bioihbjkbjnl/mcl2 huggingface dataset:
Tailored Interventions to Prevent Substance Abuse
Condition: Prevention Harmful Effects
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The overarching objective of this research is to prevent substance use in early adolescents
      through the use of innovative interactive interventions tailored to each individual's
      particular risk profile for using cigarettes and alcohol. The specific aims are: (1) To test
      the effectiveness of the computer-based profile-based tailored interventions to keep early
      adolescents smoke-free compared to a comparison group; (2) To test the effectiveness of the
      computer-based profile-based tailored interventions to keep early adolescents from using
      alcohol compared to a comparison group; and (3) To replicate findings that the tailored diet
      and physical activity interventions will be effective in reducing these two high risk
      behaviors as part of the comparison condition.
    

Detailed description: 
      Research across age groups (elementary, middle and high school), populations (U.S., U.K., and
      Israel), and substances (tobacco, alcohol and other drugs) has consistently identified four
      clusters of non-users who vary in their risks for substance use: (1) Most Protected from
      substance use; (2) High Risk to use substances; (3) Ambivalent about staying substance free;
      and (4) Risk Denial about substance use. These profiles have demonstrated both internal and
      external validity as well as good ability to predict future substance use and, therefore,
      provide an opportunity to develop a new approach to prevention. These profiles will be
      employed as the basis for designing two innovative computer-based interventions to prevent
      substance abuse by adolescents. The two new tailored interventions (smoking prevention and
      alcohol prevention) will be developed and tested in a school-based clinical trial. The
      comparison group will receive two previously developed and tested tailored health behavior
      interventions (diet and physical activity).
    

Intervention name(s): Tailored computer based intervention; Tailored computer intervention
Intervention type(s): Other; Other
Intervention description(s): Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment.; Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment
Other intervention name(s): Tailored computer based interventions
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: tobacco; alcohol; diet; exercise
Pharmacokinetic Comparison of Vitamin's D2 and D3 in Stage 5 Chronic Kidney Disease Patients on Chronic Hemodialysis
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the pharmacokinetic 25(OH)D and 1,25(OH)2D responses
      to a single oral dose of vitamin D2 or vitamin D3 in a group of Stage 5-Chronic Kidney
      Disease subjects requiring chronic hemodialysis.
    

Detailed description: 
      This is a randomized, single blind, controlled study. Subjects will be randomly assigned to
      receive 1) placebo capsules (control group); 2) capsules with ergocalciferol (the vitamin D2
      group); or 3) capsules with cholecalciferol (the vitamin D3 group).
    

Intervention name(s): Vitamin D3; Vitamin D2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): a single oral dose of vitamin D3; a single oral dose of vitamin D2; a single oral dose of placebo
Other intervention name(s): Cholecalciferol; ergocalciferol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: chronic kidney disease
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Juvenile Rheumatoid Arthritis
Condition: Rheumatoid Arthritis, Juvenile
MeSH terms: Arthritis; Arthritis, Rheumatoid; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of infliximab
      (Remicade) in patients with Juvenile Rheumatoid Arthritis (JRA).
    

Detailed description: 
      The purpose of this study is to determine if infliximab in combination with methotrexate is
      safe and effective in the treatment of patients with juvenile rheumatoid arthritis. The
      second purpose of this study is to see how children's bodies react to the combination of
      study drug and methotrexate. Patients will receive either infliximab at 3 mg/kg for 44 weeks
      or, placebo for 14 weeks followed by infliximab at 6 mg/kg for 30 weeks. Patients who
      complete the original study are eligible for additional treatment with 3 to 6 mg/kg of
      infliximab every 8 weeks for up to three years. Safety evaluations will be performed at
      specified intervals throughout the study and will consist of laboratory tests, vital signs
      (such as blood pressure), physical examinations and the occurrence and severity of adverse
      events as well as other study specific procedures. Patients will receive either infliximab at
      3 mg/kg for 44 weeks or, placebo for 14 weeks followed by infliximab at 6 mg/kg for 30 weeks.
      Patients who complete the original study are eligible for additional treatment with 3 to 6
      mg/kg of infliximab every 8 weeks for up to three years
    

Intervention name(s): Infliximab
Intervention type(s): Drug
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Juvenile rheumatoid arthritis; Infliximab; Methotrexate; remicade
Turkish Version of LIFE Habits Assessment
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational [Patient Registry]

Summary: 
      Cerebral Palsy (CP) is the most common cause of physical disability in children, is a
      non-progressive neurological impairment resulting from an injury in the developing brain and
      causing various problems related to sensory, perception, cognition, and movement. This
      problems leads activity and participation levels of the children with CP. In the literature
      various assessment tools developed for assessing participation. Assessment of Life Habits
      (LIFE-H) questionnaire is one of the assessment tools that examines activities of daily life
      and participation in detail. The scale is originally in French but English and German
      versions are also available. The aim of this study is to translate the scale to Turkish and
      to determine validity and reliability of Turkish version of Life Habits questionnaire.
    


Intervention name(s): Assessment via questionnaire
Intervention type(s): Other
Intervention description(s): All the children will be assessed via assessment questionnaires.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects will be recruited from children who lives in Ankara city and, attend special
        education centers.
      
Keywords: Cerebral Palsy; Participation; LIFE Habits (life-H); Validity; Reliability
Herbal Treatment of Hepatitis C in Methadone Maintained Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Hepatitis C (HCV) is a chronic viral illness leading to progressive liver damage that has
      emerged as a major public health issue in the United States. While HCV affects all population
      groups, individuals with a history of intravenous drug use form the largest known risk group.
      Between 90 and 100 percent of long term intravenous drug use will eventually test positive
      for HCV, and there is substantial risk that even short term experimentation will result in
      infection. Studies suggest that HCV will be the major cause of cirrhosis and liver cancer in
      the next century. Currently, approved therapy includes recombinant interferons, which lead to
      sustained remission in a minority of patients. However, patients abusing other substances,
      including alcohol, are not eligible for interferon therapy. The need for investigation into
      other potential therapies is clear. Current practice patterns in the Far East include the use
      of traditional herbal remedies for symptomatic chronic viral hepatitis. This study is
      intended to examine the effect of commonly used herbal remedies for the treatment of
      symptomatic HCV.
    


Intervention name(s): Herbal remedies
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Effects on Health Related Quality of Life Among Patients With Chronic Pain by Interventional Pain Management
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational [Patient Registry]

Summary: 
      How are the health related quality of life among patients with chronic pain effected by
      interventional pain managment?

      Hypothesis:

      Health related quality of life can be improved by interventional pain management both among
      patients with localizable pain focuses and among patients among whom no pain focuses can be
      found.

      Method:

      Health related quality of life using EQ-5D and EQ-VAS is registered at first visit, at the
      time of treatment for pain focuses an during the following 12 months.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to a specialized interventional pain management clinic in northen sweden
Vitamin D for the Prevention of Diabetes Type 2
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The prevalence of type 2 diabetes is increasing, which for most societies has considerable
      consequences not only regarding health but also economy. Type 2 diabetes develops through a
      "prediabetic" stage with impaired glucose tolerance. Intervention at this stage with change
      in lifestyle or with medication may prevent such progression. There are indications that
      vitamin D is of importance in glucose metabolism, and that supplementation with vitamin D may
      increase both insulin secretion and insulin sensitivity. Accordingly, supplementation with
      vitamin D may improve glucose tolerance and potentially prevent the development of type 2
      diabetes in subjects at risk. However, this has so far not been demonstrated in a
      prospective, randomised clinical study. In the present study we will therefore include 600
      subjects with impaired glucose tolerance (or impaired fasting glucose) detected in the Tromso
      study 2007/2008 and randomize to supplementation with vitamin D 20.000IU per week or placebo
      for 5 years. A glucose tolerance test will be performed each year, and development of type 2
      diabetes will be the main endpoint.
    


Intervention name(s): cholecalciferol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20.000 IU cholecalciferol per week for 5 years versus placebo; Placebo capsule once a week, identical to cholecalciferol capsule
Other intervention name(s): vitamin D
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: diabetes; vitamin D; cholecalciferol; glucose tolerance
A Study to Explore the Efficacy of JNJ-67953964 in the Treatment of Depression
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of JNJ-67953964 compared to placebo
      when administered as adjunctive treatment in participants with Major Depressive Disorder
      (MDD) partially responsive to selective serotonin reuptake inhibitor/
      serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) treatment in terms of reduction of
      symptoms of depression, as assessed by the change from baseline on the Montgomery Asberg
      Depression Rating Scale (MADRS) in non-responders during the placebo lead-in period.
    


Intervention name(s): JNJ-67953964; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily.; Matching placebo will be administered as 2 capsules orally once daily.
Intervention MeSH terms: Aticaprant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the immunogenicity and the safety of a quadrivalent
      vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.
    


Intervention name(s): Novartis MenACWY-CRM; Saline Placebo
Intervention type(s): Biological; Biological
Intervention description(s): All subjects had blood drawn at Day 1 and Day 29.; All subjects had blood drawn at Day 1 and Day 29.
Intervention MeSH terms: Lactitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningococcal; ACWY-CRM; Conjugate Vaccine; Meningitis; Adolescents; Persistence; Adults
Study of ADHD Children's Sensitivity to Memory Error Production
Condition: ADHD
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of the study is to test whether children with Attention Deficit/Hyperactivity
      Disorder (ADHD) are more susceptible to false memory production using a DRM paradigm. The
      number of "critical decoy production" errors will be analyzed and compared to the calibration
      of the test.
    

Detailed description: 
      During a neuropsychological assessment, as part of the clinical routine, children with a
      diagnosis of ADHD, without neurological etiology, aged 8 to 10 years will be offered an
      additional task. This task, a DRM adapted to the child, consists of learning several lists of
      words. Each list exposes words belonging to the same lexical field, to a concept not
      explicitly mentioned in the list, called critical lure. Immediately after the presentation of
      a list, the child is asked to recall as many words as possible. Recall of the critical lure
      gives an indication of the production of false memories. The number of critical lures
      produced by these children will be compared to the calibration of the test, currently being
      published. The investigator will also verify if the production of critical lures can be
      correlated with other variables such as performance on intellectual, executive and
      attentional tasks, proposed during the clinical routine assessment.

      The investigator hypothesize that ADHD children will recall more critical lures than the
      norm, and fewer correct responses than the norm.

      The data collected is taken from the child's psychological file. The only personal
      information used, beyond test performance, is the child's gender and age. The procedure is
      anonymous.
    

Intervention name(s): DRM (Deese, Roediger et McDermott task)
Intervention type(s): Other
Intervention description(s): Eight lists of nine words are presented to the participants. Each list is heard once. Immediately afterwards, the child is asked to recall the words he or she remembers. Each child's response is then repeated one by one and the participant is asked to rate his or her confidence in the response on a five-point scale (from "not at all sure" to "100% sure"). A 5-minute break is given in the middle of the task, after the first four lists are presented. The test takes about 20 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
A Study to Investigate the Safety and Efficacy of Ricolinostat
Condition: Peripheral Nervous System Diseases
MeSH terms: Nervous System Diseases; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, placebo-controlled study during which patients will receive
      ricolinostat or placebo.
    

Detailed description: 
      This is a double-blind, placebo-controlled study during which patients will receive
      ricolinostat or placebo.

      Prior to randomization, patients will participate in the Screening and Baseline assessment
      period to ensure that they meet study inclusion/exclusion criteria.

      Following the Screening and Baseline assessment period, patients who meet entry criteria will
      be randomized in a 2:1 ratio to receive either ricolinostat or placebo.
    

Intervention name(s): Ricolinostat
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): Placebo
Intervention MeSH terms: Ricolinostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Postoperative Adjuvant Chemotherapy With Bevacizumab and Maintenance Bevacizumab After Neoadjuvant Chemotherapy for Ovarian Cancer
Condition: Epithelial Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to determine the feasibility of postoperative platinum-based chemotherapy plus
      adjuvant and maintenance bevacizumab after neoadjuvant chemotherapy followed by interval
      surgery in patients with extensive stage IIIC or IV ovarian, tubal, and peritoneal cancer.
    

Detailed description: 
      This study is designed to determine the feasibility of administering adjuvant carboplatin,
      paclitaxel, and bevacizumab without unacceptable significant AE in patients with epithelial
      ovarian cancer after neoadjuvant carboplatin/cisplatin, and paclitaxel and interval
      cytoreductive surgery, primary peritoneal cancer or fallopian tube cancer. This study will
      also investigate progression free and to assess the quality of life.

      A Simon minimax two-stage design is employed to determine permit early stopping when a
      moderately long sequence of initial adverse events occurs. Under this two-stage design, 13
      subjects are enrolled at the first stage. If there are > 3 subjects discontinue treatment due
      to significant AE in the stage-1, then stop the trial. Otherwise, the second stage is
      implemented by including the other 14 subjects. The treatment safety will be evaluated and
      ensured by the occurrence rate of significant AE (or non AE). In stage-1, postoperative
      adjuvant cycles 2-6 will be observed for defined significant AE.

      Patients' or physicians' decision of discontinuation not because of the above-defined
      significant AEs or due to cancer progression should not be counted as an end-point event.
    

Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): Bevacizumab 15 mg/ Kg (from post-op cycle 2) intravenous infusion for 30 minutes in a 21 days' cycle for at least three cycles (best to 6 cycles) followed by 3-weekly maintenance bevacizumab 15 mg/ Kg intravenous infusion for 17 cycles.
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian cancer.; tubal cancer; peritoneal cancer
A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment
Condition: Amnestic Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is examine the efficacy of a combination physical exercise and
      cognitive training program on improving memory in older Veterans with amnestic Mild Cognitive
      Impairment.
    


Intervention name(s): Combined Aerobic and Resistance Exercise; Stretching Exercises; Cognitive Training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Gym and home based aerobic and resistance exercises; Gym and home based stretching exercises; Group-based cognitive training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mild Cognitive Impairment; Aging
Effect of Exercise Training in Lung Cancer
Condition: Lung Cancer, Nonsmall Cell
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      To determine the effects of exercise training in patients with lung cancer during
      chemotherapy treatment. In currently accessible literature, majority studies, met-analysis,
      and systemic reviews are related to surgical procedures and post-op pulmonary Rehabilitation
      of patients with Lung cancer. In literature, Gap related to the control group was observed
      also. The current study aimed to fulfill this gap by planning a structured intervention plan
      for the control group as well. It will also add in literature the deficiency of oncology
      rehab for patients receiving chemotherapy only.
    

Detailed description: 
      Literature suggested that a pulmonary rehabilitation program for patients with non-small cell
      lung cancer undergoing induction chemo-radiotherapy seems to improve respiratory function. It
      is particularly recommended for smokers and patients with respiratory impairment.
    

Intervention name(s): Aerobic training; Pulmonary Exercises
Intervention type(s): Other; Other
Intervention description(s): Aerobic training ( with cycle ergometer, 5-minute warm-up 15 - 30 minute cycle +5 minute cooldown) 40%-60% intensity calculated through Karvonen formula 3 days/ week; 4 weeks protocol
Deep breathing Exercises* 10 Reps 3 sets
Postural drainage (10 minutes * 2 sets /day)
Incentive spirometry* 10 Reps 3 sets
Bed activities (Active ankle and hand pumping exercise * 10 Reps 3 sets)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Nonsmall Cell Lung cancer, Chemotherapy, Exercise training