bioihbjkbjnl/mcl2 huggingface dataset:
the Cogmed Program for Youths With ADHD
Condition: ADHD; ADHD - Combined Type
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The primary objective of this study was to examine the effects of the Cogmed training program
      on working memory among youths 7 to 13 years old, while controlling presence and presentation
      of ADHD-related comorbidity. A secondary objective was to examine the generalization of
      effects to ADHD symptoms, non-verbal reasoning, attentional and executive functions, motor
      impulsivity, reading comprehension, and mathematical reasoning. Participants were under
      pharmacological treatment for ADHD combined type and a comorbidity. They were randomized into
      an experimental group that received the Cogmed program and an active control group that
      received a low-intensity comparison version of the training. They were evaluated at three
      time points: six weeks prior to intervention onset (T1), immediately prior to onset(T2), and
      one week following intervention completion (T3).
    

Detailed description: 
      Participants completed the Cogmed WM training program at home.Each training session lasted
      from 30 to 45 minutes and was supervised by a parent. For five consecutive weeks,
      participants had to complete at least five sessions per week.
    

Intervention name(s): Cognitive training Cogmed program
Intervention type(s): Other
Intervention description(s): Cognitive training Cogmed program
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized into an experimental group that received the Cogmed program and an active control group that received a low-intensity comparison version of the training
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Combined type; Cognitive training; Intervention; Youths
Oral Antibiotic Treatment of Helicobacter Pylori Reduces Intestinal Colonization Rates With Oxalobacter Formigenes
Condition: Nephrolithiasis
MeSH terms: Nephrolithiasis; Kidney Calculi
Study type: Observational

Summary: 
      The investigators are finding out if giving antibiotics for Helicobacter pylori will
      eliminate colonization of the colon by Oxalobacter formigenes.
    

Detailed description: 
      Background and objectives: Oxalobacter formigenes (OF) may play a protective role in
      preventing calcium oxalate stones. Intestinal colonization by OF is associated with reduced
      urinary oxalate excretion. Exposure to antibiotics may be an important factor contributing to
      variable rates of colonization. This is the first prospective study to evaluate the effect of
      antibiotics on OF colonization.

      Design, setting, participants, & measurements: The effect of antibiotics on OF colonization
      was compared in 2 groups: a group receiving antibiotics for gastric infection with
      Helicobacter pylori (HP) and a group without HP that not receiving antibiotics. OF
      colonization in stool was detected by oxalate degradation at baseline and after 1 and 6
      months.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing upper endoscopy for any indication and who would have determination of
        presence or absence of H. pylori. Stool samples then positive for colonization with
        Oxalobacter formigenes.
      
Keywords: nephrolithiasis; urolithiasis; hyperoxaluria; Helicobacter pylori
Electrical Impedance Tomography of Lung in Child and Young Age
Condition: Obstructive Lung Diseases
MeSH terms: Lung Diseases; Lung Diseases, Obstructive
Study type: Observational

Summary: 
      The investigator will determine a compliance of two diagnostic techniques (EIT and Body
      plethysmography) in collective of children and teenagers with obstructive lung disease and a
      matched control group.
    

Detailed description: 
      The aim of the present study is verification of the correlation between EIT-derived data and
      following extracted parameters of the pulmonary function:

        -  forced expiratory volume in 1 second (FEV 1)

        -  forced vital capacity (FVC)

        -  relative forced expiratory volume in 1 second (FEV1/FVC)

        -  maximal expiratory flow (MEF 25)

        -  total lung capacity (TLC)

        -  resistance (Raw).

      These findings could bring out new prospective opportunity for pulmonary function tests
      without cooperation.

      Furthermore, the study aims to clarify whether EIT technique can be used for regional
      pulmonary function testing.

      In addition, dynamic lung function parameter and static radiological techniques will be
      correlated with EIT.
    

Intervention name(s): patients; probands
Intervention type(s): Procedure; Procedure
Intervention description(s): The 16-electrode belt will be applied to patient's chest. Following vital signs will be recorded: respiratory rate at rest breathing, heart rate, transcutaneous oxygen saturation. Then impulse oscillometry (IOS) will be performed in a sitting position. After that, subjects with cooperation willingness will get a body plethysmography. A spirometry / forced breathing maneuvers will be performed. All patients will receive 2 strokes salbutamol inhaler for bronchospasmolysis. Please note that inhalation of salbutamol is not study related. It is used in the clinical routine to examine the reversibility of the bronchial obstruction in patients with obstructive lung disease in course of the lung function test. Ten minutes later measurements described above will be repeated.; Probands will receive the same treatment as patients, but without bronchospasmolysis.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients, who come to the consultation to the Department of Pediatric Pneumology, Children
        and Adolescent Medicine, University Hospital Aachen, will be recruited and divided into
        groups by age and diagnosis. Recriutment will be performed in accordance to the inclusion
        and exclusion criteria.
      
Keywords: obstructive pulmonary disease; children; teenager; EIT (Electrical Impedance Tomography)
Continuous Subacromial Bupivacaine
Condition: Shoulder Arthroscopy
Study type: Interventional

Summary: 
      The investigators wanted to re-evaluate the effects of subacromial bupivacaine infusion after
      shoulder arthroscopy with standard surgical techniques, including rotator cuff operations.
      The investigators hypothesized that patients having 5.0 mg/ml bupivacaine infusion at a rate
      of 2 ml/h subacromially would need less opioids than patients receiving a placebo infusion.
    

Detailed description: 
      Shoulder surgery has become a routine outpatient procedure. Previously shoulder surgery was
      associated with intense, occasionally severe postoperative pain and hence considerable use of
      opioids. Also arthroscopic shoulder surgery, especially rotator cuff procedures, may cause
      significant pain resulting sometimes in inpatient admission. Subacromial local anaesthetic
      infusion as a part of a multimodal approach is one commonly used modality to pain relief
      after shoulder surgery. Nevertheless, it has been criticized recently for its poor benefits
      and possible adverse effects. On the whole, the scientific evidence of the advantages of
      local anaesthetic infusions is inconclusive.
    

Intervention name(s): bupivacaine
Intervention type(s): Drug
Intervention description(s): bupivacaine 5 mg/ml infusion 2 ml/h 48 h
Other intervention name(s): Bicain
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: arthroscopy; shoulder surgery; subacromial; continuous bupivacaine
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K in Healthy Subjects
Condition: Healthy Volunteers; Pharmacokinetics of ASP015K
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      single ascending doses of ASP015K.
    

Detailed description: 
      Subjects will be enrolled in 1 of 3 dose cohorts (low, medium and high). Each cohort will
      consist of 8 subjects with a 3:1 randomization ratio for ASP015K to placebo. Subjects will be
      confined to the clinic for study procedures until day 4 (5 days). After all subjects in a
      dose cohort have completed study procedures through day 4, a decision will be made whether or
      not dosing and enrollment of the next dose cohort should occur, which will only take place
      after a review of the safety and tolerability data through day 4 of the most recent dose
      cohort and any additional reported adverse events (AEs) for previously dosed cohorts.
    

Intervention name(s): ASP015K; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Intervention MeSH terms: Peficitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy volunteers; ASP015K
Randomized Study to Compare the Bioavailability of Two Clobetasol Propionate 0.05% Topical Foams
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study was to compare the relative vasoconstrictive effects of test and
      reference Clobetasol Propionate 0.05% Topical Foam in healthy, female subjects.
    


Intervention name(s): Clobetasol Propionate 0.05% Foam-Reference Product; Clobetasol Propionate 0.05% Foam-Test product
Intervention type(s): Drug; Drug
Intervention description(s): Small amount applied and evaluated over the course of two days; Small amount applied and evaluated over the course of two days
Intervention MeSH terms: Clobetasol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Community Volunteers
      
Keywords: Bioequivalence; Clobetasol Propionate
A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Condition: Intermittent Exotropia
MeSH terms: Exotropia
Study type: Interventional

Summary: 
      The objective of this short-term, pilot randomized trial comparing 2.50 diopters (D)
      overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in
      children with intermittent exotropia (IXT) 3 to <7 years of age is to determine whether to
      proceed to a full-scale, longer-term randomized trial.
    

Detailed description: 
      The objective of this short-term, pilot randomized trial comparing 2.50D overminus lens
      treatment vs. non-overminus (spectacles without overminus or no spectacles) is to determine
      whether to proceed to a full-scale, longer-term randomized trial. This decision will be based
      primarily on assessing the initial (8-week) response to overminus by comparing treatment
      groups on the following outcomes:

        -  Mean distance IXT control score (each patient's score is the mean of 3 control scores)
           (primary outcome)

        -  The proportion of subjects with treatment response, defined as 1 or more points
           improvement in mean of 3 distance IXT control scores (secondary outcome)

        -  Adverse effects, near visual acuity outcomes, and spectacle wear compliance
    

Intervention name(s): Overminus treatment; Non-overminus treatment
Intervention type(s): Device; Device
Intervention description(s): 2.50D overminus spectacles; spectacles without overminus or no spectacles
Other intervention name(s): Overminus spectacles; Overminus glasses; Overminus therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intermittent Exotropia; IXT; overminus
The Effect of Korean Red Ginseng Supplementation on Glucose Control
Condition: Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a randomized, double-blind, placebo-controlled clinical trial designed to
      evaluate the effect of Korean red ginseng supplementation on glucose control in subjects with
      impaired fasting glucose, impaired glucose tolerance or newly-diagnosed type 2 Diabetes
      Mellitus and to establish a clinical evidence on glucose control effect of KRG.
    

Detailed description: 
      Study participants, who were all aged between 20 and 70, were recruited from health checkup
      center at Ilsan hospital (Gyeonggi-do, Korea) and the advertisements in local newspaper.
      After the glucose screening test, subjects with IFG (100 mg/dL ≤ fasting blood glucose ≤
      125mg/dL), IGT (140mg/dL ≤ 2-h OGTT), or newly-diagnosed T2DM (fasting glucose ≥ 126 mg/dL)
      were enrolled in this study. Exclusion criteria that all selected patients met were: 1)
      Taking glucose-lowering medications or having insulin injections. 2) Chronic alcoholism or
      having an evidence or alcoholism. 3) Pregnant or in breast feeding. 4) Having chronic
      gastrointestinal disorders. 5) Showing signs of nutrient deficiency of malnutrition. 6)
      Patients with serious kidney problems. 7) Patients with serious liver problems. 8) Patients
      whose job could be a threat when hypoglycemia occurs. 9) Patients who have experienced the
      complications such as headache, insomnia, heart palpitations and raised blood pressure after
      eating red ginseng. 10) Other patients who were considered unsuitable for this study by the
      researchers

      This study was designed for 12-week randomized, double-blinded, placebo-controlled trial.
      Sixty subjects were randomly assigned to receive placebo (corn starch) or 500 mg KRG. Both
      group consumed 10 capsules per day, three times daily after breakfast (3 capsules), lunch (3
      capsules) and dinner (4 capsules), and it comes to total 5.0g daily. Red ginseng and placebo
      capsules were provided by the Korea Ginseng Cooperation (KGC, Daejeon, Korea).

      Subjects met with the investigational team at four different time points: Screening (Week
      -1), randomization and treatment baseline (Week 0), treatment midpoint (Week 6), and
      treatment endpoint (Week 12). Daily intake by 24-hour recall method and physical activity
      were measured at baseline (Week 0), midpoint (Week 6), and endpoint (Week 12) of the
      treatment period. Compliance with study restrictions and capsule consumption was monitored
      via daily documentation by subjects on individualized study calendars and end-study count of
      returned capsules.
    

Intervention name(s): KRG; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mg Korea red ginseng (KRG); 500 mg placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of
      mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with
      moderate-to-severe adult onset Rheumatoid Arthritis (RA).
    

Detailed description: 
      Despite the therapeutic improvements with recent biologic agents approved for rheumatoid
      arthritis, there is still significant unmet medical need for the treatment of subjects with
      this chronic disease to achieve a faster, more complete response, and higher rates of
      remission. The aim of the study is to explore the optimum dose of mavrilimumab for further
      clinical development and more fully investigate the efficacy and safety profile of
      mavrilimumab after longer drug exposure (that is, 24 weeks). The results of this study will
      form the basis for future clinical studies with mavrilimumab.
    

Intervention name(s): Mavrilimumab 30 mg; Mavrilimumab 100 mg; Mavrilimumab 150 mg; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks; Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.; Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.; Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.
Other intervention name(s): CAM-3001; CAM-3001; CAM-3001
Intervention MeSH terms: Mavrilimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Mavrilimumab; CAM-3001
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 Years
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The purpose of the trial is to assess safety, tolerability
      and pharmacokinetics (the exposure of the trial drug in the body) of liraglutide in obese
      adolescent subjects aged 12 to 17 years.
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously (s.c., under skin) for 5-6 weeks. Initial dose of 0.6 mg/day. The dose will be escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day; Administered subcutaneously (s.c., under skin) for 5-6 weeks. Initial dose of 0.6 mg/day. The dose will be escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dose-dense Biweekly Docetaxel Combined With 5-fluorouracil as First-line Treatment in Advanced Gastric Cancer
Condition: Gastric Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, phase II study to evaluate the efficacy and safety of biweekly
      docetaxel and DeGramont regimen on unresectable gastric adenocarcinoma in the first-line
      therapy.
    

Detailed description: 
      Primary endpoint: Overall Response Rate

      Secondary endpoint: Time to progression, overall survival, safety data
    

Intervention name(s): Docetaxel; Fluorouracil
Intervention type(s): Drug; Drug
Intervention description(s): Docetaxel 50mg/m2 iv drip, repeat every two weeks;
Efficacy will be evaluated every three cycles.; Fluorouracil 400mg/m2 iv D1; Fluorouracil 2400mg/m2 civ 46 hours; repeat fortnightly and evaluate every two cycles
Intervention MeSH terms: Docetaxel; Fluorouracil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Docetaxel; Fluorouracil; First line therapy; Gastric cancer
Outcome Following Hylan F- 20 (Synvisc) + Corticosteroid Injections for the Treatment of Osteoarthritis of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      The goal of viscosupplementation is to replenish synovial fluid, which will improve patient
      symptoms and mobility. Viscosupplementation of the knee with hyaluronic acid injections has
      been shown to improve symptoms in patients with osteoarthritis. Recent studies have shown
      that this improvement may be highly variable based on the time from treatment, especially in
      the first 12 weeks following treatment. The purpose of this study is to document the outcomes
      following a treatment protocol in which corticosteroid is used in addition to the initial
      Synvisc injection in the series of three injections.
    

Detailed description: 
      Upon initial visit, all study patients will complete an informed consent. After consent,
      patients will complete the baseline questionnaire packet, which includes a questionnaire with
      several validated scoring systems. Following injection, patients will receive a diary to
      document any adverse events between the first and second injection. In one week, patients
      will return for a second visit to receive the second injection. Again they will be asked to
      maintain their diary of adverse events following the second injection. The patient will then
      receive the final injection at week 3 and will again complete a diary of events for one week.
      At 1 week, 3 weeks, 6 weeks, 12 weeks, and 26 weeks following the completed series of
      injections, the patients will complete a form that will include the pain, stiffness, and
      physical function subscales of the WOMAC score and a 10 point patient satisfaction question.

      At 6 months, the patients will receive by mail the same questionnaire packet they received at
      baseline, with the addition of patient satisfaction and subsequent injury/treatment
      questions.
    

Intervention name(s): Hylan F- 20
Intervention type(s): Drug
Intervention MeSH terms: Hylan
Time perspective: Prospective
Keywords: knee; injection; function; osteoarthritis
Phase IIa Study of the Product QGC001 Compared With Placebo in Patients With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      2QG1 is a Phase IIa study aiming to assess the blood pressure lowering effect of 4-week
      administration of QGC001 oral doses in patients with grade I or II essential hypertension
      compared to placebo, to assess the safety and tolerability, to obtain preliminary PK
      information for QGC001 given as multiple oral doses and to determine preliminary PD profile
      of QGC001 multiple oral doses on plasma and urine hormones, which will be compared to that of
      placebo.
    


Intervention name(s): QGC001; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment