bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Efficacy and Safety of Combination Treatment With DW1501-R1+DW1501-R2 Versus DW1501-R1 or DW1501-R2+DW1501-R3 in Patients With Hypertension and Dyslipidemia
Condition: Hypertension; Dyslipidemia
MeSH terms: Hypertension; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      A Multicenter, Randomized, Double-blinded, Double-dummy, Phase 3 Clinical Trial to Evaluate
      the Efficacy and Safety of Combination Treatment with DW1501-R1+DW1501-R2 Versus DW1501-R1 or
      DW1501-R2+DW1501-R3 in Patients with Hypertension and Dyslipidemia
    


Intervention name(s): Telmisartan + Amlodipine + Rosuvastatin; Telmisartan + Amlodipine; Telmisartan + Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo; Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo; Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Beta Glucan and Acetate Production
Condition: Pre Diabetes; Obesity
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      Based on our hypothesis that orally administered resistant starch and beta glucan will be
      fermented into a SCFA pattern high in acetate and that this will lead to beneficial effects
      on human substrate and energy metabolism, we aim to address the following primary objective:

      To investigate the effects of an acute administration of inulin/beta glucan in combination
      with resistant starch on fecal and plasma acetate, as well as on fasting and postprandial
      substrate and energy metabolism in lean normoglycemic men and obese, prediabetic men.
    


Intervention name(s): beta glucan and resistant starch; Placebo; beta gluten
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 12g per day the day before the CID Resistant starch 7.5 g; isocaloric maltodextrin before the CID; 12 g beta gluten there day before the CID
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Kt and Myofascial Release in Exc Asthma
Condition: Exercise Induced Asthma
MeSH terms: Asthma; Asthma, Exercise-Induced
Study type: Interventional

Summary: 
      Purpose of this study was to compare between the effects of kinesio tap and myofascial
      release of respiratory muscles on exercise induced asthma
    

Detailed description: 
      seventy male athletic subjects with exercise induced asthma, their age ranged from 18-30
      years old in this study , with group (A) mean age (21.03+3.6 years), and mean BMI values
      (27.6+.9 kg/m2) ,and group (B) mean age (21.9+3.8 years),and mean BMI values (27.8+1.3
      kg/m2), and group (C) mean age(22+3.1 years), and mean BMI values (27.8+1.3 kg/m2).

      Subjects were assigned randomly into tow study groups and one control group:Group(A) 30
      subjects were treated by kinesio tap therapy 2sessions per week,Ground(B) 30 subjects were
      treated by myofascial release therapy 3 sessions per week ,Group (C) 10 subjects were not
      recieved treatment.
    

Intervention name(s): Kinesio tap
Intervention type(s): Other
Intervention description(s): Applied on pulmonary muscles :diaphragm muscle and abdominal muscle and sternocleinomastoid muscle 3 time per weak for 2 mounth
Other intervention name(s): Myofascial release
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: seventy male athletic subjects with exercise induced asthma, their age ranged from 18-30 years old in this study , with group (A) mean age (21.03+3.6 years), and mean BMI values (27.6+.9 kg/m2) ,and group (B) mean age (21.9+3.8 years),and mean BMI values (27.8+1.3 kg/m2), and group (C) mean age(22+3.1 years), and mean BMI values (27.8+1.3 kg/m2).
Subjects were assigned randomly into tow study groups and one control group:Group(A) 30 subjects were treated by kinesio tap therapy 2sessions per week,Ground(B) 30 subjects were treated by myofascial release therapy 3 sessions per week ,Group (C) 10 subjects were not recieved treatment.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pulmonary function test
Changes in Pulpal Blood Flow of Teeth During Leveling and Alignment Stages of Orthodontic Treatment Using Clear Aligners
Condition: Alignment
Study type: Interventional

Summary: 
      The aims of this study were to: -

        -  Evaluate PBF in upper and lower teeth during orthodontic alignment using fixed
           appliances (0.014" super elastic NiTi arch wire) at different time intervals (20min,
           48h, 72h and 1 month) of initial arch wire placement.

        -  Evaluate the PBF in upper and lower teeth during orthodontic teeth alignment using clear
           aligners at different time intervals (20min ,48h, 72h and 1 month) of fitting the second
           aligner (first active aligner).

        -  Compare the PBF changes between the above two different types of orthodontic appliances
           (fixed appliances and the clear aligners).
    

Detailed description: 
      Aims: to evaluate the pulpal blood flow (PBF) during orthodontic teeth alignment and leveling
      using clear aligners (second aligner) and fixed orthodontic appliance at different time
      intervals of orthodontic force application.

      Materials and Methods: A total of 45 subjects were subdivided in two groups: group 1: 25
      subjects treated with pre-adjusted edgewise fixed appliance with 0.014 inch NiTi as the
      alignment arch wire and group 2: 20 subjects treated using clear aligner. In both groups, PBF
      was measured for the upper right and the lower left using Laser Doppler Flowmetry at
      different time interval (20 minutes, 48 hours, 72 hours, 1 month) after the fitting of the
      arch wire in group one and after the delivery of the second aligner in group two.
    

Intervention name(s): Orthodontic Alignment; Orthodontic Alignment
Intervention type(s): Other; Other
Intervention description(s): Group 1:- Teeth alignment in this group started using round 0.014" NiTi arch wire. The 0.014" NiTi arch wire was placed into the slots of the brackets and tied with elastomers by figure of 8. During this stage, only tipping movement was applied.; Group 2: Teeth alignment using clear aligners.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups receiving 2 interventions. In the first group patients received fixed orthodontic appliance and in the second, they received clear aligner orthodontic appliance
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulpal blood flow; clear aligners; orthodontics
Protein Supplementation Post Bariatric Surgery
Condition: Bariatric Surgery Candidate
Study type: Interventional

Summary: 
      Purpose: To evaluate adherence, tolerability, and total protein intake in bariatric surgery
      patients provided with ready-to-drink protein supplements, and to evaluate the effects of
      supplementation on body composition, metabolism, and health outcomes.

      Participants: Patients scheduled to under go bariatric surgery aged 18-70 years old.
      Participants will be included if they agree to comply with the study protocol, are free of
      medical conditions that may contraindicate participation, and do not plan to become pregnant
      during the study.

      Procedures (methods): Participants will complete five laboratory visits for the current study
      (pre-screening (visit 1), baseline testing (visit 2), and return visits at 3 weeks (visit 3),
      12 weeks (visit 4), and 24 weeks (visit 5) post-surgery). The treatment group will be given a
      12 week supply of a high protein, low-carbohydrate, low-fat supplement to be taken once daily
      during days 3-7 post-surgery, and twice daily weeks 2-12. The treatment group will follow
      standard of care recommendations put forth by the physician-nutritionist team, but using the
      provided protein supplement to meet recommendations. The control group will be asked to
      follow the standard of care recommendations from the physician-nutritionist team.

      The primary study endpoints will be adherence, tolerability, and total protein intake in
      bariatric surgery patients provided with a 12-week supply of ready-to-drink protein
      supplements. Secondary outcomes will evaluate the effect of a protein supplement on body
      composition (lean mass, fat mass, percent body fat, visceral fat, muscle thickness), resting
      metabolic rate, clinical and endocrine blood values, functional fitness, and responses to
      questionnaires evaluating mood, satiety, functional independence, and health related quality
      of life.
    


Intervention name(s): Protein
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Supportive Care
DC Vaccination for Postremission Therapy in AML
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to determine the feasibility and safety of an autologous DC
      immunotherapy in patients with AML of non-favorable risk profile.
    

Detailed description: 
      Patients ≥ 18 years of either gender with AML of non-favorable risk profile in CR or CRi not
      being eligible for allogeneic stem cell transplantation will receive as intradermal
      injections at two different sites up to ten immunotherapies with autologous DCs presenting
      two leukemia-associated antigens and one CMV antigen conserved in cryomedium over a time span
      of 26 weeks. Phase I will test the safety and toxicity in a small group of patients (n=6).
      After at least four vaccinations of three patients, the safety and toxicity data will be
      presented to the Data safety monitoring board (DSMB). Only after the DSMB has no objectives
      against the continuation of the trial, further patients will be included into the trial.
      Again, after three more patients, receiving a minimum of four vaccines, clinical data will be
      presented to the DSMB, and phase I will be terminated. The decision for continuation of the
      trial will be done by the DSMB. If there are no objectives by the DSMB, the trial will
      continue and evaluation will be started in a larger group of patients (n=14). During the
      phase II trial, safety and toxicity will be evaluated in a larger co-hort of patients).
      Besides, preliminary assessment of efficacy will be performed including induction of
      immunological responses to leukemia associated antigens as well as to a viral antigen (CMV),
      MRD control, time to progression of disease and ECOG performance status.
    

Intervention name(s): DC vaccination for postremission therapy in AML
Intervention type(s): Biological
Intervention description(s): Vaccination with TLR7/8-matured DCs electroporated with mRNA encoding WT1, PRAME, and CMVpp65
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vaccination; postremission therapy; acute myeloid leukemia; dendritic cells
A Prospective Study Comparing Two Reconstructive Operation Techniques After Myotomy of Achalasia
Condition: Achalasia
MeSH terms: Esophageal Achalasia
Study type: Interventional

Summary: 
      Achalasia is a rare motor disorder of the gastroesophageal junction which is associated with
      an increased pressure of the esophageal sphincter. This leads to impairment to swallow and
      heartburn. Esophageal myotomy, which is a surgical longitudinal incision of the esophageal
      muscle layer extending over to the gastroesophageal junction is the treatment of choice for
      achalasia. In order to prevent reflux of stomach content into the esophagus this has to be
      combined with an antireflux procedure where the upper part of the stomach (fundus) is wrapped
      around the esophagus (fundoplication). This procedure can be performed with the wrapped
      fundus either in front of the esophagus (Dor procedure) or behind (Toupet). The latter
      introduces an angulation of the esophagus, which possibly may lead to an impairment of
      swallowing ability and passage of food to the stomach. On the other hand, the Toupet
      procedure may give a better control of reflux. The primary endpoint of the study is symptoms
      of impaired swallowing 1 year after treatment. Secondary outcomes include reflux (pH
      measurements in the esophagus), radiological imaging of swallowing and quality of life.
    

Detailed description: 
      By the end of 2012 40 patients have been enrolled and passed the one year follow up.
    

Intervention name(s): Toupet; Dor
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic posterior partial fundoplication plus myotomy.; Anterior partial fundoplication plus myotomy.
Other intervention name(s): Laparascopic posterior partial fundoplication plus myotomy.; Anterior partial fundoplication plus myotomy.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Randomized; Toupet; Dor; Achalasia
Effects of Wholegrains on Children's Health (KORN)
Condition: Cardiometabolic Health; Gastro-intestinal Wellbeing; Cognitive Function; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      KORN investigates the effects of wholegrain oat and rye intake on health and cognitive
      wellbeing in children with overweight.
    

Detailed description: 
      The purpose of KORN is to investigate the effects of wholegrain oat and rye intake on
      cardiometabolic health in slightly overweight 8-13-year-old children. Moreover, KORN aims to
      investigate effects on body weight and body composition, inflammatory markers,
      gastrointestinal wellbeing and cognitive function and explore the potential underlying
      mechanisms through assessment of changes in the children's gut microbiota as well as
      potential genotype-dependent and sex-specific effects.

      The study has a randomized controlled cross-over design. In two 8-week dietary periods the
      children will receive grain products (cereals, breads, pasta etc) with either high or low
      content of wholegrain from oat and rye in random order. Measurements and biological sampling
      will be performed at 0, 8 and 16 weeks.
    

Intervention name(s): Grain products high in wholegrains from oat and rye; Grain products low in wholegrains
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products; A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products
Other intervention name(s): Wholegrain; Refined grain
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Children; Wholegrain; Cardiovascular risk markers; Overweight; Adolescents
BA Study of IMP4297 (20mg vs 10mg) in Healthy Male Subjects
Condition: Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, single-dose, 2-way crossover study to compare the bioavailability
      of two IMP4297 formulations (20 mg capsules and 10 mg capsules) after single oral
      administration of 100 mg IMP4297 under fasted condition in healthy male subjects
    

Detailed description: 
      This will be an open-label, randomized, single-dose, 2-way crossover study to compare the
      bioavailability of two IMP4297 formulations (10 mg capsules and 20 mg capsules) after single
      oral administration of 100 mg IMP4297 under fasted condition in healthy male subjects. It
      will be conducted at one site, and approximately a total of 18 subjects will be enrolled.

      Subjects will be randomized to one of the 2 treatment sequences according to a
      computer-generated randomization schedule. Each treatment sequence will consist of 2 periods,
      separated by a washout period of at least 7 days between each period.
    

Intervention name(s): IMP4297
Intervention type(s): Drug
Intervention description(s): IMP4297 10mg/capsule; IMP4297 20mg/capsule;
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparing Relative Motion Splint With Static Splint After Hand Extensor Tendon Repair
Condition: Hand Tendon Injury
MeSH terms: Tendon Injuries
Study type: Interventional

Summary: 
      Different splints are used after hand extensor tendon repair (including relative motion
      splint, static splint, etc.) There is no consensus regarding the benefits of either one.

      The aim of this study is to compare clinical outcomes after using different orthoses and
      rehabilitation methods after hand extensor tendon repair.

      Patients are randomly assigned after signing consent to either immobilization with a static
      splint or a relative motion splint. Patients are examined after 2 and 5 months
      postoperatively for finger range of motion, grip strength, and DASH questionnaire.
    


Intervention name(s): relative motion splint; static splint
Intervention type(s): Device; Device
Intervention description(s): splint with ability to move the fingers; splint with immobility of wrist, and fingers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bridging Study of the SYN023 on Healthy Adult Subjects
Condition: Communicable Disease Transmission; Zoonotic Disease; Rabies Human; Vaccine Reaction; Immunisation Reaction
MeSH terms: Rabies; Communicable Diseases; Infections; Zoonoses
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The Phase I bridging clinical trial is to evaluate on the safety, pharmacokinetics (PK),
      pharmacodynamics (PD) and ADA of a single intramuscular injection of recombinant anti-rabies
      human monoclonal antibody injection (SYN023) alone or combined with rabies vaccine in healthy
      subjects. The study primary purpose was to compare the pharmacokinetics (PK) between U.S and
      China subjects, therefore to lay a foundation for the follow-up clinical trials. The
      secondary purpose was to evaluate the PK, PD, Safety and ADA of SYN023 in Chinese Healthy
      subjects and compare with that of U.S. subjects.
    

Detailed description: 
      In this bridging study. the Pharmacodynamic, Pharmacokinetic, Safety and ADA(Anti-Drug
      Antibodies) were evaluated and compared between U.S. and China subjects.
    

Intervention name(s): recombinant anti-rabies human monoclonal antibody injection (SYN023); Rabies Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): The finished product of SYN023 is a mixture of two anti-rabies human monoclonal antibodies, CTB011 and CTB012 by equal quantity, containing 3.0 mg/mL active ingredients in both.; The Chinese licensed Vero Cell Freeze-dried Rabies Vaccine was injected to Cohort B as per the vaccination precedure on Days 1, 4, 8, 15, 28 respectively.
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort A: Intramuscular 0.3 mg/kg SYN023 Cohort B: Intramuscular 0.3 mg/kg SYN023 + China licensed Vero Cell Rabies Vaccine (PEP)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bridging study; Rabies Vaccine; Monoclonal Antibody Cocktail; Biologics,
Study to Evaluate Efficacy and Safety of MP1032 in Patients With Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this trial is to evaluate the clinical efficacy and safety of two
      oral doses of MP1032 (150 mg bid and 300 mg bid) when taken for 12 weeks by patients with
      moderate-to-severe chronic plaque psoriasis.
    

Detailed description: 
      This trial is a randomized, double-blind, parallel, placebo-controlled trial to evaluate the
      efficacy and safety of two oral doses of MP1032 (150 mg bid and 300 mg bid) in adult patients
      with moderate-to-severe chronic plaque psoriasis.

      The trial design consists of a 28-day screening period, a 12-week treatment period, and
      subsequently a 28-day follow-up period. Each patient will have 6 visits and unscheduled
      visits as needed.

      Approximately 150 patients (2 × 50 patients MP1032 and 50 patients placebo) who meet the
      entry criteria will be randomized on Day 1 to receive either 150 mg MP1032, 300 mg MP1032 or
      placebo orally twice daily for 12 weeks. The administration of IMP will stop after end of
      study (in max. 13 weeks).

      PASI (Psoriasis Area and Severity Index), PGA (Physician Global Assessment) and BSA (Body
      Surface Area) Scores will be recorded at predefined timepoints as basis for the efficacy
      evaluation.

      Safety parameter will be monitored from the signing of the informed consent form (ICF) until
      the last follow-up visit.

      To evaluate systemic concentrations of MP1032 PK (pharmacokinetics) samples will be analyzed
      in a subgroup.
    

Intervention name(s): MP1032; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): hard gelatin capsules containing 50mg MP1032 as active ingredient; hard gelatin capsules containing no active ingredient
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three-arm randomized, double-blind, placebo-controlled, parallel group phase II multi-center trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: moderate to severe; chronic; plaque psoriasis
The Impact of Hearing Loss Severity on Balance Intervention Outcomes
Condition: Hearing Loss; Fall; Postural Balance
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      The goal of this study is to learn about how hearing loss impacts balance intervention
      outcomes and risk of falling in older adults. The main questions it aims to answer are:

        -  How does the evidence-based A Matter of Balance (AMOB) program affect older adults'
           falls risk and balance-related measures?

        -  Is the severity of someone's hearing loss related to their balance intervention (AMOB)
           outcomes?

      Participants will:

        -  Complete a hearing and balance test

        -  Answer some questions about their background and health history, their thoughts about
           potential falls and how this impacts them, and their current physical activity level

        -  Participate in the A Matter of Balance Program, an evidence-based program that includes
           group discussion, activities, and exercises to reduce fall risk
    


Intervention name(s): A Matter of Balance: Managing Concerns about Falls
Intervention type(s): Behavioral
Intervention description(s): A Matter of Balance is an evidence-based program targeting physical activity and fall prevention for adults 60 years of age and older. This program incorporates active learning discussions and activities along with exercise training to reduce the fear of falling, improve fall efficacy and management, and increase physical activity levels in older adults.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment