bioihbjkbjnl/mcl2 huggingface dataset:
Safinamide for Multiple System Atrophy (MSA)
Condition: Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a placebo controlled study, with two parallel arms, in which participants will
      be randomly assigned in a 2:1 ratio to receive either active (200 mg safinamide) or placebo
      in a double blind manner. Study population is patients diagnosed, with possible or probable
      parkinsonian variant of Multiple System Atrophy who are on a stable treatment of levodopa
    

Detailed description: 
      The overall design is a parallel group, placebo controlled, double blind study. The target
      population are participants diagnosed with possible or probable parkinsonian variant of
      Multiple System Atrophy who are on stable doses of levodopa.

      Trial participation will be up to a maximum duration of 14 weeks and will comprise a
      screening period (up to 2 weeks), a 2-week run in period during which subjects will receive 1
      tablet (either 100 mg safinamide or matching placebo), followed by a 10-week period, during
      which study participants will take 2 tablets of study medication (200 mg safinamide or
      placebo) once daily, taken in the morning in addition to their morning levodopa dose. A
      telephone follow-up call will be performed 2 weeks after the end of treatment.
    

Intervention name(s): Safinamide Methanesulfonate; Safinamide Methanesulfonate matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg (free base); 100 mg placebo
Other intervention name(s): Xadago; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MSA, safinamide
Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      According to the ICH Guidance Document E14, all non-antiarrhythmic drugs should be evaluated
      for their ability to prolong the QT interval which represents the duration of ventricular
      depolarization and subsequent repolarization. The primary objective of the study is to assess
      the effect of anagrelide on QT/QTc interval following a therapeutic and supratherapeutic dose
      of anagrelide when compared to placebo and a positive control.
    


Intervention name(s): Anagrelide 0.5 mg; Anagrelide 2.5 mg; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.5mg Anagrelide single oral dose; 2.5mg Anagrelide single oral dose; 400 mg Moxifloxacin single oral dose; Anagrelide placebo + Moxifloxacin placebo single oral dose
Other intervention name(s): Agrylin, Xagrid
Intervention MeSH terms: Moxifloxacin; Anagrelide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Detecting and Addressing Preclinical Disability
Condition: Back Pain; Coronary Artery Disease; Chronic Obstructive Pulmonary Disease; Diabetes; Hypertension; Multiple Sclerosis; Osteoporosis; Osteoarthritis; Rheumatoid Arthritis; Stroke
MeSH terms: Osteoporosis; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Multiple Sclerosis; Coronary Artery Disease
Study type: Observational

Summary: 
      The Physical Functioning Inventory (PFI) is a standardized patient reported outcome measure
      that assesses preclinical disability. Preclinical disability is a functional state in which
      people are still able to complete daily living tasks (e.g., walking, bathing) but are
      changing the frequency or modifying the way that they complete the tasks. The investigators
      have done some preliminary research using the PFI as an online monitoring tool (Richardson
      2012), but further study is required to examine its psychometric properties and its
      suitability for use as a primary outcome measure. This measurement study has been designed to
      identify the optimal number of items on the PFI and to determine the reliability, validity,
      and responsiveness of the PFI when administered to a sample of adults and older adults both
      with and without chronic conditions. This project will also allow us to evaluate the use of
      self-monitoring of physical function and the added value of rehabilitation professionals to
      support self-monitoring. Using the results of the PFI, the investigators aim to develop a
      "tailored" population-based rehabilitation self-management intervention delivered through a
      secure messaging system in the patient's electronic personal health record (myOSCAR) that
      focuses on the early detection and prevention of preclinical disability.
    


Intervention name(s): Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portal
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care center
The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis
Condition: Knee Osteoarthritis; Balance; Distorted; Proprioceptive Disorders
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Somatosensory Disorders
Study type: Interventional

Summary: 
      This study aime to investigate the effects of balance and proprioception exercises using two
      different methods (classical balance training and Balance System™ SD) in addition to
      strengthening exercises on dynamic balance, pain, functional status and quality of life in
      patients with knee osteoarthritis (OA).
    

Detailed description: 
      It is known that knee OA leads to a decrease in proprioception and balance disturbances.
      Falls due to balance disorders often occur during dynamic activities such as walking and
      stair climbing. Therefore, correction of balance disorders is of great importance to prevent
      falls and associated fractures in the elderly population, in which knee OA is common. In
      addition, loss of proprioception in the knee joint, muscle weakness, and balance disorders
      are also known to contribute to the development of knee OA itself. Therefore, treatment of
      balance disorders may also slow the progression of the disease. This study was planned to
      compare the effects of isometric strengthening exercises plus balance and proprioception
      exercises performed by two different methods with isometric strengthening exercises alone.
      This is a single-center randomized trial with 3 parallel arms.
    

Intervention name(s): Balance and proprioception exercises; Home exercises program
Intervention type(s): Other; Other
Intervention description(s): Balance and proprioception exercises using two different methods (classical balance training and Biodex) in addition to strengthening exercises; Isometric exercises for the quadriceps and hamstrings at home
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was planned to compare the effects of isometric strengthening exercises plus balance and proprioception exercises performed by two different methods with isometric strengthening exercises alone. This was a single-center randomized trial with 3 parallel arms
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Tissue Glue vs Metallic Tackers in Mesh Fixation During TAPP Repair.
Condition: Hernia
MeSH terms: Hernia
Study type: Interventional

Summary: 
      This is a randomized control trial intending to study the clinical difference between
      different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for
      adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and
      surgical tackers , the target population will be divided according to an electronic generated
      randomization into two groups , they will be compared according to multiple variables which
      includes but not limited to : procedure time, early post op complication , post-operative
      pain , late complications , short term and long term recurrence rates .
    

Detailed description: 
      Laparoscopic transabdominal preperitoneal ( TAPP ) hernioplasty has emerged as an essential
      procedure for adults complaining of both unilateral and bilateral inguinal hernia , various
      descriptions of the procedure have been published recently, complications and recurrence
      rates are being calculated for each method, different mesh fixation techniques are being used
      by different surgeons, some use surgical tackers, some use fibrin glue and some demonstrated
      an equal outcome if the mesh was not fixed at all.

      This is a randomized control trial intending to study the clinical difference between those
      different mesh fixation techniques in laparoscopic TAPP hernioplasty of inguinal hernia for
      adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and
      surgical tackers , the target population will be divided according to an electronic generated
      randomization into two groups , they will be compared according to multiple variables which
      includes but not limited to : procedure time, early post op complication , post-operative
      pain , late complications , short term and long term recurrence rates .
    

Intervention name(s): tissue Glue for mesh fixation; Metallic Tackers for mesh fixation
Intervention type(s): Procedure; Procedure
Intervention description(s): one arm of the study had their mesh fixed with tissue glue applied at multiple sites; in the other arm mesh was fixed with tackers applied avoiding the triangle of pain and the triangle of doom using a three point fixation technique; Cooper's ligament, medial cranial edge of the mesh and just lateral to the inferior epigastric vessels.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized control trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopic TAPP; tissue glue; tackers; hernia
Educational Follow-up in a Cohort of Children at the Royal Marsden Hospital (RMH)
Condition: Brain Tumour
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      To document pre-diagnosis educational abilities, to document any change in educational
      achievements following treatment, to document educational support given within the statement
      process and to document the timing of support.
    

Detailed description: 
      This will be a retrospective study. Cases will be identified by looking at the Royal Marsden
      Hospital (RMH) coding database. All the patients will have completed treatment for a brain
      tumour. The children all need to have started school before the diagnosis of their brain
      tumour so that we can look at easily defined educational assessments in this cohort. Children
      will be identified by looking at RMH coding of diagnosis and include children aged between 4
      years and 18 years old (school age).
    

Observational model: Family-Based
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Cases will be identified by looking at RMH coding database. Medical information will be
        sort from the electronic patient records (EPR) and from the patient notes.
      
Keywords: brain tumour
Video Intervention to Enhance the Safety Of Cognitively Impaired Older Drivers
Condition: Impaired Driving
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This pilot study was done to assess the feasibility and possible efficacy of a video feedback
      intervention to improve the safety of cognitively impaired older drivers.
    

Detailed description: 
      The goals of this pilot study were to demonstrate that 1) g-force technology can effectively
      detect unsafe driving events by older adults, and 2) cognitively impaired older adults can
      improve their driving safety with an in-car video feedback intervention. Unsafe driving
      events were triggered by g-forces leading to capture of a video record that was then
      transmitted wirelessly to a remote office where the events were analyzed and scored. During
      the baseline phase (3 months), there was no feedback. During the intervention phase (4-6
      months), participants received a weekly progress report in the mail along with DVD of
      recorded unsafe driving events with recommendations. The research team then contacted the
      participant and informant weekly to provide additional coaching, and verify that participants
      reviewed the information and videos. During the post-intervention monitoring phase (7-9
      months), there was no further feedback. The primary quantitative outcomes were total number
      of unsafe driving events/1,000 miles and total safety driving score/1,000 miles. Secondary
      qualitative outcomes included the types and severity of unsafe driving events that were
      recorded.
    

Intervention name(s): DriveCam
Intervention type(s): Device
Intervention description(s): Video event monitoring device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
BSCU1 and Immune Function
Condition: General Population
Study type: Interventional

Summary: 
      The current study aims to explore a range of possible pathways by which BSCU1 could
      beneficially modulate the immune system, in three target populations representing the general
      population.
    

Detailed description: 
      This exploratory study is designed as a single-arm study with repeated measures, involving
      three different populations, in which each subject serves as its own control. The duration of
      the intervention is 4 weeks, with biomarker assessments at baseline, after 2 weeks, and after
      4 weeks intervention.
    

Intervention name(s): B. subtilis CU1
Intervention type(s): Dietary Supplement
Intervention description(s): 2 billion CFUs daily, for 4 weeks
Other intervention name(s): B. subtilis CNCM I-2745
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Virtual Exercise For Older Adults With Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This project is designed to develop and evaluate an Internet-based exercise intervention (tai
      ji quan Moving to Improve Brain Health) using real-time videoconferencing for older adults
      with mild cognitive impairment (MCI).
    

Detailed description: 
      The project has three major goals: (a) transforming an in-person tai ji quan brain health
      intervention protocol into an online (virtual) class protocol and evaluating its feasibility
      of implementation in older adults with MCI, (b) developing and evaluating online assessment
      and data ascertainment procedures that encompass cognitive and physical performance measures,
      and (c) conducting a randomized controlled trial comparing the effectiveness of this new
      online intervention protocol with a conventional stretching exercise group in older adults
      with MCI.
    

Intervention name(s): tai ji quan; Stretching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): cognitively enhanced tai ji quan exercise; Stretching exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: tai chi, ehealth, older adults, cognitive impairment
Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD
Condition: Fatty Liver; Insulin Resistance
MeSH terms: Fatty Liver; Insulin Resistance; Hypersensitivity; Weight Loss
Study type: Interventional

Summary: 
      To assess whether reversal of fatty liver by moderate weight loss (8% of body weight) will
      lead to improvements in insulin sensitivity, which will be associated with changes in both
      glucose status and lipid profiles, in obese children and adolescents with fatty liver who
      have normal glucose or pre-diabetes.
    

Detailed description: 
      This study will have two groups: one group that eats a moderate calorie, low-fat diet and is
      weighed regularly (every other week for 16 weeks) and the other who receives traditional diet
      therapy and returns in 16 weeks. Both groups will undergo procedures that test glucose
      tolerance and measure liver and muscle fat content before and after study period.
    

Intervention name(s): Low-fat diet; Traditional diet
Intervention type(s): Other; Other
Intervention description(s): 20% calorie from fat diet followed for 8 weeks then maintenance diet for additional 8 weeks; Traditional low-fat diet with dietitian follow-up in 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: steatosis; fatty liver; insulin sensitivity; fatty liver (steatosis)
SPARC: Shoulder PAtch for Rotator Cuff Tears
Condition: Massive Rotator Cuff Tears
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      Rotator cuff tears (injury to the muscle or tendons which stabilise the shoulder) are one of
      the most common conditions affecting the shoulder. Small and medium sized rotator cuff tears
      can be managed with arthroscopic or keyhole surgery. Very large or massive tears are
      difficult to operate on and often have poor rates of healing. As a result surgeons have
      investigated the use of products to improve the outcome of surgery on massive tears.

      The product that the investigators are currently using to try to improve the outcome of
      surgery for massive rotator cuff tears is called a patch. The patch provides a scaffold to
      support the muscles of the rotator cuff. Studies of rotator cuff surgery using similar
      patches have found that recovery is improved and there is a lower rate of postsurgical
      problems. The aim of this study is to look at whether using the patch improves pain and the
      clinical function of the shoulder after surgery. In addition, the investigators would like to
      understand how the patch works. To do this the investigators will scan (take images of) the
      shoulder using magnetic resonance imaging to look at the muscle damage in the shoulder before
      and after surgery.
    


Intervention name(s): Patch
Intervention type(s): Procedure
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Massive rotator cuff tear patients
Safety and Tolerability of ToleroMune Grass in Grass Allergic Subjects With Rhinoconjunctivitis
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Grass pollen allergens are universally recognised as a major cause of allergic diseases in
      humans and animals, including asthma, allergic rhinitis, conjunctivitis and dermatitis.
      Worldwide, at least 40% of allergic patients are sensitized to grass pollen allergens and
      between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen.

      ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine,
      currently being developed for the treatment of grass allergy.

      The purpose of the present study is to evaluate the safety and tolerability of multiple
      ascending doses of ToleroMune Grass in subjects allergic to grass.
    

Detailed description: 
      This study is designed as a randomised, double-blind, placebo-controlled study to evaluate
      the safety and tolerability of escalating multiple doses of ToleroMune Grass in subjects with
      a documented history of allergic rhinoconjunctivitis on exposure to grass. The efficacy of
      ToleroMune HDM will also be explored LPSR, EPSR, CPT and levels of grass specific IgE.

      The study will consist of 3 study periods. In Period 1, Screening will be performed up to a
      maximum of 6 weeks before randomisation.

      Period 2 (Treatment Period) will consist of 4 visits (Visits 3A-3D) four weeks apart. The
      first cohort will receive the lowest dose and successive dose groups will increasing doses of
      ToleroMune Grass, provided the first administration of the previous dose was safe and well
      tolerated.

      In Period 3, 2 Post-treatment Challenge visits will take place, the first will be 2 weeks
      after the last administration in the Treatment Period and the second will be 17 weeks after
      the first administration. Follow-up will be conducted 3-10 days after the second PTC.
    

Intervention name(s): Placebo; ToleroMune Grass
Intervention type(s): Biological; Biological
Intervention description(s): Solution resembling active solution but without peptides; 1 x4 administrations 4 weeks apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Grass Allergy; Immunotherapy; Rhinoconjunctivitis; ToleroMune Grass
TAK-438_110 Drug Interaction With Cytochrome P450 3A4 (CYP3A4) Inhibitor Clarithromycin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of multiple oral doses of clarithromycin
      on the pharmacokinetics of TAK-438 and its metabolites in healthy male adult participants
      following a single oral dose of TAK-438.
    

Detailed description: 
      The drug being tested in this study is called TAK-438. TAK 438 is being tested to assess the
      effect of multiple oral doses of clarithromycin on the pharmacokinetics of TAK-438.

      The study will enroll approximately 16 healthy adult male participants of non-Japanese
      origin. Participants will be assigned:

        -  TAK-438 40 mg

        -  Clarithromycin 500 mg

      All participants will be asked to take 2 tablet of TAK-438 20 mg orally, once on Days 1 and 8
      along with Clarithromycin 500 mg, tablets, orally twice daily from Days 3 to 9.

      This single center trial will be conducted in Europe. The overall time to participate in this
      study is maximum of 44 days. Participants will be confined to site for 10 days, and a final
      visit after 4 days after discharge from the unit for a follow-up assessment.
    

Intervention name(s): TAK-438; Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): TAK-438 tablets; Clarithromycin tablets
Intervention MeSH terms: Clarithromycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy