bioihbjkbjnl/mcl2 huggingface dataset:
Pediatric Pneumonia Lung Ultrasound
Condition: Pneumonia; Acute Respiratory Infection
MeSH terms: Pneumonia; Respiratory Tract Infections
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the impact of LUS on the diagnosis and management of
      childhood pneumonia in developing countries
    


Intervention name(s): Lung ultrasound
Intervention type(s): Device
Intervention description(s): Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cases will be children 2 through 23 months of age who present to a study hospital with
        history of cough or difficulty breathing and chest indrawing. Controls will be children 2
        through 23 months of age who present with cough or difficulty breathing, but without chest
        indrawing, fast breathing or fever.
      
Biospecimen description: 
      Respiratory and blood samples
    
Keywords: pneumonia; diagnostic; ultrasound; Pakistan; Mozambique
Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation
Condition: Epilepsy, Temporal Lobe
MeSH terms: Seizures; Epilepsy, Temporal Lobe
Study type: Interventional

Summary: 
      The overall goal of this study is to open up the promising treatment of repetitive
      transcranial magnetic stimulation (rTMS), which has been shown to be effective against
      seizures in patients with surface neocortical foci, to a much larger population of patients
      with mesial temporal lobe epilepsy (MTLE) and other forms of epilepsy with deep foci, who are
      not currently considered good rTMS candidates.

      The investigators hypothesize that rTMS can modulate the hyperexcitable state in patients
      with deep seizure foci by targeting its usage to accessible cortical partner regions. In this
      study the investigators aim 1) to map the functional connectivity of the epileptogenic mesial
      temporal lobe in patients with medically refractory mesial temporal lobe epilepsy; and 2) to
      perform a randomized controlled assessment of repetitive transcranial magnetic stimulation
      protocols applied to specific neocortical targets in mesial temporal lobe epilepsy. The
      methods used in this study will include magnetic resonance imaging (MRI) of the brain,
      electroencephalography (EEG), and transcranial magnetic stimulation (TMS).
    


Intervention name(s): Low-frequency repetitive transcranial magnetic stimulation; High-frequency repetitive transcranial magnetic stimulation; Sham repetitive transcranial magnetic stimulation
Intervention type(s): Device; Device; Device
Other intervention name(s): Nexstim eXimia TMS stimulator with neuronavigation; Nexstim eXimia TMS stimulator with neuronavigation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing
      of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe
      Hemophilia A(FRSW117) Secondary objectives: To assess Preliminary efficacy of Repeat Dosing
      of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe
      Hemophilia A.
    


Intervention name(s): FRSW117
Intervention type(s): Drug
Intervention description(s): Subjects of high dose group are being received four doses(50 IU/kg,once a week or every 7 days) of FRSW117.
Subjects of low dose group (40 IU/kg,once a week or every 7 days)are being received four doses of FRSW117.
Other intervention name(s): PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Intervention MeSH terms: Factor VIII
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics;; Safety;; immunogenicity;; Preliminary efficacy
High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer
Condition: Bleeding Peptic Ulcer
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      To describe the rate of clinically significant rebleeding during 72 hours continuous i.v.
      infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic
      haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in
    

Detailed description: 
      A multi-center, randomised, double-blind, parallel-group phase III study to assess high dose
      esomeprazole Na i.v. treatment (bolus infusion of 80 mg followed by a continuous infusion of
      8 mg per hour administered for 72 hours) for prevention of rebleeding
    

Intervention name(s): Esomeprazole Na; Cimetidine; Esomeprazole Mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous; Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours; 40 mg tablet once daily for 27 days
Other intervention name(s): Nexium; Nexium
Intervention MeSH terms: Esomeprazole; Cimetidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: peptic ulcer bleeding; prevention of rebleeding; successful endoscopic haemostatic therapy
A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods
Condition: Contraception
Study type: Observational

Summary: 
      This study will assess the continuation rates among women using oral contraceptive pills,
      Depo-Provera and Ortho Evra following a first trimester abortion.
    

Detailed description: 
      Unintended pregnancy rates among women in the United States continue to surpass that of the
      rest of the developed world at great cost to society. Contraceptive failure has been
      attributed to poor compliance with contraceptive methods and results in unintended
      pregnancies. This study will evaluate the 3-month continuation rates among women using the
      oral contraceptive pill and Depo-Provera. It will also assess the continuation rates of Ortho
      Evra®, which has not previously been studied in the adolescent population. This study will
      provide information with regard to pregnancy rates and 3-month patterns of use of
      contraception among women seeking first-trimester abortion. It will also assess other factors
      contributing to successful contraception such as the use of emergency contraception and
      concomitant condom use. The results of this study will be used to inform the practice of
      providers who provide reproductive health care to women and add to the sparse body of
      literature available comparing the success of different contraceptive methods used by women.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants were recruited from a indigent, urban, African American population.
      
Keywords: birth control; continuation; abortion; contraception
Dupilumab As An Adjunct For Subcutaneous Grass Immunotherapy
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to assess whether 16 weeks of treatment with dupilumab as an adjunct
      to Timothy Grass Subcutaneous Immunotherapy (SCIT) improves upon the efficacy of Timothy
      Grass SCIT to reduce provoked allergic rhinitis symptoms, as measured by Total Nasal Symptom
      Score (TNSS) after nasal allergen challenge (NAC) with Timothy Grass extract at week 17.

      The secondary objectives of the study are:

        -  To assess whether 16 weeks of treatment with dupilumab as compared to placebo reduces
           provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen challenge
           (NAC) with Timothy Grass extract

        -  To assess whether 16 weeks of treatment with dupilumab as compared to dupilumab + SCIT
           reduces provoked allergic rhinitis symptoms, as measured by TNSS after nasal allergen
           challenge (NAC) with Timothy Grass extract

        -  To assess changes in serum Timothy-grass-specific immunoglobulin G4 (IgG4), serum
           Timothy grass-specific immunoglobulin E (IgE), and ratio of serum Timothy Grass-specific
           IgG4 to IgE over 16 weeks of treatment with dupilumab + SCIT as compared to SCIT
           monotherapy

        -  To evaluate the safety and tolerability of 16 weeks of treatment with dupilumab as an
           adjunct to Timothy Grass SCIT
    


Intervention name(s): Dupilumab; Timothy Grass SCIT; Placebo matching dupilumab; Placebo matching SCIT
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dupilumab was administered SC in a single-use, pre-filled glass syringe; Timothy grass extract was administered SC.; Placebo matching dupilumab was prepared in the same formulation without the addition of protein; Placebo matching SCIT was prepared in the same formulation (SCIT diluent) without the addition of Timothy grass extract
Other intervention name(s): DUPIXENT®; REGN668; SAR231893
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Evaluate Safety and the Pharmacokinetic Characteristics After Oral Administration of HT-003 Compared With Choline Alfoscerate Capsule in Healthy Adult Male Volunteers
Condition: Healthy Male
Study type: Interventional
Phase: Phase 1

Summary: 
      Choline alfoscerate(L-alfa glycerylphosphorylcholine) is a natural compound found in the
      brain and breast. Choline alfoscerate contains 40.8% of choline and has a produrig structure
      and separated by a precursor of choline and nerve cell membrane precursor of acetylcholine
      glycerophosphate. Choline alfoscerate Colin normalization of nerve pathways, nerve cell
      membrane play and acetylcholine receptor function secondary symptoms caused by
      cerebrovascular deficiency and indirectly through activation of metabolism, has a
      degenerative effect on the brain organic mental syndrome.

      Currently marketed oral choline alfoscerate received a geriatric cognitive impairment,
      secondary symptoms and degeneration, or soft capsule is authorized to prescription drugs for
      degenerative brain organic mental syndrome caused by cerebrovascular deficiency. Gliatilin
      soft capsules containing 400 mg per 1 capsule 2-3 times one days're supposed to take when
      considering optimal convenience and efficiency of the drug in patients with the development
      of sustained release formulations that can be maintained for a long period of time, a certain
      concentration is required. Accordingly, the modern drug by reducing the frequency of
      administration a day circuit is to develop a sustained release formulation of choline
      alfoscerate HT-003 600 mg medication compliance for the purpose of raising. 2 tablets at a
      time (600 mg x 2) can be taken one day to 1200 mg is required by taking.

      Therefore, for the development of sustained release formulation, the test in healthy adult
      male volunteers targets choline alfoscerate soft capsule formulation of 400mg 3 times per 1
      day and sustained-release tablet 600mg 2time per 1 day, pharmacokinetic properties and safety
      of a single dose should be evaluated when compared.
    


Intervention name(s): Choline CR 600mg; Gliatilin 400mg; Choline CR 600mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00; Gliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00; HT-003 600mg*2tab, administration 1 times per 1 day 8:00 a.m.
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Lidocaine to Reduce Propofol Consumption During Gastroscopy.
Condition: Diagnostic Gastroscopy
Study type: Interventional

Summary: 
      The goal of this clinical trial is to assess if intravenous administration of linisol reduce
      the propofol consumption and the sides effects of sedation during gastroscopy in healthy
      patients (ASA 1 and 2 patients).

      Prior to propofol sedation, participants will receive either an intravenous bolus of linisol
      (1.5 mg/kg) = treated group or placebo = control group.

      After the gastroscopy, patients will be asked to complete a satisfaction questionnaire
    


Intervention name(s): Lidocaine 2% Injectable Solution; Saline administration as placebo; Propofol injection; gastroscopy
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention description(s): administration of a bolus of lidocaine 1.5 mg/kg; administration of a bolus of saline solution as a placebo; Sedation by total intravenous administration (TIVA) of propofol; esogastroduodenoscopy
Intervention MeSH terms: Lidocaine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Sleep, Diet, Exercise and Older Persons
Condition: Cognitive Change; Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      To examine the impacts of a cognitive yoga program and circuit resistance training on
      cognitive and physical performance with nutrition and sleep as modulating factors in healthy,
      older adults.
    


Intervention name(s): High-Speed Circuit Resistance Training; High-Speed Multidirectional Yoga
Intervention type(s): Behavioral; Behavioral
Intervention description(s): three times per week; 45 minutes per session; 12-weeks; two times per week; 60 minutes per session; 12-weeks
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Circuit Resistance Training; Yoga; Cognition
BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg BID
      compared with placebo on COPD symptoms in a symptomatic patients population with moderate
      COPD and chronic bronchitis, and particularly assess the effects in cough by using specific
      tools to assess the occurrence and impact of this relevant COPD symptom.
    


Intervention name(s): Aclidinium Bromide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler; Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler
Intervention MeSH terms: Bromides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: COPD
Learning Strategies for Improving Dual Task Performance in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study is a randomized controlled study in which we aim to include 60 persons with
      Multiple Sclerosis and 30 healthy controls. Two different learning strategies, an explicit
      and an implicit one, will be compared on effects on dual task performance. Further, clinical
      profile associated with these effects, and brain activity measured by functional
      near-infrared spectroscopy during dual tasking will be investigated.

      To this end, the study will cover 4 days:

      Day 1: examine clinical profile; Day 2: baseline dual task measures; Day 3: experimental
      learning paradigm with subjects randomly assigned to either the implicit or the explicit
      learning condition.

      Day 4: delayed retention dual task and fNIRS measures.
    


Intervention name(s): StraDiMS implicit; StraDiMs explicit
Intervention type(s): Behavioral; Behavioral
Intervention description(s): participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.; participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Prebiotics and Microbiota Composition and Functionality in Rural Burkinabe Infants
Condition: Growth Retardation; Infant Morbidity
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect of a mixture of prebiotics included in a
      food supplement on microbiota diversity and functionality, and to explore its subsequent
      effects on linear growth velocity and morbidity.
    

Detailed description: 
      The central role of gut microbiota in immunity and nutritional homeostasis is now
      acknowledged, albeit not fully understood. Gut microbiota composition imbalances have been
      found in malnourished children, which were not restored by nutritional interventions as
      currently conducted. Therefore, the necessity to design more complete nutritional
      interventions that include gut health has been advised by expert committees.

      Prebiotics are compound that selectively enhance the growth of beneficial gut bacteria. They
      have been recommended and used in infant formula and weaning cereals resulting in gut
      microbiota resembling that of breastfed infants in formula fed infants in developed
      countries. A healthy gut microbiota was shown to be associated with enhanced growth patterns
      and decreased morbidity in children in developed countries. Evidence of such outcome is
      lacking in developing countries, yet such results would be particularly valuable for children
      from these settings, living in rather poor sanitary conditions in an environment
      characterized with high infectious disease load, conditions that mostly explain the high
      prevalence of chronic malnutrition. This study aims to assess the effect of a 6 months'
      supplementation with a lipid based nutrient supplement fortified with fructo-oligosaccharides
      and inulin on microbiota diversity and functionality in rural Burkinabe infants, and to
      explore its subsequent effects on linear growth velocity and morbidity.
    

Intervention name(s): Fortified lipid based nutrient supplement; lipid based nutrient supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6 months intervention: participant will take a daily dose of 20g supplement. The product contains 3 g of a mixture (1:1) of inulin and fructan-oligosaccharide; Dietary Supplement: lipid based nutrient supplement (Nutributter) 6 months intervention: participant will take a daily dose of 20g supplement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Study of an Expandable Interbody Device for the Lumbar Spine
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the safety and efficacy of CALIBER
      expandable spacer for the treatment of degenerative disc disease. Radiographic outcomes,
      intra-operative parameters, clinical outcomes, and patient satisfaction will be obtained from
      patients in this 2 year follow-up clinical study.
    

Detailed description: 
      Patients will be followed-up at 3weeks, 6 weeks, 3 months, 6 months, 12 and 24 months with
      X-rays and questionnaires to determine their satisfaction, healing, fusion and return to work
      status
    

Intervention name(s): CALIBER
Intervention type(s): Device
Intervention description(s): Expandable interbody spacer
Intervention model: Single Group Assignment
Intervention model description: Lumbar interbody cages
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Effects of Cyclosporine on the Pharmacokinetics and Safety of Canagliflozin (JNJ-28431754) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how a single dose of cyclosporin affects the
      pharmacokinetics (ie, how the body affects the drug) of multiple doses of canagliflozin
      (JNJ-28431754). The safety and tolerability of canagliflozin will also be assessed in healthy
      volunteers.
    

Detailed description: 
      This study will be an open label (all volunteers and study staff know the identity of
      assigned treatments), single-center, multiple-dose study to determine how cyclosporin (a drug
      which reduces the activity of a patient's immune system) affects the pharmacokinetics of
      canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes
      mellitus). The study will consist of 3 phases: a screening phase, an open-label treatment
      phase, and an end-of study (or follow-up) phase. Each volunteer will participate in the study
      for approximately 47 days.
    

Intervention name(s): Canagliflozin (JNJ-28431754); Cyclosporine
Intervention type(s): Drug; Drug
Intervention description(s): One 300 mg capsule-shaped tablet taken orally (by mouth) on Days 1 through 8.; Four 100 mg capsules (400 mg total dose) taken orally 30 minutes before the last dose of canagliflozin (JNJ-28431754) on Day 8.
Other intervention name(s): JNJ-28431754
Intervention MeSH terms: Canagliflozin; Cyclosporine; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Cyclosporine