bioihbjkbjnl/mcl2 huggingface dataset:
Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CE-224,535; Placebo
Intervention description: 500 mg po BID; no active ingredient
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: rheumatoid arthritis DMARD methotrexate

Summary:

      CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells.
      Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18
      that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped
      that taking this drug will reduce the symptoms of rheumatoid arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active rheumatoid arthritis

          -  Incomplete response to methotrexate

        Exclusion Criteria:

          -  Must not be on biologic therapies

          -  No recent infections
Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Intervention: GSK1325760A
Intervention description: Primary evaluation period: 5 mg/day, po, 12 weeks. Dose adjustment period: 2.5 mg, 5 mg or 10 mg/day, po, 12 weeks.
Intervention MeSH terms: Ambrisentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ambrisentan; Pulmonary Arterial Hypertension; 6MWD

Summary:

      The primary objective of this study is to evaluate the effect of GSK1325760A on improvement
      in exercise capacity in subjects with pulmonary arterial hypertension (PAH).

      The secondary objectives of this study are to evaluate administration of GSK1325760A on:

        -  The safety and tolerability

        -  Improvement of PAH

        -  The steady-state plasma pharmacokinetics of GSK1325760A
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects must have a diagnosis of Pulmonary Arterial Hypertension (PAH) in clinical
             classification of Pulmonary Hypertension Group1

          -  The mean right heart catheterization parameters measured from 6 months prior to the
             administration of the investigational drug must meet the criteria below:

          -  Mean pulmonary arterial pressure (mPAP) of >25 mmHg

          -  Pulmonary vascular resistance (PVR) of >3 mmHg/L/min

          -  Mean pulmonary capillary wedge pressure or left ventricular end diastolic pressure of
             <15 mmHg (if measurable)

          -  The measured six minutes walk distance (6MWD) at screening visit is in the range of
             =>150m and <=450m
Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients
Condition: Major Depressive Disorder; Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Escitalopram; Placebo
Intervention description: 15 mg/day starting 2 weeks before and 12 weeks during interferon therapy; Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.
Intervention MeSH terms: Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major depressive disorder, chemically induced.; Peginterferon alfa-2a.; Escitalopram.; Chronic hepatitis C, psychology.; Prophylactic treatment.

Summary:

      The purpose of this study is to determine whether the use of an antidepressant (escitalopram)
      can prevent depressive episodes that appear during the treatment with peg-interferon and
      ribavirin in patients with chronic hepatitis C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with chronic hepatitis C who are going to initiate treatment with
             peginterferon alfa2a + ribavirin.

          -  Age 18-65 years.

          -  Signed informed consent.

          -  If female, they are not in fertile period or they use barrier contraceptives.

          -  Patients able to understand and fill written questionnaires.

        Exclusion Criteria:

          -  Hepatic cirrhosis or carcinoma.

          -  Less than 4000/mm3 leucocytes, or less than 70000/mm3 platelets.

          -  Hemoglobin less than 11 g/dL (females) or 12 (males).

          -  Any risk factor for hemolysis.

          -  Comorbid severe medical conditions (kidney, immune system, lung, heart, thyroid, etc).

          -  Baseline mental disorders that require antidepressants (depressive disorders and
             anxiety disorders).

          -  Other baseline mental disorders (delirium, substance use disorders).

          -  Mental disorders at any time (dementia, psychotic disorders, bipolar disorders.

          -  Contraindications of escitalopram (hypersensibility, diabetes, patients using
             serotoninergic agents, drugs that enhance the risk of bleeding, or monoamineoxidase
             inhibitors -MAOIs-).
Medical Treatment of "High-Risk" Neurofibromas
Condition: Neurofibromatosis 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Intervention: Peg-Interferon alpha-2b; Celecoxib (Celebrex); Temozolomide (temodar); Vincristine Sulfate (Oncovin)
Intervention description: age and weight dependant; age and weight dependant; age and weight dependant; age and weight dependant
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Celecoxib; Vincristine; Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 2 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Neurofibromas; Neurofibromatosis 1; Celecoxib; Celebrex; Peg-Interferon alpha-2b; PEG-Intron; Temozolomide; Temodar; Vincristine Sulfate; Oncovin

Summary:

      Patients with neurofibromatosis type 1 (NF1) commonly develop non-cancerous tumors called
      plexiform neurofibromas. These tumors can be defined as "high-risk" when they result in
      severe pain, physical disability, organ dysfunction and/or become life-threatening.
      Presently, there is no effective medical therapy to offer patients with "high-risk" plexiform
      neurofibromas, and surgery does not provide lasting help. This study will evaluate the
      effectiveness of two treatment combinations in patients with "high-risk" plexiform
      neurofibromas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  "High-Risk" Plexiform Neurofibromas associated with a diagnosis of NF1

          -  2-30 years old (minimum bodyweight of 10 kilograms)

          -  Adequate renal function

        Exclusion Criteria:

          -  Previously untreated active optic glioma

          -  History of any previous allergy to study medications

          -  History of ischemic vascular disease

          -  Pregnancy / Breast feeding
Interleukin-2 in Metastatic Kidney Cancer
Condition: Renal Cell Cancer Metastatic; Kidney Cancer Metastatic
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms; Neoplasms
Intervention: Interleukin-2
Intervention description: Interleukin-2
Intervention MeSH terms: Interleukin-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Renal Cell; Metastatic Kidney Cancer

Summary:

      The purpose of this study is to determine whether Interleukin-2 at the dose and schedule used
      in this study will help increase tumor shrinkage.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have a histologic diagnosis of metastatic kidney cancer. Patients may
             have received prior systemic therapy or may be previously untreated

          2. Patients must have bi-dimensional measurable disease on physical exam or radiologic
             studies.

          3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.

          4. White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl;
             bilirubin, ALT, AST < 3 x upper limit of normal; serum creatinine < 2.0 mg/dl.

          5. Patients must undergo a low-level cardiac stress test as a screen for possible
             atherosclerotic heart disease. Patients with a positive stress test would be excluded
             from this trial.

          6. Patients with elevated temperatures > 100.5 F must have sources of occult infection
             excluded.

          7. Patients must be felt to have recovered from effects of prior therapy, such as > 2
             weeks after prior chemotherapy.

          8. Patient consent must be obtained prior to entrance onto study.

          9. Women of childbearing potential must have a negative pregnancy test and must take
             adequate precautions to prevent pregnancy during treatment

        Exclusion Criteria:

          1. Medical illness requiring corticosteroids or other immunosuppressive agents (such as
             cyclosporin or methotrexate.

          2. Autoimmune disease such as inflammatory arthritis which could be exacerbated by
             immune-based therapy.

          3. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.

          4. Lactation or pregnancy.

          5. Evidence of significant cardiovascular disease including history of recent (< 6 months
             prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias
             (not due to electrolyte disorder or drug toxicity, for example) beyond occasional
             PVC's, angina, positive low-level stress test, or cerebrovascular accident.

          6. Current brain metastasis.
Interactive Motivational Media for Perinatal Drug Abuse - 3
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Intervention: Brief computer-delivered intervention
Intervention description: Brief (20-minute) computer delivered intervention, plus two subsequent non-tailored mailings.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 107.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Interactive Motivational Media for Perinatal Drug Abuse
    

Eligibility criteria:

        Woman in immediate postpartum period

        Inclusion Criteria:

        Screen positive for drug use (self-report)

        Exclusion Criteria:

        Frank psychosis or other cognitive impairment, fatigue, grief over medically compromised
        infant, inability to communicate in English
Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants
Condition: Complication Due to Immunization
MeSH terms: Premature Birth
Intervention: Advil® Pediatric drops for infants; Placebo
Intervention description: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants; Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 7 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Apnea; bradycardia; immunization; inflammation; preterms

Summary:

      Background: Inflammation may depress respiration in neonates. The aim of this study was to
      establish a link between post-immunization inflammation and cardio-respiratory events (CRE).

      Methods: Randomized double-blind controlled study of infants born <32 weeks gestation
      receiving the 2 months vaccine. Infants were randomized into an ibuprofen treatment group and
      a placebo control group. C-reactive protein (CRP) and prostaglandins E2 (PgE2) levels were
      assessed before and after immunization. CRE were recorded for 72 hours. Heart rate
      variability (HRV) was assessed by polysomnography.
    

Eligibility criteria:

        Inclusion Criteria:

          -  preterm infants less than 32 weeks of gestational age

          -  Postnatal age more than 7 weeks

          -  Informed parental consent

        Exclusion Criteria:

          -  anomalies in cardiac conduction

          -  congenital malformations

          -  severe intraventricular haemorrhage (grade 3 or 4) or with periventricular
             leukomalacia
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
Condition: HIV; Cancer
MeSH terms: Influenza, Human
Intervention: Fluzone High Dose Vaccine; Fluzone Standard Dose Vaccine
Intervention description: Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.; Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Fluzone; Trivalent Influenza Vaccine

Summary:

      This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated
      influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or
      HIV will be vaccinated twice with one of the two vaccines and evaluated for development of
      immune responses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 3 years (on or past their 3rd birthday) through 21 years of age (not yet reached
             their 22nd birthday) at the time of entry into the study.

          -  Written informed consent (and assent, if applicable) obtained.

          -  Participant has a diagnosis of cancer or HIV.

          -  If subject has cancer, currently receiving chemotherapy and /or radiotherapy for the
             treatment of cancer or has received chemotherapy in the past 12 weeks

        Exclusion Criteria

          -  Severe hypersensitivity to egg proteins or any component of Fluzone, or
             life-threatening reactions after any previous administration of any influenza vaccine;

          -  History of Guillain-Barre´ syndrome in the subject or subject's family (parents,
             siblings, half siblings, or children);

          -  Not willing to agree to acceptable birth control for three months after study
             immunization
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: AbobotulinumtoxinA dose level 1 or 2; placebo; AbobotulinumtoxinA dose 3; AbobotulinumtoxinA dose 4
Intervention description: Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines; Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines; Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines; Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
Intervention MeSH terms: abobotulinumtoxinA; Botulinum Toxins, Type A
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 401.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA
      treatment for glabellar lines
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe glabellar lines at maximum frown as assessed by the Investigator
             using a photographic scale

          -  Moderate to severe glabellar lines at maximum frown as assessed by the subject using a
             static categorical scale

        Exclusion Criteria:

          -  Botulinum toxin treatment in the face within 9 months prior to study treatment
A Phase 2 Study of Sitravatinib in Combination With PD-(L)1 Checkpoint Inhibitor Regimens in Patients With Advanced or Metastatic Urothelial Carcinoma
Condition: Urothelial Carcinoma; Urothelial Carcinoma Bladder; Urothelial Carcinoma Ureter; Urothelial Carcinoma of the Renal Pelvis and Ureter; Urothelial Carcinoma Urethra
MeSH terms: Carcinoma; Carcinoma, Transitional Cell; Urinary Bladder Neoplasms
Intervention: Sitravatinib; Nivolumab; Pembrolizumab; Enfortumab vedotin
Intervention description: Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases; Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody; Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody; Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)
Intervention MeSH terms: Pembrolizumab; Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 9 cohorts (having 9-55 maximum patients enrolled in each; based upon response rate). Patients are assigned to cohorts based upon their prior treatments for urothelial carcinoma.
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MGCD516; Antineoplastic Agents; Immunologic Factors; Nivolumab; Tyrosine Kinase Inhibitor; VEGFR; TAM RTKs; PD-1; PD-L1; Pembrolizumab; Enfortumab vedotin; Checkpoint Inhibitors; Antibody Drug Conjugates; ADC

Summary:

      The study will evaluate the clinical activity of PD-(L)1 Checkpoint Inhibitor regimens in
      combination with the investigational agent sitravatinib in patients with advanced or
      metastatic urothelial carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of urothelial carcinoma

          -  Adequate bone marrow and organ function

        Exclusion Criteria:

          -  Uncontrolled tumor in the brain

          -  Unacceptable toxicity with prior checkpoint inhibitor

          -  Impaired heart function
Efficacy and Safety of AQX-1125 in IC/BPS
Condition: Interstitial Cystitis; Bladder Pain Syndrome
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome
Intervention: AQX-1125; Placebo
Intervention description: Synthetic SHIP1 activator; Double blind placebo capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Interstitial cystitis; Bladder pain syndrome; IC/BPS; AQX-1125; SHIP1

Summary:

      The primary objective of this study is to evaluate the effect of 6 weeks of treatment with
      once daily administration of AQX-1125 compared to placebo on average daily pain in subjects
      with interstitial cystitis/bladder pain syndrome (IC/BPS), during and after treatment, using
      a standardized 11-point numerical rating scale (NRS) pain score recorded by electronic diary
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be females, ≥18 and ≤75 years of age, who have consistently had symptoms of bladder
             pain in addition to urinary urgency and/or urinary frequency for more than 12 months

          -  Have had the diagnosis of interstitial cystitis for > 6 months (pain for at least 12
             months) but ≤15 years

          -  Have average daily pain score of at least 5 out of 10 on the 11-point Numerical Rating
             Scale [NRS] pain scale in the 9 days prior to baseline

          -  Have undergone a cystoscopy and have documented visible signs of bladder bleeding,
             lesions or glomerulation within the last 36 months prior to baseline.

          -  Subjects if of child bearing potential, must agree to avoid pregnancy and use
             medically acceptable method of contraception from screening visit and throughout the
             study.

          -  Must be capable of voiding independently

        Exclusion Criteria:

          -  Pelvic floor pain (>5 out of 10 on the 11-point NRS pain scale following a pelvic pain
             assessment)

          -  Have a body mass index [BMI] of <18 kg/m2 or >39 kg/m2

          -  Have had a urinary tract infection including bacterial cystitis within the past 30
             days.

          -  Have greater than 1+ hematuria on dipstick test at screening from an unknown cause

          -  History of previous procedure(s) (augmentation cystoplasty, cystectomy, or cystolysis)
             that has affected bladder function