bioihbjkbjnl/mcl2 huggingface dataset:
Energy Value of Macronutrients From Pistachio Nuts and Mechanisms of Nutrient Action
Condition: Energy; Cardiovascular Disease; Cancer
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The objective of this study is to measure the energy value of pistachios in the human diet
      and study molecular mechanisms that may help explain the beneficial health effects of
      pistachios.
    

Detailed description: 
      Previous studies have suggested that nut consumption imparts a variety of health benefits,
      including reduction of cardiovascular disease and improved satiety. However, studies of
      pistachios are extremely limited. The aim of this study is to determine the energy value of
      pistachios in the human diet and to probe mechanisms by which pistachios impart health
      benefits. The metabolizable energy value of pistachio nuts will be calculated based on the
      chemical composition and energy content of the consumed diet and excreta. This will provide a
      better estimate of the energy value of pistachios than simply calculating energy value based
      on Atwater factors. In addition to determining the energy value of pistachios, we will
      evaluate the effects of pistachio-rich diets on plasma phytonutrient levels and on gene
      expression changes to determine what protective mechanisms are activated by pistachio
      consumption.
    

Intervention name(s): 1.5PD; 3.0PD; control
Intervention type(s): Other; Other; Other
Intervention description(s): average American diet plus 1.5 oz per day pistachios; average American diet plus 3.0 oz per day pistachios; average American diet without pistachios
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: pistachio; nuts; energy value; cardiovascular disease; phytonutrient; gene expression; energy value of pistachio nuts
Renal Sympathetic Denervation From The Adventitia on Hypertension
Condition: Primary Aldosteronism Due to Aldosterone Producing Adenoma
MeSH terms: Adenoma; Hypertension; Hyperaldosteronism
Study type: Interventional

Summary: 
      Renal sympathetic denervation from the intima of renal arteries has become an important
      method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly
      located in the adventitia, and there is no report about renal sympathetic denervation from
      the renal adventitia. Primary aldosteronism is an important factor of secondary hypertension,
      tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone,
      in some patients blood pressure control is still not desirable after resection of tumor
      aldosterone. This study intends to conduct renal sympathetic denervation ablation from the
      adventitia to observe its efficacy and safety on blood pressure of patients with primary
      aldosterone.
    

Detailed description: 
      Renal sympathetic denervation from the intima of renal arteries has become an important
      method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly
      located in the adventitia, and there is no report about renal sympathetic denervation from
      the renal adventitia. Primary aldosteronism is an important factor of secondary hypertension,
      tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone,
      in some patients blood pressure control is still not desirable after resection of tumor
      aldosterone.

      This study intends to conduct renal sympathetic denervation ablation（RDN）from the adventitia
      to observe its efficacy and safety on blood pressure of patients with primary aldosterone.
    

Intervention name(s): Renal Sympathetic Denervation
Intervention type(s): Device
Intervention description(s): We applied a ablation catheter for discrete radiofrequency ablations of 8 W or less and lasting up to 2 min each to obtain up to four-six ablations separated both longitudinally and rotationally from the adventitia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Renal sympathetic denervation;hypertension
A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll
      a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence
      between the oral suspension and tablet formulations of perampanel will be evaluated under
      fasted conditions; in Arm 2, bioequivalence between the oral suspension and tablet
      formulations will be evaluated under fed conditions. In both study arms, subjects will be
      randomized on Study Day 1 for Treatment Period 1 to receive a single 12-mg dose for
      perampanel as either oral suspension or a tablet, and will then receive the alternative
      treatment on Study Day 43 of Treatment Period 2. Drug administration will be separated by a
      washout of at least 6 weeks between the two treatment periods.
    


Intervention name(s): Perampanel
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Subjects; Bioequivalence; Fasted; Fed
Replication of the D58 Asthma Trial in Healthcare Claims Data
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as is possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates according to standard practice. Investigators
      assume that the RCT provides the reference standard treatment effect estimate and that
      failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims
      data for replication for a range of possible reasons and does not provide information on the
      validity of the original RCT finding.
    

Intervention name(s): Budesonide; Budesonide-Formoterol
Intervention type(s): Drug; Drug
Intervention description(s): Budesonide dispensing claim is used as the reference group.; Budesonide-Formoterol dispensing claim is used as the exposure group.
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new user, parallel group, propensity score-matched, retrospective
        cohort design comparing budesonide-formoterol versus budesonide alone. The patients will be
        required to have continuous enrollment during a baseline period of 180 days before
        initiation of budesonide-formoterol or budesonide.
Switching From Usual Brand Cigarettes to a Tobacco-heating Cigarette or Snus
Condition: Cigarette Smoking
Study type: Interventional

Summary: 
      To evaluate selected biomarkers of tobacco exposure and biomarkers of harm and assess quality
      of life measures in smokers randomly switched from their usual brand of cigarette to one of
      three test products: (1) a tobacco-heating cigarette; (2) snus (smokeless tobacco); or (3) an
      ultra-low machine yield tobacco-burning cigarette.
    

Detailed description: 
      A randomized, multi-center, 4-group study of health status measures and biomarkers in
      subjects who smoke and are switched to either a tobacco-heating cigarette, snus, or a
      tobacco-burning cigarette, with a non-treatment group of never-smokers.

      Primary Objectives:

        -  Evaluate select biomarkers of tobacco exposure and biomarkers of harm from subjects who
           smoke and who are switched to a tobacco-heating cigarette, snus, or a tobacco-burning
           cigarette.

        -  Evaluate ability of a tobacco-heating cigarette and snus to modify patient-reported
           Chronic Obstructive Pulmonary Disease (COPD)-related health status in subjects who smoke
           and are switched to either a tobacco-heating cigarette or snus relative to a control
           group (a tobacco-burning ultra-low machine yield [ULMY]) cigarette.

        -  Assess subject compliance.

      Secondary Objectives:

        -  Measure amount and repeatability of smoke components yielded from the cigarettes (yield
           in use) and determine relative uptake of selected smoke components.

        -  Evaluate the ability of a tobacco-heating cigarette and snus to modify general health
           status as measured by self-administered health questionnaires in subjects who smoke and
           are switched to either a tobacco-heating cigarette or snus relative to a control group
           (a tobacco-burning ULMY cigarette).

        -  Compare health status measures in smokers who are switched to a tobacco-heating
           cigarette to smokers who are switched to snus.

        -  Compare baseline data from all tobacco-using groups to baseline data from the
           never-smoking (non-treatment) group.
    

Intervention name(s): Tobacco-Heating Cigarette; Snus (Smokeless Tobacco); Tobacco-Burning Cigarette
Intervention type(s): Other; Other; Other
Intervention description(s): Smokers switched to a tobacco-heating cigarette for 24 weeks; Smokers switched to snus product for 24 weeks; Smokers switched to a tobacco-burning cigarette for 24 weeks
Intervention MeSH terms: Lobeline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biomarkers; Tobacco; Tobacco-heating; Smokeless Tobacco; Snus; Smoking; Exposure; Quality of Life
Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - B
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetics of CKD-330
      (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of
      the two separate drugs in healthy male volunteers.
    


Intervention name(s): CKD-330 16/5mg - B; Candesartan 16mg and Amlodipine 5mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both
      hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary
      mechanisms and can be coadministered to patients with mixed hyperlipidemia.The overall
      objective of the study is to compare the efficacy and safety of combining fenofibrate and
      simvastatin versus pravastatin monotherapy in patients with mixed hyperlipidemia at risk of
      cardiovascular diseases.
    


Intervention name(s): Fenofibrate/Simvastatin; Fenofibrate/Simvastatin; Pravastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Combination of Fenofibrate and Simvastatin 20mg; Combination of Fenofibrate and Simvastatin 40 mg; Pravastatin 40 mg
Intervention MeSH terms: Simvastatin; Pravastatin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyperlipidemia Combined, efficacy combination fenofibrate simvastatin versus pravastatin; Hyperlipidemia Combined
The Efficacy and Safety of rhTNK-tPA in Comparison With Alteplase(Rt-PA) as Fibrinolytic Therapy of Acute STEMI
Condition: Acute ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is aiming to test the hypothesis that efficacy of rhTNK-tPA was not inferior to
      rt-PA with respect to the 30-day MACCE rates after fibrinolytic therapy for STEMI patients.
      It is a multicenter, randomized, open, parallel, active-controlled, non-inferiority trial.
    

Detailed description: 
      The study includes screening and baseline, randomization & intervention, in-hospital visit,
      at 30±3 days visit after fibrinolytic therapy.

      Following an initial eligibility screening assessment, all eligible patients who have signed
      the informed consent will be randomly assigned by an interactive Web-based central system for
      fibrinolytic therapy with either rhTNK-tPA or rt-PA. The standard care should be given to all
      patients except for the study interventions.

      Prior to fibrinolytic administration, enoxaparin (30-mg intravenous) or Un- Fractionated
      Heparin (maximum 4000U, intravenous) should be administered, combined with antiplatelet
      therapy consisted of both clopidogrel and aspirin in a 300-mg loading dose followed by
      routine dosage.

      Successful reperfusion according to the clinical evidence (EKG) should be assessed after
      fibrinolytic therapy.TIMI flow should be assessed for those patients with 24 hours coronary
      angiography.

      MACCE and bleeding events should be followed up and documented during the study until 30 days
      after fibrinolytic therap. An independent adjudication committee will judge the major
      endpoint events.
    

Intervention name(s): rhTNK-tPA; alteplase
Intervention type(s): Drug; Drug
Intervention description(s): Dose:16mg; Mode of admin: Single bolus Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.; Dose:50mg; Mode of admin: administered as an 8-mg initial IV bolus followed by an infusion of 42 mg over the next 90 minutes Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.
Other intervention name(s): Recombinant Human TNK Tissue-type Plasminogen Activator; rt-PA
Intervention MeSH terms: Tissue Plasminogen Activator; Plasminogen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute ST elevation myocardial infarction
SVF Therapy for Human Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee
      osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee
      cartilage to qualitatively and quantitatively evaluate cartilage regeneration.
    

Detailed description: 
      Study participants voluntarily provided written informed consent to participate in the study.
      The two knees of each patient were randomly assigned to autologous SVF treatment group or
      non-treatment control group. The patients were evaluated every 4 weeks for safety and
      efficacy of autologous SVF therapy for 24 weeks.
    

Intervention name(s): SVF treatment
Intervention type(s): Procedure
Intervention description(s): autologous SVF (10E8 cells)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cartilage Defect; Cartilage Regeneration
Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis
Condition: Saphenous Vein Graft Disease
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude
      in the first year after bypass surgery, leading to adverse cardiovascular outcomes, including
      recurrent angina, myocardial infarction, and the need for repeat coronary intervention. While
      aspirin is the standard antiplatelet treatment after CABG surgery, 10-20% of vein grafts
      continue to occlude despite contemporary secondary preventative therapy. Compared to aspirin
      and other antiplatelet therapies like clopidogrel, ticagrelor treatment leads to a more
      pronounced platelet inhibition, and may substantially improve graft patency following CABG
      compared to aspirin. No data has yet to be collected regarding the impact of ticagrelor on
      saphenous vein graft patency following CABG. In this context, the investigators seek to
      compare vein graft patency between patients randomized to receive aspirin therapy, the
      current standard of care, or ticagrelor treatment, starting in the early postoperative
      period, and continuing for 2 years after CABG.
    

Detailed description: 
      This clinical trial will be a randomized double-blind study focusing on ticagrelor
      antiplatelet therapy as a means of improving vein graft patency after CABG. Patients will be
      eligible if they have received at least 1 vein bypass graft at time of surgery. Patients will
      be randomized to receive either aspirin 81 mg bid or ticagrelor 90 mg bid. The aspirin and
      ticagrelor medications will be prepared in blinded capsules. Patients recovering from surgery
      will be eligible for study randomization within the first 5 postoperative days. Treatment
      will continue for 1 year, at which time patients will undergo a CT coronary angiogram to
      assess graft patency. Patients will then be invited to continue participating in the trial
      for 1 more year, and a repeat CT coronary angiogram will be performed at the 2 year
      postoperative time-point.
    

Intervention name(s): Aspirin; Ticagrelor
Intervention type(s): Drug; Drug
Other intervention name(s): Brillinta
Intervention MeSH terms: Aspirin; Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Saphenous vein graft disease; Coronary artery bypass graft surgery; Antiplatelet therapy; Coronary artery disease; Secondary prevention; Graft patency
The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents
Condition: Syncope, Vasovagal
MeSH terms: Syncope; Syncope, Vasovagal
Study type: Interventional

Summary: 
      The purpose of this study to evaluate the effectiveness of metoprolol versus conventional
      treatment in the prevention of syncope recurrence in children and adolescents.
    

Detailed description: 
      Syncope is often a frustrating clinical problem seen in pediatric patients. Most pediatric
      syncope is benign, and vasovagal syncope (VVS) is the most common type of syncope seen in
      children . The diagnosis of VVS is established by history, often confirmed by tilt tests. A
      wide range of drugs has been proposed for VVS , with β-adrenergic blocking agents being
      first-line therapy. However, clinical studies have shown conflicting results in terms of
      therapy effectiveness. β-blockers have been claimed to be effective for 60% to 100% of young
      patients in many uncontrolled studies but not in most short- and long-term controlled studies
      . Sheldon et al., in a recent multicenter, double-blinded, placebo-controlled, randomized
      study of adult patients, reported that metoprolol was not effective in preventing VVS. To our
      knowledge, no pediatric randomized controlled trials with long-term follow-up have
      demonstrated the efficacy of β-blockers for the prevention of syncope.
    

Intervention name(s): metoprolol; conventional treatment
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metoprolol and Syncope
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
Condition: Upper Respiratory Tract Infection; Nasal Congestion; Rhinorrhea; Sneezing
MeSH terms: Respiratory Tract Infections; Rhinorrhea; Sneezing
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a clinical evaluation of an over the counter (OTC) combination product
      containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10
      mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea,
      sneezing and other symptoms due to upper respiratory tract infection (URTI).
    


Intervention name(s): Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets; Paracetamol (500 mg) tablets
Intervention type(s): Drug; Drug
Intervention description(s): Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets; Paracetamol (500 mg) tablets
Intervention MeSH terms: Acetaminophen; Dimethindene; Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Paracetamol; dimethindene maleate; phenylephrine hydrochloride; cold and flu symptoms
Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
Condition: End Stage Renal Failure on Dialysis; Vascular Calcification
MeSH terms: Kidney Failure, Chronic; Calcinosis; Vascular Calcification
Study type: Interventional

Summary: 
      The study aims to determine the effect size of magnesium and bicarbonate supplementation as a
      basis for future randomized controlled trials aiming at the T50-guided improvement of hard
      clinical endpoints in dialysis patients.
    


Intervention name(s): Magnesium; Bicarbonate
Intervention type(s): Device; Device
Intervention description(s): Magnesium in dialysate increased; Bicarbonate in dialysate increased
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment