bioihbjkbjnl/mcl2 huggingface dataset:
Allogeneic Hematopoietic Stem Cell Transplantation Using a Non-myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-thymocyte Globulin for Older Patients With Relapsed Lymphoid Malignancies
Condition: Haemato-lymphoid Malignancies or Syndromes in Whom Allogeneic Stem Cell Transplantation is Warranted
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Recent advances in allogeneic hematopoietic cell transplantation (allo-SCT) have led to
      reduce intensity preparative regimens that are non-myeloablative and reduce the toxicities
      associated with the transplant. Consequently non-relapse mortality has been reduced,
      including in elderly patients with comorbidities. However, despite this benefit in terms of
      toxicity, excessive reduction of the intensity preparative regimens may favor relapse of the
      initial illness. Thus, acute and chronic graft-versus-host disease and opportunistic fungal
      and viral infections are always serious complications. The aim of our study is to check if a
      new modality of reduced intensity preparative regimen combining total lymphoid irradiation
      (TLI) and thymoglobulin (ATG), would limit the toxicity of treatment and reduce the incidence
      of acute GVHD after allogeneic transplantation while preserving the antitumor benefit.
    


Intervention name(s): total lymphoid irradiation and anti-thymocyte globulin
Intervention type(s): Drug
Intervention description(s): TLI Administration: TLI is administered ten times in 120 cGy fractions on day -11 through day -7 and day -4 through day -1.
ATG: Thymoglobulin will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg.
Mobilized PBSCs (Day 0): The desired cell doses (based on recipient body weight) for MRD and MUD transplants are around 4-8 x106 CD34+ cells/kg.
GVHD Prophylaxis: Cyclosporine A (CSP) 3 mg/kg IV from day-3 and Mycophenylate mofetil (MMF) 500 mg x 4/ day PO from day 0
Intervention MeSH terms: Antilymphocyte Serum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Allogeneic hematopoietic stem cell transplantation; Non-myeloablative preparative regimen; Total lymphoid irradiation; Anti-thymocyte globulin; Lymphoid malignancies
A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
Condition: Chronic Total Occlusion of Coronary Artery
Study type: Interventional

Summary: 
      This study evaluates the safety and effectiveness of the a novel device called NovaCross to
      help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.
    

Detailed description: 
      The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™
      micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in
      coronary arteries. The procedure will be conducted on consenting patients diagnosed with a
      CTO in a coronary vessel that requires revascularization after a previously failed attempt to
      cross or refractory to 10 minutes of conventional guidewire attempt.
    

Intervention name(s): NovaCross
Intervention type(s): Device
Intervention description(s): The NovaCross™ is a guidewire positioning and support microcatheter for improving chronic total occlusion (CTO) crossability. The NovaCross™ gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extendable segment, both at its distal tip.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Diet Selection Based on Genetic Screening on Success to a Weight Loss Program
Condition: Diet Modification
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of diet type selection based on
      response to a Carbohydrate Intolerance Questionnaire (CIQ) and genetic screening on success
      to a weight loss and exercise program.
    

Detailed description: 
      The purpose of this study is to determine if stratification of individuals based on responses
      to a Carbohydrate Intolerance Questionnaire (CIQ), genetic screening, and/or DNA methylation
      affects weight loss success and/or health outcomes of women following the Curves moderate
      carbohydrate, high protein, low fat diet (30% carbohydrate, 45% protein, 25% fat) or the
      Curves carbohydrate restricted, high protein, moderate fat diet (20% carbohydrate, 45%
      protein, 35% fat).
    

Intervention name(s): Positive CIQ plus High Carbohydrate Diet; Positive CIQ plus High Protein Diet; Negative CIQ plus High Carbohydrate Diet; Negative CIQ plus High Protein Diet
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Positive Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet; Positive Carbohydrate Intolerance Questionnaire plus High Protein Diet; Negative Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet; Negative Carbohydrate Intolerance Questionnaire plus High Protein Diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether or not the Angioshield device can be safely
      applied to support saphenous vein grafts used in standard coronary bypass surgery.
    

Detailed description: 
      \This is a first in human study which is intended to determine if a larger pivotal study is
      justified.
    

Intervention name(s): Angioshield
Intervention type(s): Device
Intervention description(s): The Angioshield wrap provides external structural support for the saphenous vein graft used in CABG surgery and is intended to prevent over distention of the graft under arterial pressure, potentially improving graft patency and reducing the likelihood of graft failure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CABG; Intimal Hyperplasia; Atherosclerosis; Myocardial Infarction
Effects of Aerobic Thai Dance in Patient With Diabetic Peripheral Neuropathy
Condition: Exercise Addiction; Diabetic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      The goal of this type of study is clinical trial. This to learn about effects of applied
      aerobic Thai dance exercise on gait balance and sudomotor function in patient with diabetic
      peripheral neuropathy. Test variables of gait, balance, function of sudomotor, Physiological
      data such as pulse, blood pressure, body composition, ankle and leg muscle strength, compare
      with control and experimental group in diabetes with peripheral neuropathy.

      The main question Question 1: Dose Applied aerobic Thai dance exercise affects gait and
      balance in diabetic patients with peripheral neuropathy? Question 2: Does applied aerobic
      Thai dance exercise affect sudomotor function in diabetic patients with peripheral
      neuropathy? Participants will divided into 2 groups: the control group and the experimental
      group. By randomly sampling 22 people from each group

        1. The control group was advised to exercise at home for a period of 12 weeks.

        2. The experimental group participated in Applied aerobic Thai dance exercise 60 minutes
           per session, 3 times per week, for a period of 12 weeks.

      After 12 weeks, variable data were collected and to compare within and between groups.
    


Intervention name(s): Aerobic Thai dance exercise
Intervention type(s): Other
Intervention description(s): Aerobic Thai dance exercise 60 minute per times, 3 times per weeks of 12 weeks. Aerobic exercise of modulate intensity (12-13 Borg's RPE)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Diabetic Peripheral Neuropathy; Thai Dance; Gait; Balance; Sudomotor Function; DPN; Exercise
Walnuts to Achieve Lasting NUTrition to Prevent Diabetes
Condition: PreDiabetes; Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Prediabetes is a precursor of type 2 diabetes and an independent risk factor for
      cardiovascular disease, and currently affects one-quarter of the population of the United
      States. Individuals of overweight or obese BMI are at particular high risk for incident
      diabetes. A major modifiable risk factor for type 2 diabetes is poor dietary quality, and
      improvement of dietary quality can effectively delay and even prevent type 2 diabetes.
      Interventions to improve dietary quality thus far, however, rely on short-term intensive
      clinically designed meals replacing the entire diet which have poor sustainability.
      Persistent improvements to daily dietary patterns are often difficult without directed
      guidance, and overall dietary quality in the United States remains poor. The identification
      of a practical, daily dietary intervention to improve dietary quality and prevent diabetes in
      those at high risk remains unknown. The investigators propose to enroll 40 individuals with
      diagnosed prediabetes into a randomized controlled pilot study and provide a daily walnut
      supplementation intervention to determine feasibility and acceptability of the supplement.
      The investigators will then determine preliminary efficacy on metabolic markers and will
      investigate associations between dietary quality and circulating levels of branched-chain
      amino acids. The goal is to implement a whole-food supplement to improve dietary quality in
      patients with prediabetes as a tool for future type 2 diabetes prevention.
    


Intervention name(s): Walnuts
Intervention type(s): Drug
Intervention description(s): 1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Adults on Antibiotics
Condition: Adults on Antibiotics
Study type: Interventional
Phase: Phase 1

Summary: 
      We believe a readily available drink containing a high dose of probiotics has the potential
      to improve compliance through many of these mechanisms. This product also has the potential
      to positively impact the health of children and adults around the world, as yogurt will
      likely be more appealing to both children and their parents for long term consumption than
      pharmaceutical-like preparations. In addition to the benefits associated with the consumption
      of probiotics, there is an increased health benefit from consuming yogurt, a nutrient dense
      food.

      More specifically, the rationale for this Phase I study is to determine safety of our drink
      and comply with the FDA's recommendations pertaining to an IND application, we will conduct a
      phase I safety study.

      We hypothesize that BB-12 is safe in healthy adults ages 18 and over.
    


Intervention name(s): Bifidobacterium animalis subsp. lactis strain BB-12; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days; Strawberry flavored yogurt
Other intervention name(s): BB-12 probiotic supplemented yogurt; Strawberry flavored yogurt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Probiotics; BB-12; Yogurt; Antibiotics
Bioenergetics and Muscle Function Improvement With AMAZ-02 in Elderly Skeletal Muscle (ENERGIZE Trial)
Condition: Mitochondrial Function, Bioenergetics; Muscle Function; Aging
Study type: Interventional

Summary: 
      This is a randomized, double-blind, single-center, placebo-controlled Phase 2 trial enrolling
      66 healthy elderly subjects (33 placebo and 33 AMAZ-02 administration) who are ≥65 and ≤ 90
      years of age with evidence of low mitochondrial function. AMAZ-02 or placebo will be orally
      administered for 4 months.
    


Intervention name(s): Mitopure; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Mitopure (Urolithin A) containing softgels; Placebo containing softgels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Daily Variability of Platelet Aggregation in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The aim of this study is to compare circadian variability of antiplatelet effect of prasugrel
      and ticagrelor maintenance doses during the initial days after acute myocardial infarction.
    

Detailed description: 
      Prasugrel and ticagrelor are two oral P2Y12 receptor antagonists recommended as a part of
      dual antiplatelet therapy with aspirin in patients with acute myocardial infarction. Both
      drugs exert comparable antiplatelet effect following a loading dose. However, pharmacodynamic
      differences exist between these P2Y12 receptor inhibitors. Prasugrel is a prodrug that
      requires hepatic activation and permanently binds to platelet P2Y12 receptors, whereas
      ticagrelor is an active drug and blocks P2Y12 receptors reversibly. Another important
      difference is that prasugrel maintenance dose is administered once daily, while ticagrelor
      requires next dosage every 12 hours. These fundamental distinctions may affect the degree of
      platelet inhibition on maintenance doses during the first days after acute myocardial
      infarction.
    

Intervention name(s): Prasugrel; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Patients with myocardial infarction will receive a 60 mg prasugrel loading dose, followed by a maintenance dose of 10 mg once daily; Patients with myocardial infarction will receive a 180 mg ticagrelor loading dose, followed by a maintenance dose of 90 mg twice daily
Other intervention name(s): Efient; Brilique
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acute myocardial infarction treated invasively.
      
Keywords: prasugrel; ticagrelor; VASP; platelet reactivity; STEMI; NSTEMI
Study to Assess Whether GSK239512 Can Remyelinate Lesions in Subjects With Relapsing Remitting Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, parallel group, placebo-controlled study designed to assess whether
      GSK239512 can enhance lesion remyelination in subjects with Relapsing Remitting Multiple
      Sclerosis (RRMS). Subjects with RRMS on stable background treatment with either Avonex
      (Interferon-beta1a) or Copaxone (Glatiramer Acetate) are eligible to participate. Subjects
      will be randomized in a 1:1 ratio between placebo and GSK239512, and will continue to be
      managed with their current standard of care therapy (Copaxone or Avonex). The total treatment
      period is 48 weeks, including a standard 4 week titration period and 44 week maintenance
      treatment period (which could be adapted to a 5-week titration and 43 week maintenance
      period, if needed). Titration doses start at 10 micrograms (mcg) and increase up to 80 mcg
      (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week). Subjects will
      be titrated to the maximum tolerated dose with the objective of titrating to the highest dose
      (80 mcg GSK239512), whenever possible, based on investigator judgement of tolerability. The
      post-treatment follow-up period will be a minimum of 2 weeks in duration following the end of
      treatment at Week 48 or early withdrawal, as appropriate.
    


Intervention name(s): GSK239512; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): White to almost white, round tablets. Once daily orally, started at 10 mcg and titrated to the maximum tolerated dose, Up to the highest dose of 80 mcg (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week) followed by 44 week maintenance treatment period; White to almost white, round tablets. Once daily orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GSK239512; remyelination; magnetic resonance imaging; Relapsing Remitting Multiple Sclerosis; Histamine 3 Receptor Antagonist; magnetization transfer ratio
Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
Condition: Childhood Absence Epilepsy; Petit Mal Epilepsy; Epilepsy; Seizures
MeSH terms: Epilepsy; Seizures; Epilepsy, Absence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the best initial treatment for childhood absence
      epilepsy.
    

Detailed description: 
      Childhood absence epilepsy (CAE) is a common pediatric epilepsy syndrome that affects 10 to
      15 percent of all children with epilepsy. Individuals with CAE have brief staring spell
      seizures that occur suddenly, unpredictably, and frequently throughout the day. These
      seizures impair the children's ability to learn and play, and lead to higher injury rates.

      There are many medications used to treat seizures, but only 3 generally are used as the first
      treatment for children with CAE: ethosuximide, lamotrigine, and valproic acid. The goal of
      this study is to determine which of these 3 medicines is the best first choice as treatment
      for children with CAE.

      Approximately 439 children, recruited over a 3-year period at 32 medical centers in the US,
      will take part in this 5-year study. Participants will be randomly given one of the 3 common
      CAE treatments-ethosuximide, lamotrigine, or valproic acid-and will make regular visits to a
      clinic every 1 to 3 months for approximately 2 years. During the visits, participants will
      undergo regular testing to determine if the medicine is working, to watch for side effects,
      and to help researchers learn more about the responses to these medicines. In addition,
      researchers hope to develop methods that may be used in the future to help choose the best
      medicine for each individual diagnosed with CAE.

      Also included in the study will be pharmacokinetics and pharmacogenetics research.
      Pharmacokinetics is the study of how the body absorbs, distributes, metabolizes, and excretes
      drugs. Pharmacogenetics is the study of genetic determinants of the response to drugs.
      Knowledge gained from this study may lead to individualized treatment for children with CAE,
      and may also be beneficial for other pediatric and adult seizure disorders.
    

Intervention name(s): Ethosuximide; Lamotrigine; Valproic acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ethosuximide is a common treatment for childhood absence epilepsy.; Lamotrigine is a common treatment for childhood absence epilepsy.; Valproic acid is a common treatment for childhood absence epilepsy.
Other intervention name(s): Zarontin; Lamictal; Depakote
Intervention MeSH terms: Lamotrigine; Valproic Acid; Ethosuximide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: childhood absence epilepsy; CAE; petit mal epilepsy; epilepsy; seizures; ethosuximide; lamotrigine; valproic acid
18794 - Human Photo Toxicity Test
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To determine the phototoxic potential of a topically applied article in human subjects.
    


Intervention name(s): BAY 987517; Untreated Skin
Intervention type(s): Drug; Other
Intervention description(s): 50 μl/cm*2 or 0.05 gm/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.; This site is patched without treatment as irradiated control
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Sex Differences in Neural Response to Cannabidiol
Condition: CBD; Neural Responses
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a randomized, double-blind, within-subjects, cross-over design to assess neural
      changes following a single dose of cannabidiol (CBD) (600mg) versus placebo among healthy
      female volunteers.
    


Intervention name(s): Cannabidiol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.; Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science