bioihbjkbjnl/mcl2 huggingface dataset:
ICF in Secondary Prevention of Cardiovascular Disease
Condition: Cardiovascular Diseases; Secondary Prevention; Risk Factor, Cardiovascular
MeSH terms: Neoplasm Metastasis; Cardiovascular Diseases
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to develop a practical protocol based on the ICF(The International
      Classification of Functioning, Disability, and Health) the risk factors of cardiovascular
      disease (CVD) in secondary prevention.
    

Detailed description: 
      The original ICF assessment sheet contains CVD risk factor categories, such as comorbidities
      (depressive disorders, insomnia, heart rhythm and heart rate disorders, carotid artery
      disease, and hypertension), measures of liver and renal impairment, disorders of carbohydrate
      and lipid metabolism). The evaluation criteria for each category were determined based on
      recommendations defined in the ESC, AHA, EFSD, and KIDIGO guidelines.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 patients after ischemic stroke 60 patients after hemorrhagic stroke
The Influence of the Manipulation of the Sacroiliac Joint on Low Back Pain
Condition: Low Back Pain; Sacroiliac Disorder
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The primary focus of this study is to know the influence of sacroiliac joint manipulation on
      low back pain with or without radiation to lower limbs, in the lumbopelvic-hip joint
    

Detailed description: 
      One of the main problems faced by physiotherapists in primary care is low back pain with or
      without radiation to lower limbs. Nowadays, there are a lot of types of low back pain
      interventions, yet despite the vast amount of research findings, the evidence remains
      contradictory and inconclusive: Pharmacological treatments like NSAIDs have shown result in
      acute low back pain but not in chronic pain; conservative interventions (ultrasound,
      interferential currents, mechanical traction and massage) have been studied and found
      ineffective.

      A total of 151 low back pain patients with or without radiation to lower limbs between 18-70
      years old derived from the Physiotherapy Unit of Gévora Health Center (Badajoz, Spain)
      voluntarily entered the study
    

Intervention name(s): manipulation group (MG); electrotheraphy group (EG)
Intervention type(s): Other; Other
Intervention description(s): Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks; Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sacroiliac joint; low back pain; Osteopathic manipulation
Study of Safety and Efficacy of an Oral Contraceptive
Condition: Prevention of Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a comparative study. The primary objective of the study is to assess the efficacy of
      a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to
      assess the incidence of intracyclic bleeding of norethindrone acetate/ethinyl estradiol
      (NETA/EE) administered for 24 days and NETA/EE administered for 21 days; and to assess the
      safety and tolerability of the product.
    


Intervention name(s): Norethindrone Acetate/Ethinyl Estradiol 24 Days; Norethindrone Acetate /Ethinyl Estradiol 21 Days
Intervention type(s): Drug; Drug
Intervention description(s): One tablet per day for 24 days of each 28 day cycle followed by 4 placebo tablets; One tablet per day for 21 days of each 28 day cycle followed by 7 placebo tablets
Other intervention name(s): 21 Day NA/EE
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception
The Efficacy and Safety of Different Doses of SY-004 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study
      in patients with type 2 diabetes mellitus (T2DM).
    

Detailed description: 
      200 cases will be included and divided into four groups with 50 cases in each group
    

Intervention name(s): SY-004; SY-004 matching placebo
Intervention type(s): Drug; Other
Intervention description(s): Take orally once a day; Take orally once a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Rabeprazole Extended-Release 50 mg vs. Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of rabeprazole extended release (ER) 50
      mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing
      in subjects with healed erosive gastroesophageal reflux disease (eGERD).
    

Detailed description: 
      This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects
      who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, RAB
      ER 50 mg (once daily) or Ranitidine 150 mg (twice daily).
    

Intervention name(s): Rabeprazole ER; Ranitidine
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg capsule, taken orally, once daily for 26 weeks.; 150 mg capsule, taken orally, twice daily for 26 weeks.
Other intervention name(s): Aciphex
Intervention MeSH terms: Rabeprazole; Ranitidine; Ranitidine bismuth citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastroesophageal; Reflux; Disease; GERD
Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects
Condition: Safety Issues; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single and multiple dose, parallel group study to assess safety and
      pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects.
    

Detailed description: 
      This is a single and multiple dose, parallel group study to assess safety and
      pharmacokinetics of oral HTL0018318 in healthy Japanese and Caucasian subjects. The study
      will be conducted in two parts: (A) single doses of HTL0018318 in healthy, adult, male
      Caucasian and Japanese subjects; (B) multiple doses of HTL0018318 in healthy, adult, male
      Caucasian and Japanese subjects.
    

Intervention name(s): HTL0018318; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Part A single dose Part B five doses; Part B only
Other intervention name(s): placebo, placebo - cap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bioequivalence Study of Nimesulide 100 mg Tablets
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of nimesulide tablets are
      bioequivalent.

      Test product was Eskaflam® (Nimesulide 100 mg tablets; GlaxoSmithKline) and reference product
      Mesulid® (Nimesulide 100 mg tablets; Syntex for Productos Roche). The single dosage was one
      tablet.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 28 healthy volunteers, both genders, adults between 18-40
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Nimesulide 100 mg tablets; Nimesulide 100 mg tablets
Intervention type(s): Drug; Drug
Intervention description(s): Reference product; Test product
Other intervention name(s): Mesulid®; Productos Roche SA de CV; Eskaflam®; GlaxoSmithKline Mexico SA de CV
Intervention MeSH terms: Nimesulide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Nimesulide; Pharmacokinetics; Mexico
Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants
Condition: Mood Modulation; Modulation of Cognition
Study type: Interventional

Summary: 
      Hops have been used for many years for their supposed sedative and anxiety reducing
      properties and can be found in many natural remedies for stress, anxiety and sleeping that
      are already available to buy.

      However, human trials investigating the effects of hops have so far been limited to the
      effects of the combination of hops and valerian in relation to sleep. Such studies have
      identified that a valerian-hops mixture can result in improved sleep but Valerian alone has
      no effect.

      The current study aims to investigate the effect of hops alone in healthy human participants
      aged 18-35 years.
    


Intervention name(s): Hops Extract; Placebo (silica)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers will be used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.; All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers were used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Hops; Mood; Cognitive Function; Bioavailability; Satiety; Blood Pressure; Heart rate
A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of a prime-boost
      schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.
    

Detailed description: 
      In this study Influenza vaccine GSK1562902A is the primary study vaccine and Havrix™ will be
      administered as the active comparator and not co-administered along with the study
      vaccine.Therefore, there exist no relation between the vaccines administered in this study.
      As the study will be carried out in Philippines, Havrix™ vaccine will be used as an active
      comparator instead of saline placebo to offer an advantage to the subjects.
    

Intervention name(s): Influenza vaccine GSK1562902A Formulation 1; Influenza vaccine GSK1562902A Formulation 2; Havrix™; Havrix™ Junior
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group; Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group; Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group; Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza; H5N1; vaccine; children
Mobile Health App to Reduce Diabetes in Latina Women
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed project sought to develop a culturally- and individually-tailored,
      plain-language Spanish/English mobile phone intervention for Latinas with prior gestational
      diabetes (GDM). The intervention is based on earlier in-person to online modification of the
      CDC-funded Diabetes Prevention Program (DPP), for women with prior GDM led by co-investigator
      Dr. Ellen Seely of Brigham and Women's Hospital.
    

Detailed description: 
      The specific aims of the study were as follows:

      Primary Aim 1: Develop a culturally-tailored mobile phone intervention for Latinas with prior
      GDM based on Brigham & Women's Hospital online DPP.

      Primary Aim 2: Conduct a pilot trial of the intervention.

      Primary Aim 3:Evaluate implementation feasibility.
    

Intervention name(s): Mobile health app called "Hola Bebe"
Intervention type(s): Behavioral
Intervention description(s): For the pilot, all participants received a mobile app that contained 6 interactive audio/written modules in Spanish and English on the following topics: healthy eating; physical activity; portion control; eating healthy while eating out; eating out in Chinese, Italian, Mexican restaurants; and eating out in fast food restaurants. As noted above, the mobile app was customizable to include personalized activity reminders/notifications, and tailored action plans, along with videos for easy at-home exercises and user-friendly, easy-to-follow recipes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

      To compare long-term glycemic control and preservation of beta cell function when basal
      insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients

      Secondary objective:

      To assess the change of insulin resistance, microvascular complication incidence, patient
      satisfaction with treatment
    


Intervention name(s): Insulin glargine; Glimepiride; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once daily in the morning; Once daily in the morning; At least 1000 mg/day
Intervention MeSH terms: Metformin; Insulin Glargine; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tongue Root Retractor For Fibroscopic Intubation
Condition: Airway Management
Study type: Interventional

Summary: 
      Patients admit to the operation rooms of First Affiliated Hospital of Nanjing Medical
      University and requiring endotracheal intubation for general anesthesia will be enrolled in
      this case controlled study.

      Patients 1) aged 18 to 70 years; 2) ASA graded I~II class; 3) general anesthesia should be
      performed under endotracheal intubation, will be included from this study. Patients 1) with
      organ transplant operations; 2) with thoracic and cardiac vascular surgery; 3) with severe
      heart or lung disease; 4) BMI over 35kg/m2, will be excluded from this study.

      The primary aim is to compare airway clearance for fibreoptic tracheal intubation in each
      patient position. Secondary outcomes include times to view the vocal cord and carina, the
      time for tube advancement through the vocal cords, as well as the total time to achieve
      tracheal intubation.Two anesthesiologists with 5 years of experience in conventional
      endotracheal intubation and trained for fibreoptic intubation will perform the maneuvers.
    


Intervention name(s): Tongue Root Retractor; Conventional Fibroscope
Intervention type(s): Device; Device
Intervention description(s): Fibroptic endutracheal intubation will be performed with tongue root retractor.; Fibroptic endutracheal intubation will be performed in conventional way.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibreoptic intubation
Comparing the Pharmacological Profile of Formulations Containing Omega 3 Fatty Acids
Condition: Pharmacokinetics
Study type: Interventional

Summary: 
      The primary objective of this study is to investigate the uptake/gastrointestinal absorption
      of fatty acids in healthy adult volunteers by using enteric coated and non-enteric coated
      soft capsules containing omega 3 fatty acids. Pharmacokinetic parameters such as AUC and
      Cmax, as well as any adverse events are recorded.

      As secondary objective, the short-term effects of Omega-3 supplementation on blood lipid
      parameters in healthy volunteers are evaluated using a Cholestech LDX analyzer to measure
      cholesterol and related lipids.
    


Intervention name(s): Omega-3 LipoMicel® soft gels; RxOmega-3 soft gels (Enteric); Omega-3 Complete soft gels (Non-Enteric)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA); A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA); A maximum single dose of 1260 mg Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bioavailability; Pharmacokinetics; Omega-3 fatty acids; Fish Oil
Acute Withdrawal From Smoked Cocaine - 9
Condition: Cocaine-Related Disorders; Substance Withdrawal Syndrome; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders; Substance Withdrawal Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to develop an experimental paradigm to examine acute withdrawal
      symptoms from cocaine.
    

Detailed description: 
      Although there are clearly identifiable withdrawal syndromes following cessation of a number
      of abused drugs such as alcohol and heroin, it is unclear whether a withdrawal syndrome
      follows the cessation of crack cocaine. A laboratory model of withdrawal from smoked (crack)
      cocaine would provide a safe and systematic method of testing the efficacy of behavioral or
      pharmacological treatments for withdrawal symptoms following cocaine smoking cessation.
      Therefore, this study investigated acute behavioral, subjective, and physiological withdrawal
      symptomatology for 6 hrs following 7 deliveries of 2 dose sized (0.07 vs. 0.4 mg/kg) of
      smoked cocaine. The behavioral measure was performance on a computerized reaction time task,
      subjective measures included participant and observer ratings of mood and withdrawal
      symptomatology, and physiological measures comprised heart rate and blood pressure. It was
      hypothesized that signs and symptoms of withdrawal from smoked cocaine would be greater
      following the 0.4 mg/kg dose size, compared to the 0.07 mg/kg dose size.
    

Intervention name(s): Cocaine
Intervention type(s): Procedure
Intervention MeSH terms: Cocaine
Masking: Double
Primary purpose: Treatment
Safety, Blood Levels and Effects of GW642444
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GW642444 (the study medicine) is a new experimental medicine for treating asthma and chronic
      obstructive pulmonary disease (COPD). People with asthma and COPD suffer from breathlessness
      because the small tubes (bronchioles) that carry air in and out of the lungs become narrow.
      We hope that the study medicine will work by relaxing the muscles in the airways and help to
      keep the airways open, and make breathing easier. The study medicine might improve on
      available treatments by having fewer side-effects, and by working faster and for longer, so
      that patients could take it once daily, instead of twice daily.

      When a medicine is made into a form ready to be given to patients, inactive ingredients are
      often added. Inactive ingredients might be used to help a medicine work better, to make it
      easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In
      this study, the study medicine contains the inactive ingredient magnesium stearate.

      We need to check that the study medicine doesn't cause problems when inhaled along with
      magnesium stearate. So, we're doing this study in healthy people to find out the answers to
      these questions.

      1)Do repeated once-daily doses of the study medicine cause any important side effects when
      inhaled, along with magnesium stearate, as a fine powder? 2)How much of the study medicine
      gets into the bloodstream and how long does the body take to get rid of it?
    


Intervention name(s): GW642444M for 14 days
Intervention type(s): Drug
Intervention description(s): M salt
Other intervention name(s): GW642444 (25; 50; 100; 200 & 400 mcg) for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GW642444,; healthy subjects; magnesium stearate,