bioihbjkbjnl/mcl2 huggingface dataset:
Exercise and Disease Progression in Amyotrophic Lateral Sclerosis Patients
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study evaluated the influence of a tailored aerobic exercise protocol on the functional
      outcome in ALS patients. In addition, the investigators compare some CPET variables collected
      during exercise testing in both groups.
    

Detailed description: 
      This work aimed to evaluate the effects of a moderate aerobic exercise with controlled
      intensity determined by Cardiopulmonary Exercise Testing (CPET) and its role on the
      functional status in ALS patients versus standard care. Additionally, the investigators
      explored the performance of CPET variables - oxygen uptake (VO2) expressed in L/min, in
      percentage of predicted or in metabolic equivalents (METs) at peak effort, at anaerobic
      threshold (AT), the respiratory compensation point (RCP) when achieved, Dioxide Carbon output
      in L/min (VCO2) and the minute ventilation in L/min (VE) throughout the study.

      Assessments:(diagnostic visit - T0), at study entry (T1) and 6 months after (T2) using:

      Functional status by Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised
      (ALSFRS-R), Respiratory function tests (RFT): Forced Vital Capacity predicted (%FVC) and
      Oxygen saturation provided by pulse oximetry.

      CPET was performed in both groups at study entry and 6 months later (T1 and T2), using a
      treadmill (WOODWAY®) coupled with a gas exchange analyzer (METALYZER® 3B) with
      ergo-spirometry system using a breath-by-breath technology developed by CORTEX® systems.

      Intervention:

      G1(Interventional group) performed moderate exercise protocol two times/week in a treadmill
      in the lower range of the training zone determined by CPET + standard care (range of motion
      exercise, gait and balance training under continuous pulse oximetry observation).

      G2 (control group) performed a standard care exercise program at home or at other
      rehabilitation units without pulse oximetry observation.
    

Intervention name(s): standard care; moderate exercise
Intervention type(s): Other; Other
Intervention description(s): A standard care program based on American Academy of Neurology guidelines (Range Of Motion (ROM) exercises, gait and balance training )at home or another rehabilitation units without intensity control.; A moderate exercise protocol two times per week in a treadmill in the lower range of the training zone determined by Cardiopulmonary Exercise Testing, monitored by continuous pulse oximetry evaluation.
Other intervention name(s): Range of Motion; Gait Training; Balance training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Amyotrophic Lateral Sclerosis; aerobic exercise; functional outcome; non-invasive ventilation; oxygen uptake
Major Depression and Inflammatory Risk Markers for Coronary Heart Disease
Condition: Depression
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Depression; Depressive Disorder
Study type: Observational

Summary: 
      The overall purpose of this research is to examine whether depression influences immune
      system function. Studies indicate that individuals who are depressed experience coronary
      heart disease at a higher rate than expected. This study's goal is to begin identifying
      mechanisms that might be responsible for this process. This research also examines whether
      behavioral processes (e.g. smoking) or hormonal processes (e.g. adrenaline release) are
      responsible for immune system differences between depressed and nondepressed people
    

Detailed description: 
      To qualify for participation, subjects are to be between the ages of 18-55, medically healthy
      and free of all medication three months prior to enrollment. Half of them will be clinically
      depressed; the remaining one half will be healthy controls without a history of psychiatric
      illness. All subjects who qualify for the study will attend two laboratory sessions. During
      the first visit, participants will undergo a structured psychological interview, complete
      questionnaires about their mood, personality, and behavior, and have blood drawn to assess
      their immune system function. During the second visit, participants will complete additional
      questionnaires about their mood, personality, and behavior. The subjects will also
      participate in a mock job interview to look at their body's response to stress. Before and
      after the interview, the subjects will have blood drawn and be asked to collect saliva
      samples to assess their immune system function. In addition to the two laboratory visits,
      participants will be asked to collect additional information while going about their normal
      activities. In order to accomplish this, they will be given a small hand held portable
      computer. Four times each day for four days, the computer will signal them to collect a
      saliva sample. This will be used later to measure hormone levels. This study will explore
      changes in the immune system and metabolic system that might predispose depressed individuals
      to develop heart disease
    

Observational model: Defined Population
Time perspective: Other
Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in
      Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of
      Crohn's disease and quality of life.
    


Intervention name(s): D9421-C, 9mg; D9421-C, 15mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): D9421-C 9 mg was given once daily for 8 weeks.; D9421-C 15 mg was given once daily for 8 weeks.; D9421-C matching placebo was given once daily for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: gastrointestinal; GI; Crohn's disease; Japan; Japanese
Burden of Illness in Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The overall goal of this retrospective registry study is to investigate the burden-of.illness
      in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect
      information on the diseases epidemiology including incidence and prevalence of AF and stroke
      as well as a stroke risk stratification of the Danish AF-population, the clinical and
      economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients,
      healthcare providers / healthcare system and society as well as describing treatment patterns
      with anticoagulant agents and their consequences in terms of stroke, bleeds, death and
      according cost in a real-life setting.
    


Intervention name(s): Standard of care in AF in Denmark
Intervention type(s): Drug
Intervention description(s): As used in clinical practice, analysed as per drug class, not separate drugs.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The base population of AF patients will be identified in the National Patient Registry. For
        a given period of time (2000-2013, both years inclusive) all patients with a hospital
        contact (admission, outpatient visit or ER visit) and for whom AF was the primary or
        secondary diagnosis code will be identified.
      
Keywords: non-valvular Atrial Fibrillation
Vein External Support Trial
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and
      effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in
      patients with coronary heart disease.
    


Intervention name(s): Fluent (VGS Fluent external support device)
Intervention type(s): Device
Intervention description(s): Fluent external support device applied to saphenous vein graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Biomechanical Effects of Wearing a Sacroiliac Belt in Women
Condition: Pelvic Girdle Pain
MeSH terms: Pelvic Girdle Pain
Study type: Interventional

Summary: 
      Women with pelvic girdle pain PGP) often get relief from using a sacroiliac belt. The study
      will explore if there are differences and in the changes of lower body movement in stability
      with the belt on and with the belt off. Women with PGP will be matched with women without to
      explore if there is a difference between these two groups. This will be looked at in standing
      and in walking.
    

Detailed description: 
      SacroIliac (SI) joint dysfunction (also called pelvic girdle pain) has been associated with
      impaired load transfer across the lumbopelvic region. This can result in lower back pain as
      well as poor biomechanical adaptation during walking. Sacroiliac (SI) belts have typically
      been prescribed in order to mitigate pain and improve load transfer in individuals with SI
      joint dysfunction. It has been speculated that SI belts have the ability to instantaneously
      increase joint stability, and as a result improve load transfer and muscle activation and
      recruitment. However, this speculation is primarily based on anecdotal evidence; there is
      little biomechanical research supporting the effects of wearing an SI belt. In order to gain
      an improved understanding of the biomechanical effects of wearing an SI belt, the
      investigators propose to conduct a study with the following key objectives:

        1. Determine if there are differences with respect to neuromuscular, kinematic, or pressure
           patterns during walking and/or standing between healthy stable individuals and
           individuals with SI joint dysfunction

        2. Determine if wearing an SI belt affects neuromuscular, kinematic, or pressure patterns
           during walking and/or standing in women with sacroiliac instability

      Variables measured will include:

        1. Kinematics will be collected to quantify posture and joint angles

        2. Kinetics will be collected to quantify ground reaction forces

        3. Plantar pressure will be collected to quantify force distribution and center or pressure

        4. Joint moments (Lumbar-pelvic and Hip) will be added as variables. The investigators will
           use inverse dynamics to calculate various joint moments during walking.
    

Intervention name(s): sacroiliac belt
Intervention type(s): Device
Intervention description(s): standing and walking with the belt on and with the belt off
Other intervention name(s): pelvic belt
Intervention model: Single Group Assignment
Intervention model description: case control
Masking: None (Open Label)
Primary purpose: Screening
Keywords: sacroiliac belt; kinematics; stability; pelvic girdle pain; sacroiliac instability
Depo-Provera: Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non-Hormonal Contraception
Condition: Contraception; Bone Density
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate and compare Bone Mineral Density (BMD) in adolescent Depo-Provera Contraceptive
      Injection (DP150CI) users during depo medroxyprogesterone acetate (DMPA) therapy and
      following discontinuation of DMPA. Another group electing non-hormonal contraception or
      abstinence will be recruited as a reference population, across all study sites. The primary
      variable is BMD, measured by Dual Energy X-ray Absorptiometry (DXA). Secondary variables are:
      Total Body Composition& Total Body Calcium (TBC), measured by Dual Energy X-ray
      Absorptiometry (DXA), and surrogate biologic BMD markers. Safety will be evaluated by adverse
      event reporting, laboratory evaluations, pregnancies, weight and vital signs.
    


Intervention name(s): Depo-Provera Contraceptive Injection - DP150CI
Intervention type(s): Drug
Intervention MeSH terms: Medroxyprogesterone Acetate; Contraceptive Agents; Medroxyprogesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
REP1 Gene Replacement Therapy for Choroideremia
Condition: Choroideremia
MeSH terms: Choroideremia
Study type: Interventional
Phase: Phase 2

Summary: 
      The assessment of the efficacy (with respect to preservation of visual function and retinal
      structure) and safety of a single subretinal injection of AAV2.REP1 in participants with a
      confirmed diagnosis of choroideremia, as evaluated by various functional and anatomical
      outcomes measured over a number of time points up to 24 months post-treatment.
    


Intervention name(s): AAV-mediated REP1 gene replacement
Intervention type(s): Genetic
Intervention description(s): AAV vector carrying human REP1 gene is delivered into the treated eye by subretinal injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The decision about which eye to treat will be made on clinical grounds and will generally be the worse eye affected in cases where BCVA differs between the two eyes by 2 lines or more of ETDRS letters. The eye to be treated will be randomised in cases where the degeneration is relatively symmetrical between the two eyes, defined as:
a difference in BCVA of no more than 1 line of ETDRS letters, and
no more than 25% difference in the area of surviving RPE as measured by fundus autofluorescence.
Prospective participants having non-symmetrical retinal degeneration will be allocated to the non-randomised arm. The treated eye will generally be the worse eye. Prospective participants having relatively symmetrical retinal degeneration will be allocated to the randomised arm.
Masking: None (Open Label)
Primary purpose: Treatment
Estriol and Trimegestone Dose-response Trial With Single Dose Application of Vaginal Rings
Condition: Pregnancy
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is performed as proof of pharmacological action investigation by
      demonstration of ovulation inhibition (dose-response study) under treatment with three Test
      vaginal rings releasing varying doses of estriol (E3) and trimegestone (TMG).

      Blood samples for determination of estradiol (E2) and progesterone (PG) levels will serve as
      pharmacodynamic surrogate parameters for characterization of the treatment effect on the
      endogenous hormones.

      Blood samples for determination of E3 and TMG in plasma will be collected in order to
      characterize pharmacokinetic parameters.

      Additionally, local tolerability characterized by gynecological inspection of the vaginal
      mucosa prior to and after insertion of the Investigational Medicinal Product (IMPs) is
      planned to be assessed
    

Detailed description: 
      The IMPs, releasing either 0.400 mg E3 and 0.06 mg TMG, or 0.300 mg E3 and 0.12 mg TMG, or
      0.200 mg E3 and 0.18 mg TMG per 24 h, will be applied intravaginally and remain in the vagina
      for the subsequent 21 days (single dose, 1 treatment cycle). A total of 36 female subjects,
      12 per treatment group, are intended to be randomized.

      Blood samples for determination of E2 and PG levels will be collected during treatment and
      until 20 days after removal of the ring. Blood samples for determination of E3 and TMG in
      plasma will be collected over the treatment period and until 48 h after removal of the ring.

      Bleeding intensity will also be documented during treatment and until 20 days after removal
      of the vaginal ring in a diary to characterize the effects of the different treatments.
    

Intervention name(s): Estriol 0.400 mg/day and Trimegestone 0.06 mg/day; Estriol 0.300 mg/day and Trimegestone 0.12 mg/day; Estriol 0.200 mg/day and Trimegestone 0.18 mg/day
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vaginal ring with a nominal delivery rate of 0.400 mg/d estriol (E3) and 0.06 mg/d trimegestone (TMG), vaginal application; Vaginal ring with a nominal delivery rate of 0.300 mg/d estriol (E3) and 0.12 mg/d trimegestone (TMG), vaginal application; Vaginal ring with a nominal delivery rate of 0.200 mg/d estriol (E3) and 0.18 mg/d trimegestone (TMG), vaginal application
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single centre, open-label, randomized (assignment to treatment group), parallel-group, three-arm single-dose clinical trial with application performed over 1 treatment cycle of 21 days.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Estriol; Trimegestone; Vaginal Ring
A First-time-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of GSK189075A in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double blind, randomised, placebo controlled, single dose escalation,
      first-time-in-human, 5-way crossover study to assess the safety, tolerability,
      pharmacokinetic and pharmacodynamic parameters of ascending doses of GSK189075A in healthy
      subjects (Part A). Single doses will be given to 10 healthy subjects. The planned doses are
      20mg, 50mg, 150mg, 500mg, and 1000mg. Each subject will receive 4 of the 5 active doses and a
      placebo separated by a washout of 5-10 days. A second cohort of 6 subjects with type 2
      diabetes mellitus will receive 2 active doses and a placebo along with oral glucose in a
      three-way, randomised, placebo controlled, crossover design to assess glucose lowering
      following GSK189075A administration (Part B). Blood samples will be taken throughout the
      study day for pharmacokinetic analysis of prodrug and metabolites. Safety will be assessed by
      measurement of blood glucose, blood pressure, heart rate, ECGs, laboratory safety screens,
      and collection of adverse events.
    


Intervention name(s): GSK189075A; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 20mg, 50mg, 150mg, 500mg, 1000mg or Placebo; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: KGT-1142; safety; pharmacokinetics; single-dose escalation; tolerability
A Multisensory Music Intervention for Children With Reading Disorders (RitMoZ)
Condition: Reading Disorder
MeSH terms: Dyslexia
Study type: Interventional

Summary: 
      With this study, we wish to test how effective/ beneficial music activities can be for
      children with dyslexia.
    

Detailed description: 
      Studies have shown that music in the form of training (i.e., intervention) is able to
      facilitate linguistic processes (e.g., phonological encoding/decoding, categorical
      perception) and cognitive functions (e.g., working memory) in children that have dyslexia or
      reading difficulties. In addition to this, music trainings with a focus on entrainment can
      improve phonological as well as reading skills.

      In line with the above, we have designed and developed a music training programme. This
      programme, which is called RitMoZ Training (i.e., from Ritmus és Mozgás és Zene: meaning
      Rhythm and Movement and Music in Hungarian language), is designed for (Hungarian) children
      who have dyslexia or reading difficulties.

      In order to assess the efficacy of the music training, we are going to conduct a randomized
      controlled trial which consists of a pre-training phase, a training phase and a post-training
      phase.
    

Intervention name(s): Music Training (RitMoZ Training); Spelling Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This training is inspired by intervention concepts followed in SUVAG Polyclinic in Zagreb, Croatia and Kodaly pedagogy in Hungary. RitMoZ Training programme consists of 6 main activities: matching activity, nursery rhymes, rhythmic stimulations, music shapes, music writing and music reading. The training focuses on the perceptual overlap between language and music, embodiment and entrainment. The aim of the training is to improve characteristic features of reading disorders such as phonological awareness, perception of rhythm, phonological working memory and perception of speech sounds.; This training consists of activities which focus on practicing spelling words in a computer task; the aim is to train orthographic processing which is suggested to improve phonological awareness and phonological working memory.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: reading disorders; music intervention; rhythmic stimulations; phonological processing; Event-Related Brain Potentials