bioihbjkbjnl/mcl2 huggingface dataset:
Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post
      marketing environment in subjects who are obese and have Type 2 Diabetes.
    

Detailed description: 
      Patients with obesity are at significantly greater risk of developing complications such as
      pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel
      recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI
      Dynamics' EndoBarrier represents a viable alternative to other short-term pre-surgical weight
      loss methods. EndoBarrier is a device that can be implanted and removed through minimal
      invasive endoscopic techniques. This endoscopic procedure brings potential benefits to
      patients in that it is minimally invasive, efficacious, and allows patients to recover faster
      with less morbidity and mortality
    

Intervention name(s): EndoBarrier Gastrointestinal Liner
Intervention type(s): Device
Intervention description(s): EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 12 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Behavioral Economic Analysis of Demand for Marijuana
Condition: Marijuana Smoking
MeSH terms: Marijuana Abuse; Marijuana Use
Study type: Interventional
Phase: Phase 2

Summary: 
      This laboratory study will employ a multi-session experimental design to examine the
      behavioral economic demand for marijuana, by studying effect of marijuana administration
      (High THC) on demand for marijuana, and marijuana smoking topography. The study will recruit
      100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly.
    

Detailed description: 
      This laboratory study will employ a multi-session experimental design to examine craving for
      marijuana, the effect of marijuana administration (High THC) on behavioral economic demand
      for marijuana, and marijuana smoking topography. The study will recruit 100 non-treatment
      seeking marijuana users who smoke marijuana at least twice weekly. The relationship between
      hypothetical and actual demand for marijuana will be examined. We will also investigate
      relationship between demand for marijuana and indices of marijuana smoking topography. The
      study will recruit 100 non-treatment seeking marijuana users who smoke marijuana at least
      twice weekly to obtain a final sample of 85 with complete data (15% of attrition).
      Participants will be tested at a baseline session and during two experimental sessions (an ad
      libitum marijuana smoking session and a marijuana smoking topography session). This study
      will confirm the utility of the hypothetical marijuana purchase task as a reliable and valid
      tool for assessing behavioral economic marijuana demand.
    

Intervention name(s): Smoked marijuana cigarettes: High THC dose (6% THC)
Intervention type(s): Drug
Intervention description(s): Smoked marijuana cigarettes (High THC dose [6% THC])
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Pharmacokinetics/Pharmacodynamics Study of SCH 900518 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C (Protocol No. P05104AM2)(COMPLETED)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      SCH 900518 is a potent oral inhibitor of HCV NS3 protease which disrupts hepatitis C virus
      (HCV) polyprotein processing. SCH 900518, when added to the current standard of care (SOC),
      peginterferon-alfa plus ribavirin, would likely increase the proportion of patients achieving
      undetectable HCV-RNA levels and sustained virologic response (SVR). In this study, SCH 900518
      would be used in combination with low doses of ritonavir to enhance the levels of SCH 900518
      within the body and reduce the number of daily SCH 900518 tablets required. The purpose of
      this study is to identify the optimal dose and schedule (once or twice a day) of SCH 900518
      plus ritonavir in previously untreated patients with genotype 1 chronic hepatitis C when
      given in combination with SOC. The study compares SOC to 6 experimental arms. In the
      experimental arms, SOC plus SCH 900518 doses of 200, 400 and 600 mg once daily or 100 mg
      twice daily with ritonavir 100 mg once or twice daily will be explored. The benefits of a 4
      week lead-in with PegIntron and ribavirin prior to the addition of SCH 900518 will also be
      explored.
    


Intervention name(s): peginterferon alfa 2b; ribavirin; SCH 900518; ritonavir
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): 1.5 mcg/kg subcutaneously weekly for up to 24 or 48 weeks; ribavirin 600 to 1400 mg daily (weight-based dosing) by mouth twice daily for up to 24 or 48 weeks; SCH 900518 100 mg tablets taken as 200 mg PO QD, 100 mg PO BID, 400 mg PO QD, or 600 mg PO QD for 12 weeks.; Ritonavir 100 mg capsules taken as 100 mg PO QD or 100 mg PO BID for 12 weeks.
Other intervention name(s): PegIntron; REBETOL; Norvir
Intervention MeSH terms: Ritonavir; Ribavirin; Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: genotype 1 infection
The Effect of Instrument Assisted Soft Tissue Mobilization on Respiratory Functions in Chronic Obstructive Pulmonary Disease
Condition: COPD; Pulmonary Function; Soft Tissue Mobilization
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of instrument-assisted soft tissue
      mobilization applied to the hamstring muscle on respiratory function in patients with COPDThe
      patients to be included in the study will be divided into two groups by simple randomization.
      A group will be given breathing exercises (pursed lip breathing, diaphragmatic breathing and
      thoracic expansion exercises) as a home program. The other group will be given breathing
      exercises in the form of a home program in addition to 1 session of EDYM per week. Both
      groups will be evaluated before and 4 weeks after treatment.
    


Intervention name(s): IASTM+respiratory Exercise; Respiratory Exercise
Intervention type(s): Other; Other
Intervention description(s): Instrument assisted soft tissue mobilization; Respiratory Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Does Preconditioning Affects Other Organs in Patients Undergoing Open Heart Surgery ?
Condition: Neutrophil Lymphocyte Ratio; Serum Createnine; Mechanical Ventilation
Study type: Interventional

Summary: 
      An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and
      inflammatory process is well known . Ischemic preconditioning reduces the inflammation
    

Detailed description: 
      Preliminary evidence has suggested the role of inflammation in development and prognosis of
      cardiovascular diseases and cancers. Most of the prognostic studies failed to account for the
      effects of co-morbid conditions as these might have raised the systemic inflammation. We used
      neutrophil lymphocyte ratio (NLR) as a measure of systemic inflammation and investigated its
      association with cardiac preconditioning in open heart surgery .
    

Intervention name(s): ischemic preconditioning; Pharmacologic preconditionig
Intervention type(s): Procedure; Drug
Intervention description(s): ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles; Pharmacologic preconditionig will be attained by sevoflurane anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intervention group well be pretreated with cardiac preconditioning
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: cardiac preconditioning; open heart surgery; createnine; inflammation
e-Mobile Tablet for People With Chronic Conditions
Condition: Fibromyalgia; Multiple Sclerosis; Osteoarthritis; Sjögren's Syndrome; Parkinson's Disease
MeSH terms: Fibromyalgia; Sjogren's Syndrome; Parkinson Disease; Multiple Sclerosis; Chronic Disease
Study type: Interventional

Summary: 
      Maintaining a healthy diet and engaging in routine physical activity may help decrease
      severity of symptoms, prevent secondary conditions, and slow functional decline in people
      with disabling neuromusculoskeletal conditions. However, people with these conditions face
      many health barriers to engaging in healthy behaviors. With the advent of portable
      technologies, such as smart phones, tablets and PDAs, there is a need to explore whether
      these technologies can help people with disabling conditions to stay motivated and overcome
      barriers to engaging in healthy behaviors.
    

Detailed description: 
      The overarching goal of this mixed methods, comparative effectiveness randomized controlled
      pilot study is to evaluate whether goal setting, self-monitoring, and barrier management
      using a computer tablet can increase physical activity behavior, improve nutritional habits,
      and promote health-related quality of life in people with disabling neuromusculoskeletal
      conditions. Our hypothesis is that, in comparison to the standard care contact control group,
      participants in both the tablet group and the paper and pencil group will yield significant
      improvements in healthy behaviors,with the tablet group yielding significantly larger
      increases.
    

Intervention name(s): Computer Tablet Group; Paper and Pencil Group; Contact Control Group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): A computer tablet application to set goals,self-monitor healthy behaviors, record condition-related symptom impact, and self-manage a problematic symptom.; Use of paper and pencil diaries and worksheets to set goals, record condition-related symptom impact, and self-monitor behaviors.; Participants are prescribed an exercise program and given information on healthy eating.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Neuromusculoskeletal condition
Pharmacokinetics and Safety Study of PT010 in Healthy Subjects
Condition: COPD
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, Phase I, healthy adult subject study with a randomized, double
      blind, three period, three-treatment, cross-over design.
    


Intervention name(s): PT010; PT009; Symbicort Turbohaler
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations; PT009 administered as 2 inhalations; Symbicort Turbohaler taken as 2 inhalations
Other intervention name(s): PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol; PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations; Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder
Intervention MeSH terms: Budesonide; Glycopyrrolate; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy volunteers
Realistic Models of Gastrointestinal Bioelectromagnetism
Condition: Ischemia
MeSH terms: Ischemia
Study type: Observational

Summary: 
      The purpose of this study is to look at the electrical activity present in healthy and
      diseased smooth muscle of the intestines; and develop both mathematical and computer models.
    

Detailed description: 
      The Superconducting QUantum Interference Device (SQUID)is a large cylinder machine located in
      a large shielded room that measures magnetic activity of the intestines. Subjects will be
      asked to lie underneath and get recordings of the electrical activity of their intestines.
      They will also be asked to have a CT scan done. From these two procedures, the mathematical
      and computer models will be developed to determine the difference between normal bowels and
      those that do not have adequate blood supply.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinic
      
Keywords: Blood supply; Mesentery
Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      Atrial fibrillation is the most common cardiac arrhythmia and is expected to affect about 30
      million North Americans and Europeans by 2050. Atrial fibrillation is associated with
      increased cardiovascular morbidity and mortality, with stroke being an especially important
      and potentially devastating complication. Many studies have investigated the efficacy of
      different drugs in converting atrial fibrillation to sinus rhythm. There are numerous
      randomized controlled trials that have tested the efficacy of agents against placebo and some
      trials that directly compared the efficacy of two or more different drugs. The class III
      antiarrhythmic drug Ibutilde is approved for the acute termination of atrial fibrillation and
      atrial flutter of recent onset and has been shown to be superior to sotalol and equivalent to
      flecainide in this indication. Recently, the relatively atrial selective antiarrhythmic agent
      vernakalant has been approved by the European Commission for the rapid conversion of recent
      onset AF to sinus rhythm in adults. The investigators hypothesize that the period of time
      needed for cardioversion to sinus rhythm and the efficacy of cardioversion within 90 minutes
      is different between vernakalant and ibutilide in patients with recent-onset atrial
      fibrillation.
    


Intervention name(s): Brinavess (Vernakalant); Corvert (Ibutilide)
Intervention type(s): Drug; Drug
Intervention description(s): 3mg/kg Brinavess (Vernakalant) in 100ml normal saline over 10min. If atrial fibrillation continues after another 15 minutes of observation, patients will receive a second infusion of 2mg/kg Brinavess (Vernakalant) over 10 minutes; Patients will be given 1mg of Corvert (Ibutilide) in 100ml normal saline intravenously over 10min. If atrial fibrillation continues after another 10 minutes of observation, patients will receive a second infusion of 1mg ibutilide over 10min.
Intervention MeSH terms: Ibutilide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recent-onset
Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism
Condition: Embolism; Femoral Fractures
MeSH terms: Embolism; Embolism, Fat; Fractures, Bone; Femoral Fractures
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect on the incidence of fat emboli when
      using a Reamer-Irrigator Aspirator during reamed IM nail fixation of femoral shaft fractures
    

Detailed description: 
      The current practice of reaming the medullary canal for the fixation of femur fractures is
      recommended, however, there is an associated increase in the level of embolic events which
      confers morbidity and, occasionally, mortality.

      The RIA is a single device which is able to ream the medullary canal, irrigate the canal and
      subsequently aspirate the reamed medullary contents in order to get rid of medullary fat and
      other contents responsible for these adverse embolic events.

      A novel Reamer-Irrigator-Aspirator (RIA) (Synthes, Inc) will be evaluated in a randomized
      study, to determine its effect on the incidence of fat emboli events during reamed IM nail
      fixation of consecutive femoral shaft fractures as measured by intra-operative
      transesophageal echocardiogram and pulmonary function.
    

Intervention name(s): Reamer Irrigator Aspirator
Intervention type(s): Device
Intervention description(s): Use of standard reamer vs reamer irrigator-aspirator during IM nailing of tibial shaft fractures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: embolism; femur fracture; lavage; TEE; reamer; IM nail
Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Management of acute pain is one of the most important tasks of perioperative pediatric
      anesthesia. The alleviation of pain has been defined by the Society of Pediatric Anesthesia,
      on its 15th annual meeting as a basic human right, irrespective of age, treatment primary
      service responsible for the patient care. Pro-inflammatory cytokines increased by surgical
      trauma indirectly modulate pain through the release of substances like nitric oxide, oxygen
      free radicals, prostaglandins, and excitatory amino acids, inducing peripheral and central
      sensitivity and hyperalgesia. There has been growing interest in determining the possible
      immune consequences of analgesic administration for the management of postoperative pain
    

Detailed description: 
      60 children aged 3-10 years undergoing lower abdominal surgery will be randomized into 2
      groups (30 patients in each group) to receive caudal block with bupivacaine (0.25%) 1mg/kg
      (group 1) plus tramadol 1mg/kg (group 2) just after the induction of general anesthesia
      without premedication. All children will be assessed for the post operative immune response
      by measuring interleukin 6 and 10 (IL-6 and IL-10) and Tumour Necrosing Factor-α (TNF-α)
      using enzyme-linked immunosorbent assay (ELISA) technique one hour preoperatively and three
      hours after incision.
    

Intervention name(s): Bupivacaine; Tramadol
Intervention type(s): Drug; Drug
Intervention description(s): caudal block with bupivacaine (0.25%) 1mg/kg; caudal block with tramadol 1 mg/kg
Other intervention name(s): Marcaine; Tamol
Intervention MeSH terms: Tramadol; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: immune; interleukin; tramadol; postoperartive analgesia; pediatric; caudal bupivacaine
USS Virginia Closed-Loop for Overnight Control in Type 1 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to use the USS Virginia Closed-Loop system for overnight insulin
      delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the
      system's ability to significantly improve blood glucose levels. This protocol will test the
      feasibility of "bedside" closed-loop control - an approach comprised of standard
      sensor-augmented pump therapy during the day using off-the-shelf devices and overnight
      closed-loop control using experimental devices in an outpatient setting. The rationale for
      this study is as follows: we anticipate that closed-loop control may ultimately be adopted by
      patients with T1DM in a selective manner. Patient may choose to start using these systems for
      overnight control only, e.g. to alleviate the well documented fear of hypoglycemia while
      asleep. To test this paradigm of "bedside" closed-loop control, subjects will be studied with
      continuous glucose monitoring (CGM)-augmented usual pump therapy during the day followed by
      overnight use of USS Virginia Closed Loop Control.
    

Detailed description: 
      The subject will participate in both the Experimental and the Control Admissions. The order
      of the two admissions will be randomized. During the Control Admission at home, the subject
      will use the study insulin pump along with a continuous glucose monitor receiver. During the
      Experimental Admission, the subject will be the research house/hotel where the subject will
      be in control of the DiAs. Participation in this study will require 5 study visits over 11-14
      weeks.
    

Intervention name(s): DiAs; Sensor Augmented Pump Therapy
Intervention type(s): Device; Other
Intervention description(s): DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and help avoid hypoglycemia during the night.; Insulin pump plus CGM.
Other intervention name(s): SAP
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Artificial Pancreas Project (APP); Diabetes Assistant (DiAs); Closed-Loop Control (CLC)
Study of the: Effect of Head Rotation in Prone Position on Regional Cerebral Oxygen Saturation.
Condition: Regional Cerebral Oxygen Saturation During Head Rotation
Study type: Observational

Summary: 
      The purpose of this study is to determine whether head rotation in prone positon affects
      regional cerebral oxygenation (rSO2)in anesthetized patients undergoing lower back surgery.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing lowerback surgery under universal anesthesia at Glostrup Hospital,
        Copenhagen.