bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
Condition: Acellular Pertussis; Tetanus; Diphtheria; Haemophilus Influenzae Type b
MeSH terms: Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this booster study is to evaluate the immune persistence in healthy Chinese
      subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib)
      vaccine. The study will also evaluate the safety and immune response of these subjects to a
      booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT01086423).
    


Intervention name(s): Infanrix+Hib™; Poliorix™
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular, one dose; Intramuscular, one dose
Other intervention name(s): DTPa /Hib; IPV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: combination vaccine; booster vaccination
The Impact of Standard Medical Care (Dopamine) and Practice on Postural Motor Learning in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The study determines whether standard medical care (dopamine) affects learning and retention
      of a postural stepping task in people with Parkinson's disease (PD) and whether training on a
      postural stepping task generalises to performance on an untrained postural task. Half the
      participants will train on the stepping task after they have taken their first dose of
      dopamine for the day (i.e. "on" medication state) while the other half will train on the same
      stepping task before taking their first daily dose of dopamine (i.e. "off" medication state).
    

Detailed description: 
      Motor learning is critical for acquiring new skills and adapting behaviour, therefore the
      success of rehabilitation depends on successful motor learning through practice. Motor
      learning involves the basal ganglia, including both the associative and sensorimotor
      striatum. Although people with PD are capable of motor learning, they are less efficient and
      do not achieve the same extent of skill acquisition and retention as people without
      neurological deficit.

      Reductions in endogenous dopamine and reduced dopamine binding associated with loss of
      dopaminergic receptors due to disease progression may impair motor learning in people with
      PD. Conflicting evidence suggests that impaired motor learning in PD is due on the one hand
      to the absence of dopamine but on the other hand to "overdosing" of the basal ganglia with
      dopamine replacement therapy which suppresses activation of the associative striatum during
      the early acquisition stages of motor learning.

      Understanding which factors improve or degrade motor learning of tasks will allow
      rehabilitation parameters to be adjusted around standard medical care in order to optimize
      learning and improve the efficacy of exercise interventions for people with PD. In
      particular, successful learning of postural tasks that challenge stability may in turn reduce
      falls.
    

Intervention name(s): Stepping training
Intervention type(s): Behavioral
Intervention description(s): Participants will step rapidly to one of four cued targets. Each trial will consist of 24 steps. Participants will perform 6 blocks of 6 trials per day for 3 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Learning; Practice
Effects of Pre-, Pro- & Anti-biotics on Gut Microbiota
Condition: Human Gut Microbiota
Study type: Interventional

Summary: 
      The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes
      Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut
      microbiota of healthy volunteers. It is expected that treatment will result in the rapid and
      reproducible alterations in fecal microbiota that will spontaneously reverse in the weeks
      after treatment is discontinued.
    


Intervention name(s): Trametes versicolor extract; Saccharomyces boulardii; Amoxicillin
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug
Intervention description(s): 1,200 mg, 3 times daily on an empty stomach for 14 days; 250 mg, 3 times daily on an empty stomach for 14 days; 250 mg 3 times daily at least 1 hour before meals for 7 days
Other intervention name(s): turkey tail
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: healthy volunteers; gut microbiota; gut microbiome; prebiotic; probiotic; antibiotic; antibiotic-associated diarrhea; intestinal bacterial overgrowth
Alpha-Cell Sensitivity to GLP-1 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Glucagon-like peptide 1 is known to improve sensitivity of the pancreatic beta-cell. Further
      it inhibit secretion from the pancreatic alpha-cell by mechanisms not fully understand. With
      this study we wish to elucidate the potential of GLP-1 to increase the sensitivity of the
      alpha-cell.

      Type 2 diabetic patients and control subjects receive infusions of GLP-1 in increasing doses
      or saline, alpha- and beta-cell responses are measured in blood-samples. During the study
      plasma-glucose levels are clamped at fasting levels.

      With this study we hope to elucidate the pathophysiology behind defect glucose tolerance in
      type 2 diabetes mellitus and further more the potential of GLP-1 in treatment of type 2
      diabetes mellitus.
    

Detailed description: 
      Background: Glucagon-like peptide-1 (GLP-1) possesses insulinotropic and glucagonostatic
      properties, and, therefore, GLP-based antidiabetic therapies have been developed. Even though
      the insulinotropic potency of GLP-1 has been shown to be reduced in patients with type 2
      diabetes mellitus (T2DM), a small dose of GLP-1 is capable of normalizing the beta-cell
      responsiveness to glucose in these patients. The glucagonostatic potency of GLP-1 in patients
      with T2DM is not known, and, furthermore, the capability of GLP-1 to reestablish normal
      glucagon secretion in these patients remains to be elucidated.

      Objective: To investigate the alpha-cell sensitivity to GLP-1 in patients with T2DM and to
      establish if GLP-1 is able to reestablish normal glucagon secretion in such patients.

      Method: Ten patients with T2DM and ten healthy control subjects are clamped at their fasting
      blood glucose levels during GLP-1 infusions at increasing doses (0.25, 0.5, 1.0 and 2.0
      pmol/kg/min) and placebo, respectively. Furthermore, the patients will be hospitalized
      overnight while receiving intravenous insulin and thereafter examined under normoglycaemic
      conditions. Blood are being drawn for analysis of plasma insulin, C-peptide, GLP-1 and
      glucagon.

      Expected results and conclusions: We expect that GLP-1 will inhibit glucagon secretion in a
      dose dependent manner, leading too an increase in glucose turn-over. The results will
      potentially elucidate the interaction between GLP-1 and glucagon secretion and thereby
      broaden our knowledge on the pathophysiology of T2DM. Furthermore, the present study will
      determine the therapeutic impact of GLP-1 on the alpha-cell deficiency characterizing
      patients with T2DM.
    

Observational model: Case-Control
Time perspective: Prospective
Study population: 
        Patients with type 2 diabetes mellitus and matched control subjects.
      
Biospecimen description: 
      Blood for further analyzes and buffy coat
    
Keywords: glucoseintolerance
To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken Together
Condition: Pharmacokinetics of Mirabegron; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to evaluate if blood levels of desipramine change whilst being dosed at the
      same time with daily mirabegron.
    

Detailed description: 
      This is an open-label, one-sequence crossover design study to evaluate the drug-drug
      interaction between mirabegron and desipramine. The effect of mirabegron on the plasma
      concentration of desipramine will be evaluated after 13 day repeated administration. The
      recovery of CYP2D6 activity is also being explored by comparing the pharmacokinetic profiles
      of desipramine after a 2 week wash-out period.
    

Intervention name(s): mirabegron; desipramine
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): YM178; pertofrane; norpramin
Intervention MeSH terms: Desipramine; Mirabegron
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetics; Mirabegron; Phase 1
A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 765080
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability, and
      pharmacokinetics of BI 765080 in healthy male subjects following intravenous administration
      of single rising doses.
    


Intervention name(s): BI 765080; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 765080; Placebo; 0.9% saline for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns
Condition: Deconditioning Among Survivors of Severe Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      Burn injuries can affect how well you are able to perform daily activities. The reason this
      study is being done is to find out if aerobic exercise helps burn patients recover function,
      strength and stamina.

      Participants will come to Johns Hopkins Bayview Medical Center, Burn Rehabilitation Gym for
      treadmill exercise sessions 3 days per week for 12 weeks. Participants will be tested for
      strength and stamina before the start of the 12 week program, at the end of the 12 week
      program, as well as 6 months, 1 year and 2 years after the end of the 12 week program.

      Patients who recently suffered a burn injury and who were discharged from the hospital in the
      past six months may be eligible to participate.
    


Intervention name(s): Augmented Exercise Program
Intervention type(s): Behavioral
Intervention description(s): 12 week (3 x per week) exercise prescription
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: burn injuries; exercise
An Intervention Program to Reduce to the Risk of Persistent Symptoms After Concussion
Condition: Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates how well a new therapy program prevents persistent symptoms (e.g.,
      headaches, fatigue, irritability, etc.) after concussion. The program involves examining
      beliefs about concussion and learning healthy coping strategies, and is completed with the
      first three months post-injury.
    

Detailed description: 
      Although the majority of patients with mild traumatic brain injury (MTBI) experience complete
      recovery within three months, a sizeable group continues to report frequent and severe
      symptoms such as headaches, fatigue, difficulty concentrating, forgetfulness, and
      irritability, in what is labeled persistent post-concussion syndrome (PCS). Persistent PCS is
      associated with vocational, recreational, and social disability. Early education and
      reassurance (treatment as usual) is effective in general, but appears insufficient for this
      subgroup.

      Recent research has identified risk factors for persistent PCS, including inaccurate illness
      beliefs, maladaptive coping behaviour, and emotional distress. The present study will
      evaluate the additive efficacy of a cognitive-behavioural therapy protocol designed to modify
      these risk factors, over and above treatment as usual.

      Participants with MTBI will be recruited within six weeks of injury. Those identified as
      being at-risk for persistent PCS based on evidence-based criteria will receive treatment as
      usual and then be randomly assigned to receive either no further intervention or
      cognitive-behavioural therapy. We hypothesize that the group receiving cognitive-behavioural
      therapy will have fewer PCS symptoms and be less disabled at follow-up. We also hypothesize
      that compensation-seeking status will mitigate this improvement and that illness beliefs,
      coping behaviour, and emotional distress will mediate this improvement. A blinded rater will
      conduct the baseline and outcome assessments.
    

Intervention name(s): Treatment as usual; Cognitive-behavioural therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Single session with early intervention coordinator for assessment, education about mild traumatic brain injury, and recommendations for symptom management.; 6-session manualized cognitive-behavioural therapy protocol designed to prevent persistent post-concussion syndrome
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Mild traumatic brain injury; Concussion; Post-Concussion Syndrome; Cognitive-Behavioural Therapy
Comprehensive Elementary School Risk Prevention
Condition: Risk Behavior
Study type: Interventional

Summary: 
      This project will evaluate the benefit of an enhanced social development program in grades
      3-6 to decrease the onset of risky behaviors in pre-adolescents.
    

Detailed description: 
      Educational programs to promote the adoption of healthy behaviors and to decrease the onset
      of risky behaviors in pre-adolescents are far more likely to be successful than attempts to
      alter established patterns of high-risk behaviors. The project involves an evaluation of a
      comprehensive 4-year elementary school prevention initiative starting in 3rd grade. The
      prevention initiative, grounded in social cognitive, influence, and development theories is
      embedded within a pre-existing comprehensive elementary school social development program and
      will employ an evidence-based social skills curriculum (PATHS) in selected schools. The aim
      of the program is to teach children to use problem-solving and communication skills to
      negotiate and prevent high-risk behaviors.

      Students attending schools that will receive the enhanced social development program will be
      compared to students attending schools that will receive the current, standard social
      development curriculum. The study hypothesizes that students who participate in the 4-year
      enhanced social development program will self-report fewer risk behaviors when surveyed by
      the school system in grades 6-8.
    

Intervention name(s): Social Development Instruction
Intervention type(s): Behavioral
Intervention description(s): Weekly instruction during regular classroom time by classroom teacher using PATHS (Greenberg & Kusche) curriculum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: social development; risk behaviors; social emotional education; classroom instruction
Addition of Pyridoxine to Prednisolone in Infantile Spasms
Condition: Infantile Spasms
MeSH terms: Spasm; Spasms, Infantile
Study type: Interventional
Phase: Phase 3

Summary: 
      Infantile spasms constitute a unique age specific epilepsy syndrome of infancy, characterized
      by epileptic spasms often accompanied by neurodevelopmental regression and an EEG finding of
      hypsarrhythmia. When all 3 components are present, the eponym "West syndrome" is commonly
      used. West syndrome is a catastrophic epileptic encephalopathy. It does not respond well to
      standard anti-epileptic drugs. Hormonal therapy is the mainstay in the treatment of infantile
      spasms. This includes adreno-cortico trophic hormone (ACTH) and oral steroids. Variable dose
      of prednisolone used in the treatment. Oral prednisolone used in usual dose (2mg/kg) has been
      shown to be less effective as compared to ACTH. High dose prednisolone (4mg/kg) has been used
      in the treatment of infantile spasms, which has been shown to be as effective as ACTH.
      Pyridoxine has been used as first line treatment in Japan, however there is paucity of data
      on the efficacy of combination of pyridoxine with hormonal therapy. There are no studies
      comparing add on pyridoxine with high prednisolone versus high dose prednisolone alone in the
      treatment of infantile spasms. Therefore the study has been planned to see whether the
      addition of pyridoxine with high dose prednisolone in the treatment of infantile spasms
      improves the efficacy in terms of spasm cessation.
    


Intervention name(s): Pyridoxine plus prednisolone; Prednisolone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pyridoxine; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Efficacy and Safety of IBI305 in Patients With Advanced or Recurrent Non-squamous NSCLC
Condition: NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, double blind, multicenter phase3 study .
    

Detailed description: 
      A randomized, double blind, multicenter phase3 study in chemotherapy naive patients with
      stage IIIB,IV or recurrent NSCLC of non-squamous. the study will randomize about 436 patients
      at a 1:1 ratio to 2 treatment arms. The study is divided 4 phase, screening, combination
      treatment, maintenance and follow up.
    

Intervention name(s): Bevacizumab in Combination With Paclitaxel/Carboplatin; IBI305 in Combination with Paclitaxel/Carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg; Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
Other intervention name(s): Avastin; Bevacizumab Biosimilar
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
Condition: Relapsed NLPHL
MeSH terms: Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine the efficacy of ofatumumab in patients with
      relapsed nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).
    


Intervention name(s): Ofatumumab
Intervention type(s): Drug
Intervention description(s): 300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8
Intervention MeSH terms: Ofatumumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Cognitive Function After Carotid Endarterectomy and Stenting
Condition: Carotid Artery Occlusive Disease
Study type: Interventional

Summary: 
      This study compares cognitive function after carotid endarterectomy and stenting.
    


Intervention name(s): Carotid endarterectomy vs. carotid stenting
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stenting; Endarterectomy; Cognition
Safety and Effectiveness of Spiriva in COPD (Chronic Obstructive Pulmonary Disease) Patients Under the Real Condition of Usual Practice
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to monitor the change in the health status of severe COPD
      patients after the initiation of Tiotropium therapy. This will be assessed by the physician's
      global evaluation of the patient's health status on a 8-point scale. This measure has been
      shown to correlate with a established standard measure of the patients health related quality
      of life. The primary analysis in this trial will only include patients not pre-treated with a
      long-acting beta-agonist to establish a clear efficacy signal in this patient population. As
      the reality of COPD treatment nowadays is poly-pharmacy, a secondary analysis will analyse
      patients who are pretreated with long-acting bronchodilators to put the changes in the health
      status in a likely real world context. In parallel to these evaluations of the health status,
      the lung function response of the patients will be assessed to gain an established objective
      measure of treatment response.
    


Intervention name(s): Tiotropium
Intervention type(s): Drug
Intervention description(s): Tiotropium 18 mcg HandiHaler once daily
Intervention MeSH terms: Tiotropium Bromide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        COPD
Detection of Autologous DEHP (DiEthylHexyl Phthalate)-Free Blood Transfusion in Anti-doping
Condition: Transfusion Reaction
MeSH terms: Transfusion Reaction
Study type: Interventional

Summary: 
      The aim of the proposed project is to perform a clinical study in which volunteers will
      receive autologous blood transfusions in DEHP-free blood bags.
    


Intervention name(s): Autologous blood transfusion
Intervention type(s): Biological
Intervention description(s): Volunteers make a blood donation and after 36 days of storage this blood is re-infused in the same volunteers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science