bioihbjkbjnl/mcl2 huggingface dataset:
Stretching and Strengthening Exercise in Fibromyalgia Patients
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia is a rheumatologic syndrome characterized by widespread chronic pain, tender
      points and other symptoms as fatigue, sleep disturbances, anxiety and depression. Therapeutic
      exercises are described as an important form to management of symptoms. This study aims to
      assess strengthening and stretching exercise efficacy in symptoms and quality of life of
      Fibromyalgia patients. The study is done at General Clinical Hospital of Medicine Scholl of
      University of Sao Paulo. 63 subjects undergo the study and they are divided into three
      groups: 1 strengthening exercise, 2 stretching exercise and 3 control group. Patients are
      evaluated by following instruments: Fibromyalgia Impact Questionnaire, Medical Outcomes Study
      36-item Short-Form Health Survey (SF-36), Stanford Health Assessment Questionnaire,
      dolorimetry at tender points by a Fischer dolorimeter, finger-to-tip floor test for muscular
      flexibility, dynamometer EMG System do Brasil for strength test of extension and flexion of
      knees and elbows, time to get up and go test, functional reach test, sit-to-stand test.
      Subjects of 1 strengthening exercise group undergo a global strengthening program and 2
      stretching exercise group undergo a global stretching program. All programs have 12 weeks of
      duration and physical therapy is twice a week. The control group does not do any intervention
      during 12 weeks and after the second evaluation they enter the common program of physical
      therapy. Data are being analyzed by descriptive and interferential statistics procedures.
    

Detailed description: 
      In this study, were included subjects with fibromyalgia diagnosis aged between 30 and 55
      years old. We aimed to assess the effect of a physical therapy program on impact of
      fibromyalgia syndrome and quality of life.
    

Intervention name(s): Strengthening Exercises; Stretching exercises
Intervention type(s): Other; Other
Intervention description(s): Exercises that aim the improvement of muscular strength of arms and legs; Exercises that aim the improvement of muscular flexibility of arms, legs and spine
Other intervention name(s): strengh exercise; flexibility exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibromyalgia, exercise, strength, stretch
Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional
Phase: Phase 3

Summary: 
      A multi-center, randomized, controlled clinical trial to evaluate the short-term and
      long-term efficacy and safety of mycophenolate mofetil (MMF) in reducing proteinuria and
      preserving renal function in patients with IgAN who have pre-treated (and continue to be
      treated) with angiotensin II receptor blockers (ARB), compared to the corticosteroids.
    

Detailed description: 
      There are four phases of study for each subject. Phase 1 the screening phase. During this
      phase each potential subject will be evaluated to determine if he/she is eligible for the
      study.

      Phase 2 the ARB lead-in phase will last for three months. Phase 3 the intervention phase.
      Each subject will be randomly received 12 months treatment with the study drugs (MMF,
      prednisone or MMF plus prednisone) Phase 4 following-up phase. All the patients will be
      followed by 3 years after study drug stopped.
    

Intervention name(s): irbesartan; methylprednisolone (MP) or prednisone (pred); mycophenolate mofetil (MMF)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In the ARB lead-in phase, each subject will be on a strict sodium-restricted diet ( < 5 g NaCl/day), and then given a stable dose (150mg ~ 300mg/day) of irbesartan (Aprovel) for 3 months until reaching the target blood pressure (BP) level of ≤ 125/75 mmHg. Patients will continue ARB treatment in the drug treatment phase and at lease 3 years in the follow-up phase.; Patients will take oral Pred ( 0.5 mg/kg/d) on alternate days, and on the first, third and fifth months of the drug treatment phase, patients will be given intravenous pulse therapy with methylprednisolone ( 0.5 g/day) for 3 successive days. And after 6 months, Pred should be tapered to be stopped until the end of the 12-month course of treatment.; Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt < 50kg) for the first 6-month of drug treatment phase, then to 0.5 bid (wt ≥ 50kg) for the remaining 6-month.
Other intervention name(s): Aprovel, Sanofi-synthelabo; Cellcept,Roche
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Irbesartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IgA nephropathy; mycophenolate mofetil
EPI-743 in Friedreich's Ataxia Point Mutations
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of EPI-743 in patients with Friedreich's
      Ataxia point mutations
    

Detailed description: 
      The primary objective of this study is to investigate whether treatment with EPI-743 has a
      discernible impact on visual function-including visual acuity, visual fields and color vision
      as well as on any of a number of functional and subject/clinician-rated scales relevant in
      the treatment of Friedreich's ataxia, and to determine the safety of treatment with EPI-743.
    

Intervention name(s): EPI-743
Intervention type(s): Drug
Intervention description(s): EPI-743 (alpha-tocotrienol quinone) is a small molecule therapeutic that was rationally designed to replete reduced glutathione through NQO1-catalyzed electron transfer from NADPH.
Other intervention name(s): Vincerinone, alpha-tocotrienol quinone
Intervention MeSH terms: Tocotrienols; Tocotrienol, alpha
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Friedreich's ataxia point mutation
Core Outcome Set for Head, Neck and Respiratory Disease in Mucopolysaccharidosis II
Condition: Mucopolysaccharidosis Type II
MeSH terms: Respiratory Tract Diseases; Respiration Disorders; Mucopolysaccharidosis II; Mucopolysaccharidoses
Study type: Observational

Summary: 
      The Mucopolysaccharidoses (MPS) are a family of genetic metabolic disorders, caused by
      specific enzyme deficiencies which result in accumulation of partially degraded
      glycosaminoglycans (GAGs) within various tissues. As GAGs are common in the body a number of
      different organ systems can be affected. Involvement of the upper and lower respiratory tract
      in MPS Type II results in significant airway compromise, with progressive airway obstruction
      being responsible for a significant proportion of the morbidity and mortality associated with
      this condition. Hearing loss is a universal finding in MPS, with a third of patients
      suffering with severe profound hearing loss. There is an unmet need for strong clinical
      evidence to guide treatment of head, neck and respiratory disease in MPS disorders. A Core
      Outcome Set (COS) describes the minimum outcome data that should be measured in a clinical
      study for a particular condition. The lack of an agreed COS for MPS II in general, and
      specifically head, neck and respiratory disease, makes comparison between studies difficult.
      There is also a lack of information detailing patient and parent perspectives on the MPS
      disorders. The ideal COS for head, neck and respiratory disease associated with MPS II would
      combine both patient/parent and clinician opinion and could be used in the design of all
      subsequent clinical studies. Following literature review the investigators have created a
      list of outcomes previously reported for qualitative and quantitative studies investigating
      head, neck and respiratory disease in MPS II. For the proposed research the investigators
      will seek opinions of patients, parents, clinicians and scientists to rate these outcomes via
      the Delphi method. Outcomes scored highest by patients, parents, clinicians and scientists
      will form a COS for head, neck and respiratory disease in MPS II. The development of a COS
      can help limit variability outcomes in studies investigating different interventions in MPS
      II.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients and parents, clinicians and scientists
Myocardial Protection With Adenosine Preconditioning
Condition: Heart Defects, Congenital; Cardiac Surgical Procedures; Myocardial Reperfusion Injury; Adenosine
MeSH terms: Reperfusion Injury; Heart Defects, Congenital; Myocardial Reperfusion Injury; Congenital Abnormalities
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Adenosine has been proved to be an important mediator of myocardial protection induced by
      ischemic preconditioning. The hypothesis of this study is that adenosine preconditioning can
      provide additional myocardial protection in the setting of pediatric open heart surgery with
      cardioplegia and cardiopulmonary bypass.
    

Detailed description: 
      Adenosine has been used for diagnosis and treatment of cardiovascular diseases for many
      years. New progresses in myocardial protection in the settings of acute myocardial infarction
      treatment put forward the its clinical use to a broader field. But the safety and
      effectiveness of its use in myocardial protection in the setting of open heart surgery has
      not been investigated intensively. Our primary results suggested that adenosine
      preconditioning could decrease the release of myocardial serum markers, such as cTnI. This
      study will focus on the safety and effectiveness of adenosine in the field of pediatric
      myocardial protection during surgery repair of congenital heart defects with CPB and
      cardioplegia.
    

Intervention name(s): adenosine
Intervention type(s): Drug
Intervention description(s): 1.5mg/Kg adenosine will be administered intravenously before surgery
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic Preconditioning, Myocardial; Adenosine
Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)
Condition: Exercise-Induced Bronchoconstriction (EIB)
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the efficacy of a single dose (2
      inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in
      patients with EIB.
    

Detailed description: 
      This study is a single-dose, randomized, double-blind, placebo-controlled, 2-treatment,
      2-sequence, 2-way crossover, multicenter study in patients with a documented history of EIB,
      with or without underlying asthma. Each patient will participate in the study for
      approximately 5 weeks. Each patient will complete 2 screening visits (SV1 and SV2), 2
      treatment visits (TV1 and TV2), and a follow-up telephone call (FV).
    

Intervention name(s): Albuterol Spiromax; Placebo Spiromax
Intervention type(s): Drug; Drug
Intervention description(s): Albuterol Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) containing a blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation represents a dose of 90 mcg of albuterol sulfate. Participants received one dose of two inhalations (180 mcg).; Placebo Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) delivering placebo to match the experimental drug. Participants received one dose of two inhalations.
Other intervention name(s): Albuterol DPI, ProAir® RespiClick
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise-Induced Bronchoconstriction (EIB); Spiromax®; Albuterol sulfate
Cabergoline and Hydroxyethyl Starch in Ovarian Hyperstimulation Syndrome Prevention
Condition: Complications Associated With Artificial Fertilization; Disorder of Endocrine Ovary
MeSH terms: Ovarian Hyperstimulation Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to assess whether, in GnRH agonist in vitro fertilization (IVF)
      cycles, where there is a risk of ovarian hyperstimulation syndrome (OHSS), the addition of
      cabergoline to the hydroxyethyl starch infusion could decrease OHSS incidence and severity.
    

Detailed description: 
      Women undergoing IVF cycles with GnRH agonist protocols, at risk of OHSS (more than 20
      follicles observed larger than 12 mm in diameter and/or estradiol levels of 3000-5000 pg/mL).

      Slow infusion of 500 ml of 6% HES during follicular aspiration alone or combined with 0.5 mg
      cabergoline administration for 8 days, starting on the day of hCG administration.
    

Intervention name(s): Cabergoline and Hydroxyethyl Starch; Hydroxyethyl Starch
Intervention type(s): Drug; Drug
Intervention description(s): 0.5mg; 0.5 mg cabergoline administration 8 days
Other intervention name(s): Dostinex; Hemoes
Intervention MeSH terms: Cabergoline; Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: IVF; ovarian hyperstimulation syndrome; cabergoline; hydroxyethyl starch; prevention
Analysis of Genes Present in Cutaneous T-cell Lymphoma Cells
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous
Study type: Interventional

Summary: 
      RATIONALE: Analyzing genes that are present in cancer cells may be useful in developing
      better methods to detect, predict, and treat cutaneous T-cell lymphoma.

      PURPOSE: Clinical trial to study genes that are present in cutaneous T-cell lymphoma cells.
    

Detailed description: 
      OBJECTIVES:

        -  Identify gene expression patterns in malignant T cells that can be used to diagnose
           cutaneous T-cell lymphoma.

        -  Determine the patterns of gene expression that distinguish normal skin-homing T cells
           from malignant T cells.

      OUTLINE: Patients are stratified by disease (Sezary syndrome vs mycosis fungoides) and prior
      treatment (yes vs no).

      All patients receive a physical examination, and a medical history is taken. Patients with
      Sezary syndrome undergo leukapheresis. Patients with plaque/tumor stage mycosis fungoides
      undergo skin biopsy of involved skin. Malignant T cells from blood or skin are then isolated
      and patterns of gene expression in the malignant T cells are compared to those in normal
      skin-homing T cells from healthy donors using a "gene chip" (Lymphochip).

      Patients are followed annually for 5 years.

      PROJECTED ACCRUAL: A total of 40 patients (20 per disease stratum) will be accrued for this
      study within 2 years.
    

Intervention name(s): laboratory biomarker analysis
Intervention type(s): Other
Primary purpose: Diagnostic
Keywords: cutaneous T-cell non-Hodgkin lymphoma; mycosis fungoides/Sezary syndrome
Organ Protection With Sevoflurane Postconditioning
Condition: Hepatectomy
Study type: Interventional

Summary: 
      Organ protection, volatile anesthetics, postconditioning, hepatic surgery
    

Detailed description: 
      This study aims at the evaluation of a potential attenuation of ischemic-reperfusion injury
      in the liver with sevoflurane postconditioning upon reperfusion.
    

Intervention name(s): Sevoflurane
Intervention type(s): Drug
Intervention description(s): 3.2 Vol % for postconditioning
Intervention MeSH terms: Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemia reperfusion injury; Organ protection
Longitudinal Analysis of Right Ventricular Remodeling in Response to Prolonged Strength Training Using 3D-echocardiography
Condition: Cardiac Remodeling, Ventricular; Right Ventricular Hypertrophy
MeSH terms: Hypertrophy, Right Ventricular; Hypertrophy; Ventricular Remodeling
Study type: Interventional

Summary: 
      Right ventricular (RV) physiological remodeling in response to prolonged strength exercise
      remains poorly studied. This prospective, non-randomized, single-center study, proposes to
      follow 24 healthy sedentary volunteers who will benefit from a high-intensity pure resistance
      training program over a 6-month period. The volunteers, aged between 18 and 40 years old and
      male, will be recruited and evaluated at the University Hospital center of Caen Normandy.
      Cardiac remodeling in response to physical exercise will be analyzed by trans-thoracic
      echocardiography repeated during the follow-up. The physical impact of the training program
      will be assessed by a treadmill exercise test predicting maximal oxygen consumption (VO2max)
      before and after completing the training, and an isokinetic muscular test repeated every 3
      months. Participants rest/activity cycles will be monitor before and after 3 months of
      training. The aim of the study is to demonstrate the existence of a physiologic RV remodeling
      in response to pure high-load resistance chronic exercise. The results will help to improve
      the understanding of the physiological RV response expected in strength athletes.
    


Intervention name(s): Strength physical training
Intervention type(s): Other
Intervention description(s): progressive high-load strength training over 6 months, consisting in repeated physical exercises to increase the muscular mass and force by altering concentric and eccentric muscle contractions against high resistance.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Right ventricle; cardiac physiology; strength training; echocardiography
Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation
Condition: Chronic Spinal Cord Injury; Neurogenic Bladder
MeSH terms: Spinal Cord Injuries; Urinary Bladder, Neurogenic; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy of home transcutaneous tibial nerve
      stimulation (TTNS) in spinal cord injury(SCI) and to determine the impact on quality of life
      using TTNS at home
    


Intervention name(s): High Dose; Low dose
Intervention type(s): Device; Device
Intervention description(s): Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks,with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 10 Hz and pulse width of 200ms in continuous mode will be used.; Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes
Other intervention name(s): TTNS stimulation; TTNS stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized sham-control trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: electric stimulation
The Laryngoscopic View With C-MAC Videolaryngoscope Miller Blade Lifting the Epiglottis or the Vallecula in Children
Condition: Intubation; Laryngoscopy
Study type: Interventional

Summary: 
      In this study, the investigators aim to evaluate the glottic visualization and time to
      intubation during laryngoscopy performed with the C-MAC VL size 1 Miller blade lifting the
      epiglottis or placing the tip of the blade on the base of the tongue (vallecula) in children
      younger than 2 years of age.
    

Detailed description: 
      Direct laryngoscopy (DL) is the most widely used method to ensure airway safety. In pediatric
      patients under two years of age, Miller laryngoscope blade is recommended as it removes the
      long and drooping epiglottis from the eye during laryngoscopy and shows the laryngeal
      entrance better.

      In the classical definition, the tip of the Miller blade is placed behind the epiglottis.
      However, if the intubator wishes, the Miller blade tip can be placed on the root of the
      tongue (vallecula) and used as a Macintosh blade.

      In the literature search, no study has been found so far comparing C-MAC VL 1 numbered Miller
      blade with intubation by removing the epiglottis or placing the blade on the vallecula. In
      this study, the investigators aimed to evaluate the glottic image and intubation time during
      laryngoscopy performed by lifting the epiglottis with the C-MAC VL No. 1 Miller blade or
      placing the tip of the blade on the base of the tongue in children under 2 years of age.
    

Intervention name(s): Videolaryngoscope size 1 Miller blade
Intervention type(s): Device
Intervention description(s): An intubating device that is used for endotracheal intubation. Endotracheal intubation will be performed by anesthesiologist with C-MAC videolaryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Infant; glottis; Laryngoscopy; Intubation
Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test the effectiveness and safety of two doses of solabegron against placebo
      in reducing the symptoms of overactive bladder.
    


Intervention name(s): Solabegron
Intervention type(s): Drug
Intervention MeSH terms: Solabegron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Overactive Bladder