bioihbjkbjnl/mcl2 huggingface dataset:
Carotid Atherosclerosis: MEtformin for Insulin ResistAnce Study
Condition: Coronary Artery Disease
MeSH terms: Carotid Artery Diseases; Coronary Artery Disease; Atherosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis: Treatment with metformin in overweight non-diabetic individuals with coronary
      heart disease and on standard cardiovascular risk reducing agents including statins will have
      a beneficial impact on carotid artery atherosclerosis compared to placebo.

      Rationale: Once subjects have a heart attack, they remain at much higher than average risk of
      another heart attack and stroke, despite the best current therapies to lower their
      cholesterol and blood pressure and thin their blood. Many subjects with heart disease also
      have problems metabolising (i.e. processing) sugar even if they do not have diabetes. There
      is some evidence that metformin, a drug which improves sugar metabolism, decreases the risk
      of future heart attacks in diabetic patients. However, whether metformin further reduces the
      risk of heart disease beyond established treatments in people without diabetes is unknown.

      Method: The investigators will test the ability metformin, a drug with proven safety, to slow
      the progression of furring up (known as atherosclerosis) of blood vessels in non-diabetic
      subjects with heart disease. This will be achieved by treating 2 groups of subjects with
      metformin and placebo pills respectively. To measure atherosclerosis, the investigators will
      carry out ultrasound scans of the big blood vessels in the neck at the start of the study,
      after 1 year and after 1.5 years of therapy.The investigators will then be able to assess
      whether metformin has had a beneficial impact.
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): White film-coated tablets, 850mg tablet twice daily, 1.5 years duration; White coated tablet; one tablet twice daily; 1.5 years duration
Other intervention name(s): Glucophage; Glucophage SR; Bolamyn SR; Dummy pill
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: No diabetes mellitus; Elevated waist circumference
Efficacy of Folrex in the Superior Extremity Rehabilitation After Acute Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate whether Folrex, could improve the motor recovery of
      the upper extremity after stroke in comparison with placebo during 4 weeks of treatment.
    

Detailed description: 
      Periodical measures of the motor recovery, of the upper extremity, by Fugl-Meyer score, it
      will be done at the beginning, at fifth day and at month. Each value will be compare to
      evaluate whether the groups of patient improve.
    

Intervention name(s): Folrex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Folrex cream, in the early rehabilitations in the upper extremity, before daily rehabilitation; Placebo cream, in the early rehabilitations in the upper extremity, before daily rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical study is to establish the comparability of the pharmacokinetics and
      similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-264 and Darzalex
      following a single intravenous infusion in healthy subjects.
    

Detailed description: 
      In this clinical study, each subject will receive a single intravenous infusion of BCD-264 or
      Darzalex, depending on the group the subject will be randomized to. The drugs are
      administered at the study site at a dose of 8 mg/kg.

      The subjects will be followed up and blood samples collected for pharmacokinetics,
      pharmacodynamics, immunogenicity and safety studies up to and including 71 study days after
      the administration of IP.
    

Intervention name(s): BCD-264; Darzalex
Intervention type(s): Drug; Drug
Intervention description(s): a single intravenous infusion of BCD-264; a single intravenous infusion of Darzalex
Intervention MeSH terms: Daratumumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Double-Blind Randomized Cross-Over Trial Comparing Metabolic Effects of Candesartan, Hydrochlorothiazide and Placebo
Condition: Hypertension; Obesity
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of a 12-week candesartan treatment
      compared with hydrochlorothiazide on insulin sensitivity assessed with hyperinsulinemic
      euglycemic clamp.
    

Detailed description: 
      To investigate the mechanisms underlaying the diabetes-preventing effect of candesartan with
      respect to possible impact on insulin sensitivity, beta cell function and adipose tissue
      function and distribution. For this purpose comparisons will be performed with
      hydrochlorothiazide and placebo treatment. It is hypothesized that candesartan will improve
      insulin sensitivity as compared to hydrochlorothiazide and possibly also in comparison with
      placebo and that this could be explained by altered fat tissue function or distribution or by
      an altered sympathetic to parasympathetic balance in the autonomic nervous system.
      Hydrochlorthiazide is chosen as comparator because thiazides are a recommended firs-line
      therapy in hypertension. This drug class has some detrimental effects on glucose tolerance
      and in insulin sensitivity.
    

Intervention name(s): Hydrochlorothiazide; Placebo; Candesartan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25-50 mg once daily; Once daily; 16-32 mg once daily 12 weeks
Intervention MeSH terms: Hydrochlorothiazide; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolic; Hypertension; Abdominal obesity; Insulin sensitivity; Hyperinsulinemic euglycemic clamp
Different Preoxygenation Methods In Cesarean Section
Condition: Hypoxia; Hyperoxia
MeSH terms: Hypoxia; Hyperoxia
Study type: Observational

Summary: 
      The study aimed to evaluate different preoxygenation methods (tidal volume for 3 minutes and
      4 deep breaths) in pregnant women with oxygen reserve index (ORI).

      After the routine monitoring of healthy ASA II pregnant patients between the ages of 18-45,
      different preoxygenation methods will be applied, and the oxygen status of the patients will
      be compared with ORI monitoring.
    


Intervention name(s): Oxygen Reserve Index
Intervention type(s): Device
Intervention description(s): It is a new non-invasive and continuous measurement parameter that aims to provide information about the oxygen status of patients in the moderately hyperoxic range (100 mmHg< PaO2 ≤ 200 mmHg).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 18-45 who had cesarean section under general anesthesia
      
Keywords: Oxygen Reserve Index; Preoxygenation; General Anesthesia; Cesarean Section
Trial Using CogWatch for Tea Making Training in Stroke Apraxia and Action Disorganisation Syndrome
Condition: Stroke; Apraxias
MeSH terms: Stroke; Apraxias
Study type: Interventional

Summary: 
      Apraxia and action disorganization syndrome after stroke can disrupt activities of daily
      living (ADL). Occupational therapy has been effective in improving ADL performance, however,
      inclusion of multiple tasks means it is unclear which therapy elements contribute to
      improvement. This study evaluates the efficacy of a task model approach to ADL
      rehabilitation, comparing training in making a cup of tea with a gait training control
      condition.
    

Detailed description: 
      Apraxia and action disorganization syndrome (AADS) after stroke can disrupt activities of
      daily living (ADLs). Occupational therapy has been effective in improving ADL performance,
      however, inclusion of multiple tasks means it is unclear which therapy elements contribute to
      improvement.

      This trial evaluates the efficacy of a task model approach to ADL rehabilitation, comparing
      training in making a cup of tea with a stepping training control condition.

      Stroke survivors with AADS participate in a cross-over randomized controlled study.
      Participants attend five 1-hour tea making training sessions in which progress is monitored
      and feedback given using a computer-based system which implements a Markov Decision Process
      (MDP) task model (CogWatch). In a control condition participants receive five 1-hour stepping
      sessions.

      Analysis compares tea making training with stepping training effects on error reduction and
      time taken in making 4 different tea types. A complex tea preparation task (making two
      different cups of tea simultaneously) is used to test for generalisation of training effects.
    

Intervention name(s): Task model (CogWatch)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover randomized control
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Activity of daily living; Stroke; Apraxia; Action of daily living; Cup of tea
Effect of Introperative Ketamine and Lidocaine Infusion on Postoperative Opioid Consumption in Posterior Spinal Fusion Surgery
Condition: Spine Fusion; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Objective: The primary aim of this study was to investigate the effect of ketamine and
      lidocaine on postoperative opioid consumption in posterior spinal fusion surgery.

      Materials and Methods: Ethics committee approval was received from our faculty. Seventy-five
      cases between the ages of 18-65, who have an ASA (American Society of Anesthesiologists) risk
      classification I-II-III in the preanesthetic evaluation, planned to be operated by the
      Neurosurgery clinic for lumbar posterior spinal fusion surgery under elective conditions have
      been included in the study after the informed volunteer consent form was read and approved.

      The patients were randomly divided into 3 groups using the closed envelope method. The
      ketamine group (Group K) (n = 25), the lidocaine group (Group L) (n = 25) and the placebo
      group (Group P) (n = 25). Propofol, rocuronium and fentanyl i.v. done. In group K, 0.5 mg /
      kg i.v. ketamine bolus and 0.25 mg / kg / hr i.v. ketamine infusion was administered. In
      group L, 1.5 mg / kg i.v. lidocaine bolus and 1.5 mg / kg / hr i.v. lidocaine infusion was
      administered. In group P, i.v. saline (in the same volume and duration) was applied.
      Maintenance of anesthesia was provided by propofol and remifentanil infusion. The propofol
      and remifentanil doses were adjusted according to the BIS monitoring and the increase or
      decrease in basal blood pressure and heart rate values of 20% or more. The BIS value was kept
      between 40-60. At the end of surgery, infusions were closed. After extubation, the patients
      were taken to the recovery room. Patient controlled analgesia (PCA) prepared with fentanyl
      was applied to the patients for postoperative analgesia. The PCA device was attached for 24
      hours postoperatively.

      Postoperative 0-4 hours, 4-8 hours, 8-24 hours and total fentanyl consumption of the patients
      were evaluated. Pain scores were measured at 1, 2, 4, 8, 12 and 24 hours in the postoperative
      recovery room. Intraoperative propofol and remifentanil consumption was recorded. Tramadol 1
      mg / kg i.v. as rescue analgesia (in patients with VAS pain score of 4 and above) done.
      Possible side effects due to opioid, ketamine and lidocaine were followed.
    


Intervention name(s): Ketamine; Lidocain; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intraoperative ketamine bolus and infusion; intraoperative lidocain bolus and infusion; intraoperative saline bolus and infusion
Intervention MeSH terms: Lidocaine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Epigastric Hernia
Condition: Epigastric Hernia Repair; Erector Spinae Plane Block; Post Operative Pain; Diaphragmatic Dysfunction
MeSH terms: Hernia; Pain, Postoperative; Hernia, Abdominal
Study type: Interventional

Summary: 
      The aim of this study is to assess the efficacy of ultrasound guided erector Spinae plane
      block on postoperative pain score and diaphragmatic dysfunction in obese patients undergoing
      Epigastric hernia repair.
    

Detailed description: 
      Ventral hernia repair is an operation associated with significant postoperative pain. There
      is a lot of modalities of pain control including regional anesthesia, intravenous opioids,
      and non-opioid analgesics. Regional anesthesia is often helpful in improving respiratory
      function and analgesia.

      The dysfunction of the respiratory muscles, especially the diaphragm, caused by the upper
      abdominal surgery is a major cause of postoperative pulmonary complications, such as
      atelectasis and pneumonia. Sonografic evaluation of diaphragm is an accepted qualitative
      method of assessing diaphragmatic motion.

      The erector spinae plane block is a paraspinal fascial plane block in which local anesthetic
      is administered between the erector spinae muscle and the transverse processes, blocking the
      dorsal and ventral rami of the thoracic and abdominal spinal nerves.

      According to previous studies, erector spinae plane block provide lower postoperative pain
      score and decrease consumption of both postoperative and intraoperative analgesia for
      patients undergoing Epigastric hernia repair.
    

Intervention name(s): The erector spinae plane block group; Control group
Intervention type(s): Procedure; Procedure
Intervention description(s): The probe should then slowly be moved laterally until the transverse process is visible. The 100 mm, 25-gauge needle should be inserted using an in-plane approach in the cephalad to caudal direction and advanced under ultrasound guidance towards the transverse process; once the needle tip is below the erector spinae muscle, a small bolus of local anesthetic should be given. The erector spinae muscle should be visualized, separating from the transverse process. After aspiration the local anesthetic (20 ml of 0.25% bupivacaine was injected. Technique was repeated on the other side.; Patients in this group will receive general anesthesia alone.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fifty obese patient BMI (30-40), aged (21-65) years ASA (ІΙ and ΙΙІ) and scheduled for elective Epigastric hernia repair were enrolled in the study.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Low Intensity Extracorporeal Shockwave Therapy for Patients With Erectile Dysfunction
Condition: Vasculogenic Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      This is a prospective, pilot study for assessing the safety and efficacy of the treatments
      performed with Renova (LI-ESWT) on symptomatic ED patients.
    


Intervention name(s): Low intensity linear focused shockwave device ('Renova')
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sexual Medicine clinic
      
Keywords: Low Intensity Shockwave; Extracorporeal shockwave therapy; Erectile dysfunction
Dietary Supplementation to Increase Serum Choline Levels
Condition: Healthy
Study type: Interventional

Summary: 
      The goal is to assess whether, in adult women during the luteal phase of their menstrual
      cycle, supplementing their diet with either phosphatidylcholine or betaine increases their
      serum choline levels.
    

Detailed description: 
      Elevated maternal serum free choline has the potential to improve fetal brain development .
      However, in humans, choline can be metabolized by gut flora into two metabolites with adverse
      outcomes: trimethylurea (which causes body odor) and Trimethylamine (TMA) which is then, once
      absorbed, metabolized into Trimethylamine-N-Oxide (TMAO). There is some concern that TMAO may
      be atherogenic and thus, if elevated over an extended period of time, may increase risk for
      cardiac disease. Thus, while maternal choline supplementation may improve fetal brain
      development, there is a potential for maternal adverse effects.

      However, humans have an active choline metabolic pathway, and other components of the choline
      metabolic pathway (e.g. phosphatidylcholine and betaine) may be interchangeable with choline
      post absorption but are resistant to gut bacteria metabolism (i.e. serum TMA does not
      increase). Thus, these other compounds would be expected to increase serum but with no impact
      on TMA or trimethylurea levels. An initial study of phosphatidylcholine supplementation in
      pregnant women was consistent with this hypothesis; infant offspring demonstrated improved
      cerebral inhibition; while no adverse events were identified for either mother or infant.

      Unfortunately, because of the lipid groups incorporated into phosphatidylcholine, its
      molecular weight is high and reasonable doses require consuming several large capsules a day.
      The study represents the first attempt to determine if betaine, an alternative compound
      within the same metabolic pathway but with a much lower molecular weight, also increases
      serum choline levels. As the first step, this proposal seeks to address this in non-pregnant
      women. Specifically, the goals are to (a) assess whether changes in serum choline levels in
      response to molar equivalent supplementation of phosphatidylcholine versus betaine are
      similar, and (b) whether, for betaine, there is a dose response relationship between
      supplementation dose and serum choline levels.
    

Intervention name(s): Phosphatidylcholine; Betaine (588 mg qam and 412 mg qpm); Betaine (1000 mg BID)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Phosphatidylcholine 3600 mg qam and 2700 mg qpm; Betaine anhydrous 588 mg qam and 412 mg qpm; Betaine anhydrous 1000 mg BID
Other intervention name(s): Trimethylglycine; Trimethylglycine
Intervention MeSH terms: Betaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dietary supplements; serum choline; women
Continued Use of Effective Contraception After Use of Emergency Contraception
Condition: Emergency Contraception; Contraception; Reproductive Health
MeSH terms: Emergencies
Study type: Observational

Summary: 
      Women using an emergency contraceptive method must use back up protection for 1-2 weeks
      depending on method. The Copper-IUD is the most effective emergency contraceptive method. The
      investigators wish to explore if women choosing the Cooper IUD have a higher frequency of use
      of an effective contraceptive method 3 months and 6 months after the use of an emergency
      contraceptive method than women who choose to use the emergency contraceptive pill EllaOne
      (ulipristal acetate).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women without contraception or with a failed contraceptive method seeking emergency
        contraception
Silo Versus Primary Closure for Gastroschisis
Condition: Gastroschisis
MeSH terms: Gastroschisis
Study type: Interventional

Summary: 
      The objective of this study is to scientifically evaluate two different closure strategies
      for gastroschisis to determine if there is a difference in the two approaches.
    

Detailed description: 
      The hypothesis is that there is no difference between bedside silo placement and operative
      closure in return of bowel function, ventilator dependence, or length of stay.

      The primary outcome variable between the two techniques will be length of hospitalization.
      The likely variables will be length of time to meet discharge criteria, length of
      hospitalization, time to full feedings, time on mechanical ventilation and total hospital
      charges.
    

Intervention name(s): silo for gastroschisis; Primary closure of gastroschisis
Intervention type(s): Procedure; Procedure
Intervention description(s): silo placed around abdominal contents in gastroschisis patients; Primary closure of gastroschisis, if possible
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastroschisis; silo; primary closure