bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of 2 Hemostasis Techniques After Transradial Coronary
Condition: Coronary Artery Disease With Myocardial Infarction
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      Randomized clinical trial to compare radial artery patency after transradial coronary
      catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or
      therapeutic coronary catheterization will be prospectively enrolled in this single-center
      trial and will be randomized to radial hemostasis with TerumoBand® or a standardized
      compressive dressing with gauze and elastic bandage.
    

Detailed description: 
      Randomized clinical trial to compare radial artery patency after transradial coronary
      catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or
      therapeutic coronary catheterization will be prospectively enrolled in this single-center
      trial and will be randomized to radial hemostasis with TerumoBand® or a standardized
      compressive dressing with gauze and elastic bandage.

      Interventions: Radial hemostasis with TerumoBand® and Radial hemostasis with a standardized
      compressive dressing
    

Intervention name(s): Standardized compressive dressing; Hemostasis with TerumoBand®
Intervention type(s): Device; Device
Intervention description(s): Standardized compressive dressing; Hemostasis with TerumoBand®
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Pediatric Population
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This is a laboratory-blinded study in healthy toddlers, children, and teenagers designed to
      investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1
      vaccine (AdimFlu-S). There are 3 age strata, and each contains at least 50 subjects: greater
      than or equal to 1 year to less than 3 years, greater than or equal to 3 years to less than 6
      years, and greater than or equal to 6 years to less than 18 years. In each age strata, all
      eligible subjects received 2 injections of AdimFlu-S (A/H1N1) at a designated dosage level
      (7.5 μg, 15 μg and 15 μg for 1~<3, 3~<6 and 6~<18 years, respectively) at 3 weeks apart.

      Following immunization, safety is measured by assessment of adverse events for 6 weeks
      following the first vaccination, serious adverse events and new-onset chronic medical
      conditions through 7 months post first vaccination, and reactogenicity to the vaccines for 7
      days following each vaccination. Immunogenicity testing includes hemagglutination inhibition
      (HAI) testing on serum obtained before first vaccination, and three and six weeks after first
      vaccination.
    


Intervention name(s): Influenza A (H1N1) 2009 monovalent vaccine, inactivated
Intervention type(s): Biological
Other intervention name(s): AdimFlu-S (A/H1N1)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; H1N1; vaccine; Immunogenicity
A Pilot Study of Intermittent Calorie Restriction in Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      Experimental studies of the experimental autoimmune encephalomyelitis (EAE), a mouse model of
      multiple sclerosis, indicate that the number of calories fed to mice prevent EAE and are also
      associated with less severe disease in mice who do develop the disease. Currently, whether
      these results translate favorably in humans is unknown. This is a pilot trial of testing two
      caloric restriction (CR) diets versus a control diet in multiple sclerosis (MS) patients: one
      continuous caloric restriction (CR) diet where a small number of calories will be restricted
      every day or another intermittent CR diet where a caloric intake will be restricted more
      severely 2 days per week. Participants are randomized to one of the diets, and for the first
      8 weeks, will receive standardized, prepared meals tailored to the specific diet. At the
      conclusion of the controlled feeding study, all participants will transition to an unblinded
      phase for an additional 40 weeks where they are provided with instructions to follow an
      intermittent CR diet.
    


Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Virtual Reality Exposure Therapy Versus Exposure in Vivo for Social Phobia
Condition: Social Anxiety Disorder; Social Phobia
MeSH terms: Anxiety Disorders; Phobic Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The current study aims at comparing the efficacy of exposure in vivo and exposure via virtual
      reality for social anxiety disorder. 70 patients with social anxiety disorder will be
      randomized to either one of the active conditions or to a waiting-list condition.
      Participants on the waiting-list will be offered either exposure in vivo of in virtual
      reality after a waiting period of five weeks. Levels of psychopathology will be assessed at
      pre- and post-treatment as well as three and 12 months after treatment.
    


Intervention name(s): Exposure in vivo; Virtual Reality Exposure Therapy
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Behavior Therapy; Virtual Reality Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social Anxiety Disorder; Social Phobia; Virtual Reality; Exposure
Maintenance Programme After Weight Loss
Condition: Weight Loss; Morbid Obesity
MeSH terms: Obesity, Morbid; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The aim of this study is to compare a weight reduction programme with and without a
      maintenance programme in patients with severe obesity.
    


Intervention name(s): weight loss programme with maintenance programme; weight loss programme
Intervention type(s): Behavioral; Behavioral
Intervention description(s): After usual weight loss treatment, there will be a one-year maintenance programme with monthly visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: maintenance therapy
the Efficacy and Safety of Probiotics eN-Lac® Capsules of Children With Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis; Probiotics; Lactobacillus Paracasei GMNL-32 (eN-Lac®)
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of probiotics eN-Lac®
      capsules (Lactobacillus paracasei GMNL-32) for the treatment of children with perennial
      allergic rhinitis(PAR).
    

Detailed description: 
      This study is PhaseIII clinical trial. According the results of PhaseII study,we find out the
      optimal dose and its maximum effectiveness in relieving the nasal symptoms of eN-Lac®
      (Lactobacillus paracasei GMNL-32) in children with PAR.
    

Intervention name(s): eN-Lac®; Placebo
Intervention type(s): Biological; Other
Intervention description(s): One capsule with 2x10^9 colony forming unit (cfu) LP GMNL-32, once daily, po; One placebo capsule, once daily, po
Other intervention name(s): eN-Lac® Capsules (Lactobacillus paracasei GMNL-32); Placebo Capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: perennial allergic rhinitis; probiotics; Lactobacillus paracasei GMNL-32 (eN-Lac®); efficacy and safety
Study of Vitamin D Supplementation on Improvement of Gums Health
Condition: Gingival and Periodontal Disease; Deficiency of Vitamin D3; Pregnancy
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      There is a gap in knowledge regarding the effects of Vitamin D supplementation on periodontal
      status in pregnant wome. The investigators aim to evaluate the potential benefit, if any of
      vitamin D supplementation during pregnancy on periodontal disease and relevant outcomes
      including burden of infections and prematurity rates.

      the investigators hypothesize that

        1. Vitamin D supplementation during pregnancy improves the periodontal health.

        2. There is an association between inflammatory biomarkers and periodontal health of
           pregnant females.

        3. Vitamin D supplementation improves the outcomes of pregnancy such as prematurity rates
           and birth weight
    

Detailed description: 
      Periodontal disease is one of the most common chronic infectious diseases known to humans,
      with a reported prevalence varying between 10%-60% in adults. Periodontal health is commonly
      affected in pregnancy. The prevalence of pregnancy gingivitis varies widely, ranging from
      around 35%- 100%. Although, most of the periodontal changes during pregnancy are reversible
      but females with preexisting periodontitis or those who have metabolic disease such as
      diabetes may suffer increased periodontal destruction and may exhibit significantly greater
      probing pocket depth and attachment level. Periodontal disease, as a source of persistent
      infection, may induce systemic inflammatory responses that increase the risk of adverse
      pregnancy outcomes. However, so far the results have been mixed. As vitamin D metabolites may
      also alter the inflammatory response and have antimicrobial effects thus the use of vitamin D
      may affect periodontal status. Evidence is there which suggests that an association exists
      between low serum levels of Vitamin D and periodontal attachment loss. If the investigators
      take all of the above factors in consideration, the broad picture reveals that as vitamin D
      deficiency is prevalent in Pakistan, the pregnant females here are likely to have compromised
      periodontal health and probably poor pregnancy outcomes.
    

Intervention name(s): Vitamin D3; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4000 mg per day, one tablespoon syrup per day; one table spoon Syrup per day
Other intervention name(s): Vitamin D; Cholecaciferol; placebo syrup
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin D; pregnancy; periodontal health; biomarkers
Action Observation in Hip Replacement
Condition: Total Hip Replacement
Study type: Interventional

Summary: 
      Postoperative rehabilitation is required for a successful outcome following total hip
      arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to
      strengthen quadriceps, to restore normal gait, and to recover independence in activities of
      daily living. In the last decade action observation treatment, in addition to conventional
      physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is
      growing evidence of the applicability of action observation training in rehabilitative
      medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of
      cerebral palsy and of aphasia.

      Nevertheless those are small studies and one of them included a mixed population of hip and
      knee arthroplasty.
    


Intervention name(s): Experimental group; Control group; Conventional physiotherapy
Intervention type(s): Device; Device; Device
Intervention description(s): Video of the exercises; video of nature scenes; Mobilization, exercises and transfer practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total hip replacement; Action observation treatment; Rehabilitation; Arthroplasty
Comparison of NovoFine® Needles (4 mm vs. 6 mm)
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Europe. The aim of this investigation is to explore the safety of
      a 4 mm needle compared to a 6 mm needle when injected in children and lean adults with
      diabetes.
    


Intervention name(s): NovoFine® needle 6 mm; NovoFine® needle 4 mm
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given
      once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the
      evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children
      aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will
      receive 5mg strength SINGULAR.
    


Intervention name(s): Budesonide inhalation suspension; Montelukast Sodium
Intervention type(s): Drug; Drug
Intervention description(s): 0.5mg; 4mg or 5mg
Other intervention name(s): Pulmicort Respules; SINGULAR
Intervention MeSH terms: Budesonide; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Pulmicort; Children; paediatrics; budesonide
Seating System for Scoliosis in Non-ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial
Condition: Cerebral Palsy; Neuromuscular Scoliosis
MeSH terms: Scoliosis; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The effect of a modular seating system on coronal and sagittal balance of the spine and
      pelvic obliquity in children with non-ambulatory (Gross Motor Function Classification System
      Level IV-V) and scoliosis

      The hypothesis in our study is; a modular adaptive seating system prevents the progression of
      spinal curvature and Reimer's maturation index, improves the sagittal balance of the spine
      and pelvic obliquity.
    

Detailed description: 
      Aim: The aim of this study was to evaluate the effect of a modular adaptive seating system
      and exercise therapy for scoliosis on the progression of spinal curvature, spinal sagittal
      balance and pelvic obliquity in children aged 6 to 15 years with cerebral palsy (Gross Motor
      Function Classification System (GMFCS) level IV-V) and scoliosis.

      Materials and methods: A prospective, randomized and controlled, single-blind study was
      performed on 29 patients with cerebral palsy(CP). Patients were randomized into two groups.
      Both groups were given scoliosis home exercise program at least three days a week and 10
      repetitions for each exercise in a day. In the first group, a modular adaptive seating system
      used for at least four hours in a day with exercise program for scoliosis. This seating
      system includes a sitting elevation that corrects the pelvic obliquity, the hip block that
      prevents the sliding from the sitting floor and a body support unit that provides the
      alignment of the spine and controls of the body. Cobb angle, pelvic obliquity, sagittal
      spino-pelvic parameters (thoracic kyphosis angle (TK), lumbar lordosis angle (LL), sagittal
      vertical axis (SVA), pelvic tilt (PT), pelvic incidence (PI), sacral slop (SS)) and Reimer's
      migration index (RMI) measurements were evaluated by Surgimap® software at the before and 3
      months after treatment.
    

Intervention name(s): a modular adaptive seating system; home exercise program for scoliosis
Intervention type(s): Device; Other
Other intervention name(s): home exercise program for scoliosis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two groups in this study. In the first group, there is home exercises program for scoliosis and a modular adaptive seating system. In the second group there is only home exercises program for scoliosis. The nonambulatory children between the ages of 6-15 with cerebral palsy and scoliosis were randomly grouped according to the order of Pediatric Rehabilitation Unit of Istanbul University, Istanbul Faculty of Medicine, Physical Medicine and Rehabilitation Department.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cerebral palsy; scoliosis; adaptive seating system; sagittal balance; pelvic obliquity; coronal balance
Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships
Condition: Treatment; Control
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Children will be randomly assigned to a Parent-assisted social skills training or Wait list.
      Baseline and post intervention rating will be obtained from teachers.
    

Detailed description: 
      Targeted Area of Intervention: Social skills and development of best friend relationships.
      The specific intervention will be twelve small group sessions (90 minutes each) over a 6-week
      period. Child sessions consist of 4 components: 1) children report on homework assignments;
      2) didactic presentation, behavioral rehearsal, and coaching, 3) coached play, and 4) new
      homework activities assigned with parent. Topics to be addressed across sessions include:
      reduction of maladaptive behaviors, information exchange techniques, places and times to make
      friends, group acceptance, praising other children, negotiation, play dates, dealing with
      teasing, and winner/loser skills. At the start of the intervention, parent and children will
      work with staff to develop a list of social skills, behaviors, and goals that they would like
      targeted for each child.

      Parent component: Kathleen Mitchell (NOFAS) is an investigator to provide parent input to the
      study. Parent-only sessions will instruct them on key features being taught to their child.
      Concurrent parent sessions will include: 1) education on FAS/ARND, 2) parents present
      specific issues with their child, 3) review of current child session objectives and
      techniques, 4) new homework activities developed, 5) parent and child together review
      homework.

      Evaluation Plan: Treatment and control (WL) groups will be compared using pre- and post-tests
      measures. Post-tests will be at the conclusion of the intervention and at a 4-month
      follow-up. Baseline parent measures include Social Skills Rating Scale, FAS Behavior Scale,
      and Test of Advocacy Knowledge. Baseline child measures include knowledge of social skills.
      Process (e.g., homework completion, attendance, etc) and outcome (e.g., social skills
      ratings, progress towards individual goals) measures will be evaluated.
    

Intervention name(s): Parent assisted social skills training
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Educational/Counseling/Training
Evaluating Drug Interactions Between Doravirine With Estradiol and Spironolactone in Healthy Transgender Women
Condition: Transgender Health; Gender Dysphoria; Transgender Women; Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Gender Dysphoria
Study type: Interventional
Phase: Phase 1

Summary: 
      Transgender women living with Human Immunodeficiency Virus (HIV) may prioritize
      gender-affirming hormonal therapy over antiretroviral drug therapy. Hormonal therapy
      typically consists of oral estradiol and spironolactone, which induce drug-metabolizing
      enzymes after prolonged administration. This study evaluates the bi-directional potential
      drug interaction between the antiretroviral drug, doravirine, when co-administered with
      estradiol and spironolactone.
    


Intervention name(s): Doravirine/Lamivudine/Tenofovir; Spironolactone 100mg; Estradiol 2mg; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 100mg/300mg/300mg orally for one dose, daily; 200mg orally for two doses, twice-daily; 4mg orally for two doses, twice-daily; Placebo for one dose, daily
Other intervention name(s): Delstrigo; Aldactone
Intervention MeSH terms: Tenofovir; Lamivudine; Spironolactone; Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three period crossover
Masking: None (Open Label)
Primary purpose: Treatment
A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy, safety, and tolerability of Exelon®
      patch in patients with probable AD (MMSE 10-20), in order to support a planned regulatory
      submission and registration of Exelon transdermal patch in China. The study is designed to
      confirm the non-inferiority of the efficacy of Exelon patch (target 10 cm² patch size) versus
      Exelon capsules (target 6.0 mg bid dose) on cognition, using the Alzheimer's Disease
      Assessment Scale-Cognitive Subscale (ADAS-Cog).
    


Intervention name(s): Rivastigmine Patch; Rivastigmine Capsules; Placebo to Rivastigmine patch; Placebo to Rivastigmine capsules
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once-daily target patch size 10 cm²; Twice-daily target dose of 6 mg oral capsule; Matching placebo to Rivastigmine patch; matching Placebo to Rivastigmine capsules
Other intervention name(s): ENA713, Exelon; ENA713, Exelon; placebo; placebo
Intervention MeSH terms: Rivastigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's; Rivastigmine; Patch; Dementia