bioihbjkbjnl/mcl2 huggingface dataset:
DDI HV (ATV - Merck)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of
      raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300
      mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without
      raltegravir 400 mg BID.
    


Intervention name(s): Raltegravir; Atazanavir; Atazanavir + Raltegravir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet, Oral, 400 mg, twice daily for 5 Days; Capsule, Oral, 300 mg, twice daily for 7 Days; Capsule/Tablet, Oral, 300/400, twice daily for 14 Days
Other intervention name(s): Reyataz; Reyataz
Intervention MeSH terms: Raltegravir Potassium; Atazanavir Sulfate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antivirals / HIV
Effect Of Single-Dose PF-05175157 On Metabolic And Cardiopulmonary Parameters
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the effect of one single dose of PF-05175157 on metabolic
      and cardiopulmonary parameters before, during and after treadmill exercise in healthy
      volunteers.
    


Intervention name(s): PF-05175157; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg as powder in capsule, one dose within 5 minutes prior to AM meal; Placebo powder in capsule, one dose within 5 minutes prior to AM meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Cardiopulmonary exercise testing; metabolic parameters; Diabetes Mellitus Type 2
The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion
Condition: Cervical Pain; Pelvic Pain
MeSH terms: Pelvic Pain; Neck Pain
Study type: Interventional

Summary: 
      Increasing accessibility of long-acting reversible contraceptive methods, like intrauterine
      devices (IUDs), is an important strategy to reduce the risk of unintended pregnancy.
      Unfortunately, fear of IUD insertion in women who have not had children is common among
      health care providers and women alike, and this limits IUD use. To increase acceptance of
      this highly effective contraceptive, there is need to investigate novel, low cost, easily
      applied and accessible techniques to improve the insertion experience. This is a pilot study
      to evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an
      intervention to improve the IUD insertion experience for both patient and provider.
    

Detailed description: 
      Subjects who are have already scheduled an IUD insertion will be asked to join this study
      assessing whether or not nitroprusside gel helps with IUD insertion process. Only healthy,
      nulliparous women between the ages of 18 and 45 will be recruited. Nulliparous women report
      much more pain associated with IUD insertion than parous women so the possibility of being
      able to measure the effect of nitroprusside vs placebo is more likely. The primary outcome,
      pain with IUD insertion, and the secondary outcomes, such as satisfaction and provider ease
      of IUD insertion, will be compared between the study groups as well.
    

Intervention name(s): Nitroprusside Gel; Placebo Gel
Intervention type(s): Procedure; Procedure
Intervention description(s): 10 cc nitroprusside gel; half of the subjects will receive nitroprusside gel for IUD insertion and the other half will receive a placebo gel.
Intervention MeSH terms: Nitroprusside
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: IUD, Insertion, Decrease, Pain
Analysis of Protein and Emotional Alterations During and After Hypobaric Hypoxia
Condition: Hypoxia, Altitude
MeSH terms: Altitude Sickness; Hypoxia
Study type: Interventional

Summary: 
      This study analyses both Protein Expression and emotional alterations during hypobaric
      hypoxia in volunteers of different groups.
    

Detailed description: 
      This study analyses both Protein Expression and emotional alterations during hypobaric
      hypoxia in volunteers of different groups.

      15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group
      and 15000ft Group - all for 15, 30, and 60 minutes.
    

Intervention name(s): Hypoxia
Intervention type(s): Procedure
Intervention description(s): hypoxia
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: 15 different Groups are analysed: control Group, 5000ft Group, 8000 ft Group, 10000ft Group and 15000ft Group - all for 15, 30, and 60 minutes.
Masking: Single (Participant)
Primary purpose: Diagnostic
Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      A multicenter, retrospective cohort observational study to evaluate the effectiveness and
      safety of fresh or frozen embryo transfer after ovarian hyperstimulation (administration of
      rFSH or HP-hMG alone or co-administration of rFSH and HP-hMG)
    

Detailed description: 
      A multicenter, retrospective cohort observational study to evaluate the effectiveness and
      safety of fresh or frozen embryo transfer after ovarian hyperstimulation (administration of
      rFSH or HP-hMG alone or co-administration of rFSH and HP-hMG) to infertile female patients
      undergoing assisted reproductive technology to controlled ovarian hyperstimulation
    

Intervention name(s): rFSH
Intervention type(s): Drug
Intervention description(s): rFSH or HP-hMG or rFSH and HP-hMG
Other intervention name(s): HP-hMG; rFSH and HP-hMG
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        infertile female patients
Pharmacodynamic Drug Interaction Between Cilostazol and Statins
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacodynamic drug interaction between cilostazol
      and statins (simvastatin as a CYP3A substrate and rosuvastatin as a non-CYP3A substrate) in
      healthy male subjects.
    

Detailed description: 
      Subjects suitable for this study will visit to the Clinical Trial Center, Samsung Medical
      Center for 7 days and pharmacodynamic samplings will be performed following the
      administration of study drugs.
    

Intervention name(s): Cilostazol; Simvastatin; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): cilostazol bid for 7 days; simvastatin qd for 7 days; rosuvastatin qd for 7 days
Other intervention name(s): cilostazol (C); Plettal 100 mg; simvastatin (S); Zocor 40 mg; Rosuvastatin (R); Crestor 20 mg
Intervention MeSH terms: Cilostazol; Rosuvastatin Calcium; Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Olmutinib (BI 1482694) ADME Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the basic pharmacokinetics of BI 1482694, its metabolites M1 and M2, and
      [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a
      single oral dose of [14C]BI 1482694 given to healthy male volunteers
    


Intervention name(s): [14C]BI 1482694
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Cardiotoxic Effects of Bortezomib
Condition: Multiple Myeloma; Heart Failure, Systolic; Cardiotoxins
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Heart Failure, Systolic
Study type: Observational

Summary: 
      The purpose of this study is to learn more about how a drug commonly used to treat multiple
      myeloma can affect the heart.

      In this study, the investigators will learn whether a drug called how a drug (called
      bortezomib, or Velcade) receive for multiple myeloma affects the heart. Bortezomib is part of
      the standard treatment and its effects on multiple myeloma is not being studied here.

      The investigators want to learn whether damage occurs to the heart after taking bortezomib
      for multiple myeloma, whether it is reversible, and we can predict damage to the heart before
      it occurs.
    


Intervention name(s): Bortezomib
Intervention type(s): Drug
Intervention MeSH terms: Bortezomib
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients (>18 years and <70 years) with multiple myeloma
      
Biospecimen description: 
      Whole blood and serum for batch analysis. Once the assays have been completed, the samples
      will be discarded.
Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
Condition: Down Syndrome; Edwards Syndrome; Patau Syndrome; Klinefelter Syndrome; Turner Syndrome; DiGeorge Syndrome; Chromosome Deletion; Aneuploidy
MeSH terms: DiGeorge Syndrome; Down Syndrome; Trisomy 13 Syndrome; Turner Syndrome; Klinefelter Syndrome; Trisomy 18 Syndrome; Syndrome; Aneuploidy; Chromosome Deletion
Study type: Observational

Summary: 
      In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its
      guidelines that now recommend physicians are ethically obligated to fully inform all pregnant
      women that screening for fetal chromosomal abnormalities including biochemical screening
      tests and invasive procedures such as CVS or amniocentesis is available, regardless of age.
      Further, it is entirely up to the patient to decide whether or not she wishes to be screened
      for fetal chromosomal abnormalities without judgment from the physician.

      Noninvasive laboratory-developed tests (LDTs) that detect an abnormal amount of maternal and
      fetal DNA in an expectant mother's blood sample (known as circulating cell-free DNA) are now
      available. These LDTs have not been cleared or approved by the U.S. Food and Drug
      Administration (FDA). Although LDTs to date have not been subject to U.S. FDA regulation,
      certification of the laboratory is required under the Clinical Laboratory Improvement
      Amendments (CLIA) to ensure the quality and validity of the test.

      To sample collection study will obtain whole blood specimens from pregnant subjects to be
      used for development of prenatal assays to assist in the screening for fetal genetic
      abnormalities, infectious and other diseases, and blood group typing through detection of
      circulating cell-free DNA extracted from maternal plasma.
    

Detailed description: 
      Eligible subjects will provide written informed consent after which basic demographic and
      clinical data will be collected.

      Study procedures involve the collection of 50 mL of whole blood at one or more monthly clinic
      visits (≥25 days apart) from pregnant women (18 to 54 yrs of age) carrying a single fetus of
      8 to 22 weeks of gestational age inclusive.
    

Intervention name(s): Blood sampling for Laboratory Developed Test (LDT) analysis
Intervention type(s): Other
Intervention description(s): Each enrolled subject, either in the first or second trimester, will donate up to 50 mL (just over 3 tablespoons) of whole blood for development of the LDT
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All pregnant women undergoing standard maternal serum screening for fetal aneuploidy will
        be considered for enrollment as well as those with a priori risk factors for fetal
        aneuploidy.
      
Biospecimen description: 
      Whole blood
    
Keywords: Down syndrome; Edwards syndrome; Patau syndrome; Klinefelter syndrome; DiGeorge syndrome; Chromosome Deletion; Aneuploidy
Changes on Pain and Range of Motion by the Use of Kinesio Taping in Subjects With Myofascial Trigger Point
Condition: Mobility Limitation; Myofascial Trigger Point Pain
MeSH terms: Myofascial Pain Syndromes; Mobility Limitation
Study type: Interventional

Summary: 
      The aim of this study is to demonstrate that the application of Kinesio Taping on a
      myofascial trigger point in the trapezius muscle able to cause a decrease of the trigger
      point pain and an increase of the cervical range of motion in asymptomatic subjects
    

Detailed description: 
      The use of Kinesio Taping has become very popular for the treatment of many musculoskeletal
      disorders in recent decades. Of the six variants of application that has the Kinesio Taping,
      the space correction technique is suggested for pain management. The increased space achieved
      with this variant decreases the pressure Kinesio Taping by raising the skin directly over the
      treatment area, reducing chemical irritation receptors and therefore pain. The aim of this
      study is to demonstrate that the application of this variant of Kinesio Taping on a
      myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an
      increase of the cervical range of motion in asymptomatic subjects. For this, the pressure
      pain threshold will be measured with a algometer on the trigger point and the range of motion
      with a cervical goniometer.
    

Intervention name(s): Kinesio Taping; Sham Kinesio Taping
Intervention type(s): Device; Device
Intervention description(s): Four Kinesio Taping strips will be placed with tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin; Four Kinesio Taping strips will be placed without tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Probiotics on Testosterone in Men
Condition: Healthy
Study type: Interventional

Summary: 
      This study evaluates the effect of L. reuteri ATCC PTA 6475 supplementation on testosterone
      in men.
    

Detailed description: 
      The probiotic Lactobacillus reuteri ATCC PTA 6475 has been shown to modulate testosterone
      levels in mice. It is not known if these effects are seen in humans and this trial is
      intended to study this.

      The aim of this study is to investigate if L. reuteri ATCC PTA 6475 will effect blood
      testosterone levels in in healthy male subjects 50-65 years of age.
    

Intervention name(s): Lactobacillus reuteri (L. reuteri)
Intervention type(s): Dietary Supplement
Intervention description(s): L.reuteri high or low dose with vitamin D3 compared to vitamin D3 only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Fast Bar on Intermittent Fasting
Condition: Fasting
Study type: Interventional

Summary: 
      This study evaluates how Fast Bar(TM), a specially formulated energy bar, when consumed with
      coffee or tea, affects the physiological condition in participants after an overnight
      fasting. Participants will fast for 19 hours (Fast Group), consume a Fast Bar in the night
      (Night Bar Group) or in the morning (Bar+Coffee and Bar+Tea Groups) after an approximately
      15-hour overnight fasting. Participants will be assessed for physiological parameters
      associated with fasting.
    

Detailed description: 
      Interest in fasting-based programs (i.e. intermittent fasting) for improvement of health and
      longevity continues to grow. The short-term fasting (e.g. 12 to 48 hours in duration)
      utilized in many intermittent fasting programs are considered safe, but some individuals may
      find them subjectively difficult. As such, the question of whether the benefits of fasting
      can be obtained while small amounts of food are consumed is of substantial interest.

      One commercially available product that is designed to be consumed during periods of
      intermittent fasting is the Fast Bar™, which stems out of the well-researched
      fasting-mimicking diet to assist prolonged fasting. The unique formulation of the Fast Bar™
      is hypothesized to minimize deviations in metabolic biomarkers associated with a fasting
      state. This may ease the burdens associated with extended period of fasting. The objective of
      this study is to evaluate the metabolic and subjective effects of Fast Bar, when consumed
      with coffee or tea, after a prolonged period of fasting.
    

Intervention name(s): Dinner; Fasting; Fast Bar; Bar with Coffee; Bar with Tea
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Study subjects will consume a standardized ready-to-eat meal as dinner.; Subjects will be asked to fast overnight for approximately 15 hours.; Subjects will be asked to consume a Fast Bar.; Subjects will be asked to consume a Fast Bar with coffee.; Subjects will be asked to consume a Fast Bar with tea.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Fast Bar; Intermittent fasting; Ketone bodies; ß-hydroxybutyrate
A Medication Adherence Intervention for HIV Infected Veterans
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To
      benefit from recent improvements in anti-HIV therapy, patients need to take their medications
      consistently.
    

Detailed description: 
      Background:

      It is estimated that the VHA is caring for nearly 40 percent of all HIV-infected veterans. To
      benefit from recent improvements in anti-HIV therapy, patients need to take their medications
      consistently.

      Objectives:

      Optimizing health for HIV patients requires excellent adherence to antiretroviral medication
      regimens. However, its unclear how best to incorporate adherence education and support
      programs into VA HIV outpatient care. We implemented and evaluated a pharmacist program (ACE)
      and a Pager reminder program to support adherence in veterans with HIV.

      Methods:

      We used a quasi-experimental design with pre-post evaluation at four VA Centers. Three
      treatment conditions (ACE, Pager, Usual Care) were rolled-in sequentially over two study
      phases, allowing for group comparisons between conditions. ACE is a multi-component
      manualized 4-session, individual patient education and support program by trained
      pharmacists. The Pager intervention used alphanumeric pagers to remind patients of dosing
      times. Electronically-monitored medication adherence (MEMS), self-report questionnaires, and
      pharmacy refill records were collected. Qualitative site interviews were collected before and
      after interventions to assist with program evaluation. Multilevel mixed models were used to
      analyze main study outcomes over time. Secondary analyses compared subgroup who actually
      received all ACE sessions (�as treated�) to controls.

      Status:

      Project has been completed and Final Report submitted to HSR&D CO.
    

Time perspective: Prospective
Blinded, Randomized Study Evaluating Aurstat Versus Control in the Treatment of Atopic Dermatitis Associated Pruritus
Condition: Pruritus; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate the ability of Aurstat to reduce pruritus in subjects with mild to moderate
      atopic dermatitis. Efficacy results will be based on subject assessment, IGA, and
      photographic evidence based on ordinal scales for tolerability.
    

Detailed description: 
      This 3-day study will enroll subjects with mild to moderate atopic dermatitis, as defined by
      the Hanifin criteria.

      All subjects will be screened for study enrollment at the baseline visit. Those meeting
      inclusion/exclusion criteria will be fully consented (or assented) using an IRB-approved ICF.
      Subjects will then be randomized to either the treatment or control study arm. Those in the
      treatment arm will be instructed on product application technique and study instructions at
      baseline. Subjects will apply Aurstat BID, or as needed, to determine frequency of use as a
      surrogate marker for duration of therapy effect to affected, qualifying atopic dermatitis
      lesions.

      The investigator will assess treatment response using an ordinal scale for tolerability and
      an IGA scale for disease severity ratings. Subjects will assess treatment response using a
      VAS to rate pruritus and an ordinal scale to assess tolerability. Photography assessments
      will be obtained. All adverse events will be captured.
    

Intervention name(s): Aurstat Anti-Itch Hydrogel (Aurstat)
Intervention type(s): Drug
Intervention description(s): Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial.
Intervention MeSH terms: Diphenhydramine; Promethazine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pruritus; Atopic Dermatitis
Influence of Coffeeberry Ingestion on Soccer Skill Performance
Condition: Skill Performance; Soccer Performance; Coffeeberry Effects
Study type: Interventional

Summary: 
      The study of soccer skill performance has 3 objectives. Objective 1 is to compare effects of
      coffeeberry (300mg) and placebo ingestion on dribbling speed and precision and passing and
      shooting speed and accuracy compared to placebo. 30 subjects will be assessed before dosing,
      after a 1 hr resting absorption period, and after simulated soccer match play. Of these 30,
      20 subjects will proceed to Objective 2 (45 minutes of intense simulated soccer match play)
      and Objective 3 (repeated sprint activity continued until volitional fatigue).
    


Intervention name(s): Coffeeberry beverage; Comparator beverage
Intervention type(s): Dietary Supplement; Other
Intervention description(s): One exposure of 300 mg coffeeberry extract in a 300 ml flavored still beverage prior to exercise session; One 300 ml still beverage, color and flavor matched to experimental beverage prior to exercise session
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: coffeeberry; caffeine; polyphenols; chlorogenic acid; exercise; soccer; skill; performance