rjac/clinicaltrials.gov-summary_and_eligibility huggingface dataset:
A Study To Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Vanzacaftor/Tezacaftor/Deutivacaftor(VNZ/TEZ/D-IVA)
Status: Not yet recruiting

The purpose of this study is to evaluate the relative bioavailability, food effect, and dose proportionality of a granule formulation of VNZ/TEZ/D-IVA.

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m^2), both inclusive A total body weight greater than (>)50 kg  Key Exclusion Criteria:  History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug Any condition possibly affecting drug absorption Female participants who are pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug Male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of the study drug  Other protocol defined Inclusion/Exclusion criteria may apply. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - MaximumAge: 55 Years - StdAgeList: Adult
A Study of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) in Healthy Adult Panelists
Status: Not yet recruiting

The purpose of this study is to evaluate the flavor (basic tastes, aroma, texture, mouthfeel) of VNZ/TEZ/D-IVA fixed dose combination (FDC) granules.

Eligibility:
- EligibilityCriteria: Key Inclusion Criteria:  Panelists are trained to detect, identify, recognize, and accurately describe different taste elements and flavor combinations.  Key Exclusion Criteria:  History of any illness or clinical condition that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant. Sensitivity to VNZ, TEZ, or D-IVA. Pregnant, nursing, or planning to become pregnant during the study  Other protocol defined Inclusion/Exclusion criteria may apply. - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 25 Years - MaximumAge: 80 Years - StdAgeList: Adult, Older Adult
Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment
Status: Not yet recruiting

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  18 years of age or older; Diagnosis of IC/BPS as indicated by structured assessments; Capable of giving written informed consent; Able to enroll for the duration of the study period;  Exclusion Criteria:  Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke; Current or history of diagnosis of primary psychotic or major thought disorder within the past five years; Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD (within the past 5 years); Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, active suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months; Non-English speaking; Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking; Difficulties or limitations communicating over the telephone or via teleconferencing systems; Any planned life events that would interfere with participating in the key elements of the study; Any major active medical issues that could preclude participation; Currently being treated for cancer; Cancer-related pain; Recently or actively participating in treatment similar to those being investigated (e.g. individual psychotherapy or pelvic floor pt). - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Efficacy of Combination of Hdroxyurea and Thalidomide Over Either Hydroxyurea or Thalidomide Alone in the Treatment of Transfusion Dependent Thalassemia in Children: A Quasi-Randomised Clinical Trial
Status: Recruiting

Transfusion Dependent Thalassemia (TDT) is an emerging global public health concern. Hemopoietic stem cell transplantation (HSCT) is the only curative treatment. But its adoption is limited due to lack of HLA matched donor, experienced centers and high initial cost. So, researches are going on in search of an effective, safe, easily available treatment option. Use of fetal haemoglobin inducing agents shows promising effects in treatment of TDT patients. Thalidomide an immunomodulating and anti-angiogenic drug has been shown to induce γ-globin gene expression and increase the proliferation of erythroid cells. Furthermore Hydroxyurea (HU) is known to increase haemoglobin (Hb) by HbF induction and reduction of inflammation and hypercoagulability.

Recent studies with combination of HU and Thalidomide have shown promising results in treatment of Thalassemia patients. However, most of those studies are retrospective or single arm nonrandomized trials & The study population includes both adult and children age group . So the effectiveness of combination therapy of Thalidomide and HU needs to be established through randomized trials.

This single centered non blinded quasi randomized clinical trial will be conducted at the Department of Pediatric Hematology and Oncology in Bangabandhu Sheikh Mujib Medical University (BSMMU), Bangladesh for one year of period. Thirty transfusion dependent thalassemia children of 3-18 years old will be included in each group. The objective of this study is to assess the effectiveness of combination of Thalidomide and Hydroxyurea in TDT children. It will play an important role in planning a cost effective and affordable treatment option for TDT children.This study will involve minimum physical risk to the patient. Written informed consent will be taken from parents or study subjects after brief explanation of the purpose and procedure. They will also be informed about the freedom to participate or not to participate at any time. Privacy and confidentiality will be safe guarded. History regarding age, sex, height, weight of these patients will be taken. Thorough physical examinations and laboratory investigations including CBC, Hb electrophoresis, serum Ferritin, serum creatinine, SGPT will be done. Data will be collected in a predesigned questionnaire and will be kept confidential. Statistical analysis will be done using the statistical software SPSS.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients diagnosed as transfusion dependent thalassemia Age ranged from 3-18 years Blood transfusion more than 1 year. no bleeding disorder  Exclusion Criteria:  Active systemic co-morbidity, Past personal or family history of thrombophilia, Recent fracture or recent major surgery Use of drugs that might affect Hb levels 15 days before enrollment - HealthyVolunteers: No - Gender: All - MinimumAge: 3 Years - MaximumAge: 18 Years - StdAgeList: Child, Adult
Intervention for Managing Physical Reactions to Overwhelming Emotions
Status: Not yet recruiting

The clinical trial aims to conduct a feasibility, acceptability, and usability clinical trial of a modular CBT-based and technologically enhanced intervention for people with an SUD and recently enrolled in IOP, probe target engagement and change in clinical outcomes, and examine attrition rates in IOP.

This study will enroll 40 adults who are currently enrolled in IOP, have a substance use disorder, and experience elevated anxiety. 20 individuals will be randomized to the experimental intervention, "Intervention for Managing Physical Reactions to Overwhelming Emotions" (IMPROVE), and 20 individuals will be randomized to the active control group, "Physical Health Education Treatment" (PHET).

Participants will be asked to complete a baseline assessment of mood, substance use, and psychophysiology. Participants will then completed ecological momentary assessments (EMA) via smartphone technology 4 times a day for ~ 28 days (the day following the baseline assessment until the 3rd intervention session). Participants will complete one 45 minute - 1 hour intervention each week for 3 weeks (either the IMPROVE or PHET intervention, pending randomization). Following the last intervention session, participants will return to the lab to complete a post-intervention assessment that mirrors the baseline assessment and then complete follow-up surveys 1- and 3-months post intervention.

Eligibility:
- EligibilityCriteria: Inclusionary Criteria:  Participants will be eligible for enrollment if they:  recently enrolled in the Talbot Hall IOP >18 years old PROMIS Anxiety Short Form total score is 13 or greater  Exclusionary Criteria:  do not pass the Informed Decision-Making Capacity (IDMC) screener, suggesting severe cognitive impairment presence of a psychiatric or medical condition that would prevent them from providing informed consent or from participating in the treatments (e.g., psychosis, mania, acute intoxication) no or limited access to a smartphone that is compatible with the EMA application - HealthyVolunteers: Accepts Healthy Volunteers - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult
Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss
Status: Not yet recruiting

The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients with 18-65 years of age BMI ≥ 30 kg/m2 Capable of giving informed consent and available to return for follow-up visit  Exclusion Criteria:  Untreated H. pylori infection Active gastric or duodenal ulceration Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST)) Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D) Esophageal or gastric varices and/or portal hypertensive gastropathy Gastroparesis History of gastric surgery/endoscopic procedure Active psychological issues preventing participation in a lifestyle modification program Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism) Severe coagulopathy Active smoking Substance abuse Serious health condition that increased risk of anesthesia and/or endoscopic procedure Pregnancy or lactation Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism
Status: Not yet recruiting

The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Autistic Adolescents Must be able to interact verbally Parental consent and participants must be able and willing to give written informed assent and to comply with the requirements of the study protocol Must be willing to return for all study visits and wear the study device at home Must have access to and be able to operate a smartphone.  Exclusion Criteria:  Adolescents with severe motor impairments or schizophrenia Complex medical conditions, which would interfere with ability to take part in the study visits or outcomes. Intellectual disability, not capable to attend mainstream school - HealthyVolunteers: No - Gender: All - MinimumAge: 11 Years - MaximumAge: 15 Years - StdAgeList: Child - StudyPopulation: Participants will be recruited from paediatric and community paediatric clinics. Participants may also be identified through open invitations on websites, social media pages, and through a study specific social media page. - SamplingMethod: Non-Probability Sample
Triple Versus Quadruple Therapy for the Eradication of Helicobacter Pylori
Status: Not yet recruiting

The study aimed to compare the efficacy and safety of 7-day and 14-day vonoprazan-amoxicillin-tetracycline triple therapy with 14-day vonoprazan-amoxicillin-tetracycline-bismuth quadruple therapy for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients aged 18-70 years old; Patients with H.pylori infection (positive rapid urease test, 13C/14C-urea breath test); Patients without previous treatment for H. pylori eradication.  Exclusion Criteria:  Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%; Patients with active gastrointestinal bleeding; Patients with a history of upper gastrointestinal surgery; Patients allergic to treatment drugs; Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitor within 2 weeks; Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial; Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse; Patients who are unwilling or incapable to provide informed consents. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 70 Years - StdAgeList: Adult, Older Adult
Study to Evaluate the Effectiveness of Tafasitamab in Combination With Lenalidomide Followed by Tafasitamab Monotherapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Non-transplant Eligible Patients in Italy (PRO-MIND)
Status: Recruiting

The PRO-MIND study is an Italian, multicenter, prospective observational cohort study to evaluate the effectiveness and the safety of tafasitamab in combination with lenalidomide followed by tafasitamab monotherapy in patient with DLBCL.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Patients are aged 18 years or older. Patients with DLBCL R/R disease non-transplant eligible. Patients who will initiate the treatment with commercially available tafasitamab and lenalidomide after the ICF signature. The decision to prescribe tafasitamab must have been made prior and regardless of the enrollment of the patient in the study. Patients are able of giving the signed informed consent.  Exclusion Criteria:  Concomitant participation in an interventional clinical study Any patient in the physician's opinion from whom initial diagnosis or follow-up data is unlikely to be obtained reliably data for the purposes of this observational study. Patients who started tafasitamab treatment before signing the ICF. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The enrollment will be done consecutively and starting from the list of patients identified in the Screening/Enrollment Log. Participating sites will be encouraged to enroll patients in a consecutive manner when patients come for their regular visit, in order to minimize bias in patient selection. At each participating site, the physician will assess patients to determine their eligibility for data collection within the study based on the selection criteria listed below. All patients will give their informed consent to participate in this study and will sign privacy disclosure before data collection is performed. All subjects documented are being treated according to local labeling specifications.The inclusion/exclusion criteria reflect the current approved Summary of Product Characteristics (SmPC) and AIFA monitoring registry. - SamplingMethod: Probability Sample
Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia
Status: Not yet recruiting

The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Participants newly treated with ibrutinib for first line or relapsed CLL (treatment is being initiated or has been initiated within the last 8 days as a maximum) Participants agreed to follow the individual physical activity intervention (IPAI) Participants using or having access to a compatible and appropriate electronic device such as smartphone, laptop or tablet Participants with Internet access at home and email address Participants agreed to wear a connected watch 24 hours a day for all the duration of the study  Exclusion Criteria:  Pregnant participants or planning to become pregnant while enrolled in this study Participants with inability or deemed unsafe to practice physical activity Participants who have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the inclusion visit Participants who are currently involved in an interventional study Participants with probable difficulties in using the digital tool autonomously - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult - StudyPopulation: The study population will include participants aged at least 18 years of age with chronic lymphocytic leukemia (CLL). - SamplingMethod: Probability Sample
Clinical Outcomes of Asynchronous Telerehabilitation Are Equivalent to Synchronous Telerehabilitation in Patients With Fibromyalgia: a Randomized Control Study
Status: Recruiting

Sixty-six FMS patients received the same exercise program for 8 weeks and divided, synchronous (n: 33), asynchronous (n: 33). Pain (Visual analog Scale, VAS), functional limitations and disabilities (Revised Fibromyalgia Impact Questionnaire, FEA), health-related quality of life (HRQol; Short Form-12, SF 12), catastrophizing (pain catastrophizing scale, PCS), anxiety and depression (Hospital Anxiety and Depression Scale, HAD), functional capacity (6-minute walking test, 6MWT), muscle strength (Arm curl test) joint position sense (Laser Cursor Assisted Angle Repetition Test, LI-RATT) were assessed at baseline, mid-treatment (week 4), end of treatment (week 8), and eight weeks after treatment (week 16).

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Diagnosed with FMS by the physician in accordance with ACR 2016 criteria, Having independent mobility, Not having advanced vision and hearing loss, Minimum literacy, participating voluntarily, making video calls, Internet and smartphone access  Exclusion Criteria:  Have a rheumatic disease with more prominent symptoms than FMS, Have an active infection, Have a surgical operation in the last three months, Have an uncontrollable chronic disease, Have another musculoskeletal disorder - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult
RAFT-P&A Randomized Control Trial
Status: Not yet recruiting

Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments. In those instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker.

A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). However, this has not been directly compared to BiVP in a robust randomized control trial. There is also not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of BiVP to CSP in patients who undergo AV node ablation for treating AF, in addition to comparing both pace and ablate methods to pharmacological therapy.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  . Patients with permanent AF/persistent AF (in AF) . Patients with NYHA Class II -IVa HF symptoms . NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year despite of guideline-driven medical therapy for HF of at least 3 months . any QRS duration for patients with LVEF >35%, QRS duration <150 ms for patients with LVEF ≤35%  Exclusion Criteria:  In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1year acute coronary syndrome <4 weeks or coronary revascularization <3months unable or unwilling to provide informed consent uncorrected primary valvular disease or prosthetic tricuspid valve restrictive, hypertrophic, or reversible form of cardiomyopathy severe pulmonary diseases such as cor pulmonale or pulmonary hypertension (≥35mmHg) patients enrolled in competitive clinical trials that will affect the objectives of this study; existing CRT/BiVP or pacemaker resting heart rate ≥110 bpm on Holter monitoring patients who are pregnant or intend to become pregnant - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult