bioihbjkbjnl/mcl2 huggingface dataset:
A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic
      exposure to combination anti-retroviral therapy identified anti-retroviral associated
      long-term toxicities. Hence, there is a need to prevent these co-morbidities. GSK3640254 is a
      next-generation HIV-1 Maturation Inhibitor (MI) which may be effective for HIV-1 infection.
      This study will evaluate the antiviral effect, safety, tolerability and pharmacokinetics/
      pharmacodynamics of GSK3640254 in HIV-1 infected treatment-naive adults. This study will
      consists of two parts; Part 1 and Part 2. Part 1 will evaluate two active doses of
      GSK3640254, 200 milligrams (mg) (Cohort 1) and 10 mg (Cohort 2) along with placebo to match
      GSK3640254 Mesylate salt. Part 2 will evaluate three active doses of GSK3640254. Dose level 1
      of GSK3640254 that can provide at least 30 percent of the maximum effect (Cohort 1), dose
      level 2 of GSK3640254 that can provide at least 75 percent of the maximum effect (Cohort 2)
      and dose level 3 of GSK3640254 that can provide at least 90 percent of the maximum effect
      (Cohort 3). These doses are anticipated to be 5 mg, 40 mg and 100 mg respectively, but could
      be modified based on data obtained in Part 1. Subjects will also receive placebo to match
      GSK3640254 Mesylate salt in Part 2 of the study. All doses will be administered after a
      moderate fat meal. This study will consist of Screening period (up to 14 days), Treatment
      period (Day 1- Day 10), post-dose Follow-up (Day 11- Day 17) and final Follow-up (Day 18-24).
      A total of approximately 34 subjects will be enrolled, of which, 14 subjects will be
      randomized in Part 1 and 20 in Part 2 of the study. Six subjects will be enrolled in each of
      the active dose cohorts and 2 subjects will be enrolled in each of the placebo cohorts.
    


Intervention name(s): GSK3640254; Placebo matching GSK3640254 Mesylate salt
Intervention type(s): Drug; Drug
Intervention description(s): GSK3640254 will be available with dosing strengths of 5 mg, 20 mg, and 100 mg to be administered as an oral capsule along with 240 mL of water.; Placebo to match GSK3640254 Mesylate salt will be given as an oral capsule along with 240 mL of water
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Eligible subjects will be randomized to receive two active doses of GSK3640254 along with placebo in Part 1 of the study. In Part 2, subjects will receive three active doses of GSK3640254 along with placebo depending upon the data obtained in Part 1.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HIV-1, Antiviral Effect, GSK3640254, Proof of Concept
Tdap Vaccine in Post-Partum Women
Condition: Diphtheria; Pertussis; Tetanus
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      Monitoring immune response and longevity in serum and milk after Tdap administration to
      postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just
      delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at
      Vanderbilt University Medical Center. The enrollment period will be fifteen months. The
      duration is over two years of observation.
    

Detailed description: 
      This is a single site, prospective study involving only one intervention, receipt of a single
      0.5 mL intramuscular (IM) dose of Adacel (Tetanus toxoid, reduced diphtheria toxoid and
      acellular Pertussis) vaccine, among 55 healthy post partum women. The purpose of the study is
      to examine the immune responses and subsequent decline in serum and breast milk antibody
      titers over two years of observation. The clinical trial will involve women (aged 18 - 45
      years) who have just delivered full-term infants (greater than or equal to 37 completed weeks
      of gestation) at Vanderbilt University Medical Center. One particular population at
      Vanderbilt to target will be the "centering prenatal care group" that has breastfeeding rates
      as high as 75 percent at hospital discharge and maintained at 20 percent at 6 months. The
      enrollment period will be fifteen months. The subjects, staff assessing subjects, and
      laboratory personnel will be aware of receipt of the vaccine. Since only a single vaccine
      product is being utilized, there is no blinding needed of the subjects or staff.
    

Intervention name(s): Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate
Intervention type(s): Biological
Intervention description(s): 55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).
Intervention MeSH terms: Aluminum phosphate
Intervention model: Single Group Assignment
Primary purpose: Prevention
Keywords: Acellular; Adacel®; Diptheria toxoids; Pertussis; postpartum; Tdap; Tetanus; women
Safety and Effectiveness Study of BCI-540 Versus Placebo in the Treatment of Major Depressive Disorder With Concomitant Anxiety
Condition: Major Depressive Disorder; Anxiety
MeSH terms: Anxiety Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether BCI-540 80 mg given once daily (q.d.) or
      three times daily (t.i.d.) is effective in the treatment of major depression with concomitant
      anxiety.
    

Detailed description: 
      BCI-540 has been shown to be neurogenic in the Sponsor's in vitro neural stem cell analyses
      and in vivo animal models of depression and anxiety. These observations and the recent
      findings linking hippocampal function and neurogenesis to mood disorders support the
      evaluation of the efficacy, safety, and tolerability of BCI-540 in patients with major
      depressive disorder with concomitant anxiety.
    

Intervention name(s): BCI-540
Intervention type(s): Drug
Intervention description(s): BCI-540 80 mg once (q.d.) or three times (t.i.d.) a day versus placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depression Neurogenesis; Major Depressive Disorder with Concomitant Anxiety
Efficacy and Safety of Efalizumab in the Treatment of Moderate-Severe Hydradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effectiveness and safety of efalizumab in
      treating hydradenitis suppurativa, and to evaluate the duration of the benefit seen in people
      who respond to treatment with efalizumab, after the medication is stopped.
    

Detailed description: 
      The primary objective of this study is to assess the efficacy of subcutaneously administered
      efalizumab in the treatment of refractory, severe hydradenitis suppurativa. The secondary
      objectives of this study are to assess the ability to re-establish disease control after
      discontinuation of drug and allowance for relapse of disease, as well as to assess the safety
      of subcutaneously administered efalizumab in the treatment of refractory, severe hydradenitis
      suppurativa.
    

Intervention name(s): efalizumab
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hidradenitis suppurativa; efalizumab; biologic; Raptiva
Study to Evaluate the Pharmacokinetic Characteristics of Luckyvec 400mg Tablet, in Healthy Subjects
Condition: Chronic Myeloid Leukemia; Gastrointestinal Stromal Tumors
MeSH terms: Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and tolerance by comparing pharmacokinetic
      characteristics between the Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T) when
      administered a single-dose to healthy volunteers.
    

Detailed description: 
      Healthy volunteers are administrated single-dose over the period I and II (Crossover) of
      Luckyvec 400mg tablet(x 1T) and Glivec 100mg(x 4T)as of Imatinib 400mg.

      Every time before and after each medication, PK parameters and safety of Luckyvec 400mg
      tablet and Glivec 100mg is performed using a blood sample and conducting some
      tests(Laboratory test, V/S, Physical Examination, etc) respectively.
    

Intervention name(s): Luckyvec 400mg film coated tablet; Glivec 100mg film coated tablet
Intervention type(s): Drug; Drug
Intervention description(s): •400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover); •100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover)
Other intervention name(s): Luckyvec; Glivec
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Imatinib mesylate; Pharmacokinetics; Healthy volunteers
A Study to Determine Preferences Towards Interface Products
Condition: Sleep Disorder; Breathing-Related
MeSH terms: Sleep Wake Disorders
Study type: Interventional

Summary: 
      Enrolled Naïve participants will be randomized to one of two arms, the investigational or
      control arm. Once randomized the institutions will fit the participant with the procedures
      outlined in the protocol. Each participant will be required to trial the mask for a period of
      90 days. Any Unscheduled Visits or Calls that occur during the participants 90 days
      documented.
    


Intervention name(s): Standard of Care; Mask Advice Tool
Intervention type(s): Other; Other
Intervention description(s): Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the sites standard of care.; Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the mask advice tool.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sleep Apnea
rTMS and Conventional Physical Therapy After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      Given previous evidence that non invasive brain stimulation enhances the effects of
      conventional therapies, this randomized sham-controlled trial with 4-weeks follow-up aimed to
      determine if the repetitive transcranial magnetic stimulation (rTMS)combined with
      conventional physical therapy (VRT) would be superior to physical therapy in improving upper
      limb function and quality of life with chronic stroke individuals.
    


Intervention name(s): rTMS; conventional physical therapy
Intervention type(s): Device; Behavioral
Intervention description(s): The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the motor cortex was performed with a 70-mm figure-8 coil attached to magnetic stimulator stimulation parameters : frequency of 1Hz on the uninjured hemisphere by stroke; 1500 pulses with an intensity of 90% of MT 10 sessions of rTMS, one per day, always before conventional physical therapy; The physical therapy program was composed of the activities of flexibility, transfer and posture, strength, coordination, balance, and sensory stimulation. The physical therapy was applied for about 30 minutes, three days per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial magnetic stimulation; spasticity; physiotherapy; Rehabilitation
A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of
      GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy
      male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2
      occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837,
      after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11).

      Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with
      midazolam in healthy male subjects will be evaluated.

      A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.)
      GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg
      (500 mg b.i.d.) GLPG1837.
    


Intervention name(s): GLPG1837 500 mg; Midazolam; GLPG1837 1000 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.; Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).; Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
INTERACTION, Monitoring of Stroke Patients in Hospital and Home Environment
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      Clinical assessment and monitoring of balance and arm function in stroke patients with sensor
      based measurement, in clinical and home environment.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        subakut or chronic stroke patients
      
Keywords: upper limb; lower limb; monitoring; assessment; sensor
Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding
Condition: Bioavailability
Study type: Interventional

Summary: 
      Essentially all of the published data on anthocyanin absorption in humans are from short term
      studies - a few days or less, most typically 24 h. However human studies demonstrating
      clinical effects are typically conducted for several weeks or even months. To examine how
      anthocyanin absorption and metabolism may be affected this study will examine urinary
      excretion of anthocyanins over one month, followed by a one week washout, and then one more
      dose of blueberry juice.
    


Intervention name(s): Blueberry Juice
Intervention type(s): Other
Intervention description(s): Dietary intervention
Other intervention name(s): Single strength wild blueberry juice, commercially prepared.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: anthocyanin; bioavailability; urine; long-term
Study of the Safety, Tolerability and Immunogenicity of an Intranasal Influenza Vaccine Administered to Healthy Adults
Condition: Flu, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study were to assess the safety and tolerability of DCB07010 when
      given intranasally at escalating dose levels of 7.5μg, 15μg, 30μg and 45μg, in combination
      with 22.5μg of influenza HA antigen (7.5μg HA of each of three strains) and to generate
      sufficient immunogenicity data to enable dose selection for larger and more definitive Phase
      2 studies.

      This was a single center, double-blind, randomized (2:1), dose-escalation study to assess the
      safety, tolerability and immunogenicity of 4 different vaccine-adjuvant doses in comparison
      to influenza HA alone. The 4 treatment cohorts were given DCB07010 in a dose- escalating
      manner.
    


Intervention name(s): DCB07010; HA antigens
Intervention type(s): Biological; Biological
Intervention description(s): A protein based adjuvant originated from prokaryotic organism.; HA antigens from three strains of influenza virus ( 7.5 μg of HA each strain).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication
Condition: Helicobacter Infection
MeSH terms: Helicobacter Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      At present, triple therapy are recommended by various guidelines for the treatment of
      Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment
      failure rates with one week first line clarithromycin based triple therapy necessitating
      salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact
      duration of bismuth based second line treatment is not determined. Therefore, the
      investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple
      regimen as a second-line therapy.
    


Intervention name(s): pantoprazole; bismuth; metronidazole; tetracycline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): pantoprazole 40mg bid; bismuth 300mg qid; metronidazole 500mg tid; tetracycline 500mg qid
Intervention MeSH terms: Metronidazole; Tetracycline; Pantoprazole; Bismuth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Bismuth; Salvage treatment; Metronidazole
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (Study CL2008-02)(P07814)(COMPLETED)
Condition: Gastric Acid; Human Experimentation
Study type: Interventional
Phase: Phase 3

Summary: 
      Open-label randomized crossover design study. 60 participants will be evaluated on Day 1 to
      compare effects on stomach acid; 30 participants will continue treatment for 7 days and will
      have repeat evaluations at Day 7.
    

Detailed description: 
      Enrolled participants were divided into 2 groups, with 30 participants in each group.

      Group 1: This group was randomized into a single-dose, 2-way crossover design. These
      participants received single administrations (day 1 dosing only) of Zegerid OTC Capsules, and
      Prilosec OTC Tablets (both at a 20 mg omeprazole dose), in a 2-way randomized order, with a
      minimum of a 2-week washout period between treatment legs. This group underwent a 24-hour
      intragastric pH study on each of the 2 dosing occasions.

      Group 2: This group was randomized into a 2-way crossover design in which they received 7
      days administration of Zegerid OTC Capsules and Prilosec OTC Tablets, respectively. As with
      the prior group, there was a minimum of a 2-week washout period between treatment legs.
      Participants assigned to this treatment group underwent 24-hour intragastric pH recordings on
      the days which they received their 1st and last (7th) dose of the two treatment drugs.

      In addition to the above detailed procedures, all participants (both groups) underwent a
      24-hour baseline intragastric pH study prior to starting their randomized treatments. This
      study design enabled all 60 participants to be evaluated for effects of the first dose of
      Prilosec OTC Tablets and Zegerid OTC Capsules on change in intragastric pH during the
      subsequent 24-hour period following the first dose.
    

Intervention name(s): Omeprazole/sodium bicarbonate; omeprazole magnesium (20 mg equivalent)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of omeprazole/sodium bicarbonate per day for either 1 or 7 days.; Single dose of omeprazole magnesium per day for either 1 or 7 days.
Other intervention name(s): Zegerid; Prilosec OTC Tablet
Intervention MeSH terms: Omeprazole; Omeprazole, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to
      investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and
      Metformin IR 1000 mg after oral administration in healthy male volunteers.
    


Intervention name(s): DA-1229; metformin; DA-1229 + metformin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of SPD465 in Adults With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate how safe and how well SPD465 works compared to
      placebo in adults with ADHD. It is hypothesized that SPD465 will achieve an extended duration
      of clinical benefit.
    


Intervention name(s): Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate
Intervention type(s): Drug
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
Condition: Refractive Errors
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The study will compare the short-term clinical performance and wearer and practitioner
      acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily
      disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses
      (DD) and, subsequently, of a new-to-market hydrogel spherical daily disposable (HydDD) soft
      contact lens to three (3) other hydrogel daily disposable lenses. .

      The primary outcome variables for this study are subjective comfort and lens preference.
    

Detailed description: 
      The objective of the study is to compare the short-term clinical performance and wearer and
      practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel
      olifilcon B with Tangible Coating daily disposable soft contact lens (SiHyDD) to three (3)
      benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel
      etafilcon A with Tangible Coating spherical daily disposable (HydDD) soft contact lens to
      three (3) other hydrogel daily disposable lenses. .

      The primary outcome variables for this study are subjective comfort and lens preference.
    

Intervention name(s): Phase A - olifilcon B with Tangible Coatings; Phase B - etafilcon A with Tangible Coatings
Intervention type(s): Device; Device
Intervention description(s): Daily disposable silicone hydrogel contact lens; Daily disposable hydrogel contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized cross-over after 1 week of wear of two lens brands.
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Contact Lens