bioihbjkbjnl/mcl2 huggingface dataset:
Heparin Resistance: Predictors and Outcomes
Condition: Off Pump Coronary Artery Bypass Surgery
Study type: Interventional

Summary: 
      The investigators evaluated clinical impact of reduced heparin responsiveness (HRreduced) on
      the incidence of perioperative myocardial infarction (MI) and restenosis at 6 months after
      off-pump coronary artery bypass graft surgery (OPCAB) and identified its predictors.
    


Intervention name(s): Heparin
Intervention type(s): Drug
Intervention description(s): 150 U/kg heparin was administered intravenously at the beginning of graft anastomosis and accepted a perioperative ACT value of around 300 s. Ten minutes after the loading dose, the ACT was measured. An ACT of 300 s or greater was considered as adequate. Then follow up ACT measurement was determined after 30 min from the previous ACT measurement. If ACT fell below the target value of 300 s, an additional dose of heparin was administered. If ACT was between 250 and 299 s, additional 2000 U of heparin was administered and if ACT was between 200 and 249 s then additional 3000 U of heparin was injected. Ten minutes after additional heparin injection, ACT was remeasured.
Intervention MeSH terms: Heparin
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Heparin responsiveness; Off-pump coronary artery bypass graft surgery; Risk factors; Myocardial infarction
Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents
Condition: Endocrine System Diseases
MeSH terms: Endocrine System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to examine ghrelin, amylin, glucagon and glucagon-like peptide
      (GLP)-1 responses to a test meal in lean and obese individuals.
    

Detailed description: 
      The primary hypothesis is that obese adolescents have a disturbed balance of hormones
      associated with appetite regulation with less suppression of ghrelin and attenuated
      stimulation of GLP-1 secretion in response to meal intake compared to lean normal weight
      controls. A second aim of the study was to test which gastrointestinal peptides are most
      associated with insulin resistance.
    

Intervention name(s): test meal (500 kcal); test meal (500 kcal)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL); whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary
      function and time to first exacerbation in patients with moderate persistent asthma.
      Ciclesonide will be administered once daily in the evening at two dose levels. The study
      duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention description(s): Effect of Ciclesonide on Quality of Life
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Quality of Life; Ciclesonide
The Effect of Placental Cord Drainage on Postpartum Blood Loss
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      To determine if placental cord drainage decreases the blood loss after spontaneous vaginal
      delivery
    

Detailed description: 
      Postpartum hemorrhage complicates 3% of pregnancies in the United States and is a leading
      cause of maternal morbidity and mortality. ACOG defines PPH as cumulative blood loss greater
      than 1000cc; however a blood loss >500cc should be considered abnormal. Primary PPH occurs in
      the first 24 hours and is largely secondary to uterine agony. ACOG as well as the WHO
      recommend active management of the third stage of labor to prevent PPH. This includes
      oxytocin administration, uterine massage, and gentle cord traction. Placental cord drainage
      (PCD) is the unclamping of the umbilical cord to allow for drainage of the blood from the
      placenta. It is another technique used to shorten the third stage of labor; however, it has
      not been well studied
    

Intervention name(s): Placental Blood Drainage; Placenta Blood Not Drained
Intervention type(s): Procedure; Procedure
Intervention description(s): Immediately after vaginal delivery following delayed cord clamping and cutting of the cord, the cord will be unclamped and blood will be drained from the placenta until cessation of flow.; Placenta Blood Not Drained
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placenta Blood Drained Placenta Blood Not Drained
Masking: None (Open Label)
Primary purpose: Treatment
Fronto-limbic Functional Connectivity Via Real-time fMRI Neurofeedback
Condition: Healthy
Study type: Interventional

Summary: 
      Real-time fMRI neurofeedback training induced volitional control of brain activity and
      connectivity could help individuals to gain better control over their emotions.
    

Detailed description: 
      In the present proof-of-concept study, investigators plan to evaluate whether real-time fMRI
      neurofeedback training can enable individuals to gain volitional control over their
      fronto-limbic circuitry. Given that this circuitry has been abundantly implicated in
      emotional perception and regulation this could facilitate emotional control. Suitable
      participants underwent fronto-limbic connectivity feedback training and sham training in a
      cross over design. During both trainings participants are instructed to regulate the neural
      indices during feedback. We expect that receiving fronto-limbic feedback enhances emotion
      regulation during the training.
    

Intervention name(s): Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Neurofeedback; Emotion processing; Real-time; fMRI
Evaluation of Silica-calcium Phosphate Composite in Socket Augmentation
Condition: Ridge Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Ideal bone graft should possess osteogenic, osteoinductive, and osteoconductive properties.
      Unfortunately, all of these are solely found within the autogenous graft that is available
      only in limited quantities, and it is associated with substantial post-surgical morbidity,
      However in this study Silica-calcium phosphate composite (SCPC) confirmed clinically,
      radiographically, histomorphometricand immunohistochemically the vitality and functionality
      of the newly formed bone. Histology and immunohistochemistry demonstrated maturation of the
      newly formed bone as indicated by presence of osteocytes, Haversian systems, blood vessels,
      compact mineralized collagen type I and high immune staining for osteopontin.
    

Detailed description: 
      Alveolar ridge resorption following teeth extraction leads to 50% loss in bone width over one
      year period which corresponds to 5 -7 mm mainly from the buccal rather than palatal\lingual
      aspects. Several calcium phosphates from bovine and synthetics sources are used for
      preservation of extraction socket; however with variable degrees of success. The aim of the
      present study is to evaluate clinically, radiographically and histologically the effect of
      Silica-calcium phosphate composite (SCPC) granules on new bone formation qualitatively and
      quantitatively following socket augmentation. This case series study was performed in five (n
      = 5) participants (one male and four females), all participants underwent socket augmentation
      procedures and dental implant placement in a staged approach. All participants were fully
      informed about the procedures, including the surgery, bone substitute materials and implants.
      Each participant had one extraction socket to be grafted with silica-calcium phosphate SCPC
      dental bone graft granules and the contralateral socket served as ungrafted control.
      Clinical, radiographic and histological evaluation was assessed.
    

Intervention name(s): Socket Graft
Intervention type(s): Device
Intervention description(s): 5 patients had bilateral decayed upper premolar or anterior teeth, in one side SCPC graft was inserted in socket and in the contralateral site was a control, 5 months months postoperative core biopsies were taken from both grafted sockets and control ungrafted sockets during implant insertion. The biopsy samples from SCPC-grafted and control ungrafted sockets were fixed, decalcified and embedded into paraffin wax. All samples were serially sectioned in serial 5μm-thin sections were stained separately with Hematoxylin and Eosin staining, Sirius red and Mason trichrome and immunostaining with osteopontin.
Other intervention name(s): socket augmentation; Socket preservation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Silica-calcium phosphate composite; Socket augmentation
Short vs. Long Antibiotic Treatment of Implant-free Osteoarticular Infections
Condition: Implant Infection
MeSH terms: Infections; Communicable Diseases
Study type: Interventional

Summary: 
      The investigators tested the working hypothesis if 4 weeks of systemic antibiotic treatment
      in implant-related orthopaedic infections is non-inferior to 6 weeks after complete removal
      of the infected implant. Randomization 1:1.

      The study is completed. It halted prematurely and will not resume; participants are no longer
      being examined or receiving intervention.
    

Detailed description: 
      Former description of the study (now completed)

      Osteoarticular infections related to orthopaedic implants are associated with substantial
      morbidity, prolongation of hospital stay, and additional costs. Due to the increasing number
      of patients with orthopaedic implants in Switzerland, similar to the rest of Europe and
      elsewhere, the number of infections is expected to increase. While the surgical treatment of
      these infections has been well studied, the ideal duration of antibiotic therapy after
      removal (explantation) of the infected implant remains unknown. For almost 40 years, the
      recommended total duration of post-explantation antibiotic therapy has been 6 weeks. This
      recommendation is based on expert's personal experience rather than on prospective randomized
      studies. Shorter treatment would decrease antibiotic-related adverse events and costs
      hospital stay for patients awaiting an eventual reinsertion of a new implant. If physicians
      and surgeon prescribe antibiotics for 6 weeks, this duration should be at least supported by
      evidence.
    

Intervention name(s): Removal of infected implant; Antibiotic durations
Intervention type(s): Procedure; Drug
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: implant-related infections; orthopaedics; implant removal; antibiotic duration; outcome
Comparison Between M-Pro and ProTaper Next
Condition: Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      Comparing the postoperative pain resulting after mechanical instrumentation using M-pro files
      versus that resulting after using ProTaper Next rotary files in lower molar with symptomatic
      Irreversible pulpitis molars.
    

Detailed description: 
      Lower molars with symptomatic Irreversible pulpitis molars are selected according to the
      eligibility and exclusion criteria and patients are then randomized to receive treatment
      either using M-pro Files or ProTaper Next files. Postoperative pain is then assessed using
      the Numerical Rating scale 6, 12, 24, 48 and 72 hours post-operatively . After completing the
      treatment, patients will instructed to take placebo if they feel pain and will be asked to
      provide the quantity of placebo intake until 72 hrs. In case of pain not relieved by placebo,
      after recording the amount of pain, the patient will be instructed to take an alternative
      line of pain control (Ibuprofen 400mg tablets every 6 hours). The amount and frequency of
      Ibuprofen intake will be recorded.
    

Intervention name(s): M-pro files in rotating motion; ProTaper Next files in rotating motion
Intervention type(s): Procedure; Procedure
Intervention description(s): An endodontic file that has controlled memory properties; An endodontic file that has an off center mass of rotation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Blocks of 4 are generated on a Microsoft Excel sheet where the intervention and control are denoted A & B and randomly distributed. The table is kept with the assistant supervisor.
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Exercise-intensity on Physiological Adaptations in Overweight and Obese
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The main purpose of our study is to examine the physiological adaptations in oxygen transport
      chain for high-intensity exercise and moderate exercise in overweight and obese humans. The
      main goals are:

        1. To investigate the most effective short-and long-interval training in terms of VO2max,
           pulmonary diffusion, cardiac output, endothelial function and mitochondrial function.

        2. How these physiological adaptations affect the aerobic endurance and performance, and
           how this training can reduce the risk of cardiovascular diseases related to overweight
           and obesity.
    


Intervention name(s): Long distanse moderate training; Long interval training; Short interval training
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Moderate exercise; High-intensity exercise, long duration; High intensity exercise, short duration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; High-intensity; Interval training
Remote Ischemic Conditioning for Intracerebral Hemorrhage
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      Spontaneous intracerebral hemorrhage (ICH) results from the rupture of small vessels damaged
      by chronic hypertension, amyloid angiopathy or other disease. Hematoma volume has been
      demonstrated to be strongly correlated with the severity of white matter injury and
      conditions in ICH patients. In the past decades, surgical clot evacuation and stereotactic or
      endoscopic clot aspiration with thrombolytic drugs have been investigated for the treatment
      of ICH, however, none of them have been demonstrated to be effective. As such, medical
      management remains the standard of care for most patients with ICH, leading to ICH as the
      least treatable form of stroke.

      Remote ischemic conditioning (RIC) has been found to have neuroprotective effects by in
      patients with ischemic stroke. In addition, animal studies show that RIC is safe in ICH model
      and it could accelerate the absorption of hematoma. Therefore, the investigators plan to
      undertake this study to evaluate the safety of RIC in patients with ICH, and planned for
      future study to determine if treatment with RIC can improve the outcome of patients with ICH.

      In this study, our main objectives are: 1) to evaluated the safety of RIC, by determining the
      treatment related adverse events, in patients with ICH; and 2) to determine the preliminary
      effects of RIC on hematoma absorption and cerebral edema.

      The investigators hypothesize that RIC is well-tolerated and has minimal serious adverse
      effects in patients with ICH; and that treatment with RIC will accelerate the absorption of
      hematoma and improve patients' functional outcomes. Results of this study can potentially
      bring into account new means to improve the outcomes of ICH patients.
    


Intervention name(s): remote ischemic conditioning; Regular treatment
Intervention type(s): Device; Other
Intervention description(s): RIC is a non-invasive therapy that performed by an electric autocontrol device with cuffs placed on arm and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 4 to 5 times.; Regular treatment is based on associated guidelines for ICH.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spontenous intracerebral hemorrhage; Hemorrhage resolution; Remote ischemic conditioning; Neuroprotection
Effect of Passive Heat Therapy on Metabolism
Condition: Healthy
Study type: Interventional

Summary: 
      The goal of this prospective interventional study is to examine if repeated brief hot stimuli
      affects glucose metabolism and substrate oxidation in young non-obese adults. Young adult
      participants were asked to participate in fourteen 5-min procedures involving whole body
      passive heating at 45°C water.

      The main question it aims to answer is: "Does repeated brief noxious heat stimuli is
      sufficient to improve glucose tolerance, insulin sensitivity, and fat oxidation in young
      non-obese adults?"
    

Detailed description: 
      No studies yet addressed whether brief heat stimuli could be viable time-efficient
      alternative approach in order to improve glucose metabolism and fat oxidation. Consequently,
      we aimed to examine the ability of brief noxious heat stimuli to improve glucose tolerance,
      insulin sensitivity, and fat oxidation in young adults. Non-obese males and females completed
      fourteen 5-min sessions involving whole body passive heating at 45°C water. Changes in
      catecholamines, cytokines, substrate oxidation, resting energy expenditure, glucose tolerance
      and insulin response were assessed.
    

Intervention name(s): Heat therapy
Intervention type(s): Procedure
Intervention description(s): 14 heat sessions, during each session subjects were fully immersed in a 45°C water bath for 5 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Immune Response to Recombinant Live-Attenuated Influenza H2N2 Virus Vaccine
Condition: Influenza; Virus Diseases
MeSH terms: Virus Diseases; Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were
      associated with significant morbidity and mortality. It is estimated that, in the United
      States alone, the next influenza pandemic could cause approximately 200,000 deaths and
      750,000 hospitalizations. Thus, the development of a vaccine against potential influenza
      strains has become a priority. The purpose of this study is to determine the safety and
      immune response to an H2N2 influenza vaccine candidate.
    

Detailed description: 
      H2N2 influenza viruses emerged in the 1950s replacing the then circulating H1N1 human
      influenza virus. The first cases occurred in China in 1956, and disease became widespread in
      1956-1957, resulting in the "Asian Influenza" pandemic that was responsible for between 1 and
      4 million deaths worldwide. H2N2 viruses have not circulated since 1968, when they were
      replaced by H3N2 influenza viruses and the resurgence of H1N1 viruses. For this reason, a
      large proportion of the population is now susceptible to infection with H2N2 influenza. If
      this subtype re-emerges, it could potentially cause the next pandemic. This vaccine,
      therefore, is an important priority in the development of vaccines against potential pandemic
      influenza strains.

      This vaccine trial will be conducted in the Center for Immunization Research isolation unit
      in the Mason F. Lord Building at the Johns Hopkins Bayview Medical Center (Baltimore, MD).
      The study will be initiated between April 1st and December 20th, 2008, when wild-type
      influenza is unlikely to be circulating in the Baltimore area.

      An individual's participation in the study will last approximately 90 days. All participants
      will receive two vaccinations approximately 4 - 8 weeks apart. After each vaccination,
      participants will remain in isolation at the study site for at least nine days or until
      rRT-PCR assays for influenza are negative for 2 consecutive days. A physical examination and
      nasal wash will occur each day during the isolation period. Blood collection will occur in
      isolation beginning on Day 7 until release. Follow-up outpatient visits are scheduled on Days
      28 and 56 after the first vaccination and on Day 28 after the second vaccination. Follow-up
      visits will include serum collection, nasal wash, and interim medical history.
    

Intervention name(s): H2N2 1960 AA ca recombinant vaccine
Intervention type(s): Biological
Intervention description(s): Approximately 0.2 ml of 10^7 TCID50 doses of vaccine administered intranasally
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Influenza
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50
      mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.
    


Intervention name(s): Placebo; Brivaracetam
Intervention type(s): Other; Drug
Intervention description(s): Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
Other intervention name(s): Briviact
Intervention MeSH terms: Brivaracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Epilepsy: partial onset seizures; brivaracetam