bioihbjkbjnl/mcl2 huggingface dataset:
Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate, in 12-23 months old subjects, the
      non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when
      co-administered, compared to each vaccine administered individually.
    

Detailed description: 
      Multi-center study with 3 parallel groups. One group will receive 2 vaccines injections at
      the same visit (pneumococcal+ meningococcal), one group will receive a pneumococcal vaccine
      followed one month later by a meningococcal vaccine, and the last group will receive the
      meningococcal vaccine followed one month later by the pneumococcal vaccine.

      All subjects will have one blood sample taken before vaccination and one blood sample taken
      one month after each vaccination (i.e. the first group will have 2 blood samples taken, and
      the other two groups will have 3 blood sample taken)
    

Intervention name(s): Meningococcal vaccine GSK134612; Pneumococcal vaccine GSK1024850A
Intervention type(s): Biological; Biological
Intervention description(s): Single dose intramuscular injection.; Single dose intramuscular injection.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Safety; Routine infancy vaccination; Meningococcal vaccine; Immunogenicity; Pneumococcal vaccine
Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Infertility is defined as a couple's inability to become pregnant after one year of
      unprotected intercourse in women 35 years old and younger, and for six months in women over
      age 35 years. In any given year, about 15 percent of couples in North America and Europe who
      are trying to conceive are infertile
    


Intervention name(s): Letrozole; Clomiphene Citrate plus N acetyl cystine
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets 5 mg; Clomiphene Citrate 100 mg oral tablets+ N acetyl cystiene 600 mg
Intervention MeSH terms: Letrozole; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Open-Label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% Applied to the Upper Arms and Shoulders and Use of a T-shirt Barrier
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-center, single dose, open-label study in healthy male and female volunteers to further
      characterize the transfer potential of Testosterone Gel 1.62% formulation.
    

Detailed description: 
      Single-center, single dose, open-label study in 12 healthy male and 12 healthy female
      volunteers to further characterize the transfer potential of Testosterone Gel 1.62%
      formulation.
    

Intervention name(s): Testosterone Gel 1.62%
Intervention type(s): Drug
Intervention description(s): 5 grams
Intervention MeSH terms: Testosterone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: testosterone,; Pharmacokinetics; replacement,; therapy
Pre-operative Respiratory Rehabilitation in Coronary Artery Bypass Graft Patients
Condition: Respiratory Rehabilitation
Study type: Interventional

Summary: 
      To compare the effects of conventional preoperative respiratory rehabilitation and specific
      preoperative respiratory rehabilitation program on pulmonary functions in coronary artery
      bypass graft patients.
    

Detailed description: 
      After cardiac surgeries many postoperative changes occur that lead to pulmonary complication
      such as respiratory changes, functional capacity of lungs and gaseous changes that leads to
      hypoxemia and ischemic injury of lungs. CABG, although a successful procedure, post operative
      pulmonary complications still pursue a big challenge to the health and fitness of the
      patients. Although post operative complications have been managed in in-patient setup post
      CABG, there are pre-operative measures on the rise to prevent the complications to occur
      after CABG.

      This study will contribute in describing the rate of improvement in pulmonary functions with
      rehabilitation program including preoperative out of bed mobilization, active cycle breathing
      techniques, forced expiratory technique and volume-based incentive spirometry as compared to
      the conventional treatment of flow-based incentive spirometry and chest percussion in
      prevention of post operative pulmonary complications occurring after CABG leading to delayed
      recovery of patients.
    

Intervention name(s): Respiratory rehabilitation and out of bed mobilization; conventional treatment
Intervention type(s): Other; Other
Intervention description(s): The Respiratory rehabilitation and out of bed mobilization group will perform following exercises: pre operative out of bed mobilization, active cycle breathing techniques, forced expiratory technique and volume based incentive spirometery; The conventional exercise program group will perform :Flow based Incentive spirometery, Chest percussion if needed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical research study is to learn if aripiprazole has a drug-drug
      interaction with lamotrigine.
    


Intervention name(s): aripiprazole
Intervention type(s): Drug
Intervention description(s): Tablets, Oral, 10, 20, or 30 mg (titrated), once daily, 14 days.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Bipolar type I Disorder
Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery
Condition: Pain; Orthognathic Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to determine the analgesic effect of perioperative nefopam on acute
      pain in patient undergoing orthognathic surgery.
    


Intervention name(s): nefopam; normal saline (control)
Intervention type(s): Drug; Drug
Intervention description(s): nefopam infusion for postoperative 24 hours; normal saline infusion for postoperative 24 hours
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pain; orthognathic
Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the present study is to determine whether ulinastatin, urinary anti-trypsin
      inhibitor, attenuates cardiopulmonary bypass (CPB)-activated systemic inflammatory response
      in cardiac surgery with CPB.

      Serial measurements and analysis of several inflammatory cytokines (bactericidal permeability
      increasing protein, interleukin-6, tumor necrosis factor-α)as well as markers of cardiac
      injury, renal impairment and oxygenation profile will be performed to determine ulinastatin's
      efficacy.
    

Detailed description: 
      Applying aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) for cardiac surgery
      produces variable systemic inflammatory reactions. As a common complication of those
      reactions, pulmonary dysfunction, which usually indicated by postoperative hypoxemia, is
      frequently associated with cardiac surgery employing CPB and has been used as a major
      predictor of morbidity and mortality.

      Circulating humoral and cellular factors are involved in the development of the systemic
      inflammatory reactions including organ dysfunction. So far, many studies analyzed the
      concentration of inflammatory marker (cytokine) to determine the degree of systemic
      inflammatory responses in various conditions.

      Ulinastatin has anti-inflammatory activity and suppresses the infiltration of neutrophils.
      Previous studies suggested ulinastatin's cytoprotective effect against ischemia-reperfusion
      injury in major organs and its inhibition of inflammatory marker production.

      The purpose of the present study is to determine ulinastatin's possible protective efficacy
      of in attenuating CPB-activated systemic inflammatory response regarding postoperative
      cardiac, renal and pulmonary dysfunction in cardiac surgery with CPB. Serial measurements and
      analysis of several inflammatory cytokines, such as bactericidal permeability increasing
      protein (BPI), interleukin (IL)-6, tumor necrosis factor (TNF)-α, as well as markers of
      cardiac injury, renal impairment and oxygenation profile, such as creatine kinase-MB (CK-MB),
      troponin I (TnI), C-reactive protein (CRP), arterial O2 tension /inspired O2 fraction
      (PaO2/FiO2 ratio), will be performed to this purpose.
    

Intervention name(s): ulinastatin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): ulinastatin 5000 unit/kg iv before the initiation of CPB; placebo (the same amount of normal saline) iv before the initiation of CPB
Other intervention name(s): ulistin; normall saline
Intervention MeSH terms: Urinastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: ulinastatin; systemic inflammation; cardiac surgery; cardiopulmonary bypass
High Intensity Interval Training in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      Study objective is to determine the effect of High intensity interval training on
      psychological wellbeing, Anthropometrics and Quality of life in females with Polycystic
      Ovarian Syndrome
    


Intervention name(s): Low Intensity steady state training; High intensity interval training
Intervention type(s): Other; Other
Intervention description(s): Intervention will be provided for a period of 8 weeks. For the first 4 weeks the intervention will consist of 35-40 minutes of supervised slow paced treadmill walk, five days a week. From week 5 till 8 the intervention will consist of 50-60 minutes of supervised slow paced treadmill walk, five days a week.; Intervention will be provided for a period of 8 weeks, thrice a week. Intervention will start with a 5 minutes warm up period of jogging in place. For the first 4 weeks, 3 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery.
Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches.
Intervention will start with a 5 minutes warm up period of jogging in place. For weeks 5 to 8, 4 series of these exercises will be performed with 3 minutes of rest in between: 30 seconds burpees + 30 seconds recovery, 30 seconds lunges + 30 seconds recovery, 30 seconds skipping + 30 seconds recovery, 30 seconds squats + 30 seconds recovery.
Exercise session will be followed by a cool down of 5 to 10 minutes with upper and lower extremity stretches.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Two Formulations of Pregabalin Capsules 150 mg
Condition: Healthy
Study type: Interventional

Summary: 
      The present study was conducted to find out whether the bioavailability of 150 mg pregabalin
      capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule
      150 mg, Pfizer Manufacturing Deutschland GmbH, Germany).
    

Detailed description: 
      This was a randomized, open label, two-period, two-sequence, crossover study under fasting
      condition. The participating subjects were required to have an overnight fast and in the next
      morning were given orally one capsule of the test drug (Pregabalin 150 mg produced by Dexa
      Medica) or one capsule of the reference drug (Lyrica® 150 mg, Pfizer Manufacturing
      Deutschland GmbH, Germany).

      Blood samples were drawn immediately before taking the drug (control), at 20, 40 minutes, and
      1, 1.5, 2, 2.5, 3, 4, 6, 9, 12, 24, 36 hours after drug administration. Seven days after the
      first drug administration (washout period), the procedure was repeated using the alternate
      drug. The plasma concentrations of pregabalin were determined by using validated liquid
      chromatography with tandem mass spectrometry detection (LC-MS/MS) method.
    

Intervention name(s): Pregabalin capsules 150 mg of Dexa Medica; Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland
Intervention type(s): Drug; Drug
Intervention description(s): Each capsule contains 150 mg of pregabalin. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.; Each capsule contains 150 mg of pregabalin. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
Other intervention name(s): Test product: pregabalin capsules 150 mg of Dexa Medica; Reference product: Lyrica® 150 mg, produced by Pfizer Manufacturing Deutschland GmbH, Germany
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pregabalin; Bioequivalence; Bioavailability; Pharmacokinetic; Antiepileptic
1404003_OpenPsori.PlaqueTest to Eval.Eff.of Diff.Comp. to Mapracorat
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of efficacy and safety of Mapracorat 0.1% ointment and 4 comparator ointments in
      male and female subjects 18 to 65 years with stable plaque-type psoriasis treated once daily
      6 days a week for a maximum of 4 weeks.

      Primary objective was to compare the efficacy of all test compounds by measurement of
      psoriatic infiltrate thickness (PIT) with 20 MHz B mode ultrasound.

      Secondary objectives were to assess safety of all test compounds by measurement of the
      atrophogenic potential on non-lesional skin with 20 MHz B mode ultrasound, to assess the
      efficacy of all test compounds by measurement of intensity of erythema measured by
      chromametry, to assess the efficacy of all test compounds by visual assessment of the skin in
      the test fields using a 5-point score, to assess the safety of all test compounds by visual
      assessments of formation of teleangiectasia using a 5-point score, to assess the safety of
      all test compounds by visual assessment of atrophy using a 5-point score, to assess the
      safety of all test compounds by visual assessment of local tolerability using a 5-point
      score, to visualize the therapeutic index given by PIT versus non lesional skin thickness.
    


Intervention name(s): Mapracorat (ZK 245186, BAY 86-5319); Prednicarbate 0.25% ointment; Clobetasol 0.05% ointment; Calcipotriene 0.005% ointment; Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment; 0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment; 0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment; 0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment; 0.005% (0.05 mg/g) of the active ingredient calcipotriene/0.05% (0.5 mg/g) of the active ingredient betamethasone dipropionate as ointment
Intervention MeSH terms: Calcitriol; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Clobetasol; Prednicarbate; Calcipotriene; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People
Condition: HIV Infections; Covid19; Health Care Utilization; Gender-based Violence
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Sub Saharan Africa is home to only 12% of the population, but accounts for approximately 70%
      of the global burden of HIV infection and 84% of infections among young people aged 10-24
      years. South Africa, which currently has the largest SARS-CoV-2 pandemic in SSA, also has the
      largest HIV epidemic globally. Access and service delivery barriers to engaging in HIV care
      have contributed to estimates that only 49% of adolescents (aged 10-19 years) entering care
      from 2005-2016 have initiated antiretroviral therapy (ART). In response to the SARS-CoV-2
      pandemic the South African government has implemented national lock-down orders that we
      predict will further inhibit treatment engagement among young people. Research is needed to
      identify best practices for safely retaining young people living with HIV (YPLWH) in care
      during COVID-19.
    

Detailed description: 
      The primary objectives of this study are to examine the feasibility, acceptability, and
      preliminary efficacy of a remote service delivery model for young people living with HIV aged
      13-24 years that will include a monthly service needs assessment and optional delivery of HIV
      treatment services. YPLWH will also be randomized to receive (or not receive) mobile
      check-ins from study staff and access to two-way messaging capabilities to obtain continuous
      support for adherence to ART and COVID-19 prevention guidelines.

      Investigators will also assess the impact of the COVID-19 lock-down orders on multi-level
      factors (individual, socio-behavioral, structural) over time among young people aged 13-24
      years living with HIV (same cohort as above) and without HIV. Particular focus will be given
      to experience and perpetration of gender based violence. In addition, investigators will
      assess the impact of multi-level factors on compliance with COVID-19 prevention guidelines,
      health service utilization, and engagement in HIV care (YPLWH only). Findings will be
      examined overall and stratified by HIV status and gender.

      Ultimately investigators hope to: (i) determine whether a remote service delivery model will
      help retain young people in HIV care and (ii) Inform the development of an intervention for
      young people in the study communities who may be experiencing GBV and associated outcomes in
      the wake of the pandemic.
    

Intervention name(s): Mobile phone support; Remote service delivery model
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Mobile phone support (SMS); ART treatment delivery via a courier service
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Artificial Intelligence in Predicting Progression in Multiple Sclerosis Study
Condition: Multiple Sclerosis; Multiple Sclerosis Lesion; Multiple Sclerosis Brain Lesion
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The study proposal focuses on multiple sclerosis (MS), a chronic incurable disease of the
      central nervous system (CNS). The MS disease is characterised by recurrent transient
      disability progression, quantified by increase in the extended disability status score
      (EDSS), and subsequent remission (disappearance of symptoms and reduced EDSS score) or,
      alternatively, a gradual EDSS disability progression and exacerbation of associated symptoms.
      At the same time, the MS is characterised by multifocal inflammatory lesions disseminated
      throughout the white and grey matter of the CNS, which can be observed and quantified in the
      magnetic resonance (MR) scans. The proposed study will address the critical unmet need of
      computer-assisted extraction and assessment of prognostic factors based from an individual
      patient's brain MR scan, such as lesion count, volume, whole-brain and regional brain
      atrophy, and atrophied lesion volume, in order to evaluate the capability for personalized
      future disability progression prediction.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be based on a retrospective secondary analysis of demographic and clinical
        data and MRI scans of approximately 1200 Slovenian patients with MS that are regularly
        monitored between 2015 and present.
      
Keywords: Artificial intelligence; Prediction model; Magnetic resonance imaging; Computer-assisted image analysis
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine
Condition: Migraine; Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Study type: Interventional
Phase: Phase 3

Summary: 
      Study STS101-002 is a randomized, double-blind, parallel group, placebo-controlled,
      multicenter study to evaluate the efficacy, safety, and tolerability of single doses of
      STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine
    

Detailed description: 
      The EMERGE trial is a multi-center, single-dose, randomized, double-blind,
      placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65
      years).
    

Intervention name(s): Dihydroergotamine; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.; Placebo for STS101
Other intervention name(s): Dihydroergotamine Mesylate; STS101 Placebo
Intervention MeSH terms: Dihydroergotamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: dihydroergotamine; dihydroergotamine mesylate; migraine
Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to identify whether an Accelerated or Intensified Infliximab
      induction regimen is superior to Standard induction in Acute Severe Ulcerative Colitis in an
      open label multi-centre randomised controlled trial.
    


Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention description(s): INFLIXIMAB (REMICADE) in the form of a freeze-dried compound is conditioned in 100mg vials. Treatment will first be reconstituted in 250ml isotonic saline solution and infused
Other intervention name(s): Remicade
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Severe Ulcerative Colitis; Steroid Refractory Ulcerative Colitis