bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Safety, Efficacy, and Pharmacokinetics of Intravenous Deferiprone in HIV-Positive Subjects
Condition: Asymptomatic HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics,
      and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.
    

Detailed description: 
      This is a double-blind, placebo-controlled, randomized trial in 30 asymptomatic HIV-positive
      adults. There are two sequential cohorts, in which subjects will receive either one of 2
      doses of deferiprone or placebo twice daily.
    

Intervention name(s): Intravenous deferiprone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): In Cohort 1, the subjects who were randomized to get active product will receive deferiprone at a dose of 1.5 g per infusion, and if there are no significant safety concerns, the subjects in Cohort 2 who were randomized to get active product will receive it a a dose of 2 g per infusion.; In both cohorts, the subjects who were randomized to get placebo will receive an infusion of placebo solution that is equal in volume to that of the active product.
Other intervention name(s): IV DFP; Deferiprone injection, solution; Normal saline solution (0.9% w/v NaCl)
Intervention MeSH terms: Pharmaceutical Solutions; Deferiprone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV infection; antiretroviral drugs; deferiprone; pharmacokinetics
Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study will assess the mass balance recover of carbon-14 (14C) labelled ETC-1002
      and the routes and rates of excretion of [14C]-ETC-1002
    


Intervention name(s): [14C-ETC-1002]
Intervention type(s): Drug
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
LearningRx Brain Training for Children 8-14
Condition: Learning Problems
Study type: Interventional

Summary: 
      The purpose of this study is to examine changes in multiple cognitive skills after completing
      60 hours of cognitive training with ThinkRx, a LearningRx program.
    

Detailed description: 
      In a two-phase randomized controlled study, investigators will examine the effects of a
      one-on-one cognitive training program on memory, visual and auditory processing, processing
      speed, reasoning, attention, and General Intellectual Ability (GIA) score for students ages
      8-14. In Phase 1, participants will be randomly assigned to either an experimental group to
      complete 60 hours of one-on-one cognitive training or to a wait-list control group. In Phase
      2, the wait-list control group will complete the intervention using an alternative delivery
      model: 50% clinician delivered and 50% digital delivery.
    

Intervention name(s): LearningRx cognitive training
Intervention type(s): Behavioral
Intervention description(s): A clinician will deliver forty 90-minute cognitive training sessions over 12-14 weeks for a total of 60 training hours. There are 23 different categories of training procedures sequenced in intensity and difficulty for a total of more than 1000 training tasks.
Other intervention name(s): ThinkRx
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparison of Men's Prevention Apps to Research Efficacy
Condition: HIV/AIDS; Sexually Transmitted Diseases; Pre-exposure Prophylaxis; Risk Reduction
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      A randomized three arm control trial to examine the efficacy of two distinct apps (LYNX and
      MyChoices) developed for young men who have sex with men (YMSM) compared to standard of care
      (SOC) information about HIV testing and PrEP (Pre-Exposure Prophylaxis).
    

Detailed description: 
      COMPARE is part of the iTech NIH U19, which has an overall goal to develop innovative
      technology-focused interventions addressing the HIV prevention and care continuum for youth.
      In years 1-2 of the iTech grant, the investigators optimized and pilot tested using a similar
      study design and identical study outcomes, two distinct mobile apps called LYNX and
      MyChoices. Each app is designed to increase HIV testing and PrEP uptake among YMSM. In this
      study, the individual apps are being tested in this follow-on research study to evaluate for
      efficacy. YMSM will be randomized to receive either MyChoices, LYNX, or SOC. LYNX uses the
      Information-Motivation-Behavior Skills (IMB) model and is a highly interactive mobile app to
      promote accurate risk perception, increase HIV/STI testing, and linkage to PrEP. MyChoices is
      guided by the Social Cognitive Theory (SCT) model, is adapted from HealthMindr and developed
      using iterative feedback from youth refined to maximize acceptability among YMSM. It includes
      three major functions that are designed to promote self-efficacy, self-regulation,
      goal-setting and environmental influences to impact behavior change. The SOC includes
      information on HIV testing and PrEP with the provision of referrals to local HIV/STI testing
      and PrEP resources.
    

Intervention name(s): LYNX; MyChoices
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Access to the LYNX mobile app which includes the Sex Pro score tool, sex diary, badges, PrEP information and video testimonials, HIV/STI testing reminders and geo-location features, and asynchronous chat feature.; Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PrEP; HIV Testing; Sexually Transmitted Infections; Mobile app; Young men who have sex with men; Technology
A Study of TACI（Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor）-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia Gravis
Condition: Systemic Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to initially observe the safety and effectivity of RC18 in
      Participants with systemic myasthenia gravis.
    


Intervention name(s): RC18 160mg; RC18 240 mg
Intervention type(s): Biological; Biological
Intervention description(s): subcutaneous injection; subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Heme oxygenase 1 (HO-1) serves as a protective gene. Induction of HO-1 has therapeutic
      potential for several indications. The inducibility of HO-1 by curcumin will be evaluated in
      this pilot study. Furthermore, the influence of a modulating factor of HO-1 gene activity on
      the dinucleotide guanosine thymine repeat (GT) length polymorphism in the promotor region
      will be investigated.
    


Intervention name(s): curcumin
Intervention type(s): Dietary Supplement
Intervention description(s): one oral dose of 12 caplets = 12 g curcumin
Other intervention name(s): Curcumin C3 Complex caplets containing:; 1000 mg curcumin and 5 mg bioperine; Lot. Nr.: #BA 08072227
Intervention MeSH terms: Curcumin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heme Oxygenase; Genetic Polymorphism; Healthy Subjects
Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the way the body absorbs, distributes, breaks down and
      eliminates radioactive BMS-986856 in healthy males.
    

Detailed description: 
      Recruitment temporarily on hold due to COVID-19.
    

Intervention name(s): BMS-986256; Milk of magnesia
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Magnesium Oxide; Magnesium Hydroxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sodium Nitrite to Treat Arterial Aging
Condition: Vascular Aging
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The proposed research will determine the effectiveness of nitrite, a naturally occurring
      compound in the body, for improving the health and function of arteries in middle-aged and
      older adults. The study also will provide insight into how sodium nitrite therapy improves
      artery health by determining the physiological mechanisms (biological reasons) involved.
      Overall, the proposed research will provide important new scientific evidence on the
      effectiveness of sodium nitrite for decreasing the risk of developing cardiovascular diseases
      with aging.
    

Detailed description: 
      The improvement in blood vessel function and stiffness will be determined over a 10 week
      period. Subjects will be randomly assigned to either placebo (0 mg/day), low dose (80 mg/day)
      or high dose (160 mg/day) sodium nitrite. Main outcome measures will be performed at baseline
      and week 10.
    

Intervention name(s): Placebo; Sodium Nitrite
Intervention type(s): Drug; Drug
Intervention description(s): Sugar pill manufactured to mimic sodium nitrite capsules; 80 mg/d or 160 mg/d
Other intervention name(s): TV1001
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: endothelial function; arterial stiffness; flow-mediated dilation; pulse wave velocity; sodium nitrite; aging; vascular diseases
Safety, False-Positive Reactions and Sensitizing Properties of Leishmania Tropica Skin Test Antigen
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      The efficacy of LtSTA as a skin test antigen depends upon the sensitivity and specificity of
      the product. This study has been designed to measure the skin test responses to 15, 30, or
      50µg doses of LtSTA. The measurements of non-specific reactivity due to components of the
      antigen solution and the product's ability to sensitize lymphocytes of Leishmania naïve
      persons when administered intradermally. The presence or absence of a local inflammatory
      response to the first skin test with each of three doses of LtSTA will provide insight on the
      specificity of the antigen in a naïve population. The local inflammatory response to LtSTA
      following the first and second repeat skin tests will indicate if the antigen is sensitizing
      after intradermal administration.
    


Intervention name(s): Leishmania tropica Skin Test Antigen (LtSTA); Leishmania tropica Skin Test Antigen Placebo (Placebo)
Intervention type(s): Biological; Biological
Intervention description(s): Administer 15 ug, 30 ug or 50 ug of LtSTA into DTH positive volunteers. Repeat drug administration 30 days after initial injection and 60 days after initial injection. Read and interpret reaction 48 hours after each injection. Observe subjects for conversion or adverse reaction.; Administer Placebo concurrently with 15 ug, 30 ug and 50 ug doses of LtSTA. Read and interpret the reaction 48 hours after injection. Observe subjects for reaction to Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: Leishmaniasis; Delayed-Type Hypersensitivity (DTH); Skin Test; Conversion; Prior exposure to Leishmania major
Vigabatrin Ph 1 Cocaine Interaction Study
Condition: Cocaine Addiction
MeSH terms: Cocaine-Related Disorders; Behavior, Addictive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 safety/tolerably study to determine if there are clinically significant
      interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent
      with intravenous (IV) cocaine infusions.
    

Detailed description: 
      STUDY DESIGN: This is a randomized, double-blind, placebo-controlled, parallel group study of
      the effects of VGB compared to placebo control on the physiological and subjective effects of
      IV infusions of cocaine (cocaine experienced volunteers).

      Subjects will be randomized within each clinical site to one of four groups (placebo control
      or one of three doses of VGB twice daily).During VGB steady state dosing, subjects will
      receive double-blind infusions of saline and cocaine. Subjects will be asked to return for
      follow-up approximately 7 and 14 days after the day of clinic discharge.

      STUDY DURATION: The maximum duration is 56 days, including 14 inpatient days of assessments
      and investigational products administration, and two follow-up visits after clinic discharge.

      SAMPLE SIZE: Twenty-four subjects will be randomized to one of three doses of vigabatrin or
      placebo.

      POPULATION: Volunteer, cocaine-experienced, non-treatment seeking cocaine users, 18 to 45
      years of age.
    

Intervention name(s): Vigabatrin; Vigabatrin; Vigabatrin; Matching placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dose 1 BID; Dose 2 BID; Dose 3 BID; Matching placebo BID
Intervention MeSH terms: Vigabatrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: cocaine addiction; vigabatrin; ovation pharmaceuticals; cocaine; cocaine related disorders; behavior addictive; mental disorders; therapeutic uses; physiologic effects of drugs; disorder of environmental origin; central nervous system stimulants; central nervous system agents; pharmacological actions; substance related disorders
A Study of Brain Receptor Occupancy in Healthy Subjects
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      To measure the occupancy of brain kappa opioid receptors after single oral doses of
      LY2456302.
    


Intervention name(s): opioid receptor kappa antagonist
Intervention type(s): Drug
Intervention description(s): Starting dose of 2 mg, administered orally, once.
The potential dose range for this study is 0.2 mg to 30 mg
Other intervention name(s): LY2456302
Intervention MeSH terms: Aticaprant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)
Condition: Hepatitis A Virus
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This two-stage study evaluates the immunogenicity, safety, and tolerability of the
      administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™
      (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]) and Infanrix™ (Diphtheria
      and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the
      administration of VAQTA™ in healthy children 15 months of age at study entry.
    

Detailed description: 
      In stage I, VAQTA™ given concomitantly with Infanrix™ and/or PedvaxHIB™ was evaluated.

      In stage 2: Two (2) doses of the VAQTA™ vaccine were administered at least 6 months apart.
      Safety data was collected after each dose.
    

Intervention name(s): Comparator: VAQTA™; Comparator: Infanrix™; Comparator: PedvaxHIB™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): VAQTA™ (Hepatitis A Vaccine, Inactivated).
Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.; Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis
Vaccine Adsorbed, GlaxoSmithKline).
One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit.; PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).
One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.
Other intervention name(s): One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study; visit in all treatment groups in the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis A virus
A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to investigate the relationship of changes in measures of
      academic performance and problem behaviors, to changes in core
      Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with
      atomoxetine.
    


Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention description(s): atomoxetine 0.5 mg/kg/day once a day (QD), by mouth (PO) starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Repeated Lifestyle Intervention on Weight Loss Maintenance
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Observational

Summary: 
      In Denmark and the western world, there is an increasing prevalence of obesity probably due
      to a combination of inadequate daily physical activity and a high energy intake. One approach
      to achieve weight loss and change life style is to participate in an intensive supervised
      prolonged life style modification course. The immediate effect is often positive, but over
      time the overall effect is limited as the majority will not maintain weight loss and a
      changed life style.

      In this study we will analyse the results of the intensive lifestyle intervention as it has
      been practised at Ubberup Folk High School over the last 13 years. As some people have
      several stays at Ubberup Folk High School we want to we have a special interest in the effect
      of repeated lifestyle intervention.

      Research question:

      What is the effect of several lifestyle interventions on weight loss maintenance?

      The study design is retrospective and descriptive and will be based on a lifestyle
      intervention, as it has practiced in a real life setting at Ubberup folk high school.
    


Intervention name(s): Intensive Lifestyle Intervention
Intervention type(s): Behavioral
Intervention description(s): Intensive Lifestyle intervention at Ubberup Folk High School for 10-14 weeks. Daily exercise for 1-3hrs. Calorie restriction. Education within Nutrition, exercise and healthy living in general.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Former participants of Ubberup Folk High School.
      
Keywords: Lifestyle intervention; Change of body composition; Physical activity; Weight loss maintenance
Improvement of Short Term Outcome of Mild to Moderate Atopic Dermatitis Using a Combination of Crisaborole and a Concomitant Topical Corticosteroid Over a 8 Week Period
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      This trial is a single-center two arm, open label observational prospective study, that will
      evaluate the safety and efficacy of crisaborole ointment, 2% alone compared to a combination
      therapy of crisaborole and a topical corticosteroid (Triamcinolone Acetonide Ointment, 0.1%)
      over a 8 week period for the treatment of mild to moderate atopic dermatitis.
    

Detailed description: 
      Male and female subjects, ages 2 to 79 with mild to moderate atopic dermatitis and having an
      Investigator's Global Assessment Score on a five point scale of 2 or 3 will be enrolled.

      Sixteen subjects will be enrolled and randomized 1:1. Eight subjects will be randomized to
      receive crisaborole alone which will be applied twice daily, once in the morning and once in
      the evening for 8 weeks. Eight subjects will be randomized to receive a combination therapy
      of a topical corticosteroid (Triamcinolone Acetonide Ointment, 0.1% and crisaborole ointment,
      2% which will be applied twice a day, once in the morning and once in the evening for the
      first two weeks, followed by crisaborole alone for the following six weeks.

      Subjects who meet the inclusion criteria and none of the exclusion criteria at the Screening
      visit will return to the clinic on Week 0 for Baseline measures and to start treatment which
      will continue for a period of 8 weeks. Subjects who do not need to undergo a wash-out period
      may combine the Screening visit and Baseline visit.

      Screened subjects requiring a wash-out period (up to 4 weeks) prior to baseline measurements
      and beginning treatment will attend a total of 4 visits.

      Following the Baseline (Week 0) visit, all subjects will report to the clinic for efficacy
      and safety evaluations at weeks 2, 4 and at the end of study at week 8.
    

Intervention name(s): Crisaborole 2% Topical Application Ointment [EUCRISA]; Triamcinolone Acetonide 0.1% Ointment
Intervention type(s): Drug; Drug
Intervention description(s): Ointment; Topical Corticosteroid
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female patients age 2 to 79 years of age with confirmed diagnosis of atopic
        dermatitis