bioihbjkbjnl/mcl2 huggingface dataset:
Combined Basal-bolus Insulin and Post-exercise Carbohydrate Feeding Strategy in T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The investigators hypothesise that reducing basal insulin dose (Glargine, Lantus,
      Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk), whilst employing current carbohydrate
      feeding and rapid-acting insulin dose recommendations will protect patients with type 1
      diabetes from early- and late-onset hypoglycaemia following evening time exercise.
    


Intervention name(s): Basal insulin dose
Intervention type(s): Drug
Other intervention name(s): (Glargine, Lantus, Sanofi-Aventis, or Detemir, Levemir, Novo Nordisk)
Intervention MeSH terms: Insulin; Insulin Glargine; Insulin Detemir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: T1DM, Exercise, Hypoglycaemia
Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      The clinical trial aims to study the safety and efficacy of transfusion of COVID-19
      convalescent hyperimmune plasma for the treatment of moderate and severe forms of COVID-19
      disease in comparison with non-convalescent fresh frozen plasma (standard plasma).
    

Detailed description: 
      This is a study of the safety and efficacy of the use of COVID-19 convalescent plasma (from
      subjects who have recovered from SARS-CoV-2) in the treatment of moderate and severe forms of
      the SARS-CoV-2 infection. Currently, there are no registered drugs for the treatment of the
      SARS-CoV-2 infection in the world. The use of hyperimmune plasma is a well-known method used
      for many decades to treat many dangerous infections. The effectiveness of such a therapy for
      COVID-19 patients has recently been demonstrated in a number of clinical studies in China.
      Therefore, we plan to study the feasibility of administering multiple doses of COVID-19
      convalescent plasma in comparison with standard plasma to moderate and severe patients with
      COVID-19.
    

Intervention name(s): COVID-19 convalescent hyperimmune plasma; Non-convalescent fresh frozen plasma (Standard plasma)
Intervention type(s): Biological; Biological
Intervention description(s): Subjects to receive double convalescent hyperimmune plasma units of 300 ml each, with the 2nd unit administered no later than 24 hrs after the first one; Subjects to receive double standard plasma units of 300 ml each, with the 2nd unit administered no later than 24 hrs after the first one
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Aspirin on Hemostatic and Vascular Function After Live Fire Fighting
Condition: Cardiovascular Risk Factor; C.Medical Procedure; Vascular, Functional or Late; Electrolyte and Fluid Balance Conditions
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that

        1. an acute treatment of low-dose aspirin will lead to a) decreased resting platelet
           activation, platelet aggregation, and clotting potential, b) increased fibrinolytic
           potential following fire fighting, c) no significant effect on endothelial function or
           arterial stiffness versus the placebo condition.

        2. chronic treatment with low-dose aspirin will lead to a) decreased resting and fire
           fighting induced platelet activation, platelet aggregation, clotting potential, b)
           increased fibrinolytic potential, and c) increased endothelial function and decreased
           arterial stiffness in response to live fire fighting versus the placebo condition.

        3. short-term fire fighting activity will result in: a) a reduction in arterial function
           (reduced endothelial function, increased augmentation index and an attenuated arterial
           stiffness response); b) a disruption in hemostasis that is characterized by an increase
           in platelet number and function, an increased coagulatory potential and altered
           fibrinolytic potential; and c) an elevation in procoagulatory cytokines, systemic
           inflammation, monokine chemoattractant protein, and matrix metalloproteinases.
    


Intervention name(s): 81 mg enteric coated aspirin
Intervention type(s): Drug
Intervention description(s): 81 mg enteric coated aspirin will be provided both as an acute dosage immediately prior to firefighting (1 hour pre-activity) and as a 14 day dosage prior to firefighting
Other intervention name(s): aspirin
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vascular function; Inflammation; Oxidative stress; Hemostatic balance; Aspirin; Firefighting
Effective Dose of Dexmedetomidine for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia With or Without Fentanyl by Age Groups: Randomized Comparative Study
Condition: Benign Prostate Hyperplasia; Bladder Tumor
MeSH terms: Urinary Bladder Neoplasms; Prostatic Hyperplasia; Hyperplasia
Study type: Interventional

Summary: 
      Recently many studies reported that intraoperative dexmedetomidine administration undergoing
      spinal anesthesia give a satisfactory sedation in elderly patients and cause less respiratory
      depressions compared other sedatives(e.g. benzodiazepine) But the optimal dose of
      dexmedetomidine for sedative effect in elderly patients undergoing spinal anesthesia was not
      got general consensus.

      The investigators hypothesized that the dose requirements would be lower than in elderly
      patients than young patients. Furthermore, intrathecal small dose opioids enhance the
      analgesia provided by bupivacaine due to synergistic effects and it would reduce the dose of
      dexmedetomidine.

      The purpose of this study was to determine the dose of dexmedetomidine to provide
      satisfactory sedation undergoing spinal anesthesia with or without additive small dose
      intrathecal opioids.

      Elderly patients(65~85 years old) undergoing TURP or TURB were enrolled in this
      single-blinded study. Forty patients were randomly assigned to receive intrathecal hyperbaric
      bupivacaine 6mg coadministered with 20mcg fentanyl or placebo normal saline 0.4cc. After the
      induction (bilateral T10 sensory level to pinprick within 5 mins of intrathecal drug
      administration), continuous intravenous dexmedetomidine was started in dose of 0.8, 0.6, 0.5,
      0.4, 0.3, or 0.2mcg. Successful sedation was defined as OASS score 3 or 4 within 20 minutes
      of dexmedetomidine infusion. The dose of dexmedetomidine was selected for each patient
      according to an up and down method. Intraoperative arterial pressure, heart rate, and
      bispectral index was compared. Postoperative pain score, the time for the regression of
      sensory and motor was recorded for further analysis.
    


Intervention name(s): dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Spinal anesthesia regimen Group F: 6mg bupivacaine + 20mcg fentanyl (intrathecal) + o.4 cc 5% dextrose water Group C: 6mg bupivacaine + 0.4 cc normal saline + 0.4cc 5% dextrose water
dexmedetomidine 0.2~0.8 micro gram/kg intravenous administration after the sterilization of the spinal anesthesia level, and prehydration
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: dexmedetomidine; sedation in elderly patient; spinal anesthesia
Methylphenidate for Treating Children With ADHD and Tourette Syndrome
Condition: Attention Deficit Disorder With Hyperactivity; Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study will evaluate the safety and effectiveness of methylphenidate in treating
      attention deficit hyperactivity disorder in children with both attention deficit
      hyperactivity disorder and Tourette syndrome.
    

Detailed description: 
      Tourette syndrome is a neurological disorder that is characterized by repetitive, involuntary
      movements and vocalizations called tics. Many children with Tourette syndrome also have
      attention deficit hyperactivity disorder (ADHD), which is one of the most common childhood
      mental disorders. Symptoms of ADHD usually include impulsiveness, inattention, and
      hyperactivity. ADHD is commonly treated with a stimulant medication, such as methylphenidate.
      It is under debate, however, whether using stimulants in children with Tourette syndrome
      exacerbates tics associated with the disorder. This study will evaluate the safety and
      effectiveness of methylphenidate in treating ADHD in children who have both ADHD and Tourette
      syndrome.

      Participants in this 6-week, double blind study will receive three doses of methylphenidate
      over the course of the study. Each dose will be taken twice daily, approximately 3.5 hours
      apart, for 2 weeks. Medication will be dispensed at study visits, which will occur once every
      2 weeks. At each study visit, participants will take a dose of the medication. About an hour
      after ingesting the medication, they will be observed in a classroom setting by study
      physicians. Participants will then complete a Continuous Performance Test, which will measure
      their voluntary attention levels. The following will be assessed at study visits: ADHD
      symptoms; oppositional and aggressive behavior; frequency and severity of tics and obsessive
      compulsive disorder symptoms; rebound tic exacerbation; effects of methylphenidate on
      tic-related problems with self-esteem, family life, academic and social performance, and
      overall tic severity; anxiety and mood symptoms; and adverse drug reactions. Parents and
      teachers will also complete assessments of participants' behavior on 2 days of each week for
      the duration of the study.
    

Intervention name(s): Methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ADHD
Retrospective Analysis Assessing Clinical Risk Factors for Cardiovascular Events and Mortality and Development of a Risk Calculator in Chronic Kidney Disease Stage 5 on Dialysis
Condition: Chronic Kidney Disease (CKD)
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      The purpose of this study is to evaluate which clinical and laboratory factors are associated
      with major adverse cardiovascular event (MACE) in chronic kidney disease (CKD) patients on
      dialysis.

      The study will also establish a cardiovascular (CV) risk equation appropriate for this
      dialysis population.
    

Detailed description: 
      This study is a retrospective analysis of dialysis dependent CKD patients participating in
      AURORA. The retrospective analysis will be performed using the AURORA study database.

      AURORA was a prospective clinical trial in which dialysis patients were randomly assigned to
      rosuvastatin or placebo, sponsored by AstraZeneca. Patients included in the AURORA study who
      had end stage renal disease (ESRD) and had been treated with regular hemodialysis or
      hemofiltration for at least 3 months. Patients were recruited from approximately 300 centers
      in 25 countries.

      The clinical study data is held by AstraZeneca AB, Sweden.

      No formal sample size calculation was performed. The sample size is based on the available
      data from the AURORA study.
    

Intervention name(s): Non-interventional
Intervention type(s): Other
Intervention description(s): Exploring clinical risk factors associated with the risk for cardiovascular events and mortality, rather than to evaluate specific drugs.
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients included in the AURORA study were men and women who had ESRD and had been treated
        with regular hemodialysis or hemofiltration for at least 3 months.
      
Keywords: AURORA; Cardiovascular Events; Chronic Kidney Disease
A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee.
      Half of the patients will receive the agent via intra-articular injection and half will
      receive a placebo injection.
    

Detailed description: 
      The treatment of pain associated with osteoarthritis may include periodic intra-articular
      injections of corticosteroids or viscosupplements such as hyaluronic acid. SB-061 is
      anticipated to relieve osteoarthritis pain by reinforcing the cartilage matrix and providing
      a lubricating coating of the cartilage. Subjects will receive 1 intra-articular injection of
      either SB-061 or placebo and be followed for 3 months to evaluate pain amelioration. Subjects
      and Investigators are blinded to treatment allocation.
    

Intervention name(s): SB-061; Placebo
Intervention type(s): Device; Other
Intervention description(s): delivered via intra-articular injection; Placebo delivered via intra-articular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee
Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for
      Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is
      an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA
      can be given either intravenously or topically (placed directly on the open wound) before
      wound closure. Patients with certain medical conditions have been found to have a high risk
      of thrombosis after being given intravenous TXA, which may lead to serious complications.
      However, to date, no high-risk patients have been identified for use of topical TXA. This
      study will look at thrombogenic markers (proteins found in blood that promote clot formation)
      after TXA is given either intravenously or topically. If the effect on these markers is
      similar between intravenous and topical use of TXA, then the safety of topical TXA should be
      questioned. Of note, these markers have never been measured after TXA has been given
      topically. As a result, this information would be important for the medical community.
    


Intervention name(s): Intravenous tranexamic acid; Topical tranexamic acid; Intravenous saline; Topical saline
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tranexamic Acid; Total Knee Arthroplasty; Total Knee Replacement
A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on
      the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female
      patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child
      bearing age. The RA patients received OC in combination with TCZ, whereas the healthy
      volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8
      mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The
      healthy volunteers received OC for only one 21-day cycle.
    


Intervention name(s): Tocilizumab; Ortho-Novum® 1/35
Intervention type(s): Drug; Drug
Intervention description(s): Tocilizumab 8 mg/kg was administered in a single 1-hour infusion on Day 1 of Cycle 2.; Each Ortho-Novum® 1/35 tablet contained 1 mg of norethindrone and 0.035 mg of ethinyl estradiol.
Other intervention name(s): RoActemra; Actemra
Intervention MeSH terms: Norinyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of L-lysine on Adrenal Secretion
Condition: Male; Healthy Volunteers
Study type: Interventional

Summary: 
      Data from the literature and previous in vitro research conducted in the investigators'
      laboratory (INSERM U413/EA4310, University of Rouen) suggest that adrenal corticosteroid
      secretion might be controlled by a paracrine mechanism involving serotonin type IV receptor
      (5-HT 4). L-lysine, a common amino-acid has been shown to act as a 5-HT4 agonist in vitro as
      well as in vivo. In the present physiology trial, plasma aldosterone and cortisol levels will
      be measured under treatment with aprepitant versus placebo, in both basal conditions and
      after activation of the adrenocortical function by various stimuli, including upright
      posture, metoclopramide, and after a 3 days salt-free diet. All healthy volunteers will be
      given two substances (L-lysine and placebo) in a random order during two 13 days periods
      separated by a 14 day-wash-out. This study should allow to determine the role of 5-HT4
      receptors in the control of corticosteroid production in normal man.
    

Detailed description: 
      STUDY DESIGN Proof of concept, interventional, monocentric, randomised, double blind,
      cross-over study: The effects of L-lysine on corticosteroid secretion will be compared to
      those of a placebo. STUDY OBJECTIVES Main objective: to verify that adrenal corticosteroid
      secretion is actually controlled by L-lysine. Secondary objective: to determine the
      physiological conditions that involve the control of adrenocortical function by t5-HT4
      receptors. NUMBER OF SUBJECTS 20 healthy volunteers ELIGIBILITY CRITERIA (see below) DURATION
      OF STUDY Overall duration: 13 months Inclusion period: 12 months Follow up period (for 1
      subject): 5 weeks Exclusion period: 1 month ENDPOINTS PRIMARY ENDPOINT: blood aldosterone
      variation during orthostatic test SECONDARY ENDPOINTS Basal aldosterone alteration
      Aldosterone variation during metoclopramide & salt-free diet tests Basal and stimulated (3
      different tests) alterations of renin, cortisol & ACTH REGULATORY AUTHORIZATIONS Ethics
      committee authorization: jan 21,2010 Regulatory authorization: july 9th 2010
    

Intervention name(s): L-lysine; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): L-lysine, 4,95 G at day : 0,55 G 3 times a day, orally, during meals; placebo, 3 times a day, orally, during meals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Aldosterone; L-lysine; Cortisol; Adrenal glands
Medical Device for Drug Allergy Diagnosis
Condition: Drug Hypersensitivity
MeSH terms: Hypersensitivity; Drug Hypersensitivity
Study type: Interventional

Summary: 
      The COBIOPHAD project targets the development of a highly sensitive, selective, and
      multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address the
      most prevalent drug hypersensitivity to betalactams antibiotics, (BLCs). During a
      retrospective study, BLC structures involved in drug hypersensitivity will be identified from
      sera of allergic patients (versus controls) and coupled on the device.

      A prospective study will be performed for the recruitment of samples corresponding to
      patients with known IgE hypersensitivity to BLCs based on results from allergy tests and
      clinical history. Controls will include: non-allergic individuals with known tolerance to
      betalactams. The samples will be used for the validation of the COBIOPHAD device in real
      settings.
    


Intervention name(s): Immediate hypersensitivity to BLC
Intervention type(s): Procedure
Intervention description(s): immediate hypersensitivity to BLC by In vitro diagnosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Betalactams; In vitro diagnosis
A Study Of Pregabalin (Lyrica) Drug Levels In Urine, Plasma And Breast Milk Of Healthy Lactating Women
Condition: Healthy Lactating Women
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pharmacokinetic study to determine the safety and tolerability of pregabalin in
      healthy lactating women. The objectives are to determine whether pregabalin is secreted in
      breast milk and if so, to characterize pregabalin pharmacokinetics in breast milk. Other
      objectives are to estimate potential infant exposure to pregabalin if administered to
      lactating women and to characterize the safety and tolerability of pregabalin in lactating
      women.
    

Detailed description: 
      Post approval commitment for the FDA
    

Intervention name(s): pregabalin (Lyrica)
Intervention type(s): Drug
Intervention description(s): Subjects will receive a single 150 mg dose of pregabalin in the evening of Day 1, a 150 mg dose of pregabalin in the morning and evening of Day 2 and a 150 mg dose in the morning of Day 3.
Intervention MeSH terms: Pregabalin
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetic; pregabalin; lactation
Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors
Condition: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted in Asia, Europe, Japan and North America. The aim of this clinical
      trial is to investigate the safety and the efficacy of a prophylactic treatment option with
      long acting coagulation factor VII (LA-rFVIIa) for haemophilia patients with inhibitors.
    


Intervention name(s): activated recombinant human factor VII, long acting; activated recombinant human factor VII, long acting; activated recombinant human factor VII, long acting
Intervention type(s): Drug; Drug; Drug
Intervention description(s): After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 25 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months; After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 100 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months; After an observation period of 3 months, every 2nd day intravenous (i.v.) injection with 200 microgrammes/kg activated recombinant human factor VII, long acting, for 3 months
Other intervention name(s): NN7128; LA-rFVIIa; NN7128; LA-rFVIIa; NN7128; LA-rFVIIa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention