bioihbjkbjnl/mcl2 huggingface dataset:
Sleep Apnea: Age Effects On Prevalence and Natural History
Condition: Lung Diseases; Sleep Apnea Syndromes
MeSH terms: Apnea; Sleep Apnea Syndromes; Lung Diseases
Study type: Observational

Summary: 
      To identify the prevalence of sleep apnea in men and its relationship to age, assess the
      natural history of the disorder, and predict those men at risk.
    

Detailed description: 
      BACKGROUND:

      Sleep apnea is potentially a life-threatening disorder commonly associated with the aging
      process. Often sleep apnea is accompanied by considerable morbidity for both physical and
      mental health; the associated excessive daytime sleepiness, cardiovascular abnormalities, and
      cognitive impairment impact greatly on daytime functioning. In 1990, the prevalence of sleep
      apnea in the general population was undetermined, and there was much speculation regarding
      its natural history.

      DESIGN NARRATIVE:

      For the prevalence study, 4,364 randomly-sampled men selected from the general population and
      stratified by age were evaluated for risk factors for sleep apnea. A total of 741 men found
      to be at risk were evaluated in the sleep laboratory to determine the degree, if any, of
      sleep apnea or sleep disordered breathing. Prior to recording subjects in the sleep
      laboratory, a thorough history was obtained from each subject and a physical examination
      completed. All men entering into the first four years of the prevalence portion of the study
      who were found to have sleep apnea or sleep disordered breathing were reevaluated yearly over
      a five year period in the natural history part of the study. The natural history portion also
      included 150 men previously studied in the sleep laboratory for apnea but who were not part
      of the random sample of 4,000 and who were not part of the prevalence study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        stratified random sample following phone interview
Clinical Pharmacology of FYU-981 (Final Formulation)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, 2-period crossover study. The purpose of this study is to
      assess the pharmacokinetics and safety after single oral administration of final formulation
      of FYU-981 to healthy male adults in fasted and fed conditions. Participants are randomized
      to fasted (n=6) or fed conditions (n=6) in each step. The effect of food to pharmacokinetics
      of FYU-981 is also investigated.
    


Intervention name(s): FYU-981
Intervention type(s): Drug
Intervention description(s): Single administration of FYU-981 under Fasted and fed conditions in the morning.
Other intervention name(s): Final formulation of FYU-981
Intervention MeSH terms: Dotinurad
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Parkinson's Disease Evaluated by PET and the Effect of Memantine
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Purpose of study: To investigate whether the NMDA antagonist Memantine has a substantial
      effect of brain metabolism in patients with Parkinson's disease (PD), using Positron Emission
      Tomography (PET).

      Background: Disturbances in brain metabolism is thought to contribute to degeneration of
      neurons in brain of PD patients. Production of toxic oxygen radicals and presence of too much
      excitatory neurotransmitter (glutamate) due to over activity is involved. These factors can
      theoretically be alleviated by memantine.

      Hypothesis: Memantine decreases metabolism in areas in PD brain known to be over-active.
      Decreases in cerebral blood flow and oxygen metabolism in these areas will be the consequence
      and this can be detected by PET.
    


Intervention name(s): memantine (drug)
Intervention type(s): Drug
Intervention MeSH terms: Memantine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; Positron Emission Tomography; Memantine; NMDA antagonists; Cerebral Blood Flow; Cerebral Metabolic Rate of Oxygen
Trial With Rhinitic Patients Taking GSK256066 Versus Placebo In A Pollen Challenge Chamber
Condition: Rhinitis, Allergic, Seasonal; Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is in patients with seasonal allergic rhinitis(SAR)and will compare the effect
      versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber.
      GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in
      development by GSK for the treatment of allergic rhinitis, asthma and COPD.

      Subjects will be selected on the basis that they display a defined moderate response to the
      pre-determined dose used. Opportunity to assess the efficacy of compounds versus placebo at
      maximal and trough plasma concentrations.

      This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients
      with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.

      12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal
      examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge
      assessments will also be performed at various time points throughout the study.
    


Intervention name(s): GSK256066
Intervention type(s): Drug
Intervention MeSH terms: 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Seasonal Allergic Rhinitis Inflammation Vienna CHallenge Chamber
A Study of Taurine in Patients With First-episode Psychosis Receiving Antipsychotic Treatment
Condition: Psychotic Disorders
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether Taurine 4g is effective with antipsychotic
      medication in the treatment of First Episode Psychosis.Taurine may have an effect on
      cognition and symptoms. We are examining changes in symptoms and cognition over a 3 month
      period.
    

Detailed description: 
      The core rationale of this study will be to prospectively investigate whether Taurine will
      improve and /or protect cognitive functioning and improve symptomatology in a cohort of 128
      first episode psychosis patients.This is a randomized, double blind placebo controlled add on
      standard therapy trial of Taurine 4g , in young patients between 18-25 presenting to ORYGEN
      Youth Health a sub program of Melbourne Health and RAPPS, a subprogram of Southern Health
      with a first psychotic episode . Taurine will be compared with placebo added to standard
      treatment for a period of 12 weeks in a double blind fashion.Primary outcome measures will be
      psychopathology and cognition (MATRICS.

      Secondary outcome measures will be tolerability and safety measures (drop-out rates, general
      side effect scale (UKU).

      Patients who give informed consent will be randomised to receive treatment with Taurine 4g
      daily or placebo for 12 weeks.

      Patients will be randomised by a dynamic randomisation method called minimization which
      allocates patients to treatment group by checking the allocation of similar patients already
      randomised, and allocating the next treatment group "live" to best balance the treatment
      groups across all stratification variables. The minimization will be carried out by the NHMRC
      clinical trials centre in Sydney , and the patient will be randomized to either placebo or
      vitamin.

      Each patient will collect their tablets from the clinical trials pharmacy. The Clinical
      Trials Pharmacy will dispense either vitamin or placebo. All study personnel and participants
      will be blinded to treatment assignment for the duration of the study.
    

Intervention name(s): Taurine 4g
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: First Episode Psychosis
A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects
Condition: Healthy Subjects; Obesity; T2DM (Type 2 Diabetes Mellitus)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled, escalating single-dose
      and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of HEC88473 injection in healthy subjects, obese subjects and subjects with
      type 2 diabetes mellitus (T2DM).
    

Detailed description: 
      This study is divided into two parts, Part A is an escalating single-dose study in healthy
      subjects and obese subjects, and Part B is an escalating multiple-dose study in subjects with
      T2DM.
    

Intervention name(s): HEC88473 injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen.; Placebo will be administered by subcutaneous injection in the abdomen.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Energy Cost for Holding a MedGem® Indirect Calorimeter
Condition: Resting Metabolic Rate
Study type: Interventional

Summary: 
      The goal of this clinical protocol is to perform a randomized crossover study to determine
      the energy cost of holding the MedGem® device above a person's normal resting metabolic rate
      (RMR) compared to not holding the MedGem® device.
    

Detailed description: 
      Forty (40) subjects will be randomized to two (2) RMR measurements separated by a 40-minute
      rest (washout) period. The two RMR evaluation periods are as follows:

        1. RMR with MedGem® Indirect Calorimeter

        2. RMR without MedGem® Indirect Calorimeter

      Study recruitment will be performed at PBRC. Screening, consenting, and all study procedures
      will be performed within a single study visit at PBRC within the Inpatient Unit. All subjects
      will be introduced to the ventilated hood to determine presence of claustrophobia prior to
      enrollment (i.e., signing of the consent form).
    

Intervention name(s): Not holding, then holding the MedGem®; Holding, then not holding the MedGem®
Intervention type(s): Device; Device
Intervention description(s): Subjects will have a RMR measurement taken first while not holding the MedGem®, and then while holding the MedGem®; Subjects will have a RMR measurement taken first while holding the MedGem®, and then while not holding the MedGem®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Characterization of Product Use in Smokers Switching From Cigarettes to a RELX Electronic Nicotine Delivery System
Condition: Electronic Cigarette Use
Study type: Interventional

Summary: 
      The study will assess product use behaviors, biomarkers of exposure, subjective effects, and
      safety in smokers who switch to a RELX ENDS over 8-weeks.
    


Intervention name(s): RELX ENDS Tobacco Flavor; RELX ENDS Menthol Flavor; RELX ENDS Tobacco and Menthol Flavors
Intervention type(s): Other; Other; Other
Intervention description(s): Ad libitum use of the RELX ENDS Tobacco Flavor product; Ad libitum use of the RELX ENDS Menthol product; Ad libitum use of the RELX ENDS Tobacco and Menthol Flavor products
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electronic Nicotine Delivery System; Biomarkers; Subjective Effects; Topography; E-cigarette
Randomised Controlled Trial of the Effect of Music on Women Undergoing Assisted Reproductive Technology Treatments.
Condition: Anxiety
Study type: Interventional

Summary: 
      To investigate whether listening to music at the time of embryo transfer reduces anxiety
      levels in women undergoing assisted conception treatment.
    

Detailed description: 
      An assessor-blinded randomized case control study in an IVF center, England UK will randomise
      women into 'music' (listened to self-selected music during embryo transfer) or 'control' (no
      music) groups. Participants will complete the Spielberger State-Trait Anxiety Inventory prior
      to, and immediately following a post-treatment observation period. Total scores will be
      compared.
    

Intervention name(s): Music
Intervention type(s): Other
Intervention description(s): Self-selected music played via headphones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Music, Anxiety, IVF
Effect of a Novel Sweetener on the pH of Dental Plaque.
Condition: Dental Caries
MeSH terms: Dental Caries; Dental Plaque
Study type: Interventional
Phase: Phase 2

Summary: 
      Bacteria that live in the mouth can digest fermentable carbohydrates such as sucrose,
      fructose, and glucose to make acid. This acid can cause demineralization of the tooth and
      lead to dental caries or decay. Noncariogenic carbohydrate sweeteners, such as sugar
      alcohols, can be used to replace fermentable carbohydrates in foods, thereby decreasing the
      risk of caries. In order for a sweetener to be labeled as a noncariogenic sweetener, the FDA
      requires that when present in food, the food should not lower the dental plaque pH below 5.7
      either during or up to 30 minutes after consumption. The purpose of this study is to
      determine whether a new developmental sweetener can be fermented by the bacteria in the mouth
      and lead to acid production. This will be done by measuring the pH of dental plaque following
      consumption of the sweetener.
    


Intervention name(s): food - novel sweetener; food vehicle blank; food - sweetener, positive control; food - sweetener, negative control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): concentration to be isosweet with 4.7% sucrose; water blank; 4.7% sucrose in water; non-cariogenic sweetener at concentration isosweet with 4.7% sucrose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study Designed to Evaluate the Pharmacokinetic Profile of Abiraterone
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of
      Abiraterone Following Administration of Immediate Release Formulations
    

Detailed description: 
      This was a single centre, 2 part, open-label study in healthy male subjects. Parts 1 and 2
      were conducted in separate cohorts of subjects; subjects were not permitted to participate in
      both parts. Part 1 was a part-randomised, 4 period crossover study planned to include 24
      healthy male subjects. Part 2 was a randomised 2-period crossover study in 12 healthy male
      subjects. The aim was to evaluate the pharmacokinetic profiles of abiraterone following
      administration of immediate release prototype formulations in healthy male subjects.
    

Intervention name(s): Abiraterone Acetate
Intervention type(s): Drug
Intervention description(s): Abiraterone acetate immediate release formulations
Intervention MeSH terms: Abiraterone Acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery
Condition: Cholecystectomy, Laparoscopic; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative pain is a significant cause of increased morbidity in the perioperative period,
      leading to patient discomfort and greater hospital length of stay. Laparoscopic
      cholecystectomy associated with significant postoperative pain, a substantial component of
      which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has
      been used for providing pain relief following abdominal surgery. We designed this study with
      the hypothesis that, administering TAP block with levobupivacaine in laparoscopic
      cholecystectomy provides superior analgesic effects than port-side infiltration.
    

Detailed description: 
      In this randomized and double-blind study, 75 patients, American Society of Anesthesiology
      (ASA) I-II risk group, between the ages of 20-60, who will undergo elective laporoscopic
      cholecystectomy operation under general anesthesia will be accepted. The patients will be
      divided into three groups and they will be given postoperative pain treatment with
      patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12, 16 and 24,
      Visual analog scale (VAS) I (superficial pain), VAS II (deep pain), postoperative total
      analgesic proportion, nausea and vomiting, evaluation postoperative sedation score will be
      recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1, 2, 4, 8, 12,
      16 and 24.
    

Intervention name(s): Levobupivacaine 0.25 %; Levobupivacaine 0.5%
Intervention type(s): Drug; Drug
Other intervention name(s): chirocaine; chirocaine
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Transversus abdominis plane block; levobupivacaine
Adiponectin and Circulating Progenitor Cells (CPC) Function
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Adiponectin and exercise training contribute to the maintenance of a normal vascular tone by
      influencing vascular NO bioavailability and concentration and function of endothelial
      progenitor cells. The molecular mechanisms are only partially understood. Therefore, aim of
      the present study is to elucidate the effects of Adiponectin on endothelial progenitor cell
      migration and the underlying signaling pathways. Furthermore, the impact of exercise training
      on adiponectin-mediated endothelial progenitor cell migration will be investigated.
    


Intervention name(s): exercise training
Intervention type(s): Other
Intervention description(s): 4 weeks supervised physical exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
SEGMENTAL AND GENERAL STABILIZATION EXERCISES IN CHRONIC LOW BACK PAIN
Condition: Segmental Stabilization; Generalized Segmental Stabilization Exercises
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Chronic low back pain effects more than 50% of general population. It's prevalence is higher
      is young adults that are economically active adults.

      Its significance is often underestimated because usually young adults ignore these initial
      episodes of low back pain due to their busy life style or life full of commitments.
      Approximately 70% of adults have at least one episode of low back pain during their
      lifetimes.
    

Detailed description: 
      It will be randomized control trial with 60 patients with chronic low back pain divided into
      2 groups. One group will be given segmental stabilization whose purpose is to achieve
      segmental control over primary stabilizers. Second group will be given just generalized
      lumber stabilization exercises as it includes close chain exercises with low velocity as well
      as low load. This study will be conducted in Rehabilitation setup of Benazir Bhutto hospital
      Rawalpindi and IIRS that is Rehabilitation dept. at Al Nafees medical college and hospital,
      Islamabad. Non probability Convenience Sampling technique will be utilized
    

Intervention name(s): Segmental stabilization; Generalized Lumber stabilization exercsies
Intervention type(s): Other; Other
Intervention description(s): Physiotherapist will perform activation of multifidus in prone position. It also includes activation of transverse abdominas in crook lying position, in sitting as well as in point kneeling position to re-establish simultaneous contraction of deep muscles synergy.; It can by performed by patient him or her self under physiotherapist's assistance. Lumber neutral position is maintained. Bridging in prone as well as supine position will be maintained.
Other intervention name(s): Experimental; Active comparator
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 44 patients with chronic low back pain, distributed randomly in to two groups.
Masking: Single (Investigator)
Primary purpose: Treatment