bioihbjkbjnl/mcl2 huggingface dataset:
INSUlin Regimens and VASCular Functions
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of
      cardiovascular risk. The aim of this pilot study is, in type 2 diabetic patients now
      requiring insulin, to compare the effects of improving glycemic control on these parameters
      with 3 different insulin regimens which will act especially at fasting or in post-prandial
      periods or both. Non invasive explorations will be performed before randomization and after 4
      to 5 weeks of insulin therapy, at fasting and each hour after a standardized breakfast.
    

Detailed description: 
      Vago-sympathetic activity, arterial stiffness and endothelial function are integrators of
      cardiovascular risk. The effect of controlling fasting or post-prandial blood glucose or both
      on these parameters has not been studied in type 2 diabetic patients.

      The aim of this pilot study is to compare the effects of improving fasting or post-prandial
      blood glucose glycemic control or both with 3 different insulin regimens for 4 to 5 weeks, on
      vago-sympathetic activity, arterial stiffness and endothelial function.

      Patients will be recruited in the department of Endocrinology-Diabetology-Nutrition of Jean
      VERDIER hospital, AP-HP, and the department of Endocrinology and Metabolism of AVICENNE
      hospital, BOBIGNY, AP-HP, France. After an half day of cardiovascular explorations, 42
      patients will be randomized in 3 groups determining their treatment for the following 4-5
      weeks : insulin therapy with detemir at dinner or bed time, or with aspart at each meal, or
      with both of them.

      Investigations will be performed in the morning 1) at the time of randomisation and 2) 4-5
      weeks after the beginning of insulin therapy. We will evaluate at fasting and each hour after
      a standardized breakfast biological and metabolic parameters, arterial stiffness, endothelial
      function and nervous autonomic system with non-invasive devices: Sphygmocor®, Finapres®,
      laser-doppler et Endopat2000®. Body composition will be evaluated with impedance maestri and
      BodPod®.
    

Intervention name(s): Insulin
Intervention type(s): Drug
Intervention description(s): For diabetes treatment: metformin continued with insulin (according to arms)
Other intervention name(s): LEVEMIR; NOVORAPID
Intervention MeSH terms: Insulin; Insulin Detemir; Insulin Aspart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin Therapy; Vago-sympathetic activity; arterial stiffness; endothelial function
Atorvastatin Before Prostatectomy and Prostate Cancer
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This single-center, randomized, double-blind trial assesses the impact of short-term
      atorvastatin administration on proliferation activity, apoptotic rate and histological
      inflammation in prostate tissue.
    

Detailed description: 
      In this trial 160 men who have been diagnosed with prostate cancer, and whose first-line
      treatment will be radical prostatectomy (surgical removal of the prostate), are randomized to
      receive either 80 mg atorvastatin or placebo daily for 2-5 weeks until the operation. Blood
      cholesterol and serum PSA are measured before starting the study drug use and before the
      operation.

      After the operation change in PSA and histological inflammation, apoptotic rate and Ki-67
      staining intensity are compared between atorvastatin-treated and placebo-treated men. The
      correlation between changes in serum cholesterol or prostate specific antigen (PSA) and the
      tissue characteristics is evaluated.

      After recruiting 60 men we will perform an interim analysis on primary end-points without
      breaking the blinding to treatment allocation. If we observe a statistically significant
      difference in all primary end-points, the trial will be stopped early and the results
      published.

      Additionally, atorvastatin concentration in the blood and the prostate tissue is measured
      with mass spectrometry to determine penetrance of atorvastatin into the prostate. DNA- and
      RNA-samples are obtained from the prostate tissue and the blood. These will be used to study
      how gene expression of statin- and cholesterol-modifying enzymes affects the responses
      observed in prostate tissue.

      As a secondary end-point we will measure recovery of erectile function after the operation
      and compare between the two study arms. Erectile function is measured using IIEF-5
      questionnaire once before the operation and again 3, 6, 9 and 12 months from the
      prostatectomy.
    

Intervention name(s): Atorvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules including 80 mg of atorvastatin; Similar capsules as in the atorvastatin arm, but without the active ingredient
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Apoptosis; Atorvastatin; Inflammation; Pre-surgical trial; Proliferation; Prostate cancer
Evaluation of Surgical Stress Index (SSI) During Sevoflurane/Remifentanil Anesthesia
Condition: Analgesia
Study type: Interventional

Summary: 
      The aim of the present prospective randomized study was to challenge the ability of SSI to
      detect painful stimulation during sevoflurane - remifentanil anesthesia.
    

Detailed description: 
      General anesthesia can be considered as a combination of hypnosis, antinociception and
      immobility. Whereas monitoring of depth of hypnosis, and muscle relaxation can be regarded as
      accepted, determination of the nociception is based on clinical signs like somatic or
      autonomic responses.

      Recently, the multivariate surgical stress index (SSI)has been demonstrated to correlate with
      surgical stress intensity. Thus, SSI might be a useful variable to adjust analgesic drug
      administration in individual patients.

      We want to investigate whether SSI is able to indicate nociception following standardized
      noxious stimulation during balanced sevoflurane - remifentanil anesthesia.
    

Intervention name(s): standardized pain stimulus
Intervention type(s): Procedure
Intervention description(s): a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus
Allocation: Randomized
Primary purpose: Diagnostic
Keywords: Anesthesia General; Anesthetics Inhalation; Stress measurement; Surgical Stress; Diagnostic Techniques and Procedures
Treatment and Management of Women With Bleeding Disorders
Condition: Menorrhagia; Blood Coagulation Disorders; Blood Platelet Disorders; Von Willebrand Disease; Hematologic Disease
MeSH terms: Menorrhagia; Hemostatic Disorders; Hematologic Diseases; Blood Coagulation Disorders; Von Willebrand Diseases; Blood Platelet Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether oral contraceptives, desmopressin acetate,
      and/or tranexamic acid are effective in the treatment of women with menorrhagia who are
      diagnosed with a bleeding disorder.
    

Detailed description: 
      Menorrhagia is a common clinical problem. Morbid events include dysmenorrhea,
      hospitalizations, red blood cell transfusions, and quality of life impairment in terms of
      daily activities, chronic pain, and time lost from work and or school. Up to 60% of women
      with uncontrolled menorrhagia undergo hysterectomy. Up to 20% of women with menorrhagia may
      have undiagnosed von Willebrand disease (vWd), or other bleeding disorders. Prevalence of vWd
      in the general population is estimated at just over 1%. Intuitively, the prevalence of vWd in
      women with menorrhagia is probably higher since platelet plug formation is necessary for
      menstrual hemostasis. Current management of menorrhagia in patients in the United States
      often begins with hormonal therapy. Estrogen and estrogen derivatives in oral contraceptives
      have been shown to increase von Willebrand factor (vWf) levels. Women with menorrhagia who
      have vWd or who are hemophilia A carriers have also been successfully treated with
      desmopressin acetate (DDAVP, Stimate® Nasal Spray). Tranexamic acid (Cyklokapron) is utilized
      extensively for menorrhagia in Australia and the United Kingdom. Standard hormonal therapy
      has not been compared with desmopressin or antifibrinolytics for menorrhagia. This study will
      compare treatment options for women with menorrhagia who have a detectable bleeding disorder.
      Investigators will document the effect on quality of life, menstrual flow, and coagulation
      parameters of treatment with oral contraceptive pills, desmopressin, or tranexamic acid.
    

Intervention name(s): Tranexamic Acid; Desmopressin Acetate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Deamino Arginine Vasopressin; Tranexamic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Menorrhagia; Von Willebrand's Disease; Platelet Disorder
A Study to Investigate the Effect of Steady-State TMC278 on the Pharmacokinetics of a Single Dose of Digoxin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of steady-state (constant
      concentration of medication in the blood) TMC278 on the single dose pharmacokinetics (what
      the body does to the medication) of digoxin.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), randomized (the
      study medication is assigned by chance), crossover (method used to switch patients from one
      treatment arm to another in a clinical study) study to investigate the effect of steady-state
      TMC278 on the single dose pharmacokinetics of digoxin. The study consists of 3 phases,
      including screening phase, treatment phase, and follow-up phase. After the screening phase,
      participants will be randomized to one of 2 treatment sequences consisting of Treatments A
      and B, ie, Sequence AB (11 participants), and Sequence BA (11 participants). Treatment phase
      includes, Treatment A: digoxin 0.5 mg (single oral dose), and Treatment B: TMC278 25 mg once
      daily with digoxin 0.5 mg (single oral dose). The 2 consecutive sequences will be separated
      by a washout period (period when receiving no treatment) of at least 14 days. Safety
      evaluations for adverse events, clinical laboratory tests, electrocardiograms, cardiac
      telemetry, vital signs, physical examination, alcohol breath test, and specific toxicities
      will be monitored throughout the study.The study duration for treatment phase will be at
      least 26 days.
    

Intervention name(s): Treatment A: Digoxin; Treatment B: TMC278
Intervention type(s): Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=0.5, form=tablet, route=oral. Digoxin administered on Day 1.; Type=exact number, unit=mg, number=25, form=tablet, route=oral. TMC278 administered for 16 days, with digoxin administered in the morning on Day 11.
Other intervention name(s): Digoxin; TMC278
Intervention MeSH terms: Rilpivirine; Digoxin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; TMC278; TMC278IFD1001; Human immunodeficiency virus - type 1; Pharmacokinetics; Digoxin
Telephone and Mail Intervention for Alcohol Use Disorders
Condition: Alcohol Use Disorders
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized controlled trial and benefit-cost study of a telephone and mail intervention for
      non-treatment-seeking primary care patients with alcohol abuse or dependence
    


Intervention name(s): telephone counseling
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease
Condition: Mucocutaneous Lymph Node Syndrome; Kawasaki Disease
MeSH terms: Mucocutaneous Lymph Node Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Etanercept (Enbrel) when used in
      conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with
      Kawasaki Disease. Funding Source- FDA/OOPD
    

Detailed description: 
      Kawasaki Disease (KD) is a potentially life threatening acute vasculitis in children with a
      predilection for involvement of the coronary arteries. Aspirin and Intravenous gamma globulin
      (IVIG) are principally used for the treatment of the symptoms of Kawasaki Disease. Aspirin
      reduces inflammation and platelet formation, but has no effect in attenuating the development
      of coronary abnormalities. Although IVIG reduces inflammation and the prevalence of coronary
      artery abnormalities, it has a relatively high failure rate of 23-30%, warranting new
      treatment methods for Kawasaki Disease. We propose a placebo controlled double blinded
      randomized study to determine if etanercept 0.8 mg/kg subcutaneously (max 25 mg) given three
      times at weekly intervals starting at initial diagnosis is safe in this patient population
      and if it is a successful adjunct therapy with IVIG in reducing the incidence of persistent
      or recurrent fever.
    

Intervention name(s): Etanercept; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): etanercept 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.; Placebo 0.8 mg/kg subcutaneously (max 50 mg) given three times, once a week for three weeks starting at initial diagnosis.
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Approximately 200 subjects will be randomized in a 1:1 ratio to receive Etanercept or Placebo. Subjects are randomized after hospital admission and diagnosis of Kawasaki Disease at eight participating sites. The primary analysis time-point is visit 5 (day 44). Sample size calculation is based on initial IVIG refractory rate at Seattle Children's. Assuming a 17.4% refractory rate in the control group and a 4.3% refractory rate in the Etanercept group, 200 subjects will provide 80% power at a 5% 2-sided type I error rate. Analyses will be based on a modified intention to treat population, including all subjects who were randomized and received at least 1 dose of study drug. Efficacy analyses will be based on randomization assignment, and safety analyses will be based on the treatment actually received. The statistical analysis plan will be finalized prior to database lock and study unblinding.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Etanercept
A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Influenza Vaccine ChAdOx1-NP+M1
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in man dose escalation study, to assess the safety and immunogenicity of the
      candidate influenza vaccine ChAdOx1-NP+M1. All volunteers recruited will be healthy adults
      aged 18-50. Volunteers will be enrolled and doses will be escalated according to a "3+3"
      study plan. Up to 24 volunteers will be vaccinated. Following one dose of the vaccine,
      volunteers will be followed up to assess the side effect profile of the vaccine and to take
      blood tests. A series of immunology assays will be performed to determine how potent the
      vaccine is at inducing an immune response.
    


Intervention name(s): ChAdOx1-NP+M1
Intervention type(s): Biological
Intervention description(s): Dose escalation in a 3+3 study plan;
5 x10^8 vp, 5 x10^9 vp, 2.5 x10^10 vp, 5 x10^10 vp
Intervention model: Single Group Assignment
Masking: None (Open Label)
Nasal Fentanyl And Renal Colic
Condition: Acute Renal Colic
MeSH terms: Colic; Renal Colic
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether nasal fentanyl is effective in the
      treatment of renal colic in adults in emergency department.
    


Intervention name(s): FENTANYL; Ketorolac Tromethamine AND morphine
Intervention type(s): Drug; Drug
Intervention description(s): FENTANYL CITRATE, NASAL, 3 GAMMA/KG; morphine 5 MG diluted in saline solution 100 ml followed by 2-ml ampoule of ketorolac 30 MG in saline solution 100 ml was infused:
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Fentanyl; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: analgesia; renal colic; ketorolac; nasal fentanyl; morphine.; treatment of acute renal colic
Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Key objectives of this clinical study are to:

        -  Determine how well intramuscular (IM) olanzapine depot works compared to placebo

        -  Evaluate the safety and tolerability of IM olanzapine depot compared to placebo

        -  Evaluate different doses of IM olanzapine depot compared to placebo to identify the best
           dose(s).
    


Intervention name(s): Intramuscular Olanzapine Depot; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to compare and assess the efficacy and the safety of the combination agent of
      Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential
      hypertension
    


Intervention name(s): Lercanidipine 10mg; Lercanidipine10mg /Valsartan 80mg; Lercanidipine 10mg /Valsartan 160mg; Lercanidipin 10mg Placebo; Lercanidipine10mg /Valsartan 80mg Placebo; Lercanidipine 10mg /Valsartan 160mg Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Valsartan; Lercanidipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Stress Biomarkers Leading to Professional Burnout Among People Involved in a Mobile Intensive Care Unit During the COVID-19 Pandemic
Condition: Occupational Stress
MeSH terms: COVID-19; Occupational Stress; Burnout, Professional
Study type: Observational

Summary: 
      This study is aiming at investigating whether professional burnout in people involved in the
      mobile intensive care unit (in French: Element Mobile de Réanimation, EMR) in Mulhouse
      (France) can be predicted upstream by a low mindfulness level (as a protective factor) or by
      a dysregulation of stress pathways with a high level of perceived stress towards an emotional
      event (psychological index of allostatic load), i.e. an early and silent dysfunctional
      physiological response (measured by the electrophysiological and biological measurements of
      allostasis load and parasympathetic brake).

      It is part of a global approach aiming at identifying levers to prevent the allostatic load
      of occupational stress related to large-scale health crises.
    


Intervention name(s): Assessment of work-related stress; Saliva sample collection; Cardiac and electrodermal recordings; Assessment of behavioral response to emotional stimulation
Intervention type(s): Behavioral; Biological; Other; Behavioral
Intervention description(s): Assessment of burnout, mindfulness, interoceptive awareness, anxiety, post-traumatic stress disorder, coping flexibility and sleep through questionnaires.; Saliva sample is collected before and after emotional stimulation in order to measure resting-state allostatic load biomarkers: DHEA, cortisol and chromogranine A levels; Electrocardiogram and electrodermal activity (tonic and phasic) is collected at rest and after emotional stimulation.; Emotional stimulation involves asking the participants to remember a recent event related to the COVID-19 crisis that has been emotionally difficult for them.
Perceived stress, situational awareness and emotions is assessed after emotional stimulation through questionnaires.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is composed of people who have been deployed to serve at the mobile
        intensive care unit in Mulhouse (France) during the Covid-19 crisis.
      
Biospecimen description: 
      Saliva sample
The Transition From Blastomere to Trophectoderm Biopsy: Comparing Two PGS Strategies
Condition: Infertility; Preimplantation Genetic Screening
MeSH terms: Infertility
Study type: Observational

Summary: 
      Shortly after the implementation of Comprehensive Chromosome Screening (CCS) techniques for
      Preimplantation Genetic Screening (PGS) came the transition in biopsy timing. Trophectoderm
      biopsy is meant to overcome the limitations of cleavage stage biopsy and single cell
      analysis.
    

Detailed description: 
      The investigators have recently introduced this new approach and a frozen-thawed policy of
      euploid blastocysts is routinely performed.

      This is a single centre retrospective study in patients undergoing a PGS cycle. The aim of
      the study is to assess the results obtained in a PGS programme after the implementation of a
      new biopsy timing and transfer policy. Results obtained in PGS cycles with blastocyst biopsy
      and frozen-thawed embryo transfer were analysed in comparison to cycles with cleavage stage
      biopsy and fresh blastocyst transfer.
    

Intervention name(s): Cleavage stage biopsy group; Trophectoderm biopsy group
Intervention type(s): Procedure; Procedure
Intervention description(s): intracytoplasmatic sperm injection (ICSI)- (Invitro Fertilization)IVF
Time lapse embryo culture
Cleavage stage biopsy
aCGH analysis
Fresh euploid embryo transfer; ICSI-IVF
Time lapse embryo culture
Day 3 zona pellucida opening
Trophectoderm biopsy
aCGH analysis
Frozen-thawed euploid embryo transfer
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing a PGS cycle with own gametes for any of the following indications:
        advanced maternal age, repeated implantation failure, recurrent miscarriages, severe male
        factor, and previous affected pregnancies.
Receptor Occupancy of ITI-007 Using Positron Emission Tomography (PET) in Patients With Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the relationship between ITI-007 dose, plasma
      levels and brain receptor occupancy in patients with stable schizophrenia.
    


Intervention name(s): ITI-007
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science