bioihbjkbjnl/mcl2 huggingface dataset:
Use of Dexmedetomidine in Acute Stroke and Cerebral Vasospasm Interventions
Condition: Stroke; Brain Ischemia; Vasospasm, Intracranial; Hemorrhage, Intracranial
MeSH terms: Stroke; Brain Ischemia; Vasospasm, Intracranial; Intracranial Hemorrhages; Hemorrhage; Ischemia
Intervention: Dexmedetomidine; Fentanyl; Midazolam
Intervention description: Precedex will be given to randomized subjects in thi study to evaluate its efficacy in maintaining optimal sedation and preserving neurological exam.; Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.; Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.
Intervention MeSH terms: Midazolam; Fentanyl; Dexmedetomidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Dexmedetomidine; Endovascular procedure; Stroke; Vasospasm, intracranial; Conscious sedation

Summary:

      Dexmedetomidine is a unique sedative medication able to provide sedation without causing
      respiratory depression and maintaining neurological functions. Patients having an acute
      ischemic stroke and need to undergo endovascular therapy require constant assessment of their
      neurological status prior, during and after the interventional procedure. In this study the
      investigators will compare the efficacy of Dexmedetomidine to other standard sedative
      medications in providing optimal sedative effect while maintaining neurological function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with acute ischemic stroke who require endovascular intervention with whom
             mNIHSS score can be obtained

          -  Patients with cerebral vasospasm suspiciousness with or without subarachnoid
             hemorrhage with whom mNIHSS score can be obtained.

        Exclusion Criteria:

          -  History of severe hepatic disease or severe renal disease (GFR<20).

          -  Hemodynamic instability.

          -  Pregnancy.

          -  Known allergy to study drug.

          -  Evidence or history of cardiac electrophysiology instability including uncontrolled
             hemodynamically unstable complex atrial/ventricular arrhythmia or conduction block at
             the time of evaluation with the exception of atrial fibrillation, and heart rate less
             than 60 or systolic blood pressure less than 90.

          -  Respiratory compromise requiring intubation.

          -  Any medical (including history of cardiac conduction block, major hepatic or renal
             disease) or laboratory abnormality that may increase the risk associated with the
             trial participation or drug administration or may interfere with interpretation of
             trial results.
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
Condition: Diabetes Mellitus, Type II; Fatty Liver
MeSH terms: Fatty Liver; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: INT-747; Placebo
Intervention description: 25 mg by mouth once daily, 50 mg by mouth once daily; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Farnesoid X receptor agonist; Metabolic Disorder; Diabetes; NAFLD

Summary:

      The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus
      (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following:

        -  The safety and tolerability of multiple doses of INT 747;

        -  The effects of 2 dose levels (25 mg and 50 mg) of INT 747 on insulin resistance and
           glucose homeostasis;

        -  Effects of INT-747 on hepatocellular function as measured by assessment of liver enzymes
           and biochemical markers of hepatic and metabolic function and inflammation, and;

        -  Trough concentrations of INT-747 and its metabolites, glyco 6-ethyl chenodeoxycholic
           acid (6-EDCA) and tauro 6-ECDCA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes, defined by the American Diabetes Association (ADA), as one of the
             following criteria:

          -  Symptoms of diabetes plus casual plasma glucose concentration >200 mg/dL (11.1 mmol/L)
             or

          -  Fasting plasma glucose >126 mg/dL (7.0 mmol/L) or

          -  2-hour post-load glucose >200 mg/dL (11.1 mmol/L) during a 75 g oral glucose tolerance
             test (GTT).

          -  Presumed NAFLD, defined by one of the following criteria:

          -  Alanine aminotransferase (ALT) ≥47 U/L for females and ≥56 U/L for males

          -  Aspartate aminotransferase (AST) ≥47 U/L for females and ≥60 U/L for males

          -  Enlarged liver (demonstrated by ultrasound or other imaging technique)

          -  Diagnostic histological findings shown on prior biopsy (in the last 5 years).

        Exclusion Criteria:

          -  Bilirubin >2 × ULN

          -  ALT >155 U/L for females and >185 U/L for males.

          -  AST >155 U/L for females and >200 U/L for males.

          -  Patients taking any antidiabetic medications, with the exception of metformin and
             sulfonylureas. If the HbA1c is <11%, patients may be enrolled who have been withdrawn
             from all other diabetic medications as specified in the protocol, at the discretion of
             the Principal Investigator.
Fatty Acid Amide Hydrolase (FAAH) Inhibitor Treatment of Cannabis Use Disorder (CUD)
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Intervention: PF 04457845; Placebo Oral Tablet
Intervention description: Study medication will be administered at 4mg by mouth daily for eight weeks.; Placebo comparator will be administered by mouth daily for eight weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2B
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      A Phase 2B, 8-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to
      Evaluate the Efficacy, Safety and Tolerability of the Fatty Acid Amide Hydrolase (FAAH)
      Inhibitor PF-04457845 in Adults with DSM-5 Current Cannabis Use Disorder (CUD)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Ages 18-60 years, inclusive.

          2. Male or Female.

          3. Individuals with DSM-V criteria for Cannabis Use Disorder .

          4. Positive for urinary THC-COOH at both screening visits.

          5. Must express a willingness at screening to set a date within the first week of
             randomization to attempt to quit using cannabis.

        Exclusion Criteria:

          1. Clinically significant unstable medical disorders (as determined by the site
             investigator).

          2. Laboratory tests with clinically significant abnormalities (as determined by the site
             investigator)

          3. Pregnancy by history and or laboratory confirmation (serum HCG).

          4. Lactation.

          5. Physiological dependence on another substance.
Violence and Stress Assessment (ViStA) Project to Improve Post Traumatic Stress Disorder Management in Primary Care
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: PCM; MEU
Intervention description: Care Manager (CM) intervention; The MEU condition consists of only the clinician education and patient screening without written feedback.
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 404.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mental health; PTSD; primary care; quality improvement; collaborative care

Summary:

      The purpose of this study is to conduct a randomized trial of a Post Traumatic Stress
      Disorder (PTSD) Care Management (PCM) program to detect, treat, and improve PTSD treatment
      processes and outcomes in patients seeking primary care from FQHCs and evaluate its
      effectiveness on improving the processes and outcomes of care for PTSD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has PTSD

          -  Has a scheduled or walk-in appointment with a participating PCC

          -  Speaks English of Spanish

          -  Is between 18 and 65 years old

          -  Expects to receive care in the CHC during the next year

        Exclusion Criteria:

          -  Acutely ill and cannot participate in a discussion

          -  Does not understand the information
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects
Condition: Pandemic H5N1 Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: Adjuvanted H5N1 pandemic influenza vaccine
Intervention description: Comparison of two doses of aH5N1c vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1393.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza, Pandemic, H5N1, Elderly adults

Summary:

      Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived
      influenza vaccine in elderly subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy elderly subjects ≥65 years,

          2. Individuals willing to provide written informed consent,

          3. Individuals in good health,

          4. Individuals willing to allow for their serum samples to be stored beyond the study
             period.

        Exclusion Criteria:

          1. Individuals not able to understand and follow study procedures,

          2. History of any significant illness,

          3. History of any serious chronic medical condition or progressive disease,

          4. Presence of medically significant cancer,

          5. Known or suspected impairment/alteration of immune function,

          6. Presence of any progressive or severe neurologic disorder,

          7. Presence of any bleeding disorders or conditions that prolongs bleeding time,

          8. History of allergy to vaccine components,

          9. Receipt of any other investigational product within 30 days prior to entry into the
             study,

         10. History of previous H5N1 vaccination,

         11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into
             the study,

         12. Receipt of any other vaccine within 2 weeks prior to entry into the study

         13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended
             study vaccination,

         14. Body mass index (BMI) ≥ 35 kg/m2,

         15. History of drug or alcohol abuse,

         16. Any planned surgery during study period,

         17. Individuals conducting the study and their immediate family members,

         18. Individuals with behavioral or cognitive impairment or psychiatric diseases.
Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease; Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD2423; AZD2423 Placebo
Intervention description: 100mg Oral dose od; Oral dose od
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Respiratory disease; chronic obstructive pulmonary disease

Summary:

      The purpose of the study is to find out if AZD2423 can reduce inflammation in the lungs of
      patients with mild COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Only women of non-child bearing potential are included in the study i.e. women who are
             permanently or surgically sterilised or post menopausal.

          -  ≥ 40 years of age at Visit 1

          -  Clinical diagnosis of COPD (GOLD stage 1)

          -  FEV1 ≥ 80% of the predicted normal post-bronchodilator at Visit 1 (GOLD stage 1)

          -  FEV1/FVC <70% post-bronchodilator at Visit 1 (GOLD stage 1)

        Exclusion Criteria:

          -  Any clinically significant disease or disorder which, in the opinion of the
             Investigator, may either put the subject at risk or influence the way the drug works

          -  Any clinically relevant abnormal findings in physical examination, blood or urine test
             results, vital signs or ECG at Visit 1 that may put the subject at risk during the
             study, affect their ability or take part or influence the results of the study

          -  A past history or current indication of renal (kidney) failure

          -  Subjects at risk of active tuberculosis or of disease reactivation

          -  Subjects who have had any clinically significant illness within 4 weeks before Visit 2
             (start of treatment)
Dose-Ranging Study to Evaluate Efficacy and Safety of Weekly CJC-1134-PC in Patients With T2DM on Metformin Monotherapy
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: CJC-1134-PC Injection; Weekly placebo for CJC-1134-PC Injection
Intervention description: CJC-1134-PC administered weekly by subcutaneous injection; Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; T2DM; diabetes; ConjuChem; GLP-1; Glucagon-like peptide-1; exendin-4; modified exendin-4

Summary:

      DM200-103 is a dose-ranging study to evaluate the efficacy and safety of 17 weeks of weekly
      injections of CJC-1134-PC in patients with Type 2 Diabetes Mellitus on metformin monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 18 to 70 years of age, inclusive

          -  Body mass index of 27 to 45 kg/m2

          -  Diagnosed with T2DM for at least 6 months before screening

          -  Stable daily dose of metformin monotherapy of ≥1000 mg for at least 3 months before
             screening

          -  FPG ≤240 mg/dL at screening

          -  HbA1c ≥7.0% and ≤11% at screening

          -  A 12-lead electrocardiogram recording without clinically significant arrhythmia, left
             bundle-branch block, or corrected QT interval

        Exclusion Criteria:

          -  Pregnant or breastfeeding women

          -  Use of a weight control treatment, including over-the-counter medications (includes
             herbal supplements), or a significant change in body weight (at least ±10%) in the 3
             months before screening

          -  Treatment with any oral antidiabetic agent other than metformin within the 3 months
             before screening

          -  Treatment with insulin for longer than 1 week within the 3 months before screening or
             any treatment with insulin within the 2 weeks before screening

          -  Previous treatment with a glucagon-like peptide 1 (GLP-1) analog or other incretin
             therapy

          -  Receipt of any experimental drug in a clinical trial within 30 days before
             administration of study drug or receipt of any investigational antidiabetic product
             within 3 months before screening
Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Condition: Bacterial Infections; Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Skin Diseases, Bacterial
Intervention: BC-3781; BC-3781; Vancomycin
Intervention description: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.; BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.; Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Intervention MeSH terms: Vancomycin; Lefamulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: acute bacterial skin and skin structure infection; bacteria

Summary:

      This is a Phase II, multi-center, randomized, double-blind study comparing the safety and
      efficacy of two doses of BC-3781 versus vancomycin in patients with acute bacterial skin and
      skin structure infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients > 18

          -  Documented acute bacterial skin and skin structure infection

        Exclusion Criteria:

          -  Uncomplicated skin and skin structure infection
A Study of Nivolumab or Nivolumab Plus Experimental Medication BMS-986205 With or Without Bacillus Calumette-Guerin (BCG) in BCG Unresponsive Bladder Cancer That Has Not Invaded Into the Muscle Wall of the Bladder
Condition: Urinary Bladder Neoplasms
MeSH terms: Urinary Bladder Neoplasms
Intervention: Nivolumab; BCG; BMS-986205
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Linrodostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder Cancer; BCG-unresponsive; Nivolumab; Intravesical BCG; NMIBC; Non-Muscle Invasive; BMS-986205; CheckMate 9UT

Summary:

      A study to evaluate the safety and tolerability of nivolumab or nivolumab Plus BMS-986205
      with or without BCG in BCG-Unresponsive non-muscle invasive Bladder Cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically demonstrated BCG-unresponsive, carcinoma in situ (CIS)-containing
             high-risk non-muscle-invasive bladder cancer (NMIBC) defined as CIS with or without
             papillary component

          -  Participants must have CIS to be eligible.

          -  Predominant histologic component (> 50%) must be urothelial (transitional cell)
             carcinoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

        Exclusion Criteria:

          -  Sign of locally advanced disease or metastatic bladder cancer

          -  Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting
             systems, ureters) within 24 months of enrollment

          -  Prior immuno-oncology therapy

        Other protocol-defined inclusion/exclusion criteria apply
Study of UX003 Recombinant Human Beta-Glucuronidase (rhGUS) Enzyme Replacement Treatment in Mucopolysaccharidosis Type 7, Sly Syndrome (MPS 7) Patients Less Than 5 Years of Age
Condition: Sly Syndrome; MPS VII; Mucopolysaccharidosis; Mucopolysaccharidosis VII
MeSH terms: Mucopolysaccharidoses; Mucopolysaccharidosis VII; Syndrome
Intervention: UX003
Intervention description: solution for intravenous infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 1 Day
Maximum age: 5 Years
Healthy volunteers: No
Keywords: MPS 7; Sly Syndrome; MPS VII; Enzyme Replacement Therapy; Rare Disease; Mucopolysaccharidosis type 7; Lysosomal Storage Disease; Metabolic Disorder

Summary:

      The primary objective was to evaluate the effect of UX003 treatment in pediatric MPS VII
      participants less than 5 years of age on safety, tolerability, and efficacy as determined by
      the reduction of urinary glycosaminoglycans (uGAG) excretion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed diagnosis of MPS 7 based on leukocyte or fibroblast glucuronidase enzyme
             assay, or genetic testing.

          2. Under 5 years of age at the time of informed consent.

          3. Written informed consent of Legally Authorized Representative after the nature of the
             study has been explained, and prior to any research-related procedures.

        Exclusion Criteria:

          1. Undergone a successful bone marrow or stem cell transplant or has evidence of any
             degree of detectable chimaerism with donor cells.

          2. Any known hypersensitivity to rhGUS or its excipients that, in the judgment of the
             Investigator, places the subject at increased risk for adverse effects.

          3. Use of any investigational product (drug or device or combination) other than UX003
             within 30 days prior to Screening, or requirement for any investigational agent prior
             to completion of all scheduled study assessments at any time during the study.

          4. Has a condition of such severity and acuity, in the opinion of the Investigator, which
             may not allow safe study participation. For patients with hydrops fetalis, the ongoing
             interventions to manage fluid balance can be continued; if the addition of enzyme
             replacement therapy (ERT) is considered a fluid-overload risk, the individual should
             be excluded.

          5. Has a concurrent disease or condition that, in the view of the Investigator, places
             the subject at high risk of poor treatment compliance or of not completing the study,
             or would interfere with study participation or affect safety. Since hydropic patients
             have a high rate of mortality, the risk of death prior to 1 year of age should not be
             considered sufficient to exclude the patient from the study for compliance.