bioihbjkbjnl/mcl2 huggingface dataset:
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women
Condition: HIV Prevention
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, steady-state study of Tenofovir (TFV) and Emtricitabine (FTC)
      pharmacokinetics (PK) in transgender women taking feminizing hormones. Half of the
      participants will be transgender women on feminizing hormones, the other half will be male
      volunteers not taking any hormone therapy.
    

Detailed description: 
      The investigators propose an open-label, steady-state study of TFV and FTC PK in blood and
      colon tissue in healthy TGW on feminizing hormones to be compared to healthy cis men, all at
      risk for HIV infection. Research participants will already have received eight days of
      TDF/FTC dosing. Evaluating TDF and FTC PK at steady-state is important as it reduces
      inter-individual variability since the rate of phosphorylation of TFV and FTC is highly
      variable, resulting in highly variable TFV-DP and Emtricitabine-Triphosphate (FTC-TP) PK
      among individuals in the first day and during rise to steady-state.
    

Intervention name(s): Tenofovir Disoproxil Fumarate/Emtricitabine
Intervention type(s): Drug
Other intervention name(s): Truvada
Intervention MeSH terms: Tenofovir; Emtricitabine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of rgp120/HIV-1MN (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults.
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      PRIMARY: To examine the safety and potential improvement in immune responses elicited by
      combining rsgp120/HIV-1MN with the adjuvant QS-21. SECONDARY: To examine the role of alum in
      the vaccine/adjuvant formulation; to determine the optimal dose ratio of vaccine to adjuvant;
      and to obtain initial information on the optimal schedule of administration. AS PER AMENDMENT
      07/02/97: To determine the ability of immunization with rsgp120/HV-1MN in combination with
      QS21 with or without alum to induce an HIV-1 envelope-specific delayed-type hypersensitivity
      (DTH) response in volunteers who undergo rsgp120/MN skin testing.

      Immune responses in HIV-uninfected individuals receiving subunit envelope vaccines formulated
      with alum adjuvant suggest that functional antibodies capable of neutralizing HIV-1 in vitro
      may be induced, but the titers are relatively low in comparison to those measured in
      individuals with natural HIV-1 infection. These limitations might be overcome by the addition
      or substitution of a more suitable adjuvant such as QS-21.
    

Detailed description: 
      Immune responses in HIV-uninfected individuals receiving subunit envelope vaccines formulated
      with alum adjuvant suggest that functional antibodies capable of neutralizing HIV-1 in vitro
      may be induced, but the titers are relatively low in comparison to those measured in
      individuals with natural HIV-1 infection. These limitations might be overcome by the addition
      or substitution of a more suitable adjuvant such as QS-21.

      Volunteers are randomized to 20 treatment arms containing four patients each. rsgp120/HIV-1MN
      is administered at four dose levels: 0, 100, 300, and 600 mcg, and QS-21 adjuvant is
      administered at three dose levels: 0, 50, and 100 mcg. Some subject cohorts receive alum in
      the vaccine formulation. Sixty volunteers receive injections at months 0, 1, and 10, and 20
      volunteers receive injections at months 0, 1, and 6. AS PER AMENDMENT 07/02/97: All
      consenting volunteers who have received three immunizations will be tested for DTH response
      to HIV-1 envelope with use of intradermal MN rsgp120. Follow-up is extended to 56 days after
      administration of the intradermal injections.
    

Intervention name(s): Aluminum hydroxide; QS-21; rgp120/HIV-1MN
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Drug Therapy, Combination; Adjuvants, Immunologic; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream
Condition: Bioequivalence Study
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1%
      Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and
      female adults
    


Intervention name(s): Clocortolone Pivalate
Intervention type(s): Drug
Intervention description(s): Cream, 0.1%
Other intervention name(s): Clocortolone
Intervention MeSH terms: Clocortolone; Fluocortolone; Clocortolone pivalate
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: single-exposure, open-label, vasoconstriction response study
Masking: None (Open Label)
Primary purpose: Health Services Research
Implementation of Physical Exercise at the Workplace (IRMA10) - Occupational Load
Condition: Musculoskeletal Disorders; Stress
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      Static postures, repetitive work tasks, and work stress increase the risk for musculoskeletal
      disorders and sickness absence. Objective measurements of occupational loadings - EMG for
      muscular activity, EEG for cognitive activity, ECG for cardiovascular activity and heart rate
      variability, actigraphy for bodily movements - may provide useful early indicators of
      muscular, cognitive and cardiovascular overload.

      The aim of this study is to investigate the effect of an individually tailored
      bio-psycho-social intervention strategy versus "usual care" ergonomics and standard physical
      exercises (reference group) on these risk factors in lab technicians with a history of
      work-related musculoskeletal pain.
    


Intervention name(s): Biopsychosocial; Reference
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Assessment of Any Potential Retinal Effects of Tafenoquine (TQ)
Condition: Malaria, Vivax
MeSH terms: Malaria; Malaria, Vivax
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to provide evidence of retinal safety to support the use of tafenoquine as a
      potential single dose radical cure treatment for patients with Plasmodium vivax (P. vivax)
      malaria (i.e., co-administration of a schizonticidal drug with TQ). The study will be
      conducted as a single masked, randomized, placebo-controlled, parallel group design. It will
      assess retinal changes from baseline using spectral domain optical coherence tomography (OCT)
      and fundus auto fluorescence (FAF) at Month 3 (90 days) post-dose in adult healthy volunteers
      (participants). A placebo control group will be used to compare the results in the TQ group.
      Interim analysis will be conducted after completing 100 out of 300 participants in TQ group
      and 50 out of 150 participants in matched placebo.
    


Intervention name(s): Tafenoquine 150 mg; Matched placebo 150mg
Intervention type(s): Drug; Drug
Intervention description(s): Tablet contains TQ as tafenoquine succinate. The 2 tablets (2 tablets of 150mg) of dark pink, capsule-shaped, film coated will be administered orally with 240ml of water.; It is the matched Placebo tablet. The 2 tablets (2 tablets of 150mg) of dark pink, capsule-shaped, film coated will be administered orally with 240ml of water.
Intervention MeSH terms: Tafenoquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Malaria; Retinal; Ophthalmic; Plasmodium. vivax; Tafenoquine; Pharmacodynamic
Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers
Condition: Smoking
Study type: Interventional

Summary: 
      The goal of this study is to determine if a specific experimental brain stimulation technique
      can be used as a non-invasive way to reduce cigarette cravings in current smokers. This study
      plans to learn more about the way an experimental technique called "transcranial magnetic
      stimulation" (TMS) affects a specific part of the brain, called the insula. Some research
      suggests that this part of the brain plays an important role in craving. The investigators
      plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI)
      of subjects' brain.

      For interested participants, this study requires a single 3 hour appointment, which will
      include MRI of the brain as well as TMS.
    


Intervention name(s): Repetitive transcranial magnetic stimulation, MagStim Rapid2; Sham repetitive transcranial magnetic stimulation
Intervention type(s): Device; Device
Intervention description(s): This study plans to learn more about the way an experimental technique called "transcranial magnetic stimulation" (TMS) affects a specific part of the brain, called the insula. Some research suggests that this part of the brain plays an important role in craving. The investigators plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI) of subjects' brain.; Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Intensive Care Unit and Secondary and Primary Immune Deficiency
Condition: Primary Immune Deficiency Disorder
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Observational [Patient Registry]

Summary: 
      Primary immune deficiencies (PID) are characterized by a failure of the immune system that is
      not explained by any infectious, neoplastic, or iatrogenic cause. In 2015, more than 300
      different inherited rare disorders were described. The occurrence of PID in adult is rare and
      diagnosis may be supported by the 6 ESID signs for adult. However these warnings signs are
      based only on expert recommendations and do not include comprehensive symptoms of PIDs.
      Recurrent infections, more aggressive, are the most common mode of revelation of the PID.
      Less frequently, autoimmune manifestation, solid tumor, lymphoproliferation tumor, chronic
      granulomatosis or hemophagocytic lymphohistiocytosis syndrome (HLS) may also revealed a PID.
      The objective of this study was to evaluate the occurrence of unknown PID in adult admitted
      in critical care unit and to determinate if the investigation of PID in patients with severe
      infections or HLS should be routinely performed in MCIU.
    


Intervention name(s): Internal Medicine consultation
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 18 to 65, hospitalized in medical intensive care unit for a severe or
        opportunistic infection or an idiopathic hemophagocytic syndrome, without any known warning
        sign or predisposing factor, were included.
      
Keywords: primary immunodeficiency; secondary immunodeficiency; intensive care unit; infection; adult
Quality of Erection Study
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The study objective is to evaluate the effect that sildenafil citrate has on the hardness of
      erections in males with erectile dysfunction, based on subject responses to question 5 on the
      Event Log (hardness of erection) as measured at the end of double blind treatment (week 6).
    


Intervention name(s): Sildenafil Citrate
Intervention type(s): Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Impotence
Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and tolerability of FG-3019 in subjects with Idiopathic Pulmonary
      Fibrosis (IPF) and the efficacy of FG-3019 for attenuating fibrosis in these subjects.
    

Detailed description: 
      Major Changes: FGCL-3019-049 Protocol Amendment 3 offers long-term extension of treatment
      with FG-3019 to eligible Cohort 1-EX (approximately 14 subjects) and Cohort 2 (approximately
      28 subjects) subjects who complete the Week 48-EX and Week 48 assessments described in
      Protocol Amendment 2, respectively. A subject is eligible for long-term extension of
      treatment if the investigator, after discussion with the Fibrogen Medical Monitor, believes
      that the subject would benefit from continued treatment with FG-3019.
    

Intervention name(s): FG-3019; FG-3019
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1 and Cohort 1-EX: 15 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years).; Cohort 2 and Cohort 2-EX: 30 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years).
Other intervention name(s): Pamrevlumab; Pamrevlumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: FG-3019 administered at dose of 15 mg/kg (Cohort 1 ) by IV infusion every 3 weeks for 45 weeks in the target population.(first treatment year and first extended treatment year) and every 3 weeks thereafter for three additional extended treatment years.
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels
Condition: Phase 1; Bioavailability; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares the pharmacokinetics (PK), safety and tolerability of fixed dose
      combination (FDC) tablets containing solifenacin succinate and mirabegron with the
      co-administration of single entity tablets (SET), at three dose strengths.
    

Detailed description: 
      There are three parallel groups each with 24 healthy male and female subjects (with a minimum
      of 10 subjects per gender). Each group receives one dose strength.

      The study utilizes a partial replicate cross-over design with three periods and each subject
      receives the same strength of either the FDC or SET formulation twice.

      Screening takes place within 21 days before admission and subjects are admitted on Day -1.
      Dosing takes place on Day 1, after an overnight fast of at least 10 hours. Subjects remain
      fasted until 4 hours post-dose. There is a wash-out period of at least 14 days between each
      dose administration.

      Subjects are discharged on Day 4 and return to the clinical unit on Days 5, 6, 7, 9 and 11
      for outpatient assessments.

      An End-of-Study Visit (ESV) takes place on Day 11 of Period 3 or within 7-14 days after
      discontinuation.
    

Intervention name(s): solifenacin succinate; mirabegron; mirabegron/solifenacin succinate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Other intervention name(s): Vesicare®,; YM905; YM178; YM178/YM905
Intervention MeSH terms: Mirabegron; Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Solifenacin; Mirabegron; Fixed-dose combination (FDC); Single Entity Tablet (SET); Pharmacokinetics; Bioavailability
Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Death
Condition: Nonfatal Myocardial Infarction; Coronary Death
MeSH terms: Myocardial Infarction; Infarction; Death
Study type: Observational

Summary: 
      The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary
      death associated with use of monotherapy low dose ASA (single antiplatelet) as well as
      concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in first- time
      users of low dose ASA for secondary prevention using a UK primary care database.
    

Detailed description: 
      Number of Anticipated Subjects: In case-control analysis 5.000-10.000
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients aged 50 to 84 years with a first ever prescription of low-dose ASA (defined as
        75-300 mg/day) for the secondary prevention of cardiovascular or cerebrovascular events
        (defined as any previous ischemic cerebrovascular event or ischemic heart disease) from 1
        January 2000 to 31 December 2007.
      
Keywords: MI; low dose aspirin; PPI; epidemiology
Executive Functions in Elite Athletes
Condition: Cognitive Change
Study type: Observational [Patient Registry]

Summary: 
      In the study, it was aimed to compare the executive functions of elite athletes who do team
      sports and individual sports with each other and with individuals who do not do sports.
    

Detailed description: 
      In the study, it was aimed to compare the executive functions of elite athletes who do team
      sports and individual sports with each other and with individuals who do not do sports. 60
      elite athletes participating in national and international competitions between the ages of
      20-30, affiliated to the Republic of Turkey Ministry of Youth and Sports and federations, and
      30 individuals who did not do sports for the control group were included in the study group.
      Of the elite athletes, 30 were included in the team sports group and 30 in the individual
      sports group. Executive functions Forward and Backward Digit Span Test, Stroop Test, Trail
      Making Test A and B form (TMT-A, TMT-B) and Tower of London (ToL) Test evaluated with.
    

Intervention name(s): Executive Function Assessment
Intervention type(s): Behavioral
Intervention description(s): Digit Span (Forward and Backward) Test, Stroop Test, Trail Making Test A and B forms, Tower of London Test were used to evaluate executive functions.
Other intervention name(s): Digit Span Test; Stroop Test; Trail Making Test; London Tower Test
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Elite athletes participating in national and international competitions in Turkish
        Basketball Federation, Turkish Volleyball Federation and Turkish Football Federation clubs
        and Gaziantep Youth Sports Center
      
Keywords: Elite Athletes; Executive Function; Cognition; Sports; Team Sports
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
Condition: Smoking
Study type: Interventional

Summary: 
      The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile
      (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS),
      a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a
      menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).
    


Intervention name(s): mTHS; mCC; NRT
Intervention type(s): Other; Other; Other
Intervention description(s): Single use of Tobacco Heating System 2.2 Menthol (mTHS); Single use of subject's own menthol cigarette (mCC); Single administration of 2 mg gum (Nicorette® 2mg)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Smoking; Nicotine absorption; Candidate modified risk tobacco product; Cigarette; Nicotine replacement therapy; Nicotine gum
In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System
Condition: Diabetes
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the performance and acceptability of a new blood
      glucose meter.
    


Intervention name(s): Investigational Blood Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Subjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a laboratory glucose method.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Investigation of Blood Glucose and Insulin Response After Intake of Vitalose
Condition: Healthy Adults
Study type: Interventional

Summary: 
      The aim of this study is to assess the postprandial glucose and insulin response of Vitalose.
    


Intervention name(s): Vitalose; isomaltulose; sucrose; glucose
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): dissolved in water; dissolved in water; dissolved in water; dissolved in water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Safety and Efficacy of Intravenous Hydromorphone in Elderly Emergency Department Patients With Acute Severe Pain
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The hydromorphone protocol is more effective than usual care in Emergency Department (ED)
      patients age 65 years and older in terms of proportion who choose to forgo additional pain
      medication within 60 minutes post-baseline in the two groups.
    


Intervention name(s): Hydromorphone; Usual care
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose; Attending administers any IV opioid in any dose he chooses
Other intervention name(s): Dilaudid
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pain; Hydromorphone; Acute; Emergency Department