bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a
      single dose orally (p.o.) in pediatric patients with the diagnosis of RLS
    


Intervention name(s): MIRAPEX® - low; MIRAPEX® - medium; MIRAPEX® - high
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Pramipexole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of TAK-875 in Combination With Sitagliptin in Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of TAK-875, once daily
      (QD), in combination with sitagliptin QD in participants with type 2 diabetes mellitus
      (T2DM).
    

Detailed description: 
      TAK-875 is being developed at Takeda Global Research and Development, Inc. as an adjunct to
      diet and exercise to improve glycemic control in patients with T2DM.

      Sitagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4) approved as an adjunct to diet
      and exercise to improve glycemic control in adults with T2DM.

      This study will investigate the effects of the combination of TAK-875 with a DDP-4 inhibitor
      on glycosylated hemoglobin reduction.
    

Intervention name(s): Placebo; TAK-875; TAK-875; Sitagliptin; TAK-875 and Sitagliptin; TAK-875 and Sitagliptin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): TAK-875 and sitagliptin placebo-matching tablets, orally, once daily for up to 12 weeks.; TAK-875 25 mg, tablets, orally, once daily for up to 12 weeks.; TAK-875 50 mg, tablets, orally, once daily for up to 12 weeks.; Sitagliptin 100 mg, tablets, orally, once daily for up to 12 weeks.; TAK-875 25 mg, tablets, orally, once daily and sitagliptin 100 mg tablets, orally, once daily for up to 12 weeks.; TAK-875 50 mg, tablets, orally, once daily and sitagliptin 100 mg tablets, orally, once daily for up to 12 weeks.
Other intervention name(s): Januvia; Januvia; Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Therapy
Neurobehavioral Substrates of Propranolol's Effects on Drug Cue Reactivity
Condition: Cigarette Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      The central objective of this project is to obtain proof-of-concept data demonstrating the
      effects of propranolol (a beta-adrenergic antagonist) on neurobiological responses to
      personal smoking environments and behavioral responses in a laboratory smoking behavior task.
      Human cigarette smokers (N = 50) will take photographs of locations where they do and do not
      smoke cigarettes. They will then be randomly assigned to receive either propranolol (40 mg)
      or placebo prior to completing: A) An MRI session assessing neural responses to personal
      smoking/non-smoking environments, standard smoking/non-smoking environments and proximal
      smoking/non-smoking cues; and B) A laboratory session examining smoking behavior in response
      to environmental cues.
    


Intervention name(s): Propranolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will take one dose of Propranolol (40mg IR) on two separate occasions.; Participants will take one dose of Placebo on two separate occasions.
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to receive propranolol (40 mg) or placebo
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Protocol: Phytomedicine-AMARGOL®, Clinical Trial for Efficacy Proof on Therapeutics
Condition: Digestive System Disorders
MeSH terms: Digestive System Diseases; Gastrointestinal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3: Efficacy Study for AMARGOL® a phytomedicine used for asymptomatic
      digestive complaints.
    

Detailed description: 
      This study will be performed for proving the efficacy of AMARGOL®, a phytomedicine product,
      under the Brazilian law for registration and revalidation RDC 14/2010.

      AMARGOL® indications are for non specific digestive complaints as laxative and
      anti-dyspeptic.

      Is a mixture of 7 plant extracts: Aloe ferox, Angelica archangelica, Alpinia officinarum,
      Cinnamomum zeylanicum, Gentiana lutea, Commiphora myrrh and Rheum palmatum.

      Placebo controlled test
    

Intervention name(s): AMARGOL®
Intervention type(s): Drug
Intervention description(s): per oral solution, 40 mL single dose
Other intervention name(s): AMARGOL; Phytomedicine; Herbal Extracts Mixture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dyspepsia; Flatulence; Aerophagia; Constipation
HSV Oral Reactivation in Children
Condition: HSV-1; HIV
Study type: Observational

Summary: 
      In the proposed study, the investigators will carry out novel research to evaluate both
      symptomatic and asymptomatic daily oral herpes simplex virus (HSV) shedding rates and copy
      number in children with and without HIV.

      Study Objectives:

        1. To evaluate the frequency of oral HSV reactivation in HIV-infected and uninfected
           children

           Secondary Objectives:

        2. To determine the acceptability of performing daily oral swabs in children age 3-12
    


Intervention name(s): Underlying medical illness
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        For this Pilot study, we will enroll 20 HIV-infected and 10 HIV-uninfected children
LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression
Condition: Major Depressive Disorder
MeSH terms: Weight Gain; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with an episode of depression in late life prescribed mirtazapine recruited from a
      clinical sample will be monitored for weight and receive a blood test during their usual
      course of treatment to determine polymorphisms in a specific gene (LEPR) thought to affect
      weight gain.
    


Intervention name(s): Mirtazapine
Intervention type(s): Drug
Intervention description(s): Mirtazapine 7.5 to 45 mg/day, once daily, 12 weeks open label
Other intervention name(s): Remeron
Intervention MeSH terms: Mirtazapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Mirtazapine
The Mass Balance and Biotransformation of [14C] Vicagrel in Healthy Man
Condition: Healthy Male Adult
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was designed to evaluate the mass balance and biotransformation after single-dose
      of [14C]Vicagrel orally in Chinese healthy male volunteers, revealing the overall
      pharmacokinetic characteristics of vicagrel in humans, and providing a reference for the
      rational administration.
    


Intervention name(s): [14C]Vicagrel
Intervention type(s): Drug
Intervention description(s): Take a suspension of 20 mg vicagrel ,containing about 120 μCi [14C]Vicagrel, in fasting within 5 minutes
Intervention model: Single Group Assignment
Intervention model description: single arm with single dose of 20mg vicagrel, containing about 120μCi [14C]Vicagrel
Masking: None (Open Label)
Primary purpose: Other
Demonstration of Carbonyl Stress on Hair Follicles
Condition: Effluvium; Telogen
Study type: Interventional

Summary: 
      In this study, the investigator will try to highlight the presence of carbonyl compounds in
      the hair follicles of women with telogen effluvium (ET) linked to stress of various origins
      (fatigue, infectious diseases, emotional stress ...).
    

Detailed description: 
      At the cutaneous level, oxidative stress induces the formation of carbonyl compounds which,
      by binding to proteins, produce nonfunctional adducts inducing cutaneous aging. Is this
      mechanism, called "Carbonyl stress", also present in the scalp and can it be one of the
      mechanisms involved in the occurrence of reactive hair loss ? To demonstrate this, samples of
      hair follicles are made. The proteins are extracted from the samples and then assayed. The
      oxidized (carbonyl) proteins are labeled with specific fluorescent probes.
    

Intervention name(s): Hair follicles sampling
Intervention type(s): Other
Intervention description(s): The follicles will be collected by lock of 10 hair on the scalp (centro-parietal part), to obtain 40 follicles with epithelial sheath
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 1 group of women with effluvium télogène
1 group of women without effluvium télogène
Masking: None (Open Label)
Primary purpose: Basic Science
Study of High-dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer
Condition: Postmenopausal Women With Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the safety and efficacy of letrozole monotherapy at a dose of 2.5 mg/day in
      postmenopausal patients with breast cancer, and to determine the blood concentrations of
      letrozole and hormones.
    


Intervention name(s): Letrozole
Intervention type(s): Drug
Other intervention name(s): FEM345
Intervention MeSH terms: Letrozole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aromatase inhibitor; letrozole; breast cancer
Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1
Condition: Influenza A Subtype H5N1 Infection
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study of safety and immunogenicity of an A/H5N1 inactivated whole
      cell vaccine when given in two injections in two doses (low and high) compared to a placebo
      in 76 healthy adult subjects in Vietnam. Vaccine and placebo are manufactured by the IVAC in
      Vietnam.
    

Detailed description: 
      This is a phase 1, double blinded, randomized, placebo-controlled study. Seventy-six healthy
      male and female adults, 18 to 30 years of age, will be enrolled into the trial. Subjects will
      be randomized to one of three treatment allocations: 32 subjects to 7.5 mcg/dose vaccine (low
      dose), 32 subjects to 15 mcg/dose vaccine (high dose) and 12 subjects to placebo. This sample
      size was selected to enable at least 30 evaluable subjects in each of the groups receiving
      active vaccine. The study will utilize a "block randomization" to assure a balance of 8:8:3
      vaccine and placebo when all subjects are enrolled. The study will be double blinded, meaning
      the study subjects, investigators, and the sponsor will be unaware of the treatment allocated
      to each subject until the clinical trial database is declared final and locked.

      Since this is a first-in-human study, all injections of study product will be sequential and
      staggered and there will be a safety evaluation between a sentinel cohort of 19 subjects and
      the remaining 57 study subjects for both the 1st and 2nd doses in the study.

      A sentinel group of 19 participants' enrollment and vaccination will precede the remainder of
      the study group by approximately 2-3 weeks.

      Product administration for both injections of vaccine or placebo will be sequential and
      staggered.
    

Intervention name(s): IVACFLU-A/H5N1, 7.5 mcg; IVACFLU-A/H5N1, 15 mcg; Placebo Comparator
Intervention type(s): Biological; Biological; Other
Intervention description(s): Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.; Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose; PBS, pH 7.2 in 0.5 mL single-dose vials.
Other intervention name(s): Phosphate Buffered Saline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Avian; H5N1; Vaccine
A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      [11C]-dimethyl-diphenyl ammonium ([11C]-DMDPA) - A Phase I, Open-label, Safety and
      Tolerability, Radiation Dosimetry, Biodistribution, First-in-Human Study of a Novel
      11C-labeled Tracer for Positron Emission Tomography Myocardial Perfusion Imaging
    


Intervention name(s): [11C]-DMDPA
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Hormonal Factors in the Treatment of Anorexia Nervosa
Condition: Anorexia Nervosa; Eating Disorder; Anxiety; Depression
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators are investigating whether a hormone that is naturally produced by the human
      body, called testosterone, can help improve weight, disordered eating, depression, and
      anxiety. The investigators hypothesize that testosterone will be a novel and effective
      endocrine-targeted therapy for patients with anorexia nervosa.
    


Intervention name(s): Testosterone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Testosterone 300mcg transdermal patch x 24 weeks.; Placebo transdermal patch x 24 weeks
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Testosterone; Hormones; Mental Health
A Study of IMC-1 In Patients With Fibromyalgia
Condition: Fibromyalgia; Chronic Pain; Myofascial Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, 16-week study designed to evaluate
      the hypothesis that tissue-resident herpes virus may be causally related to fibromyalgia
      symptoms or recurrence. IMC-1 is a combination treatment that is designed to suppress this
      suspected virus and thus alleviate fibromyalgia symptoms.
    


Intervention name(s): IMC-1
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fibromyalgia; Myofascial
Buccal Estrogen in Toothpaste Study: Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women
Condition: Menopause; Postmenopause
Study type: Interventional

Summary: 
      Background: The use of estrogen in postmenopausal (or surgically menopausal) women is a
      common practice. Compliance is problematic in that estimates show only 1/3 of women use
      hormone replacement therapy (HRT) and only 30% are compliant. Estrogen has many documented
      benefits including symptomatic relief of hot flashes, improvement of the dry vagina and
      dyspareunia. Estrogen has been found to improve bone mineral density and increase the high-
      density lipoprotein portion of a cholesterol panel. To improve compliance and to provide an
      alternate method of delivery, we propose the use of estrogen which is admixed in toothpaste
      and propose to study the absorption, rate of build-up and rate of decline.

      Hypothesis: Estrogen can potentially be absorbed systemically when toothpaste is admixed with
      estradiol and is applied in a timed, consistent fashion to postmenopausal or surgically
      postmenopausal women, not on HRT. Absorption takes place across the buccal mucosa.

      Specific Aims:1) To estimate the systemic absorption of estrogen from daily use of estrogen
      containing toothpaste.

      2) To estimate the rate of build-up of serum estrogen levels based upon daily use of
      toothpaste containing estrogen for eight days.

      3) To estimate the rate of decline in serum estrogen levels when the use of estrogen
      containing toothpaste is discontinued for a week.
    

Detailed description: 
      Methods: Fifteen women ages 35-75 who are menopausal or surgically menopausal will be
      identified, with exclusion based on estrogen contraindications. Subjects will have blood
      samples taken before, during and after an eight-day course of once-daily toothpaste that is
      admixed with 0.5 mg estradiol. Toothpaste shall meet strict quality control standards and
      instructions for uniform tooth brushing shall be provided. Serum estradiol will be determined
      from the samples obtained. Statistical analysis shall address absorption by comparing
      baseline estradiol measurements with those a few hours after use. The rate of build-up will
      be assessed by comparing the post-use levels of estradiol at the start of a week and at the
      end of the week. After a week off the estrogen, the rate of decline in serum estradiol will
      be calculated.
    

Intervention name(s): Estrogen
Intervention type(s): Drug
Intervention MeSH terms: Estrogens
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Surgical menopause
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 With Single, Escalating Doses in Healthy Subjects
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of single doses of TA-8995
      in healthy Caucasian and Japanese volunteers.
    


Intervention name(s): TA-8995; TA-8995; TA-8995; TA-8995; Placebo; Placebo; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): TA-8905 5, 10, 25, 50 (fasted and fed), 100 and 150 mg; Drug: TA-8995 25 mg; Drug: TA-8995 25 mg; Drug: TA-8995 25, 50, 100 and 150 mg; Single ascending dose in Caucasian men; Age-effect in Caucasian men; Gender-effect in Caucasian women; Single ascending dose in Japanese men
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: MT-8995; Dyslipidemia; Cholesteryl ester transfer proteins
Aripiprazole Effects on Alcohol Reactivity and Consumption
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether aripiprazole (marketed dopamine stabilizer)
      is effective in reducing of alcohol craving compared to placebo.
    

Detailed description: 
      Non-treatment seeking individuals meeting criteria for alcohol dependence (N=30) will be
      recruited through advertisement and paid for their participation. Alcoholics, after baseline
      evaluation, will be assigned through urn randomization to one of two experimental groups in
      which they will receive either aripiprazole (up to 15 mg/day) or an identical placebo.
      Subjects will take the study drug or placebo for 8 days (day 1-6 being the natural
      observation period). After a minimum of 24 hours of abstinence from alcohol (day 7-8) they
      will undergo an alcohol administration (priming dose) and motivated free choice drinking
      procedure (on day 8). Alcoholic subjects will receive a brief counseling session at the end
      of the study to enhance their awareness of problem drinking and to motivate them to seek
      treatment. Referral for treatment will be offered.

      Each subject will undergo a functional MRI brain scan with cue stimulation on day 7, on the
      evening before the alcohol administration paradigm. fMRI brain imaging technology will be
      used to determine if alcoholics treated with aripiprazole differ in alcohol cue-induced
      activity in the nucleus accumbens. It is hypothesized that aripiprazole will reduce nucleus
      accumbens activation to alcohol cues compared to placebo.
    

Intervention name(s): aripiprazole (up to 15 mg/day) for 8 days
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Alcohol dependence; Alcoholism; Craving
Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to
      placebo in the glycemic management of obese diabetic adults.
    


Intervention name(s): VI-0521; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): phentermine 15mg/topiramate 100mg; matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes, Obese diabetics
Acupuncture and Massage for Depression During Pregnancy
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the efficacy of acupuncture and massage for the treatment of depression
      during pregnancy. The study also examines differential effects of study treatments on
      delivery outcome and post partum depression.
    

Detailed description: 
      Participants in this study are randomly assigned to one of the three experimental groups that
      include two types of acupuncture treatment and perinatal massage. The two acupuncture
      treatments are delivered in a double-blind fashion. Treatments consist of an acute phase
      during which participants receive 12 treatment sessions over a period of 8 weeks. Responders
      and partial responders enter a continuation phase during which they receive weekly treatments
      that end 10 weeks post delivery. At the end of the continuation phase, participants continue
      to be clinically assessed at 3 and 6 months after the end of treatment to detail the natural
      course of relapse to the index episode in the three treatment groups.
    

Intervention name(s): Acupuncture; Perinatal massage
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to
      salmeterol and placebo.
    


Intervention name(s): MK0359
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment