bioihbjkbjnl/mcl2 huggingface dataset:
MyLife MyStyle Evaluation Project
Condition: Unsafe Sex
Study type: Interventional

Summary: 
      The purpose of the MyLife MyStyle Evaluation Project is to determine whether the MyLife
      MyStyle group-level intervention reduces HIV sexual-risk behaviors among 18- to 29-year-old
      African American men who have sex with men (MSM). Specifically, the project will test whether
      participants of the MyLife MyStyle program will report at least a 15% absolute decrease in
      frequency of unprotected anal sex with male partners at three and six months
      post-intervention compared with the wait-list control participants.
    

Detailed description: 
      In Los Angeles County, as well as nationally, the primary mode of HIV transmission for
      African American men is sexual contact with another man. According to national data from 45
      states with name-based HIV surveillance in 2006, the majority of all new HIV infections among
      African American males were associated with sex with other men. The disproportionate impact
      of HIV in AAMSM in Los Angeles County is also observed in provisional HIV surveillance data.
      Between 2002 and 2004, AAMSM composed 16.3% of the new HIV diagnoses among males in Los
      Angeles County, with an average annual HIV diagnosis rate 2.0 and 2.5 times greater than the
      rates of new HIV diagnosis for White and Latino MSM, respectively. In addition to
      demonstrating the highest HIV prevalence and incidence estimates, AAMSM also had the highest
      proportion of previously unrecognized HIV infection (67%) compared with all other
      racial/ethnic groups. Given significant and continuing disparities in HIV infection among
      African Americans in the United States, and specifically among AAMSM, more intervention
      programs must be planned, implemented, and tested in order to reduce the heavy toll of
      HIV/AIDS in this population. Components of these intervention programs must be culturally
      competent and should include promotion of HIV counseling and testing to reduce the high
      prevalence of unrecognized HIV infection in AAMSM. Interventions should also take into
      consideration the many co-factors that may hinder AAMSM from addressing their HIV risk such
      as racism, poverty, stigma, and homophobia. The MyLife MyStyle Evaluation Project aims to
      implement and evaluate the efficacy of a "homegrown" group-level intervention to reduce HIV
      risk (unprotected anal sex with male partners) among young African American MSM in Los
      Angeles County, CA.
    

Intervention name(s): MyLife MyStyle group-level intervention
Intervention type(s): Behavioral
Intervention description(s): Three 1.5-hour HIV behavioral risk-reduction group sessions conducted with up to 12 young African American/Black men (ages 18-29 years) over a 1-3 week period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gay men; African American males; Unprotected anal sex; HIV risk; behavioral intervention; group-level intervention
Nocturnal Transnasal Insufflation (nTNI)
Condition: COPD; Hypercapnia
MeSH terms: Hypercapnia
Study type: Interventional

Summary: 
      On the basis of different studies the long term oxygen treatment is deemed to be routine
      treatment in patients suffering from chronic obstructive pulmonary disease (COPD) at
      appearance of hypoxaemia. Non invasive ventilation (NIV) is the treatment of choice in
      hypercapnic COPD patients with respiratory acidosis at acute respiratory decompensation.
      Several prospective randomized studies have shown a reduction of acute mortality as result.
      But everyday practice shows that COPD patients with chronic hypercapnia hardly accustom
      oneself to nocturnal ventilation. Reasons are not known yet, but substantial pulmonary
      overinflation or the appearance of depressions or rather anxiety disorders are possible
      causes. On the other hand patients may not notice any subjective improvement of symptoms and
      won't accept the burden of a tight fitting mask during the night. The aim of the present
      study is to determine the effect on gas exchange of a nocturnal transnasal application of an
      oxygen-enriched gaseous mixture via nasal cannula and the subjective acceptance. This is
      compared to a nocturnal transnasal application of oxygen alone in randomized order for at
      least 6 hours each night.

      Thirty hypercapnic COPD GOLD IV patients (PCO2 > 50 mmHg) will be included. The two night
      Polysomnographies (PSG) will be evaluated with special attention to nasal flow measurements,
      breathing effort, oxygen saturation and an additional transcutaneous PCO2 measurement. At
      begin and end of each measurement night a capillary blood gas analysis is made.
    


Intervention name(s): humidified transnasal insufflation (TNI20oxy); overnight oxygen treatment with individual flow rate
Intervention type(s): Device; Other
Intervention description(s): The alternative breathing support with TNI supplies COPD patients with 20L/min of warm humidified air. This method may be applicable to wash out the dead space between glottis and nasal opening. Pre-investigations have shown that 45 minutes of TNI during daytime reduced PCO2 and respiratory rate compared to application of oxygen alone.Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night.; The patient is treated with his individual oxygene flow rate. Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night.
Other intervention name(s): TNI20oxy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: transnasal high flow therapy; COPD
Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the analgesic efficacy of Dexketoprofen Trometamol
      and Tramadol Hydrochloride given in combinations and the analgesic efficacy of each single
      component in comparison to placebo on moderate to severe pain following impacted third
      mandibular molar tooth extraction. Ibuprofen will be used as an active control to validate
      the pain model.
    

Detailed description: 
      The aim of this study is to develop a combination of Dexketoprofen Trometamol (DKP.TRIS) and
      Tramadol Hydrochloride (TRAM.HCl) for the treatment of acute moderate to severe pain, based
      on the rationale that more than one drug is necessary in most patients suffering of acute and
      chronic pain, particularly of moderate to severe intensity.

      DKP.TRIS and TRAM.HCl have different mechanisms of action, therefore their combination is
      expect to result in an additive or synergistic analgesia, thus allowing a decrease in the
      required doses of the individual agents, and consequently a reduced risk of adverse events In
      this study, patients who present moderate to severe pain after impacted third mandibular
      molar tooth extraction will be randomised to a total of 10 treatment arms including 4
      combinations of DKP.TRIS + TRAM.HCl, the four corresponding single treatments, placebo and
      ibuprofen. Treatment administration will be followed by a 24-hour pain and analgesic effect
      assessment.
    

Intervention name(s): Dexketoprofen Trometamol; Dexketoprofen Trometamol; Tramadol Hydrochloride; Tramadol Hydrochloride; Ibuprofen; Placebo; Dexketoprofen Trometamol + Tramadol Hydrochloride; Dexketoprofen Trometamol + Tramadol Hydrochloride; Dexketoprofen Trometamol + Tramadol Hydrochloride; Dexketoprofen Trometamol + Tramadol Hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dexketoprofen Trometamol low dose, oral film-coated table, once; Dexketoprofen Trometamol high dose, oral film-coated table, once; Tramadol Hydrochloride low dose, oral film-coated table, once; Tramadol Hydrochloride high dose, oral film-coated table, once; Ibuprofen 400 mg, oral film-coated table, once; Placebo, oral film-coated table, once; DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once; DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once; DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once; DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once
Intervention MeSH terms: Ibuprofen; Dexketoprofen trometamol; Ketoprofen; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Moderate to severe pain; Postoperative pain; Analgesics; Dexketoprofen; Tramadol
Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single sequence study that is being conducted to investigate the
      potential drug-drug interaction (DDI) when GSK3640254 is co-administered with a cocktail of
      cytochrome P450 (CYP) enzymes and transporter probe substrates in healthy participants. This
      study will aid in understanding these interactions and resulting changes in exposure (if any)
      when drugs that are metabolized via these pathways are given in combination with GSK3640254.
      The study will consist of a Screening period and 3 sequential treatment regimens.
      Participants will be administered a single dose of probe substrate drugs (caffeine 200
      milligram (mg), metoprolol 100 mg, montelukast 10 mg, flurbiprofen 100 mg, omeprazole 40 mg,
      midazolam 5 mg, digoxin 0.25 mg and pravastatin 40 mg) on Day 1. Participants will then
      receive GSK3640254 200 mg once daily on Days 11 to 20 followed by co-administration of probe
      substrate drugs with GSK3640254 on Day 21.
    


Intervention name(s): GSK3640254 200 mg; Caffeine 200 mg; Metoprolol 100 mg; Montelukast 10 mg; Flurbiprofen 100 mg; Omeprazole 40 mg; Midazolam 5 mg (2.5 mL); Digoxin 0.25 mg; Pravastatin 40 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): GSK3640254 will be available as oral tablets at unit dose strength of 100 mg.; Caffeine will be available as oral tablets at unit dose strength of 200 mg.; Metoprolol will be available as oral tablets at unit dose strength of 100 mg.; Montelukast will be available as oral tablets at unit dose strength of 10 mg.; Flurbiprofen will be available as oral tablets at unit dose strength of 100 mg.; Omeprazole will be available as oral capsules at unit dose strength of 40 mg.; Midazolam will be available as syrup for oral administration at unit dose strength of 2 milligram per milliliter (mg/mL).; Digoxin will be available as oral tablet at unit dose strength of 0.25 mg.; Pravastatin will be available as oral tablet at unit dose strength of 40 mg.
Intervention MeSH terms: Flurbiprofen; Metoprolol; Digoxin; Midazolam; Caffeine; Omeprazole; Pravastatin; Montelukast
Intervention model: Single Group Assignment
Intervention model description: This is a single-sequence, one-way drug interaction study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK3640254; Human immunodeficiency virus (HIV) infections; Drug interaction; Pharmacokinetics; Probe substrate
Dehydration, Rehydration, and Blood Viscosity
Condition: Dehydration
MeSH terms: Dehydration
Study type: Interventional

Summary: 
      The purpose of this study is to examine and compare the rehydration effect of Essentia Water,
      an electrolyzed high-pH bottled water, with industry-standard bottled water purified by
      reverse osmosis with minerals added, on (1) whole blood viscosity, (2) plasma osmolality, (3)
      bioelectrical impedance analysis, and (4) body mass change, using serial measurements in
      apparently healthy adults following exercise-induced dehydration in a controlled environment.
    


Intervention name(s): Essentia Water; Bottled water
Intervention type(s): Other; Other
Other intervention name(s): Electrolyzed high-pH water; Purified bottled water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: exercise; hydration; dehydration; rehydration; alkaline water; blood viscosity; plasma osmolality; bioimpedance
Topical Phytoterpenes for Plantar Fasciitis
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      Randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary,
      clove, pepper, in a formulation with skin permeation enhancers including limonene for the
      treatment of plantar fasciitis in adult men and women. Forty-two patients will be randomized
      to receive twice daily topical application of the treatment formulation or plain tea tree oil
      as a control. Analog pain scores will be assessed at the start of treatment and at two weeks.
      Analysis will be by student's T-test.
    

Detailed description: 
      Randomized controlled trial of mixture of essential oils containing tea tree oil, rosemary,
      clove, pepper, in a formulation with skin permeation enhancers including limonene for the
      treatment of plantar fasciitis in adult men and women. Forty-two patients will be randomized
      to receive twice daily topical application of the treatment formulation or plain tea tree oil
      as a control. Analog pain scores will be assessed at the start of treatment and at two weeks.
      Analysis will be by student's T-test. Primary outcome measure will be the difference in pain
      score between baseline score and pain score at 2 weeks.
    

Intervention name(s): Topical oil application
Intervention type(s): Other
Intervention description(s): Topical Comparison
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups, plain tea tree oil control and formulated essential oil blend with permeation enhancer as treatment in a randomized trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heel pain; plantar; fasciitis; foot pain
Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation
Condition: Chronic Pain; Back Pain; Pain
MeSH terms: Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke
      SCS System with feedback control to treat chronic pain of the trunk and/or limbs.
    


Intervention name(s): Evoke Spinal Cord Stimulator (SCS) System
Intervention type(s): Device
Intervention description(s): Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Pain; Back Pain; Leg Pain; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; SCS; Closed Loop
Metabolic Disturbances in Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      The scope of the study was to investigate different metabolic aspects that may lead to or are
      a consequence of insulin resistance in premenopausal women with polycystic ovary syndrome
      (PCOS). We use gold standard methods for evaluation of insulin resistance. We take muscle and
      fat biopsies for investigation of gene expression of different cytokines associated with
      insulin resistance. We investigate the incretin hormones GIP and GLP-1. These two hormones
      play a central role in glycemic control, and diabetic subjects are known to have alterations
      in their incretin hormones. The incretin hormones have not previously been investigated in
      women with PCOS.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        lean and obese women with and without PCOS
      
Biospecimen description: 
      Fat and muscle biopsies
    
Keywords: polycystic ovary syndrome (PCOS)
Observational Study With NOVOCART® Inject in the Reconstruction of the Hip Joint With Full Thickness Cartilage Defects
Condition: Cartilage Disease
MeSH terms: Cartilage Diseases
Study type: Observational

Summary: 
      Non-interventional study to evaluate safety and efficacy of NOVOCART® Inject in patients with
      full thickness cartilage defects in the hip.
    

Detailed description: 
      Prospective and multicenter non-interventional study to evaluate safety and efficacy of
      NOVOCART® Inject in patients with impingement syndrom in the hip.

      Safety: 24-month post treatment follow up period by measuring the number of adverse drug
      reactions/serious adverse drug reactions.

      Efficacy: 24-month post treatment follow up period using iHOT 33 and EuroQuol-5D-5L.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        specialist clinical centre
      
Keywords: cartilage defect; hip; impingement
The Development of Allergic Rhinitis in Children Previously Diagnosed as Nonallergic Rhinitis
Condition: Allergic Rhinitis (Disorder)
MeSH terms: Rhinitis; Common Cold; Rhinitis, Allergic
Study type: Observational

Summary: 
      The purpose of this study is to evaluate development of allergic rhinitis in children with
      nonallergic rhinitis.
    

Detailed description: 
      Rhinitis is a common condition associated with significant effects on quality of life.
      Rhinitis may be divided into two groups, those with concurrent allergy (allergic rhinitis,
      AR) and those without allergy but who still suffer from nasal symptoms (nonallergic rhinitis,
      NAR).

      Evidence indicated that adult with NAR can have de novo sensitization to aeroallergen (24%),
      suggesting that patients with NAR might evolve to AR. Thus the purpose of this study is to
      evaluate development of allergic rhinitis in children with nonallergic rhinitis.
    

Intervention name(s): skin prick test
Intervention type(s): Procedure
Intervention description(s): skin prick test to aeroallergen
Other intervention name(s): SPT
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The patient from pediatric allergy clinic will be selected.
      
Keywords: Nonallergic rhinitis; Allergic rhinitis; Development
Iron Absorption From Biofortified Beans With Different Levels of Phytic Acid
Condition: Enrichment of Blood
Study type: Interventional

Summary: 
      Iron deficiency and iron deficiency anemia are among the major health problems in the
      developing world. Women of childbearing age as well as children are the most vulnerable
      population groups. In Rwanda, more than 40% of the population is estimated to be anemic. A
      promising approach to combat iron deficiency in Rwanda is biofortification of beans. The
      average consumption of beans is about 150 g per person per day in Rwanda and beans are a
      major staple food. Traditional plant breeding has increased the iron content of certain bean
      varieties from about 5 to 11 mg/100g. Iron absorption from beans however is with about 2-3%
      low because of high phytate and high polyphenol contents. A recently conducted study in
      Rwanda showed that the total amount of iron absorbed from a biofortified high iron bean was
      similar to the amount of iron absorbed from a control bean, which had a 50% lower iron
      concentration. This was surprising since the subjects had a low iron status and where
      therefore expected to maximize iron absorption. However, it was concluded that the additional
      iron bred into the bean was not bioavailable most likely due to the strong inhibitory nature
      of phytate in the high iron bean. To clarify that, a multiple meal study (iron absorption
      study) in collaboration of the Human Nutrition Laboratory of ETH Zurich and the Medical
      Faculty of the National University of Rwanda is planned. Subjects will receive two different
      bean varieties (normal iron vs. high iron) in combination with other food ingredients typical
      for that region. The bean varieties will be served with native phytate concentration,
      partially dephytinized (50%) or totally dephytinized.

      Subjects will be apparently healthy females of reproductive age (18-30y). Iron absorption
      will be determined by stable isotope techniques.
    


Intervention name(s): Bean varieties
Intervention type(s): Other
Intervention description(s): 10 x 50 g/ arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: beans; biofortification; phytic acid; iron; iron isotopes; different phytic acid concentrations
Pharmacokinetic Study of Single Doses of ORM-12741
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate ORM-12741 concentrations in the blood after
      different study drug formulations
    

Detailed description: 
      The purpose of this study is to evaluate the pharmacokinetics and safety of single doses of
      modified release formulations and a immediate release formulation of ORM-12741
    

Intervention name(s): ORM-12741 MR A; ORM-12741 IR; ORM-12741 MR B
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Modified release formulation of ORM-12741; Immediate release formulation of ORM-12741; Modified release formulation of ORM-12741
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteer study
A Study of RO4917838 With Rosuvastatin in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single centre, open-label study will investigate the effect of RO4917838 on the
      pharmacokinetics of Rosuvastatin, a frequently co-prescribed drug in healthy volunteers.
      Healthy volunteers will receive multiple oral doses of RO4917838 and single oral dose of
      Rosuvastatin.
    


Intervention name(s): RO4917838 and Rosuvastatin
Intervention type(s): Drug
Intervention description(s): multiple oral doses of RO4917838 and single oral dose of Rosuvastatin
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment