bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Levetiracetam in Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Essential tremor poses one of the greatest therapeutic challenges to neurologists. This study
      will examine the effectiveness of the drug, levetiracetam or keppra, for the treatment of
      essential tremor.
    

Detailed description: 
      Currently available pharmacological treatments for essential tremor are hampered by
      relatively low efficacy and intolerable side effects. Recent evidence indicates that
      levetiracetam (LEV) may modulate the dopaminergic system. In this regard LEV has been shown
      to reduce L-dopa-induced dyskinesias, tardive dyskinesia and myoclonus, and is relatively
      well-tolerated in the elderly. Previous studies examined the efficacy of LEV for the
      treatment of essential tremor. However, these were either open label or relatively short
      duration studies. A longer term study of LEV for the treatment of essential tremor is
      therefore warranted. In this randomized, double-blind, placebo-controlled crossover study,
      ten subjects with essential tremor will be randomly assigned to receive either LEV up to a
      maximum dose of 3000 milligrams (mg) per day or placebo. Study drug will be titrated up over
      6 weeks and continued at 1500 mg twice daily for an additional 6 weeks. Following a 4 week
      washout period subjects will cross over to the other arm and continued for an additional 12
      weeks. Subjects will be evaluated monthly by a blinded examining neurologist and research
      coordinator. At each study visit subjects will receive a neurological examination and will be
      evaluated using a 16-item scale for tremor and medication side effects. The data derived from
      study drug vs. placebo groups will be compared using the Mann-Whitney U and Wilcoxon W tests.
    

Intervention name(s): levetiracetam; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive levetiracetam titrated up over 6 weeks to a maximum dose of 3000 milligrams (mg) per day, and then continue at 1500 mg twice daily for an additional 6 weeks.; Subjects will receive identical placebo titrated up over 6 weeks to a maximum daily dose, and then continue twice daily for an additional 6 weeks.
Other intervention name(s): keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tremor; writing; feeding; pouring
A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions
Condition: Pulmonary Arterial Hypertention
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10
      Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil
      Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet
      in Healthy Volunteers.
    


Intervention name(s): sildenafil citrate; Sildenafil citrate; sildenafil citrate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral dose of 1 x 20 mg IR oral tablet.; single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet.; single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).
Other intervention name(s): Revatio; Revatio; Revatio
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Powder for oral suspention
Pure Fish Oil Parenteral Lipid Emulsion in Patients With Gastrointestinal Cancer
Condition: Surgery
MeSH terms: Gastrointestinal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Surgical trauma can lead to an intense inflammation and impairment of the capacity to fight
      against infections. Fish oil is composed by substances called omega-3 fatty acids which have
      anti-inflammatory effects. When infused through the vein as part of a nutritional treatment
      of some surgical patients, fish oil have been shown to preserve some defense capabilities
      against infections and to decrease postoperative release of inflammatory substances,
      contributing to the shortening of length of hospital and intensive care unity (ICU) stay and
      complications, mainly infectious complications. These reported benefits have been encouraging
      the vein infusion of fish oil as a kind of medicine to contribute for the treatment of
      surgical patients. In current study the investigators evaluated the effect of preoperative
      infusion of pure fish oil in patients with gastrointestinal cancer (stomach and colon) on
      their clinical outcomes. The hypothesis considered that preoperative infusion of fish oil,
      not as part of nutritional therapy but as a medicine agent, can attenuates inflammation and
      improves the capacity of surgical patients to fight against infections, improving their
      treatment.
    


Intervention name(s): Fish oil lipid emulsion; MCT/LCT
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.; 0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.
Other intervention name(s): Omegavenos; Lipovenos MCT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fish oil; Omega-3 fatty acids; Parenteral lipid emulsions; Immune response; Surgery
Clinical Study on Acetyl-L-Carnitine
Condition: Peripheral Sensory Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Chemotherapy-induced peripheral neuropathy (CIPN) is a common clinical dose-limiting adverse
      drug reaction, and the primary manifestations are different degree of neuromotor,
      sensorineural and autonomic nervous dysfunction.
    

Detailed description: 
      This multicenter, randomized, double-blind, placebo-controlled and parallel clinical trial is
      to observe the efficacy and safety of the Acetyl-L-Carnitine Hydrochloride enteric-coated
      tablets in treatment of peripheral sensory neuropathy that anti-cancer chemotherapeutics
      induce.
    

Intervention name(s): Acetylcarnitine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of enteric-coated tablets with warm water at half an hour after meals, 1g (2 tablets) each time, 3 times a day, and the interval at or >4 hours for 8 weeks; 3 t.i.d, two plates per time
Other intervention name(s): NICETILE
Intervention MeSH terms: Acetylcarnitine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chemotherapy-induced peripheral neuropathy (CIPN)
Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The object of this study is to compare the rate and extent of absorption of an
      investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr
      Laboratories, Inc. to an equivalent oral dose of the commercially available reference
      product, Subutex® manufactured by Reckitt Benckiser, following and overnight fast of at least
      10 hours.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA Bioequivalence Statistical Methods
    

Intervention name(s): Buprenorphine; Buprenorphine
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg Sublingual Tablets; 8 mg Sublingual Tablets
Other intervention name(s): Subutex®
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Healthy
Electromagnetic Treatment For Bone Loss After Forearm Fracture
Condition: Bone Disease, Metabolic; Osteopenia; Osteoporosis, Post-Traumatic
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will determine the usefulness of pulsing electromagnetic field (PEMF) technology
      to reverse or reduce the bone loss (osteopenia) that occurs in the forearm after fracture or
      surgery.
    

Detailed description: 
      The long-range goal of this research is to develop a new and supplementary local treatment
      for osteoporosis to reduce the risk of fracture in susceptible individuals. PEMF is a
      noninvasive method to magnetically introduce a small amount of electrical current to a
      specific bone region to stimulate bone formation. PEMFs have been used for many years to
      treat nonunited fractures and enhance spine fusion healing and have been found to improve
      bone density in animal models of osteoporosis. Such a noninvasive intervention applied to the
      hip or spine, which are especially associated with high morbidity and mortality in aging
      individuals, could have a significant national health care impact.

      If effective for the treatment of bone loss, PEMF technology may be effective in treating
      osteoporosis. The primary objective of this pilot study is to determine the feasibility of
      using PEMFs to reverse or reduce bone loss that occurs with disuse of the forearm after
      fracture or surgery and to determine the effect of daily treatment duration on efficacy.

      Eighty patients who have recently undergone immobilization after hand surgery or after lower
      forearm fracture will be enrolled in this study. Participants will be randomized to either
      the PEMF group or a control group. PEMFs will be administered by means of a magnetic coil
      transducer placed over the treatment site for 1, 2, or 4 hrs/day for 8 weeks, beginning 6
      weeks after the initial injury or surgery. A self-contained, battery-powered PEMF coil
      transducer already FDA-approved for fracture healing in the forearm will be used.
      Participants in the control group will receive inactive but otherwise identical units and
      treatment times. Measurements of bone density will be made using DEXA (dual energy x-ray
      absorptiometry) and pQCT (peripheral quantitative computer tomography) and compared to
      baseline. DEXA and pQCT provide planar and cross-sectional x-ray densitometry to determine
      forearm bone changes. Bone densities (global, cortical, and trabecular), bone cross-sectional
      structural geometry, and calculated strength index will be measured and compared to baseline
      values.
    

Intervention name(s): Pulsing electromagnetic field (PEMF)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Electromagnetic Fields; Bone; Forelimb; Radius
The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to identify the minimal effective tested dose of fruit extract
      consumed with a bread which provides a reduction in venous post-prandial blood glucose
      compared to a reference bread.
    


Intervention name(s): no added fruit extract; fruit extract; fruit extract; fruit extract; fruit extract
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Blood glucose
Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites
Condition: Premature Infant
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Our study aim to evaluate the effect of online program that provides education to parents of
      premature infants in which stayed in the neonatal intensive care units (NICU),in their
      motor,socail-communişcation development and the parents stress level.
    

Detailed description: 
      Our study aim to increase the level f knowledge of the parents of premature infants that
      stayed in the NICU,to better manage their stress and to provide them with informations to
      support the motor and social-communication development of their infants.
    

Intervention name(s): online education program; no online education program
Intervention type(s): Other; Other
Intervention description(s): The training we provided was to give exercises and advice to parents according to the age of the baby in order to stimulate the motor and social development of the baby,and then, an improvement in the stress state of the parents by their participation in the care of their baby.The training, which began with the discharge of the baby from the hospital, was in the form of slide presentations and videos.; Parents and their infants in the control group did not receive any online education program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Premature Infant,Motor Development,Social-Communication Development,Parental Stress,Online Education
Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      The current study will assess the real - life effectiveness of adalimumab in the management
      of Ankylosing Spondylitis (AS) with emphasis on the prevention and management of
      extra-articular manifestations.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Offices of community rheumatologists
      
Keywords: Assessing Effectiveness in Ankylosing Spondylitis
Microbiota in Dietary Approach to Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Main aim: Study the anthropometric, metabolic, cardiovascular and neurocognitive and gut
      microbiota changes of different approaches for the weight reduction that increase the ketone
      bodies in a different proportion in relation to the classic hypocaloric diet.

      Objective 1: Study the effect of hypocaloric diets that increase the ketone bodies on gut
      microbiota and its relationship with anthropometric changes and of the Brown adipose tissue,
      Objective 2: with the metabolic and inflammatory changes, Objective 3: on the cardiovascular
      system, Objective 4: on the neurocognition, Objective 5: if they are associated to epigenetic
      changes that may explain the changes found in the other objectives. Objective 6: Determine
      the safety of the diets that increase the ketone bodies compared to the classic hypocaloric
      diet, Objective 7: if the effects of the different dietary approaches are maintained during
      the medium time, and Objective 8: Verify in experimental models (microbiota transplants from
      humans with different diets to germ-free mice, ketosis dietary models, and ketone bodies
      administration) the causality of the gut microbiota of these findings.

      Methodology: Model 1: Dietary intervention in humans with 4 types of diet with a different
      increase of the ketone bodies: classic hypocaloric diet (DH); diet with 8h of feeding and 16h
      of starving in periods of 24h (D16); diet with intermittent caloric restriction (DA); and
      normal in protein and low in carbohydrates hypocaloric ketogenic diet (DC).
    


Intervention name(s): Standard hypocaloric die; Intermittent fasting 16/8 (early fasting); Intermittent fasting 16/8 (late fasting); Alternate-day fasting; Ketogenic diet
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Standard hypocaloric diet; Intermittent fasting 16/8 (early fasting); Intermittent fasting 16/8 (late fasting); Alternate-day fasting; Ketogenic diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ketosis; Microbiota
The Effect of Clonidine in Glycemia During Coronary Artery Bypass Graft With Cardiopulmonary By-pass
Condition: Glycemia During Coronary Artery Bypass Graft; Sedation During Pre-anesthetic Medication
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is the randomized blind research of the assessment of the different
      levels of glycemia during Coronary Artery Bypass Graft (CABG) with cardiopulmonary by-pass
      (CPB) between clonidine and placebo. As clonidine decrease the inflammatory response during
      cardiac surgery, the investigators would like to know if the glycemia levels in clondine
      group will be lower than placebo group.
    


Intervention name(s): Clonidine; Ringer lactato
Intervention type(s): Drug; Drug
Intervention description(s): bolus, clonidine 2 mg/kg IV; 1 ML ringer lactato IV, as placebo
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Effects of Zonisamide on Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study the influence of zonisamide administration over a 13 week period on alcohol
      consumption in alcoholic (alcohol dependent) subjects will be examined. The dose of
      zonisamide given to subjects will be slowly increased over a period of several weeks. They
      will receive a full dose over a 5 week period. This will be a pilot study in which all of the
      subjects will only receive zonisamide. A primary objective of this study is to determine the
      possible size of the effect that zonisamide administration has on drinking (i.e. drinks
      consumed per day) to allow us to plan for a larger clinical trial of the effects of
      zonisamide on alcohol dependence.
    


Intervention name(s): Zonisamide
Intervention type(s): Drug
Intervention description(s): Week 1 (Wk1) -100 mg daily; Wk 2- 100 mg daily; Wk 3- 200 mg daily; Wk 4- 200 mg daily; Wk 5- 300 mg daily; Wk 6- 300 mg daily; Wk 7-11- 400 mg daily; Wk 12(Days 1-5) 300 mg daily; Wk 12 (Day 6-7) Week 13 (Days 1-3)- 200 mg daily; Week 13 (Days 4-7) - 100 mg daily.
Intervention MeSH terms: Zonisamide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Zonisamide; Alcoholism; Alcohol
Reduced Intensity Transplant Conditioning Regimen for Severe Thalassemia
Condition: Severe Thalassemia
MeSH terms: Thalassemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to determine if blood cell transplants, with either bone marrow or
      cord blood from unrelated donors, are effective in children with severe thalassemia and if
      this treatment approach has acceptable risks and side effects.

      This study includes a preparative regimen with Hydroxyurea, Alemtuzumab, Fludarabine,
      Thiotepa and Melphalan that provides intense host immunosuppression without myeloablation.
      The primary hypothesis is that this regimen will promote stable engraftment of unrelated
      donor hematopoietic cells, support normal erythropoiesis, and result in an event free
      survival of > 75% of children with thalassemia major.
    


Intervention name(s): Transplant conditioning regimen of alemtuzumab, fludarabine, and melphalan
Intervention type(s): Drug
Intervention description(s): Days -50 to -21: Hydroxyurea 30mg/kg po Day -22: Alemtuzumab 3mg IV Day -21: Alemtuzumab 10mg IV Day -20: Alemtuzumab 15mg IV Day -19: Alemtuzumab 20mg IV Day -8: Fludarabine 30mg/m2 IV Day -7: Fludarabine 30mg/m2 IV Day -6: Fludarabine 30mg/m2 IV Day -5: Fludarabine 30mg/m2 IV Day -4: Fludarabine 30mg/m2 IV Day -4: Thiotepa 8mg/kg IV Day -3: Melphalan 140mg/m2 IV Day 0: Stem cell infusion
Intervention MeSH terms: Fludarabine; Melphalan; Alemtuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thalassemia; Alemtuzumab; Hematopoietic cell transplant; non-myeloablative
Low Intensity Internet Therapy for Chronic Illness (@LIIT.CI)
Condition: Chronic Medical Conditions
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      Chronic illness (CI) presents a significant and negative effect on quality of life and mental
      health. Further, emotion regulation has been considered of particular importance on the
      determination of chronic patients' well-being. Evidence suggests that Acceptance and
      Commitment Therapy (ACT) is an effective approach to improve psychological health in patients
      with CI. Further, there is some, although limited, evidence, that self-compassion training
      may be also useful in this context, and the inclusion of self-compassion elements in ACT
      interventions has even been the focus of attention by recent studies. Nevertheless, no study
      yet has compared the efficacy of these two types of intervention in CI. This is the aim of
      the present project - to analyse, in a low intensity eHealth intervention context, whether
      ACT or Compassion Focused Therapy (CFT) present superiority over the other in improving
      mental health and illness-related outcomes in CI.
    


Intervention name(s): LIIT.CI ACT; LIIT.CI CFT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 4-week online self-management intervention based on Acceptance and Commitment Therapy and adapted to people with chronic medical conditions; 4-week online self-management intervention based on Compassion-Focused Therapy and adapted to people with chronic medical conditions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic characteristics and safety
      between HCP2202 and co-administration of each component in fed condition in healthy
      volunteers.
    


Intervention name(s): HCP2202; RLD2202; RLD2203
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Take it once per period.; Take it once per period.; Take it once per period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment