bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Condition: Refractory Partial Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel
      when given as an adjunctive therapy in subjects with refractory partial seizures.
    


Intervention name(s): perampanel; perampanel; perampanel; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.; 4 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.; 8 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.; Placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily.
Other intervention name(s): E2007; E2007; E2007
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Partial onset seizures; E2007; perampanel; refractory partial seizures; adjunctive therapy; seizure frequency; reduction in seizure frequency; safety; concomitant AED(s)
Regenerative Endodontic Procedure of Immature Permanent Teeth With L-PRF: a Pilot Controlled, Clinical Trial
Condition: Endodontic Inflammation
MeSH terms: Pulpitis; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the impact of autologous 'leucocyte and platelet rich fibrin' (L-PRF) on
      the periapical bone healing and further root development of infected immature permanent
      teeth. In the test group regenerative endodontic procedure (REP) is performed with L-PRF as
      scaffold, in the control group REP without L-PRF is performed .
    

Detailed description: 
      Regenerative endodontic procedures are biologically based procedures designed to restore
      function of a damaged and nonfunctioning pulp by stimulation of existing stem and progenitor
      cells present in the root canal and/or the introduction and stimulation of new stem and
      dental pulp progenitor cells into the root canal under conditions that are favorable to their
      differentiation and reestablishment of function. L-PRF has the potential advantage of
      creating a bioactive construct that stimulates the local environment for differentiation and
      proliferation of these stem and progenitor cells. We have designed this confirmatory study to
      test the hypothesis that the use of L-PRF in REP of infected permanent immature teeth will
      accelerate periapical bone healing and stimulate the root maturation.
    

Intervention name(s): REP with L-PRF; REP; stem and progenitor cells
Intervention type(s): Procedure; Procedure; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: regenerative endodontics; platelet rich fibrin
Effect of Breathing a Mixture of 92% Oxygen (O2) + 8% Carbon Dioxide (CO2) on Flicker Induced Blood Flow Changes in Ocular Perfusion
Condition: Flicker-induced Vasodilatation
Study type: Interventional

Summary: 
      It has been shown that diffuse luminance flicker increases retinal and optic nerve head blood
      flow. This indicates that a neuro-vascular coupling between neural activity and blood flow
      exists in the retina as described previously for the brain. Although a lot of mediators such
      as NO, pO2, pCO2, H+ and K+ have been proposed, the mechanism of this coupling is still a
      matter of controversy. However, it has been shown in an animal experiment, that an increase
      in blood flow, evoked by diffuse luminance flicker stimulation is paralleled by decrease in
      pO2 in the tissue. In a recently performed study we could show that breathing of 100% O2 did
      not influence flicker induced changes in the retina and optic nerve head. However, breathing
      of 100% oxygen also leads to a pronounced vasoconstriction of the retinal vessels and in turn
      to a increased tension of the vessel wall. Recent evidence indicates that a combination of
      92% O2 and 8% CO2 can, at least partially, counteract the vasoconstrictory effect of O2 and
      increases tissue pO2. Thus, in this study the investigators set out to investigate the
      flicker light induced increase in blood flow under a mixture of O2/CO2 .
    


Intervention name(s): Oxygen + Carbondioxide; full field flickering light at 12.5 Hz
Intervention type(s): Drug; Other
Intervention description(s): Mixture of 92 % oxygen and 8 % carbon dioxide for inhalation; 1 minute stimulation with full field flickering light at 12.5 Hz during measurement of vessel diameters and measurement of blood flow.
Other intervention name(s): O² + CO²; Oxymix
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Retinal vessel diameter; Flicker-induced vasodilatation; Optic nerve head blood flow; Ocular Physiology; Regional Blood Flow
A Study of ALKS 3831 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted
      in 2 parts. The study duration for each subject will be approximately 33 weeks and will
      include 25 study visits.
    


Intervention name(s): Samidorphan (Low Dose); Samidorphan (Medium Dose); Samidorphan (High Dose); Placebo; Olanzapine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets taken once daily; Tablets taken once daily; Tablets taken once daily; Tablets taken once daily; Tablets taken once daily
Other intervention name(s): Low dose samidorphan (ALKS 33); Medium dose samidorphan (ALKS 33); High dose samidorphan (ALKS 33)
Intervention MeSH terms: Naltrexone; Olanzapine; ALKS-33
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Olanzapine; Samidorphan; Alkermes
An Open Label Dose Finding Safety and Efficacy in Children and Infants Infected With Schistosomiasis (S.Mansoni)
Condition: Schistosomiasis
MeSH terms: Schistosomiasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The Phase II study consisted of two parts, part 1 is open label, randomized, controlled and
      exploratory dose finding in children aged between 2 and 6 years infected with S. mansoni.
      Part 2 investigated efficacy and safety with the selected formulation and dosage in S.
      mansoni infected children aged between 3 months - 2 years.
    


Intervention name(s): Biltricide (racemate praziquantel) oral tablets; Racemate Praziquantel ODT; Levo Praziquantel ODT
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Biltricide (600 mg tablet) was administered to participants at a dose of 20 mg/kg in Part 1, Cohort 1 and at a dose of 40mg/kg in Part 1, Cohort 2.; Racemate Praziquantel (PZQ) (150) mg was administered at a dose of 40 mg/kg in Part 1, Cohort 3 and at a dose of 60 mg/kg in Part 1, Cohort 4.; Levo PZQ (150 mg) was administered at a dose of 30 mg/kg in Part 1 Cohort 5, 45 mg/kg Part 1 Cohort 6, 60 mg/kg Part 1 Cohort 7, 50 mg/kg Part 2 Cohort 8, and 50 mg/kg Part 2 Cohort 9.
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Praziquantel ODT formulation; Biltricide
Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g
      extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic
      remission in subjects with UC. The duration of treatment for each subject was 6 months.
    


Intervention name(s): Mesalamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Granules in sachet; Route of administration: Oral use; Pharmaceutical form: Granules in sachet; Route of administration: Oral use
Other intervention name(s): Mesalazine; Pentasa
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Feasibility Study of a Software Application for Patients Hospitalized After Suicidal Ideation or Suicide Attempts
Condition: Suicide, Attempted; Suicidal Ideation
MeSH terms: Suicide; Suicidal Ideation; Suicide, Attempted
Study type: Interventional

Summary: 
      The primary objective of this feasibility study is to assess the feasibility, and usability
      of a software application to deliver targeted interactive exercises to patients recently
      hospitalized for suicidal ideation or suicide attempts.
    


Intervention name(s): Software Application
Intervention type(s): Device
Intervention description(s): A software application targeting suicidal ideation via interactive exercises.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children
Condition: Uncomplicated Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for
      falciparum malaria treatment in African children: randomised controlled trial.

      Design: Mono-centre, two arms, open randomized controlled study in children with
      uncomplicated falciparum malaria in Burkina Faso.

      Phase: Phase II.

      Objectives: The primary objective of this trial is to study the efficacy and safety of the
      triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days
      in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local
      standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen.

      Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna
      Hospital in north-western Burkina Faso.

      Sample size: 180 patients (90 per study arm).
    


Intervention name(s): artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)
Intervention type(s): Drug
Intervention description(s): The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB over a three days period.
Intervention MeSH terms: Artesunate; Amodiaquine; Methylene Blue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children
Liraglutide and Cardio-Metabolic Risk Markers
Condition: Type-2 Diabetes
Study type: Observational

Summary: 
      Incretin-based therapies have shown significant effects beyond those on glucose metabolism.
      We aim in the present study to evaluate the effects of liraglutide on several
      cardio-metabolic risk markers.
    

Detailed description: 
      In details, we will evaluate the effects of liraglutide on carotid-intima media thickness,
      oxidative stress, ghrelin, heat shock proteins and lipoproteins.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        adult subjects with type-2 diabetes
      
Biospecimen description: 
      serum and plasma samples
    
Keywords: diabetes, cardiovascular risk
Prevention of Hypoglycaemia With Predictive Insulin Suspend Using Sensor Augmented Insulin Pump in Children
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      The aim of the study is to prove whether the use of the SmartGuard feature of the MiniMed
      system significantly reduces hypoglycemic excursions and thus provide proactive protection to
      the user.
    

Detailed description: 
      This is randomized two-arm parallel controlled open label study that will be conducted at two
      sites, in Slovenia and Israel. It is an investigator initiated pediatric clinical study.

      Study will be conducted on pediatric population during two weeks, following a 3 day Run-in
      period that will allow the patients to get familiar with study device and CGM (SmartGuard
      OFF).

      Patients will be asked to continuously wear the study device for 14 days, which will be set
      up by study staff according to randomization in the specific group. They will be provided
      with a diary for entering their daily activity, food consumption (carb count) and eventual
      adverse events.
    

Intervention name(s): Medtronic MiniMed™ 640G system
Intervention type(s): Device
Intervention description(s): The MiniMed™ 640G system is indicated for the continuous delivery of insulin, for continuous or periodic monitoring of glucose levels in the fluid under the skin, with a feature for a prediction of low or high glucose episodes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      Evaluate the relationship between ABCG2 mutation (rs2231142) and teriflunomide exposure,
      during 6-month treatment with teriflunomide 14 mg

      Secondary Objective:

      Characterize the safety (AEs, such as ALT enhancement, hair thinning, diarrhea, nausea, etc.)
      during 6-month treatment with teriflunomide
    

Detailed description: 
      Study duration per participant is approximately 28 weeks including a 24-week treatment period
    

Intervention name(s): TERIFLUNOMIDE
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:tablet Route of administration: oral
Intervention MeSH terms: Teriflunomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
High on Treatment Platelet Reactivity Following Peripheral Endovascular Procedures
Condition: Influence of PRU Values on Primary Outcome
Study type: Observational [Patient Registry]

Summary: 
      Antiplatelet therapy with clopidogrel is recommended following peripheral endovascular
      procedures. The clinical significance of an inadequate response to clopidogrel following
      percutaneous coronary interventions has been recently recognized.This study was designed to
      investigate platelet responsiveness to Clopidogrel following endovascular therapy of
      peripheral arterial disease using the VerifyNow P2Y12 point-of-care testing and to determine
      the optimal P2Y12 reactive unites (PRU) cut-off value of platelet inhibition influencing
      outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel
      antiplatelet therapy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Consecutive patient sampling of all patients undergoing pre-scheduled infrainguinal
        angioplasty or stenting due to symptomatic arterial disease in our Department from January
        2010, treated with clopidogrel 75 mg daily.
      
Keywords: Clopidogrel; platelet inhibition; antiplatelet therapy; peripheral arterial disease; endovascular treatment; angioplasty; stenting
To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
Condition: Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg
      and acetaminophen 1000 mg in dental surgery.
    

Detailed description: 
      This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen
      650 mg over a six-hour period, in subjects experiencing at least moderate post-operative
      dental pain.
    

Intervention name(s): Acetaminophen; Placebo Control
Intervention type(s): Drug; Drug
Intervention description(s): Acetaminophen Caplet - single dose; 0 mg Caplet - single dose
Other intervention name(s): Tylenol; Control
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Horton & Maizy Pilot Study for Resistant to Starch
Condition: pH; Weight Gain
MeSH terms: Weight Gain
Study type: Observational

Summary: 
      This is a pilot study and will be used to power an NIH grant application on the effect of
      resistant starch on weight gain in children.
    

Detailed description: 
      Stool fatty acids and stool pH from the baseline and week 4 stool samples will be compared by
      paired-t test. The stool microflora changes will be reported using descriptive statistics for
      the percent changes in the different bacterial phyla.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children between ages 5 and 15
      
Biospecimen description: 
      collect 3 daily stool samples are retained at baseline and after 4 weeks
    
Keywords: stool fatty acid
Partner Assistance in Learning and Performing Skin Self-Examination
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      This study is a behavioral science study designed to identify aspects of the dyadic
      relationship that promote Skin Self-Examination (SSE) in patients at high risk of developing
      melanoma. The patient is randomized to receive the educational intervention either as a solo
      learner or with the partner.
    


Intervention name(s): Skin Self Examination Information and ABCDE Rule
Intervention type(s): Behavioral
Intervention description(s): Card with condensed information about skin self examination (SSE) and color illustrations of the ABCDE (asymmetry of shape, border irregularity, color variation, diameter > or equal to 6 mm, and evolution of the lesion) rule. A research assistant gave a skill demonstration using a magnifying lens.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: skin self-examination; SSE; melanoma
Gluten Free Diet in IBS Patients Stratified According to Their Antigliadin Status
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      Gluten-free diet has been shown to improve gut symptoms in patients with celiac disease and
      also in adult patients with diagnosis of Irritable Bowel Syndrome (Rome III criteria).

      Antibodies to native gliadin (AGA) have been suggested as a potential diagnostic marker of
      response to GFD. However, this has not been tested in a prospective study in IBS patients.
      Identification of predictors of a symptomatic response to GFD within the IBS population would
      improve the clinical management of these patients.

      The purpose of this study is to evaluate the effect of gluten-free diet on gastrointestinal
      symptoms and gut motility in patients with Irritable Bowel Syndrome stratified according to
      their antigliadin antibodies status.

      Additional purposes include investigating effects gluten free diet may have on other
      parameters:

        -  Improvement of mood

        -  Quality of life and general well-being

        -  Changes in gut microbiota
    


Intervention name(s): Gluten free diet
Intervention type(s): Other
Intervention description(s): Gluten-free diet- Instructions provided by a dietitian
Intervention model: Single Group Assignment
Intervention model description: Intervention GFD in IBS and HV(controls)
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: antigliadin, gluten free diet, transit
Glycemic Load & Resistance Training on Endothelial Function & Insulin Sensitivity
Condition: 160 Participants Aged 18-35 Years and Obese (BMI ≥30) Open to Men and Women of All Ethnicity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      This project is prompted by the urgent public health need to identify novel strategies to
      prevent cardiovascular disease (CVD) and type 2 diabetes (T2D). The higher prevalence of CVD,
      T2D, and metabolic syndrome in obese individuals is a major healthcare concern. Therefore,
      finding optimal intervention strategies to combat these growing epidemics is imperative.
    

Detailed description: 
      At present, the extent to which dietary components can modify endothelial function, monocyte
      inflammation and glycemic variations is not well defined, although different carbohydrates
      are known to vary in their abilities to induce plasma glucose and insulin responses.
      Epidemiologic work suggests that high dietary glycemic load (GL) is associated with increased
      concentrations of inflammatory cytokines, endothelial dysfunction markers, and increased risk
      of T2D and coronary heart disease (CHD). We are examining using randomized control trials low
      vs. high-GL diet to determine if low-GL diets induce improvements in endothelial function or
      monocyte inflammation. Furthermore, resistance training is an alternate form of exercise from
      conventional aerobic training. Resistance Training has the potential to improve endothelial
      function or monocyte phenotype, but there is very little data in this area. We hypothesize
      that resistance training may augment the beneficial effects of a low-GL diet in improving
      metabolic health.
    

Intervention name(s): Glycemic Load; Resistance Training
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: There are four intervention arms designed to compare two factors, glycemic load and resistance training. Arms consist of high glycemic diet, no exercise, high glycemic diet, resistance training; low glycemic diet, no exercise; low glycemic diet, resistance training.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diet; obese; overweight; exercise; resistance training; nutrition; glycemic load; body composition; weight training; lifestyle
Manipulation of Dietary Protein and the Anabolic Response
Condition: Focus: Anabolic Response to Food Intake in Young Individuals; Condition Relevance: Skeletal Muscle Health, Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      In the present study, the effect of habitual dietary protein on the anabolic response will be
      investigated.
    


Intervention name(s): High protein intake; Placebo comparator
Intervention type(s): Dietary Supplement; Other
Intervention description(s): No protein intake
Other intervention name(s): control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Muscle protein synthesis; Dietary protein