bioihbjkbjnl/mcl2 huggingface dataset:
Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to
      evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety.
    

Detailed description: 
      This trial was a 8 weeks' randomized, double-blind, placebo-controlled study. The study was
      approved by the Institutional Review Board of Chung Shan Medical University hospital, and
      signed informed consent was obtained from each patient. Eighty-one patients of osteoarthritis
      of knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years;
      primary osteoarthritis in at least 1 knee, verified radiologically and scored (as normal,
      minimal, moderate or marked) for joint-space narrowing and marginal osteophytes in the
      medial, lateral and patellofemoral compartments; at least moderate pain during the 2 weeks
      before random assignment to treatment, as identified with the Western Ontario and McMaster
      Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale.

      Primary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis
      index at week 4.

      Secondary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis
      index at week 2; Visual analogue scale (VAS), Quality of life by SF-36, patient global
      assessment (PGA), at week 2 and 4; The PGA was scored from 0 to 4 (0 representing very good);
      Biomarkers: Hs-CRP, ESR.
    

Intervention name(s): TCM OA2; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): Usage: 3g twice daily; Usage: 3g twice daily
Other intervention name(s): LIOW WEY DIH HUANG WAN EXTRACT PILL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Traditional Chinese Medicine; Herbs; Liu-wei-die-Huang-Wan
Pilot Study of Hippocampal Function in Type 1 Diabetes Mellitus (T1DM)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      This study is an expansion of a previous study done to determine how thinking skills relate
      to hypoglycemia (low blood sugar) and certain regions of the brain in children and
      adolescents. In this study, the investigators are testing thinking skills and measuring brain
      activity in adolescents with and without type 1 diabetes mellitus.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young adults will be piloted in a sample of diabetic and non-diabetic adolescents ages
        13-18.
      
Keywords: T1DM; MRI
BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study
      the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and
      will further investigate the safety and tolerability profile of interferon beta 1b 500µg
      during longer-term treatment.
    

Detailed description: 
      Phase A (3 arm parallel group): All patients randomized during the BEYOND study (Bayer
      306440) to either IFNB 1b group (250µg or 500µg) will continue their previously assigned
      study medication, applying the same level of blinding as during the BEYOND study, All
      patients randomized during the BEYOND study to Copaxone and all patients with premature
      discontinuation of study medication during the BEYOND study will receive open-label IFNB 1b
      250µg.

      Phase B (single arm): All patients will receive open-label IFNB 1b 500µg)

      Randomization: No randomization in this trial, patient's allocation in this follow-up study
      depends only on prior trial groups. The preceding study was randomized.

      The trial is sponsored by Bayer Schering Pharma AG, Germany, Bayer HealthCare and Bayer
      HealthCare Pharmaceuticals Inc.

      Secondary outcome measure "Assessment of patient-reported outcomes (FAMS and EQ 5D: The
      variables FAMS and EQ-5D were not analyzed due to the termination of the study before start
      of Phase B.
    

Intervention name(s): Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaseron, BAY86-5046)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Phase A: 250ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).; Phase A: 500ug administrated s.c. every other day (double blind). For patients previously randomized in Bayer study 91162 to the same treatment. Phase B: All patients will receive 500µg s.c.every other day (open-label).; Phase A: 250ug administrated s.c. every other day (open-label). For patients previously randomized in Bayer study 91162 to 20mg Copaxone® administrated s.c. once daily and patients with premature discontinuation of study medication during the study 91162.
Phase B: All patients will receive 500µg s.c.every other day (open-label).
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Relapsing multiple sclerosis; interferon beta 1b; Betaferon; Betaseron
Teachers and Parents as Partners During Middle School
Condition: Behavior Problem
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      There are two aims of this study (a) to examine the effect of Teachers and Parents as
      Partners on student, parent, and teacher outcomes in middle school and (b) identify barriers
      and facilitators to implementing Teachers and Parents as Partners in middle school for
      students with behavior concerns.
    

Detailed description: 
      Teachers and Parents as Partners will occur in a series of stages comprised of approximately
      four structured meetings over approximately 8 weeks. A Teachers and Parents as Partners
      consultant will meet together with a student's parent(s), teachers, other school personnel
      (as appropriate), and the student (as appropriate). The Teachers and Parents as Partners team
      will collaboratively address behavior problem solving objectives. Specific CBC objectives
      include: identifying strengths and specific behaviors of concern, specifying alternative
      prosocial behaviors, creating measurable behavior goals, co-constructing behavior
      intervention/support plans to address the target concerns, creating sustainable conditions to
      support plan implementation at home and school, and evaluating the plan to assess progress
      toward goals.

      Treatment integrity in multiple dimensions (e.g., engagement, dosage, adherence) will be
      assessed at the two tiers of implementation (i.e., Teachers and Parents as Partners
      procedural integrity and behavior support plan implementation) to determine the extent to
      which procedures are implemented as designed.

      During each structured meeting, Teachers and Parents as Partners consultants will inquire
      with parents, teachers, other school personnel, and students about barriers and facilitators
      to implementation.
    

Intervention name(s): Teachers and Parents as Partners
Intervention type(s): Behavioral
Intervention description(s): A family-school partnership intervention to improve the home-school connection, parenting and teaching strategies, and child behavior outcomes.
Other intervention name(s): Conjoint Behavioral Consultation
Intervention model: Single Group Assignment
Intervention model description: Single case experimental design (multiple baseline across setting)
Masking: None (Open Label)
Primary purpose: Treatment
Navigated Brain Stimulation in Diagnosis of Minimally Conscious State
Condition: Vegetative State; Stroke; Brain Injury
MeSH terms: Brain Injuries; Persistent Vegetative State
Study type: Interventional

Summary: 
      It has already been demonstrated that mental imagining of the complex motor act, such as limb
      lifting, can evoke the activation of the involved motor centres even if it doesn't result in
      movement due to paresis. Aim of the study: using the navigated brain stimulation system
      create a new diagnostic model for the differential diagnostics between the vegetative state
      and the minimally conscious state. If the investigators could get from patient the efferent
      motor response after a verbal command, his level of conscious should not be defined less than
      the minimally conscious state.
    


Intervention name(s): Navigated transcranial magnetic brain stimulation
Intervention type(s): Device
Intervention description(s): Standard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Diagnosed vegetative state after stroke or traumatic brain injury
Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss
Condition: Alzheimer Disease; Parkinson Disease; Healthy Volunteers
MeSH terms: Parkinson Disease; Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess
      synaptic density loss.
    

Detailed description: 
      The primary objective of this protocol is to examine [18F]MNI-1126 as a tool to assess
      synaptic density loss.The specific objectives are:

        -  Examine [18F]MNI-1126 as a tool to assess synaptic density loss.

        -  To measure the dynamic uptake and washout of [18F]MNI-1126 in the brain using positron
           emission tomography (PET) in subjects with AD, PD, and healthy volunteers.

        -  To measure blood metabolites of [18F]MNI-1126 and perform kinetic modeling to assess its
           ability to measure synaptic density loss in the brain using the tracer plasma
           concentration or a reference region as indirect input.

        -  To acquire safety data following injection of [18F]MNI-1126.
    

Intervention name(s): [18F]MNI-1126
Intervention type(s): Drug
Intervention description(s): Florbetapir PET imaging will be completed in all healthy volunteers and AD subjects as part of the screening procedures.
DaTscan SPECT imaging will be completed in those PDsubjects who have not previously had DaTscan imaging as part of the screening procedures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: AD; PD; HV
Effects of Breathing Exercises Combined With Endurance and Strength Training in Patients With Cystic Fibrosis.
Condition: Cystic Fibrosis Patients
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      Cystic fibrosis (CF) is a multi-system inherited disease. It's a common autosomal recessive
      illness. It mostly affects the lungs, liver, and pancreatic exocrine glands, as well as the
      intestines. The production of viscous mucus and an environment prone to chronic airway
      blockage. This allows harmful microorganisms to infect the lungs. The role of Exercise as a
      prognostic indicator or therapeutic aid is important in CF research around the world. The
      objective of this study is to find out the Effects of Breathing Exercises Combined with
      Endurance and Strength Training on Dyspnea and Quality of Life of patients with Cystic
      Fibrosis. It will be Quasi Experimental study. Treatment will be given to all participants 3
      sessions in a week for 4 weeks. Pre and Post treat-meant evaluation will be checked by
      CFQ-R+14. All patients will be treated with exercise program of Active cycle breathing
      techniques(ACBT), Pursed lip breathing, Endurance Exercise 20 to 30 min ( walking, cycling)
      and strength training with Thera-Bands (Bilateral arm raising, Bilateral knee extension).
      Exercise capacity will be measured with 6MWT. Dyspnea and fatigue will be measured with Borg
      scale.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): There will be one group, and study will be Quasi Experimental Study. Treatment will be given to all 28 participants, 3 sessions in a week for 4 weeks. Pre and Post treat-meant evaluation will be checked by CFQR+14. All patients will be treated with exercise program of Active cycle breathing techniques(ACBT), Pursed lip breathing, Endurance Exercise 20 to 30 min ( walking, cycling) and strength training with Thera-Bands (Bilateral arm raising, Bilateral knee extension). Exercise capacity will be measured with 6MWT. Dyspnea and fatigue will be measured with Borg scale.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Active cycle Breathing technique; 6 minute walk test; Borg scale; Quality of life
Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of DA-2803 in Healthy Subjects
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, randomized, single dose, crossover study to evaluate the
      pharmacokinetics, safety and tolerability of DA-2803 in healthy subjects
    

Detailed description: 
      To healthy subjects of ninety-six (96), following treatments are administered dosing in each
      period and wash-out period is a minimum of 14 days.

      Reference drug: Vemlidy Tab. / Test drug: DA-2803 Tab. Pharmacokinetic blood samples are
      collected up to 72hrs. The pharmacokinetic characteristics and safety are assessed.
    

Intervention name(s): Vemlidy Tab; DA-2803 Tab
Intervention type(s): Drug; Drug
Intervention description(s): 1T; 1T
Other intervention name(s): Reference; Test
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tolerability and Pharmacokinetics of BIIB 722 CL Drinking Solution and of BIIB 722 CL Filmcoated Tablet in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL
    


Intervention name(s): BIIB 722 CL solution; BIIB 722 CL tablet; Placebo solution; Placebo tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Effect of High Carbohydrate vs. Low Carbohydrate Diet in Type 2 Diabetes
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The experimental approach in this study intends to investigate the role of hepatic glycogen
      content on nocturnal regulation of endogenous glucose production including the relative
      contributions of glycogenolysis and gluconeogenesis and the extent to which this differs
      between subjects with type 2 diabetes and subjects without diabetes. Both participants with
      type 2 diabetes and participants without diabetes will be studied after consuming either a
      low carbohydrate (no glycogen loading) or high carbohydrate (glycogen loading) diet.
    

Detailed description: 
      Physiology study for looking at glycogen loading vs non loading in improving nightime glucose
      tolerance by increasing glycogen in liver and resulting higher glycogenolysis at night.
    

Intervention name(s): glycogen loading; No Glycogen Loading
Intervention type(s): Other; Other
Intervention description(s): Subjects will consume an isocaloric diet [60% carbs, 20% protein, 20% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.; Subjects will consume an isocaloric diet [40% carbs, 20% protein, 40% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Diabetes Mellitus; hepatic glycogen; endogenous glucose production
A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness and tolerability of aripiprazole
      in the treatment of children and adolescents with Fragile X Syndrome.
    

Detailed description: 
      This 12-week prospective, open-label study design was chosen to gather pilot data for
      potential future lager scale, double-blind, placebo-controlled studies in Fragile X Syndrome.

      We hypothesize that aripiprazole will be effective in decreasing aggression, SIB, agitation,
      and interfering repetitive behavior commonly observed in individuals with Fragile X Syndrome.
      We also hypothesize that aripiprazole will be well tolerated.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): All subjects will initially receive 2.5 mg/day of aripiprazole during the first week. The dosage may be increased to a maximum of 20 mg/day over 8 weeks.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone
Condition: Displaced Midshaft Fracture of the Collar Bone
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      This study will compare non-operative treatment of displaced midshaft collarbone fractures
      with operative treatment using a precontoured titanium plate and screws.

      The study hypothesis is that operation will provide better pain relief, faster return to
      activities, better function of the involved upper limb, and lower the risk of a non healing
      fracture (non union).
    


Intervention name(s): Operation using a precontoured titanium plate and screws; Displaced midshaft fracture of the collar bone
Intervention type(s): Procedure; Procedure
Intervention description(s): Operation using a precontoured titanium plate and screws; Displaced midshaft fracture of the collar bone treated with an arm sling
Other intervention name(s): No other names.; No other names.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fracture; Collar bone
Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to determine whether or not inhalation of hypertonic saline
      will be tolerated by infants with cystic fibrosis and the effect of inhalation on their lung
      function.
    

Detailed description: 
      Cystic fibrosis lung disease is characterized by mucous retention which favors secondary
      bacterial infection and inflammation, which leads to lung damage and ultimately respiratory
      failure. Classically, therapeutic interventions are aimed to improve mucociliary clearance,
      to reduce both bacterial load and lower airway inflammation.

      Hypertonic saline (HS) has been used for the induction of sputum production in all age groups
      to obtain secretions from the lower respiratory for diagnostic purposes. Hypertonic saline is
      also used in older children with CF, who do not produce sputum spontaneously, to obtain
      representative samples for microbiology.

      There is evidence from studies in patients with cystic fibrosis that HS can improve
      mucociliary clearance. The improvement was more impressive in areas that were well
      ventilated, making it likely that HS will work better in patients with relatively preserved
      pulmonary function. Newer evidence also suggests that the osmotic effect on the airway
      surface that was expected to be short lived, may actually persist for longer time periods (up
      to 8 hours). All these data indicate that HS may be a useful agent in the treatment of CF
      patients.

      As the effect on mucociliary clearance was found to be better in areas with adequate
      ventilation, it is logical to assume that treatment with HS may be most efficacious when
      initiated early in the disease process. So far, no data on the tolerability of inhalation of
      HS are available for infants with cystic fibrosis. However, evidence from infants with AIDS
      as well as recent studies in infants with bronchiolitis suggest that hypertonic saline can be
      safely administered by inhalation in infants. Nevertheless, proof of tolerability in CF
      infants is a prerequisite for longer term studies of HS in this age group. In older children,
      tolerability has been tested by measuring pulmonary function both before and after inhalation
      of HS saline. Similar data are not yet available for infants.
    

Intervention name(s): Hypertonic Saline
Intervention type(s): Drug
Intervention description(s): 5 ml of 7% saline will be administered via mask with Pari LC Plus nebuliser and a Pari Ultra Ned compressor.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cystic Fibrosis; Hypertonic Saline; Infants
Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without
      dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)
      has been shown to be safe and effective in randomized controlled clinical trials with strict
      inclusion and exclusion criteria under well controlled conditions.

      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±
      RBV, used according to local label, under real world conditions in Kuwait in a clinical
      practice patient population.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with CHC, genotype 1 or 4, receiving combination therapy with the
        interferon-free ABBVIE REGIMEN ± RBV.
      
Keywords: Paritaprevir/r - Ombitasvir, ± Dasabuvir; Sustained Virological Response; Chronic Hepatitis C genotype 4; Observational Study; Chronic Hepatitis C genotype 1; Chronic Hepatitis C