bioihbjkbjnl/mcl2 huggingface dataset:
Study on the Level of Neuromuscular Blockade
Condition: Neuromuscular Blockade
Study type: Interventional

Summary: 
      On the basis of moderate pneumoperitoneum pressure(10 mmHg), this study evaluates the effect
      of different level of neuromuscular blockade to gastrointestinal barrier function during
      laparoscopic gastrectomy. 83 patients are randomized to 2 arms ,The patients in deep
      neuromuscular blockade group（group D, PTC=1-2）will receive high dose rocuronium (0.5-0.6
      mg/kg/h) ;While the patients in moderate neuromuscular blockade group（group M, TOF=1-2）will
      receive moderate dose rocuronium (0.2-0.3 mg/kg/h)
    


Intervention name(s): A continuous intravenous infusion of 0.5-0.6 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (PTC = 1-2).; A continuous intravenous infusion of 0.2-0.3 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (TOF = 1-2).
Intervention type(s): Drug; Drug
Intervention description(s): 50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.5-0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).; 33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2-0.3 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).
Intervention MeSH terms: Bromides; Pharmaceutical Solutions; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuromuscular Blockade; Gastrointestinal Barrier Function
Tailored Bilio-Pancreatic Limb and HbA1c 10 Years Post Mini-Gastric Bypass
Condition: Diabetes; Surgery
Study type: Observational

Summary: 
      Diabetes is now or soon will be a worldwide epidemic. Diabetes has impact on both healthcare
      costs in addition to the costs in human lives, suffering and disability. Treatment that
      lowers Hemoglobin A1c (HbA1c) improved outcomes. Studies have demonstrated that both general
      surgery and bariatric procedures may improve or reverse diabetes. In several studies the
      Billroth II reconstruction following gastrectomy was the most effective surgical technique in
      improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the
      Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB)
      to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the
      HbA1c changes.
    

Detailed description: 
      There is general agreement that Diabetes is now or soon will be a worldwide epidemic. Studies
      also make clear the devastating impact of diabetes on both healthcare costs in addition to
      the costs in human lives, suffering and disability. It is also clear that treatment that
      lowers Hemoglobin A1c (HbA1c) will result in improved outcomes proportional to the decrease,
      saving both lives and costs. Unfortunately medical and lifestyle therapy routinely result in
      less than ideal resolution of elevated HbA1c levels. Studies have demonstrated that both
      general surgery and bariatric procedures may improve or reverse diabetes. In several studies
      the Billroth II reconstruction following gastrectomy is the most effective surgical technique
      in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of
      the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass
      (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL)
      with the HbA1c changes.
    

Intervention name(s): Mini-Gastric Bypass Original Technique
Intervention type(s): Procedure
Intervention description(s): Follow up of the Surgical procedure outcomes in diabetics. Procedure Mini-Gastric Bypass Original Technique
Other intervention name(s): One Anastomosis Bypass
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients having undergone Mini-Gastric Bypass -Original Technique post operative patients
Effect of Waterpipe Smoking on Periodontal Health
Condition: Waterpipe Smoking; Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Observational

Summary: 
      The main objective of the study is to assess the effect of waterpipe smoking on periodontal
      health, which will be done using a well constructed validated questionnaire. Then a full
      periodontal examination and x-ray evaluation will be done for all of the participants.
    

Detailed description: 
      The primary outcome of the study is to assess the effect of waterpipe smoking on periodontal
      health, it will be assessed by questions about smoking habits, including smoking mode as well
      as duration (heads smoked per day) and extent of use (age of initiation and number of
      sessions per week) of waterpipe smoking.

      A full periodontal examination using UNC-15 periodontal probe will be done for all of the
      participants measuring the CAL, Probing Depth (PD), plaque index (PI), bleeding on probing
      (BOP) and gingival recession depth (GD). In subjects where attachment loss will be clinically
      detected, radiographic examination will be performed by digital periapical radiograph to
      detect the amount of bone loss, then staging will be done according to the new classification
      by the aid of radiographic examination.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic
        center, Faculty of Dentistry, Cairo University.
Tissue Perfusion for Different Approaches of Brachial Plexus Block
Condition: Upper Extremity Fracture; Regional Anesthesia; Brachial Plexus Blocks; Perfusion Index; Tissue Perfusion
Study type: Interventional

Summary: 
      To compare the two different approaches of infraclavicular brachial plexus block in forearm,
      wrist and hand surgery in terms of perfusion index, tissue oxygenation, sensory and motor
      block onset time and total effect time, first analgesic time, side effects and complications,
      and duration of block application.
    


Intervention name(s): Lateral sagittal approach; Costoclavicular approach
Intervention type(s): Other; Other
Intervention description(s): Lateral sagittal approach for ultrasound guided infraclavicular brachial plexus block; Costoclavicular approach for ultrasound guided infraclavicular brachial plexus block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: lateral sagittal approach; costoclavicular approach; block success; perfusion index; brachial plexus
Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the
      manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).
    

Detailed description: 
      The study is designed to evaluate lot-to-lot consistency in the manufacturing of Rotavirus
      vaccine by testing the vaccine in infants in order to demonstrate equivalence in the
      induction of specific anti-rotavirus IgA antibodies across three production lots. The study
      will also examine the potential interference of vaccine with UIP vaccines that will be
      administered concurrently by assessing non-inferiority in the immune responses to those
      vaccines when administered with / without the study vaccine.
    

Intervention name(s): BRV-PV Lot A + DPT-HepB-Hib + OPV; BRV-PV Lot B + DPT-HepB-Hib + OPV; BRV-PV Lot C + DPT-HepB-Hib + OPV; ROTARIX + DPT-HepB-Hib + OPV
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week; Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week; Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week; Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)
Other intervention name(s): Live Attenuated human-bovine reassortant pentavalent rotavirus vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: BRV-PV; Rotavirus vaccine; lot-to-lot consistency; interference with routine immunization
Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      E-Celsius device used for measuring the gastrointestinal temperature is composed of an
      ingestible capsule measuring the temperature as well as a transportable module receiving data
      from the capsule. This device allows to measure the body temperature (± 0.2 ° C) during
      transit of the pill in the digestive tract to a maximum sampling frequency of 30 seconds. The
      main risks related to such devices are related to biocompatibility (in materials used for the
      capsule shell, or level of contamination of the gastrointestinal environment due to a defect
      in the plastic envelope the pill or a lack of hygiene, previously tested in clinical trials;
      see section 10.2).

      It will compare conventional methods of estimating the central temperature continuously with
      gastrointestinal data obtained from the e-Celsius device. The main objective of the research
      is to validate the extent of gastrointestinal temperature obtained from the device under test
      consists of an ingestible electronic capsule and a data reception monitor.

      Secondary objectives will be pursued:

        -  Assess the effects of ingestion of cold drinks on temperature readings taken via
           e-device Celsius, esophageal probe and a rectal probe.

        -  Explore the thermal homogeneity of the digestive tract.

        -  Evaluate the internal memory of the capsule and its data forwarding capacity. This
           protocol will also measure the reliability of the measurement system while comparing it
           to the standards used by health staff today.
    


Intervention name(s): E-Celsius thermometer; Rectal thermometer; Esophageal thermometer; Vital sense capsule thermometer
Intervention type(s): Device; Device; Device; Device
Intervention description(s): comparison of temperature between e-celsius and thermometer, rectal thermometer, esophageal thermometer, vital sense capsule thermometer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Body Temperature; Thermometers
The Potential of Do-it-yourself Devices for Obtaining Personal Health Data
Condition: Self-monitoring of Health; Health Behaviour Change
Study type: Interventional

Summary: 
      The study aims to evaluate whether do-it-yourself devices for self-measuring health
      parameters by subjects can be used for obtaining useful data in scientific studies.

      Besides, the study aims to evaluate if increased awareness of own health status by
      self-monitoring health parameters also serves as motivational instrument for changing health
      behaviour.
    

Detailed description: 
      During this three month study subjects will self-monitor multiple parameters of health with
      do-it-yourself devices. Subjects are supplied with devices for measuring physical activity,
      food intake, body weight, blood pressure, blood glucose level and blood cholesterol level.
      These devices have to be used with varying frequencies, ranging from continuously to only a
      baseline- and endpoint measure.

      Subjects will have to upload data resulting from these self-measures to an encoded account on
      an online portal.

      At any time during the study, subjects can log-on to this portal, to gain insight in their
      own health parameters.

      Only encoded subject data can be exported from this portal for data analysis.
    

Intervention name(s): Do-it-yourself devices
Intervention type(s): Device
Intervention description(s): Medisana Vifit is worn every day all-day by each subject
Subjects use Medisana MTX Blood pressure monitor twice per week for 13 weeks to measure their blood pressure.
Blood cholesterol is measured by subjects using the Mission Cholesterol 3-1 meter once at baseline and once after 13 weeks
Subjects use Medisana BS 440 BT scale daily
In three weeks (week 1, week 7 and week 13) subjects self-record food intake at three days (two week days and on weekend day) using the FatSecret app.
Subjects self-measure fasting blood glucose twice per week for 13 weeks.
Subjects perform a do-it-yourself Oral Glucose Tolerance Test in week 1 and week 13. Subjects use the Medisana MediTouch 2 for assessing blood glucose levels at t=0, t=30, t=60, t=90 and t=120.
Other intervention name(s): Medisana Vifit - advanced activity tracker; Medisana MTX Blood pressure monitor - systolic and diastolic blood pressure; Medisana BS 440 BT scale - body weight; Medisana MediTouch 2 - blood glucose meter; FatSecret app - food intake application; Mission Cholesterol 3-1 meter - blood cholesterol level; Do-it-yourself Oral Glucose Tolerance Test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Do-it-yourself devices; User-experiences; Health behavior; Self-measurement; Methodology, Evaluation; Personal health records; Blood Glucose Self-Monitoring; Self Blood Pressure Monitoring
The Effect of Strenuous Exercise on Coagulation.
Condition: The Effect of Strenuous Exercise on Haemostasis.
Study type: Observational

Summary: 
      Many studies have shown that vigorous exercise increases the risk of developing vascular
      thrombotic events and can result in sudden death during or immediately after exercise. The
      outcome of these studies is biased by several confounding variables: subjects, type of
      exercise, duration, intensity and especially the method used for the evaluation of the
      hemostatic capacity. The goal of our study is to investigate the effect of strenuous exercise
      with the Calibrated Automated Thrombogram (CAT) assay, which is an established tool in
      detecting hyper- and hypocoagulabilty conditions. We modified the CAT assay to make it also
      feasible to measure TG in whole blood (WB-CAT), not only to go one step closer to physiology
      since all the blood cells are present, but also to avoid the centrifugation step. With our
      study we would like to see whether the other blood cells also play a role in the increase in
      TG. The objective is to investigate the effect of strenuous exercise (participation to the
      Amstel Gold Race) on coagulation and haemostatic parameters. We hypothesize that strenuous
      exercise induces a prothrombotic phenotype and that especially the tests involving blood
      cells will be altered into a prothrombotic phenotype.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy participants of the Amstel Gold Race for non-professionals will be asked to join
        our study.
Hypokalemia and Intravenous Patient Controlled Analgesia
Condition: General Anesthesia; Laparoscopic Cholecystectomy
MeSH terms: Hypokalemia; Potassium Deficiency
Study type: Interventional

Summary: 
      The increase in stress hormone level and hyperventilation caused by the postoperative pain
      may contribute to the development of hypokalemia during postoperative period. Therefore, if
      the postoperative pain is well controlled by the IV-PCA,the plasma potassium level during the
      postoperative period may be not affected by stress response. The researchers tried to
      investigate the effect of IV-PCA on potassium regulation during the postoperative period.
    

Detailed description: 
      Intravenous patient controlled analgesia(IV-PCA) has been widely used to control
      postoperative pain. The increase in stress hormone level and hyperventilation caused by the
      postoperative pain may contribute to the development of hypokalemia during postoperative
      period. Hypokalemia is a risk factor for postoperative arrhythmia. Therefore, if the
      postoperative pain is well controlled by the IV-PCA, the plasma potassium level during the
      postoperative period may be not affected by stress response, and the incidence of hypokalemia
      may be reduced. The researchers tried to investigate the effect of IV-PCA on potassium
      regulation during the postoperative period.

      The researchers divided the patients undergoing laparoscopic cholecystectomy into two groups
      of IV-PCA group and control group. The researchers compared the plasma potassium
      concentration from the preoperative to postoperative period.
    

Intervention name(s): IV-PCA; Control
Intervention type(s): Drug; Drug
Intervention description(s): IV-PCA (fentanyl 10 mcg/ml) Dose bolus-lock out time - basal = 1.5 ml - 15 min - 1.5 ml/hr; control group (No-PCA group)
Other intervention name(s): fentanyl; no drug
Intervention MeSH terms: Fentanyl
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypokalemia; intravenous patient controlled analgesia
Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is testing the effects of exercise and dietary change on weight reduction and
      biological markers associated with breast cancer risk in breast cancer survivors of Hispanic
      or African descent (n=45). This is a randomized, crossover pilot and feasibility study to
      test the effects of a 30-minute circuit-based exercise program that combines resistance
      training with aerobic exercise in conjunction with a low-fat calorie reduced diet.
      Participants will be randomized to either an immediate 6-months of exercise and dietary
      change, or a delayed group who will begin their exercise and dietary change program 6-months
      after the study begins. Participants in the immediate group will be followed for an
      additional 6-months in order to evaluate adherence to the exercise and dietary change
      recommendations. Participants in both groups will exercise at a neighborhood Curves® facility
      at least 5 times per week for six months and will participate in a series of nutrition
      education classes.
    


Intervention name(s): Physical activity and dietary change
Intervention type(s): Behavioral
Intervention description(s): 6 months of combined resistance training and aerobic exercise (5 times per week x 30 minutes) plus 6-week nutrition counseling class
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Weight loss; Physical activity; Dietary change
Allocentric Memory in MS and Resting State Functional MRI
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The goals of this study are to 1. Investigate the sensitivity of allocentric visual memory
      when compared to more established measures of cognition in identifying cognitive difficulties
      among MS subjects when compared to controls. 2. Determine which cognitive test variable will
      be most strongly associated with self and informant reports of cognition. 3. Determine which
      MRI metric will be most strongly related to neuropsychological test performance 4. Determine
      the degree to which allocentric visual memory is related to functional connectivity on fMRI.
    

Detailed description: 
      This is a cross-sectional, case-control, observational experimental design. The study will
      enroll subjects with multiple sclerosis (MS) and age/gender matched on a battery of
      neuropsychological cognitive tests and self-report measures of cognition.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with relapsing remitting Multiple Sclerosis and demographically matched controls
        will be recruited for this study. The MS subjects will consist of patients who were
        referred for a neuropsychological evaluation and neuroimaging as part of standard practice
        of care to evaluate for cognitive difficulties and/or track disease progression.
Mycobacterium w in Patients With Severe Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Recent evidence suggests that sepsis continuum includes an immune paralytic state, which may
      play a significant role in sepsis. Mycobacterium w by its TLR4 agonist activity may help in
      restoring immunity, thereby improving outcomes in patients with severe sepsis.

      In this randomized trial, the investigators propose to evaluate the efficacy of Mw in
      patients with severe sepsis.
    


Intervention name(s): Mycobacterium w; Best standard care
Intervention type(s): Biological; Other
Intervention description(s): Single daily dose of 0.3 mL of Mw (heat-inactivated Mw [0.5 × 10^9]; Immuvac, Cadila Pharma, Ahmedabad, India) in the deltoid region for 3 consecutive days; Antibiotics as early as possible; Norepinephrine > vasopressin > epinephrine for hypotension; Blood glucose 140-180 mg/dL; DVT and stress ulcer prophylaxis; Low tidal volume mechanical ventilation; Standard VAP, CLABSI prevention bundles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Effect of Humidification on Mucus Rheology
Condition: Chronic Obstructive Pulmonary Disease(COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      In this study the investigators will collect mucus from mechanical ventilated patients and
      patients with COPD to study the effect of temperature and humidity, on the biophysical
      properties of the airway mucus. It is hypothesised that changes in inspired gas temperature
      and humidity (over time) may affect the biophysical properties of the airway mucus and reduce
      the airway's ability to clear mucus, resulting in deleterious clinical affects.
    

Detailed description: 
      Expectorated sputum samples are collected and used to measure the biophysical properties of
      mucus secretions. The samples are later exposed to different temperatures and humidity levels
      during bench experiments.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinic,ICU, Pulmonary Clinic
      
Biospecimen description: 
      Sputum