bioihbjkbjnl/mcl2 huggingface dataset:
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: Multivalent; 13vPnC
Intervention description: Pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 460.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a
      Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days)
             at the time of consent (the day of birth is considered day of life 1).

          -  Healthy infant determined by medical history, physical examination, and clinical
             judgment to be eligible for the study.

        Exclusion Criteria:

          -  Previous vaccination with licensed or investigational pneumococcal vaccine.

          -  Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines.

          -  Previous receipt of >1 dose of hepatitis B vaccine.

          -  Prior hepatitis B vaccine must have been administered at age <30 days.

          -  Major known congenital malformation or serious chronic disorder. Receipt of
             blood/plasma products or immunoglobulins
Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD9668; Placebo
Intervention description: 2 x 30 mg oral tablets twice daily (bid) for 12 weeks; 2 x matched placebo to oral tablet twice daily (bid) for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic; obstructive; pulmonary; lung; respiratory disease; efficacy; placebo-controlled; COPD; FEV1; St Georges Respiratory Questionnaire; Computed Tomography; MSCT

Summary:

      The primary objective of the study is to evaluate structural changes effected by AD9668 in
      the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice
      Computed Tomography (MSCT)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of COPD with symptoms over 1 year

          -  FEV1/FVC < 70% and FEV1 >= 40 and < =70 % of predicted post-bronchodilator

          -  Ex-smokers for at least 12 months

        Exclusion Criteria:

          -  Past history or current evidence of clinically significant heart disease

          -  Current diagnosis of asthma

          -  Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or
             an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit
             1b
Effect of Resveratrol on Age-related Insulin Resistance and Inflammation in Humans
Condition: Type 2 Diabetes Mellitus; Insulin Resistance
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Inflammation
Intervention: Resveratrol
Intervention description: 1,000mg twice daily for 28 days
Intervention MeSH terms: Resveratrol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Resveratrol; Therapeutic Uses

Summary:

      Resveratrol is a natural polyphenol (a compound containing a phenol functional group) that
      can be found in many plants. The purpose of this research is to study the effects of
      resveratrol on the action of insulin (a hormone produced in the body by the pancreas that
      regulates the amount of sugar in the blood), fat accumulation, and inflammation in the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI: 26-35

          -  Non-smoker

          -  Normal screening labs (CMC, chemistry, LFTs PT/PTT)

          -  No CAD

          -  Good IV access

        Exclusion Criteria:

          -  High cholesterol

          -  <4 week history of participation in another drug trial

          -  Severe hypertension

          -  Heart disease

          -  Liver disease of liver abnormalities

          -  Cerebrovascular disease, i.e. stroke

          -  CVD

          -  Seizures

          -  Bleeding disorders

          -  Muscle disease

          -  Cancer

          -  HIV

          -  Hepatitis (all types)

          -  Mentally disabled persons

          -  Pregnant women

          -  Allergies to Novocaine, Lidocaine, Benzocaine

          -  Subjects on the following medications:

               -  Anticoagulant and antiplatelet drugs

               -  Anti-epileptic drugs

               -  Mexiletene

               -  Quinidine

               -  Cyclosporine

               -  Tacrolimus

               -  HIV protease inhibitors
Provoked Craving Assessment
Condition: Smoking Dependence; Smoking
Intervention: oral nicotine; Placebo
Intervention description: oral nicotine replacement product; no active
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: craving

Summary:

      Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a
      cigarette in smokers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current cigarette smokers who have smoked regularly, and smoke more than 20 cigarettes
             per day on a regular basis for at least a year;

          -  Good general health with (in the opinion of the investigator) no clinically
             significant and relevant abnormalities of medical history.

        Exclusion Criteria:

          -  Any disease that may interfere with the absorption, metabolism or excretion of the
             study product.

          -  A medical condition that might jeopardise the safety of the subject or the validity of
             the study results. For example, recent myocardial infarction or cerebrovascular
             incident (within 12 weeks of the screening visit), phenylketonuria, unstable or
             worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia
Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Condition: Coronary Microvascular Dysfunction
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: CLBS16
Intervention description: GCSF-mobilized autologous CD34 cells
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo
      selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with
      no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary
      infusion of CLBS16.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women age ≥18

          -  History of and currently experiencing angina at least 3 times per week

          -  No obstructive coronary artery disease

          -  On stable medical therapy for 30 days prior to enrollment

          -  Must agree to use a reliable and acceptable method of contraception for the duration
             of participation

          -  Written informed consent

        Exclusion Criteria:

          -  Myocardial infarction within 90 days

          -  Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or
             CABG)

          -  Diagnosis of other specific cardiac disease

          -  Must meet LVEF and GFR requirements

          -  Current use of coumadin or DOACs

          -  Hypersensitivity to G-CSF, apheresis or study product components

          -  Positive for HIV, hepatitis B or hepatitis C

          -  Active inflammatory or autoimmune disease, or chronic immunosuppressive state

          -  Drug abuse

          -  Pregnant or lactating

          -  Malignant neoplasm within 5 years

          -  History of Sickle Cell Disease

          -  Participation in another clinical study within 90 days
Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome
Condition: Major Depressive Disorder; Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Escitalopram; CBTI; CTRL
Intervention description: 5 to 20 mg for 12 weeks; Cognitive Behavioral Treatment for Insomnia; Control Therapy consists of Pseudo-desensitization Therapy for Insomnia
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Insomnia; Sleep; Mental Health

Summary:

      This study will examine the effectiveness of a combination of antidepressant medication and
      sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of major depressive disorder

          -  HRSD(17) score of at least 14

          -  Presence and complaint of insomnia for at least 1 month

          -  Fluent in English

          -  Use of an effective form of contraception throughout the study

        Exclusion Criteria:

          -  Other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder,
             obsessive compulsive disorder, eating disorder)

          -  Psychotic symptoms

          -  Serious, unstable, or terminal medical condition

          -  Axis II diagnosis of antisocial, schizotypal, or severe borderline personality
             disorder

          -  Substance abuse

          -  Not willing to end other psychiatric treatment

          -  Previous electroconvulsive therapy or vagus nerve stimulation treatment during the
             last year

          -  Sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after
             first sleep study)

          -  Other sleep disorders

          -  Currently pregnant or breastfeeding

          -  History of seizure disorder

          -  Disease or condition that produces altered metabolism or hemodynamic responses

          -  Liver or kidney dysfunction

          -  Current use of any over the counter medications or herbs for mood or sleep benefits
             (e.g., melatonin, valerian, kava, hop extract, St. John's Wort, SAMe)
A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: SD-6010; SD-6010; Placebo
Intervention description: 200 mg tablets once a day for 2 years; 50 mg tablets once a day for 2 years; Placebo tablets once a day for 2 years
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1457.0
Sex: All
Minimum age: 40 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: knee Osteoarthritis Disease Modifying Osteoarthritis Drug

Summary:

      The objective of this 2-year study is to evaluate the safety, tolerability and disease
      modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in
      overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be
      evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment
      of the study knee as the primary endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged >= 40 years with a BMI >= 25 and <= 40 kg/m2

          -  In the past, has been diagnosed with knee OA

          -  Radiographic evidence of OA in the study knee

        Exclusion Criteria:

          -  A diagnosis of any other rheumatic disease

          -  Current conditions in the study knee that would confound efficacy

          -  Selected, traditional clinical safety and laboratory parameters