bioihbjkbjnl/mcl2 huggingface dataset:
An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA)
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      This objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics
      of a single dose of nusinersen (ISIS 396443) administered intrathecally to participants with
      Spinal Muscular Atrophy (SMA).
    

Detailed description: 
      This study was conducted and the protocol was registered by Ionis Pharmaceuticals, Inc.

      In August 2016, sponsorship of the trial was transferred to Biogen.
    

Intervention name(s): nusinersen
Intervention type(s): Drug
Intervention description(s): Administered by intrathecal (IT) injection
Other intervention name(s): ISIS 396443; BIIB058; Spinraza; IONIS-SMN Rx; ISIS SMNRx
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Muscular Atrophy; SMA; SMN; SMNRx; ISIS-SMNRx; ISIS-SMN Rx; ISIS 396443; IONIS-SMNRx; IONIS-SMN Rx; Spinraza
Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)
Condition: Guillain Barre Syndrome
MeSH terms: Guillain-Barre Syndrome; Syndrome
Study type: Interventional

Summary: 
      Comparing whether intravenous immune globulin or plasma exchange is superior in treating
      mechanically ventilated children with Guillain Barre syndrome.
    

Detailed description: 
      Children with Guillain Barre syndrome (GBS) admitted to PICU at Mansoura University Children
      Hospital, Mansoura, Egypt with the need for mechanical ventilation were prospectively
      enrolled in the study.

      Cases were diagnosed according to clinical criteria. The decisions to initiate, wean and
      terminate mechanical ventilation were made independently by the attending consultant in
      accordance with the unit guidelines.

      Outcome variables measured were duration of mechanical ventilation, length of PICU stay and
      ability to walk unaided 4 weeks after PICU discharge.
    

Intervention name(s): IVIG; Plasma Exchange
Intervention type(s): Drug; Procedure
Intervention description(s): Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days; Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days
Other intervention name(s): Sandglobin; Plasmapheresis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Guillain Barre syndrome; IVIG; Plasma exchange
The Effect of Human Adipose Tissue-derived MSCs in Romberg's Disease
Condition: Progressive Hemifacial Atrophy; Romberg's Disease
MeSH terms: Facial Hemiatrophy; Atrophy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy and safety of autologous
      transplantation of adipose tissue derived mesenchymal stem cells (MSCs) in patient with
      progressive hemifacial atrophy.
    

Detailed description: 
      Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell
      source for stem cell therapy.

      With the recent demonstration of MSC homing properties, intramuscular aplications of MSCs to
      cell-damaged diseases have increased.

      In a human clinical trial, five patients who had suffered a progressive hemifacial atrophy(
      Romberg's disease) were intramuscular administered autologous hAdMSCs (1×10e7 cells/500ul)
      with autologous microlipoinjection one time.
    

Intervention name(s): Autologous Adipose Tissue derived MSCs Transplantation
Intervention type(s): Procedure
Intervention description(s): Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine
      following multiple dosing in patients with renal impairment and compare to those in healthy
      subjects
    


Intervention name(s): Idalopirdine (Lu AE58054) 60 mg
Intervention type(s): Drug
Intervention description(s): encapsulated film-coated tablets for oral use once daily for 10 days
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney impairment
High-Risk Factors in Patients With Colorectal Polyps a Prospective Case-Control Study
Condition: Colorectal Polyp
MeSH terms: Polyps
Study type: Observational [Patient Registry]

Summary: 
      This prospective case-control study aimed to analyze and summarize the high-risk factors and
      susceptible genes of patients with colorectal polyps. According to these high-risk factors,
      the investigators developed and validated a prediction model for colorectal polyps to
      identify high-risk individuals, in order to provide clinical basis for the etiology research
      and the establishment of effective preventive measures.
    

Detailed description: 
      A large cohort of eligible participants were included in the analysis, and classified into
      derivation and validation cohorts at a ratio of 7:3. Demographic and clinicopathological
      characteristics of participants were utilized to develop a prediction model for colorectal
      polyps. In the derivation cohort, the LASSO regression method was applied to filter variables
      and select the most useful high-risk factors. Multivariate logistic regression analysis was
      used to identify potential predictors and then a prediction model was established. The
      predictive performance of the model was evaluated with respect to its discrimination,
      calibration and clinical usefulness.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A total of 2800 confirmed eligible participants, 18 to 80 years of age, including 2000
        cases with colorectal polyps and 800 controls free of colorectal polyps, are enrolled in
        this study.
Perspections of Stroke Patients and Physiotherapists in Robotic Rehabilitation
Condition: Stroke; Paralysis; Physician's Role
MeSH terms: Stroke; Paralysis
Study type: Observational

Summary: 
      This study was a cross-sectional study. The insights of stroke patients and physiotherapists
      were assessed with the quantitative questionnaires. The results were provided as number,
      percentage, mean, and standard deviation. The results of the insights of the current sapmle
      were given and compared the previous studies. The authors though that the results of the
      study can fill the gaps in robotic rehabilitation and support a better robotic rehabilitation
      experience.
    

Detailed description: 
      Fifty stroke patients and fifty seven physiotherapists included the study. A seventeen-item
      and eight-item questionnaire s were created for stroke patients and physiotherapists,
      respectively. The descriptive data of the stroke patients and physiotherapists were
      presented. The results were compared with the literature and interpreted to guide future
      studies.
    

Intervention name(s): Questionannire
Intervention type(s): Other
Intervention description(s): The questionannaires for both physiotherapists and stroke patients were formed in this study. The perspectives of the participants were recorded.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Fifty stroke patients and fifty seven physiotherapists were participated in the study. All
        participants met the inclusion criteria.
Removable Walker for Neuropathic Ulcers
Condition: Diabetic Foot
MeSH terms: Diabetic Foot
Study type: Interventional
Phase: Phase 3

Summary: 
      1. Objective: To evaluate the efficacy of removable cast walker compared to non-removable
           fiberglass off-bearing cast in the treatment of diabetic plantar foot ulcer

        2. Research design and methods: Forty-five adult diabetic patients with non-ischemic,
           non-infected neuropathic plantar ulcer were randomized to treatment with a non-removable
           fiberglass off-bearing cast (TCC group) or walker cast (Stabil-D group). Treatment
           duration was 90 days. Percent reduction in ulcer surface area and total healing rates
           were evaluated after treatment.
    

Detailed description: 
      Study design:

      Two centers specializing in diabetic foot management (located in Sesto S. Giovanni and Milan,
      Italy) participated to this open, randomized clinical trial. The ethics-committee approved
      the study on January 10th, 2008. Enrollment of consecutive patients began February 2008 and
      ended March 2009. Eligible patients were fully informed of the study aim and procedures and
      written consent was obtained prior to study participation. Patients were then randomly
      assigned to one of the two treatment groups by opening randomization codebreak envelopes
      containing one of the two options. Separate randomization was performed for each center, and
      a copy of all randomization envelopes was kept at the statistical department of the
      Multimedica center. The two arms were composed of patients managed with non-removable
      fiberglass off-bearing cast (TCC group) and patients offloaded with the Stabil-D® (Podartis
      srl, Montebelluna, Treviso, Italy) walker cast (Stabil-D group).
    

Intervention name(s): non-removable fiberglass; Stabil-D®
Intervention type(s): Device; Device
Intervention description(s): Two types of fiberglass bandages (Softcast3M®, 3M Health Care, St. Paul, MN (USA)) were used for construction of the pressure-relief apparatus; Stabil-D Stabil-D® is composed of a specifically designed rigid, boat shaped, and rocker sole
Other intervention name(s): Softcast3M®, 3M Health Care, St. Paul, MN (USA); Podartis srl, Montebelluna, Treviso, Italy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetic foot; neuropathic plantar ulcer; ulcer healing; non-removable total contact cast; removable cast walker
Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin 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: 
      The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given
      three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with
      the addition of insulin lispro given three times daily with meals). The study is also
      comparing two different methods for adjusting the dose of insulin.
    


Intervention name(s): Lispro Mixture Therapy; Glargine Basal-Bolus Therapy
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Protein Supplementation and Endurance Exercise Adaptations
Condition: Exercise
Study type: Interventional

Summary: 
      Participants will perform three endurance training sessions weekly for 12 weeks. All
      participants will be randomly assigned to the protein supplementation group or the placebo
      (iso-caloric carbohydrate) group. During the 12 weeks endurance training program participants
      allocated to the protein group (30 g protein per beverage) will receive a protein drink after
      exercise and prior to sleep at night on training days. On non-training days participants will
      only receive a protein drink before sleep. Participants allocated to the carbohydrate group
      (30 g carbohydrates) will receive a carbohydrate drink instead of a protein drink.
    

Detailed description: 
      In the proposed study, the effects of protein supplementation after training and before sleep
      on VO2max and performance will be assessed during 12 weeks endurance exercise training in
      untrained healthy young men. The ready to drink carbohydrate beverage consists of 30g
      carbohydrate or 30g protein. Previous studies show that the supplementation of 30g protein is
      in the optimal range to stimulate the muscle protein synthetic response following resistance
      type exercise. The protein supplementation group in the present study will be compared with
      an iso-caloric carbohydrate group. In addition, to the pre- and post-intervention biopsies 1
      additional muscle biopsies will be taken (in week 6) during the 12 week intervention period.
      This will create a unique opportunity to establish the timeline of the skeletal muscle
      adaptive response at functional and mechanistic level following prolonged endurance exercise
      training, including potential differences between both groups.
    

Intervention name(s): Protein
Intervention type(s): Dietary Supplement
Intervention description(s): Three endurance training sessions weekly with protein supplementation post-exercise and before sleep.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will perform three endurance training sessions weekly for 12 weeks. All participants will be randomly assigned to the protein supplementation group or the placebo (iso-caloric carbohydrate) group. During the 12 weeks endurance training program participants allocated to the protein group (30 g protein per beverage) will receive a protein drink after exercise and prior to sleep at night on training days. On non-training days participants will only receive a protein drink before sleep. Participants allocated to the carbohydrate group (30 g carbohydrates) will receive a carbohydrate drink instead of a protein drink.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Brain Computer Interface Training After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      In this study, we want to examine the effect of a new treatment approach for patients with
      severe upper limb paresis in the subacute phase after stroke. Brain Computer Interface (BCI)
      driven functional electrical stimulation will be compared to conventional training.
    

Detailed description: 
      A randomized controlled pilot study will be conducted. Forty patients with severe UL paresis
      will be included. Patients with severe hemiparesis after stroke will be allocated to one of
      two treatment groups by a computerized randomization program. Patients in the intervention
      group will receive training with a BCI system paired with functional electrical stimulation
      and visual feedback (RecoveriX, gtec, Austria) as part of their rehabilitation. The targeted
      number of training sessions in the intervention group is 12. Patients in the control group
      will receive conventional upper limb training. All patients will receive other rehabilitation
      according to their needs.

      Patients will be assessed by blinded raters before and after the intervention and 3 months
      post stroke. Main endpoint will be UL motor function assessed by Action Research Arm Test
      (ARAT) at 3 months post stroke. Other outcome measures comprise Fugl Meyer Motor Assessment
      and Functional Independence Measure. The patients and therapists' experience with this type
      of training will be evaluated with questionnaires and interviews.
    

Intervention name(s): Brain Computer Interface training; Control
Intervention type(s): Device; Behavioral
Intervention description(s): Training with RecoveriX system.; Standard physiotherapy and occupational therapy according to clinical routines.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomized to one of two treatment options, intervention or standard rehabilitation
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: BCI; upper limb; severe paresis; subacute stroke; rehabilitation
Changes in Inflammatory Markers During Pulmonary Rehabilitation Based on Exacerbation States in COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      This study will examine the inflammatory response to exercise encompassed as part of a
      standard pulmonary rehabilitation programme in patients with chronic obstructive pulmonary
      disease (COPD). Patients will be split into two groups, frequent exacerbators or infrequent
      exacerbators, dependent upon exacerbation history to compare responses to pulmonary
      rehabilitation amongst phenotypes.
    

Detailed description: 
      Pulmonary rehabilitation has been proven to benefit COPD patients in terms of quality of life
      and functional capabilities. The effects of pulmonary rehabilitation (exercise) on immune
      function are unclear despite clear benefits of exercise on immune function in healthy
      individuals being identified. Moderate-intensity and frequency of exercise has been shown to
      decrease the risk of upper respiratory tract infections in healthy individuals in comparison
      to sedentary individuals. Respiratory infections, also known as exacerbations, in COPD are
      the main cause of hospitalisation and mortality. Therefore, if exercise can modulate immune
      function in COPD, it can be encouraged further in COPD to reduce hospitalisation risk.
      However, it is important to compare the effects of exercise amongst different phenotypes as
      frequent exacerbators are known to have elevated inflammatory markers, and may consequently
      respond to exercise differently to infrequent exacerbators, paving a rationale for a
      different approach to this subset of patients.
    

Intervention name(s): Sample collection
Intervention type(s): Other
Intervention description(s): Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation. No other intervention will be administered. Healthy controls will have resting blood samples taken.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        116 COPD patients, confirmed by diagnosis, will be recruited (58 frequent and 58 infrequent
        exacerbators in accordance with criteria listed above) to the study who have been referred
        to, and are about to enrol, on pulmonary rehabilitation.

        20 healthy smokers and 20 healthy never smokers will be recruited for baseline measurements
        to compare with COPD patients.
      
Biospecimen description: 
      Whole blood samples will be used on the day of collection and analysed before being
      appropriately disposed of on the same day. Blood samples will be centrifuged with separated
      plasma to be frozen at -80c for later analysis of cellular content. Sputum samples will also
      be centrifuged with supernatant extracted and frozen -80c for later analysis.
    
Keywords: COPD; Exercise; Immunity; Inflammation; Biomarkers
Short-term Study of Combination Treatment of Escitalopram and Gaboxadol in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses
      of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of
      treatment in patients with Major Depressive Disorder
    

Detailed description: 
      Subjects participating in this study will be respectively randomised (1:2:2:2) to receive
      either:

        -  placebo or

        -  escitalopram 20 mg/day or

        -  escitalopram 20 mg/day in combination with gaboxadol 5 mg/day or

        -  escitalopram 20 mg/day in combination with gaboxadol 10 mg/day
    

Intervention name(s): Escitalopram placebo; Gaboxadol placebo; Escitalopram 20 mg; Gaboxadol 5 mg; Gaboxadol 10 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Once daily before bedtime for 8 weeks; Once daily before bedtime for 8 weeks; Once daily before bedtime for 8 weeks; Once daily before bedtime for 8 weeks; Once daily before bedtime for 8 weeks
Other intervention name(s): Escitalopram = Cipralex/Lexapro/Seroplex/Sipralexa
Intervention MeSH terms: Gaboxadol; Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Intravenous Tamiflu (Oseltamivir) in Children With Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of
      intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2
      years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10
      doses). For patients whose conditions no longer merit continued iv dosing, therapy may be
      switched to oral Tamiflu to complete their prescribed course of treatment. If medically
      necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days.
      Anticipated time on study treatment is 5 to 10 days.
    


Intervention name(s): oseltamivir [Tamiflu]
Intervention type(s): Drug
Intervention description(s): 5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.
Intervention MeSH terms: Oseltamivir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment