hackint0sh/New-Dataset huggingface dataset:
nctId: NCT06325865 id: 23C305 briefTitle: Perception of Unpleasant Sensations During Study Procedures in ALS Patients acronym: PESALS overallStatus: RECRUITING date: 2023-04-19 date: 2024-11 date: 2024-12 date: 2024-03-22 date: 2024-03-22 name: Istituto Auxologico Italiano class: OTHER briefSummary: Diagnosis of Amyotrophic Lateral Sclerosis (ALS) is considered a traumatic life event for both the patient and their next-of-kin/carers, due to the lack of treatment. Clinical Trials can offer pioneering treatment to reduce the impact of the disease and improve future treatments worldwide. Research protocols may involve routine diagnostic and/or therapeutic procedures which the patients may be already aware of and, therefore, expecting specific sensations. These could compromise participation or drop-out rate. Despite everything, participation in a clinical trial can guarantee continuity of care also thanks to the execution of these same procedures, through preferential access compared to other patients.
Aim of this study is to investigate the unpleasant sensations perceived by ALS patients during procedures in clinical trials. Analysing what type of pain/discomfort frightens patients during diagnostic and/or therapeutic procedures, including the different methods of administration of the study drug. Provide data to implement effective therapy and offer constant patients support throughout ALS specific and needed procedures. Evaluate if this support could influence adherence rate of ALS patients to conduct clinical trials as required. Provide information for future studies to create an ALS Clinical Trials multiple-retention-factors adherence scale. Create and implement an ALS-specific pain scale accounting for its impact on daily activities, aiding an interdisciplinary approach of pain management. Identify the best pain management strategies and compliance techniques to address ALS, not merely in clinical trials. Provide the best individualized care for ALS patients improving their quality of life and mental state.
This is a descriptive phenomenological study and data will be analyzed according to Sundler's method. Based on the experience of the researchers and the recommendations proposed by Sandelowski, a total of 20 interviews are estimated in order to reach the theoretical saturation per category of reference. Data collection will be carried out through in-depth semi-structured interviews recorded (13 open-ended questions after the execution of the procedures). conditions: Amyotrophic Lateral Sclerosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 20 type: ESTIMATED name: Interview measure: Prevalence of experience of unpleasant sensations or pain measure: Study procedure that causes unpleasant sensations or pain measure: Duration of unpleasant sensations or pain caused by the study procedure measure: HADS score measure: ALSFRS score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Istituto Auxologico italiano IRCSS, San Luca Hospital status: RECRUITING city: Milano zip: 20145 country: Italy name: Martina Sodano role: CONTACT phone: +39-02619111 phoneExt: 2937 email: m.sodano@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False
nctId: NCT06325852 id: 22-5772 briefTitle: Directional Bilateral Thalamic Patterned Stimulation (Chronos) overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2027-01-01 date: 2024-03-22 date: 2024-03-25 name: Alfonso Fasano class: OTHER name: Boston Scientific Corporation briefSummary: Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads.
Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits. conditions: Essential Tremor studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 15 type: ESTIMATED name: DBS programing measure: Tremor Rating Scale (Part A-B) measure: Tremor analysis measure: Tremor Rating Scale (A-C) measure: Tremor analysis (meter per second squared) measure: Gait speed (meter per second) measure: Base of support (meter) measure: Step length (meter) measure: Stride length (meter) measure: Single stance time and double stance time (seconds) measure: Tandem gait measure: Posturography (newtons) measure: Quality of life in Essential Tremor Questionnaire (QUEST) measure: Speech analysis sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Movement Disorders Centre - Toronto Western Hospital city: Toronto state: Ontario zip: M5T 2S8 country: Canada name: Alfonso Fasano, MD, PhD role: CONTACT phone: (416) 603-5800 phoneExt: 5961 email: alfonso.fasano@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False
nctId: NCT06325839 id: GRU-SBF-ES-01 briefTitle: Effects of HypnoBirthing Training and Oxytocin Massage in Primiparous Pregnants overallStatus: COMPLETED date: 2023-04-01 date: 2023-09-10 date: 2023-09-10 date: 2024-03-22 date: 2024-03-22 name: Giresun University class: OTHER briefSummary: This study was conducted to determine the effects of hypnobirthing training and oxytocin massage on birth and postpartum period in primiparous pregnant women. conditions: Pregnancy Related studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The research is an experimental study with a randomized control group. primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: Pregnant women included in the study were randomly divided into two groups using the sealed envelope method. whoMasked: PARTICIPANT count: 50 type: ACTUAL name: HypnoBirthing training and oxytocin massage group measure: Wijma Birth Anticipation/Experience Scale A (W-DEQ-A) measure: Wijma Birth Expectancy/Expectation Scale B (W-DEQ-B) measure: Postpartum Breastfeeding Self-Efficacy Scale - Short Form measure: Mother-Infant Attachment Scale (MICS) measure: Birth satisfaction scale short form (BSS-SF) sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Giresun Gynecology and Children's Diseases Hospital city: Giresun state: Center zip: 28200 country: Turkey lat: 40.91698 lon: 38.38741 hasResults: False
nctId: NCT06325826 id: GES briefTitle: The Study of the Validation of General Evaluation Score (GES) in the Prediction of Hepatocellular Carcinoma Risk Among Patients With Advanced Fibrosis and Cirrhosis Who Achieved Sustained Virological Response for Hepatitis C Virus After Direct Acting Antiviral Drugs overallStatus: ACTIVE_NOT_RECRUITING date: 2022-02-01 date: 2023-06-30 date: 2025-06-30 date: 2024-03-22 date: 2024-03-26 name: Egyptian Liver Hospital class: OTHER briefSummary: This cohort study aims to evaluate the validation of general evaluation score in the prediction of hepatocellular carcinoma risk among patients with advanced fibrosis (F3) and cirrhosis (F4) who achieved sustained virological response for hepatitis c virus after direct acting antiviral drugs and determine the group of these patients who require intensified surveillance. conditions: Hepatocellular Carcinoma studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 500 type: ACTUAL name: General Evaluation Score (GES) measure: Hepatocellular Carcinoma sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Egyptian Liver Hospital city: Talkha state: Dakahlia zip: 36681 country: Egypt lat: 31.0539 lon: 31.37787 hasResults: False
nctId: NCT06325813 id: CIN001 - ADHD PreSMART briefTitle: ADHD PreSMA Response Inhibition Therapy overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-06-30 date: 2026-12-31 date: 2024-03-22 date: 2024-03-22 name: Children's Hospital Medical Center, Cincinnati class: OTHER briefSummary: ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control. conditions: Attention Deficit Hyperactivity Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Active repetitive TMS name: Sham repetitive TMS measure: TMS-based Short-Interval Intracortical Inhibition (SICI) measure: EEG-based beta activity measure: TMS-based Cortical Silent Period (cSP) measure: EEG-based alpha activity measure: Stop Signal Reaction Time sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD hasResults: False
nctId: NCT06325787 id: S2021-211-02 briefTitle: Image-guided Thermal Ablation vs. Lobectomy for Solitary Papillary Thyroid Microcarcinoma overallStatus: COMPLETED date: 2013-05-01 date: 2017-01-31 date: 2024-01-31 date: 2024-03-22 date: 2024-03-25 name: Chinese PLA General Hospital class: OTHER briefSummary: To evaluate the clinical outcomes of image-guided thermal ablation versus thyroid lobectomy for the treatment of papillary thyroid microcarcinoma conditions: Papillary Thyroid Cancer studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1021 type: ACTUAL name: thyroid lobectomy name: image-guided thermal ablation measure: disease progression measure: disease-free survival measure: complications measure: procedure time measure: cost measure: estimated blood loss measure: hospitalization sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06325774 id: Changhai HHospital briefTitle: Radical Hypofractionated Radiotherapy for Localized Prostate Cancer overallStatus: RECRUITING date: 2024-04-01 date: 2026-04-01 date: 2031-04-01 date: 2024-03-22 date: 2024-03-22 name: Changhai Hospital class: OTHER briefSummary: The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.
Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way. conditions: Localized Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: Hypofractionated radiation therapy measure: Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events measure: biochemical progression-free survival (bPFS) measure: local progression-free-survival(LPFS) measure: distant metastasis free survival(DMFS) measure: Overall survival (OS) measure: Quality of life (QoL) sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Changhai hospital status: RECRUITING city: Shanghai state: Shanghai zip: 200433 country: China name: Huojun Zhang, M.D. role: CONTACT phone: +8613311732399 email: chyyzhj@163.com name: Huojun Zhang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
nctId: NCT06325761 id: SY-5007-I-02 briefTitle: A Study to Evaluate the Food Effects on Pharmacokinetics of SY-5007 Tablets in Healthy Subjects overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-05-01 date: 2024-05-01 date: 2024-03-22 date: 2024-03-22 name: Shouyao Holdings (Beijing) Co. LTD class: OTHER briefSummary: This study is a single-center, randomized, open-label, single-dose, two-period, two-treatment crossover trial aimed at evaluating the pharmacokinetic (PK) profiles and safety of SY-5007 tablets administered orally to healthy subjects in both fasting and fed states in China. conditions: Health Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 28 type: ESTIMATED name: SY-5007 name: SY-5007 measure: Cmax for SY-5007 measure: Tmax for SY-5007 measure: AUC0-t for SY-5007 measure: AUC0-∞ for SY-5007 measure: t½ for SY-5007 measure: CL/F for SY-5007 measure: Vz/F for SY-5007 measure: Safety of SY-5007 sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: West China Hospital of Sichuan University city: Chengdu state: Sichuan zip: 610041 country: China name: Li Zheng role: CONTACT phone: 86-28-85423655 email: zhengli@wchscu.cn lat: 30.66667 lon: 104.06667 hasResults: False
nctId: NCT06325748 id: SENTI-202-101 briefTitle: SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-09 date: 2040-08 date: 2024-03-22 date: 2024-03-22 name: Senti Biosciences class: INDUSTRY briefSummary: This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS. conditions: AML/MDS conditions: CD33 Expressing Hematological Malignancies conditions: FLT3 Expressing Hematological Malignancies studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 21 type: ESTIMATED name: SENTI-202 measure: Safety and tolerability for dose determination of SENTI-202 measure: Anti-cancer activity of SENTI-202 measure: Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202 measure: Host immune response to SENTI-202 sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
nctId: NCT06325735 id: 98 briefTitle: Combined Systemic Inflammatory Indices and Birth Weight overallStatus: COMPLETED date: 2019-12-01 date: 2021-02-01 date: 2024-04-01 date: 2024-03-22 date: 2024-04-18 name: University of Campania "Luigi Vanvitelli" class: OTHER briefSummary: The study aimed to explore the complex relationship between various systemic inflammatory indices and birth weight conditions: Systemic Inflammation Markers conditions: Birth Weight conditions: Combined Systemic Inflammatory Indices studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 199 type: ACTUAL name: None intervention measure: Systemic inflammatory indices and birth weight sex: FEMALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn - city: Napoli state: Italia zip: 80138 country: Italy lat: 40.85216 lon: 14.26811 hasResults: False
nctId: NCT06325722 id: 10001680 id: 001680-DK briefTitle: Diet Order Effects of Low Fat vs. Low Carb Diets on Body Fat Change overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-07-31 date: 2026-07-31 date: 2024-03-22 date: 2024-04-26 name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) class: NIH briefSummary: Background:
In a previous study, participants were lived at the NIH and randomly received either a low-fat or a low-carbohydrate diet for 2 weeks and then switched to the other diet for 2 more weeks. Participants who received the low-carbohydrate diet first lost more body fat at the end of the study than those who received the low-fat diet first. Researchers want to see if they can repeat that result in a longer weight loss study when participants live at home.
Participants will complete the study at their homes, but there will be 3 required visits to the NIH. Participants will drink a special type of water 2 weeks before the baseline NIH visit and collect urine samples at home to measure how many calories they burn. Before the diets begin, participants will visit the NIH for baseline testing when they will have a metabolism test while relaxing in a bed with a plastic hood over their head to collect the air they breathe out. They will have scans to measure their bone density and how much muscle and body fat they have. They will give stool, blood, and urine samples.
Participants will weigh themselves daily. They will wear a monitor to track their physical activity and a sensor to measure their glucose levels. They will prick their finger each morning to test a drop of blood for ketones. Participants will meet virtually as a group with the study team weekly. Participants will have two more NIH visits towards the end of each diet period.... conditions: Overweight conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 100 type: ESTIMATED name: Low-carbohydrate Diet name: Low-fat Diet measure: Change in total fat mass measure: Rate of body weight change from baseline to week 8 measure: Rate of body weight change during low-carbohydrate diet measure: Rate of body weight change during low-fat diet sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States name: Kevin Hall, Ph.D. role: CONTACT phone: 301-402-8248 email: kevinh@niddk.nih.gov lat: 38.98067 lon: -77.10026 hasResults: False
nctId: NCT06325709 id: 10001580 id: 001580-I briefTitle: Base Editing for Mutation Repair in Hematopoietic Stem & Progenitor Cells for X-Linked Chronic Granulomatous Disease overallStatus: ENROLLING_BY_INVITATION date: 2024-04-17 date: 2032-12-31 date: 2032-12-31 date: 2024-03-22 date: 2024-04-26 name: National Institute of Allergy and Infectious Diseases (NIAID) class: NIH briefSummary: Background:
Chronic granulomatous disease (CGD) is a rare immune disorder caused by a mutation in the CYBB gene. People with CGD have white blood cells that do not work properly. This places them at risk of developing infections that may be life-threatening. Stem cell transplant can cure CGD but transplanting stem cells donated by other people can have serious complications. In addition, not everyone has a matched donor. Another approach is a type of gene therapy that involves base-editing to correct the mutation in a person s own stem cells. Researchers want to know if the base-edited stem cells can improve the white cells' functioning and result in fewer CGD-related infections.
Follow-up visits will continue for 15 years. conditions: Chronic Granulomatous Disease (CGD) conditions: X-Linked Chronic Granulomatous Disease studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Base-edited hematopoietic stem and progenitor cells name: Busulfan name: Palifermin name: Filgrastim name: Plerixafor measure: To evaluate the safety of base-edited autologous CD34+ cells measure: To evaluate the efficacy of base-edited autologous CD34+ cells measure: Evaluate the efficiency of base-editing. measure: Evaluate the engraftment capability of base-edited hematopoietic stem progenitor cells. measure: Evaluate the efficiency in restoring gp91phox expression. measure: Evaluate efficacy in restoring NADPH oxidase function. measure: Evaluate clinical efficacy measure: Evaluate the stability of gene correction sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Institutes of Health Clinical Center city: Bethesda state: Maryland zip: 20892 country: United States lat: 38.98067 lon: -77.10026 hasResults: False
nctId: NCT06325696 id: 10001577 id: 001577-E briefTitle: H01 in Adults With Interstitial Lung Disease (The SOLIS Study) overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2025-12-31 date: 2024-03-22 date: 2024-04-26 name: National Institute of Environmental Health Sciences (NIEHS) class: NIH briefSummary: Background:
Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Tests will be repeated at study visits. conditions: Interstitial Lung Disease conditions: Idiopathic Pulmonary Fibrosis conditions: Lung Diseases, Interstitial studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 37 type: ESTIMATED name: hymecromone measure: To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD measure: Evaluate the safety and tolerability of oral H01 in participants with progressive ILD. measure: Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01. measure: Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01. measure: Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NIEHS Clinical Research Unit (CRU) city: Research Triangle Park state: North Carolina zip: 27709 country: United States name: NIEHS Join A Study Recruitment Group role: CONTACT phone: 855-696-4347 email: myniehs@nih.gov lat: 35.90567 lon: -78.90497 hasResults: False
nctId: NCT06325683 id: NCI-2024-01995 id: NCI-2024-01995 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: A072201 type: OTHER domain: Alliance for Clinical Trials in Oncology id: A072201 type: OTHER domain: CTEP id: U10CA180821 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180821 briefTitle: Anti-Lag-3 (Relatlinib) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma overallStatus: NOT_YET_RECRUITING date: 2024-06-21 date: 2028-07-15 date: 2028-07-15 date: 2024-03-22 date: 2024-03-22 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlinib) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. Relatlinib and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma. conditions: Recurrent Glioblastoma studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 178 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Lomustine name: Magnetic Resonance Imaging name: Nivolumab name: Relatlimab name: Surgical Procedure measure: Overall survival (OS) measure: OS rate measure: Progression-free survival (PFS) measure: Radiographic response measure: Incidence of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False