bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety of Cronus® - Cobalt Chromium Coronary Stent
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective this study is evaluate the performance and safety of Chronus® cobalt-chromium
      coronary stent in patients with "de novo" native coronary artery lesions treated with
      19-mm-long stents in long-term 9 months.
    

Detailed description: 
      The use of coronary stents has optimized the results of coronary balloon angioplasty for two
      reasons:

        1. reduced acute complications, such as acute and subacute occlusion, as well as the need
           of urgent myocardial revascularization;

        2. reduced coronary restenosis. STRESS and BENESTENT 1 pivotal clinical trials7,9 laid the
           foundations for approval and confirmation of the efficacy of coronary stents. These
           studies showed a reduction in the binary angiographic restenosis rates from 42.1% to
           31.6% (p<0.05) and from 32% to 22% (p=0.02), respectively. The efficacy of coronary
           stents is due to the fact that these devices reduce the acute elastic recoil and late
           negative remodeling of coronary arteries because of their capacity to maintain the
           vessel adequately open without reducing vessel diameter.

      Cronus® stent is fabricated in cobalt-chromium. This alloy is currently used cardiovascular
      stents and permanent implants in orthopedic (hips, knees), dental and maxillofacial
      surgeries. Guidant and Medtronic have conducted clinical evaluations of stents fabricated
      with a similar cobalt-chromium alloy and demonstrated safety and efficacy of the
      investigational devices. Both stents are currently available in the European market.
    

Intervention name(s): Stent implantation
Intervention type(s): Device
Intervention description(s): Stent implantation
Other intervention name(s): Angioplasty
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Stent; Cobalt-Chromium coronary stent
Aminopterin Pharmacokinetic Study In Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetic properties (the
      absorption, distribution and excretion) of two preparations of aminopterin (0.25 mg tablets
      and 1.0 mg tablets) following oral administration by subjects with moderate to severe
      psoriasis.
    


Intervention name(s): Aminopterin
Intervention type(s): Drug
Intervention description(s): oral tablets, 1.0 mg dose, once weekly, two weeks
Intervention MeSH terms: Aminopterin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antifolate; Psoriasis; Antiinflammatory drug; Autoimmune disease; Treatment
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the drug-drug interaction when given the study drug,
      bexagliflozin, with three commonly prescribed medications, probenecid, verapamil or rifampin.
      The study is to evaluate how safe the study drug is and how well the study drug is tolerated
      when taken with probenecid, verapamil or rifampin.
    

Detailed description: 
      In this study, a total of 48 healthy subjects were enrolled and assigned to one of three
      groups of 16 subjects. Each group participated in an open-label, non-randomized,
      fixed-sequence studies to assess potential interaction of bexagliflozin tablets, 20 mg with
      probenecid, rifampin or verapamil.

      Sequence 1: Bexagliflozin/probenecid Sixteen healthy subjects were dosed with bexagliflozin,
      qd and/or probenecid tablets, 500 mg, bid, in sequential order as follows: on Day 1 subjects
      took bexagliflozin; on Days 3 and 4 subjects took probenecid, bid; on Day 5 subjects took one
      bexagliflozin, and probenecid, bid; and on Day 6 subjects took probenecid tablets, 500 mg,
      bid.

      Sequence 2: Bexagliflozin/rifampin Sixteen healthy subjects were dosed with bexagliflozin, qd
      and/or 600 mg of rifampin daily in sequential order as follows: on Day 1 subjects took one
      bexagliflozin tablet; on Days 3 to 5, subjects took rifampin once daily; on Day 6 subjects
      took one bexagliflozin tablet and rifampin; and on Day 7 subjects took rifampin.

      Sequence 3: Bexagliflozin/verapamil Sixteen healthy subjects were dosed with bexagliflozin,
      and/or verapamil tablets, 120 mg in sequential order as follows: on Day 1 subjects took one
      bexagliflozin tablet, on Day 4 subjects took one verapamil tablet, 1 hour before taking a
      bexagliflozin tablet.
    

Intervention name(s): Bexagliflozin; Probenecid; Rifampin; Verapamil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Bexagliflozin 20 mg, tablet; qd; Probenecid tablets, 500 mg; bid; Rifampin, 600 mg (2 x 300 mg capsules); qd; Verapamil hydrochloride tablet, 120 mg; qd
Other intervention name(s): EGT0001442, EGT0001474; Probalan; Rifadin; Verelan
Intervention MeSH terms: Bexagliflozin; Rifampin; Probenecid; Verapamil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Conservative Treatment For Ventral Hernia
Condition: Ventral Hernia
MeSH terms: Hernia; Hernia, Ventral
Study type: Observational

Summary: 
      The aim of this study is to evaluate on which indication patients are offered operative
      treatment for their ventral hernia, and to investigate the natural course of ventral hernia
      in the population of patients not offered operation.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients referred to the Surgical Department of Køge University Hospital in the
        timeperiod from 2009 - 2014 with the diagnosis ventral hernia
Single Lumen Intubation and Heart-Lung Machine (HLM) Mode Ventilation
Condition: Anesthesia Time
Study type: Interventional

Summary: 
      In this trial, we aimed to compare anesthetic outcomes of single lumen intubation with
      Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic
      thoracic sympathetic blockade.
    


Intervention name(s): single vs double
Intervention type(s): Procedure
Intervention description(s): we aimed to compare anesthetic outcomes of single lumen intubation with Heart-Lung Machine mode ventilation versus double lumen intubation study in endoscopic thoracic sympathetic blockade
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Safety and Efficacy Study of Thymoglobulin Versus IL2 Receptor Antagonists
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of induction therapy with
      Thymoglobulin in comparison with IL2 receptor antagonists (daclizumab or basiliximab).
    

Detailed description: 
      A 12 month, prospective, randomized, single center, open-label study to evaluate the safety
      and efficacy of Rabbit anti-thymocyte globulin versus IL2 receptor antagonists in combination
      with tacrolimus, corticosteroids and mycophenolate mofetil in a predominantly high risk
      kidney transplant population.
    

Intervention name(s): Rabbit Antithymocyte globulin; Daclizumab
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4; 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7
Other intervention name(s): Thymoglobulin; daclizumab, zenapax
Intervention MeSH terms: Thymoglobulin; Antilymphocyte Serum; Daclizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Upper Airway Stability During Wakefulness and Sleep
Condition: Sleep Apnea Syndromes; Snoring
MeSH terms: Sleep Apnea Syndromes; Snoring
Study type: Interventional

Summary: 
      Negative expiratory pressure is a technique that has been the focus of many studies in the
      last few years.

      Airway response to the application of a negative expiratory pressure (NEP) can be used to
      detect the presence of upper airway collapsibility. In normal subjects, an increase in
      expiratory flow is observed while in patients with collapsible upper airway, the flow will
      show a transient decrease due to airway collapse.

      The objectives of this study will be initially to investigate the diagnostic utility of this
      technique as a noninvasive measurement of the stability of the upper airway in sleep-related
      breathing disorders. Secondly, we aim to see the sites of airway obstructions, discovered by
      NEP, through nasal endoscopy. Finally, we aim at testing the utility of NEP technique in the
      evaluation of therapeutic response. For this purpose, we will apply it in patients before and
      after airway stabilization interventions like ENT surgery, oropharyngeal exercises,
      orthodontic mandibular advancement electrical stimulation of the hypoglossal nerve.
    


Intervention name(s): Negative expiratory pressure
Intervention type(s): Device
Intervention description(s): Using a cough assist, a negative expiratory pressure will be applied while recording the respiratory flow in patients suffering from sleeping disorders or snoring.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Negative expiratory pressure, sleep apnea, Snoring, Sleep-disordered breathing
Effect of Rifaximine on Sleep Disorders in Patients Suffering From Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional

Summary: 
      Hepatic encephalopathy is responsible for sleep disturbances and daytime sleepiness. The
      purpose of our study is to assess sleep quality, quantity, sleep schemes and physical
      activity in patients suffering from HE, before and after a 2 weeks treatment with rifaximine,
      which is currently given to lower blood ammoniac levels.
    

Detailed description: 
      Hepatic encephalopathy (HE) is a complex neuropsychiatric syndrome related to chronic/acute
      hepatic failure. Sleep architecture is disturbed in this syndrome, and patients complain
      mainly of excessive daytime sleepiness and sleep disturbances. Hypothesis to explain these
      symptoms is, among others, disturbed melatonin metabolism. Few studies have been conducted in
      order to study sleep disorders during HE, and effect of treatment is unknown. Recently,
      rifaximine, an oral broad spectrum antibiotic, have been proved to decrease ammoniac
      production in patients with HE. The purpose of our study is to assess sleep quality,
      quantity, sleep schemes and physical activity in patients suffering from HE, before and after
      a 2 weeks treatment with rifaximine.
    

Intervention name(s): rifaximine
Intervention type(s): Drug
Other intervention name(s): Targaxan
Intervention MeSH terms: Rifaximin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sleep quality; physical activity; daytime sleepiness; actigraphy; quality of life
Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children
Condition: Obstruction; Airway, With Asthma
MeSH terms: Airway Obstruction
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the association of signals recorded and analysed
      with Ventica® LFTS in infants and preschoolers during acute airway obstruction/asthma
      exacerbation and recovery thereof for changes in the IP-derived TBFV curves within and
      between nights.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young children admitted to the ward at the hospital due to acute lower airway
        obstruction/asthma exacerbation.
Safety and Immunogenicity of Priming With Live Attenuated A/H7N9 Influenza Virus Vaccine Followed By Inactivated A/H7N9 Influenza Virus Vaccine With AS03 Adjuvant
Condition: Influenza A Virus, H7N9 Subtype
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9
      pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9
      pandemic inactivated influenza vaccine (H7N9 pIIV).
    

Detailed description: 
      This study will evaluate the safety and immunogenicity of one dose of H7N9 pandemic live
      attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic
      inactivated influenza vaccine (H7N9 pIIV).

      This study will enroll healthy adults who will choose which study group to join. Participants
      in Group 1 will receive one dose of H7N9 pLAIV in an inpatient setting at study entry (Day
      0). They will remain in an isolation unit through at least Day 9. They will also receive one
      dose of AS03-adjuvanted H7N9 pIIV on Day 84.

      Participants in Group 2 will receive one dose of AS03-adjuvanted H7N9 pIIV at study entry
      (Day 0) and a second dose of AS03-adjuvanted H7N9 pIIV at Day 84. Participants in Group 3
      will receive one dose of AS03-adjuvanted H7N9 pIIV at study entry (Day 0).

      All participants will attend multiple study visits through Day 264. Study visits may include
      blood collection, physical examinations, and nasal wash and nasal wick procedures.

      These three groups will be compared to two historical control groups who received one dose of
      H7N9 pLAIV at study entry (Day 0), one dose of H7N9 pLAIV at Day 28, and one dose of
      unadjuvanted H7N9 pIIV at Day 84.
    

Intervention name(s): H7N9 pLAIV; H7N9 pIIV; AS03 adjuvant
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 10^7.0 fluorescent focus units (FFU); delivered by an Accuspray device; Administered by intramuscular injection in the deltoid.; Mixed with H7N9 pIIV vaccine; administered by intramuscular injection in the deltoid
Other intervention name(s): Live Influenza A Vaccine H7N9 (6-2) AA ca Recombinant (A/Anhui/1/2013 (H7N9) x A/Ann Arbor/6/60 ca)
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Doctor's Health - Health Behavior of Physicians in Germany
Condition: Chronic Diseases; Chronic Illnesses
MeSH terms: Chronic Disease
Study type: Observational

Summary: 
      This is an observational study to assess the health behavior of Physicians from medical
      practices in Germany. Physicians will be asked by a questionnaire (self-report) on health
      behavior, self-diagnostics and self-medication in case of sickness. We will send the
      questionnaire to 1000 General Practitioners and to 300 medical specialists in Germany. We
      expect a response rate of 25-30 %. After electronically data-entry we will run a descriptive
      analysis for primary outcome. Results may provide a better understanding of the Physicians
      health behavior.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Physicians in Germany
This Study Tests the Effect of Risankizumab on the Metabolism in the Liver of Five Additional Drugs to Study Possible Drug Interactions in Patients With Psoriasis With or Without Psoriatic Arthritis
Condition: Psoriasis
MeSH terms: Arthritis, Psoriatic; Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the influence of risankizumab on kinetics of cytochrome P450 (CYP) probe drugs as a
      means of predicting drug-drug interactions.
    


Intervention name(s): Caffeine; Warfarin; Omeprazole; Metoprolol; Midazolam; Risankizumab
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Other intervention name(s): ABBV-066; BI 655066
Intervention MeSH terms: Metoprolol; Midazolam; Caffeine; Omeprazole; Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ABBV-066; BI 655066; risankizumab
Home Fortification of Complementary Foods in Bihar India
Condition: Anemia; Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This study evaluates the program effectiveness of home fortification along with infant and
      young child feeding (IYCF) counseling as a strategy to address anemia and complementary
      feedings gaps in a program setting of the Integrated Family Health Initiative being
      implemented by CARE India (a non-profit organization) in partnership with the Government of
      Bihar. The study also seeks to assess the field level worker experience with counseling and
      dissemination of home fortification products.
    

Detailed description: 
      This study evaluates the program effectiveness of home fortification along with infant and
      young child feeding (IYCF) counseling as a strategy to address anemia and complementary
      feedings gaps in a program setting of the Integrated Family Health Initiative being
      implemented by CARE India (a non-profit organization) in partnership with the Government of
      Bihar.The key objectives of this study are to examine acceptability and utilization by target
      population, assess impact on infant and young child feeding (IYCF) practices, evaluate impact
      on child growth, evaluate impact on hemoglobin concentration, and assess front line worker
      experience and motivation to disseminate enhanced counseling and home fortification products.
    

Intervention name(s): Home Fortification Product (HFP); Infant and Young Child Feeding (IYCF) Practices Counseling
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The home fortification product (HFP) is a sachet containing multiple vitamins and nutrients as follows:
Iron (Ferrous Fumarate) 12.5 mg Zinc (Zinc Gluconate) 5 mg Folic Acid 0.160 mg Vitamin-A (Vit-A Acetate) 0.30 mg Vitamin-C (Ascorbic Acid) 30 mg Vitamin-B12 0.9 mcg Iodine 90 mcg Maltodextrin (Base); Infant and Young Child Feeding (IYCF) Practices Counseling provides direction on breast milk and milk feeding, food variety, and frequency for caregivers of children aged 6 to 18 months. Participants will be visited at least monthly by a field line worker for IYCF counseling and educational materials distribution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Vitamins; Public Health; Nutrition
Effectiveness of Mat Pilates Exercises in Individuals With Chronic Nonspecific Low Back Pain
Condition: Nonspecific Chronic Low Back Pain; Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      To analyze the effectiveness of mat Pilates compared to no intervention in individuals with
      chronic nonspecific low back pain.
    

Detailed description: 
      There is evidence that exercises based on the Pilates method reduce pain in chronic
      nonspecific low back pain (CNLBP). However, is noticed the lack of studies that compare the
      effectiveness of mat Pilates to no intervention in the treatment of individual with CNLBP.
      Therefore, the main objective of the study is to analyze the effectiveness of mat Pilates
      compared to no intervention in patients with chronic nonspecific low back pain. It is a
      randomized controlled trial with two arms and double blinded (caregiver, assessor and outcome
      assessor), composed of 30 patients, aged between 18- 65 years (±22,47) of both sexes,
      diagnosed with chronic non-specific low back pain persisting for more than three months and
      pain intensity greater than 3 points in the Pain Numerical Rating Scale. The participants
      were randomly divided into two groups: Pilates Group (n = 15), intervention based on mat
      Pilates exercises, and Control Group (n =15) with no intervention. The mat Pilates group
      performed 16 sessions, twice a week in 60-minute duration each throughout eight weeks,
      whereas the control group participants kept usual cares until the end of the intervention.
      Both groups were evaluated before and after the program by a researcher who was unaware of
      the patients' allocation. The primary assessed outcomes: pain intensity (Pain numerical
      rating scale, and McGill questionnaire), quality of life (SF-36), and disability (Oswestry
      Low Back Pain Disability Questionnaire). In addition, the strength and muscle activation of
      transverse abdominal as secondary outcome assessed through the Stabilizer Pressure
      Biofeedback Unit test. As a result, the study infers that mat Pilates exercises have
      significantly improved all the evaluated outcomes. Thus, supporting clinical decisions for
      the treatment of chronic nonspecific low back pain.
    

Intervention name(s): Pilates Group
Intervention type(s): Other
Intervention description(s): The Pilates group program (PG) was composed of 16 sessions, 2x per week, 60 minute session each for 8 weeks. The intervention was based on 20 out of the 34 original mat exercises proposed by the Pilates method, classified into basic, intermediate or advanced levels divided into 4 cycles of 5 exercises each. The exercises were performed during two series of 10 repetitions respecting the patients skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mat Pilates; Chronic Nonspecific low back pain; Quality of life; Disability; transverse abdominal muscle
Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
Condition: Diarrhoea;Acute
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to demonstrate the antidiarrheal efficacy of colloidal silicon
      dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.
    

Detailed description: 
      Background: Diarrhea is a medical condition characterized by frequent stool, more than 3
      times (and more than 5-7 times in newborns) within the last 24 hours, and/or loose stool. The
      fecal matter is liquid, its daily mass exceeds 200 g per day, and water content reaches 95%.

      Objectives: To demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet
      dosage form (Carbowhite) in patients with acute diarrhea.

      Methods: A randomized clinical trial, double-blind, placebo-controlled, multi-center.
    

Intervention name(s): Carbowhite; Carbowhite placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Colloidal Silicon Dioxide; Placebo
Intervention MeSH terms: Silicon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diarrhoea; Carbowhite; Colloidal silicon dioxide