bioihbjkbjnl/mcl2 huggingface dataset:
Aged Garlic Extract Study
Condition: Coronary Artery Disease; Microcirculation; Biomarkers
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      The primary intention of the study is to examine the effect of aged garlic extract (AGE) on
      the absolute change in coronary artery calcium (CAC). The second intention is to examine the
      effect of AGE on inflammatory biomarkers and microcirculation. It is a double blind placebo
      controlled study. The participants will ingest AGE during a period of one year. The CAC will
      be controlled by computer tomography (CT) scan; the inflammatory biomarkers through blood
      sample test and the microcirculation through laser speckel imagining and laser doppler before
      and after the one year period of AGE ingestion.
    

Detailed description: 
      Objectives:

      Effect on coronary artery atherosclerosis / the progression of atherosclerosis Effect on
      inflammatory and oxidation biomarkers Cholesterol lowering effect Effect on microcirculation

      Type of study:

      Randomized double blind controlled trial

      Number of patients: 80 patients

      Duration of the study:

      The patients will be studied for one year after they have entered the study. The total time
      of the study duration from the including date of the first patient to the analysis of the
      last patient entering the study estimated to be 2-3 years. An inclusion rate off 1 to 2
      patients per week.

      Treatment:

      Dose: Treated with a placebo capsule or a capsule containing a total of AGE 2400 mg daily for
      1 year (2 Kyolic capsule (600 mg) twice daily).

      Methods:

      Placebo-controlled double blind randomized trial to determine whether AGE can influence the
      rate of atherosclerosis plaque burden measured by coronary artery calcium, improve vascular
      function and microcirculation and favorably change biomarkers of oxidative stress.

      Randomization:

      The participants are assigned to AGE or placebo in a double-blinded manner, using numbered
      containers assigned to a computer-generated randomization chart by a nurse coordinator.
    

Intervention name(s): Aged Garlic Extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): Kyolic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind placebo controlled prospective study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: garlic
Plasma Amino Acid Response to Whey Protein Ingestion Following 28-days of Probiotic Supplementation
Condition: Focus of Study is Amino Acid Appearace in Blood
Study type: Interventional

Summary: 
      Active males and females consumed a probiotic for 28-days. Before and after the intervention
      period, participants reported to the lab in a fasted state where they consumed 25 grams of
      whey protein. Following drink consumption, participants provided blood draws at 15-minute
      intervals. Blood samples were analyzed for amino acid concentrations.
    


Intervention name(s): Bacillus subtilis DE111; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 x10-9 CFU Bacillus subtilis DE111 probiotic; Maltodextrin placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Transcranial Magnetic Stimulation (TMS) for Motor Symptoms in Psychiatric Disorders
Condition: Psychomotor Retardation; Psychomotor Slowing; Schizophrenia and Related Disorders; Major Depressive Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      Psychomotor slowing may occur in major psychiatric disorders, such as major depressive
      disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills,
      motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor
      slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and
      basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15
      sessions of repetitive transcranial magnetic stimulation (rTMS) may ameliorate psychomotor
      slowing in schizophrenia or major depression.
    

Detailed description: 
      Psychomotor slowing may occur in major psychiatric disorders, such as major depressive
      disorders or schizophrenia spectrum disorders. It refers to slowing of fine motor skills,
      motor planning and gross motor behavior. In major depression and schizophrenia, psychomotor
      slowing is associated with alterations of premotor cortex, dorsolateral prefrontal cortex and
      basal ganglia. This randomized, sham-controlled, prospective trial will test, whether 15
      sessions of rTMS in 3 weeks may ameliorate psychomotor slowing in schizophrenia or major
      depression.

      Eligible participants will be randomized to one of four arms:
    

Intervention name(s): DLPFC facilitatory; SMA inhibitory; SMA facilitatory; sham TMS
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli; 1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli; Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli; Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session
Other intervention name(s): rTMS facilitatory DLPFC; rTMS inhibitory SMA; iTBS facilitatory SMA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
GSK1349572 Proton Pump Inhibitor Drug Interaction and Supratherapeutic Dose Study
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1349572 is an integrase inhibitor that is currently being evaluated for the treatment of
      HIV infection. The primary objective of this study is to determine whether the addition of a
      proton pump inhibitor, omeprazole, to GSK1349572 impacts the blood levels of GSK1349572. It
      will also evaluate if a high fat meal impacts the blood levels of GSK1349572. In addition,
      the safety, tolerability, and pharmacokinetics of single supratherapeutic (high) dose of
      GSK1349572 will be evaluated.
    

Detailed description: 
      Official Study Title: A randomized, double-blind study to evaluate the safety, tolerability,
      and pharmacokinetics of a supratherapeutic dose of GSK1349572 250 mg and a randomized,
      open-label study to evaluate the effects of omeprazole 40 mg daily and a high fat meal on the
      pharmacokinetics of GSK1349572 50 mg in healthy adult subjects (ING112941)
    

Intervention name(s): GSK1349572; GSK1349572; Placebo; Omeprazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK1349572 250 mg suspension as a single dose. GSK1349572 is an investigational (not approved by the FDA) medication for the treatment of HIV in the class of integrase inhibitors.; GSK1349572 50 mg tablets as a single dose on three separate occasions. GSK1349572 is an investigational (not approved by the FDA) medication for the treatment of HIV in the class of integrase inhibitors.; Placebo Suspension as a single dose.; Omeprazole 40 mg once a day for 5 days. Omeprazole is approved by the FDA currently to reduce stomach acid, treat stomach ulcers, and gastroesophageal reflux disease.
Other intervention name(s): PRILOSEC. PRILOSEC is a registered trademark of AstraZeneca, LP.
Intervention MeSH terms: Dolutegravir; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; GSK1349572; omeprazole; Prilosec; supratherapeutic dose; pharmacokinetics; drug interaction; HIV Infections
A Study in Healthy Subjects to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways
Condition: Bioavailability and AUC
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at drug levels of AZD5423 in blood when the drug is
      administered in different ways - orally, intravenously or inhaled (with four different
      devices), to healthy subjects
    

Detailed description: 
      A Phase I, Single Centre, Open, Partly Randomised, Crossover Study in Healthy Subjects to
      Evaluate AZD5423 Absolute Pulmonary Bioavailability when Administered Inhaled via a New Dry
      Powder Inhaler, Turbuhaler, Spira nebulizer and I-neb AAD system
    

Intervention name(s): AZD5423; AZD5423; AZD5423; AZD5423; AZD5423; AZD5423
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): solution for injection, administered as intravenous infusion Corr to total dose of 250 µg AZD5423; nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423; nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423; nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423; dry powder inhaled via Turbuhaler, corr to approximately 200 µg lung deposited dose AZD5423; dry powder inhaled via New Dry Powder Inhaler, corr to approximately 200 µg lung deposited dose AZD5423
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I, Healthy male volunteers, pharmacokinetics
TD-1792 in Gram-positive Complicated Skin and Skin Structure Infection
Condition: Staphylococcal Skin Infection
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether TD-1792 is safe and effective when used to
      treat complicated skin and skin structure infections caused by Gram-positive bacteria.
    

Detailed description: 
      TD-1792 is compared to vancomycin for the treatment of cSSSI.
    

Intervention name(s): TD-1792; Vancomycin
Intervention type(s): Drug; Drug
Intervention description(s): TD-1792 2 mg/kg/day IV; Vancomycin 1 Gm IV q 12 hrs
Intervention MeSH terms: Vancomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cSSSI; Staph; MRSA
Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of AZD1722 in Healthy Male and Female Japanese Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate the safety, tolerability, pharmacodynamics and
      pharmacokinetics of AZD1722 in healthy Japanese subjects at increasing doses given for 7 days
      in order to allow for including Japanese subjects in future global studies. A cohort of
      Caucasian subjects will be included in the study to evaluate cardiac effects, assessed by
      digital ECGs (dECG) recordings, also in Caucasian subjects.
    


Intervention name(s): AZD1722; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): RDX5791; Tenapanor
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Oxypurinol Compared With Placebo for Class III-IV NYHA Congestive Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The OPT-CHF (OxyPurinol Therapy for CHF) study is designed to demonstrate the efficacy and
      safety of oral oxypurinol vs. placebo in a randomized, double-blind, twenty-four week trial
      in 400 patients in up to 50 centers. Measures of clinical efficacy (NYHA class and Patient
      Global Assessment) as well as clinical outcomes (e.g., death, worsening heart failure, and
      hospitalization) will be assessed as a composite endpoint in this trial.
    


Intervention name(s): Oxypurinol
Intervention type(s): Drug
Intervention MeSH terms: Oxypurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Safety and Feasibility of St. Mark's Electrode for the Hypoglossal Nerve and Cortico-lingual Pathway Study
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The possibility of registering the M-response and the motor evoked potential (MEP) from the
      muscles of the tongue by using the St. Mark's electrode will be evaluated. The safety of
      method will be confirmed. Registered parameters will be compared with other known methods and
      comparative effectiveness of proposed method will be determined.

      The study will involve healthy volunteers without clinical symptoms of hypoglossal nerve and
      cortico-lingual pathway lesions and without surgical interventions in the tongue .The
      volunteers will be examined once for the parameters of the amplitude and latency of the
      M-response and MEP, as well as the difference between these indicators at different sides of
      the examination during nerve conduction study (NCS) and transcranial magnetic stimulation
      (TMS) of the hypoglossal nerve and the cortico-lingual pathway.
    


Intervention name(s): Hypoglossal nerve conduction study; Transcranial magnetic stimulation of hypoglossal nerve
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): NCS of nervus hypoglossus (evaluation of M-response parameters) was carried out using a 4-channel electromyographic machine. The stimulation will be carried out from three points:
angle of the lower jaw (proximal point),
the area of the carotid triangle (distal point),
directly from the electrode of St. Mark when it is localized on the muscles of the tongue.
The initial stimulation parameters: strength of an electric current 20 mA, stimulus duration 0.2 ms, and frequency 1 Hz. To achieve supramaximal stimulation, the stimulation strength will be increased with a step of 1-2 mA to a maximum of 35 mA, the duration of the stimulus will be increased to 0.3 ms.; TMS will be carried out using a Magstim 200 magnetic stimulator connected with a BiStim module (Magstim Co. Ltd., Whitland, Wales, UK). The generated magnetic pulses will be delivered by the coil 65 mm in diameter tangentially located relative to the scalp in the F7 projection - T3 and F8-T4 (according to the international scheme "10-20"). The area of cortical stimulation will be localized by supplying single pulses with gradual increase, with a coil displacement with a step of 1 cm, until the contraction of the facial muscles will be obtained, followed by the determination of the MEP threshold value. Analysis of conduction by cortical-lingual pathway will be performed at TMS with magnetic stimulus intensity 20-30% above the MEP threshold.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: hypoglossal nerve
The Effects of Altering Physical Activity on Cardiometabolic Health
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The effects of physical inactivity on variations in blood glucose and vascular health are not
      fully understood. The purpose of this study is to determine if an acute transition from
      physical activity to inactivity alters vascular health. Specifically, the investigators wish
      to examine in healthy, lean physically active individuals (obtaining greater than 10,000
      steps/day) if decreasing physical activity (obtaining less than 5,000 steps/day) will alter
      blood flow following a meal a marker of vascular health. Furthermore, the investigators wish
      to examine if a one day return to physical activity (obtaining >10,000 steps/day) can restore
      the detrimental effects on blood flow following a meal.
    

Detailed description: 
      Herein, we tested the hypothesis that an acute reduction in daily activity (from >10,000 to
      <5,000 steps/day) for 5 days in healthy individuals reduced meal-stimulated blood flow and if
      a 1 day return to activity improved this outcomes.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): short period of inactivity (5 days) followed by a return to physical activity (1 day)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: insulin resistance; exercise; continuous glucose monitoring; blood flow; endothelial function
Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to assess the potential mechanism of action by which WelChol®
      (colesevelam) may improve blood glucose control in patients with type 2 diabetes
    


Intervention name(s): Colesevelam; Colesevelam matching placebo; Insulin glargine (Lantus)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Colesevelam 3.8g for 12 weeks; Colesevelam matching placebo for 12 weeks; Insulin glargine for 12 weeks
Intervention MeSH terms: Insulin Glargine; Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Mechanism of action insulin sensitivity
Bicalutamide in Treating Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Androgens can cause the growth of breast cancer cells. Antihormone therapy, such
      as bicalutamide, may stop the adrenal glands from making androgens.

      PURPOSE: This phase II trial is studying how well bicalutamide works in treating patients
      with metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the 6-month efficacy rate of bicalutamide as first-, second-, or third-line
           therapy in patients with androgen receptor-positive and estrogen receptor- and
           progesterone receptor-negative metastatic breast cancer.

      Secondary

        -  Determine the 6-month progression-free survival of patients treated with this drug.

        -  Evaluate the safety of this drug in these patients.

        -  Evaluate changes in estradiol, total and free testosterone, and sex-hormone binding
           globulin in response to androgen blockade in patients treated with this drug.

        -  Evaluate tissue, including cytokeratins 5/6 and 17, SPDEF, ALCAM, ERBB2, FGFR4, and
           prostate-specific antigen (PSA), using immunohistochemical analysis in patients treated
           with this drug.

      OUTLINE: This is a open-label study.

      Patients receive oral bicalutamide once daily for 4 weeks. Treatment repeats every 4 weeks
      for 6 months in the absence of disease progression or unacceptable toxicity. Patients
      achieving complete response, partial response, or stable disease may continue to receive
      bicalutamide as above at the discretion of the investigator.

      Patients undergo blood and tissue sample collection for correlative studies. Samples are
      analyzed for hormonal levels, including estradiol, total testosterone, free testosterone, and
      sex-hormone binding globulin, and proteins, including ALCAM, SPEDF, and CK 5/6, by
      immunohistochemical analysis at baseline, after course 1, and at the end of the study.

      After completion of study treatment, patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
    

Intervention name(s): bicalutamide; diagnostic laboratory biomarker analysis; immunohistochemistry staining method
Intervention type(s): Drug; Other; Other
Intervention MeSH terms: Bicalutamide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer; male breast cancer
A/H5N1 Dose Ranging Study With Adjuvant Patch
Condition: Pandemic Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1/2, randomized, observer-blind, placebo-controlled clinical trial. A maximum
      of 500 eligible subjects in 10 groups will be enrolled, randomized and vaccinated in this
      study. Subjects will receive an intramuscular injection of either the influenza A/H5N1 (low,
      medium or high dose) or placebo on Day 0 and Day 21 with or without a patch. This study will
      be performed in two parts.

      In Part 1, an initial safety evaluation will be performed in 100 randomized subjects. A
      Safety Review Committee (SRC)will review all safety data, including laboratory values,
      through the Day 7 visit, and compare those data against Stopping Criteria. If the treatments
      are considered safe, Part 2 of the study will be initiated and a second vaccination will be
      administered to subjects in Part 1 on Day 21.

      In Part 2, the remaining 400 subjects will be randomized, treated, and will follow the same
      visit structure and protocol-defined requirements as subjects in Part 1, without the
      additional laboratory safety measurements. An SRC review will also be performed of all safety
      data through the Day 28 visit for subjects participating in Part 1.
    


Intervention name(s): A/H5N1; A/H5N1; A/H5N1; A/H5N1; A/H5N1; A/H5N1; A/H5N1; A/H5N1; A/H5N1; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; No LT Patch Day 0 or Day 21; Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21; Low dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21; Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21; Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21; Medium dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21; High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21; High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; no LT patch on Day 0; LT Patch on Day 21; High dose A/H5N1 (0.5mL); Route IM - Day 0 and Day 21; LT patch on Day 0 and Day 21; Placebo (0.5ml); Route IM - Day 0 and Day 21; no LT patch on Day 0 or Day 21
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Avian; Pandemic; Influenza; A/H5N1