bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Brivaracetam Oral Tablet (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam Injection (100 mg) in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg,
      75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.
    


Intervention name(s): Brivaracetam 10 mg oral tablet; Brivaracetam 50 mg oral tablet; Brivaracetam 75 mg oral tablet; Brivaracetam 100 mg oral tablet; 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)
Intervention type(s): Other; Other; Other; Other; Other
Intervention MeSH terms: Brivaracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteers; Brivaracetam
rTMS and Retraining in Focal Hand Dystonia
Condition: Focal Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is exploring a new experimental procedure in dystonia called repetitive
      transcranial magnetic brain stimulation (TMS) combined with rehabilitation. The purpose of
      the study is to determine whether repetitive TMS is effective as a treatment to reduce
      symptoms in dystonia as demonstrated by improved motor performance.
    

Detailed description: 
      BACKGROUND: Though the etiology of focal hand dystonia (FHD) is uncertain, two primary
      factors implicated in the development of dystonic symptoms are excessive cortical
      excitability and impaired sensorimotor processing.

      OBJECTIVE: The purpose of this study was to determine the functional efficacy and neural
      effects of a Dual intervention of rTMS and sensorimotor retraining. Our working hypothesis
      is: subjects receiving the combined intervention will (1) display significantly improved
      handwriting measures; (2) report significant improvement in daily functional ability; (3)
      display reduced hand cramping compared; and (4) demonstrate reduced corticospinal
      excitability after the Dual intervention when compared to the rTMS+ stretching and massage
      (Sham) intervention.

      METHODS: A randomized, single-subject, multiple baseline design with crossover is used for
      this study that will examine ten subjects with FHD with two interventions: five days of
      low-frequency 1 Hz rTMS + sensorimotor retraining (Dual intervention) vs. rTMS + stretching
      and massage (Sham). The rTMS is applied to the premotor cortex at 1 Hz at 90% resting motor
      threshold for 1200 pulses. For sensorimotor retraining, a subset of the Learning-based
      Sensorimotor Training program was followed.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation; Sensorimotor Retraining; Non-specific Therapy
Intervention type(s): Device; Behavioral; Behavioral
Intervention description(s): Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.; For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed; A non-specific massage and stretching program directed to the hand, wrist and forearm
Other intervention name(s): Magstim stimulator (Magstim Co. LTD, Whitland,UK); Neuromodulation; Learning-based Sensorimotor Training program,; Sensory and motor Retraining; Massage; Stretching
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: focal hand dystonia (FHD); repetitive transcranial magnetic stimulation (rTMS); sensorimotor retraining
Efficacy and Safety of TAK-875 in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and efficacy of multiple doses of
      TAK-875, once daily (QD), in subjects with Type 2 Diabetes Mellitus.
    

Detailed description: 
      TAK-875 is under clinical development for the treatment of type 2 diabetes mellitus in
      humans. Non-clinical as well as Phase I clinical data suggest that TAK-875 stimulates insulin
      secretion only at elevated blood glucose levels.

      This study is being conducted to study glycemic effects and safety of TAK-875 compared with
      placebo and glimepiride in subjects with type 2 diabetes who are inadequately controlled on a
      stable dose of metformin as monotherapy.

      Subjects participating in this study are required to fast for 8 hours prior to each study
      visit, and will be educated in recognition and self-management of hypoglycemia. In addition,
      during this Run-in Period compliance with study medication will be documented. Subjects who
      are less than 80% or more than120% compliant with the single-blind, placebo regimen during
      the run-in period will not be randomized.

      At the conclusion of the Run-in period, appropriate subjects will be randomized into the 12
      week double-blind treatment period.
    

Intervention name(s): TAK-875; TAK-875; TAK-875; TAK-875; TAK-875; Glimepiride; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): TAK-875 6.25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.; TAK-875 25 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.; TAK-875 50 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks.; TAK-875 100 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks; TAK-875 200 mg, tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks; TAK-875 placebo-matching tablets and Glimepiride 2 mg or 4mg, capsules, orally, once daily for up to 12 weeks.; TAK-875 placebo-matching tablets and Glimepiride placebo-matching capsules, orally, once daily for up to 12 weeks
Other intervention name(s): Amaryl®; Glyree
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Non Insulin Dependent; Diabetes Mellitus, Type II; Type 2 Diabetes Mellitus; Drug Therapy
Assessment of Acute Disease to Reduce Imaging Costs
Condition: Acute Coronary Syndrome; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Acute Coronary Syndrome; Embolism
Study type: Interventional

Summary: 
      Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk
      Emergency Department(ED) patients can increase exposure of nondiseased patients to radiation,
      intravenous contrast and anticoagulation. This project addresses question of whether
      quantitative Pre-Test Probability(PTP) assessed from two validated web-based computer
      algorithms (the project "webtool"), can improve the diagnostic evaluation of adult patients
      with charted evidence of chest pain and dyspnea. After a validation phase, the main study
      will randomize patients to either the Standard care group or the Intervention group, which
      will receive the output of the ACS and PE webtool that includes the PTP estimates of ACS and
      PE and one of three recommendations regarding next steps: 1. No further testing, 2. Exclusion
      with a biomarker protocol, or 3. Immediate imaging +/- empiric anticoagulation.
    


Intervention name(s): Webtool
Intervention type(s): Device
Intervention description(s): Webtool provides the numeric PTP estimate for ACS and PE, and one of three testing recommendations. For ACS, PTP <2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5 to 5.5%: obtain a troponin I measurement at presentation and 120 minutes later, and if both are normal, no further testing; PTP >5.5%: proceed to provocative testing. For PE, PTP<2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5-10%, obtain a quantitative D-dimer and if normal, no further testing. PTP 10-20%, proceed directly to pulmonary vascular imaging, and if PTP>20% consider empiric anticoagulation with heparin if no contraindications.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Computer-derived, quantitative pretest probability (PTP); Overtesting; Radiation; Intravenous Contrast; Anticoagulation
Study on Whether Tart Cherry Juice Can Reduce Oxidative Stress and Inflammation
Condition: Oxidative Stress; Antioxidant Capacity; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Oxidative stress has been linked to many diseases associated with aging, including coronary
      heart disease and Alzheimer's disease. Antioxidants and special proteins in the body work
      together to help prevent damage by free radicals. Some studies have indicated that as people
      age, they are less able to fight off oxidative stress and have increased levels of
      inflammation.

      Tart cherries are known to be rich in antioxidants and plant-nutrients. The product we are
      using in this study is an all-natural tart cherry juice, mixed with apple juice concentrate
      and containing no additives and no preservatives.

      We hope to learn whether antioxidant supplementation, such as tart cherry juice, can
      measurably decrease oxidative damage and inflammation associated with aging.
    

Detailed description: 
      Objectives

      The primary objective of this pilot study is to investigate whether tart cherry juice
      consumption can reduce oxidative stress in older adults as measured by attenuation of
      F2-isoprostane responses to a forearm ischemia-reperfusion, and a decrease in urinary
      excretion products of oxidative damage. The secondary objective is to examine whether
      age-sensitive markers of inflammation are reduced in response to the cherry juice
      consumption.
    

Intervention name(s): Tart Cherry Juice
Intervention type(s): Dietary Supplement
Intervention description(s): 8 fl.oz. twice per day
Other intervention name(s): CherryPharm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: oxidative stress; aging; ischemia-reperfusion
Impact at One Year of a Secondary Prevention Educational Program on Cardiovascular Risk Factors
Condition: Myocardial Infarction; Acute Coronary Syndrome
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Syndrome; Infarction
Study type: Observational

Summary: 
      In secondary prevention, the beneficial role of cardiac rehabilitation programs after
      myocardial infarction, percutaneous coronary intervention or coronary artery bypass is now
      well established. The large majority of patients don't benefit from cardiac rehabilitation
      but for those who do, they usually follow an inhospital short health educational program with
      a sensibilisation to different coronary risk factors like smoking, overweight and inactivity.
      The impact of these inhospital short health educational programs combined to cardiac
      rehabilitation has never been totally evaluated, especially the impact on smoking cessation,
      weight loss and daily physical activity.

      Therefore, the present study aims to evaluate the impact at one year on 400 consecutive
      patients' coronary risk profile of:

        -  an inhospital short health educational program alone

        -  an inhospital short health educational program combined to cardiac rehabilitation

        -  a cardiac rehabilitation program alone
    

Detailed description: 
      Classical CV risk factors, quality of life, daily physical activity and energy expenditure,
      smoking dependency and a daily quantification of fat intake are assessed with previously
      validated self-administrated questionnaires. Further factors like the lipid profile and
      glycaemia (with HbA1c in case of diabetes) will also be assessed. These evaluation will take
      place once at the of the hospitalization for acute coronary events in all patients, once at
      the end of any of the three rehabilitation programs for the concerned patients and, finally,
      one year after the hospitalization or the end of the rehabilitation program (mailed
      questionnaires and biological check-up). At this time, smoking dependency, medication, body
      mass index, any coronary event or need of coronary revascularization along with the
      professional ongoing situation (return to work) will be investigated.

      As this study aims to evaluate the efficiency of France's clinical practice in spotting most
      relevant risk factors, the results of the present study could help us to focus the medical
      and paramedical resources on the modification of specific relevant risk factors.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with acute coronary syndrome or myocardial infarctus
      
Keywords: Health Education; Myocardial Infarction; Acute Coronary Syndrome; Quality of Life
Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human
      endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical
      role in multiple sclerosis (MS).

      This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of
      GNbAC1 in patients with relapsing remitting multiple sclerosis.
    


Intervention name(s): GNbAC1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Monthly IV repeated dose; Monthly IV repeated dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Multiple Sclerosis Relapsing-Remitting; GNbAC1; MRI; Monoclonal antibody; Multiple Sclerosis associated retrovirus MSRV; MS; RRMS; HERV-W; Temelimab
BlueCQ Bioavailability
Condition: Methylene Blue; Chloroquine; Pharmacokinetics; Bioavailability
Study type: Observational

Summary: 
      Bioavailability of methylene blue (MB) - comparison of an i.v. and two oral MB formulations -
      and influence of sustained release MB on chloroquine (CQ) concentrations in whole blood,
      plasma and urine.

      Intraindividual cross over open comparison in healthy male and female individuals (6:6) with
      different MB formulations in randomised order for the determination of the absolute
      bioavailability of MB (part 1), followed by an explorative randomised parallel group
      comparison of CQ disposition when CQ is given alone (3 males and 3 females) or in combination
      with 1000 mg sustained release MB (3 males and 3 females) in the participants of study part 1
      (part 2).
    

Detailed description: 
      Maximum whole blood methylene blue (MB) concentrations after i.v. and oral administration may
      differ in the magnitude of 100:1. For achieving MB concentrations possibly effective against
      malaria when using different pharmaceutical formulations, determination of oral
      bioavailability of MB is necessary. To investigate this 12 healthy subjects (6 females, 6
      males) will receive in a randomised cross over design MB 50 mg i.v. and MB 500 mg as a oral
      solution.

      For generating this information for a planned phase II/III study in Africa, an intravenous
      and an oral MB preparation will be investigated.

      A second part of the study will explorative investigate the influence of MB on chloroquine
      (CQ) plasma concentrations. During this part 6 healthy subjects (3 females, 6 males) will
      receive either CQ alone or in combination with MB 500 mg, the design of this part will be a
      parallel design.
    

Observational model: Defined Population
Time perspective: Other
Protein Hydrolyzation and Glycemic Control
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to
      regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic
      controls. The objective of the study is to investigate the optimal dose of such an
      insulinotropic mixture.
    


Intervention name(s): Protein hydrolyzation
Intervention type(s): Dietary Supplement
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Diabetes; protein; protein hydrolysate
Biomarker Changes and Anxiolytic Effects-Phase 2
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic
      properties of kava. The investigators will conduct a one week, double blind, randomized
      placebo controlled trial of kava, dosed at three 75 mg capsules per day, vs placebo, in
      adults with generalized anxiety disorder.
    

Detailed description: 
      This study will examine the utility of plasma and urinary based biomarkers for the anxiolytic
      properties of kava, a natural dietary supplement. The investigators will conduct a one week,
      double blind, randomized placebo controlled trial of kava, dosed at three 75 mg capsules per
      day, vs placebo, in adults with generalized anxiety disorder. Clinical measures of anxiety,
      blood, and urine will be obtained. Biomarkers of interest include PRKACA, cortisol, urinary
      TCE, and NA5HT. Participants will be assessed pre- and post-treatment. The participants will
      also be followed for 12 weeks after the end of treatment to identify any potential rare
      adverse events, particularly liver toxicity, that appear in a delayed fashion.
    

Intervention name(s): Kava Dietary Supplement; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be given three 75mg kava capsules per day for one week; Participants will be given three placebo capsules per day for one week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: kava; dietary supplement; anxiety; generalized anxiety disorder (GAD)
Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea
Condition: Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Newer home sleep study device and algorithm provides an alternative for inpatient sleep study
      and improve the service provides to patients
    

Detailed description: 
      Purpose: Assess different potential algorithms to improve the service and cost utility for
      diagnosis and treatment of obstructive sleep apnea syndrome (OSAS) in patients with high
      pretest probability in Hong Kong.

      Hypothesis: Newer home sleep study device and algorithm provides an alternative for inpatient
      sleep study Design: Prospective randomized study Subject: High pretest probability of OSAS
      patients referred to a tertiary centre.

      Study instruments: a portable sleep study device, AutoCPAP and inpatient sleep monitoring
      system.

      Interventions: comparison between 3 different algorithms of health service for OSA patients
      would be made: conventional in-patient sleep study, empirical treatment and home sleep study.

      Main outcome measures: The primary outcome is the validity of the home sleep study device
      compare to inpatient sleep study. The secondary outcomes are the relative efficacy of
      different algorithms and the numbers of failed procedures in each algorithm.
    

Intervention name(s): home sleep study; home CPAP titration (Autoset); CPAP
Intervention type(s): Device; Device; Device
Intervention description(s): different in algorithm arrangement for diagnosing sleep apnea; continuous positive airway pressure device for treatment of sleep apnea; usual practice
Other intervention name(s): different algorithm arrangement; Autoset
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Health utility; Home sleep study
Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia
Condition: COVID-19
MeSH terms: COVID-19; Hypoxia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study with the primary objective of identifying the maximum tolerated dose
      (MTD) of FT516 using 3 dose-escalation strategies (number of doses and cell dose) for the
      treatment of coronavirus disease 2019 (COVID-19). This study provides initial estimates of
      safety and efficacy based on stable respiratory function, as well as, determining the
      feasibility for full-scale studies designed both for efficacy and safety.
    

Detailed description: 
      Given the urgency of COVID-19 and the known anti-viral activity of natural killer (NK) cells,
      this clinical trial uses immediately available off-the-shelf induced pluripotent stem cell
      (iPSC) derived NK cells already being used to treat cancer patients.

      FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was
      transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16
      on the cell surface, which remains fully functional after NK cell activation. The
      investigators expect that natural developing anti-COVID IgG (early data suggest that some
      develop in 7-10 days after diagnosis) will enhance targeting of FT516 to infected cells.
    

Intervention name(s): FT516
Intervention type(s): Drug
Intervention description(s): FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The study starts with a fast-track design by proceeding in cohorts of one patient until the first DLT is observed. If no DLT is observed, escalation continues by one patient per cohort until Dose Strategy 3 is reached. If the MTD is not yet established by Dose Strategy 3, Dose Strategy 3 is expanded to 6 patients using the final stage of a "3+3" design. An extension of 4 additional patients is planned if FT516 continues to be safe for a total of 10 patients treated at the MTD.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Corona Virus; SARS-COV-2