bioihbjkbjnl/mcl2 huggingface dataset:
Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Atherosclerosis (in particular stroke and heart attack) is the most important health issue in
      modernized society and high blood pressure is an important predisposing factor. Hypertensive
      subjects with other chronic disease such as diabetes mellitus or impaired renal function are
      particularly vulnerable to these atherosclerotic complications in spite of standard
      antihypertensive therapies.

      Danshen and Gegen are commonly used in Chinese materia medica as treatment for cardiac
      symptoms and atherosclerosis-related disorders.

      The objective of this study is to test Danshen and Gegen as an cardiovascular-protective
      adjunctive regimen to prevent high-risk hypertensive cohort from primary atherosclerosis.
    

Detailed description: 
      Danshen and Gegen (D&G) are two traditional herbal medicines used for cardiac symptoms in
      ancient Chinese medicinal literature. Recent studies suggest their therapeutic effects in
      blood pressure and lipid-lowering, anti-oxidation, microcirculation-promoting, foam
      cells-modulation and have beneficial effects on atherogenic process in coronary patients.

      To evaluate the potential of D&G in primary atherosclerosis prevention in high risk
      hypertension. Patients with high risk hypertension associated with left ventricular
      hypertrophy, diabetes mellitus and renal insufficiency were randomized to receive D&G herbal
      capsules (2gm/day), or (1gm/day) or identical placebo capsules in double-blind and parallel
      fashion for 12 months on top of their anti-hypertensive treatments. Flow-mediated dilation
      (endothelium-dependent dilation, FMD) and nitroglycerin-induced dilation
      (endothelium-independent dilation, NTG) of brachial artery, and carotid intima-media
      thickness (surrogate atherosclerosis marker, IMT) were measured by high resolution B-mode
      ultrasound.
    

Intervention name(s): D&G 2g; D&G 1g; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Danshen consists of the dried root and rhizome of the perennial herb Salvia miltiorrhiza Bge. Gegen is the dried roots of Pueraria lobata (willd.). The combination in the ratio of 7:3 of the raw herbs. Capsule form, Orally taken 2g per Day; Danshen consists of the dried root and rhizome of the perennial herb Salvia miltiorrhiza Bge. Gegen is the dried roots of Pueraria lobata (willd.). The combination in the ratio of 7:3 of the raw herbs. Capsule form, Orally taken 1g per Day; Image-matched placebo, made with starch.
Other intervention name(s): Danshen Gegen; Danshen Gegen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are
      otherwise known as electronic cigarettes. These may look like conventional cigarettes but do
      not contain tobacco.

      The 'vapour' produced by such devices typically consists of humectants (propylene glycol or
      glycerol), nicotine, water, and flavours.

      This trial is to evaluate the pharmacokinetic profile of an EVP.
    

Detailed description: 
      The principal part of this study evaluates the nicotine pharmacokinetic profile of
      conventional cigarettes, a nicotine inhalator, an unflavoured EVP and a flavoured EVP.

      A second part investigates the nicotine delivery of an EVP with four different nicotine
      doses.
    

Intervention name(s): EVP unflavoured; EVP flavoured; Nicotine inhalator; Conventional cigarette
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 15 mg nicotine Nicorette
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Pharmacokinetic Study of Dexmedetomine in Infants
Condition: Cardiac Surgical Procedures
Study type: Interventional
Phase: Phase 1

Summary: 
      Blind randomized trial of a single bolus dose of dexmedetomine followed by a continuous
      infusion (CIVI) for up to 24 hours in infants who immediately post-operative from cardiac
      surgery and require tracheal intubation with mechanical ventilation in the post-operative
      period. Three bolus and infusion dose will be administered to a total of 36 patients.
    

Detailed description: 
      This clinical trial of three dose rates of dexmedetomine will determine the pharmacokinetics
      of the drug in infants who remain tracheally intubated postoperatively. An exploratory
      pharmacodynamic study of a non-invasive device measuring sedation will be performed. Although
      the pharmacokinetics of dexmedetomine have been described for pediatric patients, the drug
      disposition in infants has not been well described. A range of doses has been studied, yet
      there are no reports describing the optimal dose for post-operative pediatric patients. This
      study will provide data that may allow for improved dosing recommendations in this critically
      ill population of children.
    

Intervention name(s): Dexmedetomine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Dexmedetomine; Post-operative cardiac surgery
Assessment of Clinical Effectiveness and Safety of Adalimumab and High Dose Methotrexate in Routine Clinical Practice
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      This was a single-arm, multicenter, open label, prospective cohort study (post-marketing
      observational study) to determine the effectiveness and safety of adalimumab in combination
      with high-dose methotrexate (≥12 mg/week) in participants with rheumatoid arthritis in a
      routine clinical setting in Japan.
    

Detailed description: 
      Study assessments occurred at baseline, Week 12, Week 24, Week 52, Week 76, and Week 104.
      Most participants received 40 mg of adalimumab every other week during the study. Two
      participants started at 40 mg of adalimumab every other week, and increased to 80 mg every
      other week. A few participants had a different dose regimen: 40 mg every three weeks for 3
      participants; 40 mg every four weeks for 1 participant; and 40 mg every other week with a
      switch to 50 mg every three weeks for 4 subjects.
    

Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): Pre-filled syringe, administered by subcutaneous injection
Other intervention name(s): Humira; ABT-D2E7
Intervention MeSH terms: Adalimumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with rheumatoid arthritis treated in a daily clinical setting, who received
        adalimumab (and high dose methotrexate [≥12 mg/week]), were observed prospectively.
      
Keywords: Rheumatoid arthritis; Methotrexate
Self-Management in Stroke Survivors
Condition: Stroke; Hypertension
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a feasibility study of using health-IT to promote self-management of risk factors in
      stroke survivors.
    


Intervention name(s): Self-Management / MTM using Health IT
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Pharmacokinetic Interactions of Losartan and Hydrochlorothiazide
Condition: Healthy Normotensive Participants
Study type: Interventional

Summary: 
      This study was conducted to investigate any potential reaction between losartan and
      hydrochlorothiazide.
    


Intervention name(s): Losartan/hydrochlorothiazide; Losartan; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Losartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy Normotensive Participants; Fixed dose combination; Pharmacokinetics; Losartan; Hydrochlorothiazide
4-choice Reaction Time Test for the Measurement of Psychomotor Recovery After General Anaesthesia
Condition: Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Observational

Summary: 
      The recovery of patients after general anaesthesia is usually estimated by using clinical
      signs and scores. Since there is a lack of the agreed objective methods for assessing
      cognitive and psychomotor recovery after general anaesthesia in ambulatory settings, the aim
      of this study was to evaluate three psychological tests for this purpose. Patients, who were
      scheduled for ambulatory gynaecological surgery, underwent 3 standard psychological tests
      before (T1), 15 minutes after the surgery (T2) and on discharge from the recovery room (T3).
      The tests used were Wechsler memory scale (test 1, working memory capacity), d2 - test (test
      2, concentration endurance) and computer-based 4-choice-reaction time (4CRT, test 3, reaction
      time) as well as Postanesthesia Discharge Scoring System (PADSS). The same test battery was
      used in healthy female volunteers, all test results were compared at the different time
      points.
    


Intervention name(s): General anaesthesia
Intervention type(s): Procedure
Intervention description(s): Standard general anaesthesia for gynecologic surgery in patient group
Intervention MeSH terms: Anesthetics
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients scheduled for ambulatory gynaecologic surgery were asked to
        participate in the study during the routine informed consent process for anaesthesia. The
        inclusion criteria are listed in previous Section. A group of healthy female volunteers,
        meeting the eligibility criteria, completed the same study procedure without a surgery at
        three matched time points; none of them was taking any medication at the time of the study.
        Written informed consent was obtained from all individuals.
      
Keywords: postoperative recovery; psychomotor function; measurement
Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of multiple doses of verapamil on the
      plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to
      assess the safety and tolerability of co-administration of SAM-531 and verapamil.
    


Intervention name(s): SAM-531
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of the Glycemic Index of Ethiopian Honey
Condition: Hyperglycemia, Postprandial
MeSH terms: Hyperglycemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to determine which of the Ethiopian honeys slowly/rapidly raise
      the blood glucose level.
    

Detailed description: 
      Addis Ababa University, College of Natural Sciences, Research Institutional Review Board
      (IRB) approved this study. Written consent forms were obtained from all 14 volunteers (7
      females and 7 males). The subjects were randomly recruited from twenty eight 3rd year Food
      Science and Postharvest Technology students. People volunteering to participate in the study
      were excluded if they are: overweight, dieting, smoking, a family history of diabetes,
      pregnant, metabolic disorders, suffering from any illness or food allergy and regularly
      taking medication. The participants were checked for glucose tolerance according to the WHO
      (World Health Organization) classification (fasting glucose <7 mmol/L(millimole per lite) and
      2-hour blood glucose concentration after a 25g glucose load <7.8 mmol/L). Ten (5 females and
      5 males) were selected from fourteen using lottery sampling methods. Reference glucose and
      monofloral honeys were used as experimental foods. To determine the GI value, 25 grams of
      available carbohydrate was fed for ten healthy people in the morning after they have fasted
      for 11 hours overnight. After fasting blood sample was obtained. The study participants were
      consumed each honey and reference glucose served. Additional blood samples were taken at 15,
      30, 45, 60, 90 and 120 minutes after eating commenced. Blood glucose response (Area under the
      curve, AUCt) for test food was compared to the blood glucose response of reference glucose
      (AUCr). AUC was calculated using SAS (Statistical Analysis Software), 2002. Glycemic index
      (GI) was calculated using:

      GI= AUCt/AUCr*100

      Where:

      AUCt = Area Under the Curve for honey; AUCr = Area Under the Curve for the reference glucose
    

Intervention name(s): Provision of experimental honey
Intervention type(s): Biological
Intervention description(s): Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense and reference glucose were used as test food.
25g available carbohydrate of the test food was provided to ten human subjects after fasted for 11 hours overnight.
Other intervention name(s): Honey Glycemic Index
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Glycemic index; honey; reference glucose
Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study will test the effect of dopamine, serotonin, and direct 5-HT2A receptor stimulation
      on empathy, mood perception, and amygdala activity to fearful stimuli. In addition, we
      predict associations between subjective effects/alterations in emotion processing tests and
      functional imaging (fMRI) activity.
    


Intervention name(s): LSD; MDMA; Amphetamine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100ug per os, single dose; 125mg per os, single dose; 40.3mg per os, single dose; Capsules containing mannitol looking identical to the other drugs
Other intervention name(s): Lysergic Acid Diethylamide; 3,4-methylenedioxymethamphetamine; d-amphetamine sulfate
Intervention MeSH terms: Amphetamine; Dextroamphetamine; N-Methyl-3,4-methylenedioxyamphetamine; Lysergic Acid Diethylamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
Condition: Cocaine Dependence; Cocaine Addiction; Cocaine Abuse; Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine if it is safe to use the study drug,
      clavulanic acid, in combination with cocaine. In this study, subjects will receive
      intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid
      is being studied so future studies can be done to find out if this drug is helpful in
      treating cocaine dependence. Currently, there is no available medication treatment for
      cocaine dependence.
    

Detailed description: 
      This is a prospective, placebo controlled inpatient crossover safety study of 3 doses (250
      mg/day, 500 mg/day, 750 mg/day) of CLAV with an intravenous infusion of cocaine 40 mg.
      Subjects will be non-treatment seeking experienced cocaine dependent adults, ages 18-65 (N=12
      completers, 21 estimated to enroll). Subjects will undergo a washout of the study drug for 5
      half-lives between study drug administration sessions.

      The primary objective will be to determine whether there are clinically significant adverse
      interactions between CLAV (250 mg/day; 500 mg/day; 750 mg/day) and intravenously administered
      cocaine in healthy, non-treatment seeking adults with cocaine use disorder.
    

Intervention name(s): Clavulanic acid; Intravenous cocaine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clavulanic acid will be administered orally in 250mg capsules; 20/40mg Cocaine will be administered by IV; Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose
Other intervention name(s): CLAV; Coc; PBO
Intervention MeSH terms: Clavulanic Acids; Clavulanic Acid; Cocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine; Clavulanic Acid
Functional and Neurochemical Brain Changes in First-episode Bipolar Mania
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      The purpose of this study is to use magnetic resonance imaging (MRI) to examine brain
      structure, function and chemistry in people with bipolar disorder who are being treated with
      either quetiapine or lithium. Both of these medicines are FDA-approved to treat mania in
      adults and lithium is also FDA approved in children; quetiapine is commonly used in children
      with mania, but is not FDA approved for this indication in this age group.
    


Intervention name(s): lithium; quetiapine
Intervention type(s): Drug; Drug
Intervention description(s): standard clinical care; standard clinical care
Intervention MeSH terms: Quetiapine Fumarate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        You are being asked to take part in this research study because you have been diagnosed
        with bipolar disorder and are currently experiencing mania. Mania is identified by periods
        of extreme elation or irritability, excessive energy, racing thoughts, difficulty sleeping,
        poor judgment and/or reckless behavior. Bipolar disorder is an illness in which people
        experience mania as well as mood swings into depression. To participate in this study you
        must be at least 12 years old and no older than 35.
Single Ascending Dose Study to Evaluate Pharmacokinetics and Food-Effect in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability, and determine the blood
      levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of ASN002.
      Healthy volunteers will be participants in the study.
    


Intervention name(s): ASN002
Intervention type(s): Drug
Intervention description(s): Single dose study with food effect
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
EnMotion, Embryo's Natural Motion
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of the study is to determine if a dynamic embryo microenvironment impacts embryo
      development and reproductive potential in comparison to static culture.
    

Detailed description: 
      The proposed research design is a prospective randomized control trial. Patients with normal
      ovarian reserve, who would be expected to have reasonable outcomes after in vitro
      fertilization, will serve as the subjects. Embryos from the same patient will be randomized
      to either static or dynamic culture. They will then be cultured to the blastocyst stage of
      embryo development and biopsied for preimplantation genetic screening. The best chromosomally
      normal embryo from each culture group will be selected and transferred to complete a double
      embryo transfer in a subsequent frozen embryo transfer cycle the following month.
    

Intervention name(s): Dynamic culture platform
Intervention type(s): Other
Intervention description(s): Patients will have their cohort of embryos split in half. Half will be cultured in the dynamic platform and the other half cultured in static.
Other intervention name(s): NSSB-300 microvibration platform
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Preimplantation Embryo Development
Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - St. Joseph Mercy Oakland
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to test the safety and efficacy of a noninvasive cortical
      electrostimulation therapy known as "Reduced Impedance Noninvasive Cortical
      Electrostimulation" (RINCE) in the management of fibromyalgia. Patients who meet the 1990
      American College of Rheumatology criteria for fibromyalgia will receive up to 24 RINCE
      treatments delivered by a medical device called "NeuroPoint". Approximately 45 fibromyalgia
      patients will be randomized into one of three study groups. One of these groups will receive
      sham treatment, meaning they will receive no treatment at all, while the remaining two groups
      will receive different amounts of RINCE therapy. The study's primary outcome measure will be
      the patient's change from baseline in self-reported 24-hour average pain intensity. The
      study's hypothesis is that there will be a difference between treatment groups in primary
      outcome measure.
    


Intervention name(s): RINCE
Intervention type(s): Device
Intervention description(s): The intervention uses the NeuroPoint device to deliver repeat applications of RINCE therapy stimulation. The sham uses the NeuroPoint device, but the RINCE therapy stimulation is not turned on.
Other intervention name(s): RINCE therapy; RINCE therapy delivered by the NeuroPoint device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Pain; Brain; Stimulation; Device