bioihbjkbjnl/mcl2 huggingface dataset:
Clinical and Economic Burden of Bleeding Events in Patients in the UK With Non-valvular Atrial Fibrillation Treated With Vitamin k Antagonists
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Financial Stress
Study type: Observational

Summary: 
      The purpose of the study is to estimate the impact of bleeding events in patients in the UK
      with non-valvular atrial fibrillation (NVAF) treated with vitamin K antagonists (VKA).
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Retrospective cohort with study period from January 1, 2003 to December 31, 2013 using the
        Clinical Practice Research Datalink (CPRD). The study will identify AF patients treated
        with VKA during the study period and will follow them from the first record of VKA use
        (index date). until the first of end of study period, leaving the database, VKA
        discontinuation/switch, or death. It will use person-time denominators to handle the
        varying length of follow-up of patients
Methadone in Pediatric Anesthesia
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will determine the pharmacokinetics of intravenous (IV) methadone in children
      undergoing surgery.
    


Intervention name(s): Methadone 0.1mg/kg; Methadone 0.2mg/kg; Methadone 0.3mg/kg; Control
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive methadone as their intraoperative opioid.; Subjects will receive methadone as their intraoperative opioid.; Subjects will receive methadone as their intraoperative opioid.; Subjects will not receive methadone as their intraoperative opioid.
Intervention MeSH terms: Methadone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric patients undergoing surgery
A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome
Condition: Clinically Isolated Syndrome
MeSH terms: Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this initiative is to assess the effectiveness of subcutaneous (sc)
      interferon (IFN) beta - 1a, (Rebif®), versus No Treatment in delaying the conversion to
      Clinically Definite Multiple Sclerosis (CDMS) - as defined by the occurrence of a second
      exacerbation - over 96 weeks in subjects that present with Clinically Isolated Syndrome (CIS)
      accompanied by an abnormal magnetic resonance imaging (MRI). The secondary objectives are to:

        -  Assess the effectiveness of sc IFN beta - 1a (Rebif®) therapy in reducing the proportion
           of patients with CIS converting to CDMS

        -  Assess the safety of sc IFN beta - 1a (Rebif®) in the patients with CIS
    


Intervention name(s): Rebif®; No Treatment
Intervention type(s): Drug; Other
Intervention description(s): 44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks; No treatment for 96 weeks
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Leukapheresis Sampling for Immune Responses After BCG Vaccination in BCG-naïve Healthy Adults in the US
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this protocol is to obtain biological samples through leukapheresis and
      cryopreservation of cells for the future study, by in vitro assay, of immune responses after
      one dose of BCG in BCG-naïve healthy adults.
    

Detailed description: 
      This is an open-label protocol in 12 healthy adults who are BCG-naïve. All participants will
      receive a single dose of BCG, by percutaneous administration, on Study Day 0. There will be
      two follow-up visits on Study Days 54 and 56, with telephone contact every 2 weeks in between
      these visits. Leukapheresis will be conducted on Study Days 0 and 56. The Study Day 56
      leukapheresis was selected based on results from functional biological assays that suggest
      analysis of samples at this time point may provide insight into the protective immune
      responses elicited by BCG. The study will be conducted at a single site in the US (University
      of Rochester Medical Center [URMC]).
    

Intervention name(s): BCG
Intervention type(s): Biological
Intervention description(s): BCG Vaccine USP attenuated live culture for percutaneous use (Merck) at 1-8 x 10^8 CFUs.
Other intervention name(s): TICE BCG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Analysis of Neuromuscular Responses and the Balance After the Application of Physiotherapy Resources
Condition: Musculoskeletal Injuries; Cryotherapy Effect; Complication of Diathermy Procedure
MeSH terms: Hyperthermia
Study type: Interventional

Summary: 
      The aim of this study was to evaluate the effect of ice and shortwave diathermy in different
      regions of lower limb neuromuscular response and balance.
    

Detailed description: 
      Applying ice and shortwave diathermy was performed separately (on different days) in the
      foot, ankle and calf. To assess the neuromuscular response was evaluated electromyographic
      activity of the rectus femorals, biceps femorals, gastrocnemius and tibialis anterior. To
      assess the effect of applications on balance, through a force platform was evaluated
      oscillation of the center of pressure as well as ground reaction forces.
    

Intervention name(s): Physiotherapy resources
Intervention type(s): Other
Intervention description(s): The application of ice has been accomplished by means of a plastic bag containing 1.5 kg of crushed ice. The duration of the application was 30 minutes. The use of shortwave diathermy was performed by means of rectangular electrodes having a duration of 20 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ice; Heat; Ground reaction forces; Electromyography; Lower Limb; Center of pressure
Family Based Treatment for Weight Loss With Breakfast Prescription
Condition: Obesity; Overweight; Overeating; Weight; Childhood Obesity
MeSH terms: Obesity; Overweight; Pediatric Obesity; Body Weight; Weight Loss; Hyperphagia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether a behavioral weight loss group in
      conjunction with a prescribed breakfast can help children between 8 and 12 years of age
      change their behaviors to help them lose weight and become healthier.
    

Detailed description: 
      The purpose of this application is to evaluate the acceptability and initial efficacy of
      consumption of an egg breakfast, compared to a cereal breakfast, in the context of
      Family-based Behavioral Treatment (FBT) with overweight and obese children and their parents.
      Investigators will randomize 66 parents and their overweight and obese child (85-99.9%BMI) to
      FBT+egg or FBT+cereal groups. Families will eat their assigned breakfast (eggs or cereal) 5
      out of 7 days during the 4 month FBT treatment. However, all other aspects of FBT will be the
      same in the two groups. Children and parents will complete assessments at three time points;
      baseline, post-treatment and 4-months post-treatment.
    

Intervention name(s): Family Based Behavioral Treatment
Intervention type(s): Behavioral
Intervention description(s): The intervention for both groups will be a 4-month Family-Based Behavioral Treatment (FBT), which includes dietary changes, physical activity changes, and behavioral therapy. Treatment is provided in separate parent and child groups. Families will learn to reduce caloric consumption and increase caloric expenditure (physical activity). Behavior therapy includes stimulus control, self-monitoring, goal setting and contracting, parenting skills, skills for managing high-risk situations, and maintenance and relapse prevention. Families will self-monitor caloric intake, breakfast consumption, physical activity, and hunger and satiety throughout the day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: overweight children; overweight parents; eating in the absence of hunger; families with overweight child; bmi; body mass index; treatment; behavioral treatment; family based treatment; experiments; intervention; psychophysiological response to food cues
Glycemic Stability During the Intraoperative Period Among Patients With DM Undergoing CABG Surgery
Condition: Blood Glucose
Study type: Interventional

Summary: 
      Objectives: Intraoperative glycemic stability and control among patients with diabetes
      mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant
      concern. In this study, the intraoperative glycemic stability among diabetic patients
      undergoing CABG surgery was compared between patients who received an intravenous continuous
      insulin infusion (CII) for tight glycemic control with those who received an CII for
      conventional glycemic control, during the intraoperative period.

      Research Design and Methods: This study implemented a quasi-experimental design with a
      convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in
      Amman, Jordan.
    

Detailed description: 
      Objectives: Intraoperative glycemic stability and control among patients with diabetes
      mellitus (DM) undergoing coronary artery bypass grafting (CABG) surgery remains a significant
      concern. In this study, the intraoperative glycemic stability among diabetic patients
      undergoing CABG surgery was compared between patients who received an intravenous continuous
      insulin infusion (CII) for tight glycemic control with those who received an CII for
      conventional glycemic control, during the intraoperative period.

      Research Design and Methods: This study implemented a quasi-experimental design with a
      convenience sample of 144 patients with DM undergoing CABG surgery at a major hospital in
      Amman, Jordan. Participants were randomly assigned to either a tight glycemic control group
      (n=72) or a conventional glycemic control group (n=72). Patients who received the tight
      glycemic control protocol had significantly more consistent and lower mean intraoperative BG
      levels than those who received the conventional glycemic control protocol. The tight glycemic
      control protocol resulted in significantly lower BG levels and fewer variations across each
      time-point and more consistent and stable BG levels than the conventional glycemic control
      protocol.
    

Intervention name(s): Continuous insulin infusion
Intervention type(s): Drug
Intervention description(s): This study aims to explore the hypothesis that diabetic patients undergoing coronary artery bypass graft (CABG) surgery receiving intravenous continuous insulin infusion (CII) for tight glycemic control (110-149 mg/dl) protocol during the intraoperative period would have improved intraoperative glycemic stability, efficacy and consistency compared to patients receiving conventional glycemic control (150-180 mg/dl) protocol during the intraoperative period
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Abortive Treatment of Migraine With the Cefaly® Abortive Program Device
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the efficacy of the Cefaly® Abortive Program
      device used at home for 2 hours to treat a migraine attack. This open clinical trial will
      study the abortive treatment of migraine using the Cefaly® Abortive Program device, prior to
      development of a sham-controlled trial.
    

Detailed description: 
      The main objective of this study is to have a pilot assessment of the efficacy of the Cefaly®
      Abortive Program device used at home for 2 hours to treat a migraine attack, as triptans are
      generally used. That is to say having pilot data to assess the efficacy of the Cefaly®
      Abortive Program device in the abortive treatment of acute migraine as measured by 2-hour
      pain freedom, pain relief and migraine associated symptoms freedom, plus evolution of these
      measurements for 24 hours after the beginning of the treatment session.
    

Intervention name(s): Cefaly® Abortive Program device
Intervention type(s): Device
Intervention description(s): The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-JNJ-42847922 After a Single Oral Dose of 40 mg in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the absorption, distribution, metabolism, and
      excretion (ADME) of 14C-JNJ-42847922 in healthy subjects after a single oral dose of 40
      milligram (mg) 14C-JNJ-42847922 containing maximally 100 MicroCurie. Safety and tolerability
      will also be assessed.
    


Intervention name(s): 14C-JNJ-42847922 40 mg
Intervention type(s): Drug
Intervention description(s): Participants will receive a single 40 mg oral dose of 14C-JNJ-42847922 containing maximally 100 MicroCurie as a 40 milliLitre (mL) solution.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Vibratory Perturbation-based Pinch Task Training for Stroke Patients
Condition: Stroke Rehabilitation
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The investigator assumed that perturbed-event-induced vibrotactile cueing enable more
      precision arm movement adjustment, sensory function and dexterity improvement in the spastic
      arm. Thus the specific aim of the study was to develop a vibrotactile therapy system that can
      provide vibrotactile feedback through the pinch performance of the hand when countering
      mechanically induced perturbations and also analyzed training effects of the
      perturbation-based pinch task training system on the sensorimotor performance of the hands
      for stroke patients.
    


Intervention name(s): Vibratory perturbed task-specific movement training; Traditional task-oriented facilitation; Sensorimotor training
Intervention type(s): Other; Other; Other
Intervention description(s): The perturbation-based pinch task training was conducted with the affected hand placed on the pinch device. The horizontal vibratory perturbation was generated for a total of 20 minutes by two recoil-type actuators with a frequency of 30 Hz and an amplitude of 2 mm, and intermittent exposure (10 s per 30 s). Each training session was divided into eight cycles with a training interval of 2 min per 2.5 min.; Reach-to-grasp training and hand release training; Targeted to goals that are relevant to the sensorimotor facilitation of the patient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; perturbation-based training; task-specific motor training; recovery of function
The Effect of CV4 and Sacral Technique on the Alpha Bands Power
Condition: Healthy; Osteopathic Manipulation
Study type: Interventional

Summary: 
      Compression of the fourth ventricle (CV4), is the most studied cranial technique, commonly
      used by Osteopathy in Cranial Field practitioners. Evidence attributed to CV4 some effects on
      nervous system functions, however, the supporting evidence for CV4 clinical benefits is
      promising but still poor. The osteopathic tradition considers the sacrum linked to the
      cranium through anatomical and functional connections. To our knowledge, no studies explored
      the potential effect of a sacral technique on brain activity as an indicator of a
      neurophysiological connection between the occiput and sacrum. This study aims to explore this
      effect by measuring the alpha-band activity during the application of a sacral technique (ST)
      compared to the CV4 application.
    

Detailed description: 
      Forty healthy volunteers will receive a combination of CV4 technique, CV4 sham, sacral
      technique (ST) and sacral sham technique (sST).

      Each session, split by a 4-hour washout, will start with 10 min of no treatment (resting
      state), followed by two randomized interventions. Alpha EEG will be continuously recorded
      during each intervention and 10 min after, for a total of approximately 50-60 min per
      session.
    

Intervention name(s): CV4; ST; Sham CV4; Sham ST
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The osteopath was sitting at the head of the examination table, with the subject lying supine. The osteopath approximated with the hands the lateral angles of the occipital squama, taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved.; The subject was lying in the supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point; the sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch; The sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: EEG; Alpha Rhythm; CV4
Evaluate the Safety, Tolerability and Pharmacokinetics of BG00010 (Neublastin) Administered to Sciatica Participants
Condition: Sciatica
MeSH terms: Sciatica
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to determine the safety/tolerability profile, systemic
      PK behavior, and immunogenicity of single IV and SC administrations of BG00010 to sciatica
      participants.
    


Intervention name(s): BG00010 (Neublastin); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose, weight-based IV administration; Single dose IV matched placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Chest Physical Therapy in Patients Waiting for Allogeneic Hematopoietic Stem Cell Transplantation"
Condition: Allogeneic Hematopoietic Stem Cell Transplantation
Study type: Interventional

Summary: 
      evaluate the efficacy of Chest Physical Therapy (CPT) performed during the pre-transplant
      period on spirometric values as well as Respiratory Muscle Strength (RMS) in patients waiting
      for Allogeneic Hematopoietic Stem Cell Transplantation
    

Detailed description: 
      patients scheduled for HSCT at the bone marrow transplant will randomly be assigned into two
      groups; one will receive Chest Physical Therapy in addition to routine medical treatment and
      the control group will receive routine medical treatment only. Outcomes will be a pulmonary
      function that will be measured by spirometry and respiratory muscle strength measure by
      Respiratory Pressure Meter. Measurements will be before three weeks before then at the end of
      treatment immediately before Hematopoietic Stem Cell Transplantation and the last assessment
      at three weeks after hematopoietic Stem Cell Transplantation for all measured variables.
    

Intervention name(s): chest physical therapy; routine medical treatment
Intervention type(s): Other; Other
Intervention description(s): The program will consist of postural drainage, diaphragmatic breathing exercises, coughing, huffing, percussion, shaking, and exercise training using an incentive spirometer in addition to routine medical treatment; medical treatment
Other intervention name(s): chest p.t
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fifty patients scheduled for HSCT at the bone marrow transplant will randomly be assigned into two groups; one will receive Chest Physical Therapy in addition to routine medical treatment and the control group will receive routine medical treatment only. Outcomes will be a pulmonary function that will be measured by spirometry and respiratory muscle strength measure by Respiratory Pressure Meter. Measurements will be before three weeks before then at the end of treatment immediately before Hematopoietic Stem Cell Transplantation and the last assessment at three weeks after hematopoietic Stem Cell Transplantation for all measured variables..
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria
Condition: Allergic Rhinitis; Urticaria
MeSH terms: Rhinitis; Rhinitis, Allergic; Urticaria
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to evaluate the effects of Bilastine on patients' attention and
      reactivity levels by measuring psychophysical performance at a F1-high speed simulator
      driving test.
    

Detailed description: 
      This was a phase IV, interventional, prospective, mono-centric, single arm, uncontrolled,
      open label trial. The study included outpatient affected by Allergic Rhinitis and/or Chronic
      Urticaria, responding to inclusive criteria and able to perform a preliminary driving test on
      F1-high speed simulator (at the simulator centre) without experiencing signs or symptoms of
      intolerance towards the drive simulation (e.g., nausea, vomiting or dizziness etc). Each
      subject underwent 3 ambulatory visits at the hospital site and 3 driving test at the
      simulator centre.
    

Intervention name(s): Bilastine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bilastine tablets once a day for 7+3 days; Placebo tablets once a day during 7+3 days run in period
Other intervention name(s): Robilas
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: driving simulator