bioihbjkbjnl/mcl2 huggingface dataset:
Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients
Condition: B-cell Acute Lymphoblastic Leukemia; Relapsed B-cell Acute Lymphoblastic Leukemia; Refractory B-cell Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a single arm, open-label, multi-center, phase II study to determine the efficacy and
      safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell
      acute lymphoblastic leukemia, who were refractory to standard chemotherapy regimen or
      relapsed after allogeneic stem cell transplant.
    


Intervention name(s): CTL019 T-cells
Intervention type(s): Biological
Intervention description(s): A target dose of CTL019 transduced cells will consist of a single infusion of 2.0 to 5.0 x 10^6 CTL019 transduced cells per kg body weight (for patients ≤ 50 kg) and 1.0 to 2.5 x 10^8 CTL019 transduced viable T cells (for patients > 50 kg). The following cell dose ranges may be infused if all other safety release criteria are met: 0.2 to 5.0 x 10^6 CTL019 transduced viable T cells per kg body weight (for patient ≤ 50 kg) and 0.1 to 2.5 x 10^8 CTL019 transduced viable T cells (for patients > 50 kg).
Other intervention name(s): tisagenlecleucel
Intervention MeSH terms: Tisagenlecleucel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: relapsed/refractory; Philadelphia chromosome positive acute lymphoblastic leukemia; Pharmaceuticals; Philadelphia chromosome positive; Acute Lymphoid Leukemia (ALL); Acute Lymphocytic Leukemia (ALL); CTL019; tisagenlecleucel
Fiberoptic Evaluation of the LMA(Laryngel Mask Airway) Position During Anesthesia With Spontaneous Respiration or Controlled Ventilation in Children
Condition: Pediatric Urologic Surgery
Study type: Observational

Summary: 
      LMA(Laryngel Mask Airway) is useful for pediatrics surgery, and there are various methods of
      LMA insertion. When the investigators evaluate the LMA position, the investigators can use
      fiberoptic bronchoscope (Grade 1 to 4). For pediatric patients, clinical signs(airway
      pressure<20cmH2O, expiratory CO2 level)are seen normal but the grade is 3 or 4. And this will
      bring high risk of aspiration. Recent studies reported the LMA position after general
      anesthesia induction not after operation. Therefore, the investigators will observe the LMA
      position three times; after general anesthesia induction, after caudal block, and after
      operation as well as the difference regarding to spontaneous and controlled ventilation.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients who are planed to get urologic surgery under general anesthesia using
        LMA
      
Keywords: fiberoptic, LMA, caudal block
Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever (YF) Vaccines Followed by a Booster of the Malaria Vaccine.
Condition: Malaria; Malaria Vaccines
MeSH terms: Malaria; Rubella; Yellow Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the
      SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and
      yellow fever vaccines to children aged 6 months at the first vaccination.
    


Intervention name(s): Vitamin A; Candidate Plasmodium falciparum malaria vaccine; MR-Vac; Stamaril
Intervention type(s): Dietary Supplement; Biological; Biological; Biological
Intervention description(s): Oral administration of Vitamin A (1 dose); Intramuscular administration of SB257049 vaccine (4 doses); Subcutaneous injection of a combined measles and rubella vaccine (1 dose); Intramuscular injection of a yellow fever (YF) vaccine (1 dose)
Other intervention name(s): GSK Biologicals' candidate Plasmodium falciparum malaria vaccine adjuvanted with GSK Biologicals' proprietary Adjuvant System AS01E (RTS,S/AS01E); Live attenuated measles virus and rubella virus vaccine (MR-Vac); Yellow Fever (YF) Vaccine
Intervention MeSH terms: Vitamin A; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; Infants; SB257049; Malaria; Immunogenicity; Surveillance; Efficacy; Safety; Africa; Plasmodium falciparum
Gel-One Treatment in Knee Osteoarthritis
Condition: Osteoarthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Gel-One demonstrates a superior
      effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS)
      injections.
    


Intervention name(s): Gel-One; PBS
Intervention type(s): Device; Device
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Knee; Osteoarthritis; Intra-articular injection
The Effect of Whole-body Vibration Training
Condition: Biomarkers
Study type: Interventional

Summary: 
      The whole-body vibration programme employed in this study partly improved the biomarkers and
      health beliefs of the prefrail community-dwelling older adults.
    

Detailed description: 
      The experimental group participated in a 12-week whole-body vibration training that conducted
      3 times per week, with 5-min continuous vibration at 12-Hz frequency and 3-mm amplitude each
      time
    

Intervention name(s): whole-body vibration training
Intervention type(s): Device
Intervention description(s): The experimental group participated in a 12-week whole-body vibration training that was conducted 3 times per week, with 5-min continuous vibration at 12-Hz frequency and 3-mm amplitude each time. The control group were provided home DVDs on resistance exercise and manuals for preventing frailty
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: older adults; community; frailty biomarkers; health belief; prefrailty; quasi-experimental design; whole-body vibration training
Pediatric Disease Registry in Essential Thrombocythaemia (ET)
Condition: Essential Thrombocythemia (ET)
MeSH terms: Thrombocytosis; Thrombocythemia, Essential
Study type: Observational

Summary: 
      The aim of this study is to evaluate the progression of ET in children (aged 6-17years
      inclusive) over a period of 5 years maximum. The study will also assess how children are
      diagnosed, treatment options for those children with symptoms and events related to their ET
      and the outcomes of those treatments.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Paediatrics aged between 6 years and 17 years
MD Ezetimibe Cyclosporine Interaction (0653-057)
Condition: Cholesterol
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the effect of multiple oral doses of ezetimibe on the pharmacokinetics of
      a single oral dose cyclosporine in young healthy males and females.
    


Intervention name(s): ezetimibe; Comparator: cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): ezetimibe 20 mg (2 x 10 mg tablets) on Days 1 through Day 7.; single oral dose of cyclosporine 100 mg capsules on Day 1 or Day 7.
Other intervention name(s): MK0653; Zetia®
Intervention MeSH terms: Cyclosporine; Ezetimibe; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Orall Administered Probiotics to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is the improvement of the vaginal flora by at least two grades of the
      Nugent scale after application of oral probiotics.
    

Detailed description: 
      The aim of this study is the improvement of the vaginal flora by at least two grades of the
      Nugent scale. Improvement of Nugent scores should be considered the primary end point of the
      study. The outcome of the study would be considered positive if significantly more women in
      the verum cohort achieve such improvement than in the placebo cohort.
    

Intervention name(s): Probiotics; Oral lactose placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotics oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains,L.rhamnosus/ LbV96 (DSM 22560),L.jensenii /LbV 116 (DSM 22567),L.crispatus/ Lbv88 (DSM 22566),L.gasseri /LbV 150N (DSM 22583); Placebo
Other intervention name(s): L.rhamnosus/ LbV96 (DSM 22560); L.jensenii /LbV 116 (DSM 22567); L.crispatus/ Lbv88 (DSM 22566); L.gasseri /LbV 150N (DSM 22583)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: chemotherapy; vaginal flora
Sleep Intervention for Pediatric Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The purpose of the study is to develop and evaluate a sleep intervention program for
      improving sleep and health in youth with epilepsy and their parents.
    

Detailed description: 
      Sleep problems are more prevalent and serious in children with epilepsy whose sleep can be
      disrupted by seizures occurring during the night and/or during the day. Inadequate sleep has
      long been recognized as a trigger for seizure and poor sleep habits have been associated with
      unfavorable outcomes in children with epilepsy. Attention to sleep in children with epilepsy
      as a result is critically important for seizure control and health-related quality of life.
    

Intervention name(s): Sleep intervention
Intervention type(s): Behavioral
Intervention description(s): Standard pediatric neurology care plus education and augmented support around adequate sleep habits, appropriate daylight exposure, and beneficial and safe physical activity tailored to each epileptic child's capabilities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Rapid Transfusion With Fluid Management System 2000® (FMS)
Condition: Liver Transplantation
Study type: Interventional

Summary: 
      Rapid infusion of red blood cells is known to result in the increase of plasma potassium. The
      researchers are trying to investigate the change in plasma potassium during rapid infusion of
      mixed blood components in the reservoir of the fluid management system (FMS) in liver
      transplant recipients.
    

Detailed description: 
      FMS is a standard equipment to prepare for the massive bleeding during the liver transplant
      surgery. This device usually delivers a mixture of red blood cell (RBC), fresh frozen plasma
      and normal saline. Rapid infusion of RBC is known to result in the increase of potassium and
      the decrease of calcium in the plasma of the patient. However there is no report about the
      consequence of rapid transfusion of the blood mixture in the reservoir of the FMS, especially
      in the liver transplantation recipients. The primary end point of this study is to
      investigate the change in the plasma potassium and to assess the possibility of hyperkalemia
      and related morbidity. Changes of blood pH and plasma calcium will also be sought.
    

Intervention name(s): Fluid management system 2000 (FMS)
Intervention type(s): Device
Intervention description(s): The FMS has an integrated large volume (about 3000 ml) reservoir and delivers a blood mixture (4 unit RBC, 4 unit FFP and 800 ml normal saline) put in the reservoir at a maximum rate of 750 ml/min.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: transfusion; potassium
Self Cranial Electrical Stimulation (CES) for Pain in Older Adults With Knee Osteoarthritis (Self CES for Knee Pain)
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study is to determine the feasibility, safety, and preliminary efficacy
      of a two-week self Cranial Electrical Stimulation(CES) on pain in older adults with knee
      osteoarthritis(OA)
    


Intervention name(s): Cranial Electrical Stimulation (CES); Sham-CES
Intervention type(s): Device; Device
Intervention description(s): CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).; For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
Other intervention name(s): Alpha-Stim M; Alpha-Stim M
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of
      clozapine in patients with treatment-resistant schizophrenia.

      This study is not recruiting in the United States.
    

Detailed description: 
      Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of
      clozapine in patients with treatment-resistant schizophrenia.
    

Intervention name(s): Clozapine
Intervention type(s): Drug
Other intervention name(s): Clozaril
Intervention MeSH terms: Clozapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia, treatment-resistant, clozapine
Effect of Tigulixostat on the Pharmacokinetics of Theophylline
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      A phase 1, open-label, drug-drug interaction study to evaluate the effect of multiple doses
      of tigulixostat on the pharmacokinetics of single-dose theophylline in healthy adult
      volunteers.
    


Intervention name(s): Tigulixostat; Theophylline
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg oral dose; 400 mg oral dose
Other intervention name(s): LC350189
Intervention MeSH terms: Theophylline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
CYT003-QbG10 for Treatment of Allergic Asthma Bronchial
Condition: Allergic Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to test whether treatment with CYT003-QbG10 can improve asthma
      symptoms in patients with allergic bronchial asthma. The active treatment will be compared
      against placebo.
    


Intervention name(s): CYT003-QbG10; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection; subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study Assessing the Feasibility of Treating Foot Drop With the Neurostep™ System.
Condition: Stroke; Craniocerebral Trauma
MeSH terms: Craniocerebral Trauma
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot feasibility study is assessing the safety and technical performance of the
      Neurostep™ System for the restoration of independent gait in subjects with gait disorder
      (i.e. foot drop) secondary to a CNS lesion (e.g. stroke).
    

Detailed description: 
      The Neurostep™ System is a neurostimulation investigational medical device. The entire system
      is designed to be implanted into the subject's leg via a surgical procedure, during which
      electrodes are attached to the peripheral nerves responsible for sensing and stimulating the
      proper muscles that lift the foot during normal walking.
    

Intervention name(s): Neurostep™ System
Intervention type(s): Device
Intervention description(s): The Neurostep™ System is a neurostimulation investigational medical device. The entire system is designed to be implanted into the subject's leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking.
Other intervention name(s): Neurostep
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Self Help for Fatigue in Multiple Sclerosis
Condition: Multiple Sclerosis; Fatigue
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to determine if cognitive behavioural therapy (CBT) based self
      help is effective for the management of symptoms of fatigue in Multiple Sclerosis (MS).
    

Detailed description: 
      Background: Fatigue is a common disabling symptom in patients with Multiple Sclerosis (MS).
      Cognitive behavioural therapy (CBT) has been shown to be effective in the reduction of
      fatigue in MS and CBT-based self-help has been shown to be effective as a low intensity
      intervention for anxiety and depression.

      Objectives: To evaluate the effectiveness of a CBT based self-help workbook at reducing
      perceived impact of fatigue in a clinical sample of MS patients.
    

Intervention name(s): Cognitive behavioural therapy based self help; Treatment as usual
Intervention type(s): Other; Other
Intervention description(s): Comparison of cognitive behavioural therapy based pure self help and guided self help (support of a therapist) compared to treatment as usual; Usual care from healthcare professionals with regard to patients symptoms of fatigue
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Randomised controlled trial; Multiple Sclerosis; Fatigue; Cognitive Behavioural Therapy; Self Help
Single Center Experience Over a Decade in Living Donor Liver Transplantation for Egyptian Patients With Hepatocellular Carcinoma: Stretching the Limits
Condition: Recurrence of HCC After LDLT
MeSH terms: Carcinoma, Hepatocellular; Recurrence
Study type: Observational

Summary: 
      Within community with high incidence of HCC, stretching the limits could be justified based
      on tumor characters and its biological behavior
    

Detailed description: 
      590 Egyptian patients underwent LDLT; of them, 172 (32%) patients were transplanted for HCC.
      Twenty six cases (15.1%) were excluded due to early postoperative mortality (n=22) or due to
      non HCC related mortality (n=4). One hundred forty six patients were retrospectively reviewed
      to determine prognostic factors for recurrence.
    

Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Egyptien Patient with HCC who underwent LDLT
      
Keywords: LDLT,HCC, Microvascular invasion
Open-Label Pilot Study of Namenda in Adult Subjects With ADHD and ADHD NOS
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to assess the efficacy and tolerability of a 12-week
      trial of memantine hydrochloride administered twice daily in 20 adults (ages 18-55) with ADHD
      and ADHD NOS. Improvement will be defined as: 1) changes from baseline on the
      investigator-rated DSM-IV based ADHD Rating Scale; 2) changes from baseline in a
      questionnaire aimed at assessing executive functions (BRIEF); and 3) changes from screening
      in a computerized neuropsychological battery (CANTAB). We hypothesize that memantine
      hydrochloride will be associated with improving ADHD symptoms and associated deficits in
      executive functions. We also expect that memantine will be well-tolerated with predictable
      adverse events.
    

Detailed description: 
      Memantine (Namenda) is a low-affinity N-methyl-D-aspartate (NMDA) receptor antagonist
      believed to work by blocking prolonged low-level activation of the NMDA receptor and
      resultant neuronal damage caused by abnormal glutamatergic activity, yet also allowing normal
      physiological activity of the NMDA channel. Memantine (Namenda) was approved by the U.S. Food
      and Drug Administration in 2003 for the treatment of moderate to severe Alzheimer's disease.
      Memantine improves or delays the decline in cognition (attention, language, visuo-spatial
      ability), as well as functional and behavioral symptoms in adults with moderate Alzheimer's
      disease.

      Although the efficacy and safety of memantine has not been tested in people with ADHD, the
      spectrum of disorders possibly amenable to NMDA receptor antagonist treatment may include
      ADHD and associated executive function deficits (EFDs). To this end, we are proposing an
      open-label pilot study of memantine in adult subjects with ADHD and ADHD Not Otherwise
      Specified (NOS).

      This will be a 12-week, open-label pilot study to assess the efficacy and tolerability of
      memantine hydrochloride (Namenda) administered to 20 adults 18-55 years of age with ADHD and
      ADHD NOS. All subjects that enter the study will undergo standard screening and diagnostic
      procedures. After obtaining written informed consent from the subject, the diagnosis of ADHD
      will be established through clinical evaluation by an expert clinician. Only consenting
      subjects satisfying inclusion and exclusion criteria will be included in the study.
    

Intervention name(s): memantine hydrochloride
Intervention type(s): Drug
Intervention description(s): tablet, 5-20 mg, twice daily, by mouth, 12 weeks
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Namenda
Synovitis in Patients With Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      To study synovial membrane (SM) inflammation in suprapatellar fossa in advanced knee
      osteoarthritis (OA), and to correlate the pathological features with clinical findings.
    


Intervention name(s): Total knee arthroplasty due to advanced osteoarthritis.
Intervention type(s): Procedure
Intervention description(s): Postoperative usage of intravenous methylprednisolone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with advanced knee osteoarthritis