bioihbjkbjnl/mcl2 huggingface dataset:
Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability of 2 new
      bead-in-capsule formulations compared to the commercial extended-release formulation (both
      fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on
      the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).
    


Intervention name(s): Fesoterodine ER (fasted); Fesoterodine SR3 (fasted); Fesoterodine SR3 (fed); Fesoterodine ER (fed); Fesoterodine SR3 (sprinkle); Fesoterodine ER (fasted); Fesoterodine SR4 (fasted); Fesoterodine SR4 (fed); Fesoterodine ER (fed); Fesoterodine SR4 (sprinkle)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Commercial Fesoterodine ER 4 mg (single dose); Fesoterodine SR3 4 mg (single dose); Fesoterodine SR3 4 mg (single dose) with high-fat meal; Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal; Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce; Commercial Fesoterodine ER 4 mg (single dose); Fesoterodine SR4 4 mg (single dose); Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal; Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal; Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fesoterodine; SR3; SR4; bioavailability; pharmacokinetics; sprinkle; applesauce
Bisphosphonate Treatment of Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this trial is to evaluate whether the investigational medication is
      safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta
      (OI) patients.
    


Intervention name(s): Zoledronic Acid
Intervention type(s): Drug
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteogenesis Imperfecta; OI; bone markers; fracture; bone loss; pediatric; bisphosphonate; brittle bone disease; pamidronate
Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate and compare the safety and immune responses
      following a two vaccination regimen by transcutaneous immunization with heat-labile
      enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing
    


Intervention name(s): Heat-Labile Enterotoxin of E. coli (LT); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Travelers' Diarrhea Vaccine System; Travelers' Diarrhea Vaccine System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention of Travelers' Diarrhea
Microbiology & Immunology of the Chronically-inflamed Airway
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Chronic obstructive pulmonary disease (COPD) is the fourth most common cause of death and the
      only one of the common causes that is still rising. The main effects of the disease are the
      destruction and inflammation of lung tissue rendering breathing difficult. COPD has
      significant effects on the quality of life of sufferers and the disease is predicted to be
      the fifth most common cause of disability in the world by 2020. Patients with COPD are prone
      to periods of worsening disease symptoms, known as exacerbations, which are often caused by
      viral and bacterial infections of the lung and current vaccines appear to have little
      efficacy in limiting these exacerbations. The loss of lung function caused by infectious
      exacerbations is irreversible and patients who frequently exacerbate experience more rapid
      disease progression. Nontypeable Haemophilus influenzae (NTHi) is a major bacterial species
      that colonises the airways and causes exacerbations in COPD. With the development of more
      sensitive molecular techniques it has been possible to ascertain that it is the acquisition
      of new strains of NTHi that correlate strongly with exacerbations. However, not all patients
      with COPD have NTHi in their lungs and the question remains as to why some COPD patients are
      susceptible to such infections. This study aims to answer this question by comparing the
      airways of COPD patients who are colonized by NTHi and those who are not to analyse whether
      the levels of protective antibodies in the lungs and the function of the immune cells in the
      NTHi colonized airway are reduced. Moreover, we aim to correlate this reduction in immunity
      with areas of lung damage ascertained by high resolution computed tomography. The aim of this
      research is to better understand this apparent deficiency in airway immunity as this is
      likely to impact on vaccine efficacy in COPD.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Volunteers will be recruited from General Practice in the form of patient screening
        clinics,and GP Mailshot. Quitters and pulmonary rehabilitation, would also be approached.
        The Respiratory Centre, patient support groups, and outpatient departments and wards, would
        also be areas of recruitment.
      
Biospecimen description: 
      Serum, plasma, inflammatory cell RNA/DNA, nasopharyngeal swabs, urine, sputum supernatants,
      sputum cells, bronchial epitehlial cells, BAL supernatants, BAL cells, bronchial biopsies.
Efficacy of a Novel Multivitamin-Mineral Supplement in Preventing Vitamin Deficiency in Postoperative Bariatric Patients
Condition: Bariatric Surgery Candidate
MeSH terms: Avitaminosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Approximately 33% of the US adult population can be classified as obese based on body mass
      index. This epidemic of obesity has resulted in over 200,000 bariatric surgeries performed
      every year for the treatment of "clinically severe obesity". Roux-en-Y gastric bypass (RYGB)
      is the most common bariatric procedure performed in the United States and has both
      restrictive and malabsorptive components. Despite the success of this procedure in creating
      long lasting weight loss, vitamin and iron deficiencies are common and can lead to
      significant morbidity if not appropriately addressed. Despite the American Association of
      Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic &
      Bariatric Surgery Medical Guidelines that include vitamin and mineral supplementation
      recommendations, there has been very little prospective research conducted to assess the
      efficacy and compliance of these micronutrient interventions.

      This prospective randomized controlled clinical study will evaluate the efficacy of a novel
      vitamin/mineral supplement in decreasing micronutrient deficiencies in post operative
      bariatric patients.
    


Intervention name(s): AquaVanta Chewable Tablet; Flinstones Complete; Nature Made Calcium Softgels; Nature Made Calcium Softgels; Twin Labs Iron Caps; Rexall Vitamin B12 Tablet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 months; Flinstones Complete Multivitamin 2 times a day for 6 months; Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months; Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months; Twin Labs Iron Caps (Ferrous Fumarate) 18 mg per day for menstruating women for 6 months; Rexall Vitamin B12 Tablet (Cyanocobalamin 500 mcg)per day for 6 months
Intervention MeSH terms: Calcium, Dietary; Vitamin B 12; Hydroxocobalamin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Rehabilitation Programs Based on Eccentric Exercise of Knee Extensor Muscles in Isotonic and Isokinetic Conditions After Partial Menisectomy
Condition: Meniscal Tear
Study type: Interventional

Summary: 
      A randomized clinical trial involving 32 individuals submitted to partial menisectomy will be
      conducted.

      Participants will be randomized into: Group I, submitted to a muscular rehabilitation program
      based on eccentric isokinetic exercise; and Group II, submitted to a muscular rehabilitation
      program based on eccentric isotonic exercise. Concomitantly with the muscular rehabilitation
      protocols, individuals will undergo the same physiotherapeutic protocol with analgesia, edema
      reduction, range of motion, proprioception and functionality goals. Muscle rehabilitation
      programs based on eccentric isotonic and isokinetic exercise will begin 15 days after partial
      menisectomy. The programs will last six weeks, with training frequency of two sessions per
      week, separated by a minimum interval of 72 hours.
    


Intervention name(s): Isokinetic eccentric exercises; Isotonic eccentric exercises
Intervention type(s): Other; Other
Intervention description(s): The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality.
15 days after partial menisectomy, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isokinetic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.; The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality.
15 days after partial menisectomy, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isotonic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Percutaneous Electrolysis, Ultrasound-guided Percutaneous Neuromodulation Therapy and Eccentric Exercise in Supraspinatus Tendinopathy.
Condition: Supraspinatus Tendinitis
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The supraspinatus muscle tendinopathy show a big impact, however, there is a lack of
      awareness about the options of the physiotherapist treatment. It is necessary to do studies
      about effectiveness of therapeutic percutaneous electrolysis and neuromodulation. This
      technique enables treatment of the tendinopathies. To analyze the effectiveness of
      therapeutic percutaneou electrolysis and neuromodulation in the treatment of supraspinatus
      muscle tendinopathy. Single center randomized controlled trial, parallel treatment design. A
      specialist physician will be diagnosed the supraspinatus muscle tendinopathy. Participants
      will be randomly assigned to receive treatmen for 4 weeks: percutaneou electrolysis and
      neuromodulation associated with eccentric exercises or conventional treatment of
      Physiotherapy with the same eccentric exercises. Both interventions were performed under
      ultrasound guidance with a portable ultrasound (General Electric LogicE). Data will be
      collected by a blinded evaluator.
    

Detailed description: 
      Eccentric exercises of the supraspinatus muscle were performed in 3 sets of 10 repetitions.
      Participants were asked to perform the exercise program on an individual basis twice every
      day for 4 weeks. The eccentric program consisted of 3 exercises, focusing on the
      supraspinatus, infraspinatus, and scapular muscles. Participants were asked to do a normal
      abduction (concentric phase) and a slow return to the initial position (eccentric phase)
      included first the concentric phase, and the eccentric phase was slowly conducted. The
      exercise program was taught by a physiotherapist in the first session and monitored in the
      subsequent sessions.
    

Intervention name(s): Therapeutic Percutaneous Electrolysis an neuromodulation; Conventional group
Intervention type(s): Other; Other
Intervention description(s): Therapeutic Percutaneous Electrolysis an neuromodulation associated with eccentric exercises devices at home.; Ultrasound pulsatil therapy (US), transcutaneous electric nerve stimulation (TENS) for 20 minutes and associated with eccentric exercises devices at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A specialist physician will be diagnosed the supraspinatus tendinopathy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tendinopathy; electrolysis; exercise; dry needling
Effects of Neuromuscular Training on Functional Capacity in Acute Coronary Syndrome Patients
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to analyse the effects of neuromuscular training on functional
      capacity in patients with acute coronary syndrome, compared to the classic strength training
      of the cardiac rehabilitation programs
    

Detailed description: 
      So far, there are no previous studies that analyze the effects of neuromuscular training on
      functional capacity in patients with acute coronary syndrome.

      Aim: The main objective of this study is to assess the effects of a 10 weeks neuromuscular
      training vs traditional strength training programme in patients with acute coronary syndrome.

      Design: Randomized clinical trial
    

Intervention name(s): Neuromuscular training; Conventional strength training
Intervention type(s): Other; Other
Intervention description(s): The exercise training was developed based on assuring the correct performance of the exercise focusing in motor control.; The exercise training was developed based on standard strength training used in cardiac rehabiliation programmes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a mixed-design study. It includes a two-group parallel, randomized clinical trial with acute coronary syndrome patients.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute coronary syndrome; neuromuscular training; cardiac rehabilitation; functional capacity
Study To Evaluate Pf-04965842 In Subjects With Moderate To Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Study B7451006 is a Phase 2b POC study which is planned to assess four PF 04965842 once daily
      (QD) doses (10, 30, 100, 200 mg) relative to placebo over 12 weeks to characterize the
      efficacy and safety of PF 04965842 in subjects with moderate to severe AD. The objectives of
      the study are to demonstrate the efficacy of PF 04965842 by showing improvement in disease
      severity in patients with moderate to severe AD as measured by the Investigator's Global
      Assessment (IGA) and Eczema Area and Severity Index (EASI) scores, and safety to support
      further clinical development of PF 04965842.
    


Intervention name(s): PF-04965842; PF-04965842; PF-04965842; PF-04965842; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 mg of PF-04965842 QD for 12 weeks; 30 mg of PF-04965842 QD for 12 weeks; 100 mg of PF-04965842 QD for 12 weeks; 200 mg of PF-04965842 QD for 12 weeks; Placebo QD for 12 weeks
Intervention MeSH terms: Abrocitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 2; randomized; double-blind; placebo; atopic dermatitis; safety; efficacy; JAK; janus kinase; moderate; severe
Aripiprazole Treatment of Prodromal Patients
Condition: Schizophrenia; Psychosis
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We hypothesize that symptoms will improve in patients who meet diagnostic criteria for the
      schizophrenia prodrome when they are prescribed aripiprazole.
    

Detailed description: 
      This is an 8 week trial with extension for responders out to one year. All patients receive
      active medication; there is no placebo. Patients must meet criteria for the schizophrenia
      prodrome according to the Structured Interview for Prodromal Syndromes. Patients receive
      counseling as well. All counseling and medication are free of charge.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prodrome; ultra high risk; aripiprazole
Trial of Operative Fixation of Fractured Ribs in Patients With Flail Chest
Condition: Flail Chest; Ventilation
MeSH terms: Flail Chest
Study type: Interventional
Phase: Phase 2

Summary: 
      Background: Fracture of several ribs in more than one place as the result of trauma, leads to
      paradoxical movement of the chest wall and ventilatory failure. The mainstay of management in
      these patients has traditionally been analgesia and positive pressure ventilation to splint
      the chest wall and allow healing of the ribs to begin. However, this management option leads
      to prolonged intensive care unit (ICU) stay with increasing complication rates as patients
      remain on a ventilator for prolonged periods. Patients often remain on a ventilator for two
      to three weeks while waiting for enough rib healing to provide sufficient chest wall
      stability to allow the patient to take over all their breathing themselves. Until that time,
      patients are at risk of pneumonia and sepsis and other complications. Long term disabilities
      which have been reported in these patients include ongoing pain syndromes, inability to
      return to work, particularly manual type labour and cosmetic chest wall deformities.

      An alternative treatment strategy is to operatively fix the ribs. By fixing the ribs
      operatively, the patient no longer requires internal pneumatic stabilization (provided by
      mechanical ventilation) and can be weaned from the ventilator within days rather than weeks.
      This can potentially lead to earlier discharge from the intensive care unit, and an avoidance
      of the multiple complications which arise in the ventilated patient. Rib fixation may also
      lead to less pain and deformity, improved mobility in the post injury phase and earlier
      return to work.

      Hypothesis: that early operative fixation of ribs in patients presenting with flail chest
      secondary to trauma will result in less mechanical ventilatory requirements, earlier
      discharge from the intensive care unit and lower rate of complications associated with
      prolonged mechanical ventilation. This will lead to cost savings in the treatment of these
      patients.
    


Intervention name(s): operative fixation of fractured ribs
Intervention type(s): Procedure
Intervention description(s): ORIFof fractured ribs in flail chest patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
FLOW-Finding Lasting Options for Women
Condition: Menstruation
Study type: Interventional

Summary: 
      1. Purpose: To compare the use of the menstrual cup "The DivaCupTM " to a menstrual
           strategy using tampons as the primary method of menstrual flow management using
           indicators of user-satisfaction, urinary tract infection, vaginal irritation, cost and
           waste.

        2. Hypothesis: The "The DivaCupTM" will have similar rates of user-satisfaction, urinary
           tract infection, and vaginal irritation as a menstrual strategy using tampons as the
           primary method of menstrual flow management but will likely be more reasonable in terms
           of cost and will generate less waste.
    

Detailed description: 
      Method:

      Prospective study of 100 women from family practice offices in Vancouver, Victoria and Prince
      George who currently use tampons to manage menstrual flow. After an information session and
      consent, subjects will be randomized to tampon use or Diva Cup use and record their
      experience on a diary for 3 months. Women who attend the information session and who do not
      enrol, or those who drop out will be asked their reasons for discontinuing, and their
      pre-study questionnaire will be used for analysis.
    

Intervention name(s): Diva Cup TM
Intervention type(s): Device
Intervention description(s): See Detailed Description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Menstruation
Safety and Efficacy Study of Treatment With Single Doses of CHF 4226 pMDI in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to characterize the dose-response profile of peak and trough
      FEV1 after single dose administrations of carmoterol in patients with COPD.
    


Intervention name(s): CHF 4226 pMDI; CHF 4226 pMDI; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhaled solution, single therapeutic dose; Inhaled solution, single supratherapeutic dose; Inhaled solution, single dose of placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment