bioihbjkbjnl/mcl2 huggingface dataset:
Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia
Condition: Catecholaminergic Polymorphic Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Interventional

Summary: 
      The purpose of this study is to test whether the addition of oral flecainide to standard
      therapy will reduce ventricular ectopy on exercise test compared to placebo plus standard
      therapy in patients with Catecholaminergic Polymorphic Ventricular Tachycardia.
    

Detailed description: 
      Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) is a genetic arrhythmia syndrome
      characterized by frequent ventricular ectopy and polymorphic, classically bidirectional
      ventricular tachycardia with physical or emotional stress, which also carries a risk of
      ventricular fibrillation and sudden death, despite no structural heart abnormality. Treatment
      consists of beta-blockers and/or calcium channel blockers, but up to 30% of patients require
      implantable cardioverter-defibrillators (ICDs) due to recurrent symptoms on medical therapy.
      In an animal model, flecainide was found to directly target the molecular defect in CPVT. In
      a retrospective clinical study in patients with CPVT we have seen improvement of ventricular
      ectopy on exercise tests when flecainide is added to standard therapy. We propose a
      prospective trial of flecainide added to standard therapy in CPVT patients to test the
      hypothesis that flecainide will reduce ventricular ectopy on exercise testing compared to
      placebo plus standard therapy.

      This will be a single-blind (blinded subjects) randomized cross-over study, in which each
      patient will receive treatment A (flecainide or placebo) for at least 3 months and, after a 1
      week wash-out, treatment B (placebo or flecainide) for at least 3 months.
    

Intervention name(s): Flecainide Acetate; Placebo; Beta blocker
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral flecainide with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml; placebo, similar in appearance to flecainide; Standard therapy with beta-blocker (nadolol, atenolol, metoprolol, or propranolol) continues throughout the trial.
Intervention MeSH terms: Flecainide; Adrenergic beta-Antagonists
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Catecholaminergic Polymorphic Ventricular Tachycardia; implantable cardioverter-defibrillator; flecainide
Treatment of Hypersensitivity Using Diode Laser and Desensitising Agent on Fluorosed and Non-fluorosed Teeth
Condition: Fluorosis, Dental; Non-Fluoride Enamel Opacities; Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Fluorosis, Dental; Hypersensitivity
Study type: Interventional

Summary: 
      The present study was designed as a randomised controlled clinical trial which was unicenter,
      double-blinded, parallel designed study, according to the Consolidated Standards of Reporting
      Trials (CONSORT) criteria, 2010. The study period was from July 2014 to September 2015.
    

Detailed description: 
      90 Patients visiting the Out Patient of Department of Periodontology, Krishnadevaraya College
      of Dental Sciences and Hospital, Bengaluru, India, presenting with a chief complaint of
      dentinal hypersensitivity were enrolled in the study. Patients' age ranged from 18-60 years.
      The subjects interested in participating were explained in detail the treatment protocol. A
      verbal consent as well as a written informed consent was obtained from each patient Treatment
      of dentinal hypersensitivity with a combination of diode laser and potassium nitrate
      desensitising agent was considered as the test group and this was compared with diode lasers
      alone and desensitising agent alone as the positive control groups. The study was conducted
      in full accordance with the declared ethical principles (World Medical Association
      Declaration of Helsinki, version VII, 2013)13 and was approved by the Institutional review
      board of Krishnadevaraya College of Dental Science and Hospital, under the registration
      number of (ACA/DCD/SYN/KCODS - B/PG/2013-2014).
    

Intervention name(s): Fluorosed Group; Non Flourosed Group
Intervention type(s): Procedure; Procedure
Intervention description(s): A single episode of laser therapy with without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, A group only with desensitising paste and A group with desensitising paste and laser treatment depending on the study group they were assigned; A single episode of laser† therapy with or without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, depending on the study group they were assignedGROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment$. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal**) treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The present study was designed as a randomised controlled clinical trial which was unicenter, double-blinded, parallel designed study, according to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Single Dose and Multiple Dose Trial to Assess Pharmacokinetics of Obeticholic Acid (OCA)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open label, randomized, parallel design, single and multiple dose
      trial to evaluate the pharmacokinetics(PK), safety and tolerability of obeticholic acid
      (OCA).
    

Detailed description: 
      Twenty-four eligible subjects will be enrolled and randomized to 1 of 3 treatment groups (5
      mg, 10 mg, or 25 mg) in a treatment ratio of 1:1:1 and no less than a ratio of 1:1 for
      female: male subjects. The study comprises single dose and multiple dose phases. The
      randomized dose administered in the single dose phase will be the subject's dose level for
      the multiple dose phase. A single dose of OCA (5 mg, 10 mg, or 25 mg) will be administered on
      Day 1. PK, safety, and tolerability will then be assessed for 3 days. On Day 4, the multiple
      dose phase will begin at the same dose level (5 mg, 10 mg, or 25 mg), with subjects receiving
      OCA once daily for 14 days. PK, safety, and tolerability will be assessed for 2 weeks at the
      clinical site following the last investigational product (IP) dose on Day 17. Subjects will
      be confined at the inpatient trial site from Day 0 until the morning of Day 30. They will
      return to the study site on Day 37 for follow up.
    

Intervention name(s): OCA 5 mg; OCA 10 mg; OCA 25 mg
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): INT-747; 6α-ethyl chenodeoxycholic acid; 6-ECDCA; INT-747; 6α-ethyl chenodeoxycholic acid; 6-ECDCA; INT-747; 6α-ethyl chenodeoxycholic acid; 6-ECDCA
Intervention MeSH terms: Chenodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: MAD; SAD; Obeticholic Acid (OCA)
Neuromuscular Warm-up Intervention to Improve Postural Control in Female Handball Players
Condition: Postural Balance
Study type: Interventional

Summary: 
      Female handball athletes are at a particular risk of sustaining lower extremity injuries. The
      study examines time-dependent adaptations of static and dynamic balance as potential injury
      risk factors to a specific warm-up program focusing on neuromuscular control.
    


Intervention name(s): Neuromuscular warm-up; Standard warm-up
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention group replaced their regular warm-up routine with seven neuromuscular warm-up exercises performed for 15 minutes prior to each practice session (3x/week) over a period of eleven weeks.; Athletes in the control group followed their regular 15 minutes warm-up routine provided by the team coaches.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in
      Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a
      single-dose by intravenous infusion.
    

Detailed description: 
      To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity
      when ONO-4685 is administered by single-dose intravenous continuous infusion in Japanese and
      Caucasian healthy adult male subjects. In addition, in Japanese healthy adult male subjects,
      to investigate dosing condition of Keyhole limpet hemocyanin (KLH) and to investigate safety,
      tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is
      administered by single-dose intravenous continuous infusion after treating with KLH.
    

Intervention name(s): ONO-4685; Placebo; KLH; KLH, ONO-4685; KLH, placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed.; Placebo will be administered by intravenous continuous infusion at the designated speed.; KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration.; Part C will be conducted in a study design that ONO-4685 will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose regimens selected according to the investigation result in Part B.; Part C will be conducted in a study design that placebo will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose resimens selected according to the investigation result in Part B.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Efficacy of the Lumbar Stabilization and Thoracic Mobilization Exercises in Chronic Low Back Pain Patients
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Chronic low-back pain (CLBP) is a heterogeneous group of disorders, which according to the
      new classification of the International Association for Pain Research (IASP), is recognized
      as an independent entity and belongs to a mixed type of pain caused by central sensitization
      , which is present for more than 12 weeks. Studies have found that lumbar segmental
      instability (LSI) is one of the most significant cause of lumbar pain through the movement of
      each spinal segment where degenerative changes were observed in the discs. The aim of this
      study was to compare the program of lumbar stabilization exercises in the open and closed
      kinetic chain, in relation to the program of lumbar stabilization exercises and thoracic
      mobilization in a closed kinetic chain, to evaluate the clinical efficacy of both exercise
      programs and determine whether initial pain intensity values and disability levels affect the
      outcome of patients with chronic low back pain. The study was conducted as randomized,
      single-blind, controlled trial in 80 chronic low-back pain (CLBP) patients of both sexes (35
      male, 45 female), average age (48.45 +/- 10.22 years, treated at the Rehabilitation Clinic
      "Dr. Miroslav Zotović" in Belgrade between June 2017 and March 2018. Respondents were divided
      into two groups of 40 patients by simple randomization. Participants were given laser
      therapy, transcutaneous electrical nerve stimulation (TENS) and an eight-week kinesiotherapy
      that included exercises to strengthen the deep lumbar spine stabilizers. Retesting was done
      after 4 and 8 weeks. Patients who performed lumbar stabilization and thoracic mobilization
      exercises program in a closed kinetic chain had better functional recovery and a significant
      reduction in pain intensity compared to respondents who performed a lumbar stabilization
      program in opened and closed kinetic chain.
    


Intervention name(s): Lumbar stabilization exercises
Intervention type(s): Other
Intervention description(s): Patients performed exercises to stabilize and strengthen paravertebral muscles. Three sets of ten repetitions with a minute break between each.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Progressive Collective-exercise Program on the Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The investigators hypothesized that an eight-week collective group exercise program would
      improve pain, quality of life and functional capacity in patients with knee osteoarthritis
      (KOA) compared with those receiving no exercise intervention.
    


Intervention name(s): Collective group exercise program in patients with KOA; Orientation (without exercise)
Intervention type(s): Other; Other
Intervention description(s): Orientation about osteoarthritis disease but without any exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pilot Trial of "My Meal Mate" (MMM), a Smartphone Application for Weight Loss
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to implement an exploratory pilot trial of "My Meal Mate" (MMM), a
      smartphone application developed to facilitate weight loss, assessing its feasibility and
      acceptability. Overweight and obese adults will be recruited from large employers within the
      local area. The trial will aim to recruit a sample size of 135 which is a pragmatic decision
      based on randomizing 45 people to each arm. Participants will be randomized to one of three
      groups. The researchers have developed a smartphone application for weight loss called "My
      Meal Mate" (MMM) which incorporates a large branded food and drink database. MMM was
      developed using focus group data collected from potential system users and by benchmarking
      with similar commercially available diet tracking applications. One group will receive a
      smartphone with the MMM app downloaded on it, one group will receive access to an online food
      diary and one group will be given a paper food diary. Participants will be asked to set a
      goal for weight loss and self-monitor their food intake and activity using their allocated
      study equipment. Participants will be weighed at the beginning of the trial, at 6 weeks and
      at 6 months. Feasibility and acceptability outcomes will be assessed.
    


Intervention name(s): "My Meal Mate" (smartphone application); Paper food diary; Online food diary
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A smartphone application called "My Meal Mate" (MMM) designed to facilitate weight loss. The app allows system users to set a goal for weight loss and self monitor diet and activity in an electronic diary. Users receive instant nutritional feedback and feedback via text message.; The paper food diary is provided by a commerical slimming organisation called "Weight Loss Resources". The diary allows the user to record daily food and drink consumed. It is accompanied by a book which provides a database of the nutritional content of 40,000 food and drinks. The diary also encourages participants to record their physical activity.; The online food diary is provided by a commerical slimming organisation called "Weight Loss Resources". The electronic diary allows the user to record daily food and drink consumed. System users are also encouraged to record their physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: smartphone; smartphone app; smartphone application; obesity; overweight; self monitoring
Evaluation of Energy Expenditure, Body Composition and Recovery Rates in Children With Severe Acute Malnutrition
Condition: Children; Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional

Summary: 
      This project is being conducted with an aim to find out energy expenditure, body composition
      and recovery rates in children with severe acute malnutrition (SAM) receiving community-based
      nutritional rehabilitation therapy
    

Detailed description: 
      Objectives

        1. To assess energy expenditure and body composition by stable isotope techniques in
           children with Severe Acute Malnutrition

        2. To evaluate the potential usefulness of body composition assessment as a predictor of
           outcome in children with SAM, based on stable isotope technique and multi-frequency
           bioelectrical impedance analysis (BIA)

      Inclusion criteria

        -  Parents of children of age 6 months to 3 years

        -  Resident of study area

      Exclusion criteria

        -  Children with congenital malformations

        -  Chronic debilitating illnesses

        -  Refusal by parents to enroll in study
    

Intervention name(s): Nutrition education; RUTF
Intervention type(s): Behavioral; Dietary Supplement
Intervention description(s): Parent/care givers of children with severe malnutrition in enrolled in this group will be given nutrition education using the principles of infant and young child feeding (IYCF) and dietary diversification; Ready to use therapeutic food (RUTF / PlumpyNut) will be provided to the parent/care givers of children with severe malnutrition in enrolled in this group
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SAM; RUTF; BIA; D2O; Children with severe malnutrition
Physiotherapy or Acupuncture for Lateral Epicondylitis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      Work-related upper extremity disorders are common problems in working populations in western
      countries. Lateral epicondylitis (LE) or tennis elbow is the most frequent type of soft
      tissue syndrome of the elbow, with an annual incidence of four to seven cases per 1000
      patients in general practice, and as high as 15 % of workers in highly repetitive hand task
      industries.

      LE is a painful condition, leading to loss of function of the affected limb. Therefore it can
      have a major impact on the patient's work and personal life. If untreated, it persists for an
      average of six to 24 months and associated with significant sickness absence in 5 % of
      affected working-aged adults. The cost is therefore high, both in terms of loss of
      productivity and health care utilization.

      Many treatments have been advocated in the management of LE, possibly implying that much is
      unknown about its etiology and how it best should be treated. Systematic reviews have failed
      to draw any firm conclusions as to what treatment is most effective in managing this
      condition.

      Over the past 10 years acupuncture has gained wider acceptance for treating pain, by both
      clinicians and consumers of health, and there is some evidence suggesting that acupuncture
      treatment is effective in of acute symptoms in LE. A recent study supports that also elbow
      manipulation have a short-term relief of acute symptoms in LE, especially when combined with
      eccentric exercise. Our study will therefore explore the clinical effectiveness of
      physiotherapy versus acupuncture treatment of LE, compared with watchful waiting.
    

Detailed description: 
      The study design is three armed and randomized, single blinded. The study aims, in a pilot
      stydy, to test if physiotherapy or acupuncture treatment of lateral epicondylitis, compared
      with watchful waiting, is useful means in pain relief for patients with lateral
      epicondylitis.
    

Intervention name(s): Acupuncture; Physiotherapy and eccentric exercise; Watchful waiting and eccentric exercise; eccentric exercise
Intervention type(s): Device; Other; Other; Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: physiotherapy; manual therapy; acupuncture; eccentric exercise
A 6-Month Extension Study to Assess the Long-Term Safety of Engensis in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the long-term safety of intramuscular (IM)
      administration of Engensis in Participants with Amyotrophic Lateral Sclerosis (ALS) who were
      previously randomized, received treatment, and completed the Day 180 Visit of Study
      VMALS-002-2. Safety will be assessed by incidences of treatment-emergent adverse events
      (TEAEs), treatment emergent serious adverse events (TESAEs), adverse events of special
      interest (AESIs), and the clinically significant laboratory values. See the table below for
      additional, exploratory endpoints.
    


Intervention name(s): Engensis; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Lyophilized biologic to be reconstituted containing Engensis; Injectable Liquid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment