hackint0sh/temp-data huggingface dataset:
protocolSection identificationModule nctId: NCT06299254, orgStudyIdInfo id: 21C305, briefTitle: Placebo Effect About Fatigue in Obesity, acronym: POF, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-02-27, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, collaborators name: University of Turin, Italy, descriptionModule briefSummary: Fatigue is a central symptom of obesity: it significantly impacts daily functioning, psychological well-being, compliance with physical therapy, and quality of life. However, the full understanding of the origin and treatment of fatigue in obesity is still a matter of debate, requiring further research, especially from new perspectives. From a neuroscientific perspective, fatigue is more than the subjective perception of tiredness resulting from mental or physical exertion or illness. It results in the complex interaction between (bottom-up) sensory input coming from the periphery, and motivational and psychological input, which is related to top-down cognition. In this framework, placebos may affect the output of the top-down cognitive processing by altering the individual evaluation of the ongoing peripheral performance. Indeed, evidence from both healthy conditions and clinical contexts suggests that fatigue can be modulated. The after-effect of such a modulation can be observed not only at a behavioural level, in terms of physical endurance, but also a psychological (i.e., decreased of perceived fatigue) and neurophysiological (changes in brain activity, especially in the fatigue-related components as the RP) levels., conditionsModule conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Placebo-Natural History, outcomesModule primaryOutcomes measure: Behavioural outcome of fatigue, secondaryOutcomes measure: The individual level of perceived fatigue, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe, status: RECRUITING, city: Piancavallo, state: VCO, zip: 28824, country: Italy, contacts name: Federica Scarpina, PhD, role: CONTACT, phone: +39032351, phoneExt: 4003, email: f.scarpina@auxologico.it, hasResults: False
protocolSection identificationModule nctId: NCT06299241, orgStudyIdInfo id: 01C313, briefTitle: Evaluation of Physical Performance in Old Adults With Sarcopenic Obesity, acronym: PREFISAR, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-21, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: The primary objectives of the present study are to estimate the sarcopenic proportion in a cohort of obese older subjects who have been hospitalized. The secondary objective is to individuate several clinical variables that differ between the sarcopenic obese patient and the not sarcopenic obese patient., conditionsModule conditions: Obesity, conditions: Sarcopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ESTIMATED, outcomesModule primaryOutcomes measure: Fat free mass, primaryOutcomes measure: Evaluation of lower limb muscle strength, primaryOutcomes measure: Senior Fitness Test (SFT), primaryOutcomes measure: Physical performance test (PPT), primaryOutcomes measure: Fat mass, secondaryOutcomes measure: Questionnaire SF-12 (Short Form Health Survey), secondaryOutcomes measure: Oswestry Disability Index questionnaire, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, Site Piancavallo, city: Oggebbio, state: Verbania, zip: 28824, country: Italy, geoPoint lat: 45.99088, lon: 8.64663, hasResults: False
protocolSection identificationModule nctId: NCT06299228, orgStudyIdInfo id: HSA, briefTitle: Is Sensorimotor Training Effective Following a Distal Radius Fracture?, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Hand Surgery Associates LLC, class: OTHER, collaborators name: Touro University Nevada, collaborators name: Orthopaedic Specialty Group PC, Fairfield, descriptionModule briefSummary: The purpose of this study is to compare the short-term outcomes of individuals who have surgery (volar plate) for a wrist (distal radius) fracture who have routine hand therapy treatment versus routine hand therapy treatment and sensorimotor activities. Individuals who meet inclusion criteria at the facilities collecting data will be invited to participate. If they agree to participate, they will randomly and blindly (via concealed envelopes) be assigned to the control (routine treatment) or the sensorimotor treatment group. Data collection will occur at 3- and 6-weeks post initiation of skilled therapy and will include measurement of joint position sense, function via the Patient Rated Wrist and Hand, pain via the Numeric Pain Rating Scale, and range of motion at the digits and wrist., conditionsModule conditions: Distal Radius Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Experimental Group, interventions name: Control Group, outcomesModule primaryOutcomes measure: Active Joint Position Sense (AJPS), secondaryOutcomes measure: Patient Rated Wrist and Hand Evaluation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hand Surgery Associates, status: RECRUITING, city: Olyphant, state: Pennsylvania, zip: 18447, country: United States, contacts name: Nancy Naughton, OTD, role: CONTACT, phone: 570-780-8681, email: nancynaughton10@gmail.com, contacts name: Lori Algar, OTD, role: CONTACT, phone: 2034514938, email: Lori.Algar@gmail.com, geoPoint lat: 41.46841, lon: -75.60297, hasResults: False
protocolSection identificationModule nctId: NCT06299215, orgStudyIdInfo id: APHP240044, briefTitle: Factors and Prognosis of Obstructive Pyelonephritis Patients, acronym: PYELO-OBS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Acute obstructive pyelonephritis is a condition with a high risk of complications and may require admission to the intensive care unit.Most of the available data on this condition comes from small, retrospective, single-centre series.To date, no large-scale study has examined the factors associated with the prognosis of patients admitted to intensive care for acute obstructive pyelonephritis.The aim of this study is to describe the population and prognosis of patients admitted to the intensive care unit for the management of acute obstructive pyelonephritis, and to identify factors associated with a poor prognosis in these patients., conditionsModule conditions: Pyelonephritis, conditions: Prognostic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: The primary endpoint will be a combined endpoint of death, and/or stage 3 AKI ( KDIGO classification), and/or non-recovery of renal function., secondaryOutcomes measure: Death, secondaryOutcomes measure: Stage 3 Acute kidney injury (KDIGO classification), secondaryOutcomes measure: failure to recover renal function, secondaryOutcomes measure: the incidence of acute renal failure defined by KDIGO 1, secondaryOutcomes measure: the incidence of acute renal failure defined by KDIGO 2 and 3, secondaryOutcomes measure: the incidence of Renal replacement therapy, secondaryOutcomes measure: the incidence of non-recovery of renal fuction, secondaryOutcomes measure: The number of days alive without Renal replacement therapy, secondaryOutcomes measure: The number of days alive without catecholamines, secondaryOutcomes measure: The number of days alive without antibiotics, secondaryOutcomes measure: The number of days alive without, secondaryOutcomes measure: Death rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Saint Louis, city: Paris, zip: 75010, country: France, contacts name: Maxime Dr COUTROT, MD, role: CONTACT, contacts name: François DEPRET, MD, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
protocolSection identificationModule nctId: NCT06299189, orgStudyIdInfo id: 309264, briefTitle: A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit / Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care, acronym: MinADHD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Haukeland University Hospital, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on:i) Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program., conditionsModule conditions: ADHD, conditions: ADHD - Combined Type, conditions: ADHD Predominantly Inattentive Type, conditions: ADHD, Predominantly Hyperactive - Impulsive, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: MinADHD, outcomesModule primaryOutcomes measure: The Adult ADHD Self-Rating Scale, primaryOutcomes measure: Adult ADHD Quality of Life Measure, secondaryOutcomes measure: The Patient Health Questionnaire, secondaryOutcomes measure: Generalized Anxiety Disorder-7, secondaryOutcomes measure: Personality Disorder Severity ICD-11, secondaryOutcomes measure: EuroQoL 5D-5L, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bjørgvin DPS, status: RECRUITING, city: Bergen, country: Norway, contacts name: Gunn Elise Sæthre, role: CONTACT, phone: 00000000, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False
protocolSection identificationModule nctId: NCT06299137, orgStudyIdInfo id: RE2022-0000000349, secondaryIdInfos id: RE2022-0000000349, type: OTHER_GRANT, domain: Society of Academic Emergency Medicine, briefTitle: Ultrasound Guided Serratus Anterior Plane Block in ED Patients With Rib Fractures, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Rhode Island Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to test the effectiveness of the Serratus Anterior Plane Block in patients with rib fractures. The main questions it aims to answer are:* Determine if UG-SAPB results in an improved pain, incentive spirometry, and cough ability (PIC) score when compared to usual care over the first five hours.* Evaluate if UG-SAPB results in fewer opioid medications administered when compared to usual care over the first 24 hours.Participants will undergo the Serratus Anterior Plane. Researchers will compare this to usual care to see if this intervention improves pulmonary function and reduces opioid requirements for ED patients with rib fractures., conditionsModule conditions: Rib Fractures, conditions: Pain Acute, conditions: Regional Anesthesia, conditions: Opioid Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Research Assistants who collect the data will be blinded to which arm of the study the participants are in., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Serratus Anterior Plane Block, interventions name: Ropivacaine injection, outcomesModule primaryOutcomes measure: PIC Score, secondaryOutcomes measure: Total oral morphine equivalents over the first 24 hours, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rhode Island Hospital, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Leland K Perice, MD, role: CONTACT, phone: 401-429-3441, email: lperice@lifespan.org, contacts name: Leland K Perice, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.82399, lon: -71.41283, hasResults: False
protocolSection identificationModule nctId: NCT06299124, orgStudyIdInfo id: RGT-419B-102, briefTitle: A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-17, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Regor Pharmaceuticals Inc., class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2- advanced/metastatic breast cancer and other advanced solid tumors., conditionsModule conditions: Breast Cancer, conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: RGT-419B, outcomesModule primaryOutcomes measure: Safety & Tolerability - Number of subjects with Dose-Limiting Toxicities (DLTs) at each cohort dose level, secondaryOutcomes measure: Safety & Tolerability - Incidence, Severity, and Causality of all Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Day 1 and steady-state pharmacokinetics(PK) assessment of RGT-419B and major metabolites - Cmax, secondaryOutcomes measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Area Under Concentration-TimeCurve to Infinity (AUC0-inf), secondaryOutcomes measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Plasma Decay Half-Life (t1/2), secondaryOutcomes measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Time to Reach Maximum ObservedPlasma Concentration (Tmax), secondaryOutcomes measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Accumulation rate after multipledoses, secondaryOutcomes measure: Day 1 and steady-state PK assessment of RGT-419B and major metabolites - Cumulative urinary excretion, secondaryOutcomes measure: Tumor Response assessed by Investigator according to RECIST v1.1, secondaryOutcomes measure: QTc Interval - Changes in corrected QT interval, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fudan University Shanghai Cancer Center, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Yan Zhou, role: CONTACT, phone: 86-021-31168233, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
protocolSection identificationModule nctId: NCT06299111, orgStudyIdInfo id: R9933-DVT-2308, secondaryIdInfos id: 2023-508603-21-00, type: OTHER, domain: EU CT Number, briefTitle: A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC), acronym: ROXI-CATH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2026-06-08, completionDateStruct date: 2026-06-08, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in your vein, also called a 'PICC line'.The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.The study is looking at several other research questions, including:* What side effects may happen from taking the study drug* How much study drug is in your blood at different times* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects), conditionsModule conditions: Venous Thromboembolism, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 195, type: ESTIMATED, armsInterventionsModule interventions name: REGN9933, interventions name: REGN7508, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of confirmed VTE per central reading center (CRC) review, primaryOutcomes measure: Incidence of treatment-emergent adverse event (TEAEs), primaryOutcomes measure: Severity of TEAEs, secondaryOutcomes measure: Incidence of confirmed PICC associated venous thrombosis per CRC review, secondaryOutcomes measure: Incidence of major bleeding, secondaryOutcomes measure: Incidence of clinically relevant non-major (CRNM) bleeding, secondaryOutcomes measure: Concentrations of REGN9933 in serum, secondaryOutcomes measure: Concentrations of REGN7508 in serum, secondaryOutcomes measure: Change in activated partial thromboplastin time (aPTT), secondaryOutcomes measure: Change in prothrombin time (PT), secondaryOutcomes measure: Incidence of anti-drug antibody (ADA) to REGN9933 over time, secondaryOutcomes measure: Titer of ADA to REGN9933 over time, secondaryOutcomes measure: Incidence of ADA to REGN7508 over time, secondaryOutcomes measure: Titer of ADA to REGN7508 over time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
protocolSection identificationModule nctId: NCT06299085, orgStudyIdInfo id: OSTEO-BS (L4191), briefTitle: Clinical-functional Effects of Bariatric Surgery on the Musculoskeletal System in Relation to Bone Turnover., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-10-31, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio, class: OTHER, descriptionModule briefSummary: By studying "in vivo" new possible predictive factors of increased bone turnover and risk of fractures after bariatric surgery, our study aims to improve health not only musculoskeletal but general of patients with severe obesity, a pathology which represents one of the main causes of disability and mortality., conditionsModule conditions: Bariatric Surgery Candidate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The minimum sample size was determined by considering the circulating levels of gastro-entero hormones (PYY, ghrelin, GLP-1, GIP), adipokines (leptin and adiponectin) and hormones associated with the anabolism of muscle and bone tissue (insulin). as primary endpoints; the highest calculated sample size obtained for ghrelin levels was used for the purposes of this study.The calculation was performed using G\*Power software (v3.1.9.7) assuming a type I error (α error) of 0.05, a Power (1-β error) of 0.8, an effect size of 0.44.The resulting minimum sample size is 42 patients. Taking into account the presence of any drop-outs, 20% more patients will be considered, for a total of 50 patients to be enrolled., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 50 adult patients suffering from severe or morbid obesity, male and female, candidates for bariatric surgery., outcomesModule primaryOutcomes measure: Study of new predictive markers of possible bone remodeling through specific blood tests before (pre-admission) and 12 months after bariatric surgery., secondaryOutcomes measure: Evaluation of the bone health status of patients pre- and post-bariatric surgery using different methods., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False