bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial to Compare the Pharmacokinetics of TAH Tablet in Comparison to the Co-administration of Telmisartan, Amlodipine and Hydrochlorothiazide in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      randomized, open-label, single dose, replicate crossover clinical trial to compare the
      pharmacokinetics of TAH tablet in comparison to the co-administration of telmisartan,
      amlodipine and hydrochlorothiazide in healthy male volunteers
    


Intervention name(s): TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide); TWYNSTA(Telmisartan+Amlodipine besylate); Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 25 mg combination-drug would be administered orally once; TWYNSTA 2 Tab. 40/5mg(Telmisartan 40 mg, Amlodipine besylate 6.935 mg(Amlodipine 5 mg) would be administered orally once; Dichlozid 1 Tab.(Hydrochlorothiazide 25.0 mg) would be administered orally once
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Telmisartan; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Human epicardial fat is the true visceral fat depot of the heart, and its regional
      distribution and physiology is of growing scientific and clinical interest. This study aims
      to characterize the expression profile and function of the epicardial and pericardial adipose
      tissue compartments of the heart (EAT and PAT). EAT and PAT adipose biopsies will be obtained
      from patients undergoing coronary artery bypass graft surgery (CABG) or valve replacement
      surgery.
    

Detailed description: 
      The epicardial adipose tissue (EAT) stretches from the myocardium to the visceral layer of
      the pericardium. Adipose located on the outside of the visceral pericardium to the external
      site of the pericardium is called the pericardial adipose tissue (PAT), and is of a separate
      origin than EAT. Therefore, this study aims to investigate the global expression profile of
      the EAT and PAT compartments, in addition to characterizing the function, structure,
      metabolic and inflammatory profile. Furthermore, this study will determine whether CABG and
      valve replacement patients display different EAT and PAT characteristics
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing open elective cardiac surgery, specifically coronary artery bypass
        graft and valve replacement surgery.
      
Biospecimen description: 
      Plasma Whole blood Serum Cardiac adipose tissue Cardiac adipose tissue cell culture
Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma
Condition: Malignant Melanoma; Recurrent Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated two chemotherapy regimens with and without the addition of interferon in
      patients with advanced or recurrent melanoma.
    


Intervention name(s): Dacarbazine; Fotemustine; Interferon Alfa-2b
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 900 mg / m2 every 3 weeks; 100 mg / m2 every 3 weeks; 5 M units every 3 weeks
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Dacarbazine; Fotemustine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of TG100-115 for Heart Attack Treated With Angioplasty
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      TG100-115 is able to reduce the size of heart attacks in pre-clinical models. The hypothesis
      of this study is that TG100-115 can be given safely to patients who suffer a heart attack and
      undergo angioplasty to restore blood flow. We will also evaluate whether TG100-115 reduces
      heart muscle damage.
    


Intervention name(s): TG100-115
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: myocardial infarction; infarct size; angioplasty; percutaneous coronary intervention; Acute Myocardial Infarction
Personalized Dietary Program and Markers of Wellness
Condition: Healthy; Metabolism
Study type: Interventional

Summary: 
      The objective of this study is to determine the impact of an integrated personalized dietary
      and wellness program which includes dietary advice, meals, and counseling on health and
      wellness.
    

Detailed description: 
      The objective of this study is to determine the impact of an integrated personalized dietary
      and wellness program, which includes personalized dietary advice, meals, and behavior
      guidance, on markers of health and wellness, body composition, and psychosocial measures.
      Behavior questionnaires, motivational interviewing, psychosocial questionnaires, and
      participants' self-generated data on diet, preferences, activity, and sleep will be used in
      combination with anthropometric and biological data (fasted blood-based measures following an
      oral protein glucose lipid tolerance test [liquid meal challenge test], and selected single
      nucleotide polymorphisms) to create individualized, tailored dietary advice, meal and
      counseling plans.
    

Intervention name(s): Personalized dietary and wellness program
Intervention type(s): Other
Intervention description(s): Single arm intervention containing three periods: (1) run-in (control), (2) personalized advice/counseling and meals, (3) personalized advice/counseling only
Intervention model: Single Group Assignment
Intervention model description: Single arm (open-label) containing three periods: (1) run-in (control), (2) personalized advice/counseling and meals, (3) personalized advice/counseling only.
Masking: None (Open Label)
Primary purpose: Other
Keywords: personalized dietary and wellness program; oral protein glucose lipid tolerance test; metabolism; behavior; health; body composition; single nucleotide polymorphisms; genotype; dietary and wellness coaching/advice; liquid meal challenge test
A Study of IBI351 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, two-cycle clinical study to evaluate the drug interaction between
      itraconazole or dextromethorphan and IBI351 in healthy subjects. A total of two cohorts of 12
      healthy male subjects were planned to be enrolled in each cohort.
    


Intervention name(s): Itraconazole; IBI351; Dextromethorphan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Itraconazole was administered orally; IBI351 was administered orally; Dextromethorphan was administered orally
Intervention MeSH terms: Itraconazole; Dextromethorphan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who
      had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)
    


Intervention name(s): eletriptan
Intervention type(s): Drug
Intervention description(s): 40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response
Intervention MeSH terms: Eletriptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Measure Pain Perception With Electronic Pressure Algometer of Different Size Probes : a Healthy Subjects Research
Condition: Pain
Study type: Interventional

Summary: 
      This study was conducted to explore the influencing factors, subjects and testers' evaluation
      about pain measurement with hand-held pressure algometer with different size probes.
      Methods:100 healthy undergraduate students(50 males and 50 females) were recruited into this
      study. Pain measurement including pressure pain threshold (PPT) and pressure pain
      tolerance(PTO) was carried out by the hand-held pressure algometer with different size probes
      (from 1cm2 to 0.01cm2) on three different measuring spots in right forearm. We recorded
      subjects' skinfold thickness, time per test procedure, types of pain perception, receptivity
      and degree of accuracy as well as testers' level of laborious.
    

Detailed description: 
      Subjects with the following diseases were excluded: known history of chronic disease,
      psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular
      diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy
      smoker, Pregnancy or at lactation period .
    

Intervention name(s): pressure algometer
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Condition: Total Parenteral Nutrition-induced Cholestasis
MeSH terms: Cholestasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the omega-3 fatty acid emulsion
      (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is
      effective in treating parenteral nutrition associated liver disease (PNALD) in children.

      The study hypothesis is that Omegaven® can be safely provided to children who are dependent
      on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until
      the child can take adequate nutrition by mouth.
    

Detailed description: 
      Rationale for Omegaven® Treatment

      Unlike conventional intravenous fat emulsions, Omegaven® is comprised solely of fish oils
      containing primarily omega-3 fatty acids. Animal studies have shown that IV lipid emulsions
      such as fish oil that are high in eicosapentaenic and docosahexaenoic acid reduce impairment
      of bile flow as seen in cholestasis caused by conventional fat emulsions(1,2). By
      administering Omegaven® in place of conventional phytosterol/soybean fat emulsions, the
      cholestasis may be reversed and patients will be able to be maintained on adequate PN until
      they are able to ingest adequate nutrition enterally.

      References

        1. Chen W. Effects of fat emulsions with different fatty acid composition on plasma and
           hepatic lipids in rats receiving total parenteral nutrition. Clinical Nutrition
           1996;15:24.

        2. Yeh S. Effects of fish oil and safflower oil emulsions on diet-induced hepatic steatosis
           in rats receiving total parenteral nutrition. Clinical Nutrition 1996;15:80.
    

Intervention name(s): Omegaven®
Intervention type(s): Drug
Intervention description(s): 10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Other intervention name(s): IV Fish Oil Based Lipid Emulsion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PNALD; Cholestasis; Omegaven®; Short Bowel Syndrome
Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens
Condition: HIV Infections; Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      This study evaluates an educational web-based intervention designed to increase adolescent
      boys' and girls' motivation and skills to engage in safer sexual behavior (HEART: Health
      Education and Relationship Training). Half of participants will receive HEART and half of
      participants will receive Growing Minds, an attention-matched control website focused on
      growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to
      help youth reduce their risk of HIV and other sexually transmitted diseases and to avoid
      unplanned pregnancies.
    

Detailed description: 
      This study evaluates an educational web-based intervention designed to increase adolescent
      boys' and girls' motivation and skills to engage in safer sexual behavior (HEART: Health
      Education and Relationship Training). Half of participants will receive HEART and half of
      participants will receive Growing Minds, an attention-matched control website focused on
      growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to
      help youth reduce their risk of HIV and other sexually transmitted diseases and to avoid
      unplanned pregnancies.

      Primary outcomes for this study include 1) acceptability of the program, 2) safer sex
      self-efficacy, and 3) safer sex intentions.
    

Intervention name(s): HEART; Growing Minds
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.; Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections
Condition: Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial evaluated how effective and safe Cipro XR was in treating female patients with
      signs and symptoms of a lower urinary tract infections. After 3 days of treatment, patients
      were evaluated to determine if signs/symptoms disappeared and the infecting bacteria was
      eliminated.
    


Intervention name(s): Ciprofloxacin
Intervention type(s): Drug
Intervention description(s): Cipro XR 500 mg tablets taken once daily
Intervention MeSH terms: Ciprofloxacin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: UTI; Urinary Tract Infection
Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of
      INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a
      study of the food effect in Chronically-infected Genotype 1 Hepatitis C Virus (HCV),
      Treatment-naïve subjects.
    

Detailed description: 
      Primary Objectives:

      To evaluate in chronically-infected, non-cirrhotic, genotype 1 treatment naïve-subjects dosed
      with Study Drug for 7 consecutive days

      Safety

      - The safety of each of the 4 dosing cohorts of INX-08189 (200 mg daily (QD), 100 mg twice a
      day (BID), 100 mg QD with low-fat meal, and 100 mg QD with adjunctive ribavirin).

      Pharmacokinetic

      - To characterize the pharmacokinetic (PK) profile of oral doses of INX-08189 (200 mg QD, 100
      mg BID, 100 mg QD with low-fat meal, and 100 mg QD with adjunctive ribavirin) and the PK
      profile of the metabolite (INX-08032).

      Pharmacodynamic

      - To evaluate the relationship between the kinetics of the reduction from baseline in serum
      HCV RNA and PK parameters of INX-08189 and the metabolite INX-08032

      Efficacy

      - To measure the kinetics of viral load reduction in plasma HCV RNA by each of the 4 dosing
      cohorts of INX-08189 (200 mg QD, 100 mg BID, 100 mg QD with low-fat meal, and 100 mg QD with
      adjunctive ribavirin).
    

Intervention name(s): 200 mg INX-08189 Fasted; Placebo QD Fasted; 100 mg INX-08189 QD; Placebo QD; 100 mg INX-08189 with low-fat meal; Placebo with low-fat meal; 100 mg INX-08189 BID Fasted; Placebo BID Fasted; ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200 mg capsule INX-08189 fasted x7 days; Placebo capsule QD fasted x7 days; 100 mg INX-08189 capsule QD x 7 days; Placebo capsule Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID); INX-08189 100 mg capsule, with low-fat meal QD for seven days; Placebo capsule administered with a low-fat meal QD for seven days; 100 mg INX-08189 BID fasted x7 days; Placebo BID fasted x7 days
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Inhibitex; Chronic Hepatitis; Hepatitis C Virus
Effects of a Long-term Grapefruit Juice Consumption on Vascular Protection and Bone Metabolism
Condition: Post-menopausal Status
Study type: Interventional

Summary: 
      Epidemiological studies definitively show that fruit and vegetable consumption is an
      important factor for the prevention of age-related diseases such as cardiovascular diseases
      (CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently
      consumed worldwide, essentially as juices.

      Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely
      flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively
      significant source of a specific flavanone called naringin.
    

Detailed description: 
      Epidemiological studies definitively show that fruit and vegetable consumption is an
      important factor for the prevention of age-related diseases such as cardiovascular diseases
      (CVD) and osteoporosis. Citrus fruits are among the fruits which are the most frequently
      consumed worldwide, essentially as juices.

      Citrus fruits are the exclusive sources of a particular class of dietary flavonoids, namely
      flavanones. Grapefruit consumed as whole fruit or juice corresponds to a quantitatively
      significant source of a specific flavanone called naringin.

      Some scientific data obtained from animal studies or in vitro experiments suggested that
      flavanones could exert positive effects on several biomarkers of the cardiovascular or
      osteoporosis risks. However, until now, the clinical proof of the efficacy of these compounds
      is far to be obtained and more clinical trials are needed.

      The main goals of this project are (1) to characterize the effect of a long-term grapefruit
      juice consumption on both vascular and bone protections and (2) to assess the specific role
      of naringin, in these potential protective effects.

      To reach these goals, a randomized, cross-over clinical trial will be performed on 52 healthy
      post-menopausal women (50 to 65 years old, 3 to 10 years since menopause, waist > 88 cm).
      Such a population shares an increased risk of CVD and osteoporosis.

      They will consume for two periods of 6 months either 340 ml of grapefruit juice or a control
      isoenergetic beverage.

      Major outcomes will be measured at baseline and at the end of each experimental period.
    

Intervention name(s): Long-term grapefruit juice consumption
Intervention type(s): Behavioral
Intervention description(s): The main goals of this project are (1) to characterize the effect of a long-term grapefruit juice consumption on both vascular and bone protections and (2) to assess the specific role of naringin, in these potential protective effects.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Post-menopausal women; Grapefruit juice; Naringin; Vascular protection; Bone metabolism
Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness
Condition: Excessive Daytime Sleepiness; Narcolepsy; Obstructive Sleep Apnea/Hypopnea Syndrome; Chronic Shift Work Sleep Disorder
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Parasomnias; Narcolepsy; Disorders of Excessive Somnolence; Sleep Disorders, Circadian Rhythm; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of
      Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated
      with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep
      Disorder
    


Intervention name(s): Armodafinil 100 to 250 mg/day
Intervention type(s): Drug
Intervention description(s): Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD).
Intervention MeSH terms: Modafinil
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment