bioihbjkbjnl/mcl2 huggingface dataset:
Buprenorphine/Raltegravir Pharmacokinetic Interaction Study
Condition: HIV Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      The main purpose of this protocol is to study the effect of an HIV medication known as
      Raltegravir on Buprenorphine in people who have been receiving the same dose of Buprenorphine
      for at least 3 weeks before study entry. This will be determined by giving Raltegravir along
      with Buprenorphine and by measuring the amount of Raltegravir and Buprenorphine in the blood.
      The investigators will also learn about the effects of Buprenorphine on Raltegravir and about
      the safety of taking these two medications together.
    

Detailed description: 
      A large number of people who are infected with HIV have acquired it through injection drug
      use. Some of these people are currently being treated with Buprenorphine for their addiction
      and with medications for HIV infection. Raltegravir is a medication that was approved by the
      Food and Drug Administration (FDA) for the treatment of HIV infection. Raltegravir acts by
      making it more difficult for the virus that causes AIDS to multiply and cause more damage to
      the immune system in someone who is HIV infected.

      Earlier studies looking at the effect of Buprenorphine and HIV medications have shown that
      Buprenorphine and some HIV medications act differently when taken together. It is important
      to learn if taking Buprenorphine and HIV medications together results in changes in the blood
      level of either medication. If the HIV medication affects the level of Buprenorphine in the
      blood, an individual taking Buprenorphine and HIV medications may experience symptoms of
      withdrawal, even while taking their usual dose of Buprenorphine. On the other hand, if
      Buprenorphine decreases the amount of HIV medication in the blood, then the HIV medication
      may be less effective in controlling HIV infection. It is therefore important to learn if
      Raltegravir and Buprenorphine will affect each other when taken together.

      In order to learn about the effects of Buprenorphine and Raltegravir, we will need to measure
      the amount of Buprenorphine in your blood for 24 hours before you have taken Raltegravir and
      then compare that to the amount of Buprenorphine in your blood after you have taken
      Buprenorphine and Raltegravir together .
    

Intervention name(s): Raltegravir
Intervention type(s): Drug
Intervention description(s): 400 mg of raltegravir orally twice daily together with normally prescribed stable dose of buprenorphine for a minimum of 4 days and up to 14 days.
Other intervention name(s): Isentress
Intervention MeSH terms: Raltegravir Potassium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Pharmacokinetics; Pharmacodynamics; Buprenorphine; Raltegravir; HIV seronegativity; Interaction
Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)
Condition: Prophylactic Salpingectomy; Opportunistic Salpingectomy; Laparoscopic Cholecystectomy
Study type: Interventional

Summary: 
      Prophylactic salpingectomy (also called opportunistic, risk-reducing or incidental
      salpingectomy) has been advocated at the time of gynecologic surgery to reduce the risk of
      serous ovarian cancer. This study explores the acceptability and feasibility of opportunistic
      salpingectomy at the time of elective laparoscopic cholecystectomy (LCHE).
    

Detailed description: 
      Many serous ovarian cancers are now thought to originate in the fimbria of the fallopian
      tubes. This has led a number of professional societies worldwide to recommend consideration
      of prophylactic salpingectomy at the time of elective gynecologic surgery or tubal
      sterilization.

      This study explores the acceptability and feasibility of incidental (opportunistic,
      risk-reducing, prophylactic) salpingectomy at the time of a common nongynecologic procedure
      in women, i.e. elective laparoscopic cholecystectomy (LCHE). The study addresses whether
      women ≥45 years would accept opportunistic salpingectomy and the technical feasibility (time,
      port placement, complications) in women who consented to salpingectomy.
    

Intervention name(s): Salpingectomy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy of Probiotics on Iron Status During Pregnancy
Condition: Prevention of Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Determine the effect of probiotics on improving iron status in a population of healthy,
      pregnant women.
    


Intervention name(s): Probiotics; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Community Health Worker Home Intervention to Improve Pediatric Asthma Outcomes
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The investigators propose to test the hypothesis that a home-based asthma intervention, the
      Wee Wheezers program, delivered by the Community Health Workers and tailored to the needs of
      the investigators community, will improve anti-inflammatory medication adherence, parental
      asthma knowledge and management behaviors, which in turn will reduce asthma morbidity
      (defined as days with asthma symptoms) and health care utilization (defined as asthma-related
      Emergency Department visits) among low-income, minority children with persistent asthma in
      the Bronx.
    

Detailed description: 
      Asthma disproportionately burdens low-income inner city and minority children residing in
      inner cities. Daily use of inhaled corticosteroids (ICS) control symptoms and reduce asthma
      morbidity. Less then 50% of children with persistent asthma adhere to such therapy. Poor
      adherence to ICS medications is one of the major contributors to asthma morbidity. One way to
      reduce asthma disparities is to work in partnership with communities. Community Health
      Workers (CHWs) share the ethnic, cultural, social, and environmental experiences of the
      people in the community. Although, CHW home interventions have been successful in reducing
      asthma allergens, no studies using CHWs to deliver a previously identified evidence-based
      home intervention to improve ICS adherence and health outcomes in a population of inner-city,
      minority children with persistent asthma have been found. Objective: To evaluate the
      effectiveness of an evidence-based asthma home intervention, the Wee Wheezers program,
      tailored to the needs of the community and delivered by CHWs, in improving medication
      adherence, health outcomes and parental management behaviors among low-income, minority
      children with persistent asthma in the Bronx.
    

Intervention name(s): Wee Wheezers
Intervention type(s): Behavioral
Intervention description(s): The intervention, Wee Wheezers, modified to the needs of the targeted population will include 6 bi-weekly 1 hour educational home visits conducted by Community Health Workers at homes of children with persistent asthma
Other intervention name(s): Wee Wheezers at Home
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: asthma; children; community health workers; home intervention
The Effect of Phosphorus on Diet Induced Thermogenesis
Condition: Imbalance of Constituents of Food Intake; Healthy
Study type: Interventional

Summary: 
      The aim of the trial is to investigate the effect of ingestion of 75g of glucose (with or
      without phosphorus) on diet induced thermogenesis (using indirect calorimetry) and appetite
      (using visual analogue scales) in lean and obese healthy subjects
    


Intervention name(s): Phosphorus; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Safety of Transcranial Direct Current Stimulation in Pediatric Hemiparesis
Condition: Hemiparesis
MeSH terms: Paresis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary objective of this proposal is to investigate the safety of use of transcranial
      Direct Current Stimulation (tDCS)in children with hemiparesis.

      The research question, "Is transcranial Direct Current Stimulation safe for use in children
      with congenital hemiparesis?" relates to two hypotheses:

        1. tDCS will not produce a major adverse event, including seizure activity.

        2. No change in paretic or nonparetic hand function or cognitive status will occur.
    

Detailed description: 
      Completing a pilot safety study is paramount to the future goal of incorporating the tDCS
      pediatric safety data and combining tDCS and rehabilitation with constraint-induced movement
      therapy in order to improve motor outcomes beyond what rehabilitation therapies alone can
      provide and enhance quality of life for these children with hemiparesis.
    

Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): transcranial direct current stimulation- non-invasive brain stimulation
Other intervention name(s): transcranial direct current stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
The Treatment of Insomnia in Patients With HIV Disease
Condition: HIV Infections; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to evaluate the efficacy of two commonly prescribed sleep aids for use
      in patients who are HIV positive and suffer from insomnia.
    

Detailed description: 
      Insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or
      non-restorative sleep which is associated with diminished daytime function without any
      identifiable underlying cause. This condition is extremely common among HIV infected
      individuals and can lead to significant distress and reduction in the quality of life. The
      mechanisms for disrupted sleep in this population are diverse, including potential direct
      effects of the tat protein upon the sleep centers in the central nervous system. Insomnia has
      been documented to be one of the most common psychiatric disorders in HIV disease, but no
      trial has systematically examined the efficacy of available hypnotic agents, which are
      commonly used in this population.

      Comparison(s): Two commonly prescribed hypnotic agents used for insomnia will be compared to
      placebo over a 6 month treatment study.
    

Intervention name(s): Doxepin; Temazepam; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Doxepin 10 mg po nightly x duration of study length OR Temazepam 15 mg po nightly x duration of study length OR Placebo nightly x duration of study length; Temazepam capsule 15 mg po nightly x duration of study; Placebo capsule nightly for duration of study
Intervention MeSH terms: Doxepin; Temazepam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; Insomnia; Cytokines; Adherence
Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 48-week, randomised, multi-centre, double-blind, placebo-controlled, parallel group
      investigation of the efficacy and safety of intravenous (IV) ozanezumab (GSK1223249) compared
      to placebo in subjects with Amyotrophic Lateral Sclerosis (ALS). Following a screening period
      of up to four weeks, eligible subjects will be randomised (1:1) to receive IV placebo or 15
      milligram (mg)/ kilogram (kg) IV ozanezumab every 2 weeks for a period of 48 weeks with a
      follow-up visit around 14 weeks after the last infusion. A total of approximately 294
      eligible subjects will be randomised from approximately 37 centers worldwide. The primary
      objective is to assess the effect of ozanezumab on the physical function and survival of ALS
      subjects over a treatment period of 48 weeks. Function will be measured using the ALS
      Functional Rating Scale - Revised (ALSFRS-R). Secondary objectives include the evaluation of
      other clinical outcomes associated with ALS (respiratory function, muscle strength,
      progression free survival and overall survival) in support of the primary objective. Quality
      of life, safety, tolerability, immunogenicity and pharmacokinetics (ozanezumab and riluzole)
      will also be assessed.
    


Intervention name(s): Ozanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ozanezumab injection solution; Normal saline (0.9% sodium chloride) infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic lateral sclerosis; efficacy; ozanezumab; safety
Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System
Condition: Mitral Valve Insufficiency
MeSH terms: Mitral Valve Insufficiency
Study type: Interventional

Summary: 
      Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral
      regurgitation in subjects determined appropriate for mitral valve surgery.
    

Detailed description: 
      Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral
      regurgitation in subjects determined appropriate for mitral valve surgery.

      This trial is designed in accordance with the 2014 ACC/AHA guidelines for valvular heart
      disease, and the consensus statement of MVARC 2015.

      Subjects will undergo transcatheter implantation of the Millipede IRIS implant.
    

Intervention name(s): Mitral Valve IRIS Ring
Intervention type(s): Device
Intervention description(s): Transcatheter implantation of the IRIS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Effects of Isometric Muscle Fatigue on Trunk Muscle Stiffness
Condition: Muscle Tightness
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Interventional study of the effects of a trunk extensor muscles fatigue protocol on trunk
      extensors stiffness.
    

Detailed description: 
      Single visit interventional study of the effects of a trunk extensor muscles fatigue protocol
      on multifidus and erector spinae muscle stiffness measured by Ultrasound based Shearwave
      elastography.
    

Intervention name(s): isometric trunk extensor muscles fatigue
Intervention type(s): Other
Intervention description(s): Participants will perform three sets of intermittent isometric efforts between 50 and 60 percents of their maximal isometric strength. A padded force sensor will be placed approximately at the level of the 7th thoracic vertebrae. The first two sets will last six minutes each, while the third set will last three minutes. Between each set participants will rest for two minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: multifidus; erector spinae; muscle stiffness
Determination of the Lowest, Safe and Effective Dose of Proellex
Condition: Amenorrhea
MeSH terms: Amenorrhea
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the effects of five different doses of Proellex on
      menses, ovulation, liver function, and steady state exposure in women of reproductive age.
    

Detailed description: 
      A phase I/II, 5 arm, single blind study, comparing five doses of Proellex to matching placebo
      in healthy adult female subjects of reproductive age. Exposure to study drug will be for up
      to 10 weeks. In-clinic pharmacokinetic (PK) assessments will be made on the first day of
      dosing and on the last day (week 10). Office visits will occur every week to assess liver
      function and trough blood concentrations for Proellex and primary metabolite. Daily vaginal
      bleeding diaries will be maintained during the course of the study. A single blind run-in
      period of up to 56 days will begin the study to assess baseline menstrual patterns will be
      utilized. Twelve subjects per treatment group (total 60 subjects) will be assigned to each
      dose. New groups will not begin dosing until the previous dose group has completed. Daily
      treatments will be either 1 mg, 3 mg, 6 mg, 9 mg, 12 mg Proellex. A single blind run-in
      period using placebo will be incorporated to establish baseline parameters.
    

Intervention name(s): Proellex
Intervention type(s): Drug
Intervention description(s): 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
Other intervention name(s): CDB-4124; Telapristone acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Liver Function; Steady State Exposure
Dual Triggering in Patients With a High Immature Oocyte Rate
Condition: INFERTILITY
MeSH terms: Infertility
Study type: Observational

Summary: 
      In in vitro fertilization (IVF) cycles, even after adequate triggering, some patients present
      a high rate of immature oocytes retrieved after controlled ovarian stimulation. In vitro
      oocyte maturation is still an experimental technique, with poorer results than conventional
      IVF. For that reason improve in in vivo maturation could have a better impact on reproductive
      outcome.
    

Detailed description: 
      Investigators performed an observational study analyzing the difference in the percentage of
      mature oocytes retrieved in patients with more than 50% immature oocytes in a previous IVF
      cycle triggered with human chorionic gonadotropin (rhCG) compared to the rate of mature
      oocytes retrieved in subsequent cycles, triggered with both gonadotropin-releasing hormone
      agonist (GnRHa) and (hCG). The main outcome measure was the number and percentage of mature
      oocytes retrieved.
    

Intervention name(s): hCG; hCG + GnRH agonist
Intervention type(s): Other; Other
Intervention description(s): Oocyte maturation with hCG; Oocyte maturation with hCG + GnRH agonist
Other intervention name(s): OVITRELLE (Merck Serono); Ovitrelle (Merck Serono) + Decapeptyl (Ipsen Pharma)
Intervention MeSH terms: Triptorelin Pamoate; Chorionic Gonadotropin
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing controlled ovarian stimulation with a high immature oocyte rate
      
Keywords: IVF; Dual trigger; GnRH agonist; hCG; mature oocytes
Duloxetine for Pain in Older Adults With Knee Osteoarthritis (OA)
Condition: Pain Reduction; Function Improvement
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis
      worldwide.Pain is the leading symptom and is often chronic in na. Current treatment options
      have had limited symptomatic effect and are associated with significant side effects.
      Duloxetine, a selective serotonin norepinephrine reuptake inhibitor has been demonstrated to
      have, besides its antidepressant properties, a centrally acting analgesic effect.

      The aim of the present study was to investigate the efficacy of duloxetine in reducing pain
      in older adults with knee OA.

      288 patients aged 65 years and above with ACR clinical and radiographic criteria of primary
      knee OA attending the outpatient clinic of our institution were enrolled in this study. All
      patients underwent a physical examination and where questioned about the number of flares.
      Exclusion criteria included any inflammatory, autoimmune, psychiatric illness and morbid
      obesity. Patients were randomized 1:1. One hundred and forty four received 60mg/day of
      duloxetine HCL and 144 received placebo together with their usual therapy for 16 weeks. The
      primary outcome measure was pain reduction. Secondary outcome measures included improvements
      in physical functioning scores. Pain was assessed using the Brief Pain Inventory (BPI) and
      Visual Analogue pain Scale, (VAS, 0-100 mm). Functional assessment using the self-reported
      physical function as measured with the Western Ontario and McMaster Universities
      Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores and the Geriatric Depression
      Scale (GDS) was conducted. Alterations in dosage of analgesic/NSAID drugs used were recorded.
      Safety and tolerability were also assessed. Data was collected at baseline and at monthly
      intervals for 4 months. All staff involved in data collection was blinded to the treatment
      assignment groups.
    


Intervention name(s): duloxetine HCL; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg/day duloxetine for 16 weeks; similar looking tablets to the active agent for 16 weeks
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: duloxetine; osteoarthritis; pain; function