bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Efficacy and Safety of Pagoclone for Adults With Stuttering
Condition: Stuttering
MeSH terms: Stuttering
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A multicenter, randomized, 3 arm, placebo-controlled clinical trial to assess the efficacy,
      safety and tolerability of pagoclone for adults with stuttering.
    

Detailed description: 
      A multicenter, randomized, 3-arm, placebo controlled, parallel group study with 24 weeks of
      double blind treatment followed by an 8 week double blind washout and then long-term
      open-label extension phase.
    

Intervention name(s): pagoclone; placebo
Intervention type(s): Drug; Other
Intervention description(s): 0.30 mg BID, 0.60 mg BID; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stutter; stuttering; Adults with a history of stuttering
Effectiveness of Dry Needling (DNHS Technique) in Patients With Chronic Stroke
Condition: Stroke; Spasticity
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional

Summary: 
      Study hypothesis:

      The DNHS technique, performed via one session of deep dry needling of myofascial trigger
      points applied to the biceps brachii, brachialis, flexor digitorum superficialis, flexor
      digitorum profundus, triceps brachii, extensor digitorum and adductor pollicis muscle is
      effective for decreasing spasticity and muscle stiffness (both of which are components of
      hypertonia) as well as for improving the upper limb function of the previously described
      muscles in patients with chronic cerebral vascular accident (CVA), assessed both
      post-intervention and after 15 days.

      General aims

      To analyse the immediate therapeutic effect of the DNHS technique and the effect at 15 days
      follow-up, for the following variables:

        -  Spasticity

        -  Muscle stiffness

        -  Upper limb function

        -  Patient perceived quality of life

      Materials and methods Population: patients from the province of Zaragoza (Spain) diagnosed
      with a haemorrhagic or ischemic CVA by a neurologist.

      Recruitment strategy: recruitment will take place via the Stroke Association in Aragon (AIDA)
      [Aragon Stroke Association] in the province of Zaragoza, Spain, seeing as the greater
      proportion of patients who have suffered a stroke and are in the chronic stage of the illness
      go to this centre to receive treatment. Thus, this avoids patients having to travel elsewhere
      for the study. Furthermore, in the case of patients who wish to participate in the study
      after having received information via third persons or via other means and who are not
      members of the Association or do not attend the centre on a regular basis, the Association
      AIDA has offered to allow these people to attend for free, making its facilities available
      and supporting the development of this study.
    


Intervention name(s): Dry Needling; Sham Dry Needling
Intervention type(s): Other; Other
Intervention description(s): Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis; Sham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
Other intervention name(s): DNHS technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: myofascial trigger point; dry needling; spasticity; stroke
Learning Curve of Robotic Pancreatoduodenectomy
Condition: Pancreaticoduodenectomy
Study type: Observational

Summary: 
      A few reports were focused on the RPD learning curve for surgeons with extensive experience
      in LPD. Therefore, this study aimed to investigate the number of cases required for such
      surgeons to overcome the learning curve for RPD and to analyze the impact of different phases
      of the learning curve on perioperative outcomes.
    

Detailed description: 
      With the development of robotic surgery systems, their unique advantages over traditional
      laparoscopic surgery systems, such as a three-dimensional 10-fold magnified view, seven
      degrees of freedom for flexible wrist movements, tremor filtering, and good ergonomic design,
      have significantly improved the precision and quality of surgery. The literature has reported
      that, compared with the laparoscopic surgery system, the robotic surgery system can reduce
      intraoperative blood loss and the conversion rate to laparotomy, in addition to the
      dissection of more lymph nodes. Therefore, robotic surgery has become increasingly popular.
      As the economy develops and surgeons gain more experience in LPD, many are shifting their
      focus to robotic pancreatoduodenectomy after mastering laparoscopic techniques. There are a
      few reports on the RPD learning curve for surgeons with extensive experience in LPD.
      Therefore, this study aimed to investigate the number of cases required for such surgeons to
      overcome the learning curve for RPD and to analyze the impact of different phases of the
      learning curve on perioperative outcomes.
    

Intervention name(s): Different phase of the learning curve of RPD
Intervention type(s): Other
Intervention description(s): Different phases of the learning curve of RPD (learning phase or proficiency phase)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From April 2020 to October 2022, consecutive patients with RPD performed for benign or
        malignant lesions at Peking Union Medical College Hospital
      
Keywords: robotic pancreaticoduodenctomy; learning curve
Bioequivalence Study for Donepezil Hydrochloride 10 mg Tablets Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, balanced, randomized, two-treatment, two-period, two sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      The study was an open label, balanced, randomized, two-treatment, two-period, two
      sequence,single dose, crossover, oral bioequivalence study of Donepezil Hydrochloride tablets
      10 mg of Dr. Reddy's Laboratories Limited, India comparing with that of ARICEPT® (containing
      Donepezil Hydrochloride) tablets 10 mg of Pfizer Inc, New York, 10017 in healthy, adult,
      human subjects under fasting condition. 28 subjects are enrolled in the study, and 26
      subjects are completed the study.
    

Intervention name(s): Donepezil Hydrochloride; Aricept
Intervention type(s): Drug; Drug
Intervention description(s): Donepezil Hydrochloride Tablets 10 mg; Aricept 10 mg Tablets
Other intervention name(s): Aricept 10 mg
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Donepezil; crossover
Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis
Condition: Active Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      A Phase IV, Multi-Centric, Prospective, Observational Study to Assess the Clinical Efficacy
      and Safety of Leflunomide in Egyptian Patients with Active Rheumatoid Arthritis. (CLEAR)
    

Detailed description: 
      CLEAR is a phase IV, multi-centric, prospective, observational study to assess the clinical
      efficacy and safety of Leflunomide as first-line therapy and as add-on therapy to other
      DMARDs (such as Methotrexate, Hydroxychloroquine, Sulfasalazine) with or without Steroids use
      in Egyptian patients with Active Rheumatoid Arthritis.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients are between 18 and 60 years of age, with Active Rheumatoid Arthritis selected
        according to the ACR/EULAR classification criteria with score ≥ 6 points.

        Patients are Leflunomide naïve or with previous Leflunomide administration (after at least
        6-month wash out period from date of baseline visit).

        Patients are with or without other DMARDs including Methotrexate, Sulfasalazine and/or
        Hydroxychloroquine with or without steroids use who experienced therapy resistance,
        inadequate response or intolerance.
      
Keywords: RA
Study of Fampridine-ER Tablets in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the safety and efficacy of a lower dose of
      dalfampridine extended release tablets compared to the currently approved dose in improving
      walking in Multiple Sclerosis (MS) patients.
    

Detailed description: 
      The current study is designed as a prospective placebo-controlled trial to investigate the
      safety and efficacy of a lower dose of dalfampridine extended release tablets (5 mg twice
      daily) compared to the approved commercial dose of 10 mg twice daily in improving walking in
      MS patients during a four-week period of treatment.
    

Intervention name(s): Dalfampridine-ER 5mg; Dalfampridine-ER 10mg; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 5mg, twice daily; 10mg, twice daily; placebo, twice daily
Other intervention name(s): Fampridine, Dalfampridine, Ampyra; Fampridine, Dalfampridine, Ampyra
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to see if using a mobile phone application asthma action plan
      will help improve asthma management.
    

Detailed description: 
      The investigators propose to conduct a randomized trial to examine the effectiveness of a
      mobile-based Asthma Action Plan that will meet the national guidelines recommendation for
      individualized Asthma Action Plan treatment plans. The mobile app will provide immediate
      instructions and feedback once data is entered by the participants. This is an randomized
      trial which will be compared with an paper asthma action plan. Participants will be
      randomized through a statistical table. The mobile app will be password and Health
      Information Portability and Protection Act protected.
    

Intervention name(s): Paper Asthma Action Plan; Mobile Phone
Intervention type(s): Other; Device
Intervention description(s): Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.; Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.
Other intervention name(s): IPhone and Android mobile phones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; Asthma; Asthma Symptoms
Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis
Condition: Atopic Dermatitis; Atopic Eczema; Infantile Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on
      clinical and immunological parameters in infants with AD with and without CMA and to compare
      effectiveness of different strains of probiotics.
    

Detailed description: 
      -  To determine the effect of supplementation of a hydrolyzed formula with probiotic
           bacteria on clinical and immunological parameters in infants with AD with and without
           CMA

        -  To determine the effect of supplementation of a hydrolyzed formula with probiotic
           bacteria on clinical and immunological reactivity to cow' milk challenge in infants with
           AD with CMA

        -  To compare the effectiveness of different strains of probiotic bacteria in improving
           clinical and immunological outcome in these infants
    

Intervention name(s): probiotics: Lactobacillus GG, lactobacillus Rhamnosus
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Atopic Dermatitis; SCORAD; probiotics; cytokines; Infant
Driving Pressure-guided PEEP Titration in Robot-assisted Laparoscopic Surgeries
Condition: Atelectasis, Postoperative Pulmonary
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of driving-pressure guided positive
      end-expiratory pressure (PEEP) titration.
    


Intervention name(s): Titrated PEEP based on driving pressure; Conventional PEEP
Intervention type(s): Procedure; Procedure
Intervention description(s): Alveolar recruitment and PEEP titration is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. The level of PEEP which makes the driving pressure lowest is selected and applied during the operation.; Alveolar recruitment is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. Conventional PEEP (5cmH2O) is applied during the operation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Driving pressure; Positive end-expiratory pressure; Lung ultrasound
Optimizing Pharmacotherapy for Bipolar Alcoholics
Condition: Bipolar Disorder; Alcohol Dependence
MeSH terms: Alcoholism; Bipolar Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test the efficacy of naltrexone and valproate in the
      treatment of comorbid bipolar disorder and alcohol dependence.
    

Detailed description: 
      Bipolar disorder has the highest rate of association with alcohol and other substance use
      disorders. This complex clinical presentation is asociated with severe disabilities,morbidity
      and heightened risk for suicide. There is a significant gap in our knowledge regarding
      effective treatment interventions for this high risk clinical population. This proposal will
      test the efficacy of a promising pharmacological approach for the treatment of comorbid
      alcohol dependence and bipolar disorder. We propose a randomized, double blind, placebo
      controlled 12-week trial to test the efficacy of valproate plus naltrexone vs. valproate
      alone in decreasing alcohol use and stabilizing mood symptoms among patients with comorbid
      alcohol dependence and bipolar disorder. All participants receive supportive psychosocial
      treatment.
    

Intervention name(s): Naltrexone hydrochloride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Naltrexone hydrochloride 50 mg capsule daily for 12 weeks; Placebo arm
Other intervention name(s): Revia
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone
Impact of Anti-citrullinated Protein Antibody Status on Treatment Response and Treatment Persistence in Participants With Rheumatoid Arthritis (RA) Who Are Treated With Abatacept or Tumor Necrosis Factor Inhibitors in Australia
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Necrosis
Study type: Observational

Summary: 
      An observational study assessing the impact of anti-citrullinated antibody (ACPA) in
      rheumatoid arthritis (RA) participants who have received abatacept or tumour necrosis factor
      inhibitors (TNFi) from the Optimising Patient outcome in Australian rheumatoLogy (OPAL)
      registry
    


Intervention name(s): Non-Interventional; Non-Interventional
Intervention type(s): Other; Other
Intervention description(s): Non-Interventional; Non-Interventional
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with a diagnosis of rheumatoid arthritis (RA) who have received a TNFi or
        abatacept and registered in the OPAL registry
Individually Timed Stair Climbing and Descending to Lower Postprandial Glucose
Condition: Postprandial Hyperglycemia; Postprandial Insulin
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      Effect of individually timed exercise to attenuate postprandial glucose excursions
    

Detailed description: 
      Participants will perform 1 and 3 minutes stair climbing and descending at a self-selected
      pace after a mixed meal on separate visits. The timing of these exercise bouts will be
      determined from an initial control condition where the participant remains seated. Timing of
      exercise will coincide with the peak glucose from the control condition. Glucose will be
      measured every 10 minutes.
    

Intervention name(s): Stair climbing and descending for 1 minute; Stair climbing and descending for 3 minutes; Seated control
Intervention type(s): Other; Other; Other
Intervention description(s): Stair climbing and descending for 1 minute; Stair climbing and descending for 3 minutes; Seated control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Clip-assisted Fixation to Prevent Migration of Fully Covered Self-expandable Metal Stent in Patients Undergoing ERCP
Condition: Pancreaticobiilary Diseases; Endoscopic Retrograde Cholangiopancreatography
Study type: Interventional

Summary: 
      Fully covered self-expandable metal stent (FCSEMS) has been widely used in ERCP patients with
      malignant or benign biliary stricture, difficult CBDS, post-EST bleeding, bile leak or
      perforation. Compared with uncovered SEMS, FCSEMS can be removed several months later and has
      the advantage of longer patency. Proximal or distal migration is one of major disadvantages
      of FCSEMS. The migration rate ranged from 7.0%-33% in previous reports.

      We hypothesized that the fixation of the distal end of FCSEMS by a metal clip could decrease
      the migration rate and migration-related cholangitis.
    


Intervention name(s): FCSEMS plus Clip; FCSEMS
Intervention type(s): Device; Device
Intervention description(s): After successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla.; FCSEMS was released as the same as mentioned above. No fixating method was used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ERCP; Fully Covered Self-expandable Metal Stent
Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan Study
Condition: Cognitive Disorders
MeSH terms: Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK1034702 is being developed for improving cognitive impairment in diseases such as
      Alzheimer's disease and schizophrenia. This study will be done in healthy men to investigate
      how much of the study drug gets into the brain. This will be done using Positron Emission
      Tomography (PET).
    

Detailed description: 
      This is an open label, single dose, non-randomized PET study in healthy male subjects to
      ascertain if GSK1034702 is crossing the blood-brain barrier to enable it to elicit a central
      effect. GSK1034702 has been shown in vitro to be a substrate for human Pgp, therefore the
      distribution of GSK1034702 into human brain could be adversely affected. This use of PET in
      conjunction with radioactively labelled GSK1034702 will help ascertain the role Pgp plays in
      limiting brain penetration in the presence and absence of a pharmacological relevant oral non
      labelled dose of 5 mg. Subjects will have an MRI scan to aid definition of brain anatomy, a
      baseline PET scan and a post-dose PET scan. For each subject the study will consist of at
      least three visits; screening visit, scanning day and follow-up.
    

Intervention name(s): GSK1034702
Intervention type(s): Drug
Intervention description(s): Single oral 5 mg dose in liquid formulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cognitive impairment; Schizophrenia; Alzheimer's Disease; PET