bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Absorption, Metabolism, and Excretion, of TAK-994 in 6 Healthy Male Adults
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to understand how TAK-994 is processed by the body.

      This study will require participants to stay at the clinical research unit for 3 weeks to be
      monitored after receiving TAK-994.
    

Detailed description: 
      The drug being tested in this study is called TAK-994. TAK-994 is being tested in healthy
      male participants. This study will characterize how TAK -994 is absorbed, metabolize,
      excreted by the body, after single oral administration by collecting plasma, urine, and feces
      samples for testing.

      The study will enroll approximately 6 participants. The study consists of 2 parts: Part A and
      Part B.

      In Part A, all participants will receive TAK-994 as tablet and [14C]TAK-994 as intravenous
      infusion. In Part B, all participants will receive a single dose of [14C]TAK-994 as an oral
      suspension.

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 67 days, including a 28-day screening period plus
      approximately 30 days for follow up.
    

Intervention name(s): TAK-994 Oral Tablet; [14C]TAK-994 Intravenous Infusion; [14C]TAK-994 Oral Suspension
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-994 tablet.; [14C]TAK-994 intravenous infusion.; [14C]TAK-994 oral suspension.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation
      to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in
      adult patients.
    


Intervention name(s): Bowel Prep
Intervention type(s): Drug
Intervention description(s): Orally ingested liquid bowel preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluating the Safety and Antiviral Activity of Monoclonal Antibody VRC01 in Infants With HIV Receiving Combination Antiretroviral Therapy
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to evaluate the safety and antiviral activity to promote
      clearance of HIV-1 infected cells of VRC01 in infants with HIV beginning combination
      antiretroviral therapy (cART).
    

Detailed description: 
      VRC01 is an experimental human immunoglobulin G1 (IgG1) monoclonal antibody. The purpose of
      this study was to evaluate the safety and antiviral activity to promote clearance of HIV-1
      infected cells of VRC01 received within 12 weeks of birth in infants with HIV initiating
      cART.

      All infants were required to have initiated cART within 14 days before or at study entry.
      Infants were randomly assigned to either receive VRC01 (VRC01, Arm 1) or not receive VRC01
      (No-VRC01, Arm 2). Randomization was stratified by whether the initial cART regimen included
      an integrase inhibitor.

      Infants in the VRC01 arm received VRC01 injections at study entry (Week 0) and Weeks 2, 6,
      and 10. Infants in the No-VRC01 arm received no study product.

      Infants attended study visits at Weeks 1, 2, 3, 6, 7, 10, 11, 14, 16, 20, 24, 36, and 48.
      Visits included physical examinations, blood and urine collection.

      Infants' mothers could optionally be enrolled in the study for one-time specimen collection
      for exploratory evaluations. Maternal study participation was not required for infant study
      participation.

      The study was closed to enrollment prematurely on March 19, 2020 due to the outbreak of
      coronavirus disease 2019 (COVID-19) and after enrolling 61 of the targeted 68 infants.
    

Intervention name(s): VRC01; Combination Antiretroviral Therapy (cART)
Intervention type(s): Biological; Drug
Intervention description(s): 40 mg/kg of VRC01 administered by subcutaneous injection.; All infants received non-study provided cART selected by their primary care provider and supplied through non-study sources (i.e., cART not provided through the study).
Other intervention name(s): VRC-HIVMAB060-00-AB
Intervention MeSH terms: Anti-Retroviral Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Amlodipine Diabetic Hypertension Efficacy Response Trial
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the percentage of subjects that reach the diabetic hypertensive blood pressure
      goal of <130/80 with amlodipine versus placebo in subjects initially treated with quinapril
      or losartan.
    


Intervention name(s): Amlodipine
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Study Utilizing Rilonacept in Gout Exacerbations
Condition: Acute Gout Flare
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This purpose of this clinical research was to determine the efficacy and safety of an
      experimental drug called Rilonacept in participants with an acute gout attack. Participants
      participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin
      alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.
    


Intervention name(s): Rilonacept; Indomethacin; Placebo (for Indomethacin); Placebo (for Rilonacept)
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).; Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).; Placebo (for Indomethacin) orally TID for 12 days.; Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).
Intervention MeSH terms: Indomethacin; Rilonacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolism, Inborn Errors; Allopurinol; Metabolic Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Joint Diseases; Arthritis; Rheumatic Diseases; Metabolic disorder; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Flare
Testing Self-Directed Care in Florida
Condition: Mental Disorder
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      This study tests a psychosocial intervention called mental health self-directed care by
      assessing its impact on recovery, mental health status, rehabilitation outcomes, and service
      costs in the state of Florida.
    

Detailed description: 
      With additional funding from the National Institute on Disability, Independent Living, and
      Rehabilitation Research (NIDILRR), a new cohort of 40 study subjects will be recruited in the
      state of Florida to test mental health self-directed care (SDC). SDC is a self-directed model
      of service delivery in which participants manage a personal budget from which they purchase
      goods and services, including specific types of mental health care, social supports, and
      items that allow them to recover their health and emotional wellness and live independently.
      Investigators are studying the impact of SDC on recovery, mental health status,
      rehabilitation outcomes, and service costs. Working with Lutheran Services Florida, a public
      managing entity coordinating mental health care management in northeastern and central
      Florida, adults with mental health conditions will be recruited into the study and randomly
      assigned to receive SDC for one year or continue receiving services as usual. Assessments
      will occur at baseline, 6- and 12-month followup.
    

Intervention name(s): Self-Directed Care; Services as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants meet with self-directed care program staff called brokers to receive a program orientation, share perceptions of their current life situation and mental health status, and review past year behavioral health service use as well as participants' views of service helpfulness. This culminates in participants' choice of recovery goals and development of an individual budget to pay for for services and material goods directly related to recovery goals. After budget approval by the program supervisor, brokers make purchases. At quarterly meetings, brokers and participants discuss the latter's progress toward recovery goals and create the next quarter's budget. After receiving 12 months of SDC services, participants are helped to transition back to usual community mental health services.; Participants receive usual outpatient psychiatric care delivered at community programs from which the person can choose from an array of services negotiated with the state mental health authority.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Self-directed care is a recovery-oriented model of community mental health service delivery in which participants manage a personal budget from which they purchase goods and services, including specific types of mental health care, social supports, and items that allow them to recover their health and emotional wellness and live independently.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: self-directed care
Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers Receiving a Seven Day Dose Regimen
Condition: Malaria; Glucose 6 Phosphate Dehydrogenase Deficiency
MeSH terms: Glucosephosphate Dehydrogenase Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the comparative tolerability, metabolism and pharmacokinetics of individual
      enantiomers of PQ in healthy human volunteers, receiving study drug over the course of 7
      days.
    

Detailed description: 
      The primary objective of this project is to investigate the comparative tolerability,
      metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers.
      Based on the results of this study, if one enantiomer seems to show a better safety profile
      (in terms of hematological effects), an analogous study will be carried out in G6PD deficient
      individuals (under a separate protocol). The studies are primarily aimed at understanding the
      tolerability and safety of the enantiomers in G6PD deficiency. If one shows a better safety
      profile, ultimately the evaluation of its efficacy will be required.
    

Intervention name(s): RPQ; SPQ; Primaquine Phosphate; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.; The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.; The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.; The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
Other intervention name(s): R-(-) Enantiomer of Primaquine Phosphate; S-(+) Enantiomer of Primaquine Phosphate; Racemic Primaquine
Intervention MeSH terms: Primaquine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a single center, prospective, cross-over phase 1 trial. Thirty-six participants will be enrolled into a two Cohort pharmacokinetic study evaluating the metabolism, pharmacokinetic behavior and tolerability of two dose levels (low/high) of primaquine enantiomers (and placebo) over the course of 7 days.
Placebo will be added in order to assess tolerability of enantiomers. Placebo control is needed in non-drug related clinical responses.
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Hemolysis; Primaquine; Pharmacokinetics
Control and Intervention Programme on Alzheimer's Disease Risk Factors
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Recent epidemiologic studies are identifying a number of modifiable risk and protective
      factors that may influence in the incidence of Alzheimer's disease (AD). Therefore, the
      combination of an early detection of individuals at risk together with interventional studies
      targeted to the control of modifiable risk factors makes primary prevention programmes to
      become a new and real therapeutic strategy.

      In this scenario, the investigators have designed the ALFAlife study, a programme of control
      and intervention on the modifiable AD risk factors. Throughout this study, participants will
      be given a number of healthy lifestyle guidelines that are personalised depending on their
      specific risk profile. These guidelines refer to smoking and dietary habits and physical,
      cognitive and social activity. The investigators hypothesis is that the follow-up of these
      guidelines will favor a change of participants' lifestyle habits towards healthier ones. In
      addition, the investigators hypothesise that changes in these lifestyle habits will have an
      effect on objective physiological measures (such as blood pressure and cholesterol levels).
    


Intervention name(s): Lifestyle recommendations
Intervention type(s): Other
Intervention description(s): Dietary, and physical, cognitive and social activity recommendations
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Primary Prevention
Evaluating the Impact of Evidence-based Information About Mammography on Breast Cancer Screening Decisions
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Patient decision aids are tools that help guide individuals through a healthcare-related
      decision making process. They help users combine evidence-based information and
      recommendations by a health care provider with their personal needs, values and preferences.
      Through this project, Dr. Dobbins and her research team will explore whether the use of
      patient decision aids with high-quality and user-friendly summaries of research evidence, or
      summaries of research evidence alone, help to improve the quality of decision making by women
      facing breast cancer screening decisions.
    

Detailed description: 
      Guidelines for breast screening in Canada are based on low-moderate quality evidence of
      effectiveness and screening is associated with potential harms. Patient Decision Aids (PDAs)
      are tools that assist users to understand treatment options, risks and benefits to align
      decisions with values and preferences. The investigators would now like to know whether use
      of a PDA alongside evidence-based information provided through the McMaster Optimal Aging
      Portal, or simply access to evidence-based information alone, can help users to make informed
      decisions about breast cancer screening in women.
    

Intervention name(s): Evidence-based information; Patient Decision Aid; Sham information
Intervention type(s): Other; Behavioral; Other
Intervention description(s): Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).; Patient Decision Aid for breast cancer screening decision; Educational information not specific to mammography or cancer screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Screening; Mammography; Patient Decision Aid
The Unstable Thoracic Cage Injury
Condition: Thoracic Spine Fracture; Concomitant Sternal Fracture
MeSH terms: Aortic Dissection; Fractures, Bone; Spinal Fractures
Study type: Observational

Summary: 
      -  Analysis of patient data and computed tomography scan of polytraumatized patients
           thoracic spine fractures

        -  A concomitant sternal fracture was identified an indicator for an unstable thoracic
           spine fracture
    

Detailed description: 
      Previous studies stated, that sternal fractures can be regarded as an indicator for thoracic
      spine fractures and described the combined injury pattern of thoracic spine fracture and
      sternal fracture as "upper thoracic cage injury". But literature research is lacking data
      that in patients with a thoracic cage injury a highly unstable thoracic spine fracture can be
      expected.

      In a large cohort of 130 patients with a thoracic spine fracture and concomitant sternal
      fracture the investigators analyzed the injury pattern and evaluated associated injuries,
      trauma mechanism, and clinical outcome.

      The investigators could prove that in patients with a thoracic cage injury the concomitant
      sternal fracture may be regarded as an indicator for an unstable thoracic spine fracture,
      which requires surgical stabilization. Furthermore the analysis revealed that even a highly
      rotationally unstable type C fracture has to be expected, if sternal and thoracic spine
      fractures are located in the same segment.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering a thoracic spine fracture and a concomitant sternal fracture
      
Keywords: Sternal fracture; Thoracic spine fracture; Thoracic cage injury
Acromegaly: Patient And Physician Perspectives
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Observational

Summary: 
      The purpose of the study is to assess the experiences of individuals with acromegaly who are
      receiving injections as part of their treatment regimen. Another objective of the study is to
      compare the patients' perception with their doctors' perceptions. The answers are important
      to help researchers and physicians understand what it is really like to take currently
      available treatments so that they can make efforts to improve patients' healthcare
      experiences, reduce treatment burden and, ultimately, improve patient's quality of life.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with acromegaly will be sent invitations to participate. Their
        physicians will be identified at the time of participant enrollment and will be contacted
        by the study team for a telephone interview.
Short Term Effects and Risks of Physical Exercise in Subjects With Hypohidrotic Ectodermal Dysplasia
Condition: X-Linked Hypohidrotic Ectodermal Dysplasia; Exercise-induced Rise of Body Temperature
MeSH terms: Ectodermal Dysplasia; Ectodermal Dysplasia 1, Anhidrotic; Hyperplasia
Study type: Observational

Summary: 
      Because of their lack of sweat glands individuals with hypohidrotic ectodermal dysplasia
      (HED) are at particular risk of life-threatening hyperthermia during exercise in a warm
      environment. In this study, the effects of physical exercise are investigated in boys and
      male adolescents with X-chromosomally inherited HED as well as age-matched controls, who
      undergo standardized exertion on a bicycle ergometer at ambient temperatures of 25°C and
      30°C. Body core temperature during and after ergometry, heart rate, performance, and serum
      lactate as a marker of metabolic stress are measured. Subjects with HED are expected to show
      an endangering rise of body temperature in connection with physical exercise. To clarify,
      whether novel cooling devices may reduce the likelihood of overheating, the effects of such
      devices are evaluated at 30°C.
    


Intervention name(s): Skin cooling devices
Intervention type(s): Device
Intervention description(s): Cooling vest and cooling bandana
Other intervention name(s): Cooline
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        subjects with X-chromosomally inherited hypohidrotic ectodermal dysplasia (HED) and
        age-matched controls
      
Biospecimen description: 
      Serum
    
Keywords: hypohidrotic ectodermal dysplasia; exertional hyperthermia; cooling device
Relative Bioavailability Study of GSK1265744 Formulations
Condition: Infections, Human Immunodeficiency Virus and Hepatitis
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods)
      in healthy adult subjects. During each period, subjects will receive a single dose of
      GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8
      days) and safety assessments will be performed. Each period will be separated by a washout
      period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose
      of study drug.
    


Intervention name(s): GSK1265744 Na Salt Tablets; GSK1265744 Free Acid Nanomilled Capsules; GSK1265744 Free Acid Micronized Capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each tablet contains 30 mg of GSK1265744 sodium salt and excipients.; Each capsule contains 30 mg of nanomilled and spray dried GSK1265744 free acid, blended with excipients.; Each capsule contains 30 mg of micronized GSK1265744 free acid, blended with excipients.
Intervention MeSH terms: Cabotegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy subjects; relative bioavailability; HIV; GSK1265744
Brief Eclectic Psychotherapy for PTSD - a Randomized Controlled Trial
Condition: Chronic Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      Participants are randomly assigned to either 16 sessions of Brief Eclectic Psychotherapy
      (Gersons et al. (2000) Journal Trauma Stress 13: 333-348), comprising psychoeducation,
      exposure, mementos and writing assignments, domain of meaning and integration, farewell
      ritual, or a minimal attention control group that will be offered 16 sessions of BEP after a
      waiting time of four months. Participants in the minimal attention control group receive
      monthly telephone calls and complete a symptom self monitoring diary (Tarrier, N. et al.
      (1999) Behavior Therapy 30: 597-605) for three weeks.
    


Intervention name(s): Brief Eclectic Psychotherapy for PTSD
Intervention type(s): Behavioral
Intervention description(s): 16 weekly sessions (50min) of Brief Eclectic Psychotherapy for PTSD
Other intervention name(s): BEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment