bioihbjkbjnl/mcl2 huggingface dataset:
Incretins and Metabolism
Condition: Type 2 Diabetes
Study type: Observational

Summary: 
      Incretin hormones (GLP-1 and GIP) have insulin secretory effects on the pancreas that are
      glucose dependent. Extrapancreatic effects of incretin hormones are reported, however the
      glucose dependency of these effects have not been examined. In type 2 diabetes, pancreatic
      endocrine function and incretin metabolism are impaired. The investigators hypothesize that
      extrapancreatic effects of incretin hormones are glucose depedent and dysregulated in
      subjects with type 2 diabetes.

      Healthy control subjects and type 2 diabetics will undergo pancreatic clamps. In brief,
      somatostatin will be infused to inhibit pancreatic endocrine function and basal levels of
      insulin, glucagon, and growth hormone will be replace via infusion. Metabolic flux will be
      studied during euglycemic and hyperglycemic stages of the pancreatic clamp. Each subject will
      undergo 3 trials involving the co-infusion of either saline(Control Trial), GLP-1, or GIP.
      Glucose metabolism will be assessed using 13C-glucose stable isotope methodology combined
      with indirect calorimetry and expired breath isotope ratio analysis. Blood flow and
      flow-mediated dilation will be measured using ultrasound Doppler. Skeletal muscle and
      abdominal adipose biopsies will be taken to examine intracellular signalling.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Local community volunteers
Tea-beetroot-venous Occlusion Plethysmography
Condition: Insulin Resistance; Obesity
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      In the present study, muscle perfusion will be studied before and after an oral glucose
      challenge following a fasting period.
    

Detailed description: 
      Based on data from previous studies, this physiological response is blunted in obese
      subjects, and the investigators expect these responses to be restored when the glucose load
      is combined with tea or beetroot juice in obese, insulin resistant men.
    

Intervention name(s): Tea; Beet root; Placebo
Intervention type(s): Other; Other; Other
Intervention description(s): Oral intake of tea containing 75 grams of glucose; Oral intake of beetroot juice containing 75 grams of glucose; Oral intake of 75 grams of glucose in water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity, insulin resistance, muscle perfusion
A Prospective Study Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia
Condition: Prostate Neoplasm
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This trial aims to prospectively assess the feasibility, complications and functional results
      of free-hand transperineal image fusion targeted biopsies under local anesthesia in a large
      group of patients.
    

Detailed description: 
      12-core transrectal ultrasound (TRUS) biopsy is one of the most performed urological
      procedures and remains the standard method for prostate cancer (PCa) histological diagnosis
      according to the most recent Guidelines. During the last decade, the transperineal prostate
      biopsy has attracted renewed interest. However, only a few studies and no large prospective
      studies investigated complications of the transperineal approaches.

      Image fusion of Multi-parameter MRI (mpMRI) and TRUS guided prostate targeted biopsy had
      equivalent results with standard 12-core biopsy. Combination of targeted and standard biopsy
      was recommended in recent Guidelines. Image fusion targeted biopsy needs satisfactory
      anesthetic effect, and no prospective studies investigated feasibility in this approach under
      local anesthesia.

      The scientific urological community is focusing on detection rate and concordance with final
      pathology of the radical prostatectomy specimen, which remain the cornerstones to assess the
      accuracy of a prostate biopsy technique. In this study, the investigators will additionally
      assess the functional results of erectile function and urinary function.

      Together, the investigators will perform free-hand image fusion targeted biopsies plus
      standard biopsies under local anesthesia in patients recruited in this study. Then,
      Feasibility, such as peri-procedural pain, changes in patients quality of life;
      complications, such as infection rate and bleeding rate; functional results, such as erectile
      function and urinary function; and concordance with final pathology will be evaluated.
    

Intervention name(s): Standard prostate biopsy; Targeted and standard prostate biopsy
Intervention type(s): Procedure; Procedure
Intervention description(s): Transperineal TRUS guided standard prostate biopsy (SB).; Transperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Comparison Between the SBK Microkeratome Versus Femtosecond Laser in Flap Creation During LASIK Surgery for Myopia
Condition: Refractive Surgery
MeSH terms: Myopia
Study type: Interventional

Summary: 
      LASIK is the most commonly performed refractive surgery worldwide. It has been shown to be
      safe and effective procedure with predictable results over long term follow ups. With the
      advancement of technology, sub-Bowman keratomileusis allows thin flap of approximately 100
      microns thickness thus preserving thicker stromal bed as compared to conventional LASIK. The
      femtosecond laser corneal flap has th advantage of producing a flap of uniform thickness,
      adjustable flap diameter, relatively few complications. The disadvantages of this procedure
      is the high cost of surgery, development of bubbles in the corneal layer and anterior chamber
      which may affect pupil trackingduring the procedure. Despite the emergence of femtosecond
      laser-assisted flap creation, mechanical microkeratomes remain the preferred choice in the
      majority of developing countries. Recent studies have shown that SBK corneal flap has the
      same advantages as femtosecond laser flap regarding flap uniformity, regularity, and accuracy
      with less suction time and cost, but with its specific complications as well.
    

Detailed description: 
      It is a prospective comparative non randomized interventional clinical study

      Primary outcomes of this study include:

        1. Comparison between the SBK microkeratome versus Femtosecond laser in flap creation
           during LASIK surgery for myopia using anterior segment OCT (AS-OCT) 1 month after
           surgery in each group of patients.

        2. Measuring corneal flap diameter using (AS-OCT)

      Secondary outcomes:

        1. Measuring uncorrected and best corrected visual acuity after 1 day, 1 week, 1 month
           postoperative.

        2. Recording any related complications in each group.
    

Intervention name(s): SBK microkeratome versus femtosecond laser in flap creation
Intervention type(s): Device
Intervention description(s): prospective comparative non randomized interventional clinical study
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LASIK, SBK, femtolaser, flap creation, myopia
Occupational Performance Coaching in Mothers of Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      A single-blind Randomized Controlled Trial will be used to test the efficacy of the OPC on
      self-efficacy and occupational performance with mothers of children with cerebral palsy.
      Canadian Occupational Performance Measurement and Sherer general self-efficacy scale will be
      employed to data collection. The sample size was determined for each group of 15 people. The
      participants conveniently and according to inclusion and exclusion criteria will be
      randomized into the groups. Participants in the intervention group will be participated in 10
      sessions of OPC. At the end the questionnaires will be completed by both groups.
    


Intervention name(s): occupational performance coaching; standard OT
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Clemastine Fumarate + Dexamethasone Compared to Dexchlorpheniramine Maleate in Eczema Treatment
Condition: Eczema
MeSH terms: Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      Atopic dermatitis is a recurrent pruritic skin disorder which has a significant morbidity and
      impaired quality of life due specially pruritus and physical visible skin lesions. The
      propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g +
      dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.
    

Detailed description: 
      Study design:

      • Double blinded, superiority, prospective parallel-group, intend to treat trial.

      Study design:

        -  Experiment duration: 22 days

        -  2 visits (days 1,7,15 and 22)

        -  Reducing Eczema Area and severity index evaluation

        -  Adverse events evaluation
    

Intervention name(s): Group 1; Group 2
Intervention type(s): Drug; Drug
Intervention description(s): Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion; Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dermatitis; Dermatitis, Atopic
A Study to Evaluate the Efficacy and Safety of JNJ-42847922 as Adjunctive Therapy to Antidepressants in Adult Participants With Major Depressive Disorder Who Have Responded Inadequately to Antidepressant Therapy
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the dose-response relationship of 2 doses of
      JNJ-42847922 before interim analysis, and potentially 3 doses based on interim analysis
      results, compared to placebo as adjunctive therapy to an antidepressant drug in improving
      depressive symptoms in participants with Major Depressive Disorder (MDD) who have had an
      inadequate response to current antidepressant therapy with a selective serotonin reuptake
      inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI); and to assess the
      safety and tolerability of JNJ-42847922 compared to placebo as adjunctive therapy to an
      antidepressant in participants with MDD.
    

Detailed description: 
      The study will investigate the antidepressant effects of a range of doses of JNJ-42847922
      (seltorexant) (versus placebo), as adjunctive treatment to antidepressant drugs for treatment
      of MDD, and will assess the safety and tolerability of JNJ-42847922. The study will be
      conducted in 3 phases: a screening phase (up to 4 weeks), a double-blind treatment phase (6
      weeks), and a post-treatment follow-up phase (2 weeks). Efficacy, safety, pharmacokinetic,
      and biomarker evaluations will be performed in the study at defined timepoints. The duration
      of the study will be up to approximately 12 weeks (84 days).
    

Intervention name(s): Placebo; JNJ-42847922
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive 2 placebo capsules matching JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).; Participants will receive 2 capsules of JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).
Other intervention name(s): MIN-202;; Seltorexant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Adjunctive Steps for Disinfection of Teeth With Primary Endodontic Infections
Condition: Periapical Periodontitis; Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Periodontitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      This study aims to evaluate an endodontic treatment protocol using adjunctive steps for
      disinfection of teeth with primary endodontic infections.
    

Detailed description: 
      The success of endodontic treatment in teeth with necrotic pulp and apical periodontitis
      depends on the reduction of viable microorganisms of root canals by endodontic disinfection
      procedures. This study aims to evaluate by molecular methods the effect of different
      disinfection procedures on reduction, diversity and microbial metabolic activity. Patients
      with necrotic pulps and apical periodontitis in single-rooted teeth will be selected.
      Microbiological samples will be taken from root canals after access cavity (S1), after
      chemomechanical preparation with Reciproc System and 2.5% NaOCl (S2), after irrigant
      activation using the XP-Endo Finisher instrument (S3a) and ultrasonic activation (S3b); and
      after intracanal medication with calcium hydroxide for 14 days (S4), followed by 2nd-visit
      root canal preparation (S5). DNA and RNA will be extracted from root canal samples, and
      complementary DNA (cDNA) synthetized using reverse transcription reaction. The effect of
      treatment protocols on total microbiota levels will be determined by DNA-based quantitative
      polymerase chain reaction (qPCR) using universal primers for Bacteria domain. RNA of root
      canal samples will be used to determine the diversity of metabolically active microbiota by
      Reverse Transcriptase Reaction (RT), followed by amplification (PCR) and high throughput
      sequencing of the hypervariable region V4-V5 of 16S rRNA gene. The metabolic activity of the
      most prevalent species / taxa will be calculated by rRNA- and DNA-based molecular methods.
      Ratios between rRNA and DNA levels will be calculated to search for active bacteria (rRNA/DNA
      ≥ 1) in root canal samples. Data will be analyzed by statistical tests, with 5% significance
      level.
    

Intervention name(s): Root canal preparation; Intracanal medication
Intervention type(s): Procedure; Procedure
Intervention description(s): First endodontic treatment session includes the root canal preparation with Reciproc System and NaOCl 2.5%, followed by final irrigation protocol using activation techniques: XP Endo-Finisher and ultrasonic activation.; The second endodontic treatment includes the intracanal medication with calcium hydroxide paste, followed by an 2nd-visit root canal preparation
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Periapical Periodontitis; Bacterial Infections; Root Canal Preparation; Calcium Hydroxide; Real-Time Polymerase Chain Reaction; RNA-Directed DNA Polymerase
Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of NYX-2925 versus placebo for the treatment of fibromyalgia.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study to assess the efficacy and
      safety of NYX-2925 in subjects with fibromyalgia.

      This 13- to 16-week study will include a 1- to 4-week Screening Period followed by a 12-week
      double-blind, randomized, placebo-controlled Treatment Period.
    

Intervention name(s): NYX-2925; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NYX-2925 administered orally; Placebo administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neurobiological Basis of Response to Vayarin in Adults With ADHD: an fMRI Study of Brain Activation Pre and Post Treatment
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The objective of this research is to use functional magnetic resonance imaging (fMRI) with a
      neuropsychological task to test the prefrontal mechanism of action of the medical food
      Vayarin.
    

Detailed description: 
      The investigators prior research suggests that effective non-stimulant treatments for ADHD
      act through key prefrontal regions that subserve inhibitory and executive functions, although
      different medications may achieve these effects via distinct mechanisms. The objective of
      this research is to use functional magnetic resonance imaging (fMRI) with a face go/no-go
      task to test the prefrontal mechanism of action of the medical food Vayarin. Participants are
      not treated at the Icahn School of Medicine, but instead will be recruited from trials of
      Vayarin that are enrolling and treating participants at New York University and The Medical
      Research Network.
    

Intervention name(s): Vayarin; Placebo
Intervention type(s): Drug; Drug
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be subjects participating in a Vayarin clinical trial being conducted at
        NYU and The Medical Research Network in NYC.
      
Keywords: Medical food; ADHD; Vayarin; Fish Oil
Docetaxel in Treating Patients With Stage IV Prostate Cancer
Condition: Pain; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial of docetaxel in treating patients who have stage IV prostate cancer
      that has not responded to hormone therapy.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the efficacy of weekly docetaxel as measured by disease response,
      strength and duration of pain reduction, and either a decrease in analgesic use without an
      increase in pain, or a decrease in PSA, in patients with hormone refractory metastatic
      prostate cancer. II. Assess the efficacy of this regimen in terms of survival in this patient
      population. III. Evaluate the effect of this regimen on quality of life in these patients.
      IV. Determine qualitative and quantitative toxicities of this regimen in these patients.

      OUTLINE: Patients receive docetaxel IV over 15-30 minutes weekly for 6 weeks. Courses repeat
      every 8 weeks. Therapy continues in the absence of disease progression or unacceptable
      toxicity. Quality of life is assessed at weeks 1, 3, 5, and 7 of each course, and a daily
      pain medication diary is maintained during treatment. Patients are followed for 1 month or
      until resolution of toxicity, then every 3 months until death.

      PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
    

Intervention name(s): docetaxel; pain therapy; quality-of-life assessment
Intervention type(s): Drug; Procedure; Procedure
Intervention MeSH terms: Docetaxel
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage IV prostate cancer; recurrent prostate cancer; pain
Intracranial Pressure and Brain Function: Effects of Head Down Tilt Upon Brain Perfusion and Cognitive Performance
Condition: Intracranial Hypertension
MeSH terms: Intracranial Hypertension
Study type: Interventional

Summary: 
      The aim of the study is to understand the relationship between intracranial pressure
      regulation, cerebral tissue oxygenation and cognitive functioning. More specifically, the
      study tests the hypothesis that head down tilt will increase intracranial pressure (not
      measured in this study, but demonstrated in previous studies), will induce venous congestion
      and facial swelling, decrease intracranial tissue oxygenation and hamper brain functioning.
      The objectives of the study therefore are to assess young healthy people during head-down
      tilt (HDT), and to assess cognitive brain functioning, cerebral tissue oxygenation
      (non-invasively), frontal skin thickness, cerebral perfusion and neuronal functioning via
      event-related potentials.
    


Intervention name(s): 12° head down tilt
Intervention type(s): Other
Intervention description(s): supine head down tilt
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cognitive functioning; Brain tissue oxygenation; cerebral perfusion; head down tilt
Combined Modality Therapy With Growth Factor Support in Locally Advanced Non-small Cell Lung Cancer (NSCLC)
Condition: Unresectable Locally Advanced NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the safety and efficacy of administering filgrastim with concurrent
      chemoradiotherapy and the potential benefit of administering pegfilgrastim with consolidation
      chemotherapy in patients with unresectable locally advanced NSCLC patients.
    


Intervention name(s): Cisplatin; Etoposide; Radiation therapy; Docetaxel; Neulasta
Intervention type(s): Drug
Intervention description(s): Cisplatin 75 mg/m2 day 1 and 22
Etoposide 80mg/m2 days 1-3, 22-24
Radiation therapy: (initial fields 1.8gy/day (5 weeks) to 45Gy, then boost 2.0Gy/day (8 days) to a total of 61Gy) beginning day 1 (Total elapsed time: approximately 6 weeks, 3 days)
Filgrastim 5µg/kg* SQ injection days 4-13 and days 25-34
Docetaxel 75mg/m2 Q 3 Weeks X 3 Cycles
Pegfilgrastim 6 mg SQ injection day 2 of each cycle
Intervention MeSH terms: Docetaxel; Etoposide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Advanced NSCLC; Lung Cancer; Mount Sinai Medical Center CCOP
Vaccination in the Peripheral Stem Cell Transplant Setting for Acute Myelogenous Leukemia
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate clinical and laboratory safety associated with the
      administration of GVAX leukemia vaccine and to determine the feasibility of generation of
      GVAX leukemia vaccine in subjects with acute myelogenous leukemia (AML).
    


Intervention name(s): GVAX leukemia vaccine (therapeutic cellular vaccine, GM-CSF producing)
Intervention type(s): Biological
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; Acute Myelogenous Leukemia; GVAX; Vaccine; Stem Cell Transplant; Autologous