bioihbjkbjnl/mcl2 huggingface dataset:
Dose Timing of D-Cycloserine to Augment CBT for Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to examine the efficacy of 50 mg of d-cycloserine in comparison
      to placebo (a pill containing no medication) for improving the effectiveness of
      cognitive-behavioral therapy (CBT) in reducing symptoms associated with social anxiety
      disorder. In addition, the study will examine whether the effectiveness of d-cycloserine
      depends on the timing of the pill administration (i.e., 1- hour before the session or
      immediately after the session) as well as the success of the CBT therapy sessions. The
      investigators hypothesize that the tailored post-session DCS administration condition will
      outperform the other conditions (pre-session DCS, placebo, and non-tailored post-session
      DCS). This will be evidenced by short- and long-term improvements in social anxiety severity.
    


Intervention name(s): D-Cycloserine; Placebo; Cognitive Behavioral Therapy
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): D-cycloserine is a medication thought to be associated with fear extinction.; Sugar pill; This will be a 5-session version of a group CBT protocol with 4-6 patients and 2 therapists per group emphasizing repeated exposure practices. Session 1 involves an introduction and orientation to the CBT model. Sessions 2-5 emphasize repeated exposure tasks, which consist of role-play activities to confront fearful situations in a group setting while disputing cognitive distortions (coupled with the fading of safety behaviors). At the conclusion of each exposure session, patients will be encouraged to continue to apply home-practice strategies (such as giving speeches in front of a mirror). Continued practice of the interventions will be considered part of treatment, and patients will be asked to refrain from alternative treatment for four weeks following completion of the last treatment session.
Other intervention name(s): D-cycloserine, DCS; CBT
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social Phobia
Value of Genetic Counseling and Testing for Patients Who Would Like to Know More About Their Personal Risk of AMD
Condition: Age-Related Macular Degeneration; Choroidal Neovascularization; Genetic Counseling
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Study type: Interventional

Summary: 
      The goals of this study are:

      To assess the impact of genetic testing based on how it alters behaviors, to assess the
      utility of serum biomarker measurement in combination with genetic testing, to assess the
      utility of genetic counseling in personal analysis of risk for age-related macular
      degeneration (AMD), and to assess the impact of presymptomatic genetic testing for choroidal
      neovascularization (CNV).
    


Intervention name(s): Early disclosure; Late disclosure
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effectiveness of the Pelican Instrument in Medical Care
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The objective of this project is to establish the effectiveness of implementation of a
      self-administered electronic asthma-specific quality of life instrument for childhood asthma
      in primary care and specialist care.
    

Detailed description: 
      Health related quality of life (HRQL) is important to the asthmatic child and if HRQL aspects
      are taken into account in daily care this could result in improved treatment satisfaction,
      compliance, asthma control and, ultimately, improved HRQL. The Pelican instrument we have
      developed has the essential features to be useful in daily care. In this study, the
      effectiveness of implementing the Pelican instrument in medical care is assessed. An
      intervention study with 9 months follow-up in primary and secondary care will be carried out.
    

Intervention name(s): PELICAN Primary Care; PELICAN Secondary Care
Intervention type(s): Other; Other
Intervention description(s): The intervention is the integration of the output of the Pelican instrument in daily care to guide disease management for children with asthma treated in primary care. The general practitioner can integrate the information of the Pelican instrument in their consultation and disease management decisions. The general practitioner will be trained and supported to negotiate the child's, and physicians' agendas based on the outcome of the instrument, and discuss possible interventions. All participating children of a GP will be allocated to the same treatment group (i.e., hierarchical or nested design).; The intervention is the integration of the output of the Pelican instrument in daily care to guide disease management for children with asthma treated in secondary care. The nurse can integrate the information of the Pelican instrument in their consultation and disease management decisions. The paediatricians will be trained and supported to negotiate the child's, and nurses' agendas based on the outcome of the instrument, and discuss possible interventions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Asthma; health-related quality of life; patient-centred care
The Impact of Legumes vs Corn-soy Flour on Environmental Enteric Dysfunction in Rural Malawian Children 6-11 Months
Condition: Enteropathy
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      To determine if 6 months of legume-based complementary foods is effective in reducing or
      reversing EED and linear growth faltering in a cohort of Malawian children, aged 6-11 months
      to see if these improvements are correlated with specific changes in the enteric microbiome.
    


Intervention name(s): Cow pea complementary food; Corn soy flour; Common bean
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): A legume-based complementary food made from cowpeas will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.; Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.; A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Environmental; Enteric
A Study of Modified Release Formulations of Danicopan in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate and compare the plasma pharmacokinetic profiles of
      ACH-0144471 (danicopan) in healthy participants after administration of single oral doses of
      modified release prototype formulations.
    


Intervention name(s): Danicopan Modified Release Prototype 1; Danicopan Modified Release Prototype 2; Danicopan Modified Release Prototype 3
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Danicopan (400 milligrams [mg]) oral tablet.; Danicopan (400 mg) oral tablet.; Danicopan (800 mg) oral tablet.
Other intervention name(s): ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471; ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471; ALXN2040; ACH-0144471 (formerly); ACH-4471; ACH4471; 4471
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Danicopan; ALXN2040; ACH-0144471; Pharmacokinetics; Modified Release; Factor D Inhibitor; Relative Bioavailability
Airway Inflammation and Bronchial Hyperresponsiveness in Rhinitic Children With or Without Asthma
Condition: Rhinitis; Asthma; Inflammation; Hypersensitivity
MeSH terms: Rhinitis; Asthma; Bronchial Hyperreactivity; Hypersensitivity; Inflammation
Study type: Observational

Summary: 
      This is a prospective observational study , to clarity the characteristics of airway
      inflammation, airway reactivity and airway resistance in rhinitic children with or without
      asthma and to explore the possible predictors in the progression of allergic rhinitis to
      asthma.
    

Detailed description: 
      Children 6-15 years old with allergic rhinitis and/or asthma diagnosed by specialist
      physician are enrolled in the department of respiratory and otorhinolaryngology and
      pediatrics in Guangzhou Institute of Respiratory Disease. According to presence of typical
      symptoms and signs, patients are divided into allergic rhinitis without asthma (AR group) ,
      allergic rhinitis concomitant asthma (AS+AR group), asthma without rhinitis (AS group). In
      addition, healthy students in a school are enrolled as normal control group. History of all
      subjects are collected, the following measurements are performed: skin prick test (SPT),
      peripheral blood cells five-classification test, serum total immunoglobulin E (IgE) and
      specific IgE of common inhalant allergens testing, nasal lavage and induced sputum cells
      classification ，pulmonary function test, bronchial provocation test using methacholine，airway
      resistance measured by impulse oscillation technique, the levels of
      eosinophil（ECP），eosinophil peroxidase（EPO）.Meanwhile myeloperoxidase （MPO）and
      eosinophil-derived neurotoxin (EDN) are measured in induced sputum ,in nasal lavage and in
      serum.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children 6-15 years old with allergic rhinitis and/or asthma diagnosed by specialist
        physician were enrolled in the department of paediatrics,respiratory and
        otorhinolaryngology in Guangzhou Institue of Respiratory Diseas .In addition, healthy
        students in a school were enrolled as normal control group.
      
Biospecimen description: 
      serum ,nasal lavage fluid ,induced sputum
    
Keywords: child; allergic rhinitis; asthma; nitric oxide; bronchial hyper-responsiveness
Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate (MTX)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical study is to see if an experimental drug, called MM-093, is safe
      and effective in the treatment of rheumatoid arthritis. MM-093 is a genetically engineered
      version of a naturally occurring protein called alpha fetoprotein (AFP). Adults normally have
      very small amounts of AFP in their bloodstream. However, during pregnancy, AFP levels in both
      the mother and the fetus are much higher than normal. It has been observed that women with RA
      (Rheumatoid Arthritis) have fewer symptoms during pregnancy, particularly during the third
      trimester. At this time, the levels of AFP in the blood of the mother and fetus are the
      highest. This observation led researchers to begin examining AFP as a possible treatment for
      RA.
    


Intervention name(s): MM-093
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this research study is to collect information on a new treatment of prostate
      tissue participants with intermediate risk prostate cancer using a medical device called the
      Poseidon System. The Poseidon System is intended to ablate prostate tissue in areas of the
      prostate where cancer has been identified. The medical device delivers thermal energy in the
      form of water vapor to the prostate tissue through the urethra. Previous research has shown
      successful prostate tissue ablation. Additional research may help show successful ablation of
      the prostate tissue where cancer is located.
    


Intervention name(s): Poseidon System
Intervention type(s): Device
Intervention description(s): Multicenter Pilot Study of the Poseidon System for the Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients with Intermediate Risk Localized Prostate Cancer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Biological Adaptations of Strength Training.
Condition: Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      A two-trial repeated measures design will be employed in this investigation. Both the control
      trial and the exercise trial will last for 3 months. During a week before the start of the
      study, participants will complete dietary recalls and record their habitual physical activity
      using accelerometers. Thereafter, body composition, ultrasound imaging of the muscle and
      liver, biochemical and hematological markers were measured. This range of measurements will
      be repeated the ended each month for both trials. Control trial succeeds exercise trial. An
      exercise intervention program will take place in the second trial, three times a week.
    

Detailed description: 
      A sample size of 30 volunteers, aged 35-45 years, will participate in the present study. Of
      them, 15 will be normal weight and 15 will suffer from fatty liver disease (BMI 29-35 kg/m2,
      waist size >102 cm). The exclusion criteria will be a) medication, b) musculoskeletal
      problems that will prevent participation in the training program, c) known condition or
      medical condition preventing participation in the program e.g. hypertension, d) BMI> 35kg /
      m2, (e) a severe family medical history up to first degree relatives with cardiovascular
      disease and / or diabetes at the age of less than 65 for women and less than 55 years for men
      and (f) smoking. After informing and receiving a questionnaire and medical history,
      volunteers will sign for their participation in the survey.

      A two-trial repeated measures design will be applied in this investigation. Both control and
      exercise trials will last for 3 months. During the week preceding the commencement of the
      study, participants will complete dietary recalls and will have their habitual physical
      activity monitored, by utilizing accelerometers. Thereafter, body composition, ultrasound
      imaging of muscle and liver, biochemical and hematological markers will be measured. The same
      measurements will be repeated at the end of each month, in both trials. Control trial will be
      executed prior to exercise trial. An exercise intervention program, combining strength and
      cardiovascular exercises performed three times a week, will take place in the exercise trial.
    

Intervention name(s): Control Trial; Exercise Trial
Intervention type(s): Other; Other
Intervention description(s): Participants will abstain from exercise throughout a 3-month period; Participants will execute a 3-month exercise training program
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity, training, inflammation, Liver, oxidative stress
The Efficacy of Influenza Vaccine Program in Children With Juvenile Idiopathic Arthritis. A Single Centre Results From Hungary
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of our study is to compare the immune function of patient treated with DMARD
      (methotrexate), or tumor necrosis factor (TNF)-alpha inhibitor (adalimumab) to healthy
      children. The study consists of three parts. In each part physical examination and routine
      laboratory tests are done.

      At the first examination flow cytometry analysis is performed, after that the participants
      are immunized with influenza (3Fluart) vaccine. At part two and three further flow cytometry
      is carried out and seroconversion is measured.
    


Intervention name(s): Influenza vaccine, Immune function
Intervention type(s): Biological
Intervention description(s): Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Infections; Virus Diseases; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to compare the antiviral effect of ALS-008176 compared to a placebo
      control in the respiratory syncytial virus challenge model.
    


Intervention name(s): ALS-008176; vehicle
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study on The Oral Immune Tolerance of CMPA Infants Using Amino Acid Formula
Condition: Cow's Milk Protein Allergy
MeSH terms: Milk Hypersensitivity
Study type: Observational

Summary: 
      The main purpose of this study was to observe the effect of amino acid formula on infants
      with cow's milk protein allergy; to evaluate the role of food avoidance and Open Food
      Challenge test in the diagnosis of infants with cow's milk protein allergy; to observe the
      allergic process in infants with cow's milk protein allergy and to explore the criteria for
      diagnosis and treatment.
    

Detailed description: 
      This is a multi-center, prospective cohort study. This study plans to recruit 200 subjects.
      The suitable subject will be enrolled and there are seven visits through the 6-month study.
      Efficacy parameters are the positive incidence of open food challenge test, growth and
      development index (Weight, Height, Head circumference;), and the improvement of CMPA symptoms
      (such as SCORAD, gastrointestinal tract, respiratory, comfort scores).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cow's milk protein allergy infants in 0~6 months
      
Keywords: Cow's Milk Protein allergy; Open Food Challenge test; Immune Tolerance; Amino Acid Formula
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days
      treatment in patients with painful diabetic polyneuropathy.
    


Intervention name(s): AZD2423; AZD2423; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg tablet; 150 mg tablet; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesic effect
Clinical Outcomes About Heparin Surface Modified Aspheric Lens
Condition: Inflammatory Reaction
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to obverse the effect of this type lens in the same as
      traditional aspheric intraocular lens at the same time, whether can further improve the
      effects of operation.
    

Detailed description: 
      1. Heparin surface treatment lens can reduce inflammatory reaction.

        2. Modified aspheric lens are more in line with human optical properties than the
           traditional aspheric lens.

        3. To obverse the effect of this type lens in the same as traditional aspheric intraocular
           lens at the same time, whether can further improve the effects of operation.

        4. After one day, one week, one month, three month follow-up，Key observation on the flare,
           the optical quality, contrast sensitivity and other parameters.Study the postoperative
           inflammatory reaction with test group lens，and the impact on the visual quality.
    

Intervention name(s): traditional lens; heparin surface modified aspheric lens
Intervention type(s): Device; Device
Intervention description(s): A random eyes with traditional lens; the other eye implant heparin surface modified aspheric lens
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment