bioihbjkbjnl/mcl2 huggingface dataset:
Group Study of the Safety of and Immune Response to a Single Dose of Bird Flu Vaccine (H7N3) in Healthy Adults
Condition: Influenza; Virus Diseases
MeSH terms: Influenza, Human; Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Over the past decade, avian influenza (AI) has become a major health concern. The development
      of safe and effective vaccines against avian strains that infect people is important. The
      purpose of this study is to determine the safety of and immune response of an investigational
      AI vaccine in healthy adults against the H7N3 strain of avian influenza.
    

Detailed description: 
      The current pandemic risk associated with avian influenza H7N3 infection is significant, as
      an increasing number of humans are infected. H7 influenza transmission usually occurs in
      humans when they are exposed through direct contact to infected poultry or surfaces and
      objects contaminated by infected poultry feces. A pandemic occurs when a new influenza
      subtype emerges that infects humans, causes serious illness, and spreads easily between
      humans. The development of a safe and effective vaccine is necessary. The purpose of this
      study is to evaluate the safety and immunogenicity of a one-dose administration of the live,
      attenuated AI virus vaccine, H7N3 (6-2) AA ca Recombinant (A/chicken/British
      Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca).

      This study will last approximately 180 days. Participation in this study includes one 12-day
      hospital stay in an isolation unit at the University of Rochester Vaccine Evaluation
      Isolation Unit at St. Mary's Hospital in Rochester, NY. All participants will receive one
      dose of vaccine in nasal spray form at study entry. Participants will be admitted to the
      isolation unit 2 days prior to vaccination. A targeted physical exam, vital signs
      measurement, and nasal wash will occur daily following each vaccination until discharge.
      Participants will be discharged after two consecutive nasal washes on or after Day 7 are
      negative. Blood and urine collection will occur at selected timepoints throughout the study.
      Follow-up outpatient visits will occur approximately at Days 28, 56, and 180. A nasal wash
      and adverse events evaluation will occur at each follow-up visit.
    

Intervention name(s): Live Influenza A Vaccine H7N3 (6-2) AA ca Recombinant (A/chicken/British Columbia/CN-6/2004 x A/Ann Arbor/6/60 ca)
Intervention type(s): Biological
Intervention description(s): Vaccine administered by nasal spray
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bird Flu
Role of Metabolites in Nicotine Dependence (1) - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effects of cotinine with or without a
      transdermal nicotine replacement on tobacco withdrawal symptoms.
    

Detailed description: 
      The purpose of this study was to determine the effects of a metabolite of nicotine, cotinine,
      on tobacco withdrawal symptoms. Cotinine has been shown to have psychoactive effects that are
      similar as well as different from those of nicotine, however, little research has been
      conducted examining the role cotinine plays in nicotine addiction. This study compared the
      effects of cotinine with the nicotine patch, and a combination thereof on tobacco withdrawal
      symptoms. The results showed that cotinine antagonizes the beneficial effects of the nicotine
      patch in reducing withdrawal symptoms.
    

Intervention name(s): Cotinine fumarate
Intervention type(s): Drug
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: nicotine dependence
Glucosamine and Chondroitin in Gut in Preventing People From Inflammation
Condition: Healthy Subject
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial studies glucosamine and chondroitin in preventing inflammation. Glucosamine and
      chondroitin often used as a dietary supplement to promote joint health may have a preventive
      role in inflammation and cancer. This trial may help identify the bacteria that help process
      them in the gut.
    


Intervention name(s): Glucosamine Sulfate/Chondroitin Sulfate Tablet; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Given PO; Given PO
Other intervention name(s): PLCB; sham therapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Nutrition Intervention for Arthritis -2
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      The purpose of the study is to assess whether, in individuals with rheumatoid arthritis, a
      low-fat, vegan diet improves pain and other subjective symptoms more effectively than a
      control supplement or a placebo. The principal measure is pain as measured by Visual Analog
      Scale (VAS) and disease activity as measured by number of painful swollen and tender joints,
      respectively. The study duration is 36 weeks.

      This study tests that a low fat, plant-based (vegan) diet free of foods commonly identified
      as triggers improves mood, using the Center for Epidemiologic Studies Depression
      Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).
    

Detailed description: 
      Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional
      supplements can help reduce pain and also reduce the need for pain medications for some
      people. The investigators will ask about 100 people to participate. All of them will get a
      low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a
      placebo), although some will get the diet first, and others will get the supplement first.
      This order in which they will get the diet and the supplement will be determined randomly,
      that is, by chance (like the toss of a coin). The principal measure is pain as measured by
      Visual Analog Scale (VAS) and disease activity as measured by number of painful swollen and
      tender joints, respectively. The Beck Depression Inventory II (BDI-II)will be used to measure
      changes in mood. The study duration is 36 weeks.
    

Intervention name(s): Plant-based diet; Supplement
Intervention type(s): Other; Other
Intervention description(s): Weekly instructions will be given to the participants in the intervention group about following vegan diet.; Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
Other intervention name(s): Vegan diet; Vitamin E
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Rheumatoid Arthritis, Diet, Fat-Restricted, Diet, Vegetarian
Exercise Testing for Early Stage Breast Cancer Patients Receiving Radiation Treatment
Condition: Breast Cancer; Fatigue
MeSH terms: Breast Neoplasms; Fatigue
Study type: Observational

Summary: 
      Many patients receiving radiation therapy for breast cancer experience fatigue although
      doctors do not fully understand why. The purpose of this study is to test if patients who
      experience fatigue during radiation treatment for breast cancer have changes in their
      capability to perform exercise on a treadmill.
    


Intervention name(s): FACIT-Fatigue 52-point questionnaire
Intervention type(s): Behavioral
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are undergoing or have recently completed radiotherapy for breast cancer (in
        the last 3 months) will be assessed in outpatient clinics of the Radiation Oncology
        Department of MSKCC. The protocol is available for consenting only at OneMSK Sites Basking
        Ridge, Rockville Center, Commack, Monmouth and Westchester.
      
Keywords: Exercise; Radiation Treatment; 16-941
Enhancing Cognitive Training Using tDCS
Condition: Cognition
Study type: Interventional
Phase: Phase 1

Summary: 
      Cognitive rehabilitation involves enhancing an individual's capacity to process information
      to improve their everyday functioning. One common form of intervention is computerised
      cognitive training (CT); however, efficacy results have been mixed. This research aims to
      investigate a novel method for enhancing outcomes from CT through combining CT with
      transcranial direct current stimulation (tDCS), a non-invasive and painless form of brain
      stimulation. In this study we aim to determine the efficacy of this approach through
      comparing in a randomized controlled study tDCS combined with CT versus CT and tDCS alone in
      healthy participants. We hypothesise that tDCS combined with CT will have greater
      generalisability effects than the other conditions.
    


Intervention name(s): Transcranial direct current stimulation (tDCS)
Intervention type(s): Procedure
Primary purpose: Basic Science
Keywords: tDCS; cognitive training
Study Comparing Muraglitazar With Glimepiride in Type 2 Diabetics Who Are Not Controlled With Metformin Alone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical research study is to learn whether a muraglitazar-metformin
      combination is at least as effective as a glimepiride-metformin combination to treat type 2
      diabetics who are not sufficiently controlled with metformin alone. The safety of this
      treatment will also be studied.
    


Intervention name(s): muraglitazar
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Diabetes
Atomoxetine Versus Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in Children and Adolescents With Autism Spectrum Disorder
Condition: Autistic Disorder; Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Autistic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD
      (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD
      (Autism Spectrum Disorder).
    


Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
New Biomarkers in Axial Sypondyloarthropathy; SII and SIRI
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Study type: Observational

Summary: 
      investigators aimed to evaluate the relationship between Systemic Immune Inflammation Index
      (SII) and Systemic Inflammation Response Index (SIRI) and disease activity in patients with
      axial spondyloarthropathy (SpA).
    

Detailed description: 
      The clinical characteristics and laboratory data of the patients and healthy controls
      participating in our study were obtained through the hospital system. Then, the new
      biomarkers SIRI and SII values were calculated. SIRI= neutrophil count*monocyte
      count/lymphocyte count and SII= neutrophil count*platelet count/lymphocyte count. Then, SIRI
      and SII values were compared between groups. The relationship between disease activity and
      SIRI and SII values in the patient group was examined.
    

Intervention name(s): lab testing
Intervention type(s): Other
Intervention description(s): Complete blood count and erythrocyte sedimentation rate and C-reactive protein values of the participants were analyzed by laboratory test.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Group 1:healthy controls working in our hospital,

        Group 2: SpA patients diagnosed according to the 2009 Assessment of Spondyloarthritis
        International Society classification criteria
      
Keywords: Axial Spondyloarthritis; Systemic Immune Inflammation Index; Systemic Inflammation Response Index
A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to
      determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of
      subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20
      (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone,
      insulin aspart + rHuPH20, and insulin aspart alone.
    


Intervention name(s): Recombinant human hyaluronidase PH20 (rHuPH20); Insulin lispro; Insulin glulisine; Insulin aspart
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): HYLENEX; PH20; Humalog; Lispro; Apidra; Glulisine; NovoLog; Aspart
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: insulin; recombinant human hyaluronidase; Healthy volunteers
Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus
      PA-824 plus pyrazinamide regimen after 8 weeks of treatment.
    


Intervention name(s): Moxifloxacin (M); Pretomid (Pa); Pyrazinamide (Z); Rifafour
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: 2 tablets, 38-54 kg: 3 tablets, 55-70 kg: 4 tablets: 71 kg and over: 5 tablets
Other intervention name(s): PA-824
Intervention MeSH terms: Moxifloxacin; Pyrazinamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tuberculosis; Serial Sputum Colony Counts; Colony Forming Units; Time to Sputum Culture Positivity; PA824; pretomanid
Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease
Condition: NAFLD
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Objectives To evaluate the efficacy, safety, and tolerability of lubiprostone in patients
      with nonalcoholic fatty liver disease (NAFLD).

      This study will include 100 patients with nonalcoholic fatty liver disease (NAFLD) recruited
      from the specialized NAFLD outpatient's clinic in National Hepatology and Tropical Medicine
      Research Institute (NHTMRI).

      Study design: Randomized controlled trial.
    


Intervention name(s): Lubiprostone 24Mcg Oral twice daily
Intervention type(s): Drug
Intervention description(s): The patients will be randomized (closed envelopes) into one of two groups:
Fifty patients will receive lubiprostone 24 mcg (microgram) twice daily.
Fifty patients will receive placebo twice daily (control group). All patients will be followed for 48 weeks.
Intervention MeSH terms: Lubiprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Risperidone Augmentation for PTSD
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to (1) compare the response of civilians with Posttraumatic
      Stress Disorder(PTSD) currently receiving sertraline without an optimal response to
      risperidone augmentation vs. placebo, and (2) to evaluate the tolerability of risperidone
      augmentation, and (3) to identifiy predictors of response to risperidone augmentation. the
      hypothesis is that risperidone augmentation of sertraline treatment of PTSD is safe and
      effective.
    

Detailed description: 
      This is a multi-center, two-phase study to evaluate the efficacy and safety of risperidone
      augmentation to sertraline treatment of Post-Traumatic Stress Disorder (PTSD). In the first
      phase, all patients will be assigned to take open label sertraline for 8 weeks (up to 200
      mg/d). Those who have not achieved a significant decrease in their PTSD symptoms by week 8
      will be entered into the second phase. In the second phase, patients will continue with the
      sertraline, but will then be randomly given either risperidone (up to 3 mg/d) or matching
      placebo in double-blind fashion.
    

Intervention name(s): sertraline and risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: PTSD; sertraline; risperidone; antidepressant; antipsychotic; anxiety; trauma
11ß-HSD1 and Metabolic Syndrome
Condition: Metabolic Syndrome; Impaired Glucose Tolerance
MeSH terms: Metabolic Syndrome; Glucose Intolerance; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the insulin sensitizing effects of
      rosiglitazone were accompanied by changes in 11ß-HSD1 expression and activity in different
      tissues. Furthermore the metabolic and hormonal effects of PPAR gamma stimulation by
      rosiglitazone will be analysed in several tissues.
    

Detailed description: 
      The PPARgamma agonist rosiglitazone (R) increases insulin sensitivity, which is comparable to
      the effects of a reduction in 11ß-hydroxysteroid dehydrogenase type 1 (11β-HSD1) activity in
      animal models. We therefore aimed to investigate whether rosiglitazone-induced insulin
      sensitivity is associated with changes in 11β-HSD1 activity in different tissues in subjects
      suffering from impaired glucose tolerance. Furthermore the metabolic and hormonal effects of
      PPAR gamma stimulation by rosiglitazone will be analysed in those tissue samples.
    

Intervention name(s): rosiglitazone
Intervention type(s): Drug
Intervention description(s): 89 mg BID for 8 weeks, orally
Other intervention name(s): Avandia
Intervention MeSH terms: Rosiglitazone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 11ß-hydroxysteroid dehydrogenase; rosiglitazone; insulin sensitivity; Impaired glucose tolerance
Analysis of Cisatracurium Consumption in Balanced Anesthesia With 1% Sevoflurane, and With Only Sevoflurane, Using a Closed-loop Computer Controlled System Infusion.
Condition: Drug Interaction Potentiation
Study type: Interventional

Summary: 
      The aim in this study was to quantify the difference in cisatracurium and sufentanil
      consumption, and its recovery period, when patients are under balanced general anesthesia
      with 1% sevoflurane and patients under only sevoflurane general anesthesia, using a closed
      loop computer control infusion. Investigators further investigated this effect on its
      recovery period and sufentanyl consumption.
    

Detailed description: 
      156 patients of American Society of Anesthesiologists (ASA) physical status I and II were
      assigned to three groups. The patients were all on schedule for elective general surgery
      under general anesthesia with duration of at two to four hours. All patients were induced
      with Etomidate (0.2mg/kg), Midazolam (0.05-0.1mg/kg), Sufentanil (0.3-0.5µg/kg) and a bolus
      dose of Cisatracurium (0.15mg/kg). Patients were aged between 20 and 65. The maintenance of
      anesthesia in each group varies as follows: Patients in Group 1 were all maintained with
      Total Intravenous Anesthesia, Group 2 with Sevoflurane at 1% and propofol infusion, Group 3
      with only sevoflurane. Muscle paralysis is maintained using a closed-loop computer gated
      infusion of Cisatracurium which kept T1 <1% by giving increasing the infusion rate
      intra-operatively when required. Analgesia was maintained by intermittent bolus dose of 10-20
      µg of Sufentanil.
    

Intervention name(s): 1% Sevoflurane; Propofol; Sevoflurane
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In this group of patients, the maintenance of anesthesia is done by 1% sevoflurane + propofol infusion. Propofol infusion is adjusted according to the Bispectral Index.; In this group the maintenance of anesthesia is maintained by only propofol infusion.; In this group only sevoflurane was used for maintenance of anesthesia. the dose of sevoflurane is adjusted to maintain Bispectral Index within 45 and 55.
Other intervention name(s): Total Intravenous Anesthesia
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Sevoflurane; Cisatracurium infusion consumption; Closed loop computer control system; Recovery Index