hackint0sh/New-Dataset huggingface dataset:
2. Design: A dose block-randomized, double-blind, placebo controlled, single- and multiple dosing, dose-escalation phase 1 clinical trial conditions: Non-alcoholic Steatohepatitis studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ACTUAL name: Single administration Amg dose Group name: Single administration Bmg dose Group name: Single administration Cmg dose Group name: Single administration Dmg dose Group name: Single administration Emg dose Group name: Single administration Amg dose Group-Placebo name: Single administration Bmg dose Group-Placebo name: Single administration Cmg dose Group-Placebo name: Single administration Dmg dose Group-Placebo name: Single administration Emg dose Group-Placebo name: Multiple administration Amg dose group name: Multiple administration Bmg dose group name: Multiple administration Cmg dose group name: Multiple administration Dmg dose group name: Multiple administration Emg dose group name: Multiple administration Amg dose group - Placebo name: Multiple administration Bmg dose group - Placebo name: Multiple administration Cmg dose group - Placebo name: Multiple administration Dmg dose group - Placebo name: Multiple administration Emg dose group - Placebo measure: Cmax measure: Emax sex: MALE minimumAge: 19 Years maximumAge: 45 Years stdAges: ADULT facility: J2H Biotech city: Suwon state: Gyeonggi-do zip: 16684 country: Korea, Republic of lat: 37.29111 lon: 127.00889 hasResults: False
nctId: NCT06308848 id: PR-22077 briefTitle: Microbiota Directed Food for Children With Severe Acute Malnutrition overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-10-31 date: 2026-12-31 date: 2024-03-13 date: 2024-03-13 name: International Centre for Diarrhoeal Disease Research, Bangladesh class: OTHER name: Washington University School of Medicine briefSummary: Severe acute malnutrition (SAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing SAM is crucial to prevent its progression to other childhood morbidity and mortality and to ensure healthy child development. To meet the nutritional requirement of SAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use therapeutic food. The investigators propose this proof-of-concept trial to establish evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF. conditions: Severe Acute Malnutrition studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized controlled trial (Proof of concept study) primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 256 type: ESTIMATED name: Microbiota-Directed Food name: Ready-to-Use Therapeutic Food measure: Mean change in Weight-for-Length Z-score (WLZ) measure: Gut microbial community repair measure: Improvement in the levels of plasma protein biomarkers of healthy growth measure: Mean change in Weight-for-Age Z-score (WAZ) measure: Mean change in Length-for-Age Z-score (LAZ) measure: Mean change in body composition (% body fat mass and % fat-free mass) sex: ALL minimumAge: 6 Months maximumAge: 24 Months stdAges: CHILD facility: Kurigram Study site city: Kurigram country: Bangladesh name: Md Hasan Hafizur Rahman, MPH, MBBS role: CONTACT phone: 01813333444 email: hasan.hafizur@icddrb.org hasResults: False
nctId: NCT06308835 id: APHP231652 briefTitle: Prevalence and Risk Factor of Post-intensive Care Syndrome in Neuro-ICU acronym: STRESSréa overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-08 date: 2025-08 date: 2024-03-13 date: 2024-03-18 name: Assistance Publique - Hôpitaux de Paris class: OTHER briefSummary: Post-intensive care syndrome (PICS) is the set of disabling symptoms that can appear or worsen following a stay in intensive care. These symptoms are physical, cognitive, or psychiatric. The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. patients with neurological diseases are frequently excluded from studies due to difficulties for the non-specialist resuscitator to perform the neurological examination and assess whether the symptoms of RPS are secondary to brain damage or complications inherent in resuscitation.The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it. conditions: Post Intensive Care Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: questionnaires measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a physical symptom measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a cognitive symptom measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom measure: Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GH Pitié Salpêtrière city: Paris zip: 75013 country: France name: Clémence Marois, MD, MSc role: CONTACT phone: 0142161858 phoneExt: 33 email: clemence.marois@aphp.fr lat: 48.85341 lon: 2.3488 facility: CH Saint Anne city: Paris zip: 75014 country: France name: Camille Legouy, MD role: CONTACT phone: 0145656200 phoneExt: 33 email: c.legouy@ghu-paris.fr lat: 48.85341 lon: 2.3488 hasResults: False
nctId: NCT06308822 id: NCI-2024-01151 id: NCI-2024-01151 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-K1 type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-K1 type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1) overallStatus: ACTIVE_NOT_RECRUITING date: 2018-06-19 date: 2024-06-30 date: 2024-06-30 date: 2024-03-13 date: 2024-03-13 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well JNJ-42756493 (erdafitinib) works in treating patients with tumors that have more copies of the FGFR gene than is normal (amplification). Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Computed Tomography name: Erdafitinib name: Magnetic Resonance Imaging measure: Objective response rate measure: Overall survival measure: Progression free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
nctId: NCT06308809 id: Shuzhen Ma briefTitle: Effect of PNF Training as an Intervention for Functional Ankle Instability in College Student overallStatus: NOT_YET_RECRUITING date: 2024-03-30 date: 2024-05-30 date: 2024-06-20 date: 2024-03-13 date: 2024-03-15 name: Ma Shuzhen class: OTHER briefSummary: The lower limb stability test was carried out by MicroSwing 6.0 gravity center moving trajectory tester made in Germany. conditions: Adolescent Behavior studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE maskingDescription: Single (Participant)
nctId: NCT06308796 id: RADIOCARIES2023 briefTitle: Prevention of Caries in Head and Neck Cancer Survivors Who Underwent Radiotherapy acronym: RADIOCARIES overallStatus: RECRUITING date: 2023-04-01 date: 2026-01-31 date: 2026-03-31 date: 2024-03-13 date: 2024-03-15 name: University of Milan class: OTHER briefSummary: One of the long-term side effects of head and neck radiotherapy (RT) is radiation-induced tooth decay. Hyposalivation, associated with radiation therapy, further increases caries susceptibility and caries progression, due to the lack of salivary protective effects and of tooth minerals useful for remineralization processes, especially calcium phosphate (CaP). Dental extractions that could be required in case of severe tooth decay expose the patient to the risk of osteoradionecrosis of the jaws (i.e. the necrosis of the bone tissue following a local trauma, including surgical trauma). This protocol aims at verifying the effectiveness of CaP mousse in the prevention of carious lesions, added to topical fluoride. A randomized controlled clinical trial will be performed comparing CaP + fluoride treatment versus no treatment in head and neck cancer patients, who received radiotherapy. The hypothesis is that CaP, which is lacking in the mouth of these patients due to hyposalivation, can combine with fluoride to promote remineralization, reducing the risk of carious lesions. conditions: Caries,Dental conditions: Head and Neck Cancer conditions: Radiotherapy; Complications studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 40 type: ESTIMATED name: Application of CaP dental mousse measure: Number of new cavitated caries per each patient (incidence of caries) measure: Number of extracted teeth per patient (incidence of extracted teeth) measure: Number of patients with a diagnosis of osteoradionecrosis (incidence of osteoradionecrosis) measure: Number of dental surfaces with caries or filling, and missed teeth measure: Rate of dentinal hypersensitivity per patient measure: Rate of dental surface with plaque per patient measure: Rate of bleeding gingival sites per patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Univeristy of Milan status: RECRUITING city: Milan zip: 20142 country: Italy name: Elena M Varoni, PhD role: CONTACT phone: +3950319017 email: elena.varoni@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06308783 id: UFranciscoVitoriaRPGBREATH23 briefTitle: Diaphragmatic Breathing and Global Postural Reeducation on Stress and Sleep Quality in University Students acronym: RPGBREATH23 overallStatus: NOT_YET_RECRUITING date: 2024-05-05 date: 2024-07-17 date: 2024-07-18 date: 2024-03-13 date: 2024-03-13 name: Universidad Francisco de Vitoria class: OTHER briefSummary: Introduction: Nowadays, the reduction of perceived stress and the improvement of sleep quality are considered fundamental aspects in the quality of life of both healthy subjects and patients with disease. Stress has become a pandemic in recent years due to the socio-labor demands faced by society. On the other hand, it has a direct relationship with the quality of sleep, its influence being bidirectional. In this regard, several tools have been reported for the management of these conditions. These include strategies such as yoga, mindfulness, diaphragmatic breathing (DR) or Pilates. On the other hand, other proposals such as global postural reeducation (GPR) lack evidence in the management of these conditions.
Method: The study will be carried out with physiotherapy students of the University Francisco de Vitoria. The participants will be randomly divided into three groups: GPR group, DR group and control group. Perceived stress (Perceived Stress Scale - PSS14) and reported sleep quality (Pittsburgh Sleep Quality Index - PSQI) will be measured three times throughout the study: pre-intervention, 3 weeks after the start of the intervention and post-intervention. The intervention will last 6 weeks, during which time all participants will be required to complete the 5 Grade Scale (5GS) each morning. The GPR group will perform; Frog to the ground posture, while the DR group will follow a set breathing protocol at a 4/6 rhythm. Both GPR and DR will be performed 10 minutes before going to sleep.
Subjects will be asked to participate on a voluntary basis and may withdraw from the study at any time. conditions: Stress conditions: Sleep Disturbance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: One group receives Diaphragmatic Breathing, one group receives Global Postural Reeducation, and the other group receives no intervention. primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 33 type: ESTIMATED name: Diaphragmatic Breathing name: Global Postural Reeducation measure: Stress measure: Sleep Quality measure: Sleep Quality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06308770 id: AC21137 briefTitle: Fatigue in Lupus Intervention Programmes (FLIP) acronym: FLIP overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04 date: 2027-04 date: 2024-03-13 date: 2024-03-13 name: University of Edinburgh class: OTHER name: Accord Clinical Research briefSummary: Systemic Lupus Erythematosus (SLE) is an autoimmune rheumatic disease. Patients report that fatigue has a significant impact on their quality of life but is often not discussed in healthcare settings. Fatigue is more prevalent in SLE than other Rheumatic diseases. Management across the NHS is very variable ranging from a booklet to one to one appointments or, less often, a group intervention. Previous studies in other Rheumatic diseases have shown that a group cognitive behavioural approach can be effective in helping patients manage their fatigue. The COVID-19 pandemic changed the way healthcare is delivered in the NHS . Healthcare professionals had to find alternate solutions e.g. Virtual appointments.
The investigators will also compare a shortened 4-week to the standard 7-week programme to lessen the time commitment for participants and potentially reduce waiting times.The investigators will measure the effectiveness of the interventions through the use of Patient Reported Outcome Measures (PROMs) at several intervals whilst the participant is enrolled in the study.The pilot study will run in a single site in Edinburgh. The investigators aim to find a manageable, cost effective solution for the NHS and patients to address this frequently unmet need. conditions: Systemic Lupus Erythematosus studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The pilot study for the FLIP trial is a single centre three arm, randomised controlled trial (RCT) comparing the effectiveness of a virtual group fatigue management intervention with standard care in SLE participants. Participants will self-enrol via a secure database and then be randomised electronically to one of the three interventions;
3. SC and 7 week FMP Results will be measured by comparing Patient Reported Outcome measures (PROMs) submitted before and after the intervention and, at 6 and 12 months. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The statistician who analyses the results will be blind to the intervention to which the participant was randomised. whoMasked: OUTCOMES_ASSESSOR count: 90 type: ESTIMATED name: Standard Care name: 4 week FMP name: 7 week FMP measure: Modified Fatigue Impact Score (MFIS) measure: Lupus quality of life questionnaire (LupusQoL) measure: Pittsburgh Sleep quality Inventory ( PSQI) measure: Visual Analog scale of fatigue impact (FI-VAS) measure: Participant Health Questionnaire (PHQ4) measure: Self-Efficacy for Managing Chronic Diseases 6-item Scale measure: Quick Systemic Lupus Erythematosus Activity Questionnaire (Q-SLAQ) measure: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06308731 id: 23-26 briefTitle: Exercise-Induced Rates of Fat Oxidation With and Without Ingestion of a Caffeine-Based Energy Drink acronym: EDX overallStatus: RECRUITING date: 2024-01-19 date: 2024-07-01 date: 2024-07-01 date: 2024-03-13 date: 2024-03-13 name: Lindenwood University class: OTHER briefSummary: The purpose of this study is to evaluate acute changes in rates of fat oxidation during exercise with and without the ingestion of a caffeine-based energy drink. conditions: Substrate Oxidation conditions: Energy Expenditure conditions: Reaction Time conditions: Cognition conditions: Exercise Performance studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Double-blind, placebo controlled, crossover design primaryPurpose: OTHER masking: DOUBLE maskingDescription: All energy drink supplements are provided in identical, unlabeled cans, using a randomization code. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 15 type: ESTIMATED name: Caffeine-Based Energy Drink name: Placebo measure: Impact of a caffeine-based energy drink ingestion on fat oxidation rates during exercise. measure: Impact of a caffeine-based energy drink ingestion on energy expenditure rates during exercise. measure: Impact of a caffeine-based energy drink ingestion on carbohydrate oxidation during exercise measure: Impact of a caffeine-based energy drink ingestion on plasma glycerol concentration measure: Impact of a caffeine-based energy drink ingestion on plasma free fatty acid concentration measure: Impact of a caffeine-based energy drink ingestion on ratings of perceived exertion measure: Impact of a caffeine-based energy drink ingestion on exercise performance measure: Impact of a caffeine-based energy drink ingestion on reaction time measure: Impact of a caffeine-based energy drink ingestion on trail making test performance measure: Impact of a caffeine-based energy drink ingestion on Cognition measure: Impact of a caffeine-based energy drink ingestion on adverse events measure: Impact of a caffeine-based energy drink ingestion on heart rate measure: Impact of a caffeine-based energy drink ingestion on blood pressure sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Exercise and Performance Nutrition Laboratory status: RECRUITING city: Saint Charles state: Missouri zip: 63301 country: United States name: Anthony M Hagele, MS role: CONTACT phone: 636-949-4785 email: ahagele@lindenwood.edu name: Joesi M Krieger, MS role: CONTACT phone: 636-949-4785 email: jkrieger@lindenwood.edu name: Chad M Kerksick, PhD role: PRINCIPAL_INVESTIGATOR lat: 38.78394 lon: -90.48123 hasResults: False
nctId: NCT06308705 id: 2022-19 briefTitle: The SsRI/NIE Recombinant Antigen ELISA for the Follow up of Patients Infected by Strongyloides Stercoralis overallStatus: COMPLETED date: 2023-06-06 date: 2023-10-18 date: 2023-10-18 date: 2024-03-13 date: 2024-03-13 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: This is a single-center interventional study with an IVD medical device.
The test The InBios Strongy Detect TM IgG ELISA detects specific IgG antibodies against recombinant Strongyloides NIE and SsIR antigens in serum. It consists of an enzymatically amplified sandwich immunoassay. Positive and negative control samples are provided in the kit. The test will be performed and interpreted according to the manufacturer's instructions. The results are expressed as OD and nOD. Clinical interpretation of the results will be performed by receiver operating characteristic (ROC) curve analysis generated using data from confirmed positive and confirmed negative samples.
The laboratory technicians will receive from the PI of the study a list of pseudo-anonymized sera to be tested with SsIR/NIE ELISA, they will check their availability and proceed with the test according to the Manufacturer's instructions. Laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the Strong Treat study). A single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. Both baseline and follow-up sera will be tested. The resulting OD and nOD will be reported in an Excel file by the laboratory technicians performing the tests. conditions: Strongyloides Stercoralis Infection studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 38 type: ACTUAL name: InBios Strongy Detect TM IgG ELISA measure: Result of the SsIR/NIE ELISA measure: Seroconversion sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital city: Negrar state: Verona zip: 37024 country: Italy lat: 45.52918 lon: 10.93899 hasResults: False
nctId: NCT06308692 id: 2022-11 briefTitle: Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Real Time PCR-ARES PCR Methods overallStatus: RECRUITING date: 2022-06-28 date: 2024-12 date: 2024-12 date: 2024-03-13 date: 2024-03-13 name: IRCCS Sacro Cuore Don Calabria di Negrar class: OTHER briefSummary: Experimental study without drug and device, on pseudo-anonymized samples archived at the Tropica Biobank.
The evaluations will be carried out taking into consideration the data obtained from the diagnostic routine at the DITM. conditions: Drug Resistant Bacterial Infection studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: ARES PCR measure: PCR results measure: Gene mutations sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Sacro Cuore Don Calabria hospital status: RECRUITING city: Negrar state: Verona zip: 37024 country: Italy name: Elena Pomari role: CONTACT phone: +390456013111 email: elena.pomari@sacrocuore.it name: Elena Pomari role: PRINCIPAL_INVESTIGATOR name: Pierantonio Orza role: SUB_INVESTIGATOR name: Francesca Perandin role: SUB_INVESTIGATOR lat: 45.52918 lon: 10.93899 hasResults: False
nctId: NCT06308679 id: BE 001-24 briefTitle: A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers Under Fasting Conditions overallStatus: NOT_YET_RECRUITING date: 2024-05-28 date: 2024-05-31 date: 2024-06-07 date: 2024-03-13 date: 2024-03-13 name: Pharma Nueva class: INDUSTRY briefSummary: Objectives:
A Bioequivalence Study of Two Formulations of 10-mg Empagliflozin Tablets in Healthy Thai Volunteers under Fasting Conditions conditions: Healthy Vollunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 28 type: ESTIMATED name: Empagliflozin 10 mg tablets name: JARDIANCE® measure: Plasma area Under the Curve (AUC(0-48hr)) for Empagliflozin measure: Peak Plasma Concentration (Cmax) of Empagliflozin sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False