hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06356246 id: APHP240363 briefTitle: Oral Health Status of Cystic Fibrosis Patients. An Online Survey in Collaboration With the Vaincre la Mucoviscidose Patient Association. acronym: E-MUCODENT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-08-01 date: 2024-08-01 date: 2024-04-10 date: 2024-04-10 name: Assistance Publique - Hôpitaux de Paris class: OTHER name: Vaincre la Mucoviscidose briefSummary: Cystic Fibrosis (CF) is a rare hereditary disease with autosomal recessive transmission, affecting 1 in 4700 births in France. Numerous studies have explored the links between oral health and CF, predominantly focusing on a children population. These studies reveal hyposalivation, a risk of dental erosion, an increased prevalence of enamel structural defects, but a reduced prevalence of dental caries in CF children, potentially explained by better oral hygiene. Periodontal disease does not appear to be increased in this population, while the oral quality of life of CF patients has been insufficiently studied.
To deepen understanding of the links between oral health and CF, as well as to improve oral health of these patients, it is crucial to update the specific oral profile of this population. A cross-sectional survey using a questionnaire is proposed to include a large number of CF patients in France, aiming for real-life data. This questionnaire is constructed around internationally recognized tools for comparative analysis with normative data. Collaboration with the Patients Association "Vaincre la Mucoviscidose" (VLM) facilitates questionnaire creation, dissemination, and interpretation of results. conditions: Cystic Fibrosis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 400 type: ESTIMATED measure: Periodontal Risk Screening Score PESS measure: Assess the adherence to good oral hygiene practices and dental follow-up in adult CF patients according to French Union for Oral Health (UFSBD) 2021 measure: Evaluate the risk of dental caries and tooth wear measure: Assess the oral quality of life measure: Evaluate oral dryness sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Marjolaine GOSSET city: Ivry-sur-Seine state: Ile-de-France zip: 94270 country: France name: Marjolaine GOSSET, MD, PhD role: CONTACT phone: +33 (0)1 49 59 48 20 email: marjolaine.gosset@aphp.fr name: Anne Sophie Duflos, Vaincre La Mucoviscidose role: CONTACT phone: +33 (0)1 40 78 91 97 email: asduflos@vaincrelamuco.org lat: 48.81568 lon: 2.38487 hasResults: False
nctId: NCT06356233 id: FIMBEX briefTitle: Phenotyping and Identification of Biological Markers in STXBP1 Encephalopathy acronym: FIMBEX overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-10-01 date: 2027-12-31 date: 2024-04-10 date: 2024-04-10 name: Fundación Iniciativa para las Neurociencias (FINCE) class: OTHER briefSummary: This is a prospective observational study to evaluate the phenotype of 10 patients under 10 years of age with developmental epileptic encephalopathy due to mutation of the STXBP1 gene. The study will consist of a clinical and neurodevelopmental evaluation, magnetic resonance imaging, prolonged electroencephalogram, cardiological study, and analysis of biomarkers in cerebrospinal fluid. These patients will be followed up for 3 years. The aim of the study is, knowing the baseline phenotype, to analyse the response to commonly used drugs and to anticipate the response to different drugs available on the market in this group of patients based on clinical and biomarker assessment (EEG, MRI and study of specific proteins and neurotransmitters in plasma, urine and CSF). conditions: STXBP1 Encephalopathy With Epilepsy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 10 type: ESTIMATED name: No intervention will be performed measure: CSF biomarkers measure: EEG markers measure: MRI markers measure: Clinical phenotype sex: ALL minimumAge: 1 Month maximumAge: 10 Years stdAges: CHILD facility: Hospital Ruber Internacional city: Madrid zip: 28034 country: Spain name: Alvaro Beltran Corbellini, MD role: CONTACT phone: +34913875250 email: info@neurologiaclinica.es name: Antonio Gil-Nagel, MD, PhD role: CONTACT name: Antonio Gil-Nagel, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
nctId: NCT06356220 id: IRB-P00046867 briefTitle: GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health) acronym: GF-NOURISH overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2026-01 date: 2026-07 date: 2024-04-10 date: 2024-04-10 name: Boston Children's Hospital class: OTHER briefSummary: We propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. We hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits conditions: Celiac Disease in Children conditions: Nutrition Disorder, Child studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 1. Study Design: Prospective randomized controlled trial.
3. Intervention: Gluten-Free Food Guide, a nutritional education program focused on minimizing ultra-processed foods in gluten-free die(GFFG), OR a conventional GFD nutritional education class. The nutrition educational program will be based on validated GFD education program. We will use a randomized control trial to assess improvement of overall diet quality, changes in body composition, and minimize toxic and nutrient metal exposures associated with processed gluten-free foods. primaryPurpose: PREVENTION masking: NONE count: 120 type: ESTIMATED name: Gluten-Free Diet Education measure: To compare the effect of GFFG versus conventional GFD class on body composition, specifically fat free mass measure: To compare the effect of GFFG vs conventional GFD class on diet quality measure: To compare the effect of GFFG versus conventional GFD on arsenic exposure sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States name: Lauren Robertson role: CONTACT name: Nan Du, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 hasResults: False
nctId: NCT06356207 id: 113-2023 briefTitle: Syncope-Asystole Latency Time in Tilt Table Test: The SALT-TILT Study acronym: SALT-TILT overallStatus: RECRUITING date: 2024-03-20 date: 2026-03 date: 2027-03 date: 2024-04-10 date: 2024-04-11 name: Azienda Ospedaliera di Bolzano class: OTHER briefSummary: Syncope is a common presenting condition. Pacemaker implantation can significantly reduce syncope recurrences in reflex syncope. However, despite careful selection, a substantial proportion of patients treated with pacemakers suffer recurrences of syncope. It is thought that a pronounced vasodepressor component may hinder the efficacy of pacing in patients, preventing adequate cerebral perfusion during the reflex, thus relativizing the anti-bradycardia function of the pacemaker to prevent syncope. It is hypothesised that the time elapsed from the actual loss of consciousness to the asystole recorded on the ECG during Tilt Table Test may be predictive in terms of response to pacemaker therapy, so this parameter becomes the subject of the present study. conditions: Syncope conditions: Pacemaker conditions: Asystole conditions: Neurally Mediated Syncope studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 64 type: ESTIMATED name: Tilt Table Test measure: SALT (Syncope-Asystole Latency Time) measure: Recurrence of syncope measure: Recurrence of syncope sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Sanitaria di Bolzano status: RECRUITING city: Bolzano zip: 39100 country: Italy name: Marco Tomaino, Dr. role: CONTACT lat: 46.49067 lon: 11.33982 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-06 uploadDate: 2024-04-04T15:15 filename: Prot_SAP_000.pdf size: 334779 hasResults: False
nctId: NCT06356194 id: AT-01B-006 briefTitle: Drug-drug Interaction Study of Biktarvy and Bemnifosbuvir/Ruzasvir overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-30 date: 2024-05-30 date: 2024-04-10 date: 2024-04-10 name: Atea Pharmaceuticals, Inc. class: INDUSTRY briefSummary: Drug-drug interaction study of Biktarvy and Bemnifosbuvir/Ruzasvir conditions: Healthy Volunteer Study studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: Cohort 1: Days 1-7 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. Days 8-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 BIK name: Cohort 2: Days 1-10 Biktarvy (BIK). Days 11-17 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered + Biktarvy (BIK). Days 18-24 Bemnifosbuvir (BEM)/Ruzasvir (RZR) co-administered. measure: PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) on the pharmacokinetics (PK) of Bemnifosbuvir (BEM) and Ruzasvir (RZR). measure: To determine the effect of Bemnifosbuvir (BEM)/Ruzasvir (RZR) combination on the PK of Biktarvy (BIK: Bictegravir, tenofovir alafenamide, emtricitabine) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Atea Study Site city: Québec state: Montreal country: Canada name: Atea Study Site role: CONTACT phone: 888-481-1607 email: ateaclinicaltrials@ateapharma.com lat: 46.81228 lon: -71.21454 hasResults: False
nctId: NCT06356181 id: Pro00135143 briefTitle: Training Adaptations With and Without Ventilatory Training Device overallStatus: RECRUITING date: 2024-03-18 date: 2024-09-01 date: 2024-09-01 date: 2024-04-10 date: 2024-04-10 name: University of South Carolina class: OTHER name: MAXIMUS briefSummary: This project aims to assess the effectiveness of using a Respiratory Muscle Training (RMT) device during high-intensity functional training (HIFT) to improve fitness and ventilatory parameters. Primary outcome measures include aerobic, anaerobic, and HIFT measures. Secondary measures include sleep, affect, and mood state questionnaires. Participants will be randomized into one of two groups: with the RMT device and without the RMT device. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 30 type: ESTIMATED name: Respiratory Maximus Training Device name: No Respiratory Training Device measure: Changes in spirometry measure: Changes in aerobic capacity measure: Changes in peak power measure: Changes in ventilatory threshold measure: Changes in countermovement jump measure: Changes in anaerobic capacity measure: Changes in high-intensity functional training test measure: Changes in heart rate at ventilatory threshold measure: Changes in body composition measure: Changes in sleep quality measure: Changes in total mood disturbances measure: Changes in positive mood and emotion measure: Change in blood lactate responses measure: Changes in negative mood and emotion sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of South Carolina Sport Science Lab status: RECRUITING city: Columbia state: South Carolina zip: 29208 country: United States name: Shawn M. Arent, PhD role: CONTACT phone: 803-576-8394 email: sarent@mailbox.sc.edu name: Sten O Stray-Gundersen, PhD role: CONTACT email: sten@mailbox.sc.edu lat: 34.00071 lon: -81.03481 hasResults: False
nctId: NCT06356168 id: SVR/IVR briefTitle: Virtual Reality in End Stage Kidney Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2025-01-31 date: 2024-04-10 date: 2024-04-15 name: University of Pennsylvania class: OTHER briefSummary: The goal of this clinical trial to compare the social virtual reality and individual virtual reality in patients with end stage kidney disease who are hemodialysis. The main aim is to determine if there are differences in symptoms between the groups. Participants will use virtual reality glasses for 30-45 minutes during dialysis sessions for 4 weeks. conditions: End Stage Kidney Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Social Virtual Reality name: Individual Virtual Reality measure: De Jong Gierveld Scale sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06356155 id: UMCC 2023.011 briefTitle: Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer acronym: NEPTUNE overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2027-07 date: 2027-07 date: 2024-04-10 date: 2024-04-10 name: University of Michigan Rogel Cancer Center class: OTHER briefSummary: This trial is a multi-site, single-arm, phase 2 trial of neoadjuvant combination of enfortumab vedotin and pembrolizumab in cisplatin-eligible patients with high-grade localized/locally advanced cT1-4 N0-1 M0 upper tract urothelial cancer who are deemed eligible for curative-intent surgery (radical nephroureterectomy or distal ureterectomy) followed by adjuvant pembrolizumab. conditions: Urothelial Carcinoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Enfortumab vedotin name: Pembrolizumab measure: Efficacy of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in cisplatin-eligible patients based off pathological response measure: Assess the safety and toxicity of the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy in UTUC measure: Assess whether patients who receive the combination of enfortumab vedotin and pembrolizumab as neoadjuvant therapy have increased surgical complications. measure: Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring RECIST v1.1 measurable disease. measure: Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year recurrence-free survival (RFS). measure: Estimate secondary measures of efficacy of neoadjuvant combination enfortumab vedotin and pembrolizumab and pembrolizumab adjuvant therapy (if tolerated) in response evaluable patients with UTUC by measuring 2-year overall survival (OS). measure: Estimate the number of patients who are able to complete neoadjuvant combination enfortumab vedotin and pembrolizumab and safely complete definitive surgery. measure: Assess comprehensive profiling of tumor and host characteristics (including genomics and assessment of tumor mutational burden) as predictors of response to treatment. measure: Explore circulating biomarkers as early detectors of cancer recurrence sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan Comprehensive Cancer Center city: Ann Arbor state: Michigan zip: 48109 country: United States name: Irene Tsung, M.D. role: CONTACT phone: 734-936-4385 email: itsung@umich.edu name: Irene Tsung, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
nctId: NCT06356142 id: UMMC-IRB-2023-317 briefTitle: The Effects of Palmar Cooling on Repeated Sprinting Ability overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2025-03-01 date: 2025-03-01 date: 2024-04-10 date: 2024-04-10 name: University of Mississippi Medical Center class: OTHER briefSummary: Repeated sprinting ability is key for athletic performance in a variety of sport settings. Significant degradations in work output (i.e. fatigue) have been shown to develop after just one sprinting bout1. This pilot study aims to investigate the effects that noninvasive transient temperature manipulation has on an individual's ability to perform repeated sprints. The investigators aim to enroll 90 healthy individuals, 18-30 years of age. Participants will be randomized into two groups (Group A, and B). All groups will perform a ten-minute warm-up followed by two minutes of rest. Following the warm-up and rest period, all groups will participate in a series of five sprints, 60 meters in total length with two 180 degree changes in direction. Between sprints, participants will have 10 seconds rest. After the first series of five sprints participants will be given a 2-minute rest interval. Then participants will perform another series of five sprints followed by another 2-minute rest interval. During each rest interval, Group A will utilize a palmar cooling device. Group B will utilize a placebo version of the palmar cooling device. All sprints will be timed. Heart rate recovery will be measured during all rest breaks, and a rating of perceived exertion will be measured at the beginning and end of each resting interval. Delayed onset muscle soreness will be assessed 48 hours post sprinting, utilizing a visual analog scale. conditions: Exercise Induced Fatigue studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: SINGLE whoMasked: PARTICIPANT count: 90 type: ESTIMATED name: Palmar Cooling name: Placebo Palmar Cooling measure: Participants Sprinting times measure: Participants Heart Rate Recovery measure: Participants Rating of Perceived exertion measure: Participants Reported Delayed Onset Muscle Soreness sex: ALL minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: University of Mississippi Medical Center city: Jackson state: Mississippi zip: 39216 country: United States name: Jacob Daniels, DPT, EdD role: CONTACT phone: 601-815-4038 email: jbdaniels@umc.edu lat: 32.29876 lon: -90.18481 hasResults: False
nctId: NCT06356116 id: CMUH111-REC3-029 briefTitle: Rehabilitation After Direct Anterior Approach for Total Hip Arthroplasty overallStatus: RECRUITING date: 2023-11-14 date: 2024-10-31 date: 2024-12-31 date: 2024-04-10 date: 2024-04-11 name: China Medical University Hospital class: OTHER briefSummary: The causes for total hip arthroplasty (THA) in Taiwan include ischemic necrosis of the femoral head and degenerative osteoarthritis. Contemporary, the surgical approach for total hip replacement mostly adopts the lateral approach. However, the direct anterior approach (DAA) has gained attention gradually due to its characteristics such as muscle preservation, small surgical incision length, and few surgical complications. Nevertheless, literature lacks detailed exploration or long-term follow-up on the recovery of physical functions related to fall occurrence after this type of surgery. It limits the establishment and design of suitable post-operative rehabilitation plans. Therefore, this study aims to explore and follow-up the functional recovery in patients who undergo the DAA for hip replacement using current usual care and new-designed accelerated rehabilitation program. The proposed method involves recruiting 30 patients who will undergo the DAA for total hip replacement, who will receive the current usual care plan; and another 30 patients will receive the accelerated rehabilitation program. The assessments will be conducted before the surgery and at 2, 4, 8, and 12 weeks after the operation, evaluating hip joint function, hip abduction and flexion muscle strength, balance function, and gait performance. The statistical analysis will utilize mixed-model two-factor ANOVA, comparing the preoperative and postoperative recovery of patients undergoing the DAA with different intervention programs and at different time points. The expected outcome of this study is to enhance the understanding of the functional recovery of patients undergoing the DAA for total hip replacement in terms of hip joint function, muscle strength, balance function, and gait performance after surgery. This information will help establish the targeted DAA postoperative treatment plans, which will be practically applied to patients and compared with the current usual care to assess its effectiveness, ultimately contributing to more efficient rehabilitation plans in the future. conditions: Total Hip Arthroplasty studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Usual care name: Accelerated rehabilitation measure: Functional recovery questionaire measure: Maximum muscle strength measure: Quality of Life questionaire measure: Balance function measure: Gait performance measure: Walking speed sex: ALL minimumAge: 25 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China Medical University Hospital status: RECRUITING city: Taichung zip: 404 country: Taiwan name: Hsiu-Chen Lin, PhD role: CONTACT phone: +886-4-22053366 phoneExt: 7303 email: hclin@mail.cmu.edu.tw lat: 24.1469 lon: 120.6839 hasResults: False
nctId: NCT06356090 id: 2023.0322 - NL84369.018.23 briefTitle: SPACE: a Parent-based Treatment for Pediatric OCD overallStatus: RECRUITING date: 2023-11-23 date: 2025-03-31 date: 2025-03-31 date: 2024-04-10 date: 2024-04-10 name: Chaim Huijser class: OTHER name: Levvel briefSummary: This study will investigate the parent-based treatment SPACE: Supportive Parenting for Anxious Childhood Emotions. The aim of this study is to investigate whether SPACE is effective in reducing family accommodation (FA) and OCD symptoms in children with a complex obsessive-compulsive disorder (OCD), that did not or cannot benefit from first line treatment. conditions: Obsessive-Compulsive Disorder conditions: Obsessive-Compulsive Disorder in Children conditions: Obsessive-Compulsive Disorder in Adolescence conditions: Anxiety Disorders and Symptoms studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single case experimental design (SCED) with multiple baselines primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: Supportive Parenting for Anxious Childhood Emotions (SPACE) measure: (Change in) OCD severity measure: (Change in) family accommodation (parent report) measure: (Change in) Family accommodation (child report) measure: Daily (change in) OCD symptoms measure: Daily (change in) family accommodation measure: Symptoms of child anxiety measure: Symptoms of child depression measure: Symptoms of autism measure: Quality of life (parent-report) measure: Quality of life (child-report) measure: Clinical impression of outcome measure: Treatment progress measure: Session experience measure: Treatment adherence measure: Demographic variables measure: Psychiatric DSM-5 diagnosis of the child measure: Parenting burden measure: Psychopathology and adaptive functioning of parents measure: Child Behavior Checklist (CBCL, parent-report) measure: Youth Self-report (YSR) (child-report) measure: Teacher Report Form Emotional- and behavioral problems of the child (teacher- report) measure: Treatment satisfaction sex: ALL minimumAge: 7 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Amsterdam UMC / Levvel (Academic centre for child & adolescent psychiatry) status: RECRUITING city: Amsterdam country: Netherlands name: J.D.K. Veeger role: CONTACT name: C. Huijser, Dr. role: PRINCIPAL_INVESTIGATOR lat: 52.37403 lon: 4.88969 hasResults: False