bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Heparin Rebound in Cardiac Surgery
Condition: Coagulation Delay
Study type: Observational

Summary: 
      Recent work has shown that heparin rebound is common after cardiac surgery.

      The exact doze of protamine required to neutralize heparin at the end of CPB is unknown.
      Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also
      unknown if precise titration of protamine perioperatively in cardiac surgery can influence
      transfusion requirements after cardiac surgery.
    

Detailed description: 
      This study will assess how much protamine is required to neutralize residual heparin
      perioperatively in cardiac surgery through measurement of functional assays of heparin
      (anti-Xa and anti-IIa levels). In the first phase of this study, protamine titration assays
      will be carried out on normal pooled plasma incubated with heparin in the laboratory.

      Once the correct dose of protamine required to neutralize the heparin is established in the
      laboratory, the second phase will begin. Herein, plasma samples from patients undergoing
      cardiac surgery (with anticoagulation with two different commercial preparations of heparin)
      will be evaluated for residual heparin (Anti-Xa and anti-IIa levels). Protamine titration
      assays wil then be carried out in vitro to assess neutralization of heparin.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing elective cardiac surgery
      
Keywords: heparin rebound; protamine; cardiopulmonary bypass; cardiac surgery; anti-Xa; anti-IIa
A Study to Evaluate the Safety and Effectiveness of Novantrone Therapy Followed by Copaxone for Multiple Sclerosis.
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      It is thought that treating multiple sclerosis with Novantrone for a short period of time
      prior to treatment with Copaxone may enhance the onset effect of Copaxone.
    


Intervention name(s): glatiramer acetate 20 mg; glatiramer acetate 20 mg, with mitoxantrone
Intervention type(s): Drug; Drug
Intervention description(s): glatiramer acetate 20 mg; glatiramer acetate 20 mg, with mitoxantrone
Other intervention name(s): Copaxone; Copaxone, Novantrone
Intervention MeSH terms: Mitoxantrone; Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Drug Interaction Study With Dabigatran Etexilate and Dronedarone in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to assess the relative bioavailability of a single dose of
      dabigatran after concomitant multiple oral administration of dronedarone with the aim to
      investigate whether and to what extent the P-gp inhibitor dronedarone affects pharmacokinetic
      parameters of dabigatran when administered to healthy subjects
    


Intervention name(s): Dabigatran etexilate plus dronedarone; Dabigatran etexilate; Dabigatran etexilate plus dronedarone; Dabigatran etexilate plus dronedarone; Dabigatran etexilate plus dronedarone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose; 150 mg as single dose; dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration); dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid; dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)
Intervention MeSH terms: Dronedarone; Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interpretation Bias Modification for Body Dysmorphic Disorder
Condition: Body Dysmorphic Disorder
MeSH terms: Body Dysmorphic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a computerized intervention designed to
      reduce appearance and evaluation related interpretation biases will reduce symptoms
      associated with body dysmorphic disorder.
    

Detailed description: 
      The present study aims to examine the feasibility of a remote treatment for body dysmorphic
      disorder delivered via the Internet. To evaluate the efficacy of the IBM protocol we have
      developed in reducing negative appearance and evaluative related interpretations, we will
      conduct a two-arm randomized controlled trial over the internet. Individuals with a diagnosis
      of body dysmorphic disorder (N = 40) will be randomized to one of two conditions: 1) IBM or
      2) progressive muscle relaxation. Each condition will consist of eight 10-25 minute treatment
      sessions. Participants will complete two sessions per week for four weeks and will be
      administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up.
      We hypothesize that: 1) IBM will lead to greater reductions in BDD symptoms than the PMR
      condition; 2) IBM will lead to greater reductions in depression, anxiety and suicidal
      ideation than the PMR condition; 3) IBM will lead to greater reductions in threat
      interpretations and greater increases in benign interpretations than the PMR condition; 4)
      The effects of condition on BDD symptoms will be mediated by changes in BDD-related
      interpretation bias; and 5) The effects of training in the IBM condition will be maintained
      at the 3-month follow-up assessments.
    

Intervention name(s): Interpretation Bias Modification; Progressive Muscle Relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to appearance.; Eight 15-minute sessions of progressive muscle relaxation (PMR).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Probiotic Supplementation on Weight Loss
Condition: Bariatric Surgery Candidate
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The investigators are trying to better understand how bariatric surgery leads to weight loss,
      and the role of bacteria that live in the gut in making this happen.
    

Detailed description: 
      The investigators are interested in seeing how a probiotic, which is a dietary supplement
      containing large amounts of 'good' bacteria, can influence the make-up of the gut bacterial
      population and what effect it has on weight loss and loss of fat. Before undergoing weight
      loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study participants will be
      asked to provide a stool sample to assess the make-up of their gut bacterial population. They
      will also undergo a limited CT scan of the abdomen and DEXA (Xray) to help assess the amount
      of fat present inside the body.

      After undergoing weight loss surgery (sleeve gastrectomy or roux-en-y gastric bypass), study
      participants will be given either a probiotic supplement or dummy pill (placebo) for 3
      months, in addition to all usual care that occurs after surgery. The CT scan, DEXA scan and
      stool sample will be repeated at the end of the 3 month period and analyzed for changes.
    

Intervention name(s): Probiotic; microcrystalline cellulose
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lactobacillus rhamnosus GG 10 billion cells and microcrystalline cellulose; Placebo
Other intervention name(s): Culturelle®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Probiotic; Microbiome
Influence of Participation in Randomized Controlled Trials on adheRence to Medicines' Intake and regUlar viSits to the docTor
Condition: Adherence, Patient
Study type: Observational

Summary: 
      A prospective non-interventional single-center study aimed to evaluate the influence of
      participation in international randomized controlled trials (RCT) of cardiovascular patients
      on their compliance and adherence to medicines' intake and regular visits to the doctor in
      comparison with those patients, who had never participated in RCT within the outpatient
      registry PROFILE (prospective, observational study).
    


Intervention name(s): Not Provided
Intervention type(s): Other
Intervention description(s): Not Provided
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All patients will be taken from the outpatient register PROFILE
      
Keywords: patient adherence, randomized clinical trials
AGC Mode vs Minimal Flow in Breast Surgery
Condition: Volatil Agent Consumption; Automatic End-tidal Controlled Anesthesia; Anesthesia; Functional; Breast Diseases
MeSH terms: Breast Diseases
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to compare the AGC mode and manually controlled minimal-flow
      anesthesia for volatile anesthetic consumption, hemodynamic parameters, and recovery from
      anesthesia
    

Detailed description: 
      Modern anesthesia machines use circular systems in which ventilated gas re-circulates to a
      certain degree and is therefore reused, preserving temperature, and humidity. The rebreathing
      fraction is increased by a reduction in fresh gas flow, which leads to a considerable
      decrease in consumption of fresh gas and volatile anesthetics, resulting in reductions in
      cost and atmospheric pollution. In a closed ventilation system, only the patient's
      requirements for oxygen and anesthetic agents are supplemented. A fresh gas flow-rate of 0.5
      l/min is defined as the minimal-flow technique. The oxygen and anesthetic gas titration can
      be manually controlled by the anesthetist. To assure safe and appropriate anesthesia,
      manually controlled anesthesia requires constant monitoring and numerous adjustments to the
      gas dosage by the anesthetist, especially for low- and minimalflow anesthesia. Oxygen flow
      and volatile anesthetics can also be automatically controlled by anesthesia machines using
      end-tidal control (such as AGC mode of Maquet FLOW-i anesthesia machine), which ensures
      constant end-tidal concentration of oxygen and anesthetic gas via feedback and continuous
      automatic adjustment mechanisms. Anesthesiologists needing to make fewer interventions during
      a case may have clinical importance in terms of distraction, record keeping and patient
      safety. In addition to this advantage, we wanted to compare the AGC mode and manually
      controlled minimal-flow anesthesia for volatile anesthetic consumption, hemodynamic
      parameters, and recovery from anesthesia.
    

Intervention name(s): AGC mode
Intervention type(s): Device
Intervention description(s): Automated Gas Control mode at Maquet FLOW-i anesthesia machine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Between 18-65 years, female patients underwent breast surgery
      
Keywords: anesthesia machine; sevoflurane; minimal fresh gas flow; breast surgery; AGC mode
A Double-Blind Comparison of Concerta and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double-blind, placebo-controlled study using daily doses of up to 1.3 mg/kg/day of
      Concerta in the treatment of adults with the DSM-IV diagnosis of attention deficit
      hyperactivity disorder (ADHD) (childhood onset). We hypothesize ADHD symptomatology in adults
      with DSM-IV ADHD will be responsive to Concerta treatment and Concerta-associated response of
      ADHD symptomatology in adults will be sustained over time.
    

Detailed description: 
      Concerta was specially developed to replace three-times-a-day IR methylphenidate, making it
      an ideal option for patients with ADHD. Moreover, the once-a-day administration of Concerta
      secures a steady delivery of methylphenidate across the day, minimizing the well-known risks
      of peaks and valleys of IR methylphenidate, which could offer an added advantage to the
      pharmacokinetic advantage of once-a-day administration. Despite these putative advantages,
      whether this new delivery system will lead to the same results as those documented with
      immediate-response methylphenidate in the treatments of adults with ADHD requires empirical
      corroboration. To this end we are conducting a randomized controlled clinical trial to
      evaluate the short- and medium-term safety and efficacy of Concerta in the treatment of
      adults with ADHD with and without co-morbid psychiatric disorders. We also wish to examine
      the role of genetics in predicting ADHD treatment response to Concerta. There is growing
      literature that supports the role of genetic factors in treatment response in youth with
      ADHD, and we seek to further explore this relationship in adults.

      The proposed study includes the use of a 34-week design to document the response rate,
      assessment of the impact of Concerta on functional capacities (quality of life, psychosocial
      function) and cognition, and careful assessment of safety and tolerability.
    

Intervention name(s): methylphenidate HCl (Concerta); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): up to a maximum dose of 1.3 mg Concerta/kg/day, and not more than 144 mg/day for any subject regardless of weight.; up to a maximum dose of 1.3 mg Placebo /kg/day, and not more than 144 mg/day for any subject regardless of weight.
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD; Adults; Concerta; Double-Blind
Postpartum Hypertension: Remote Patient Monitoring
Condition: Hypertension, Pregnancy-Induced
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to see if Honeywell Genesis Android Touch Bluetooth System
      (mobile health) can improve patient satisfaction and quality of care provided to women
      experiencing complications due to high blood pressure during pregnancy.
    

Detailed description: 
      For six weeks postpartum, patients will use Honeywell Genesis Android Touch Bluetooth System
      to record and submit their daily blood pressure and weight measurements to a mobile health
      nurse and research team. Subjects will be provided with the kit (Honeywell tablet, mobile hot
      spot, blood pressure cuff, and scale) at no cost. Subjects will participate in video
      telehealth visits at 48 hours and 7 days after discharge to help provide management for
      hypertension related issues.
    

Intervention name(s): Mobile Health
Intervention type(s): Other
Intervention description(s): Subjects will submit blood pressure and weight measurements daily for 6 weeks postpartum. Subjects will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Inflammatory Responses Subsequent to Different Cesarean Section Techniques
Condition: Delivery; Cesarean Delivery; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      In this study, the investigators aimed to find out whether there are any differences in
      inflammatory reactions occured subsequent to two different cesarean delivery techniques;
      modified Misgav-Ladach vs Pfannenstiel-Kerr techniques.
    

Detailed description: 
      Cesarean section is one of the most undertaken operations in women of childbearing age.
      However, there is not a unique cesarean surgery technique. Pfannenstiel , reported his own
      technique in 1897. Because of the applicability of the technique, it went down well among
      obstetricians. After three decades, Kerr evolved this technique, and Pfannenstiel-Kerr
      technique became the method of choice until late 70's. In 1972, Stark et al defined the
      Misgav Ladach technique and in the following years this technique became popular among
      obstetricians. In late 80's Misgav Ladach technique was modified and started to be more
      popular. But, still Pfannenstiel-Kerr technique continued to be used frequently and studies
      comparing clinical outcomes of these two techniques were conducted for several times.
      However, the inflammatory responses which occured subsequent to application of these
      techniques were not investigated. This is the first study investigating the inflammatory
      response emerged after different cesarean surgery techniques.
    

Intervention name(s): cesarean section(C/S) via the modified Misgav-Ladach technique; cesarean section via the Pfannenstiel-Kerr technique
Intervention type(s): Procedure; Procedure
Intervention description(s): the first consecutive 44 patients underwent C/S via the modified Misgav-Ladach technique; the second consecutive 44 patients underwent C/S via the Pfannenstiel-Kerr technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: inflammatory reaction; IL-6; TNF; Misgav Ladach technique; Pfannenstiel-Kerr technique; cesarean delivery; cesarean technique
General Anesthesia and Paravertebral Blocks vs. General Anesthesia Only: Influence Inflammation Factors and Clinical Outcomes in Modified Radical Mastectomy
Condition: Anesthesia, Local; Anesthesia; Inflammatory Response; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      Regional anesthesia and analgesia may maintain immune function, reduce surgical stress, and
      also reduce volatile anesthetics and opioids requirements. Local anesthetic drugs used in
      regional anesthesia and analgesia work to have anti-proliferative and cytotoxic effects on
      cancer cells. Pro-inflammatory cytokines such as IL-1, IL-6, and TNF-alpha increase in levels
      in peripheral nerves, spinal cord, brain (brain stem, locus sereleus, thalamus, hippocampus,
      and prefrontal cortex) after peripheral nerves are injured. The anti-inflammatory cytokine
      IL-10 is decreased in levels after peripheral nerve injury. The balance between
      pro-inflammatory and anti-inflammatory cytokines affects the severity of pain.
    


Intervention name(s): Paravertebral block; General Anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): The subjects in this group received general anesthesia and USG-guided paravertebral block; The subjects in this group underwent MRM under routine general anesthesia without peripheral nerve block supplementation.
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with breast cancer (stadium Ia-IIIb) who underwent MRM surgery under general
        anesthesia in Sanglah General Hospital
A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about a new formulation of insulin lispro
      when given by an insulin pump to participants with type 1 diabetes mellitus. The study will
      investigate how the body processes the drug and how the drug affects the body. Information
      about side effects will be collected. The study will last from six to 12 weeks for each
      participant.
    


Intervention name(s): LY900027; Insulin Lispro
Intervention type(s): Drug; Drug
Intervention description(s): LY900027 administered to participants with T1DM using CSII.; Insulin lispro administered to participants with T1DM using CSII.
Other intervention name(s): Humalog; LY275585
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia
Condition: Attention Deficit Hyperactivity Disorder; Dyslexia
MeSH terms: Hyperkinesis; Dyslexia; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effects of atomoxetine on brain activation during attention and
      reading tasks via functional Magnetic Resonance Imaging (fMRI) in participants ages 10 to 16
      years old with ADHD and comorbid dyslexia
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind, single site study that uses an fMRI
      measurement to assess brain activation during attention and reading tasks and the effects of
      atomoxetine in reducing symptoms of ADHD in participants with ADHD and comorbid dyslexia.
      Similar assessments are performed in two additional groups of participants with ADHD only and
      dyslexia only to determine to what extent symptomatic change in the comorbid ADHD & dyslexia
      is achieved independently by atomoxetine effects on either condition. A healthy control group
      of non-ADHD, non-dyslexia subjects (20) will be included to monitor practice effects &
      effects of treatment that may be interpreted as normal maturation. The healthy control group
      will not be treated with any study medications.
    

Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks; oral, daily, for 16 weeks
Other intervention name(s): LY139603
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment