bioihbjkbjnl/mcl2 huggingface dataset:
Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Lung Diseases; Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study are to evaluate the safety, tolerability and preliminary
      efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in
      patients with cystic fibrosis (CF) lung disease.
    


Intervention name(s): denufosol tetrasodium (INS37217)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: lung disease
Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula
Condition: Cow Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess the hypoallergenicity of a new thickened extensively
      hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a
      double blind placebo controlled food challenge, followed by a 3-month open feeding period.
    


Intervention name(s): Extensively Hydrolyzed formula; Amino acid formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Educational and Exercise Program as Secondary Prevention of Recurrent Lower Back Pain in Healthcare Workers
Condition: Acute Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      At Lyon University Medical Center, back problems are the leading cause of sick leave. The
      course of lower back pain is usually relatively short (recovery occurs within 4 to 6 weeks in
      90% of cases). However, about 5-10% develop chronic lower back pain. Although this is a
      relatively small group, the economic consequences are enormous (accounting for 70 to 80% of
      the total cost of lower back pain).

      Nowadays, some very general training sessions are offered to workers at Lyon University
      Medical Center, irrespective of their lower back pain status. These very general training
      sessions are mostly preventive and primary in nature (like back school program) despite the
      fact that these people already have a history of lower back pain, the main risk factor of
      recurrence and chronic pain.

      Since the 1980, some multidisciplinary functional restoration programs have been advised as a
      strategy for secondary and tertiary prevention of lower back pain.

      The purpose of this randomized controlled trial is to assess the effectiveness of physical
      exercise combined with an educational program and self-led exercise for Lyon University
      Medical Center workers with lower back pain. We hope this intervention will reduce the risk
      of recurrence and chronic lower back pain.
    


Intervention name(s): educational program; exercise program; Self-led exercises
Intervention type(s): Other; Other; Other
Intervention description(s): Educational program will consist of 1, 2-hour, small-group (8-patient) session with a specialist physician in Physical and Rehablilitation Medecine. Workers will be given information about lower back pain, pain and psychosocial risk factors for persistent or recurrent back-related disability; The exercise program will consist of 5, 90-minute, small-group (8-patient) sessions with a physical therapist. Healthcare workers will be taught exercises including warm-ups, floor exercises, and endurance training. Only one absence will be allowed, otherwise the worker will be considered as non-compliant.; Self-led exercises to perform as part of a daily exercise routine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Low back pain; recurrence; chronic low back pain; educational program; physical therapy; home exercise; compliance
Pilot Study of Pregnenolone Augmentation Targeting Cognitive Symptoms in Persistently Symptomatic Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Neurobehavioral Manifestations; Schizophrenia
Study type: Interventional

Summary: 
      This is a pilot study of pregnenolone as an augmentation treatment for schizophrenia. The
      goal of this placebo-controlled study is to provide preliminary efficacy data for potential
      pregnenolone effects on cognitive symptoms and negative symptoms in patients with
      schizophrenia. Depressive symptoms and positive symptoms will also be assessed.
    

Detailed description: 
      See brief summary
    

Intervention name(s): Pregnenolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pregnenolone 50 mg twice a day (BID) x 2 weeks, Pregnenolone 150 mg BID x 2 weeks, Pregnenolone 250 mg BID x 4 weeks; Placebo (similar to active comparator) 50 mg BID x 2 weeks, Placebo (similar to active comparator) 150 mg BID x 2 weeks, Placebo (similar to active comparator) 250 mg BID x 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Pregnenolone; Cognition; Negative Symptoms
An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has
      considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric
      emergencies and is associated with significant morbidity and mortality. The purpose of the
      study is to evaluate the safety and efficacy of open-label memantine in the acute management
      of adults with bipolar I disorder hospitalized for mania.
    


Intervention name(s): Memantine HCl
Intervention type(s): Drug
Intervention MeSH terms: Memantine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar I Disorder; Mania; Memantine HCl
Pulmonary Function and Neuromuscular Disease
Condition: Neuromuscular Diseases
MeSH terms: Neuromuscular Diseases
Study type: Observational

Summary: 
      This study aims to describe the evolution of pulmonary function in 3 neuromuscular diseases :
      Duchenne muscular dystrophy, Werdnig-Hoffinann disease, congenital myopathy, monitored in
      Besançon university hospital.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children suffering from neuromuscular diseases and followed-up in Besançon University
        Hospital between 2006/01/01 and the beginning of this study
Safety, Tolerability and Relative Bioavailability of Pegvisomant in Healthy Subjects
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis to be tested is that the bioavailability of the new 30-mg vial is similar to
      that of the current approved 15 -mg vials. In addition, the SC injection using the new 30-mg
      vial is safe and well-tolerated.
    


Intervention name(s): pegvisomant; pegvisomant; pegvisomant; pegvisomant
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One 1-mL subcutaneous injection at 30 mg/mL. A 30-mg vial is supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).; Two 1-mL subcutaneous injections at 15 mg/mL each. Two 15-mg vials are supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).; Two 1-mL subcutaneous injections at 15 mg/mL each. Two 15-mg vials are supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).; One 1-mL subcutaneous injection at 30 mg/mL. A 30-mg vial is supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).
Other intervention name(s): B2036-PEG; B2036-PEG; B2036-PEG; B2036-PEG
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Relative bioavailability; pegvisomant
Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy
Condition: Tonsillar Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      -  Tonsillectomy is a common pediatric procedure for the treatment of sleep-disordered
           breathing and chronic tonsillitis. Up to half of children having this procedure
           experience a perioperative respiratory adverse event.

        -  We tried to determine whether tulobuterol patch (transdermal bronchodilator)
           premedication decreases the risk of perioperative respiratory adverse events in children
           undergoing anesthesia for tonsillectomy.
    


Intervention name(s): Tulobuterol Hydrochloride; Placebo transdermal patch
Intervention type(s): Drug; Drug
Intervention description(s): The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.; The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.
Intervention MeSH terms: Tulobuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Multicentre, Randomised, Open-label, Controlled, 12-month Follow-up Study to Assess Impact on Renal Function of an Immunosuppression Regimen Based on Tacrolimus Minimisation in Association With Everolimus in de Novo Liver Transplant Recipients.
Condition: Liver Transplant
Study type: Interventional
Phase: Phase 3

Summary: 
      Assuming greater efficacy in the prevention of acute rejection in the EVR arm with
      minimisation of TAC levels, the hypothesis of the present trial was that the introduction of
      EVR in combination with the minimisation of TAC (rTAC) may offer improved kidney function
      compared with standard therapy with TAC-MMF.
    

Detailed description: 
      A multicentre, randomized, open-label, controlled, exploratory clinical trial with 12-months
      (52 weeks) of follow-up.
    

Intervention name(s): Minimisation of TAC; TAC + MMF + corticosteroids
Intervention type(s): Drug; Drug
Intervention description(s): •EVR: Treatment started at a total daily dose of 2 mg within 24 hours after randomisation. The dose of EVR was adjusted upon reaching trough levels (C-0h) in whole blood of 3-8 ng/mL. The daily dose (in two administrations) of EVR may have been modified to maintain trough levels (C-0h) in whole blood of 3-8 ng/mL until Week 52 post-transplant. •TAC: Once confirmation was obtained, beginning in Week 5, that trough levels (C-0h) in whole blood of EVR were between 3-8 ng/mL, minimisation of TAC began, in order to reach trough levels (C-0h) of TAC in whole blood of ≤5 ng/mL no later than four weeks after randomisation (Week 8), which were levels that should have been maintained until Week 52 post-transplant. •MMF was withdrawn at the same time that EVR was introduced. •oral corticosteroids was administered in accordance with local clinical practice, although a therapeutic strategy free of corticosteroids was permitted; •Dose of TAC: Trough levels (C-0h) of TAC in whole blood should have been maintained between 6-10 ng/mL until Week 52 post-transplant. •Dose of MMF: Doses of 500-1000 mg/12 hrs was maintained until Week 52. •Corticosteroids: During the study, oral corticosteroids was administered in accordance with local clinical practice, although a therapeutic strategy free of corticosteroids was permitted (e.g. in patients with a history of HCV). It was recommended in any case that corticosteroids not be administered beyond Week 24 post-transplant except in cases of hepatopathy of autoimmune origin. At each centre all patients should have followed the same administration protocol for corticosteroids based on history of HCV.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A multicentre, randomized, open-label, controlled, exploratory clinical trial with 12-months (52 weeks) of follow-up".
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: De Novo Liver Transplant, Tacrolimus Minimisation, Everolimus, Renal Function, Liver transplant, allograft rejection, xenograft rejection, host vs graft disease
Moxibustion in Osteoarthritis of the Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter , double-blinded, double-dummy, randomized controlled clinical trial to
      evaluate the efficacy of moxibustion for osteoarthritis of the knee.
    

Detailed description: 
      Aim: To evaluate the effectiveness of moxibustion treatment for patients with osteoarthritis
      of the knee, with respect to relieving pain, improving the dysfunction and improving their
      quality of life as well.

      Design: A multicentre, double-blinded, double-dummy, randomized controlled clinical study
      will be performed in China. Eligible participants will be randomly assigned to moxibustion
      group (real moxibustion plus placebo gel) and the control group (diclofenac sodium gel plus
      sham moxibustion) with a 1:1 allocation ratio. Participants in both groups will receive 12
      sessions of real/sham moxibustion in 4 weeks at 3 acupoints (ST35, EX-LE4, ST36 ). Either
      diclofenac sodium gel or placebo gel will be applied 4 g per knee 4 times daily for 4 weeks.
      The whole study period is 13 weeks, with a 1-week run-in period, 4-week treatment phase, and
      8-week follow-up phase. The primary outcome measure will be the change of the global scale of
      the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the end of the
      course. The secondary outcomes include the change of other subscales (pain, stiffness, and
      function) of WOMAC, Visual Analogue scale (VAS) and Patient Global Assessment (PGA). Safety
      will be assessed at every visit.
    

Intervention name(s): real moxibustion; placebo gel; diclofenac sodium gel; sham moxibustion
Intervention type(s): Other; Drug; Drug; Other
Intervention description(s): 3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 ); 4 grams per knee, 4 times per day, for 4 weeks; 4 grams per knee, 4 times per day, for 4 weeks; 3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 )
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee osteoarthritis; moxibustion; diclofenac sodium gel
Treatment of Unresectable Colorectal Metastases by Radiofrequency Ablation Combined or Not With Resection, With or Without Neoadjuvant Chemotherapy.
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Study type: Interventional

Summary: 
      The hypothesis is that radiofrequency ablation combined or not with resection may allow a
      local control (the liver) in patients suffering from unresectable colorectal liver
      metastases. Patients may have benefit or not from a preoperative (neoadjuvant) chemotherapy.
    


Intervention name(s): Ablathermy
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Radiofrequency ablation; Colorectal cancer; Liver metastases
Prevention of Atrial Fibrillation After Coronary Artery Bypass Grafting in Patients With Obstructive Sleep Apnea
Condition: Atrial Fibrillation; Obstructive Sleep Apnea; Coronary Artery Bypass Grafting
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Atrial Fibrillation
Study type: Interventional

Summary: 
      Background. Atrial fibrillation is one of the most common complications in the postoperative
      period of coronary artery bypass grafting (CABG) surgery and usually associated with
      increased length of hospital stay and higher hospital costs. Among the main mechanisms
      involved, excessive sympathetic activation, oxidative stress and inflammation are fundamental
      elements in the pathophysiology of obstructive sleep apnea. Objectives. To evaluate the
      effects of continuous positive airway pressure (CPAP) in reduction of atrial fibrillation
      after CABG in patients with obstructive sleep apnea. Methodological procedures: A multicenter
      randomized controlled study to compare the incidence of atrial fibrillation between the
      intervention group and the control group, both monitored seven days with Holter.
    


Intervention name(s): CPAP
Intervention type(s): Device
Intervention description(s): patients will receive CPAP therapy with Auto-CPAP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Study type: Interventional
Phase: Phase 1

Summary: 
      Limited data are available on valaciclovir use in children and valaciclovir is not currently
      approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use
      in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An
      extemporaneous suspension formulation of valaciclovir has been developed to expedite the
      provision of benefits to children similar to those from administration of valaciclovir solid
      formulations in adults.
    


Intervention name(s): Valaciclovir
Intervention type(s): Drug
Intervention description(s): Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
Intervention MeSH terms: Valacyclovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics herpes varicella herpes labialis Epstein-Barr virus
Comparison Between Different Technologies That Measure Respiratory Rate
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Respiration rate is a critical vital sign that provides early detection of respiratory
      compromise and patient distress. Continuous monitoring of respiration rate is performed in
      patients under different clinical conditions, including post-surgery or different respiratory
      diseases. Clinician observation, pulse oximetry, and capnography are used individually or in
      combination to monitor ventilation during sedation and on post-surgical patients. The
      American Society of Anesthesiologists mandates the monitoring of respiration by measuring end
      tidal carbon dioxide (RRetco2) during procedural sedation and anesthesia. Other techniques
      for respiration rate measurement include different technologies such as acoustic respiratory
      rate (RRa). The aim of this study is to compare the accuracy of RRetco2 and RRa under certain
      respiratory conditions.
    


Intervention name(s): Radical 7; Capnostream20p; PTAF2
Intervention type(s): Device; Device; Device
Intervention description(s): Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Radical 7 measures respiratory rate according to acoustic respiratory rate (RRa).; Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Capnostream20p measures respiratory rate using capnography (RRetCO2).; Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. PTAF2 measures respiratory rate using flow pressure (RRflow).
Other intervention name(s): Flowmeter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Respiratory Conditions for Adults
Vaginal Progesterone for Prevention of Preterm Labor in Asymptomatic Twin Pregnancies With Sonographic Short Cervix
Condition: Premature Labour
MeSH terms: Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in
      asymptomatic twin pregnancies who have sonographic short cervix
    

Detailed description: 
      Women with twin pregnancy with transvaginal sonographic cervical length of 20-25 mm at 20-24
      weeks gestational age without symptoms, signs or other risk factors of preterm labor will be
      included in the study. All women will be randomly divided into two groups; one group (study
      group) received vaginal progesterone suppositories in a dose of 400 mg daily beginning at
      20-24 weeks gestational age (study group) and the other group received no treatment (control
      group)
    

Intervention name(s): Progesterone
Intervention type(s): Drug
Intervention description(s): Women received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age
Other intervention name(s): Cyclogest
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Twins; Preterm labor; Progesterone; Short cervix
Examining the Impact of Blood Flow Restricted Aerobic Exercise on PGC-1α mRNA Expression in Young Healthy Males
Condition: Mitochondrial Biogenesis
Study type: Interventional

Summary: 
      This crossover study investigates the effects of restricting arterial blood flow during
      cycling exercise on PGC-1α and its upstream signalling pathways. In a randomized order,
      participants will exercise once for 30 minutes with restricted blood flow and then will
      exercise once for 30 minutes with no blood flow restriction.
    


Intervention name(s): BFR Exercise; CTL Exercise
Intervention type(s): Other; Other
Intervention description(s): Participants will exercise on a recumbent bike placed on a 45 degree incline (BFR).; Participants will exercise on a recumbent bike placed on flat ground (CTL).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Acute Exercise; Mitochondria; Skeletal Muscle; PGC1α; Mitochondrial Biogenesis; Intracellular Signalling