bioihbjkbjnl/mcl2 huggingface dataset:
Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This
      will be an open-label, dose-ascending study in 7 healthy male subjects to establish well
      tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is
      to confirm an IV and oral dose for a definitive human radiolabel metabolic study.
    


Intervention name(s): GSK233705
Intervention type(s): Drug
Intervention description(s): GSK233705 will be available as IV infusion and oral solution containing Cellobiose octaacetate.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Muscarinic Receptor Antagonist,; intravenous infusion,; pharmacokinetics; healthy subjects,; safety,; tolerability,; Anticholinergic,; oral dosing,
Brexpiprazole in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the proposed study is to evaluate the safety and efficacy of
      Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be
      tested is that brexpiprazole will be more effective and well tolerated in adults with BPD
      compared to placebo. The proposed study will provide needed data on the treatment of a
      disabling disorder.
    

Detailed description: 
      Borderline personality disorder is characterized by mood instability, cognitive symptoms,
      impulsive behavior, and disturbed relationships (1-3). A variety of psychotherapies have been
      developed (4-6) and, while research on the use of medication is ongoing, no drug has been
      approved in the United States or elsewhere for its treatment (7). Second generation
      antipsychotics have been the most intensively studied (8-11). Current treatments for BPD are
      often inadequate. Dialectical behavioral therapy has been shown to reduce BPD but finding
      trained psychologists is difficult.

      Dysfunctions in the serotoninergic and dopaminergic systems have been demonstrated in-and
      considered as possible causes for-symptoms associated with the disorder (25-28). Several
      studies on the use of traditional (29) and atypical antipsychotic agents in patients with
      borderline personality disorder (30-31) have shown a positive effect on individual symptoms
      (29, 32-36). However, we are not aware of any study evaluating Brexpiprazole in the treatment
      of patients with borderline personality disorder. In the proposed double-blind,
      placebo-controlled study, the influence of Brexpiprazole on the multifaceted
      psychopathological symptoms and aggression of patients with borderline personality disorder
      will be investigated.

      Brexpiprazole therefore has distinctive properties that make it a promising option for
      patients with BPD. Brexpiprazole is a novel D2 partial agonist, has affinity for 5-HT1A, acts
      as an antagonist of the noradrenergic α1/2 receptor, partial agonist for D3, and antagonist
      for 5-HT2A (37-39). In addition, because of low rates of side effects, Brexpiprazole should
      be a well-tolerated and in fact desired medication approach to BPD.
    

Intervention name(s): Rexulti; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Atypical antipsychotic; Pill that contains no medicine
Other intervention name(s): Brexpiprazole; no other names
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit
Condition: Gout
Study type: Interventional

Summary: 
      The objective of this research is to evaluate the correlation between DECT and US
      explorations performed in a routine clinical setting for the measurement of change in tophus
      size in gout patients after 24 months of treatment.
    


Intervention name(s): ultrasonography; DECT
Intervention type(s): Procedure; Procedure
Intervention description(s): The tophus volume will be assess using ultrasonography.; The tophus volume will be assess using dual-energy computed tomography (DECT).
Other intervention name(s): dual-energy computed tomography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Dual-Energy Computed Tomography; UltraSonography; Gout; Urate deposition
A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases
Condition: Acute Bronchitis
MeSH terms: Bronchitis; Coinfection; Respiratory Tract Diseases; Respiration Disorders; Acute Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the clinical efficacy and safety in patients with Acute Bronchitis or Secondary
      Infection of Chronic Respiratory Diseases receiving a dose of 2 g of azithromycin in the SR
      formulation.
    


Intervention name(s): Azithromycin SR
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigating the Regulation of Reproductive Hormones in Adult Men
Condition: Kallmann Syndrome; Hypogonadism; Gonadal Disorder
MeSH terms: Kallmann Syndrome; Hypogonadism; Gonadal Disorders
Study type: Interventional

Summary: 
      The purpose of the research study is to learn more about the regulation of reproductive
      hormones in adult men. We would like to understand what role testosterone and estradiol play
      in controlling the release of LH (lutenizing hormone) and FSH (follicle stimulating hormone).
      Testosterone and estradiol come from the testes, and LH and FSH are released from a gland in
      the head called the pituitary.

      Men involved in the study will have detailed evaluations that involve overnight stays in the
      hospital and frequent blood sampling. The men in the study will also be receiving medications
      that affect the levels of various hormones in the body. This will allow the researchers to
      learn how various hormones influence each other. Men that participate in the study will
      receive medical evaluations and monetary compensation. Information gathered from this study
      will help in the development of new treatments for infertility and potentially new hormonal
      forms of contraception.
    

Detailed description: 
      In the United States 10-15% couples seek evaluation for infertility, of whom a male factor is
      identified in approximately 50% of cases. To date, however, most infertility research has
      focused on the female partner and in the majority of instances the etiology of male
      infertility remains poorly understood with inconsistent elevation in FSH levels. Given that
      spermatogenesis is highly dependent on FSH secretion, this project will focus on delineating
      the feedback control of FSH in the human male. Such studies, although difficult to perform in
      the human, are critical to understanding not only the pathophysiology of male infertility,
      but also to determining the feasibility of hormonal approaches to male contraception. In this
      protocol, studies of normal, GnRH-deficient and agonadal men employing reversible sex steroid
      ablation, physiologic sex steroid replacement and manipulation of the GnRH input to the
      pituitary will permit the non-steroidal, sex steroid, and GnRH-dependent components of FSH
      regulation to be selectively elucidated.
    

Intervention name(s): ketoconazole; gonadotropin releasing hormone (GnRH)
Intervention type(s): Drug; Drug
Intervention description(s): loading dose of 1g followed by a maintenance dose of 400 mg PO QID for 7 days; Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump titrated to reach normal serum testosterone levels)
Intervention MeSH terms: Ketoconazole; Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Idiopathic Hypogonadotropic Hypogonadism; Kallmann Syndrome; Agonadal
Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate if the treatment could maximize intestinal
      absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need
      for parenteral support (PS) to achieve normal growth, to avoid parenteral nutrition
      complications and to achieve the best possible quality of life for the patient
    

Detailed description: 
      The short bowel syndrome (SBS) may be defined as a severe malabsorption caused by reduction
      of intestinal absorptive surface following massive resection of the small intestine.
      Teduglutide (Revestive®) is an analog of glucagon-like peptide 2 (GLP-2), a naturally
      occurring hormone that regulates the functional and structural integrity of the cells lining
      the gastrointestinal tract. The aim of the treatment is to maximize intestinal absorption,
      minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for
      parenteral support (PS) to achieve the best possible quality of life for the patient. The
      rationale for the use of Revestive® is based on data obtained, especially in the trial in SBS
      patients.

      Treatment with 0.05 mg/kg/day was safe and well tolerated (no recorded side effects).

      Patients remained stable despite substantial reduction in parenteral nutrition (PN) supply as
      evidenced by stable body weight and height, serum electrolytes, pancreatic enzymes and renal
      function tests.

      Treatment was associated with:

        -  Reduced PN volume and calories delivered by 25 and 45% respectively with 20% of patients
           weaned off PN during the study period

        -  Increased Enteral Nutrition (EN) supply in volume and calories by 40 and 62%
           respectively

        -  Increased in plasma citrulline during the treatment period, but decreased after
           Teduglutide discontinuation The recommended dose of Revestive® in children and
           adolescents (aged 1 to 17 years) is the same as for adults (0.05 mg/kg body weight once
           daily).
    

Intervention name(s): Teduglutide
Intervention type(s): Drug
Intervention description(s): Daily sub cutaneous injection 0,05 mg/kg/day
Intervention MeSH terms: Teduglutide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Teduglutide; Short Bowel Syndrome; Parenteral nutrition; Intestinal failure
A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and
      sertraline Tablet in Japanese healthy male subjects.
    


Intervention name(s): Placebo; ASC-01
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A New Class IIb MD in Proctological Disorders
Condition: Proctological Disorders
Study type: Interventional

Summary: 
      The aim of this study is primarily to investigate the performance of a new medical device not
      yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult
      patients reporting symptoms of hemorrhoids (grade 1-3), anal fissures and proctitides.
    


Intervention name(s): Medical device Procto; Matching placebo
Intervention type(s): Device; Device
Intervention description(s): Medical device Procto presents itself as a translucent green gel with a typical smell.; IP placebo presents itself as a translucent green gel with a typical smell.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a randomised, double-blind, parallel-groups, multicentric, placebo-controlled, prospective clinical study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Use of Diffuse Optical Spectroscopy to Characterize in Response to Weight-Loss Intervention
Condition: Overweight
MeSH terms: Overweight; Weight Loss
Study type: Observational [Patient Registry]

Summary: 
      The first step in any clinical intervention against obesity involves sustained lifestyle
      changes. Researcher can use these strategies to beneficial the effects of weight and on
      cardiovascular risk. The researcher develope methods for assessing the effectiveness use
      optical technology to make such assessments, specifically in the area of fatty tissue can
      predict the effectiveness of the intervention in causing weight reduction and treating
      metabolic disease.
    

Detailed description: 
      Optical technologies under development at the Beckman Laser Institute.

      Diffuse Optical Spectroscopy Imaging is a method for studying absorption and scattering
      (optical properties) of tissue in humans. It is related to near-infrared spectroscopy , but
      allows for more quantitative and thorough measurements. The researcher use Diffuse Optical
      Spectroscopy to measure fatty tissue, water, blood concentration level during weight loss
      program to determine the effect of sustained changes in weight or relapses.
    

Intervention name(s): Weight Control
Intervention type(s): Other
Intervention description(s): Weight Control
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study population will be selected from University of California Irvine Medical Center
        Department of Cardiology, preventive cardiology intervention program.
A Study to Investigate the Regional Brain Kinetics of Brain Drug Transporters Using P-glycoprotein and Breast Cancer Resistance Protein Substrates and by Using the Positron Emission Tomography Ligand 11C-JNJ-63779586 in the Human Brain
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the total body biodistribution and radiation
      dosimetry of 11C-JNJ-63779586 by Positron Emission Tomography (PET) in healthy young adult
      males (Part A); to estimate and compare the uptake, distribution, and clearance of
      11C-JNJ-63779586 in the brain by PET between mild Alzheimer Disease (AD) participants
      (males/females) and age- and gender-matched control participants (Part B), corrected for
      regional cerebral blood flow differences; and to model the tissue specific kinetics of
      11C-JNJ-63779586 in human brain with the appropriate input function (IF) (Part B).
    


Intervention name(s): 11C-JNJ-63779586
Intervention type(s): Drug
Intervention description(s): Participants will receive IV injection with 11C-JNJ-63779586 in Part A and Part B.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel in HIV-1 Seronegative Adults
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, acceptability, and PK/PD profile of
      maraviroc gel following rectal and vaginal administration. The study also includes oral
      exposure to maraviroc.
    

Detailed description: 
      Trail 11991 is a Phase 1 randomized, open label, single-site trial. Approximately 19
      participants (9 female, 10 male) will be randomized to the 9 female study arms and 4 male
      study arms with 1-3 participants per arm. The randomization will be completed for the product
      sequence and the timing of tissue sample collection.

      All participants will receive both study products by multiple routes of administration (i.e.,
      PO, PR, [and PV for female participants]), and they will be randomized to the order of
      product sequence and specimen sampling schedule. The male participants will receive oral and
      rectal MVC and the female participants will receive oral, rectal, and vaginal MVC, in
      randomized sequence.

      Participant accrual will take approximately 6 months. Male participants will be on study for
      approximately 9 to 12 weeks. Female participants will be on study for approximately 12 to 16
      weeks. The total duration of the study will be approximately 9 months.
    

Intervention name(s): Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)
Intervention type(s): Drug
Intervention description(s): Tablets: daily 300 mg oral maraviroc, Selzentry®,(MVC) for 8 consecutive days Gel: daily rectally administered 1% MVC gel for 8 daily consecutive days Female Participants - will receive an additional third regimen of daily vaginally administered MVC 1% gel for 8 consecutive days.
Each treatment regimen will be followed by a washout period of 14 to 21 days.
Participants will also be randomized to a biopsy sampling schedule (i.e., D8, D9, or D10 sampling).
Other intervention name(s): Tablet - Selzentry®, (MVC)
Intervention MeSH terms: Maraviroc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Phase III Randomized Study of Poloxamer 188 for Vaso-Occlusive Crisis of Sickle Cell Disease
Condition: Sickle Cell Anemia
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES: I. Assess the efficacy of poloxamer 188 in reducing the duration of painful
      vaso-occlusive crisis in patients with sickle cell disease.

      II. Assess the effect of poloxamer 188 on duration and intensity of pain, total analgesic
      use, and length of hospitalization of these patients.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
      Patients are stratified according to hydroxyurea use.

      Patients are randomized to treatment poloxamer 188 or placebo. Treatment begins within 12
      hours of presentation with crisis. Patients receive poloxamer 188 or placebo by continuous
      infusion for 48 hours. Pain is assessed before, during, and after treatment.

      Patients are followed on days 7-14 and 28-35.
    

Intervention name(s): poloxamer 188
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: disease-related problem/condition; genetic diseases and dysmorphic syndromes; hematologic disorders; pain; rare disease; sickle cell anemia
Chromium Picolinate for the Treatment of Metabolic Syndrome
Condition: Metabolic Syndrome X; Prediabetic State; Insulin Resistance; Obesity; Metabolic Diseases
MeSH terms: Metabolic Syndrome; Insulin Resistance; Metabolic Diseases; Prediabetic State; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether chromium supplements can reduce symptoms of
      metabolic syndrome, a collection of symptoms that increase one's risk for developing heart
      disease, stroke, and diabetes.
    

Detailed description: 
      Metabolic syndrome is a serious condition that may lead to a number of life-threatening
      diseases. A reduction in the symptoms of metabolic syndrome could result in decreased
      morbidity and health care costs and increased quality of life.

      Chromium is an essential mineral that is used in the breakdown of fats, protein, and
      carbohydrates. The cholesterol-lowering and blood sugar-stabilizing properties of chromium
      make the supplement a strong candidate for reducing the symptoms of metabolic syndrome. This
      study will determine whether chromium supplements can reduce symptoms of metabolic syndrome
      in abdominally obese individuals.

      Participants will be randomly assigned to receive either chromium supplements or placebo
      daily for 16 weeks. Participants will have study visits at study start and at Months 2 and 4.
      A follow-up visit will occur 5 months after the end of the intervention period. Blood tests,
      urine tests, and nail clippings will be used to assess lipoprotein cholesterol, insulin
      response to glucose, lean body mass, blood pressure, oxidative stress, and chromium levels in
      participants.
    

Intervention name(s): Chromium picolinate
Intervention type(s): Drug
Intervention MeSH terms: Chromium; Picolinic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chromium; Chromium picolinate; Blood Glucose; Cholesterol; Complementary Therapies
Efficacy and Safety of 3 Doses of S47445 Versus Placebo in Patients With Alzheimer's Disease at Mild to Moderate Stages With Depressive Symptoms
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to assess the efficacy and safety of S47445 versus placebo in
      patients with Alzheimer's disease at mild to moderate stages with depressive symptoms. An
      optional 28-week extension period will be performed to evaluate safety/tolerance and efficacy
      of S47445 in co-administration with donepezil.
    


Intervention name(s): S47445 5mg; S47445 15mg; S47445 50mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): S47445 5 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).; S47445 15 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).; S47445 50 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).; Placebo tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment