bioihbjkbjnl/mcl2 huggingface dataset:
Insulin Detemir Compared to Insulin Glargine: Appetite and Calories Consumed in Type 1 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Patients with diabetes treated with insulin often gain weight, which may deter patients from
      adhering to insulin treatment. Detemir is one type of long acting insulin approved by the
      Food and Drug Administration for use in people with diabetes. It is similar to other long
      acting insulins (Neutral Protein Hagedorn [NPH], glargine) except that it has been associated
      with less weight gain compared to other types of insulin. The reasons for this are still
      unclear. One possibility is that detemir insulin acts differently than do other insulins in
      affecting how diabetic patients eat meals. The purpose of this study is to determine whether
      appetite and calories eaten during a meal are affected by the type of insulin used to treat
      diabetes. This is a pilot study which means we are gathering preliminary information to
      determine if a larger study can be done.
    

Detailed description: 
      Insulin detemir is a neutral, soluble long acting insulin analog with weight neutral
      properties. In limited studies, it has been shown to result in less weight gain in type 1 and
      type 2 diabetics compared with other long acting insulin formations. A possible mechanism for
      its weight neutrality is the fatty acid chain that may allow for improved central nervous
      system activity and effects on satiety. The primary objective of this study is to determine
      if patients with type 1 diabetes consume fewer calories when allowed to eat to satiety while
      treated with insulin detemir compared to insulin glargine. Secondary objectives are 1)
      subject responses on validated satiety scales and food diaries, 2) bioelectrical impedance
      analysis, 3) resting energy expenditure on indirect calorimetry/metabolic cart measurement,
      and 4) centrally acting mediators of satiety measured in the serum (Peptide YY [PYY],
      ghrelin, leptin).
    

Intervention name(s): Insulin Detemir; Insulin Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be given a dose of detemir equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks.; Subjects will be given a dose of glargine equivalent to their current long acting insulin regimen. Study insulin will be injected subcutaneously at 8 AM and 8 PM for at least 3 weeks.
Other intervention name(s): Levemir; Lantus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: diabetes; insulin dependent diabetes; diabetes mellitus; detemir; levemir; glargine; lantus; insulin; appetite; satiety; centrally acting mediators of satiety; three factor eating questionnaire; PYY; ghrelin; leptin
Tissue, Blood and Biomarkers to Predict Future Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational [Patient Registry]

Summary: 
      Patients undergoing coronary artery bypass grafting (CABG), aortic (valve) or mitral valve
      surgery are at risk of developing postoperative and new-onset atrial fibrillation (AF), but
      adequate risk prediction is currently impossible. This study aims to discover tissue and
      circulating microRNAs and protein biomarkers that may help to unravel the pathophysiological
      processes underlying AF and are potential tools for risk stratification and prognosis or may
      become future targets of therapy.

      This study will be a single-center cohort study of 150 patients undergoing cardiac surgery,
      which will constitute the beginning of the follow-up period. Left atrial appendages, whole
      blood and epicardial mappings will be collected. Patients will be followed for 2 years with
      regular holter investigations to detect postoperative and new-onset AF.
    

Detailed description: 
      Study procedures:

      The left atrial appendage (LAA) will be removed for research and intended prophylactic
      purposes, using a surgical stapler or surgical knife prior to the standard procedure.
      Epicardial mappings may be performed during cardiac surgery with a 48-multi-electrode.
      Patients will be followed with regular 24-hour Holter investigations.

      This study will be an exploratory study with a required inclusion of 150 patients, based on
      the estimated event rate. Patients will be recruited by the investigators during
      pre-operative assessment.

      Clinical data will be gathered at baseline and stored in a customized microsoft access entry
      database. Statistical analysis will be performed in collaboration with the Bioinformatics
      Laboratory from the Academic Medical Center.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All consecutive patients are eligible that are referred to the investigators' tertiary
        cardiothoracic center for mitral valve surgery, (aortic) valve surgery or coronary artery
        bypass surgery and meet in- and exclusion criteria.
      
Biospecimen description: 
      Left atrial appendages will be deep frozen and fixed Plasma samples and whole blood will be
      collected
    
Keywords: microRNA; biomarker
STUDY OF PREFERENCES IN MEN FACED WITH THE DIFFERENT TREATMENT OPTIONS FOR LOCALIZED PROSTRATE CANCER WITH A GOOD OR INTERMEDIATE PROGNOSIS
Condition: Patients Seen at a Urology Consultation
Study type: Interventional

Summary: 
      This study will be based on two questionnaires

        1. One specific questionnaire that has already been developed from social sciences
           interviews conducted in men who have been treated for localized prostrate cancer, with a
           good or intermediate prognosis. This questionnaire comprises 11 pairs of scenarios. Each
           scenario gathers in a random manner, the modalities of 7 possible characteristics of the
           management strategy for localized prostrate cancer, with a good or intermediate
           prognosis:

             -  the risk of death at 5 years (modalities: 5%, 15%),

             -  the risk of impotence (modalities: 0%, 25%, 50%, 75%),

             -  the presence of urinary leaks (modalities: no protection during the day, one
                protection pad per day, several protection pads per day),

             -  the duration and frequency of care provided (modalities: 2 days of care in your
                whole life, 7 days of care in your whole life, 5 half-days of care per week for 8
                weeks, every 3 months for 2 years then every 6 months for life),

             -  ablation of the prostate (modalities: Yes, No),

             -  the existence of possible treatments in case of aggravation or recurrence
                (modalities: Yes, No),

             -  the nature of the technology used (modalities: innovative technology, standard
                technology).

           The objective is to ask each participant of the study for each pair of scenarios, to
           choose from the two scenarios (binary-choice survey), the scenario he prefers.

        2. The "Spielberger Inventory Trait" scale to evaluate stable characteristics in the
           propensity to anxiety in study participants.
    


Intervention name(s): Questionnaire
Intervention type(s): Other
Primary purpose: Other
Multiple Dose Safety Study of SRX246 Capsules in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple dose clinical study to be conducted with SRX246 capsules to determine the
      safety, tolerability and pharmacokinetics of the drug over a 14 day dosing period.
    

Detailed description: 
      This study is intended to evaluate the safety, tolerability and pharmacokinetic profile of
      multiple oral doses of SRX246 in healthy adult volunteers.
    

Intervention name(s): SRX246
Intervention type(s): Drug
Intervention description(s): capsules
Intervention MeSH terms: SRX246
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety in Healthy Volunteers
A Study in Healthy Men to Test Whether Four Capsules of 25 mg Nintedanib Are Taken up in the Body in the Same Way as One 100 mg Capsule
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the relative bioavailability of 100 mg
      nintedanib given as four capsules of 25 mg nintedanib compared with one capsule of 100 mg
      nintedanib.
    


Intervention name(s): nintedanib 25 mg; nintedanib 100 mg
Intervention type(s): Drug; Drug
Intervention description(s): soft gelatin capsule; soft gelatin capsule
Other intervention name(s): Ofev®
Intervention MeSH terms: Nintedanib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Novartis Vaccine and Diagnostics Carriage Trial
Condition: N. Meningitidis Carriage
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial was to evaluate the effect of Novartis Vaccine's Meningococcal
      vaccines on carriage of Neisseria meningitidis in a young adult population.
    


Intervention name(s): Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ); MenACWY-CRM conjugate vaccine; Japanese Encephalitis vaccine
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): IXIARO
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningococcal vaccines; Meningococcal B; Meningococcal ACWY serogroups
Effects of Intranasal Oxytocin on Functional Brain Network in Resting-state and Tasks
Condition: Healthy
Study type: Interventional

Summary: 
      To investigate whether and how intranasal oxytocin of 8IU treatment will alter the topology
      of functional brain network in resting-state and multiple tasks in healthy males.
    

Detailed description: 
      In a randomized, double-blind, cross-over, placebo controlled design, healthy male volunteers
      receive intranasal oxytocin or placebo prior to functional magnetic resonance
      imaging.Subjects will then go through a decision making task, a emotion judgement task and an
      eight-minute resting-state scan in MRI scanner to investigate whether and how intranasal
      oxytocin alter the topology of functional brain network in resting-state and multiple tasks
      in healthy males. State anxiety and mood are measured before and after experiment as
      covariates to be controlled.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intranasally administrated; intranasally administrated
Other intervention name(s): Saline
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study utilized a randomized, double-blind, PBO controlled, within-subject design, in which each participant was tested under two acute treatment conditions separated by at least 1 wk wash-out period.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: intranasal oxytocin; functional brain network; multiple tasks; resting state
Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function
      measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon
      either activation or apoptosis from different cell types such as platelets, leucocytes and
      endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the
      blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells
      are inversely correlated to cardiovascular risk factors.

      As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation
      marker used in asthmatic patients - after inhalation of electronic cigarette vapor.
    


Intervention name(s): Electronic cigarette
Intervention type(s): Device
Intervention description(s): Inhaling e-cigarette vapor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: endothelial dysfunction; microvesicles; endothelial progenitor cells; electronic cigarettes
Intravenous Versus Perineural Dexmedetomidine as Adjuvant in Adductor Canal Block for Total Knee Arthroplasty
Condition: Post Spinal Anesthesia Shivering
Study type: Interventional

Summary: 
      Shivering increases the cardiac and systemic energy expenditure, oxygen consumption and
      carbon dioxide production. Definitive prevention and treatment of shivering is necessary to
      decrease the related complications and increase post-anesthetic comfort.
    

Detailed description: 
      Dexmedetomidine a highly selective α2 adrenergic agonist used effectively as a safe analgesic
      via different routes and mechanisms, including intravenous (i.v.), neuraxial and perineural
      routes. Dexmedetomidine has been used for prevent shivering but, the results of its efficacy
      is still controversy.

      No studies to date have investigated the best administration route of dexmedetomidine to
      dominantly prevent the occurrence of shivering after spinal anesthesia or associated with the
      least grade.

      This prospective, randomized, double blinded study was designed to investigate the best
      administrative route of dexmedetomidine firstly, as a preventive of neuraxial shivering and
      secondly as adjunctive analgesic.

      The incidence of post-spinal anesthesia shivering was the primary outcome. Perioperative
      hemodynamics, postoperative pain scores during rest and at 45-degree flexion of the knee, the
      analgesic duration, the first postoperative day analgesic consumption, the sedation score and
      early ambulation ability were the secondary outcomes.
    

Intervention name(s): intravenous dexmedetomidine; adductor canal block dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): adductor-canal-blockade with 20 mL 0.25% levobupivacaine plus 1 mL normal saline while, the intravenous solution; consists of 0.5µg.kg-1 dexmedetomidine diluted in 20 mL normal saline; adductor-canal-blockade with 20 mL 0.25% levobupivacaine plus 1 mL of 0.5µg.kg-1 dexmedetomidineline while, the intravenous solution;consists of 20 mL normal saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dexmedetomidine-adductor canal block
Phase I Study of MLN 9708 in Addition to Chemotherapy for the Treatment of Acute Lymphoblastic Leukemia in Older Adults
Condition: Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma; B-cell Adult Acute Lymphoblastic Leukemia; T-cell Adult Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is evaluating a combination of drugs considered standard treatment for
      children and young adults with acute lymphoblastic leukemia (ALL), in combination with a new
      drug called MLN 9708. Additionally, the study is also evaluating if bone marrow or stem cell
      transplantation, which will be given to some participants, helps to prevent ALL from
      returning.
    

Detailed description: 
      In this research study, the investigators are studying the optimal dose of the drug MLN 9708
      when given with a standard multi-drug regimen. In the first part of the study, up to 18
      participants will be enrolled at different doses of MLN 9708. Once the maximally tolerated
      (highest, safest dose) is established, an additional 10 participants will be enrolled.

      Additionally, bone marrow (tissue found in the inside of bones) or stem cell transplantation
      will be given to some participants to study whether it helps to prevent ALL from returning.

      The study treatment consists of several different stages

        -  Induction

        -  Consolidation 1

        -  Or Stem Cell or Bone Marrow Transplant (if you are eligible based on your medical
           condition and the availability of a matched stem cell donor)

        -  Or If you do not have a transplant:

             -  CNS Therapy

             -  Consolidation 2

             -  Continuation Therapy
    

Intervention name(s): MLN 9708; Vincristine; Cytarabine; Doxorubicin; Mercaptopurine; Cyclophosphamide; Methotrexate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Patients will received standard chemotherapy as well as MLN 9708 in escalating doses.; Standard chemotherapy dosage and duration; Standard chemotherapy dosage and duration; Standard chemotherapy dosage and duration; Standard chemotherapy dosage and duration; Standard chemotherapy dosage and duration; Standard chemotherapy dosage and duration
Other intervention name(s): Ixazomib; Oncovin; Vincasar PFS; Vincrex; Vincristine sulfate; VCR; Ara-C; Cytosar-U; Cytosine arabinoside; Adriamycin, Rubex; 6-MP; Purinethol; Purixan; Cytoxan; Neosar; CTX; Folex; Mexate; MTX; Methotrex (formerly Amethopterin)
Intervention MeSH terms: Cytarabine; Cyclophosphamide; Doxorubicin; Methotrexate; Vincristine; Mercaptopurine; Ixazomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute lymphoblastic Leukemia; Lymphoblastic lymphoma; B-cell Adult Acute Lymphoblastic Leukemia; T-cell Adult Acute Lymphoblastic Leukemia
Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs.
      placebo in patients with Major Depressive Disorder who are on concomitant treatment with
      escitalopram.

      The secondary objective of this study is to document clinical safety and tolerability of
      SR58611A in association with escitalopram.
    


Intervention name(s): SR58611A; escitalopram; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral administration; oral administration; oral administration
Intervention MeSH terms: Escitalopram; Amibegron; Amibegron hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Mental Disorder; Mood Disorder; Depressive Disorder
Pharmacokinetic (PK) and Safety Study of Plasma-derived Human Butyrylcholinesterase Administered Intravenously
Condition: Healthy Volunteers; Chemical Terrorism; Chemical Warfare
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this placebo-controlled study is to evaluate the safety, tolerability and
      pharmacokinetics of a single dose regimen of human butyrylcholinesterase (HuBChE) in healthy
      adults at 3 ascending dosage levels administered IV. HuBChE, which occurs naturally in human
      plasma, is being evaluated for prophylaxis and treatment in the event of exposure to chemical
      nerve agents (as employed during chemical warfare or as an act of terrorism). Volunteers in
      each dosage cohort will be randomized to treatment with HuBChE active drug or normal saline
      placebo in a 3:1 ratio. The volunteers will remain in the study for 90 (+/- 7) days. For the
      first 3 days following dose administration, they will remain at the clinical trial site as
      inpatients and will be closely monitored for patient safety. Afterwards, they will return to
      the trial site (at pre-determined intervals) as outpatients for 8 further visits, where
      patient safety will be assessed.
    


Intervention name(s): Human Butyrylcholinesterase (HuBChE) derived from human plasma; Placebo: Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Administration via IV infusion at a rate of 50 mg/min (2 mL/min); Administration via IV infusion at a rate of 50 mg/min (2 mL/min)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chemical nerve agent intoxication
Effects of the Combination of L-Arabinose and Indigestible Dextrin on Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study aims to investigate the effect of supplement containing L-arabinose and
      indigestible dextrin on body mass index, body fat mass, abdominal circumference, visceral fat
      mass, and serum biochemical parameters in overweight subjects.
    


Intervention name(s): Oolong tea containing L-arabinose and indigestible dextrin; Oolong tea (Placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
ProAliFun_6.7_Health Effects of a Low-Salt Bread on Hypertensive Subjects (ProAliFun67)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this clinical study is to evaluate the health properties of a dietary
      intervention carried on with an innovative low-salt bread.

      The hypothesis is that the introduction of a low-sodium bread as part of a low-salt diet may
      improve the compliance to the own regime and that the vascular function, the inflammatory and
      oxidative state, the composition of the intestinal microbiota and that neurocognitive and
      neurodegenerative processes can improve in hypertensive patients fed a low-salt diet with
      low-salt bread.
    

Detailed description: 
      This clinical trial is a multi-center, randomized, controlled, open label, pilot study,
      lasting 6 months.

      A target number of seventy individuals with hypertension meeting inclusion and exclusion
      criteria, assessed at enrollment, and which have signed the informed consent, will be
      recruited.
    

Intervention name(s): Low-sodium diet with standard bread; Low-sodium diet with low-sodium bread
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): low-sodium diet (2300 mg Na/die) with use of standard bread (750 mg Na/100g) for 6 months; low-sodium diet (2300 mg Na/die) with use of low-salt bread (280 mg Na/100g) for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: salt intake; functional food; low-salt bread; blood pressure