bioihbjkbjnl/mcl2 huggingface dataset:
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in
      non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with
      insomnia.
    

Detailed description: 
      This is a multicenter, randomized, double-blinded study to evaluate the long-term safety of
      SEP-190 (2, 3 mg) in non-elderly patients with insomnia and SEP-190 (1, 2 mg) in elderly
      patients with insomnia.
    

Intervention name(s): Eszopiclone 1 mg- Elderly; Eszopiclone 2 mg- Elderly; Eszopiclone 3 mg- Non-elderly; Eszopiclone 2 mg- Non-elderly
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Elderly participants: Eszopiclone 1 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.; Elderly participants: Eszopiclone 2 mg tablet and 1 tablet placebo 1 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.; Non-elderly participants: Eszopiclone 3 mg tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment.; Non-elderly participants: Eszopiclone 2 mg tablet and 1 tablet of placebo 3 mg daily by mouth at bedtime for 24 weeks.
Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg tablet additionally until the end of study treatment.
Other intervention name(s): SEP-190; SEP-190; SEP-190; SEP-190
Intervention MeSH terms: Eszopiclone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: insomnia; primary insomnia; insomnia associated with psychiatric or physical disorder(s)
Acute Lung Injury After Cardiac Surgery: Pathogenesis
Condition: Acute Lung Injury; Metabolic Disturbances; Inflammation; Coagulation; Intravascular; Postoperative; Dysfunction Following Cardiac Surgery
MeSH terms: Lung Injury; Acute Lung Injury; Inflammation; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of the present study is to visualize the inflammatory response and coagulation
      disorders during cardiac surgery in order to identify possible predictors for acute lung
      injury postoperatively.
    

Detailed description: 
      Acute lung injury after cardiac surgery is a common complication. The pathophysiology is
      complex and still not fully elucidate. No specific biomarkers are identified and the
      diagnosis is solely based on impaired oxygenation.

      The purpose of the present study is to identify biomarkers of inflammation and coagulation in
      blood withdrawn simultaneous from the pulmonary artery and the left atrium during surgery and
      up to 20 hours after weaning from cardiopulmonary bypass.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No treatment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for elective coronary artery bypass grafting (CABG)
      
Biospecimen description: 
      Plasma samples stored at -80 degrees of Celcius
Quality of Life Study of Helixate NexGen
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      The aim of this study is to describe Health Related Quality of Life (HRQoL) in adolescents
      and adults with Hemophilia A treated prophylactically or on-demand with Helixate NexGen. The
      study will also assess the kinds of determinants, including key transitional life events,
      that might impact HRQoL in this patient population.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a diagnosis of moderate or severe Hemophilia A using Helixate NexGen
        identified by selected European hemophilia treatment centers.
      
Keywords: Hemophilia; Quality of Life
Study on the Protective Effect of RIPC in Patients Undergoing Cardiac Surgery.
Condition: Cardiac Surgery
Study type: Interventional

Summary: 
      To observe the effect of RIPC on the function of vital organs after cardiac surgery, and to
      explore its possible mechanism.
    


Intervention name(s): RIPC
Intervention type(s): Device
Intervention description(s): The tourniquet attached to the upper limb was inflated and blocked for 5 minutes, then deflated for 5 minutes to restore blood flow and induce ischemic preconditioning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Proof-of-concept, Open-label Study in Patients With Early Alzheimer's Disease
Condition: Early Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2a study in men and women with early Alzheimer's disease to evaluate the
      pharmacodynamics, pharmacokinetics and safety of obicetrapib therapy.
    

Detailed description: 
      This study will be a proof of concept, Phase 2a study in patients with early Alzheimer's
      disease (clinical diagnosis of Alzheimer's disease Stage 3 or 4 based on the National
      Institute on Aging Alzheimer's Association Research Framework criteria) to evaluate the
      Pharmacodynamic, cognitive effects, Pharmacokinetic, and safety and tolerability of
      obicetrapib therapy.
    

Intervention name(s): Obicetrapib
Intervention type(s): Drug
Intervention description(s): 10mg obicetrapib
Other intervention name(s): TA-8995
Intervention model: Single Group Assignment
Intervention model description: Open-label
Masking: None (Open Label)
Primary purpose: Prevention
Effectiveness of Telerehabilitation on Subacromial Pain Syndrome
Condition: Subacromial Pain Syndrome
MeSH terms: Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effectiveness of supervised exercise therapy with
      active soft tissue and joint mobilization.

      The effectiveness of telerehabilitation- active mobilization and exercises in the evaluation
      of pain and function in patients with subacromial pain syndrome will be examined and compared
      with face-to-face treatment, which is passive manual therapy.
    

Detailed description: 
      Shoulder pain is common in the population. Various treatment modalities are used. Due to the
      Coronavirus disease (COVID-19), the problems in patients' access to hospitals and
      rehabilitation services caused telerehabilitation to be on the agenda. Telerehabilitation can
      be summarized as the delivery of rehabilitation services to those in need by using
      communication technologies. This method covers the steps of evaluation, monitoring,
      prevention, intervention, control, training, and consultation. In addition, as a new
      treatment application, its effectiveness will be measured in patients with shoulder pain.
    

Intervention name(s): Home Exercise Group; Manual Therapy Group; Telerehabilitation Group
Intervention type(s): Other; Other; Other
Intervention description(s): The home exercise program includes an educational training program and posture correction exercises. The program includes stretching and strengthening exercises of the neck and shoulder complex.; Manual Therapy includes deep friction massage and myofascial relaxation techniques to shoulder and neck complex, active and resistant shoulder complex movements, shoulder complex mobilization, mobilization cervical joints.
The home exercise program includes an educational training program and posture correction exercises. The program includes stretching and strengthening exercises of the neck and shoulder complex.; The telerehabilitation program applied to the same home exercise group. In addition, to the home exercises, these patients will apply active mobilization called self-mobilization. Self-myofascial release, active glenohumeral joint mobilization, thoracic mobilization, and active cervical mobilization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pain; Functionality; Patient Satisfaction
Development and Evaluation of the Healthy Beat Accupunch (HBA) Exercise Program for the Community Older Adults
Condition: Functional Fitness
Study type: Interventional

Summary: 
      The goals of this research project were: 1) to develop a senior-tailored Healthy Beat
      Accupunch (HBA) exercise program for community-dwelling older adults, 2) to test the effects
      of a six-month, instructor-led HBA exercise program, and 3) to evaluate the feasibility,
      compliance, and long-term effects of a six-month, DVD-guide HBA exercise program.
    

Detailed description: 
      A three-year, longitudinal, triangulation research method was applied. First Year (Phase I):
      A preliminary HBA exercise program, including hard copy descriptions and DVD demonstrations
      of each exercise, was mailed to the 16 experts in the Delphi advisory panel for their
      critique and evaluation. First Year (Phase II): A quasi-experimental, one-group,
      pretest-posttest design was used to pilot-test the feasibility of the HBA exercise program on
      a group of 31 community-dwelling older adults in a community care station. Second Year: A
      cluster randomized controlled trial was used to test the effects of a six-month,
      instructor-led HBA exercise program on the functional fitness (cardiovascular-respiratory
      function, body flexibility, muscle strength, and muscle endurance) of the community-dwelling
      older adults. Through the use of convenience sampling strategy, eight community care stations
      with 232 older adults in Kaohsiung were recruited and randomly assigned based on their
      community care stations to a HBA experimental group or a wait-list control group.
      Participants in the experimental group received the HBA exercise program led by trained and
      certified instructors, three times per week, 40 minutes per practice for six months;
      participants in the wait-list control group continued with their regular daily activities.
      One pre-test and two post-tests, three months apart, were conducted. Third Year: Using the
      same method as in the second year, participants from the second year continued practicing the
      HBA exercise program, but guided by a DVD, for another six months. The feasibility,
      compliance, and effectiveness of the DVD-led HBA exercise program on the community-dwelling
      older adults were tested, and another two post-tests, three months apart, were conducted on
      the same outcome measurements as in the second year.
    

Intervention name(s): Healthy Beat Accupunch exercise program; control
Intervention type(s): Other; Other
Intervention description(s): HBA has three phases and takes 40 minutes to complete.; participants maintain their daily activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effects of Phototherapy by Light-emitting Diode Therapy (LEDT) on Clinical, Biochemical and Biomechanical of Muscle Performance in Athletes
Condition: Athlete
Study type: Interventional

Summary: 
      Light-emitting diode Therapy (LEDT) has been used to improve human muscle performance in
      experimental models and human researches. Now, the investigators used LEDT to increase muscle
      performance of professional athletes with high performance.
    

Detailed description: 
      The study assessed muscle performance by vertical jump (height of jump and muscle power);
      creatine kinase; lactate; metabolism by resonance nuclear magnetic in urine; oxygen uptake
      (VO2) and its onset kinetic response.
    

Intervention name(s): Light-emitting diode therapy; Placebo light-emitting diode therapy
Intervention type(s): Device; Device
Other intervention name(s): LED; LED therapy; Other Names:; LED; Light-emitting diode therapy; LED therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Light-emitting diode therapy; Muscle performance; Aerobic performance; Lactate; Creatine kinase
A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed the interaction between single and multiple doses of aliskiren (150 mg
      and 300 mg) and furosemide (60 mg) in patients with heart failure.
    


Intervention name(s): Aliskiren 150 mg; Furosemide 60 mg; Placebo for Aliskiren; Aliskiren 300 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Aliskiren 150 mg tablet; Furosemide 60 mg commercially-available tablets; Matching placebo for aliskiren 150 mg and 300 mg; Aliskiren 300 mg tablet
Intervention MeSH terms: Furosemide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Heart failure,; aliskiren,; furosemide,; diuretic efficacy,; interaction
Effects of Kinesio Taping Techniques in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Study will investigate effects of two different kinesio taping techniques on pulmonary
      parameters of patients with COPD.
    

Detailed description: 
      Chronic Obstructive Pulmonary Disease (COPD) is an irreversible, progressive, treatable
      airway disease which causes dyspnea, wheezing, coughing and increased secretions in airways.
      Thoracic and respiratory mechanics are impaired, respiratory muscle strength and functional
      exercise capacity is decreased in patients with COPD. As a result dyspnea, limitation in
      activities of daily living, postural impairments, muscle length-strength relationship changes
      and increased mechanical loads on respiratory muscles occur. In literature it has been
      demonstrated that Kinesio Taping have therapeutic effects on respiratory functions and
      functional exercise capacity in patients with chronic neurological diseases who has
      additional respiratory impairments. Although there are several studies in literature
      investigating the effects of facilitation and inhibition taping techniques applied on
      respiratory muscles in patients with COPD, effects of thoracic and postural mechanical
      correction techniques as an alternative treatment modality in patients with COPD have not
      been investigated yet. In present study, effects of thoracic mechanical correction and
      facilitation taping techniques in patients with COPD will be investigated, and data will be
      collected for effects of thoracic mechanical correction taping on pulmonary parameters in
      patients with COPD.
    

Intervention name(s): Kinesio Taping
Intervention type(s): Device
Intervention description(s): Kinesio Taping is a special taping method developed by Dr. Kenzo Kase in 1973. This technique triggers natural healing responses of human body by activating nervous and circulatory systems. The tapes are thin, latex-free, cotton, porous and anti-allergenic, with equal thickness of epidermis. It has elastic properites which allows the tape to elongate to %55-60 of its original lenght. Tape can be used up to 1 week even after sweating or cleaning with water. There are different application techniques for different purposes. Facilitation technique facilitates muscle contractions and supports muscle function. Mechancial correction technique is used for joint positioning and correcting motion of muscle-joint dynamics.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Prospective, Double-Blinded, Randomized Crossover Study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; Mechanical Correction; Facilitation; Thoracic Taping; Kinesio Taping; Respiratory Muscle Strength; Pulmonary Functions; Functional Exercise Capacity
Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group
      study designed to evaluate the efficacy, safety, and tolerability of solabegron immediate
      release low dose or high dose tablets, compared to matched placebo, administered twice daily
      for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency,
      and predominantly urgency incontinence) for at least 6 months.
    


Intervention name(s): Solabegron immediate release tablets, low dose; Solabegron immediate release tablets, high dose; Matching Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): twice daily for 12 weeks.; twice daily for 12 weeks.; twice daily for 12 weeks.
Intervention MeSH terms: Solabegron
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Eligible female subjects (N=406) with symptoms of overactive bladder for at least 6 months will enter a 14-day single-blind Run-in Period. Subjects (N=375) who meet prespecified criteria based on data entered into an electronic diary over 3 days will be randomized 1:1:1 (125 subjects per arm) to receive solabegron immediate release tablets, low dose or high dose, or matching placebo.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: overactive bladder; urinary conditions; urgency urinary incontinence; urgency; micturitions
Clinical Endpoint Trial Investigating Once Daily and Bronchodilator Dosing
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Subjects will attend the unit for out-patient visits on Day 1, Day 7, Day 14 and Day 15 of
      each treatment period. The washout period between each treatment period will be a minimum of
      10 days and maximum of 28 days. Subjects will participate in 3 treatment periods.
    


Intervention name(s): GSK256066
Intervention type(s): Drug
Intervention MeSH terms: 6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: ASTHMA; CLINICAL ENDPOINT,
Timing of Iron Supplementation in Very Low Birth Weight Infants
Condition: Nutritional Status
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      To examine if early iron supplementation (starting oral iron at 14 days of life) would
      improve the nutritional iron status(measured by serum ferritin) of very low birth weight
      infants at postnatal age of 60 days, when compared to the standard regime of starting iron at
      2 months of life.
    

Detailed description: 
      Smaller the preterm infants at birth, more susceptible they are to iron deficiency due to low
      body iron stores. Despite having low iron stores, very low birth weight (VLBW) infants are
      not usually started on iron supplementation till they reach a postnatal age of 6 to 8 weeks.
      Such delayed supplementation can lead to rapid depletion of iron stores when erythropoiesis
      becomes active (by 8 weeks of life).

      Depletion of iron stores is the first step in the continuum of changes that occur in iron
      deficiency. Iron deficiency induces biochemical defects (such as impaired synthesis of DNA
      and collagen) even before any features of microcytic, hypochromic anemia become evident. The
      rapidly maturing preterm brain is especially vulnerable to the effects of iron deficiency;
      poor school-age performance has been reported among children who had low iron stores in their
      neonatal period.

      Early iron supplementation i.e. starting iron once the infant reaches full enteral feeds
      could potentially improve the iron stores and prevent its depletion. Surprisingly, few
      studies are available till date to support (or refute!) this view. The current study was
      designed to test the hypothesis whether early iron supplementation would increase the
      nutritional iron status (as measured by serum ferritin) at 60 days of life when compared to
      the existing regime of starting iron at the age 2 months.
    

Intervention name(s): Elemental iron
Intervention type(s): Drug
Intervention description(s): Iron in the dose of 3-4 mg/kg/day (of elemental iron) PO once daily mixed with expressed breast milk from 14 days of life till the end of study period
Other intervention name(s): 'Tonoferon' drops, East India Co
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Iron supplementation; Timing; Serum ferritin; Very low birth weight infants
Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis
Condition: Pouchitis
MeSH terms: Pouchitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic
      Antibiotic-resistant Pouchitis
    

Detailed description: 
      A Phase 2 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the
      Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
    

Intervention name(s): AMT-101 (oral)-Dose A; AMT-101 (oral)-Dose B
Intervention type(s): Drug; Drug
Intervention description(s): AMT-101 is an orally administered biologic therapeutic, taken once daily.; AMT-101 is an orally administered biologic therapeutic, taken once daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Disease
Dose Escalation Study of QR-010 in Homozygous ΔF508 Cystic Fibrosis Patients
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A randomized, double-blind, placebo-controlled study of single and multiple ascending doses
      of QR-010 in adults homozygous for ΔF508 Cystic Fibrosis.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability, and to determine the
      pharmacokinetics of QR-010 administered via inhalation in adult homozygous for ΔF508 Cystic
      Fibrosis.
    

Intervention name(s): QR-010; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton; Normal Saline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cystic fibrosis; ΔF508; RNA therapies; antisense oligonucleotide; CFTR; F508del; CF; RNA therapy