bioihbjkbjnl/mcl2 huggingface dataset:
An Assistive Powered Wheelchair: Stage 2 Trial
Condition: Multiple Sclerosis; Stroke; Cystic Fibrosis; Motor Neurone Disease; Craniocerebral Trauma; Guillain-Barre Syndrome
MeSH terms: Cystic Fibrosis; Multiple Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Guillain-Barre Syndrome; Craniocerebral Trauma
Study type: Observational

Summary: 
      Preliminary evaluation of an obstacle alerting system to enhance the user's independent
      mobility by improving their confidence to drive and their safety in driving a powered
      wheelchair.
    

Detailed description: 
      Many powered wheelchair users find that collision free driving presents a significant
      challenge to confident and safe driving. In some cases so much so that the user will not
      drive their chair in some environments.

      Interviews with users in the EDUCAT project confirmed that users had problems driving safely
      and confidently in a confined space, passing through doorways or down narrow corridors and
      when reversing.

      Therefore the goal of this stage of the project is to improve the quality of life of the
      powered chair user by developing an obstacle alerting system which will help improve their
      confidence and safety in driving.

      This was to be achieved by asking expert users to provide feedback on the impact and
      usefulness of providing information about the presence and location of obstacles in the
      vicinity of their powered wheelchair.

      There are two aspects to this.

        1. User assessment of the usefulness of the obstacle alerting feedback. This will include
           user evaluation of the value of the different modes of feedback - audio, visual and
           haptic - and how best to adapt these to the range of driving environments and driving
           speeds. And what level of control the user requires to select and deselect these
           options.

        2. Monitoring the user's driving patterns with and without obstacle alerting -using the
           Stage 1 recording device.

      The analysis of this data, and feedback from the Users and carers will inform the development
      and design of the obstacle alerting system.

      Because of the COVID-19 pandemic the trial could not be carried out with powered wheel-chair
      users participating as they represented a clinically vulnerable part of the population. The
      trial was, therefore, adapted and carried out with adult non-wheelchair users.
    

Intervention name(s): Powered Wheelchair Obstacle Alerting System
Intervention type(s): Device
Intervention description(s): Evaluation of an Obstacle Alerting System
Intervention MeSH terms: Caffeine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult non-powered wheelchair users
TRI102 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether TRI102 is effective in the treatment of
      Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-12.
    

Detailed description: 
      A Phase 3, randomized, double-blind, placebo-controlled, parallel group, multicenter,
      laboratory classroom study. After Screening and Baseline evaluations, eligible subjects are
      enrolled in the study and entered the open-label phase, dose-optimization phase. TRI102 is
      taken once daily and subjects undergo dose optimization activities for 5 weeks.
    

Intervention name(s): TRI102; Placebo
Intervention type(s): Drug; Other
Intervention description(s): formulation containing active moiety (amphetamine); formulation without active moiety
Other intervention name(s): amphetamine extended-release oral suspension
Intervention MeSH terms: Amphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTP-543 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.
    

Detailed description: 
      This two-part study will assess, in healthy volunteers, under fasted conditions, and in a
      sequential manner, the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)
      of single- and multiple-ascending doses of CTP-543.
    

Intervention name(s): CTP-543; Placebo for CTP-543
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Effects of Replacing Starchy Vegetables and Refined Grains With Beef on Cardio-metabolic Disease Risk Factors (S53)
Condition: Diet Modification
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of replacing starchy vegetables and
      refined grains with beef in a vegetarian diet on cardio-metabolic disease risk factors in
      adults in a cross-over, randomized controlled feeding trial.
    

Detailed description: 
      The purpose of this study is to assess the effects of replacing starchy vegetables and
      refined grains with beef in a vegetarian diet on cardio-metabolic disease risk factors in
      adults in a cross-over, randomized controlled feeding trial. The hypothesis is that
      isocalorically replacing predominantly starchy vegetables and refined grains with 6 oz. of
      beef/day will enhance improvements in cardiometabolic disease risk factors, particularly
      atherosclerotic-promoting lipids and lipoproteins. It is also hypothesized that participant
      satisfaction and acceptance of a healthy eating pattern with 6 oz. of beef per day will be
      higher compared to without beef.
    

Intervention name(s): Controlled healthy vegetarian diet; Controlled beef diet
Intervention type(s): Other; Other
Intervention description(s): The controlled healthy vegetarian diet will follow the Dietary Guidelines for American's recommendations. All foods and beverages will be provided during intervention to achieve the desired eating pattern.; The controlled beef diet will incorporate various cuts of lean unprocessed red meat into the healthy vegetarian eating pattern, as approved by the American Heart Association's Food Certification Program. The beef diet will isocalorically replace starchy vegetables and/or refined grains with 6 oz. of beef/day for five weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 16-week randomized, cross-over, controlled, single-blind study. During weeks 1 and 11, participant's usual, unrestricted dietary intakes will be assessed. At week 2, they will be randomized and assigned to consume either the controlled lacto-ovo vegetarian diet or beef diet for the first 5-week dietary intervention during weeks 2-6. They will consume the other diet during weeks 12-16. Two fasting-state serum samples and one stool samples will be collected during study weeks 1,6,11, and 16.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: beef; cardio-metabolic disease
Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The aim of this dispensing study is to evaluate the clinical performance of existing wearers
      of Avaira toric lenses following a refit with Clariti toric over 1 month of daily wear.
    

Detailed description: 
      This is a 30-subject, prospective dispensing study comparing the clinical performance of the
      subjects' habitual Avaira toric lenses following a refit with Clariti toric lenses. Subject's
      habitual Avaira toric lenses will be evaluated at the first visit and then re-fitted with a
      pair of Clariti toric lenses for 1 month of daily wear. After the dispensing visit, subjects
      will return for evaluations at 1 week, 2 weeks and 4 weeks.
    

Intervention name(s): somofilcon A
Intervention type(s): Device
Intervention description(s): somofilcon A lens
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
3D Rotational CT Angiogram With Embolization Guidance and CBCT in Prostatic Artery Embolization
Condition: Enlarged Prostate
Study type: Interventional

Summary: 
      The purpose of this research study is to learn about how cone-beam Computerized Tomography
      scans (X-ray images taken from different angles) work together with an embolization guidance
      software (helps the doctor see the arteries that feed the prostate)to find and see arteries
      in the prostate.
    


Intervention name(s): cone-beam CT 3D Emboguide
Intervention type(s): Device
Intervention description(s): cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: BPH; Lower Urinary Track Infection; Urine Retention
Characterization of the Gut Microbiota Composition and Activity After Three Weeks of Chitin-glucan Supplementation
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this research study is to characterize gut microbiota composition and activity
      after a daily supplementation of 4.5 g of chitin-glucan during 3 weeks. For this purpose, a
      monocentric longitudinal intervention study without control will be performed. Fecal
      microbiota composition and fecal concentrations of gut microbiota-derived metabolites (bile
      acids, conjugated-polyunsaturated fatty acids and short-chain fatty acids) will be measured.
      In addition, during ten hours following the ingestion of a test meal rich in fibers, the
      kinetic of production of H2, methane and volatile compounds exhaled from breath will be
      evaluated.
    


Intervention name(s): Chitin-glucan fiber
Intervention type(s): Dietary Supplement
Intervention description(s): 4.5g per day of chitin-glucan during 3 weeks
Intervention model: Single Group Assignment
Intervention model description: Supplementation during 3 weeks with 4.5g of chitin-glucan
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents
Condition: Diabetes Mellitus, Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and
      effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with
      type 1 diabetes mellitus.
    


Intervention name(s): Insulin glulisine; insulin lispro; insulin glargine; NPH insulin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous injection; Subcutaneous injection; Subcutaneous injection once daily; subcutaneous injection twice daily
Other intervention name(s): apidra
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Insulin glulisine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes,Insulin-Dependent, pediatric,rapid acting injection
Sexual Health and Rehabilitation After Ovarian Suppression Treatment
Condition: Breast Cancer Survivors; Sexual Function Disturbances; Ovarian Suppression Treatment
MeSH terms: Breast Neoplasms; Vision Disorders
Study type: Interventional

Summary: 
      This research study is evaluating an educational intervention for breast cancer survivors who
      have experienced changes in sexual function after ovarian suppression treatment to reduce the
      risk of breast cancer recurrence.
    

Detailed description: 
      The purpose of this research is to study the effectiveness of an educational intervention for
      breast cancer survivors who have experienced changes in sexual function after ovarian
      suppression treatment to reduce the risk of cancer recurrence. The aim is to develop an
      effective intervention to help women manage these changes and restore sexual health and
      functioning.

      - This study consists of attending a group educational session followed by a one-on-one
      telephone coaching session.

        -  The group educational session will last about 4 hours, and will include information on
           resources, self-help strategies, and relaxation techniques.

        -  The telephone coaching session will take place four weeks after the group session, and
           will last about 15 minutes
    

Intervention name(s): Group Session; Telephone Booster
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The 4-hour group session will be structured around three 60-minute modules and creation of a personal action plan; One month following the group session, women will receive a telephone booster session (<15 minutes). This brief telephone check-in is intended to help women review progress with their individualized action-plan, problem-solve around continuing problems, and plan for maintenance moving forward.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast Cancer Survivors; Sexual Function Disturbances; Ovarian Suppression Treatment
A Single Dose Study Of PF-04620110 In Overweight And Obese, Otherwise Healthy Volunteers
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The
      purpose of this study is to characterize the safety, tolerability, pharmacokinetics and
      pharmacodynamics following a single oral dose.
    


Intervention name(s): Placebo; PF-04620110
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be given placebo or PF-04620110; A single oral dose of PF-04620110 will be given. The specific dose will depend on the cohort to which the subject is assigned and the period of the cross-over for that cohort. Initial planned doses are 0.3-30 mg but may be modified based on emerging PK and safety data.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Single Ascending Dose Study in Overweight subjects
EMG Guided Botulinum Toxin Type A Injections for Refractory High Tone Pelvic Floor Dysfunction
Condition: High Tone Pelvic Floor Dysfunction
Study type: Interventional

Summary: 
      This is a prospective, pilot, longitudinal study to evaluate the use of EMG guidance for
      Botox A injection for chronic pelvic pain and HTPFD. The objective of this study is to
      determine the efficacy of injecting botulinum toxin type A into pelvic floor muscles that are
      high tone. Patients who have been diagnosed with high tone pelvic floor muscle dysfunction
      and have failed other treatments will be eligible to participate in this study. Study related
      procedures will include perineometry readings. Patients will be required to complete 7
      questionnaires for this study. These include visual analog scale (scale from 0-10) for pain
      (VAS), the O'Leary-Sant urinary symptoms and problem questionnaires (ICSI/ICPI), Pelvic Floor
      Distress Inventory 20 (PFDI-20), the Female Sexual Distress Scale (FSDS), Global Response
      Assessment Scale and the SF-12 quality of life scale. The use of the EMG guidance is the
      experimental part of the study. We will perform EMG Needle testing in order to pin-point the
      best location for the patients Botox injections. This is a prospective, pilot, longitudinal
      study to evaluate the effect of Botox A injection for chronic pelvic pain and HTPFD.
    


Intervention name(s): EMG Guidance of Injection
Intervention type(s): Other
Intervention description(s): The use of the EMG guidance is the experimental part of the study. We will perform EMG Needle testing in order to pin-point the best location for the patients Botox injections.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High Tone Pelvic Floor Dysfunction; Botulinum toxin type A; EMG
Fenofibrate Bioequivalence Study (0767-031)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine definitive bioequivalence of the United States (U.S.) and United
      Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy
      adult subjects.
    


Intervention name(s): fenofibrate (U.S. formulation); fenofibrate (UK formulation)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.; Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.
Other intervention name(s): Tricor®; Supralip®
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Aesthetic Impact in Patients With Systemic Sclerosis
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Study type: Observational

Summary: 
      The primary objective is to assess the burden of aesthetic complication in systemic
      sclerosis. Systemic sclerosis is associated with changes in skin aspect which can impact the
      appearance. Aesthetic burden will be assessed through several scales and compared to a
      control group of health subjects.
    


Intervention name(s): appearance scales
Intervention type(s): Other
Intervention description(s): appearance scales : AVS; ASWAP; DAS 59
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        systemic sclerosis patients
Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) < 7% with no severe or
      nocturnal hypoglycemic episodes at 6 months

      Secondary Objectives:

        -  Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months

        -  Insulin glargine dose at 3 and 6 months

        -  Hypoglycemic episodes (all types)
    


Intervention name(s): INSULIN GLARGINE
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)
Intervention MeSH terms: Insulin Glargine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Genomic Signatures to Predict Treatment Response
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      A genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based
      chemotherapy as neoadjuvant treatment. The primary aim of this study is to prospectively
      evaluate the microarray-based, genomic test as a predictor of axillary lymph node response.
      Also, to determine whether the probability of achieving negative axillary nodes, is
      sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to
      support omitting axillary dissection.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Breast cancer patients with advanced HER 2 negative breast cancer
      
Biospecimen description: 
      Breast cancer tissue
Surgical Prevention of Atrial Fibrillation in Patients With Rheumatic Mitral Valve Lesion and Left Atrium Enlargement
Condition: Atrial Fibrillation; Rheumatic Heart Disease
MeSH terms: Rheumatic Heart Disease; Rheumatic Diseases; Atrial Fibrillation; Heart Diseases
Study type: Interventional

Summary: 
      This study evaluates the safety and efficiency of surgical prevention of atrial fibrillation
      in patients with valvular heart disease and left atrium enlargement
    

Detailed description: 
      Preservation or appearance of AF(atrial fibrillation) after mitral valve surgery
      substantially reduce the number of excellent and good results of the operation in the
      long-term period, causing circulatory insufficiency, increased pulmonary hypertension,
      increasing the risk of thromboembolic events and stroke.

      Significant predictors of AF after surgery are the initial size of the left atrium more than
      6.0 cm, stenotic lesions and rheumatic genesis of mitral defect. 80% of patients in this
      group had AF during the first year after operation.
    

Intervention name(s): surgical prevention of atrial fibrillation; cardiomonitor
Intervention type(s): Procedure; Device
Intervention description(s): Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. Pulmonary veins, posterior wall of the left atrium will be isolated by the scheme box-lesion with additional lines to the mitral valve and appendage of left atrium.; in both groups cardiac rhythm will be controlled by a cardiomonitor
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: atrial fibrillation; radiofrequency ablation; prevention of AF; mitral valve; left atrium enlargement; cryoablation