bioihbjkbjnl/mcl2 huggingface dataset:
How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to look at how using glargine insulin with oral diabetes medications
      and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics.

      The main study will last 32 weeks. However, all participants completing 32 weeks will be
      invited to continue for another 24 weeks taking the insulin and oral medication and exenatide
      treatment. This extension comparing insulin and oral medication with insulin and oral
      medication and exenatide will look at the long term weight loss/gain and blood sugar level
      control effects of this new drug regimen.

      There is also a sub-study in the Clinical Research Center (CRC), which requires two 38-hour
      inpatient stays during the main study. This study offers the opportunity to study 24-hour
      blood sugar and metabolic patterns quantitatively.
    


Intervention name(s): exenatide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5mcg twice a day, increasing to 10mcg twice a day for 24 weeks; 5mcg twice a day, increased to 10mcg twice a day for 24 weeks
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: diabetes; insulin; byetta; glucose; blood sugar; metformin; A1c
Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse
Condition: Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the relative abuse potential of ramelteon, once
      daily (QD), compared to triazolam in subjects with a history of drug abuse.
    

Detailed description: 
      Insomnia is characterized by a complaint of either difficulties initiating and maintaining
      sleep, or of nonrestorative and non-refreshing sleep. Transient insomnia affects
      approximately one-third to one-half of the US population, based on the results of 2 surveys
      of representative samples of the adult US population conducted by the Gallup Organization in
      which respondents were asked if they had "ever had difficulty sleeping." Based on reports of
      "regular" or "frequent" sleep difficulty, results from the same studies suggest that
      approximately one-tenth of the US population experiences chronic insomnia. The ideal
      treatment for insomnia would reduce the latency to onset of sleep and increase total sleep
      time, without a negative impact on sleep architecture and without safety concerns or next-day
      effects.

      Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical
      Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment
      of Circadian Rhythm Sleep Disorders.

      Participation in this study is anticipated to be about 1 month.
    

Intervention name(s): Ramelteon, triazolam, and placebo (56 possible combinations total)
Intervention type(s): Drug
Intervention description(s): Randomized sequence over eight consecutive days to include the following:
Ramelteon 16 mg, tablets, orally, one day only;
Ramelteon 80 mg, tablets, orally, one day only;
Ramelteon 160 mg, tablets, orally, one day only;
Triazolam 0.25 mg, capsules, orally, one day only;
Triazolam 0.50 mg, capsules, orally, one day only;
Triazolam 0.75 mg, capsules, orally, one day only;
Ramelteon placebo-matching tablets, orally, one day only, OR Triazolam placebo-matching capsules, orally, one day only;
Additional dose of study medication or placebo, tablets or capsules, orally, one day only.
Other intervention name(s): Rozerem™; TAK-375
Intervention MeSH terms: Triazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Addiction
The Non-Optical Resect and Discard Study (NORD)
Condition: Polyp of Colon
MeSH terms: Polyps; Colonic Polyps
Study type: Observational

Summary: 
      Eliminating the need for conventional histopathological assessment of diminutive colon polyps
      - The Non-Optical Resect and Discard (NORD) study
    

Detailed description: 
      Implementation of this approach by community-based gastroenterologists has failed to reach
      the required quality benchmarks and studies evaluating optical biopsy have not shown
      diagnostic test performance results that meet standards set by society guidelines in order to
      promote its widespread clinical adoption. Optical polyp diagnosis and the current resect and
      discard approach are too complex for clinical adoption. Thus, clinical implementation of this
      valuable concept has not been achieved to date and its cost-saving potential has not been
      realized. In order to effectively operationalize a resect and discard strategy, one must find
      a different way to distinguish neoplastic from non-neoplastic polyps. There exist differences
      in the proportion of polyps found to be adenomatous in the left and right colon. One recent
      study reported that 30% of left-sided polyps and 76% of right-sided polyps were found to be
      adenomas on histology. Since polyps located in the proximal colon are more likely to be
      adenomas and polyps in the recto-sigmoid colon are more likely hyperplastic we hypothesized
      that a model based on polyp location might be able to replace optical biopsy and
      histopathology. Such an approach would be very simple to adopt by every clinician and would
      allow for easy adoption into clinical practice.
    

Intervention name(s): iScan
Intervention type(s): Diagnostic Test
Intervention description(s): this instrument provides extra confidence for in vivo diagnosis through improved vessel and mucosal pattern characterization.
Other intervention name(s): Optivista
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All 45-80 year old patients scheduled for an elective colonoscopy with the potential of a
        polyp removal will be considered for the study. This includes patients hospitalized that do
        not require an emergency colonoscopy (defined as colonoscopy in the emergency or intensive
        care unit or patients with active upper or lower gastrointestinal bleeding). Potential
        study subjects are approached to participate: 1) during an outpatient clinic; 2) at their
        arrival at the endoscopy clinic on the day of the colonoscopy; or 3) on the hospital ward
        (for patients hospitalized).
      
Keywords: Polyp resection; Colorectal cancer
Randomized Trial of Adult Participants With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy of troriluzole versus placebo in
      participants with generalized anxiety disorder.
    


Intervention name(s): Troriluzole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg capsule; Placebo matched to troriluzole
Other intervention name(s): BHV-4157
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Generalized Anxiety Disorder (GAD)
The Effect of Dexamethasone Added to Bupivacain in Nasal Surgery
Condition: Nasal Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      Nasal packing is frequently applied after nasal surgery. Nasal packing reduces epistaxis,
      prevents septal hematoma and stabilizes nasal septum. Nasal mucosa is quite sensitive to
      pain, therefore the most common problems after surgery are postoperative pain and anxiety
      during removal of the nasal packing. Lots of methods have been tried to control this pain
      (non-steroidal anti-inflammatory drugs, nerve blockade with long-acting local anesthetics,
      local anesthetics infiltration into nasal packing).

      Glucocorticoids have been used as an adjuvant in the management of acute postoperative pain.
      Perineural dexamethasone as an adjuvant for the single-injection nerve block can prolong
      analgesia and reduce opioid-requiring after surgery. Furthermore dexamethasone reduces
      postoperative nausea and vomiting incidance.
    


Intervention name(s): Bupivacaine; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): %0.5 bupivacaine; 8 mg Dexamethasone
Other intervention name(s): Bupivacaine only; Bupivacaine plus dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: dexamethasone; bupivacaine; nasal surgery; nasal packing
Study of Idebenone in the Treatment of Mitochondrial Encephalopathy Lactic Acidosis & Stroke-like Episodes
Condition: MELAS Syndrome
MeSH terms: MELAS Syndrome; Brain Diseases; Acidosis; Acidosis, Lactic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy of two (2) different doses of idebenone
      with that of a placebo over a one month period on cerebral lactate concentration as measured
      by magnetic resonance spectroscopy.
    

Detailed description: 
      MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-Like Episodes), a
      progressive and often devastating multisystem disorder, is most commonly associated with
      mitochondrial Deoxyribonucleic acid (mtDNA) point mutation at nucleotide 3243. Seizures,
      cognitive deterioration, and neurobehavioral abnormalities are frequent features of this
      disease which typically shortens life expectancy. Idebenone, an ATP production modulator and
      antioxidant, improves neurological function in Friedreich's ataxia, a disease also associated
      with mitochondrial dysfunction.

      Given that there is no effective treatment for MELAS, the investigators propose a Phase II
      proof of concept trial of idebenone to study its preliminary efficacy in patients with MELAS
      and the A3243G mtDNA mutation, and to study its safety and tolerability in this patient
      group.

      The investigators propose to evaluate 21 patients with the A3243G mitochondrial DNA mutation
      and MELAS (defined by a history of either seizures or stroke). Patients will receive
      idebenone (900 mg/day or 2250 mg/day) or matching placebo for one month. The primary outcome
      measure is cerebral lactate levels measured by Magnetic Resonance Spectroscopy (MRS), a
      biomarker associated with disease worsening. This study will help the investigators to
      determine if there is sufficient signal to proceed to efficacy studies. Also it will provide
      additional information on the safety and tolerability of two different doses of idebenone in
      MELAS.
    

Intervention name(s): Idebenone; Idebenone; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 900 mg/day for 1 month; 2250 mg/day for 1 month; Placebo - No idebenone
Other intervention name(s): active drug; active drug; No active drug
Intervention MeSH terms: Ubiquinone; Idebenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immunologic Profile of Children With Severe Allergies to Peanuts and Nuts After Induction of Tolerance
Condition: Immune Tolerance
MeSH terms: Peanut Hypersensitivity
Study type: Observational

Summary: 
      Many authors propose the strict avoidance of allergenic food as the only treatment for
      children known to be allergic to certain food. However, it has been observed an increase of
      the frequency and severity of the allergic accidents in these children in the long term.
      Other teams have suggested treating these allergies (in particular peanut allergies) by
      controlled and progressive reintroduction of the allergenic food. A good tolerance and a
      prevention of allergic reactions consecutive to the ingestion of the same allergenic food
      were observed. The immunological mechanisms of this type of treatment are not well known.

      A decrease of specific IgE and an increase of IgG4 have been observed in the case of egg
      allergies after this kind of treatment. Certain experiments realized in mice models testing
      the allergenic stimulation challenge showed an increase of lymphocytes T regulators (foxp3+ ,
      CD4+, CD25+), stimulated by dendritic cells, and also an increase of interleukin 10, leading
      to the modification of the balance between Th1 and Th2.Our hypothesis is that after treating
      allergies by the reintroduction of the allergenic food, the immunological mechanism of
      acquisition of tolerance is associated to variations in populations of lymphocytes and in the
      activation or decrease of pro and anti-inflammatory cytokines. This reaction will be studied
      in two groups: 1. Children with a confirmed allergy to peanuts or nuts and 2. Children
      without antecedents of allergy or familiar atopy.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Children with allergy to peanuts and nuts hospitalized for initial diagnosis or for
        treatment in the Allergology Center of GHICL.
      
Biospecimen description: 
      Blood, serum, saliva
Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The Objective was to Develop a Cost-Effectiveness study that compares Ciclesonide and
      Beclomethasone in pediatric asthma control.
    

Detailed description: 
      Cost-effectiveness study, of cohorts, observational, analytic, prospective, from health
      institution perspective. Based on published data related to percentage of patients free of
      crisis for both molecules, it was estimated that the sample size to detect significant
      differences between the two alternatives was 20 patients per alternative. Medical records of
      94 patients with diagnosis of uncontrolled asthma were included, aged between 6 and 15 years,
      47 received Beclomethasone randomly, and 47 received Ciclesonide randomly, treatment
      physician was blind related to this assignation, both cohorts were followed for 6 months, and
      primary effectiveness variable was defined as number of patients free of crisis with each
      alternative. Cost generating variables were defined as medication use, and hospital stay.
      Decision analysis was based on a decision tree.
    

Intervention name(s): Beclomethasone; Ciclesonide
Intervention type(s): Drug; Drug
Intervention description(s): 200 to 400 mcg per day for 6 months; 80 to 160 mcg per day for 6 months
Intervention MeSH terms: Ciclesonide; Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Fragmin in Ovarian Cancer: Utility on Survival (FOCUS)
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      Epithelial ovarian carcinoma (EOC) is the 5th leading cause of death among women. Long-term
      survival is poor for the majority of women with EOC because many present with advanced
      disease. Chemotherapy and cytoreductive surgery produces a 50% - 60% response rate but
      relapse is not uncommon. Adding more systemic agents has failed to show a clear benefit in
      survival and is associated with unacceptable toxicity. This phase II, dose-finding, open
      label trial will enrol women with newly diagnosed EOC and randomize them to receive one of 3
      doses of a LMWH dalteparin in conjunction with standard adjuvant taxane- and platinum-based
      chemotherapy. The primary outcome is disease response, measured according to Gynaecologic
      Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 response criteria. Secondary outcomes
      include symptomatic venous thromboembolism, bleeding, and compliance. The dose of dalteparin
      associated with the best response will be tested further in a phase III randomized clinical
      trial in the same patient population.
    


Intervention name(s): dalteparin
Intervention type(s): Drug
Intervention description(s): 50, 100, 150 IU/kg administered subcutaneously once daily for 3 cycles of chemotherapy
Other intervention name(s): brand name is fragmin
Intervention MeSH terms: Dalteparin; Tinzaparin; Heparin, Low-Molecular-Weight
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antineoplastic agent; ovarian cancer; fragmin; dalteparin
Effect of Mental Stress on Platelet Function
Condition: Mental Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The aim of the project is to study the acute and chronic effect of mental stress on platelet
      adhesion and aggregation in two population composed of normal subjects at different ages
    

Detailed description: 
      Psychological stress is an important cardiovascular risk factor. Activation of platelets
      plays an important role in atherosclerosis development and it could be one of the mechanisms
      linking psychological stress and cardiovascular diseases.

      We plan to include 32 healthy subjects. (16 in every group). One group with subjects at age
      20 - 49 and the other group with subjects at age 50 - 70 years.

      The aim of the study will be to assess the acute and chronic effect of a standard short
      mental stress (2-minute Bondet Test) on platelet function and of the level of endothelin-1,
      catecholamines and cortisol. We plan to evaluate if age may play a role in the effect of
      psychological stress on platelet function.
    

Intervention name(s): 2-minute Bondet test
Intervention type(s): Behavioral
Intervention description(s): 2-minute Bondet test
Other intervention name(s): 2-minute Bondet light test
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: mental stress; platelet adhesion; platelet function; catecholamines
Tolerability, Pharmacokinetics, and Efficacy of APD371 in Participants With Crohn's Disease Experiencing Abdominal Pain
Condition: Crohn's Disease; Abdominal Pain
MeSH terms: Crohn Disease; Abdominal Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this randomized, open-label, parallel, phase 2a study is to determine the
      tolerability, pharmacokinetics, and efficacy of olorinab in participants with Crohn's disease
      experiencing abdominal pain.
    


Intervention name(s): Olorinab
Intervention type(s): Drug
Intervention description(s): Olorinab active treatment for 8 weeks.
Other intervention name(s): APD371
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of Montelukast sodium chewable tablets 4mg and 5mg of
      Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (containing
      Montelukast sodium) chewable tablets 4mg and 5 mg of Merck Sharp & Dohme Ltd., USA in
      healthy, adult, human subjects under fed conditions.
    

Intervention name(s): Montelukast sodium chewable tablets 4mg and 5mg
Intervention type(s): Drug
Intervention description(s): Montelukast sodium chewable tablets 4mg and 5mg
Other intervention name(s): SINGULAIR®
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Montelukast Sodium; crossover
Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess both the antibody persistence of the investigational vaccine and the
      immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers
      who participated in an earlier study in order to determine if they are still protected before
      they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the
      quality of the induced immune memory in response to a booster dose of the same vaccine as in
      the primary series.

      Primary Objective:

      To describe the antibody persistence at 18 months of age and the booster effect of a dose of
      PENTAXIM™ on immunogenicity.

      Secondary objective:

      To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by
      the vaccines received during the primary series.
    


Intervention name(s): DTaP-IPV//PRP~T combined vaccine; DTaP-IPV//PRP~T combined vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): PENTAXIM™; PENTAXIM™
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; whooping cough; Haemophilus influenzae type b; Hepatitis B; Poliomyelitis