bioihbjkbjnl/mcl2 huggingface dataset:
Isradipine Enhancement of Virtual Reality Cue Exposure for Smoking Cessation
Condition: Nicotine Dependence; Smoking, Cigarette; Smoking Cessation; Smoking Behaviors; Smoking Reduction; Craving
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The proposed study represents a crucial and important stage in translating basic research to
      strategies for treating nicotine dependence. The investigation addresses an important public
      health issue by testing an intervention - informed by basic research - that may lead to a
      more effective and efficient treatment for smokers. The expected findings should provide
      initial effect size data for the addition of isradipine to an integrated
      psychosocial/behavioral and pharmacological smoking cessation intervention for smokers, and
      thus provide the necessary data for a large-scale follow-up trial.
    

Detailed description: 
      The current protocol will apply a pharmacologic augmentation strategy informed by basic
      research in animal models of addiction. Our goal is to evaluate the enhancing effect of
      isradipine, an FDA-approved calcium channel blocker, on the extinction of craving-a key
      mechanism of drug relapse after periods of abstinence. To activate craving robustly in human
      participants, we will use multimodal smoking cues including novel 360° video environments
      developed for this project and delivered through consumer virtual reality headsets. Adult
      smokers will take either isradipine or placebo and complete the cue exposure protocol in a
      double-blind randomized control trial. In order to test the hypothesis that isradipine will
      enhance retention of craving extinction, participants will repeat cue exposure in a
      medication-free state 24 h later. The study will be implemented in a primary care setting
      where adult smokers receive healthcare, and smoking behavior will be tracked throughout the
      trial with ecological momentary assessment.
    

Intervention name(s): Isradipine; Cue Exposure
Intervention type(s): Drug; Behavioral
Intervention description(s): Isradipine will be administered 90 minutes prior to the initiation of cue exposure.; Participants will be exposed to visual smoking cues (i.e., immersive 360 degree video environments) delivered through consumer virtual reality headset and handle cigarette packs to activate and extinguish craving.
Other intervention name(s): DynaCirc; Prescal
Intervention MeSH terms: Isradipine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to receive isradipine (ISR) or placebo (PBO).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nicotine; craving; virtual reality cue exposure; smoking relapse; immersive video environment; extinction enhancer
HIV Testing in Pregnant Women: Evaluating an Opt-Out Testing Strategy
Condition: HIV; AIDS Virus; Pregnancy
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Observational

Summary: 
      Mother-to-child transmission of HIV is an important but preventable mode of infection.
      Prevention depends on identifying pregnant women infected with HIV and offering medications
      during pregnancy which can dramatically decrease the chances of transmission. Currently
      universal screening of all pregnant women for HIV is recommended in the province of Ontario.
      Unfortunately the rates of screening are still low: estimates place the average rate at 50%
      -60%. We believe that rates in our clinic at the Women's Health Care Centre are significantly
      higher in part because all our patients have a first obstetrical visit. This is an unhurried
      visit with a trained obstetrical nurse who offers pre-test counselling and explores reasons
      why patients refuse testing. We hypothesize that with this system, acceptance rates for HIV
      screening are significantly higher than the provincial average.
    

Detailed description: 
      We hypothesize that by having a dedicated and unhurried intake visit with a trained
      obstetrical nurse, pregnant women will be more likely to accept antenatal HIV testing. We
      further hypothesize that in our obstetrical clinic at the Women's Health Care Centre, the
      application of a universal opt-out screening policy will result in a testing rate that is
      higher than the provincial average.

      This is a two part study. The first part will be a retrospective chart review while the
      second part will be a prospective cohort study. All antenatal patients with first visits at
      our clinic will be included. For the retrospective portion, 537 charts will be reviewed. For
      the prospective portion, 537 patients will be enrolled prospectively using a data sheet which
      will be included in all charts starting when the study begins. For both portions, the
      following information will be obtained:

        -  presence of HIV test

        -  result of test

        -  if test not performed, the reason documented, in any

        -  if testing refused, the reason for refusal

      Additional information that will be obtained includes:

        -  number of HIV positive pregnant women cared for in our clinic during the study period

        -  percentage of positive cases

        -  difference in testing (acceptance) rates between the retrospective and prospective (when
           data sheet in use) portions of the study.
    

Intervention name(s): HIV screening in pregnancy
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        All pregnant women attending antenatal intake appointments at the Women's Health Care
        Centre at St. Michael's Hospital in Toronto, Canada between September 2003 and February
        2006.
      
Keywords: HIV testing in pregnant women
A Single-dose, Randomised, Crossover, Placebo-controlled Study Assessing Two Fixed-dose Combinations of Inhaled Long-acting Beta-agonist and Corticosteroid
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the the ability of a single dose of LAS40468
      administered via Genuair® and a single dose of salmeterol/fluticasone propionate (Seretide®)
      administered via Accuhaler to produce bronchodilation (opening of the airways) and the safety
      and tolerability of the treatments
    

Detailed description: 
      This is a Phase 1, randomised, double-blind, double-dummy, cross-over trial to assess the
      bronchodilation effect of a single dose of LAS40468 and a single dose of
      salmeterol/fluticasone propionate (Seretide®) administered to adult patients with stable
      asthma.

      The study will consist of a screening visit and treatment periods of approximately 13 hours
      separated by washout periods of 7 to 14 days from the time of Investigational Medicinal
      product (IMP) administration.
    

Intervention name(s): LAS40468; Salmeterol/fluticasone propionate; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Seretide®
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of Lumbar Interbody Fusion With MatriTMBONE Associated With Autologous Bone Marrow
Condition: Degenerative Osteoarthritis; Degenerative Lumbar Vertebra
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this clinical study is the estimation of the rate of intersomatic
      fusion observed 12 months after lumbar interbody fusion by posterior approach with PEEK
      interbody cage of fusion in PEEK performed with autologous bone of decortication and osseous
      substitute with a biomaterial (MatriBONE associated with the autologous bone marrow),
      associated with a posterolateral bone graft performed with MatriBone waxed with bone marrow.
      Indication is dedicated for patients by painful degenerative osteoarthritis, by narrow lumbar
      canal and\or spondylolisthesis.
    

Detailed description: 
      This clinical study corresponds to a TLIF surgery using a per-operating artificial substitute
      specific biomaterial: autologous osteoblasts punctured on iliac crest and put on a collagen
      support waxed with tri-calcium phosphate (which is osteoconductive) to perform a
      intervertebral body fusion.

      Biomaterial MATRITM BONE: Device of class III, with marking IT in the indication of
      arthrodesis. It will be administered during the lumbar interbody fusion's procedure.

      The material is a matrix of collagen mineralized containing a homogeneous mixture of collagen
      cleansed of type I+III and an osseous biphasic substitute HA / TCP. The proportion of both
      constituents is 90 % of osseous substitute for 10 % of collagen en masse. The collagen is
      reduced in approximately 1 month and the osseous substitute leads to an osseous reshaping in
      6 - 9 months approximately.

      The follow up will last 12 months with 2 visits (6 and 12 months after surgery), 2 CT scan
      slides before inclusion and at 12 months, classical X-rays before inclusion and at 6 and 12
      months, questionnaires (visual analogic scale for pain, and quality of life with OSWESTRY and
      SF36 scales) before inclusion and at 6 and 12 months, and biological exams (CRP/VS, for
      inflammation) at each visit.
    

Intervention name(s): The Transforaminal Lumbar Interbody Fusion (TLIF) surgery
Intervention type(s): Procedure
Intervention description(s): The TLIF surgery use a per-operating artificial substitute specific biomaterial: autologous osteoblasts punctured on iliac crest and put on a collagen support waxed with tri-calcium phosphate (which is osteoconductive) to perform a intervertebral body fusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Orthopedic Procedures; Spine; Interbody fusion; Arthrodesis; Lumbar Vertebrae; CT Scan; Spine balance; Instrumented fusion; Posterior fusion; Degenerative spine; painful
PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with rheumatoid arthritis have a significantly higher risk to develop heart attacks
      and other complications of their blood vessels. New therapies are needed to prevent this
      complication. The purpose of this study is to establish the role of the medication
      pioglitazone in improving the function of the blood vessels and heart and decreasing the risk
      of future atherosclerosis development in individuals with rheumatoid arthritis. As a
      secondary aim-point, we will evaluate the efficacy of pioglitazone in improving rheumatoid
      arthritis disease activity and markers of inflammation.
    

Detailed description: 
      This study will establish the role of pioglitazone in improvement of endothelial function,
      arterial compliance and disease activity in patients with rheumatoid arthritis. This will be
      a placebo-controlled, double blind, cross-over trial.

      Two of the measures which were initially listed as separate outcome measures: (Decrease in
      inflammation) and Efficacy of pioglitazone in improving rheumatoid arthritis disease activity
      and markers of inflammation are now shown as a combined score (DAS-28-CRP). The Risks or Side
      Effects as an outcome measure would be duplicative of the tables in the adverse event section
      and therefore were deleted as an outcome measure.
    

Intervention name(s): pioglitazone; Sublingual nitroglycerine
Intervention type(s): Drug; Drug
Intervention description(s): daily dose, 30 mg daily for 2 weeks followed by 45 mg daily until completing 3 months unless higher dose not tolerated in which case patient remained at 30 mg daily; Used during nitroglycerin-mediated dilatation vascular function measures in both arms of the study if patient's blood pressure permitted. One single tablet was used per vascular test performed.
Other intervention name(s): Actos
Intervention MeSH terms: Pioglitazone; Nitroglycerin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effects of Breakfast on Mental Workload
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The aim of the study is to investigate the influence of nutritive (high-protein or
      high-carbohydrate) and non-nutritive (low energy) breakfast on psychological and
      physiological responses of mental workload during multitasking in healthy volunteers.
    


Intervention name(s): Breakfast juice
Intervention type(s): Dietary Supplement
Intervention description(s): single dose (300 ml) in the morning of study day, 3 separate sessions (high-protein vs. high-carbohydrate vs. low-calorie juice), total duration 3 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Mental workload; Multitasking; Protein; Tryptophan
A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2
      doses of GSK Biologicals' RSV candidate vaccine adjuvanted with AS01B for the prevention of
      lower respiratory tract diseases caused by RSV in ethnic Japanese adults 60-80 years of age.
    


Intervention name(s): RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.; Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparing the Effects of Pilates and McKenzie in Power Looms Workers Having Nonspecific Chronic Low Back Pain
Condition: Nonspecific Chronic Low Back Pain; Pain; Disability Physical
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      to check the effects of Mckenzie intervention & Pilates intervention on power looms workers
      having nonspecific chronic low back pain
    

Detailed description: 
      The purpose of this study is to check and compare the effects of McKenzie back extension
      exercise and Pilates pelvic tilt exercise on power looms workers having nonspecific chronic
      low back pain. To check the effects of these interventions on pain, disability, and anterior
      pelvic tilt angle.

      In this study pain intensity of the subjects will be noted via a numeric pain rating scale.
      Pain will be measured at baseline, after 2 weeks and 4 weeks of intervention.

      In this study disability of the patients will be measured via Quebec back pain disability
      scale. Disability will be measured at baseline, after 2 weeks and 4 weeks of intervention.

      In this study, a goniometer will be used to measure the anterior pelvic tilt angle. Anterior
      pelvic tilt angle will be measured at baseline, after 2 weeks and 4 weeks of intervention.
    

Intervention name(s): McKenzie back extension exercise; Pilates pelvic tilt exercise; Baseline treatment
Intervention type(s): Other; Other; Other
Intervention description(s): McKenzie's back extension exercise consists; start with your belly facing down on the mat. Angle your legs in line with your hips, point your toes, and breathe into the next movement. Gently bending your elbows, push yourself up off the floor, until you feel the extension in your back. Be mindful not to lock your elbows as you support your weight with your hands and wrists for 10 seconds. Take deep inhales and exhales as you move in and out of the pose. Patients will be performed these activities under the supervision of physiotherapist.; Pilates pelvic tilt exercise consists; lie with your back on the floor in a neutral position with your legs bent and toes facing forward. Pull your belly button in toward your spine, pushing your pelvis up toward the ceiling. Tighten your gluteus and hip muscles as you tilt your pelvis forward. Hold for 10 seconds.; Postural guidelines + proper lifting technique + stretch break Rest
Other intervention name(s): Postural guidelines + stretch break + rest
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was based on the research design of a randomized clinical trial. The single-blind study, in which participants were blind. The sample size of this study was 46. Patient was divided into 2 groups, 23 in each group.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pilates pelvic tilt exercise & McKenzie back exercise
Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy
Condition: Heartburn in Pregnancy
MeSH terms: Heartburn
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the efficacy of alginate-based reflux suppressant and
      magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. Half of the
      participants will receive alginate-based reflux suppressant, while the other half will
      receive magnesium-aluminium antacid gel.
    


Intervention name(s): Alginate-based reflux suppressant; magnesium-aluminium antacid gel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Antacids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users
Condition: Recreational Drug Use
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the abuse potential and pharmacokinetics of PF614
      compared with a non-abuse deterrent, commercially available, immediate release (IR) oxycodone
      hydrochloride (HCl) formulation and placebo.
    

Detailed description: 
      This will be a randomized, double-blind, placebo-and active-controlled, 3-way crossover study
      to evaluate the abuse potential and pharmacokinetics of intranasally administered PF614,
      relative to crushed oxycodone HCl IR tablets and placebo in non-dependent recreational opioid
      users. The study will consist of 4 phases: Screening, Qualification, Treatment, and
      Follow-up.
    

Intervention name(s): PF614; Oxycodone; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): PF614 100 mg capsules; Oxycodone HCl IR 40mg; placebo powder
Other intervention name(s): Oxycodone prodrug; Oxycodone hydrochloride (HCl) immediate-release (IR) tablets
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a 3 way crossover study to evaluate the abuse potential of PF614.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Lispro to Humalog® in Healthy Subjects
Condition: Clamp Study
Study type: Interventional

Summary: 
      Pharmacokinetics and pharmacodynamics study Study of 2 formulation of insulin lispro (Insulin
      Lispro GEROPHARM vers. Humalog® Eli Lilly)
    

Detailed description: 
      A randomized duble blinded two-way crossover single-dose pharmacokinetics and
      pharmacodynamics study of Insulin Lispro (LLC "GEROPHARM", Russia) versus Humalog® (Eli
      Lilly) in normal healthy subjects using the euglycemic clamp technique
    

Intervention name(s): Insulin Lispro; Humalog®
Intervention type(s): Drug; Drug
Other intervention name(s): insulin lispro
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two-way crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Pharmacodynamics; Insulin Lispro
Quantitative Evaluation of Bitter Taste in Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      Although taste influences food choices and favours diseases like obesity, there is no
      consensus about the existence of correlations between bitterness and anthropometric
      variables. Also, an electronic-based method for data collection could provide a more
      appropriate way for the evaluation of taste perception and save time.

      The objective is to search for correlations between bitterness and anthropometric variables.
    

Detailed description: 
      A cross-sectional study evaluating correlations between the bitterness rates given on a
      generalized Labeled Magnitude Scale, anthropometrics and other variables. Bitterness
      perceptions at the tip of the tongue (TOTp) and at the whole mouth (WMp) were recorded using
      a locally developed novel cloud-based software (Cloud-gLMS). The ANCOVA test was adjusted
      using TOTp and WMp as dependent variables and age, height, weight, BMI, gender, waist
      circumference, alcohol intake, comorbidities, and use of medications as independent
      variables.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy people without obesity and people with obesity.