bioihbjkbjnl/mcl2 huggingface dataset:
Glutamine in Treating Side Effects in Children Who Are Undergoing Stem Cell Transplantation
Condition: Oral Complications; Unspecified Childhood Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Glutamine may be able to decrease inflammation of the mouth and digestive system
      in children who are undergoing stem cell transplantation.

      PURPOSE: Randomized double-blinded phase II trial to study the effectiveness of glutamine in
      reducing inflammation of the mouth and digestive system in children who are undergoing
      peripheral stem cell transplantation.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of supplemental oral glutamine in reducing the severity
      and duration of mucositis in children undergoing stem cell transplantation. II. Determine the
      safety of this regimen in these patients. III. Determine serum glutamine levels achieved
      during this regimen in these patients.

      OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified
      according to inclusion of total body irradiation in the conditioning regimen (yes vs no).
      Patients receive either oral glutamine or oral placebo (glycine) twice a day beginning on the
      day of admission for the stem cell transplant and continuing for 28 days or until hospital
      discharge, whichever is first.

      PROJECTED ACCRUAL: A total of 120 patients (60 per arm) will be accrued for this study within
      2 years.
    

Intervention name(s): glutamine
Intervention type(s): Dietary Supplement
Intervention description(s): Oral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: unspecified childhood solid tumor, protocol specific; oral complications
Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Living donor organ transplantation has increased in recent years due to an increased need for
      organs. The objective of this study was to investigate the effects of a TAP block on
      postoperative analgesia and opioid consumption in liver transplantation donors in whom a
      right lateral extending upper mid-line abdominal incision was used.
    

Detailed description: 
      This prospective randomized controlled double-blinded study was conducted with 50 liver
      transplantation donors between 18-65 years who were scheduled to undergo right hepatectomy
      surgery. Cases to whom TAP block with ultrasound was applied after standard general
      anesthesia were determined as Group 1 and cases to whom only standard general anesthesia was
      applied, were determined as Group 2.
    

Intervention name(s): Transversus Abdominis Plane Block; standard general anesthesia
Intervention type(s): Drug; Drug
Intervention description(s): Cases to whom used bupivacaine with ultrasound guided transversus abdominis plane block was applied after standard general anesthesia were determined as Group 1; Cases to whom applied alone standard general anesthesia were determined as Group 2
Other intervention name(s): Marcaine plain+morphine; morphine
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transversus abdominis plane block; living liver transplantation; postoperative analgesia
Effect of Cognitive Behavioral Therapy in Patients With Chronic Nonspecific Low Back Pain
Condition: Low Back Pain, Mechanical
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effectiveness of cognitive-behavioral therapy on
      functional outcomes, pain, and pain-related anxiety in patients with chronic nonspecific low
      back pain
    

Detailed description: 
      Back pain has considerable negative effects on the quality of life of affected individuals.
      Individuals with new-onset back pain have an increased risk of lower quality of life scores,
      and the negative effect on quality of life increases with persistent pain. Patients with
      chronic back pain report a quality of life that is lower than individuals without pain and
      that is comparable to those of individuals with life-threatening diagnoses. In addition, back
      pain is associated with worry and fears, particularly about the (sense of) self and
      socialrelationships and especially when pain persists longer than expected.
    

Intervention name(s): Cognitive Behavioral Therapy; Home program exercises
Intervention type(s): Other; Other
Intervention description(s): The first 6 sessions: the cognitive part was explained with the support of a PowerPoint presentation using diagrams, images, and texts. The therapist explained the lumbar engine behavior, the neurophysiologic basis of pain, the importance of the participant's involvement in the treatment (e.g., coping and motivation), and the maintenance of good ergonomics which was aimed at modifying the physiologic response to the pain system.
The second 12 sessions: concepts viewed in the first session were revised; as well, the operant and respondent parts were explained.; Each session will include 10 minutes of aerobic activity (walking or stationary bicycle), followed by five types of muscle stretches and eight types of ground exercises aimed at strengthening the lumbar muscles responsible for stabilization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Talampanel on Patients With Advanced Parkinson's Disease
Condition: Dyskinesias; Parkinson Disease; Movement Disorders
MeSH terms: Parkinson Disease; Dyskinesias; Movement Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research study is to test the safety and effectiveness of the study drug,
      Talampanel, when used to treat patients with involuntary movements known as dyskinesias, as a
      result of treatment to Parkinson's disease.

      It is not clear why people with Parkinson's disease develop involuntary movements
      (dyskinesias) but studies show that blocking receptors in the brain for a chemical called
      glutamate decreases these movements. Talampanel is a drug which blocks these receptors.
    


Intervention name(s): talampanel
Intervention type(s): Drug
Intervention description(s): 75mg per day divided into 3 doses for 22 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Involuntary Movements; Abnormal Movements; Advanced Parkinson's disease; Levodopa induced dyskinesia
Yoga Effects on Heart Rate Variability and Electroencephalography
Condition: Health Behavior; Quality of Life
Study type: Interventional

Summary: 
      Since yoga breathing exercises are traditionally used to tranquilize the mind, and have a
      well-known positive effect on the cardiovascular system, it is our hypothesis that a
      respiratory yoga exercise named bhastrika pranayama may have positive effects on heart rate
      variability, electroencephalography, quality of life and salivary cortisol (stress hormone).
    

Detailed description: 
      The effects of yoga interventions on heart rate variability have been previously shown in our
      laboratory, having its efficacy in improving autonomic heart modulation of hypertensives and
      elderly subjets proven. However, there is a lack of data addressing the effects of such
      interventions on EEG patterns of health fit male subjects, as well as there are no study
      investigating if there is a relationship between heart autonomic modulation changes and EEG
      patterns. Thus, the aim of this study was to investigate the effects of 1 month respiratory
      yoga training on heart rate variability, EEG, salivary cortisol and quality of life of health
      fit male subjets.
    

Intervention name(s): 1 month respiratory training; 1 month waiting period
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Bhastrika yoga respiratory training: 30 kapalabhati and 1 surya bedhana form 1 bhastrika; waiting or detraining period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Yoga; Electroencephalography; Heart rate variability; Breathing Exercises; Quality of life
A Study of Intravenous Thrombolysis With Alteplase in MRI-Selected Patients
Condition: Acute Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was jointly developed and is jointly led by investigators at Massachusetts General
      Hospital and the intramural division of NINDS. We are doing this research study to find out
      if Activase ® (also called alteplase or rt-PA) can safely be given to people with an acute
      ischemic stroke when their stroke onset was not witnessed making them ineligible for standard
      thrombolytic (clot busting) therapy. We also want to find out if rt-PA can help people
      recover better from their stroke.

      The purpose of this study is to: 1) see if it is safe to give intravenous (IV) rt-PA to
      people with unwitnessed stroke but with MRI evidence of early ischemic stroke, 2) see if
      rt-PA is effective if given to people who are selected for treatment based on MRI evidence of
      an early stroke, and 3) get information about this new MRI diagnostic methods for guiding
      stroke treatment.
    

Detailed description: 
      This study was jointly developed and is jointly led by Massachusetts General Hospital and the
      NINDS. This is a multi-center, open-label, Phase IIa safety study in adult acute ischemic
      stroke patients to determine if it is safe to extend intravenous thrombolytic treatment to
      subjects who are evaluated within 24 hours from last known well ("stroke onset") and eligible
      to receive thrombolytic treatment within 4.5 hours from symptom discovery with the assistance
      of an MRI-based "witness" when no human witness of stroke onset is available. The study is
      designed to investigate the safety in using standard diagnostic MRI in selecting patients for
      thrombolytic therapy when the last known well time places the patient beyond the current IV
      thrombolytic time-window.
    

Intervention name(s): IV rt-PA
Intervention type(s): Drug
Intervention description(s): open-label
Other intervention name(s): Alteplase, Activase
Intervention MeSH terms: Tissue Plasminogen Activator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute stroke, IV rt-PA, Activase, Alteplase
Study to Evaluate the Safety of BF-200 ALA (Ameluz®) for Photodynamic Therapy (PDT) in the Treatment of Expanded Fields of Actinic Keratosis (AK)
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to assess the pharmacokinetics (PK) of the parent drug
      5-aminolevulinic acid (ALA) and its active metabolite protoporphyrin IX (PpIX) during
      photodynamic therapy with 3 tubes of BF-200 ALA 10% gel (Ameluz®) in combination with the
      BF-RhodoLED® lamp in the systemic circulation of diseased individuals presenting with actinic
      keratosis (AK) on the face/scalp or in the periphery (neck/trunk/extremities) along with
      subjects' safety/tolerability during and after treatment.
    


Intervention name(s): BF-200 ALA and red light LED lamp
Intervention type(s): Combination Product
Intervention description(s): Combination Product: Photodynamic therapy (PDT) using BF-RhodoLED® (ALA-PDT, Ameluz®-PDT).
Intervention MeSH terms: Aminolevulinic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Actinic keratosis; Photodynamic therapy; 5-aminolevulinic acid; Protoporphyrin IX; Pharmacokinetics
A Study on the Interaction Between Danoprevir/Ritonavir and Methadone
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This multicenter, open-label study will assess the effect of multiple doses of
      danoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on stable
      methadone maintenance therapy (20 - 120 mg daily as single oral morning dose) will receive
      danoprevir 100 mg orally twice daily and ritonavir 100 mg orally twice daily for 10 days.
    


Intervention name(s): danoprevir; methadone; ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg daily (100 mg q12h) orally, Days 1-10; stable maintenance therapy: 20-120 mg daily single oral morning dose; 200 mg daily (100 mg q12h) orally, Days 1-10
Intervention MeSH terms: Ritonavir; Methadone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Microencapsulated Fish Oil or Conjugated Linoleic Acid in Metabolic Syndrome
Condition: Insulin Resistance; Oxidative Stress; Lipid Profile; Blood Pressure; Anthropometric Measure
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      Our aim was to assess the effects of a hypocaloric diet, including diet fruit jelly with
      microencapsulated fish oil or conjugated linoleic acid or placebo, on anthropometry, body
      composition, insulin resistance and lipid profile in women with metabolic syndrome and
      genotype Pro12Pro in the PPAR gamma 2 gene.
    


Intervention name(s): microencapsulated conjugated linoleic acid; microencapsulated fish oil; light fruit jam
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The microencapsulated conjugated linoleic acid received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.; The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.; The placebo group received light fruit jam (15 g/day) during 12 weeks.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of infliximab (Remicade) in
      patients with early rheumatoid arthritis.
    

Detailed description: 
      This is a randomized, multicenter, double-blind, active-treatment-controlled, three-arm,
      parallel study of chronic treatment with infliximab. This study will determine whether
      infliximab, at two different doses (3 mg/kg or 6 mg/kg) in combination with methotrexate
      (MTX), reduces the signs and symptoms (such as joint pain, swelling and stiffness) of
      rheumatoid arthritis. The study will also compare their effect on slowing down the joint
      damage associated with rheumatoid arthritis. Additional information on the safety of
      infliximab treatment will be obtained. The study will last for about 1 year. Patients will
      receive methotrexate and total of eight intravenous infusions of the study medication
      (Infliximab or placebo) spaced out over the first year. After the final infusion of study
      medication, several follow-up visits are to be made. Patients will receive methotrexate
      (start at 7.5mg/wk, increased to 20mg/wk by week8) and intravenous infusions of the study
      medication (Infliximab 3 or 6mg/kg, or placebo) at week 0, 2, and 6, and every 8 weeks
      thereafter through week 46.
    

Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Early Rheumatoid Arthritis
Comparing Liquid Versus Solid Forms of Sugars and Whey Protein
Condition: Diabetes; Obesity
Study type: Interventional

Summary: 
      To compare the effect of eating solid vs. drinking liquid forms of gelatin, sucrose and its
      component mixtures and whey protein on subjective appetite and food intake in young men.
    

Detailed description: 
      Three randomized cross-over design experiments were used to compare the effect of solid and
      liquid forms of gelatin (6 g) in experiment 1, sucrose (75 g) and a mixture of 50% glucose/
      50% fructose (G50:F50) in experiment 2, and acid and sweet whey protein (50 g) in experiment
      3 on healthy normal weight males . The controls were water (experiment 1 and 3) and
      calorie-free sweetened water with gelatin (sweet gelatin, experiment 1) or without gelatin
      (sweet control, experiment 2). Subjective average appetite was measured by visual analogue
      scales frequently over 1 h and ad libitum food intake was measured 1 h after the treatment
      consumptions.
    

Intervention name(s): Compare the effect of solid vs. liquid forms of sugars on satiety and food intake; the effect of solid vs. liquid forms of gelatin on appetite and food intake; The effect of solid vs. liquid forms of whey protein on food intake
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary Care
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine if the administration of small doses of Acarbose can
      prevent or delay the appearance of Type 2 Diabetes Mellitus in a population of subjects with
      prediabetes.
    


Intervention name(s): Acarbose (Glucobay, BAYG5421); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg TID; 50 mg TID
Intervention MeSH terms: Acarbose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolic Disease; IGT Impaired Glucose Tolerance
Use of Phenylbutyrate Therapy for Patients With Pyruvate Dehydrogenase Complex Deficiency.
Condition: Pyruvate Dehydrogenase Complex Deficiency
MeSH terms: Pyruvate Dehydrogenase Complex Deficiency Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study phenylbutyrate is used for patients with pyruvate dehydrogenase complex
      deficiency. The aim of the study is to investigate the safety and efficacy of therapy.
    

Detailed description: 
      The Investigator will evaluate the safety and efficacy of a 4-weeks treatment with sodium
      phenylbutyrate in patients with pyruvate dehydrogenase complex deficiency. Efficacy will be
      evaluated based on biochemical endpoints (blood lactate and pyruvate).
    

Intervention name(s): sodium phenylbutyrate
Intervention type(s): Drug
Intervention description(s): Enrolled subjects will receive a four-week period of treatment with sodium phenylbutyrate (oral use)
Intervention MeSH terms: 4-phenylbutyric acid
Intervention model: Single Group Assignment
Intervention model description: An open-label, uncontrolled, multicentric clinical trial will be performed on pediatric patients with PDC deficiency. Enrolled subjects will receive a four-week period of treatment with NaPB; primary and secondary endpoints will be evaluated at defined time points. Before NaPB treatment, all patients will undergo a four-week period of observation during which the same parameters will be analyzed at different time points, with the aim of evaluating basal conditions in the absence of treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of High Dose atorvaSTATIN Loading Before Primary Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction (STATIN STEMI)
Condition: Myocardial Infarction; Angioplasty; Percutaneous Coronary
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Although statin prior to PCI has favorable effects in stable angina and ACS except ST
      elevation MI (STEMI), there have been few studies for STEMI. Celik T et al. reported in
      patients with STEMI that prior statin use may improve coronary blood flow after PCI in
      patients with AMI, possibly by its beneficial effects on microvascular function. But this
      study was retrospective, non-randomized study and evaluated the effects for chronic statin
      therapy not acute high dose effect. Therefore, the investigators investigated whether acute
      high-dose statin prior to primary PCI in ST segment elevation myocardial infarction can have
      beneficial effect or not for periprocedural period and 30 days-cardiac events.
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): Atorvastatin 10 mg vs. 80 mg before intervention
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myocardial Infarction; Coronary Angioplasty; Myocardial infarction, Angioplasty, Transluminal, Percutaneous Coronary