: 2024-02-23 date: 2024-02-23 name: Biora Therapeutics, Inc. class: INDUSTRY briefSummary: This is a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BT-600 when administered in single and multiple ascending doses to healthy participants. The study will enroll up to 48 participants, with participation lasting 2-3 weeks in addition to up to 28 days (about 4 weeks) for screening.
The purposes of this study are to learn about the safety and tolerability of single and multiple rising oral doses of BT-600, assess the blood and tissue levels of tofacitinib released from BT-600, and assess the body's effects to the study drug following oral doses of BT-600 in blood and tissue in healthy adult participants.
BT-600 is a swallowable drug/device combination product designed to deliver a liquid formulation of tofacitinib to the colon and dispense the study drug throughout the colon. BT-600 consists of two components, the drug part containing a reservoir, which will be filled with liquid tofacitinib, and the drive part. The drive part contains the hardware and software that identifies the colon region and then dispenses the drug to the specific region. The device which contains the drug is referred to as the NaviCap™ device. The NaviCap device is approximately the size of a fish oil pill, is made of plastic material known to be safe for ingestion and has rounded ends for ease of swallowing. Liquid tofacitinib in the reservoir is automatically released when the BT-600 localization technology determines that it has reached the colon. BT-600 passes through the colon and the NaviCap device is excreted via a bowel movement. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: BT-600 name: BT-600 Placebo measure: Adverse Events measure: Pharmacokinetic (PK) Assessments sex: ALL minimumAge: 19 Years maximumAge: 50 Years stdAges: ADULT facility: Celerion status: RECRUITING city: Lincoln state: Nebraska zip: 68502 country: United States lat: 40.8 lon: -96.66696 hasResults: False
<|newrecord|> nctId: NCT06275451 id: EssaiClinique_QUALI-RES briefTitle: Qualitative Study of Emotional Regulation in Schizophrenia acronym: QUALI-RES overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2025-01 date: 2026-01 date: 2024-02-23 date: 2024-02-28 name: University Hospital, Grenoble class: OTHER briefSummary: The main aim of this study is to investigate emotional regulation in individuals with schizophrenia using a qualitative methodology (semi-structured interview) and, therefore, from the person's point of view.
Given the qualitative nature of the methodology used in this study, the investigators have no specific hypothesis. The investigators have a general hypothesis suggesting that the patients' discourse will enable us to highlight the emotional regulation difficulties described in the literature. conditions: Schizophrenia conditions: Schizophrenia Schizoaffective studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Semi-structured interview measure: Emotional regulation in schizophrenia measure: Factors influencing emotional regulation in schizophrenia measure: Improved emotional regulation in schizophrenia measure: Stages of emotional regulation in schizophrenia sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<|newrecord|> nctId: NCT06275438 id: 81829502.903/39 briefTitle: Comparison of Oxytocin Receptor Immunoreactivity in Placentas Obtained From Women Having Cesarean and Natural Birth overallStatus: COMPLETED date: 2018-08-25 date: 2019-07-01 date: 2019-12-01 date: 2024-02-23 date: 2024-02-23 name: Kafkas University class: OTHER briefSummary: Our study examines the effects of oxytocin hormone receptors. mechanisms of placental tissue cells and therefore intrauterine development. It was conducted to investigate the effects on newborn babies apgar score, fontanel openings, birth weights, etc. By collecting data, normal and They were compared between cesarean births by statistical analysis. normal in this regard Based on the hypothesis that there is a difference between labor and cesarean delivery, this study has been made.OXTR primary antibody was used for immunohistochemical examination. There was no significant difference between the groups in terms of histological examination. In the study, it was found that OXTR immunoreactivity was strong in decidual cells and stromal cells in villi. A stronger OXTR immunoreactivity was detected in villous stroma of placenta of the natural birth group compared to the cesarean birth group. Reaction was not observed in syncytotrophoblast cells and syncytial nodes in both groups, but strong immunoreaction was observed fetal endothelial cells and fetal capillaries in both groups. conditions: Healthy Mothers Who Have Had Both Vaginal and Cesarean Deliveries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: "Our study was conducted on the placentas of 40 women admitted to the obstetrics clinics of Kars Harakani State Hospital and Kafkas University Training and Research Hospital, after obtaining necessary permissions. Out of 40 placentas, 5 were excluded due to blood incompatibility, 2 were excluded due to subsequent diagnosis of chronic conditions (thyroid disorder, Behçet's disease), and 1 was excluded due to the presence of an accessory placenta, resulting in a total of 32 placentas included in the study. Among these, 16 were from women who had undergone normal vaginal delivery (control group), and 16 were from women who had undergone cesarean section (case group). Tissue samples obtained from the placentas were subjected to histological and immunohistochemical methods to obtain various findings primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 32 type: ACTUAL name: The delivery being performed via cesarean section surgery rather than natural childbirth measure: Oksitosin Receptor Immunoreactivity measure: Pearson correlation analysis sex: FEMALE minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: Kafkas Universty city: Kars state: Merkez zip: 36100 country: Turkey lat: 40.59825 lon: 43.08548 hasResults: False
<|newrecord|> nctId: NCT06275425 id: 4-2023-0429 briefTitle: Comparison of the Coughing Frequency of Remimazolam Total Intravenous Anesthesia Versus Inhalational Anesthesia overallStatus: COMPLETED date: 2023-06-25 date: 2023-11-29 date: 2023-11-29 date: 2024-02-23 date: 2024-02-23 name: Yonsei University class: OTHER briefSummary: This study is a randomized controlled trial. Adult patients undergoing thyroidectomy under general anesthesia at Severance Hospital and Yonsei Cancer Center are included in tis study. For intervention group, patients receive anesthesia with total intravenous remimazolam, while for control group, patients receive anesthesia with inhalation anesthetic.
The primary end point of the study is to determine whether coughing during endotracheal tube extubation is less when anesthesia is maintained with intravenous remimazolam compared to inhalation anesthetics. The secondary end points are cough score (graded into 4 levels), frequency of reoperation due to postoperative bleeding, These include the frequency of hypertension during the extubation process and whether additional painkillers are used in the recovery room. conditions: Thyroid Neoplasm conditions: Cough studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a single-blinded randomized controlled trial primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 106 type: ACTUAL name: Total intravenous anesthesia with Byfavo name: Inhalation anesthesia with Sevoflurane measure: Proportion of patients not coughing during postoperative extubation measure: Cough score sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, College of Medicine, Yonsei University, city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
<|newrecord|> nctId: NCT06275412 id: IRB-23-04-5675 id: 5R01MD018583-02 type: NIH link: https://reporter.nih.gov/quickSearch/5R01MD018583-02 briefTitle: Family Intervention for Black Teens With Type 1 Diabetes acronym: 3Ms overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-03 date: 2028-03 date: 2024-02-23 date: 2024-02-23 name: Wayne State University class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages). conditions: Type 1 Diabetes conditions: Family Relations studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: CARE_PROVIDER count: 216 type: ESTIMATED name: The 3Ms 2.0 Intervention name: Educational Attention Control (EAC) measure: Glycemic Control measure: Caregiver Diabetes Distress measure: Diabetes-Specific Family Conflict measure: Diabetes-Specific Parental Monitoring measure: Diabetes-Specific Family Support measure: Illness Management measure: Intervention Satisfaction sex: ALL minimumAge: 10 Years maximumAge: 14 Years stdAges: CHILD facility: Children's National Hospital city: Washington state: District of Columbia zip: 20010 country: United States name: Angelica Eddington, Ph.D., ABPP role: CONTACT phone: 202-476-2342 email: aeddington@childrensnational.org name: Angelica Eddington, Ph.D., ABPP role: SUB_INVESTIGATOR lat: 38.89511 lon: -77.03637 facility: LeBonheur Children's Hospital city: Memphis state: Tennessee zip: 38103 country: United States name: Kristoffer S Berlin, Ph.D. role: CONTACT email: ksberlin@memphis.edu name: Kathryn Sumpter, MD role: SUB_INVESTIGATOR name: Kristoffer S Berlin, Ph.D. role: SUB_INVESTIGATOR lat: 35.14953 lon: -90.04898 facility: University of Tennessee Health Science Center-Memphis city: Memphis state: Tennessee zip: 38163 country: United States name: Kristoffer S Berlin, Ph.D. role: CONTACT email: ksberlin@memphis.edu name: Kathryn Sumpter, MD role: SUB_INVESTIGATOR name: Kristoffer S Berlin, Ph.D. role: SUB_INVESTIGATOR lat: 35.14953 lon: -90.04898 hasResults: False
<|newrecord|> nctId: NCT06275399 id: INTERFORCE briefTitle: Comprehensive Assessment of Morphometric, Functional, Biomechanical and Biological Interactions Between Atherosclerotic Plaque and Platelets Within the Stenosed Coronary Artery acronym: INTERFORCE overallStatus: RECRUITING date: 2023-07-21 date: 2025-07-21 date: 2026-07-21 date: 2024-02-23 date: 2024-02-23 name: Medical University of Warsaw class: OTHER name: National Science Centre, Poland name: University College, London name: Queen Mary University of London briefSummary: The main objective of the present study is to verify, in vivo, whether shear forces computed solely based on coronary angiography and computational fluid dynamics (CFD) techniques are associated with the biomarkers indicating the prothrombotic tendency of circulating blood in situ - distally and proximally to the coronary stenosis. The study will prospectively assess the relationship between i) the value and distribution of shear rate and shear stress (SS) estimated using three-dimensional angiography and CFD techniques, and ii) atherosclerotic plaque characteristics as assessed by optical coherence tomography (OCT), iii) functional parameters of diseased vessels assessed by vessel fractional flow reserve (vFFR), and iv) in situ platelet activation, as expressed by platelet-derived microvesicles (pMVs) and small extracellular vesicles (sEVs), platelet aggregometry and other serum prothrombotic or inflammatory biomarkers sampled within the coronary artery. conditions: Chronic Coronary Syndrome conditions: Atherosclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: OCT examination name: Blood sampling name: Assessment of vFFR and shear stress parameters measure: Correlation between the mean shear rate and shear stress values at the lesion's site and the concentration of pMVs and sEVs sampled in the distal segment of the artery. measure: Correlation between the shear stress measurements at the site of the lesion and the concentration of inflammatory biomarkers in the distal segment of the artery measure: Correlation between the shear stress measurements at the site of the lesion and the platelet reactivity parameters in the distal segment of the artery measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of the pMVs and sEVs measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) concentration of inflammatory biomarkers measure: Correlation between the shear rate and shear stress values at the site of the lesion and the gradient (delta) of platelet reactivity measure: Concentrations of inflammatory biomarkers categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel measure: Platelet reactivity levels categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel measure: Concentrations of pMVs and sEVs categorized by the atherosclerotic plaque morphology and the mean value of shear stress affecting the endothelium at the stenosis site and as well as according to the vessel measure: Platelet reactivity levels in blood sampled from the stenosed vs. the non-stenosed coronary artery measure: Concentrations of analyzed pMVs and sEVs in blood sampled from the stenosed vs. the non-stenosed coronary artery measure: Concentrations of analyzed inflammatory biomarkers in blood sampled from the stenosed vs. the non-stenosed coronary artery measure: Correlation between vFFR delta pressure and the delta platelet reactivity in stenosed artery compared to these gradients in a non-stenosed artery in the same patient measure: Correlation between vFFR delta pressure and the delta concentration of the pMVs and sEVs in stenosed artery compared to these gradients in a non-stenosed artery in the same patient measure: Correlation between vFFR delta pressure and the delta concentration of the inflammatory biomarkers in stenosed artery compared to these gradients in a non-stenosed artery in the same patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medical University of Warsaw status: RECRUITING city: Warsaw state: Mazowieckie zip: 02-097 country: Poland name: Mariusz Tomaniak, MD, PhD, Assoc. Prof. role: CONTACT email: mariusz.tomaniak@wum.edu.pl name: Adrian Bednarek role: CONTACT email: adikbednarek@gmail.com name: Mariusz Tomaniak, MD, PhD, Assoc. Prof. role: PRINCIPAL_INVESTIGATOR lat: 52.22977 lon: 21.01178 hasResults: False
<|newrecord|> nctId: NCT06275386 id: 2.31/II/24 briefTitle: Drug-Coated Balloon in Native Chronic Total Occlusion Percutaneous Coronary Intervention acronym: IMAGINATION overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-09-01 date: 2025-09-01 date: 2024-02-23 date: 2024-02-23 name: National Institute of Cardiology, Warsaw, Poland class: OTHER briefSummary: The IMAGINATION trial is an investigator-initiated, prospective, single-center study of symptomatic patients with a native chronic total occlusion (CTO) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) with a drug-coated balloon (DCB). Post-PCI IVUS and fractional flow reserve (FFR) at baseline and at 6-months follow-up will be performed. In addition, patients included in the coronary computed tomography angiography (CCTA) substudy will undergo photon-counting CCTA at 12-months follow-up. The aim of this study is to evaluate the efficacy and safety of DCB-only approach in native coronary CTO. conditions: Coronary Artery Disease conditions: Total Occlusion of Coronary Artery studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Paclitaxel Drug-coated balloon measure: In-segment late lumen loss measure: Angiographic outcomes assessed directly post-PCI measure: HQ-IVUS outcomes assessed directly post-PCI measure: Physiologic outcomes assessed directly post-PCI measure: Angiographic outcomes at 6-months follow-up measure: HQ-IVUS outcomes at 6-months follow-up measure: Physiologic outcomes at 6-months follow-up measure: Computed tomographic outcomes at 12-months follow-up (CCTA substudy) measure: Clinical outcomes at 12-months follow-up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institute of Cardiology city: Warsaw state: Mazowieckie zip: 04-628 country: Poland name: Agnieszka Zdziennicka role: CONTACT email: azdziennicka@ikard.pl lat: 52.22977 lon: 21.01178 hasResults: False
<|newrecord|> nctId: NCT06275373 id: 20-10974 briefTitle: The Effect of Teprotumumab on Thyroid Eye Disease and Thyroid Dysfunction acronym: Teprotumumab overallStatus: RECRUITING date: 2021-05-12 date: 2026-05-12 date: 2027-12-12 date: 2024-02-23 date: 2024-02-23 name: Walter Reed National Military Medical Center class: FED briefSummary: This protocol studies the clinical outcome of patients with active thyroid disease with visually significant signs and symptoms of proptosis, pain, diplopiam lid/orbital edema, or lid/orbital erythema recommended for treatment with teprotumumab infusion (Tepezza®). Patients recommended for treatment will be evaluated by an oculoplastic surgeon (Dr. Eva Chou) and endocrinologist (Dr. Thanh Hoang). conditions: Thyroid Eye Disease conditions: Graves Ophthalmopathy conditions: Graves Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 100 type: ESTIMATED name: Teprotumumab Injection [Tepezza] measure: Ophthalmological Clinical Activity Score (CAS) scoring measure: Thyroid stimulating immunoglobulin measure: HLA subtypes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Walter Reed National Military Medical Center status: RECRUITING city: Bethesda state: Maryland zip: 20889 country: United States name: Thanh D Hoang, DO role: CONTACT phone: 301-295-5165 phoneExt: 6220 email: thanh.d.hoang.mil@health.mil name: Iris E Morris, PhD role: CONTACT phone: 3013194599 email: iris.e.morris3.civ@health.mil lat: 38.98067 lon: -77.10026 hasResults: False
<|newrecord|> nctId: NCT06275360 id: SPLP-002-23F briefTitle: Repositioning Immunotherapy in VetArans With Lung Cancer acronym: RIVAL overallStatus: RECRUITING date: 2024-03-01 date: 2027-02-28 date: 2030-03-31 date: 2024-02-23 date: 2024-03-12 name: VA Office of Research and Development class: FED briefSummary: This study is a multicenter Phase II single arm trial to assess the safety and efficacy of chemotherapy and immunotherapy followed by radiotherapy in patients with unresectable Stage III NSCLC. conditions: Non-Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Carboplatin, paclitaxel, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for squamous cell lung cancer) OR Carboplatin, pemetrexed, and nivolumab for three cycles followed by radiotherapy followed by nivolumab (for lung adenocarcinoma) primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Nivolumab measure: Progression-free survival measure: Treatment Tolerance measure: Adverse Events measure: Best overall response rate (BOR) measure: Overall survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA status: NOT_YET_RECRUITING city: West Los Angeles state: California zip: 90073-1003 country: United States name: Daniel Shin, MD role: CONTACT phone: 310-478-3711 email: Daniel.Shin@va.gov name: Michelle Treadwell role: CONTACT phone: 3104783711 phoneExt: 45003 email: Michelle.Treadwell@va.gov lat: 34.0464 lon: -118.44813 facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT status: RECRUITING city: West Haven state: Connecticut zip: 06516-2770 country: United States name: Michal Rose, MD role: CONTACT phone: 203-932-5711 phoneExt: 2832 email: Michal.Rose@va.gov name: Alicia Roy role: CONTACT phone: 2039325711 phoneExt: 3006 email: Alicia.Roy@va.gov lat: 41.27065 lon: -72.94705 facility: VA Ann Arbor Healthcare System, Ann Arbor, MI status: RECRUITING city: Ann Arbor state: Michigan zip: 48105-2303 country: United States name: Brittany M Pannecouk, BS role: CONTACT phone: 734-845-3966 email: brittany.pannecouk@va.gov name: Laura A Randolph, BA role: CONTACT phone: (734) 845-5091 email: Laura.Randolph@va.gov name: Michael D Green role: PRINCIPAL_INVESTIGATOR name: Nithya Ramnath, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68105-1850 country: United States name: Apar Kishor P Ganti, MD role: CONTACT phone: 402-346-8800 phoneExt: 3846 email: Aparkishor.Ganti@va.gov name: Anna Kellogg role: CONTACT phone: 4029954143 email: Anna.Kellogg@va.gov lat: 41.25626 lon: -95.94043 facility: Durham VA Medical Center, Durham, NC status: NOT_YET_RECRUITING city: Durham state: North Carolina zip: 27705-3875 country: United States name: Michael Kelley, MD role: CONTACT phone: 919-286-0411 phoneExt: 172199 email: Michael.Kelley6@va.gov name: Maya Robinson role: CONTACT phone: 9192866926 email: Maya.Robinson@va.gov lat: 35.99403 lon: -78.89862 facility: Louis Stokes VA Medical Center, Cleveland, OH status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44106-1702 country: United States name: Charles Nock, MD role: CONTACT phone: 216-791-3800 phoneExt: 64825 email: Charles.Nock@va.gov name: Margaret Titkin role: CONTACT phone: 2167913800 phoneExt: 36241 email: MargaretTiktin@va.gov lat: 41.4995 lon: -81.69541 facility: Hunter Holmes McGuire VA Medical Center, Richmond, VA status: NOT_YET_RECRUITING city: Richmond state: Virginia zip: 23249-0001 country: United States name: Bhaumik Patel, MD role: CONTACT phone: 804-675-5446 email: Bhaumik.Patel@va.gov lat: 37.55376 lon: -77.46026 hasResults: False
<|newrecord|> nctId: NCT06275347 id: 19CI 30 087 041 id: 1/1142021 type: OTHER domain: Comite del Centro de alta especialidad del Estado de Veracruz briefTitle: Very Low Calorie Ketogenic Low-fat Diet (VLCKLFD) acronym: Zelé2021 overallStatus: COMPLETED date: 2021-01-15 date: 2021-12-30 date: 2023-05-25 date: 2024-02-23 date: 2024-02-23 name: Universidad Veracruzana class: OTHER briefSummary: This study aimed to assess the efficacy and safety of the Zélé program, a controlled ketogenic diet, for weight loss and maintenance. It involved a randomized clinical trial with participants aged 18-60, BMI between 30-34.9 kg/m², and no severe health issues conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A Randomized Clinical Trial was conducted in patients with obesity type I patients primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Eligible patients were assigned to a one of the four VIME Weight Loss and Wellness Center for management and follow up according to their preference, a sequential number in inclusion order was given, with all the patients coded with a 4-digit number. This code was sent to the people in the food production plant where the patients were randomized in a double blinded study, with a 2:1 allocation for low-fat, normo-protein, controlled ketogenic diet (Zélé method) or low calories diet whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 88 type: ACTUAL name: Low-fat normoprotein Controlled Ketogenic Diet. name: Hypocaloric Balanced Diet measure: Evaluate the efficacy of this nutritional intervention measure: Volume of total body tissue corresponding to muscle measure: Percentage of body weight made up of adipose tissue measure: Visceral Fat measure: Bone mass measure: Total body water measure: Waist circumference measure: Hip circumference measure: Muscular strenght measure: Weight measure: Height measure: BMI Body index mass measure: Hemoglobin measure: Hematocrit measure: Leukocytes measure: Fasting Blood Glucose measure: Glycated hemoglobin (HbA1c) measure: Insulin measure: Creatinine measure: Urea measure: Uric acid measure: Sodium measure: Potassium measure: Calcium measure: Phosphorus measure: Magnesium measure: Albumin measure: Direct bilirubin measure: Indirect bilirubin measure: Total bilirubin measure: Alanine aminotransferase measure: Aspartate Amino Transferase measure: Total cholesterol measure: Triglycerides measure: High Density Lipoproteins measure: Low Density lipoproteins measure: Protein C Reactive measure: Thyroid stimulating hormone measure: Triiodothyronine measure: Thyroxine measure: Cholecalciferol measure: Gasometric variables, Partial pressure of oxygen (PaO2) measure: HCO3 (Bicarbonate ion plasma concentration) measure: Arterial pH measure: Lactic acid measure: Adherence to this nutritional intervention measure: Satisfaction survey sex: ALL minimumAge: 18 Years maximumAge: 61 Years stdAges: ADULT facility: Francisco J Nachón García city: Ciudad de Mexico country: Mexico lat: 19.42847 lon: -99.12766 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2021-04-23 uploadDate: 2024-02-16T19:37 filename: Prot_SAP_000.pdf size: 549651 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2021-04-23 uploadDate: 2024-01-14T23:04 filename: ICF_001.pdf size: 249137 hasResults: False
<|newrecord|> nctId: NCT06275334 id: 9133 briefTitle: Dinutuximab Beta at the HUS and the Toulouse Oncopole acronym: DNB overallStatus: RECRUITING date: 2023-11-28 date: 2024-11 date: 2024-11-28 date: 2024-02-23 date: 2024-02-23 name: University Hospital, Strasbourg, France class: OTHER briefSummary: In this study the investigators wish to describe the cohort of pediatric patients suffering from neuroblastoma and treated with Dinutuximab and to compare the costs and quality of life between the two French centers, the University Hospital of Strasbourg (HUS) and the Oncopole of Toulouse. conditions: Neuroblastoma studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 40 type: ESTIMATED measure: Comparison of two methods of treating a pediatric pathology in two French health establishments, the HUS and the Oncopole of Toulouse. sex: ALL minimumAge: 2 Years maximumAge: 25 Years stdAges: CHILD stdAges: ADULT facility: Service de Pharmacie - Stérilisation - CHU de Strasbourg - France status: RECRUITING city: Strasbourg zip: 67091 country: France name: Anne EL AATMANI, Pharm, PhD role: CONTACT phone: 33 3 88 12 78 06 email: Anne.ELAATMANI@chru-strasbourg.fr name: Emilie BERTHON, Pharm, PhD role: CONTACT phone: 33 3 88 12 78 06 email: emilieberthon@orange.fr name: Anne EL AATMANI, Pharm, PhD role: PRINCIPAL_INVESTIGATOR name: Emilie BERTHON, PhamD, PhD role: PRINCIPAL_INVESTIGATOR name: Sophie PERRIAT, PhamD, PhD role: PRINCIPAL_INVESTIGATOR lat: 48.58392 lon: 7.74553 hasResults: False
<|newrecord|> nctId: NCT06275321 id: Elena Garcia Roca briefTitle: Physical Exercise Benefits for Cancer Patients overallStatus: RECRUITING date: 2021-11-05 date: 2024-07-27 date: 2025-07-30 date: 2024-02-23 date: 2024-02-23 name: Universitat Jaume I class: OTHER briefSummary: The purpose of the study was to analyze the effect of a synchronous-supervised online home-based group during a 6-month exercise program on physical fitness, body composition and adherence compared to an exercise recommendation group of patients undergoing breast cancer treatment without supervision. conditions: Cancer, Breast conditions: Sports Physical Therapy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: A prospective ramonized clinical trial with two groups primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Synchronous-supervised online home-based group name: Exercise recommendation group measure: Cardiorrespiratory fitness measure: Strength - Chair Stand (repetitions) measure: Flexibility measure: Incidence of treatments on quality of live assessed by EORTIC QLQ-C30 measure: Adherence measure: Rating of perceived exertion measure: Strength - Hand Grip (Kilograms) measure: Strength - Squat Jump (height in centimeters) sex: FEMALE minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jaume I University status: RECRUITING city: Castellón De La Plana state: Castellón zip: 12071 country: Spain name: Elena Garcia Roca, MSc role: CONTACT phone: +34 629112367 email: garciroc@uji.es name: Eladio J Collado-Boira, PhD role: CONTACT phone: +34 606133368 email: colladoe@uji.es lat: 39.98567 lon: -0.04935 hasResults: False
<|newrecord|> nctId: NCT06275308 id: STUDY21100163 briefTitle: Effect of Raised End-Tidal pCo2 on Choroidal Volume overallStatus: RECRUITING date: 2023-02-27 date: 2025-02-27 date: 2025-02-27 date: 2024-02-23 date: 2024-02-23 name: University of Pittsburgh class: OTHER briefSummary: This study is to investigate the relationship between arterial carbon dioxide (CO2) concentration and vitreous pressure on the choroidal volume by integrated intraoperative OCT imaging under eye exams under anesthesia. conditions: Intraocular Pressure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is a descriptive case series. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Ventilation manipulation measure: Intraocular Pressure (IOP) (mmHg) measure: Choroidal thickness ( microns) sex: ALL maximumAge: 8 Years stdAges: CHILD facility: University of Pittsburgh Medical Center status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15224 country: United States name: Amy Monroe, MPH, MBA role: CONTACT email: monroeal@upmc.edu name: Kanwal Nischal, MD,FRCOphth role: PRINCIPAL_INVESTIGATOR name: Lieu Tran, MD role: SUB_INVESTIGATOR lat: 40.44062 lon: -79.99589 hasResults: False
<|newrecord|> nctId: NCT06275295 id: ZRJY2021-BJ08-03-01-01 briefTitle: A Retrospective Study of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2024-12-24 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this observational study is to learn about the diagnostic effectiveness, safety, and influencing factors of transbronchial cryobiopsy（TBLC） in progressive pulmonary fibrosis. conditions: Pulmonary Fibrosis conditions: Transbronchial Cryobiopsy studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 300 type: ESTIMATED measure: The diagnostic rate of MDD2 based on TBLC measure: The diagnostic rate of MDD1 sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06275282 id: HUM00235849 briefTitle: Regenerative Peripheral Nerve Interfaces for the Control of Above-knee Prostheses overallStatus: RECRUITING date: 2024-03-01 date: 2027-06-30 date: 2027-09-30 date: 2024-02-23 date: 2024-03-25 name: University of Michigan class: OTHER name: United States Department of Defense briefSummary: Individuals with an above-knee lower limb amputation are known to walk more slowly, expend more energy, have a greater risk of falling, and have reduced quality of life compared to individuals without amputation and those with below knee amputation. One of the driving factors behind these deficits is the lack of active function provided by above-knee prostheses with prosthetic knees and ankles. While many prosthetic devices have been developed for functional restoration after major lower extremity amputation, there remains no stable interface to facilitate reliable, long-term volitional control of an advanced robotic limb capable moving multiple joints. Moreover, there is no existing interface that provides useful sensory feedback that in turn enhances the functional capabilities of the prosthesis. To achieve both greater signal specificity and long-term signal stability, we have developed a biologic interface known as the Regenerative Peripheral Nerve Interface (RPNI). An RPNI consists of a peripheral nerve that is implanted into a free muscle graft that would otherwise go unused in the residual limb. As the nerve grows, it reinnervates the free muscle graft which undergoes a predictable sequence of revascularization and regeneration.
The main questions it aims to answer are:
1. Can the amplitude, movement specificity and stability of sciatic nerve RPNI electromyography (EMG) signals be detected up to one year post RPNI surgery?
2. Do RPNIs contain information to enable control of a physical motorized prosthetic leg with multiple degrees of freedom?
3. Does stimulation of sciatic nerve RPNIs provides meaningful sensory feedback?
Consenting participants with unilateral transfemoral amputation (TFA) will:
1. Undergo RPNI surgery and electrode implantation in the residual limb.
2. Attend regular follow-up visits following surgery to assess the health and signal strength of the RPNIs and their ability to use a prescribed prosthesis between 3- and 12-months following implantation.
3. Undergo explantation of electrodes following the conclusion of data collection. conditions: Amputation conditions: Prostheses and Implants studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 3 type: ESTIMATED name: Intramuscular electrodes measure: Intensity of pain in residual and phantom limbs measure: Neuropathic Pain in residual limb measure: Health-Related Quality of Life measure: Amplitude and signal-to-noise ratio for each RPNI measure: Classification accuracy for movements of the phantom limb measure: Threshold for sensation after electrical stimulation of RPNI sex: ALL minimumAge: 22 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan status: RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Deanna Gates, PhD role: CONTACT phone: 723-647-2698 email: gatesd@umich.edu name: Deanna Gates, PhD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
<|newrecord|> nctId: NCT06275269 id: ZRJY2021-BJ08-04-02 briefTitle: Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-10-31 date: 2024-12-31 date: 2024-02-23 date: 2024-02-23 name: China-Japan Friendship Hospital class: OTHER briefSummary: This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods. conditions: Subglottic Stenosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Ultrasound-Guided name: Translaryngeal Endoscopic Mucosal Injection measure: Incidence of Short-Term Postoperative Complications measure: Overall medical expenses incurred by patients sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<|newrecord|> nctId: NCT06275256 id: HS26226 briefTitle: Outcomes of MIST for BPH: A Single-Institution Prospective Study overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-02-23 date: 2024-02-23 name: University of Manitoba class: OTHER briefSummary: The investigators wish to perform a prospective study at the Men's Health Clinic in Winnipeg, Manitoba to accomplish two goals: 1) Prospectively describe 1 year outcomes for MIST therapies performed at the clinic 2) perform a head to head comparison of Rezum water vapor therapy vs the iTind device in respect to symptom score improvement, uroflow parameters and side effect profile. conditions: Benign Prostatic Hyperplasia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Rezum name: iTind measure: Symptom Scores measure: Uroflow measure: Uroflow measure: Symptom Scores measure: Symptom Scores measure: Symptom Scores measure: Pain Scale sex: MALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Men's Health Clinic city: Winnipeg state: Manitoba zip: R3K 1M3 country: Canada name: Premal Patel, MD role: CONTACT phone: 204-221-4476 email: ppatel5@hsc.mb.ca name: Harliv Dhillon, BSc role: CONTACT phone: 2049904153 email: harlivmhc@gmail.com lat: 49.8844 lon: -97.14704 hasResults: False
<|newrecord|> nctId: NCT06275243 id: ETICA-ULE-021-2022 briefTitle: Polymorphism of ApoE in Alzheimer's Disease: Genetic Study in Castile and Leon (Spain) overallStatus: ACTIVE_NOT_RECRUITING date: 2022-07-06 date: 2023-03-13 date: 2024-03-22 date: 2024-02-23 date: 2024-02-23 name: Universidad de León class: OTHER name: Consejo General de Colegios Oficiales de Enfermería España briefSummary: The general objective of this randomized and longitudinal clinical study was to estimate the frequencies of ApoE variants both in the user population of the "Messengers of Peace" Residences and the "Associations of Relatives of Alzheimer's Patients" in Castile y Leon, since, due to its geographical location at the crossroads, it has received multiple genetic contributions from both northern Europe, the Mediterranean area and northern Africa.
The main questions it aims to answer are:
* What are the allelic frequencies of ApoE variants in the population of individuals with Alzheimer's disease in Castile and Leon?
* Is there a correlation between the ApoE4 variant and the lipid profile in the blood of individuals with Alzheimer's disease in this region? conditions: Alzheimer Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It is a longitudinal randomised clinical study, in which two study groups were used. A group of cases diagnosed with Alzheimer's disease and a control group of healthy individuals without Alzheimer's disease. primaryPurpose: DIAGNOSTIC masking: NONE count: 511 type: ACTUAL name: Kit Buccal swab collection & stabilization de Canvax® name: Cholesterol levels according to ApoE Genotype name: Assessing cardiovascular risk factors in all participants measure: Distribution of ApoE variants in the Alzheimer's disease population diagnosed in Castile and Leon. measure: Cardiovascular factors in individuals with Alzheimer's disease and healthy subjects. measure: ApoE genotypes and cholesterol levels in the Alzheimer's disease population diagnosed in Castile and Leon. sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of León city: León zip: 240071 country: Spain lat: 42.60003 lon: -5.57032 hasResults: False
<|newrecord|> nctId: NCT06275230 id: ZRJY2021-BJ08-02-07 briefTitle: Establishment of Human Lung Stem Cell Proliferation System and Organoid Construction in COPD overallStatus: NOT_YET_RECRUITING date: 2024-03-20 date: 2025-12-31 date: 2025-12-31 date: 2024-02-23 date: 2024-02-23 name: China-Japan Friendship Hospital class: OTHER briefSummary: The goal of this study is to proliferate human lung stem cell in vitro in order to establish a lung organoid derived from patients with COPD. The main question it aims to answer are:
* Can human lung stem cell proliferate in vitro.
* Can a lung organoid derived from patients with COPD be established. Participants will be sampled during pulmonary bronchoscope for organoid establishment. conditions: Chronic Obstructive Pulmonary Disease studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED measure: Number of Patients completed bronchoscope. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False