bioihbjkbjnl/mcl2 huggingface dataset:
Study of Oral Fampridine-SR in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in
      patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled,
      parallel group study.
    

Detailed description: 
      Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central
      nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal
      cord, providing communication between the brain and the arms and legs. In people with MS, the
      fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates,
      causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience
      periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of
      coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the
      ability to think and/or remember. These periods of illness may come (exacerbations) and go
      (remissions). Fampridine-SR is an experimental drug that has been reported to possibly
      improve muscle strength and walking ability for some people with MS. This study will evaluate
      the effects and possible risks of taking Fampridine-SR in subjects with MS.
    

Intervention name(s): Fampridine-SR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, 10 mg, twice daily, 14 weeks; sugar pill, twice a day (b.i.d.)
Other intervention name(s): Sustained release 4-aminopyridine, 4-AP
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Walking Ability
Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics
Condition: Asthma; Bronchospasm; Wheezing; Shortness of Breath
MeSH terms: Dyspnea; Bronchial Spasm; Respiratory Sounds
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine
      Inhalation Aerosol USP, an HFA-MDI (E004), using a stable isotope deuterium-labeled
      epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous
      epinephrine, in healthy male and female adult volunteers. The current study is designed for a
      more thorough evaluation of the E004 Pharmacokinetics. Safety of E004 will also be evaluated,
      under augmented dose conditions.
    

Detailed description: 
      E004 is formulated with epinephrine free base as the active ingredient, and hydrofluoroalkane
      (HFA-134a) as the propellant.

      In order to differentiate the inhaled epinephrine from the fluctuating background of
      endogenous epinephrine 1, a stable-isotope deuterium (2H) labeled epinephrine
      (epinephrine-d3) preparation will be used to formulate E004 inhalers, denoted as E004-d3. PK
      of E004 at 125 mcg of epinephrine-d3 per inhalation, will be compared to that of the
      currently marketed, non-labeled, Epinephrine-CFC MDI as the Reference Control (220 mcg per
      inhalation).

      This study is a randomized, evaluator-blind, single dose, two-arm, crossover, PK study, to be
      conducted in ~18 healthy, male and female, adult volunteers. PK will be studied using E004-d3
      at 125 mcg per inhalation (Arm T). A currently marketed, non-labeled, Epinephrine CFC-MDI
      will be used as a Reference Control (Arm C).
    

Intervention name(s): Epinephrine Inhalation Aerosol, HFA; Epinephrine Inhalation Aerosol
Intervention type(s): Drug; Drug
Intervention description(s): 10 inhalations of epinephrine inhalation aerosol, 125 mcg/inhalation; Epinephrine Inhalation Aerosol, 220 mcg/ inhalation, 10 inhalations
Other intervention name(s): HFA epinephrine inhalation aerosol, 125 mcg/inhalation; Primatene Mist; Epinephrine Inhalation Aerosol, USP
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; bronchospasm; wheezing; shortness of breath
PillCam® Platform With the PillCam Crohn's Disease Capsule
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a prospective, multi-center (up to 6 sites) study which aims to To establish the
      effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by
      visualizing the small bowel and colon in patients with active symptoms associated with
      Crohn's disease (CD).
    

Detailed description: 
      This is a prospective, multi-center (up to 6 sites) study which aims to evaluate the
      diagnostic yield and safety of the PillCam Platform with the CD capsule in subjects with
      symptoms associated with Crohn's disease. All subjects to be enrolled in this study will have
      evidence of active symptoms associated with Crohn's disease. Each subject will be required to
      follow a bowel preparation regimen and will undergo the Crohn's Disease capsule endoscopy
      procedure and thereafter the ileocolonoscopy procedure on the same day. The ileocolonoscopy
      procedure may be done the following day per physician discretion. If the ileocolonoscopy
      procedure is done within 24 hours from the CE procedure, the subject will stay on clear
      liquid diet. Observations/ assessments to be conducted in the trial detailed in the sections
      below:

      Visit 1; Screening visit

        -  Informed consent process

        -  screening for eligibility to participate in the study

        -  Inclusion/exclusion criteria

        -  Small bowel patency test

        -  Demographic data

        -  Pregnancy test

        -  General medical history

      Visit 2; PillCam® Crohn's capsule ingestion

        -  PillCam® CD bowel preparation

        -  Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours)

        -  Ileocolonoscopy with intubation of terminal ileum

      Follow up period (5-9 days following visit 2)

      • CE Follow up telephone contac
    

Intervention name(s): Pillcam colon capsule and PillCam™ Prep Procedure; Ileocolonoscopy
Intervention type(s): Other; Device
Intervention description(s): PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.; Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure
• Ileocolonoscopy with intubation of terminal ileum
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: All subjects will have evidence of active symptoms associated with Crohn's disease
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 in Healthy Japanese Males
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety and tolerability of ascending single oral doses of SAM-315, an
      investigational drug, in healthy Japanese male subjects.To obtain preliminary pharmacokinetic
      (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy Japanese male subjects.
    


Intervention name(s): SAM-315
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Comparison of Effectiveness and Complications of Catheter Lock Solutions in Non-tunneled Hemodialysis Catheters
Condition: Catheter Blockage; Catheter-Related Infections; Dialysis Catheter; Thrombosis; Catheter Infection; Catheter Related Complication; Catheter Dysfunction
MeSH terms: Infections; Communicable Diseases; Catheter-Related Infections; Thrombosis
Study type: Interventional

Summary: 
      In our study, investigators will investigate the effectiveness and complications of two
      catheter lock solutions one of which is the standard heparin routinely used in comparison to
      Sodium bicarbonate. Both solutions were used but not compared head to head. Investigators aim
      to compare both solutions in terms of catheter lumen patency and their effect on
      catheter-related infections.
    

Detailed description: 
      The most important problem in patients with end-stage renal disease or patients with acute
      renal failure needing urgent hemodialysis treatment is the lack of appropriate vascular
      access. In acute situations, vascular access is usually provided by non-tunneled catheters.
      Main problems with this temporaray vascular access is failure due to lumen thrombosis. anther
      major problem is catheter related infection. In some patients, there is a handicap of using
      heparin. In some situations, heparin is not preferred for use. In terms of the probable
      shortage of resources and cost-effectiveness, Investigators aimed to compare head to head the
      superiority and non-inferiority of each solution. Sodium bicarbonate was compared to the
      isotonic solution and found to be effective for a short time. The main aim of this study is
      to compare both classic Heparin and sodium bicarbonate in Femoral and Jugular catheters aimed
      for dialysis. In both arms, the maximum patency and the observed side effects will be
      recorded. The maximal time used will be recorded. statistical analysis will be planned to
      compare the two groups.
    

Intervention name(s): Sodium bicarbonate; Heparin
Intervention type(s): Drug; Drug
Intervention description(s): Dialysis catheter lumen will be filled (locked) by sodium bicarbonate solution. The amount of solution depends on the diameter and length and will be in accordance with the manufacturer's specifications.; Dialysis catheter lumen will be filled (locked) by classic heparin. The amount of pure heparin depends on the diameter and length and will be in accordance with the manufacturer's specifications.
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Bicarbonate vs Heparin group (femoral vs jugular catheter)
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: catheter lock solution; sodium bicarbonate; heparin; Non-tunneled dialysis catheter
Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double blind, placebo-controlled clinical trial of 15 months duration designed to
      examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in
      patients with new onset Parkinsons disease
    


Intervention name(s): pramipexole
Intervention type(s): Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Esophageal Squamous Cell Carcinoma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the efficacy and safety of S1 combined with cisplatin in treatment of
      recurrence/metastasis of ESCC
    


Intervention name(s): S1 combined with cisplatin
Intervention type(s): Drug
Intervention MeSH terms: Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ESCC
Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of
      Plavix with Astrix.
    


Intervention name(s): Closone; Plavix with Astrix
Intervention type(s): Drug; Drug
Intervention description(s): Closone 75mg/100mg, 4weeks, PO; Plavix 75mg with Astrix 100mg, 4weeks, PO
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover
      study of cobimetinib in healthy participants to evaluate the effect of the proton-pump
      inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy
      participants when administered in the fed or fasted states.
    


Intervention name(s): Cobimetinib; Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast or approximately 30 minutes after starting the standardized FDA high-fat meal.; Rabeprazole 20 mg will be administered orally once daily for 4 days starting on Day -4 and on Day 1 of the treatment period.
Other intervention name(s): GDC-0973; XL518
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose Study in Subjects With Severe Hemophilia A Comparing Pharmacokinetic Parameters for BAY81-8973 and Advate
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics of BAY81-8973 and Advate after
      intravenous administration.
    


Intervention name(s): BAY81-8973; Advate
Intervention type(s): Drug; Drug
Intervention description(s): BAY81-8973 infusion to analyze pharmacokinetics; Advate infusion to analyze pharmacokinetics.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Gene Expression in Intervened Athletes
Condition: Genetic Change; Athlete
Study type: Interventional

Summary: 
      Background: Exercise represents an important challenge for the homeostasis of the entire body
      that occurs on a cellular and systemic level in which micronutrients play an important role
      in regulating the processes that sustain athletic performance. Objective: The investigators
      measured changes in gene expression of whole blood in a group of athletes and sedentary
      participants and compared gene modulation before and after nutritional intervention with
      micronutrients. Methods: Blood samples were taken from thirteen athletes and thirteen
      sedentary age- and gender-matched participants. The study design was carried out over a
      period of 4 months where three time points were established: (T0) baseline conditions in the
      sedentary and athlete groups; (T2) after two months of supplementation; (T4) after two months
      in the absence of nutritional supplementation. Differential gene expression was evaluated in
      112 genes using RT-qPCR analysis with the QuantStudioTM 12K Flex Real-Time PCR System.
    

Detailed description: 
      Background: Exercise represents an important challenge for the homeostasis of the entire body
      that occurs on a cellular and systemic level in which micronutrients play an important role
      in regulating the processes that sustain athletic performance. Objective: The investigators
      measured changes in gene expression of whole blood in elite athletes and sedentary subjects
      and compared gene modulation before and after nutritional intervention with micronutrients.
      Methods: Thirteen elite athletes and thirteen sedentary controls were enrolled in the present
      study. Blood samples were taken from athletes and sedentary age- and gender-matched subjects.
      The study design was carried out over a period of 4 months where three time points were
      established: (T0) baseline conditions in the sedentary and handball groups; (T2) after two
      months of supplementation; (T4) after two months in the absence of nutritional
      supplementation. Differential gene expression was evaluated in 112 genes using RT-qPCR
      analysis with the QuantStudioTM 12K Flex Real-Time PCR System.
    

Intervention name(s): Multicentrum
Intervention type(s): Dietary Supplement
Intervention description(s): The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 2 months
Other intervention name(s): Multicentrum 2 months
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Gene Expression; Athletes; Micronutrient Intervention; Whole Blood
Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
Condition: Cytomegalovirus Infection
MeSH terms: Infections; Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647
      cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years
      of age.
    

Detailed description: 
      mRNA-1647-P202 is a 2-part study. Part 1 of the study evaluates the safety and immunogenicity
      of 3 dose levels of mRNA-1647 vaccine or placebo, administered on a 0, 2, 6-month schedule in
      healthy CMV-seronegative and CMV-seropositive males and females, 18 to 40 years of age. A
      planned interim analysis of safety and immunogenicity through Month 3 (1 month after the
      second dose) of Part 1 of the study informed the selection of the middle dose level for
      further development. Part 2 of the study is designed to further evaluate the safety and
      immunogenicity of the middle dose level of mRNA-1647 vaccine or placebo on a 0, 2, 6-month
      schedule in approximately 200 healthy participants 18 to 40 years of age, comprised of
      CMV-seronegative and CMV-seropositive female population, which includes the target population
      for the pivotal Phase 3 efficacy trial.
    

Intervention name(s): mRNA-1647; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration; 0.9% sodium chloride (normal saline) injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Moderna; mRNA-1647; Cytomegalovirus; CMV; Cytomegalovirus Vaccine; Cytomegalovirus Infections; Cytomegalovirus Congenital; Virus Diseases; Infection Viral; DNA Virus Infections; Messenger RNA
Executive Function Training in Childhood Obesity: Food Choice, Quality of Life and Brain Connectivity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This study evaluates if executive function training in obese children can improve
      food-related choices and produce cognitive and neuroimaging changes, but also improve
      psychological and physical status and quality of life measures.
    

Detailed description: 
      Based on the limited success of current behavioural weight-loss programmes and coupled with
      data on executive function deficiencies in obesity, this study aims to explore the impact of
      executive function training on food-related choices, cognitive and neuroimaging outcomes, but
      also on the psychological and physical status and quality of life measures.

      The specific hypotheses are:

        1. Obese children undergoing the training programme will perform better than those
           receiving the control programme in cognitive, emotional state, physical activity and
           quality of life measures at the end of the intervention and follow-up at 12 months.

        2. Obese children receiving the training programme will take better food-related decisions
           at the end of the intervention and follow-up at 12 months.

        3. Obese children receiving the training programme will show changes in brain connectivity,
           which will be observable immediately at the end of the intervention and during the
           follow up period at 12 months.

        4. There will be an association between changes in neuroimaging biomarkers and food choice,
           cognitive, emotional, physical and quality of life outcomes in individuals receiving
           training.
    

Intervention name(s): Executive function training; Psychoeducation; Placebo non-adaptive training
Intervention type(s): Device; Other; Device
Intervention description(s): Home-based executive function training with adaptive difficulty, through Cogmed and Cognifit systems over 6 weeks (30-45 minuts/day, 5 days per week). Cognitive training will consist on working memory training (Cogmed, www.cogmed.com) and executive/inhibitory function training (Cognifit, www.cognifit.com).; Learning basic healthy habits through daily Prezi presentations that include healthy food recommendations, funny receipts to families, ideas for exercising, emotion and behavioral management strategies, etc.; Executive function training with non-adaptive difficulty through Cognifit system over 6 weeks (30-45 minuts/day, 5 days per week). Exercices will be the same as the ones in the experimental group but minimizing the executive/working memory component and without incresing difficulty.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: childhood obesity; cognitive training; executive function; quality of life; neuroimaging; magnetic resonance; connectivity; decision making