bioihbjkbjnl/mcl2 huggingface dataset:
Dual-task Training in Children With Cerebral Palsy
Condition: Cerebral Palsy; Diplegia; Hemiplegic Cerebral Palsy; Physical Disability; Participation, Patient; Activity, Motor
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      There are studies investigating the dual-task effect in sitting, standing up without sitting
      and walking in children with spastic CP. Some of these studies investigated motor-motor, some
      of them motor-cognitive dual-task states, and children with CP were compared to typically
      developing children. In all these studies, it is clearly seen that children with CP have more
      dual-task complexities than their typically developing peers. Some of these studies draw
      attention to dual-task education in children with CP. However, other than a randomized
      controlled study and a case report in the literature, we did not find any studies
      investigating the effectiveness of dual-task training in children with CP. When the
      literature is examined in detail, there is no study that examines the effect of dual-task
      exercise programs on walking activities and children's participation in daily life in
      children with CP.

      This study has been planned based on this deficiency in the literature. Based on ICF, This
      study has been planned dual-task training for children with CP.
    


Intervention name(s): dual-task training
Intervention type(s): Other
Intervention description(s): dual-task training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cerebral palsy; dual-task training; activity; participation
Additive Effects of QVAR to (Seretide) on Surrogate Markers of Airway Inflammation in Refractory Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to establish whether addition of extra-fine particle steroid
      inhalers achieve additional suppression of small airways inflammation when added to
      'standard' Fluticasone/Salmeterol combination therapy in refractory asthma.
    


Intervention name(s): HFA-BDP; Fluticasone; Seretide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HFA-BDP (Qvar) 100ug 2puff b.i.d; Fluticasone propionate Accuhaler 250ug b.i.d.; Fluticasone/Salmeterol (Seretide) 500/50ug, 1 puff b.i.d
Intervention MeSH terms: Fluticasone; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Tolerability of Erenumab in the Prophylactic Treatment of Persistent Post-Traumatic Headache
Condition: Post-Traumatic Headache; Mild Traumatic Brain Injury; Post-Concussion Syndrome
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome; Post-Traumatic Headache; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      An exploratory open-label study of PPTH patients to study the efficacy and tolerability of
      erenumab in the prophylactic treatment of persistent headache attributed to mild traumatic
      injury to the head. Approximately 100 subjects will be included to erenumab 140 mg. Patients
      who have participated in study with prior provocation (Ethics Committee of the Capital Region
      of Denmark (H-1801147 and H-18050498) and who have consented to be contacted will primarily
      be included. The study will begin February 2019 and is expected to last one year. Patients
      responding to advertisement (see add) will be contacted by phone.
    

Detailed description: 
      The reasons and justification of choosing an open-label design are the following:

        1. To date, there are no evidence for prophylactic drugs treating post-traumatic headache.
           Post-traumatic headache patients are notoriously known to be refractory to prophylactic
           treatment and have usually tried several prophylactic drugs such as amitriptylin, which
           is recommended as a prophylactic drug in migraine and chronic tension-type headache, and
           other drugs developed for the treatment of primary headache disorders. First step is
           therefore to show if there is an effect at all following erenumab treatment in these
           refractory PPTH patients.

        2. The refractory nature of PPTH will lower the bias that could occur through placebo
           effects.

        3. The treatment period is also quite long, and the endpoint is assessed in the last month
           of treatment, which will also minimize a placebo effect.

        4. Furthermore, this relatively small exploratory open label study is needed to show if
           there is an effect of erenumab in post-traumatic headache at all and what this effect
           is, before initiating larger multicenter double-blind studies in this patient group.
    

Intervention name(s): AMG 334
Intervention type(s): Drug
Intervention description(s): 100 subjects with persistent post-traumatic headache will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8)
Other intervention name(s): Erenumab
Intervention MeSH terms: Erenumab
Intervention model: Single Group Assignment
Intervention model description: Exploratory Open-Label Study
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler With Seretide Diskus
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler
      with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
    


Intervention name(s): Seretide Diskus and charcoal; Seretide Diskus; SF Easyhaler and charcoal; SF Easyhaler
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 inhalations as a single dose; 2 inhalations as a single dose; 2 inhalations as a single dose; 2 inhalations as a single dose
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Rebalancing Thoraco Abdominal Heart Disease in Infants (RTAC)
Condition: Infants With Heart Disease; Respiratory Therapy; Techniques
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      It gave a clinical trial which will be included in the 60 infants, aged up to 24 months,
      diagnosed with congenital's population will be divided by simple randomization into three
      groups: 20 infants in the intervention group, 20 infants in the control group, not receive
      the RTA technique and another 20 infants in a placebo group, we just get the support manual
      therapist for 5 minutes. Initially the data will be collected cardio heart rate, respiratory
      rate and oxygen saturation. Then the researcher will apply three specific rating scales,
      based on clinical presentation and behavior of infants. Hypothesis: The RTA improves
      cardiorespiratory parameters and reduces signs of discomfort and pain of infants with
      congenital heart acyanogenic.
    


Intervention name(s): Thoracoabdominal rebalancing
Intervention type(s): Procedure
Intervention description(s): In this group the infants received four handlings thoracoabdominal rebalancing, in order: 1) 5min support thoracoabdominal, in which the therapist leaned one hand on the lower chest and upper abdomen of the newborn, with some of its fingers on the ribs, pulling them gently down and keeping them in that position during inspiration, 2) more than 5 minutes of abdominal support, carried by hand in the lower abdomen of the newborn, applying light pressure during inspiration enough to be beaten by the diaphragm of the newborn and not to increase the use of accessory muscles of inspiration, 3) 5min support ileo-costal, by a slight manual pressure of the physiotherapist on the lateral chest and abdomen of the newborn, maintained throughout inspiration and 4) finally ran up 5min ginga thoracic maneuver slight manual pressure on the lower chest of newborns, directing the costal movement during expiration, now an then the other hemithorax.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Infant; Physical Therapy
Immunogenicity and Safety Study of a Three-Dose BioThrax® Regimen for Post-Exposure Prophylaxis in Healthy Adults
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this Phase 3 clinical trial is to evaluate the immunogenicity and safety of
      BioThrax anthrax vaccine in healthy adults following 3 doses of BioThrax. Results of this
      study will be used to support a post-exposure prophylaxis (PEP) indication for BioThrax.

      This study will be conducted in the United States (U.S.), in 200 healthy male and female
      volunteer subjects ages 18 to 65 years.

      The duration of study participation for each individual subject will be approximately 128
      days (4.25 months), including a screening period of approximately 28 days followed by 100
      days on study.
    

Detailed description: 
      BioThrax® (also called Anthrax Vaccine Adsorbed or AVA) is the only FDA-licensed vaccine for
      the prevention of anthrax infection. This study will evaluate the immunogenicity of the
      vaccine using a post-exposure vaccination schedule. Correlations will be drawn to
      immunogenicity and survival data from animal models to demonstrate that BioThrax® can elicit
      a protective immune response for PEP.
    

Intervention name(s): BioThrax
Intervention type(s): Biological
Intervention description(s): BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.
Other intervention name(s): Anthrax Vaccine Adsorbed (AVA)
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: post-exposure prophylaxis; toxin neutralization assay
Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy
Condition: Depression
MeSH terms: Recurrence; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine the effectiveness of mindfulness-based cognitive therapy (MBCT) in
      preventing depression relapse.
    

Detailed description: 
      Depression is a serious condition that can cause significant social and emotional problems
      and reduce the overall quality of life. Relapses in depressive episodes are common and may
      result in a patient's reluctance to follow a treatment regimen, thus making the episode more
      severe. Safe and effective therapies to prevent depression relapse are needed. This study
      will compare three different approaches to determine which is most effective in preventing
      relapses in depressive episodes.

      This study will comprise 2 parts. In Part 1, all participants will receive antidepressant
      medication for 6 months. Participants whose depression symptoms do not improve will complete
      their study participation at the end of Part 1. Participants who respond to their regimen
      will be enrolled in Part 2. This part will last 18 months. During Part 2, participants will
      be randomly assigned to one of three groups. Participants in Group 1 will continue the drug
      regimen they began in Part 1. Participants in Group 2 will discontinue their antidepressants
      and attend an 8-week relapse prevention program. This MBCT program is designed to help
      participants learn skills that can increase their awareness and change their reaction to
      stressful events. Participants in Group 3 will have their antidepressant medication from
      Phase 1 switched to a placebo without their knowledge. Self-report scales will be used to
      assess the depressive symptoms of participants at the beginning of the study, at the end of
      Phase 1, and at the end of the study, after Phase 2.
    

Intervention name(s): Mindfulness based cognitive therapy (MBCT); Antidepressants; Placebo plus clinical management
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): Following antidepressant discontinuation, participants receive MBCT, an 8-week group program that integrates aspects of cognitive therapy and mindfulness meditation.; Participants continue on dosage of the antidepressant that was used to achieve clinical remission.; Following discontinuation of active antidepressant, participants are placed onto the placebo and clinical management regimen.
Other intervention name(s): MBCT; Antidepressant medication; Placebo and Clinical Management
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Depression Recurrence; Drug Therapy; Cognitive Therapy; Relapse; Antidepressants
CSD210202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems
Condition: Smoking; Smoking Behaviors; Tobacco Use; Tobacco Smoking
Study type: Interventional

Summary: 
      This is an open-label, randomized, 5-way crossover study designed to evaluate plasma nicotine
      pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery
      System (ENDS) investigational products (IPs) in a confinement setting by generally healthy
      combustible cigarette (CC) smokers.
    

Detailed description: 
      Potential subjects will complete a pre-screening interview and a Screening Visit to assess
      their eligibility within 45 days prior to enrollment, randomization and confinement.

      Following the Screening Visit, eligible subjects will be scheduled for a check-in and
      randomization visit. At the check-in and randomization visit, subjects' continued eligibility
      will be confirmed prior to being randomized to a product use sequence and beginning their 6
      nights and 7 days of confinement.

      Starting on study Day 1, subject will start a Pre-study ENDS IP Acclimation Period through
      Day 2. Subjects will be asked to acclimate to each of the ENDS IP at least once, while having
      access to their usual brand (UB) cigarettes for ad libitum use. Starting on Day 3, subjects
      will participate in five separate Test Sessions for nicotine PK assessment, one for each ENDS
      IP. For approximately a half day prior to each respective Test Session (starting on Day 2),
      subjects will use their assigned ENDS IP for the following day's Test Session at least twice.
    

Intervention name(s): Product A; Product B; Product C; Product D; Product E
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): P0213420, a 1.8% nicotine ENDS product; P0213520, a 1.8% nicotine ENDS product; P0211220, a 1.8% nicotine ENDS product; P0211820, a 1.8% nicotine ENDS product; P0213417, a 2.4% nicotine ENDS product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Double-Blind Naltrexone in Kleptomania
Condition: Kleptomania
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in
      kleptomania.
    

Detailed description: 
      The proposed study will consist of 8 weeks of treatment with either naltrexone or placebo in
      20 subjects with kleptomania. The hypothesis to be tested is that naltrexone will be
      effective in reducing the urges to steal in patients with kleptomania. The proposed study
      will provide needed data on the treatment of a disabling disorder that currently lacks a
      clearly effective treatment.
    

Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): daily; daily
Other intervention name(s): Revia
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Compulsive Shoplifting; Kleptomania; Compulsive Stealing
Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder
Condition: Schizophrenia; Bipolar I Disorder
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate
      (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.
    


Intervention name(s): quetiapine fumarate
Intervention type(s): Drug
Intervention description(s): Oral dosing, flexible dosing
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Bipolar I Disorder
Antioxidants and Pulmonary Rehabilitation in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease; COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      On the basis of published data and investigators results indicating that systemic redox in
      balance may contribute to the peripheral muscle dysfunction in COPD patients, the
      investigators propose a study testing the effects of antioxidants and exercise training in
      COPD patients. The results may have major implication in the improvement of pulmonary
      rehabilitation benefits
    

Detailed description: 
      COPD will constitute the third cause of mortality in 2012. This chronic respiratory disease
      is characterized by peripheral dysfunction of skeletal muscle which is associated with major
      clinical outcomes (prognostics, symptoms, and health related quality of life). Muscle and
      systemic oxidative stress has been incriminated in this peripheral muscle
      dysfunction.Exercise training constitute the main validated therapeutic intervention leading
      to significant muscle function and clinical improvement.Our preliminary results have shown
      that COPD patients experiment dietary and enzymatic antioxidants defects.Yet, generic
      antioxidant supplementation has not shown significant muscle function improvement.Therefore,
      we aim to test the effects of an antioxidant supplementation targeted on the antioxidant
      defects associated with exercise training on the peripheral muscle function, exercise
      tolerance and health quality of life in COPD patients.At the cellular level, this muscle
      dysfunction is related with a fiber atrophy and a metabolic switch (reduce proportion of
      oxidative fiber).This study will compare the effects of an antioxidant supplementation on the
      peripheral muscle function and skeletal muscle cellular properties in association with
      exercise training during a pulmonary rehabilitation course.Volunteers will be randomised in 2
      groups: - 1 group treated with the antioxidant supplementation ( 28 days)- 1 group treated
      with the placeboIntervention will be allocated by chance and a double blind manner.
      Antioxidant supplementation will associate vitamins and trace elements that won't exceed the
      maximal nutritional dose recommended.
    

Intervention name(s): Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program
Intervention type(s): Dietary Supplement
Intervention description(s): Vit E, Vit C, Selenomethionine, Zinc gluconate
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: COPD; exercise training; pulmonary rehabilitation; antioxidant; muscle
A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
Condition: Ductal Carcinoma in Situ
MeSH terms: Carcinoma; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Study type: Interventional

Summary: 
      The investigators hypothesize that black cohosh, as a potentially therapeutic agent, will
      reduce the overall size and aggressiveness of ductal carcinoma in situ (DCIS) when given in a
      pre-operative setting.
    

Detailed description: 
      The overarching hypothesis of our research is that black cohosh has potential to be a
      well-tolerated, effective agent for the treatment of early breast cancer. This pilot study
      represents a first step in exploring this hypothesis by demonstrating preliminary evidence of
      specific anti-tumor effect of black cohosh on areas of ductal carcinoma in situ (DCIS) in the
      breast.
    

Intervention name(s): Black cohosh
Intervention type(s): Dietary Supplement
Intervention description(s): Remifemin 20 mg tablet orally twice per day x 4 weeks
Other intervention name(s): Remifemin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Black Cohosh; Ductal Carcinoma in situ; Breast Cancer
Histopathologic Evaluation of High Grade Brain Tumors by High Order Diffusion Tensor Imaging
Condition: High Grade Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Interventional

Summary: 
      This study will examine the use of a variation of standard magnetic resonance imaging (MRI)
      called diffusion tensor MRI (DT-MRI), in order to evaluate the peripheral white matter
      infiltration of high grade brain tumors. Organized architecture is destroyed once brain tumor
      cells are infiltrating surrounding tissue. The infiltrated tissue is then isotropic (or less
      anisotropic). DT-MRI can assess anisotropy after datasets post treatment. Primary outcome is
      to find if a correlation exists between GA (generalized anisotropy) and the infiltration
      percentage of stereotactic peritumoral biopsies.
    

Detailed description: 
      Patients with high grade brain tumor undergo a usual brain tumor MRI protocol as well as a 20
      or 60 directions DT-MRI sequence upon patient collaboration. Images are acquired using a 3
      Tesla MRI scanner (GE MR750 Discovery).

      The usual brain tumor MRI protocol contains the following sequences: 3DT1, Axial T2, Flair,
      T2 EG, diffusion (b0-b1000), 3DT1CE.

      They will then undergo stereotactic tumor biopsies with Leksell frame mounted.

      Biopsy targets will be surgically planned. The coordinates of this first biopsy will be
      recorded for later coregistration with DT-MRI datasets.

      Histopathologic analysis of the biopsies will be done using usual procedure. various
      immunologic markers such as MAP2, Ki67 will be used on the first biopsy sample in order to
      estimate the percentage of infiltration (ratio of tumor cells number over total cells
      number).

      Analysis of DT-MRI datasets will be done using home-made software for high order tensor
      resolution and GA estimation at the exact coordinates of the biopsy sites.

      Finally a statistical analysis (Pearson or Spearman) will be done to correlate GA and the
      infiltration percentage.
    

Intervention name(s): peritumoral glial cell infiltration
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: High grade brain tumor; Glioma; Glioblastoma Multiform; Brain Cancer; Diffusion-Weighted Magnetic Resonance Imaging; High order diffusion tensor; Imaging guided biopsy; Histopathologic evaluation; Infiltration percentage