bioihbjkbjnl/mcl2 huggingface dataset:
Study of Eteplirsen in DMD Patients
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to provide evidence of efficacy of eteplirsen (AVI-4658)
      in Duchenne muscular dystrophy (DMD) patients that are amenable to skipping exon 51.
      Additional objectives include evaluation of safety, biomarkers and the long-term effects of
      eteplirsen up to 96 weeks, followed by a safety extension (not to exceed 48 weeks).
    

Detailed description: 
      This is an open-label, multi-center study to evaluate the efficacy and safety of eteplirsen
      in patients with genotypically confirmed Duchenne muscular dystrophy (DMD) with genetic
      deletions amenable to exon 51 skipping (treated group), with a concurrent control arm of DMD
      patients not amenable to exon 51 skipping (untreated group). Following primary efficacy
      endpoints, dosing will continue to week 144 to evaluate the long term effects of eteplirsen.

      Patients in the treated group will receive once weekly intravenous (IV) infusions of 30 mg/kg
      Eteplirsen for 96 weeks, followed by a safety extension (not to exceed 48 weeks). Patients in
      the untreated group will not receive treatment.

      Clinical efficacy will be assessed at regularly scheduled study visits, including functional
      tests such as the six minute walk test. Patients in the treated group will undergo a muscle
      biopsy at Baseline and a second muscle biopsy over the course of the study. Patients in the
      untreated group will not undergo muscle biopsy.

      Safety, including adverse event monitoring and routine laboratory assessments, will be
      continuously monitored for all patients.
    

Intervention name(s): eteplirsen
Intervention type(s): Drug
Intervention description(s): Eteplirsen 30 mg/kg will be administered as an IV infusion once a week for 96 weeks, followed by a safety extension (not to exceed 48 weeks).
Other intervention name(s): AVI-4658; EXONDYS 51®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DMD, Duchenne, Eteplirsen, dystrophy, dystrophin, exon 51
Venous Thromboprophylaxis in Bariatric Surgery
Condition: Obesity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The main aim of this study is to compare the influence of total body-weight (TBW), lean
      body-weight (LBW), ideal body-weight (IBW) or Body Mass Index (BMI) on peak anti-Xa levels at
      steady-state in bariatric surgery (BS) morbidly obese patients receiving a fixed double dose
      of dalteparin (5000 IU subcutaneously, twice daily a day) for venous thromboembolism (VTE)
      prevention. Secondary aims of this study are to identify which body size descriptors (BSD)
      has the greatest impact and could further be explored for an adjusted low molecular weight
      heparin (LMWH) dosing algorithm for achieving optimal VTE prevention in BS severely obese
      patients.
    

Detailed description: 
      Severely obese patients undergoing bariatric surgery (BS) are at increased risk for venous
      thromboembolism (VTE). How standard LMWH regimen should be adapted to provide both sufficient
      efficacy and safety in this setting is unclear. The aim of this study is to compare the
      influence of four BSD on peak anti-Xa levels in BS obese patients receiving high LMWH fixed
      doses to identify which one had the greatest impact and could further be proposed in
      LMWH-based thromboprophylaxis dosing algorithms.
    

Intervention name(s): Dalteparin
Intervention type(s): Drug
Intervention MeSH terms: Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese patients undergoing bariatric surgery
      
Keywords: Obesity; Venous thromboembolism; Heparin, Low-Molecular-Weight; Body Composition; Glomerular filtration rate; Bariatric Surgery
Rehabilitation by Effort for Patients With Advanced Bronchial Cancer
Condition: Bronchial Cancer; Malignant Mesothelioma
MeSH terms: Mesothelioma; Mesothelioma, Malignant; Carcinoma, Bronchogenic
Study type: Interventional

Summary: 
      Bronchopulmonary cancers or mesothelioma are associated with effort deconditioning due to
      pathology (chronic inflammation) and also to treatments (surgery, radiotherapy,
      chemotherapy); it's considerably alters patients quality of life.

      Investigators want to ensured the feasibility of rehabilitation by effort for these patients.
    


Intervention name(s): rehabilitation by effort
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: bronchial cancer; rehabilitation
Embryo Transfer: Direct Versus Afterloading Trial
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate two types of embryo transfer procedure.

      The investigators will compare direct embryo transfer against afterloading embryo transfer.
    


Intervention name(s): Afterloading embryo transfer procedure; Direct embryo transfer procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): Afterloading embryo transfer procedure; Direct embryo transfer procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Embryo transfer; IVF; Ultrasound embryo transfer
Propranolol Versus Placebo for Induction of Labor in Nulliparous Patients
Condition: Induction of Labor Affected Fetus / Newborn
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, prospective trial will be offered to women admitted to the labor floors at
      Mount Sinai Medical Center for labor induction.
    

Detailed description: 
      Induction of labor is a common obstetric procedure, which is performed to provoke the onset
      of labor and lead to delivery of the fetus. While some early studies suggested a possible
      increased rate of cesarean with induction of labor, more recent meta-analyses have shown that
      induction does not influence this rate. There is data from small randomized studies that
      demonstrates the effectiveness of propranolol, a non-selective beta-blocker, for induction of
      labor. This literature suggests a decrease in the amount of time to delivery and a possible
      reduction in cesarean section rates when propranolol is used in conjunction with oxytocin for
      induction of labor compared to oxytocin alone.
    

Intervention name(s): Propranolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol.; After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline
Other intervention name(s): saline
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Induction; Labor; Propranolol
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to demonstrate the superior clinical effectiveness of
      Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent
      asthma in children aged 6-14 years, and to assess the effect of each treatment
      [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)] on lung function,
      asthma control, Health Outcomes including the child's quality of life as measured by
      Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life
      as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at
      selected centers where a valid translation is available.
    

Detailed description: 
      Pediatric Asthma Clinical Effectiveness study (PEACE). A Randomized, Double-Blind, Double
      Dummy, Parallel Group comparative clinical study of Salmeterol/Fluticasone propionate
      Inhalation Powder (50/100mcg BID) via DISKUS† with Oral montelukast (5mg QD) Chewable Tablets
      in Children 6-14 years of Age with Persistent Asthma
    

Intervention name(s): montelukast (5mg QD); Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)
Intervention type(s): Drug; Drug
Other intervention name(s): montelukast (5mg QD)
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Persistent Asthma; pediatric asthmatic; asthma control
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
Condition: Hepatitis B; Liver Transplantation
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of
      Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV)
      reinfection in patients submitted to liver transplantation due to HBV-induced liver disease
      by reaching and maintaining certain hepatitis B antibody (HBsAg) levels considered as
      protective during the first six and twelve months post-transplantation.
    


Intervention name(s): Hepatitis B immune globulin
Intervention type(s): Drug
Intervention description(s): Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively.
Other intervention name(s): Niuliva
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; HBV; Orthotopic liver transplantation; Liver transplantation; Recurrence; Reinfection; Protective titers; HBsAb; Hepatitis B virus immune globulin; Niuliva
Effects of Robotic-assisted Gait Training In Non-Ambulatory Patients After Guillain-Barré Syndrome
Condition: GBS
MeSH terms: Guillain-Barre Syndrome
Study type: Interventional

Summary: 
      This study investigates the effects of Robotic-assisted gait training in non-ambulatory
      patients after Guillain-Barré syndrome.The participants are randomly divided into two
      groups.Patients of the treatment group receive robotic-assisted gait training,while the
      contorls receive conventional rehabilitation.
    

Detailed description: 
      Guillain-Barré syndrome (GBS) is an acute autoimmune disease of the peripheral nervous
      system, which may lead to rapidly developing motor deficits, sensory deficits, autonomic
      dysfunction and respiratory failure. Approximately, 20.3% of patients cannot walk unaided at
      4 weeks of symptom onset and 18.0% at 6 months. So, restoration and improvement of
      independent walk are one of major goals of GBS rehabilitation. For severely affected
      neurological patients, gait training using conventional therapy is technically difficult due
      to their motor weakness and balance problems. Robotic-assisted gait training （RAGT）is an
      effective alternative to treadmill therapy with partial body weight in intense gait
      rehabilitation after some neuropathy. And the proven reliability and safety of RAGT suggest
      that it may be effective for treating non-ambulatory patients after some neuropathy. In our
      study, we investigated the anti-inflammatory effects of RAGT in non-ambulatory patients of
      GBS.
    

Intervention name(s): Robot-assisted Gait Training; conventional rehabilitation
Intervention type(s): Device; Other
Intervention description(s): Robot-assisted Gait Training is an effective alternative to treadmill therapy with partial body weight in intense gait rehabilitation and provided to the feet and the patient actively controls the knee and hip joints.; The participants of controls receive 60 min conventional rehabilitation daily for 8 weeks. Interventions included physiotherapy for muscle strengthening, endurance and gait training; occupational therapy to improve activity of daily living (domestic, community tasks).
Other intervention name(s): LokoHelp
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Taekwondo Training and Postmenopausal Women With Stage-2 Hypertension
Condition: Menopause; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Aging is associated with hormonal imbalances and progressive decreases in arterial health and
      function. It is crucial to prevent or reduce the negative effects of aging on hormonal
      balance and the vasculature by implementing appropriate lifestyle interventions, such as
      exercise training. We examined the effects of a 12-week Taekwondo training program on blood
      catecholamines, arterial stiffness (pulse wave velocity, PWV), blood pressure (BP), resting
      heart rate, and muscular strength in postmenopausal women with stage 2 hypertension.
    

Detailed description: 
      Using a parallel experimental design, participants were randomly assigned to either a
      Taekwondo exercise training group (n=10) or non-exercising control group (n=10) for 12 weeks.

      Participant in the Taekwondo training group trained 3 days/week for 60 minutes per session,
      and the intensity progressed weekly. Participants in the control group performed no exercise
      intervention.
    

Intervention name(s): Taekwondo training
Intervention type(s): Behavioral
Intervention description(s): Exercise group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel design with treatment group and control
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Taekwondo; Menopause; Hypertension; Arterial Stiffness; Blood Catecholamines
A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress
Condition: Stress, Psychological; Healthy
MeSH terms: Stress, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical trial is to determine whether Probiotic can modulate the
      psychological stress experienced by healthy medical, dental and health science students
      preparing for university/institute of technology semester examination (s), measured by
      self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.
    

Detailed description: 
      The purpose of this clinical trial is to determine whether Probiotic can modulate the
      psychological stress experienced by healthy medical, dental and health science students
      preparing for university/institute of technology semester examination (s), measured by
      self-report scales and hypothalamic pituitary adrenal axis activity, compared with placebo.

      The target group of the proposed study will consist of stress vulnerable / sensitive, healthy
      male and female adult participants currently enrolled in medical, dental or health science
      university course that are experiencing psychological stress induced by preparation for
      university/institute of technology semester examination (s).
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Probiotic; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Probiotic; Stress; Gut-brain axis
Mind-Body Medicine Day Care Clinic in Breast Cancer Patients Undergoing Endocrine Therapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This randomized controlled trial aims to investigate the effectiveness of a mind body day
      care clinic program of breast cancer patients undergoing endocrine therapy.
    

Detailed description: 
      Breast cancer patients undergoing endocrine therapy are often suffering from side effects.
      This randomized controlled trial analyzes the effects of an 11-week day care clinic group
      program including mind body medical elements (yoga, relaxation, meditation, education) and
      acupuncture in breast cancer patients with menopausal symptoms under endocrine therapy.
    

Intervention name(s): Mind body medicine day care clinic; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education; Patients continue usual care by their practitioner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast cancer; meopausal syptoms; mind body medecine; yoga; acupuncture
A Comparison of Two Adjunctive Treatments in Arthroscopic Cuff Repair
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      This Clinical Trial is being conducted to study two adjunctive treatments for rotator cuff
      repair; soft tissue and bone trephination. "Trephination" is a procedure that involves making
      small perforations either in the torn tendon near its edge, or in the bone that the tendon is
      repaired to. The rotator cuff is repaired by sewing the tendon down to the bone in the
      shoulder. Trephination is a new technique that is used in addition to the standard method of
      repairing the rotator cuff tendon.

      This study will help to determine whether this technique improves the speed of healing, the
      strength and the re-tear rate of the repair. You are being asked to take part in this study
      because you have a tear of the rotator cuff that requires surgical treatment. A total of 90
      participants will participate in this study.
    


Intervention name(s): Bone Trephination; Soft Tissue Trephination
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rotator cuff tear
Pharmacokinetic Study of 4 mg Nicotine Lozenge.
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, single center, open label, single dose, four way crossover study in
      fasted healthy male subjects to compare the pharmacokinetics of nicotine following
      administration of 3 prototype 4mg nicotine lozenge to an internationally marketed 4mg
      nicotine lozenge. Blood samples will be drawn at pre-specified intervals for a total of 12
      hours post dose in each treatment session and plasma samples analyzed for nicotine levels.
    


Intervention name(s): nicotine
Intervention type(s): Drug
Intervention description(s): 4 mg nicotine lozenge experimental
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
IV Paracetamol, Dexketoprofen or Morphine for the Treatment of Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous
      single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain.
    

Detailed description: 
      Study Design and Setting:

      This is a single-center, prospective, randomized, double-blind, clinical trial performed in
      an ED of a tertiary care hospital with annual census of approximately 37.000 visits. The
      local ethics committee approved the study.

      Interventions:

      We conducted a randomized, controlled clinical trial comparing single intravenous doses of
      paracetamol (1 g), dexketoprofen (50 mg) and morphine (0.1 mg/kg) for patients presenting to
      the emergency department (ED) with suspected low back pain. Subjects with inadequate pain
      relief at 30 minutes received rescue fentanyl (0.75 microg/kg). We compared changes in pain
      intensity 30 minutes after treatment.

      Methods of Measurements:

      Subjects reported pain intensity on both a 100-mm visual analogue scale (limited by 'no pain'
      and 'the worst pain') and a 4-point verbal rating scale (no pain, mild, moderate, or severe
      pain) just before the drug administration, 15th minutes and 30th minutes after the study drug
      administration. The demographic features of study patients and adverse effects, nausea,
      vomiting, dizziness, vertigo, headache, hypotension, altered mental status, allergic
      reaction, itching, urinary retention, thoracic rigidity, respiratory depression and dry
      mouth, were recorded to the study form.

      Outcome Measures The primary outcome measure was the pain reduction in VAS and VRS at 15th
      and 30th minutes. Secondary outcome measures were the need for rescue drug and the presence
      of any adverse event.

      Primary Data Analysis:

      The present study was planned as a superiority trial. When the 20 mm difference in VAS is
      accepted as clinically significant and the standard deviation is accepted as 25 mm, 35
      patients are needed with each group with 95% power. All the analysis were implemented
      according to the intention to treat analysis. The precise of differences between time
      intervals within groups and between groups and statistical significance were expressed by 95%
      confidence intervals (95% CI).
    

Intervention name(s): paracetamol; morphine; Dexketoprofen; Paracetamole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 gr; 0.1mg/kg intravenous in 100 ml serum physiologic; 50 mg; 1 gr
Other intervention name(s): Perfalgan; Morphine CHL 0.01 gr; Arveles; Perfalgan
Intervention MeSH terms: Acetaminophen; Dexketoprofen trometamol; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Low back pain; paracetamol; dexketoprofen; morphine