bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Use of Trental and Vitamin E For Prophylaxis of Radiation Necrosis
Condition: Brain Metastasis
MeSH terms: Neoplasm Metastasis; Brain Neoplasms; Necrosis
Intervention: Trental; Vitamin E
Intervention description: 400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months; 400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months
Intervention MeSH terms: Vitamin E; Pentoxifylline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: brain metastasis

Summary:

      The purpose of this study is to determine whether the use of Trental and Vitamin E can help
      reduce the incidence of radiation necrosis (a lesion that usually occurs at the original
      tumor site) after radiosurgery. These two drugs are commonly used to treat radiation necrosis
      when it occurs but the hope is that these drugs can be used to prevent radiation necrosis
      from ever occurring.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Plan to undergo single or five fraction radiosurgery for a metastatic brain tumor

          -  Diagnosis of a metastatic brain tumor may be accomplished by histologic confirmation
             or by clinical confirmation by the treating physician based on MR imaging
             characteristics in the setting of a known history of cancer

          -  Age > 18 years

          -  Partial or total resection of a metastatic tumor are eligible

        Exclusion Criteria:

          -  Known sensitivity to vitamin E or Trental

          -  Recent intracranial bleed or retinal hemorrhage

          -  Treatment with a non-approved or investigational drug within 30 days before day 1 of
             study treatment

          -  History of Avastin treatment

          -  Anticipated need for treatment with Avastin

          -  History of bleeding disorder

          -  History of liver disorder
Safety and Tolerability After Four Weeks of Treatment With AZD1656 in Patients With Type 2 Diabetes
Condition: Type II Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: AZD1656; Placebo
Intervention description: Tolerable dose given twice daily; Tolerable dose given twice daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 20.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Type II Diabetes

Summary:

      The purpose of this study is to assess the 1 month safety and tolerability after multiple
      oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Insulin
    

Eligibility criteria:

        Inclusion Criteria:

          -  type II diabetes patients, female with non child-bearing potential

          -  Subjects with T2DM diagnosis for at least one year, treated with insulin alone or
             insulin in combination with other anti-diabetic drugs. Subjects must have been treated
             with insulin the last 3 months prior to enrolment (screening)

          -  HbA1c <11% at enrolment (screening) (HbA1c value according to international Diabetes
             Control and Complications Trial [DCCT] standard).

          -  FPG in the range of 7.0 to 13.0 mmol/L (126 to 234 mg/dL)

        Exclusion Criteria:

          -  History of ischemic heart disease, symptomatic heart failure, stroke, transitory
             ischemic attack or symptomatic peripheral vascular disease

          -  Use of glitazones, warfarin, amiodarone within 3 months prior to enrolment (screening)
             and use of potent CYP450 inhibitors, eg, ketoconazole and macrolide antibiotics within
             14 days before randomisation.

          -  Any clinically significant abnormality identified on physical examination, laboratory
             tests or ECG, which in the judgment of the investigator would compromise the patients'
             safety or successful participation in the clinical study.
Safety, Tolerability and Efficacy of SPD503 in Treating ADHD in Children Aged 6-17
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: SPD503 (Guanfacine HCl); Placebo
Intervention MeSH terms: Guanfacine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 182.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks
      of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a primary diagnosis of ADHD

          -  Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =>4

          -  Male or non-pregnant female subject who agrees to comply with any applicable
             contraceptive requirements

          -  Subject weighs > 55 lbs and is not morbidly overweight

        Exclusion Criteria:

          -  Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms
             such as any severe comorbid Axis II disorders or severe Axis I disorders

          -  Subject has a history of seizure disorder

          -  Subject has any specific cardiac condition or family history of significant cardiac
             condition

          -  Subject is pregnant, lactating or within six month post-partum
Oral DS107 in Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Oral DS107; Placebo
Intervention MeSH terms: Evening primrose oil; Mineral Oil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients
      with moderate to severe atopic dermatitis.

      Oral DS107 (2 g) will be orally administered for 8 weeks, and will be compared against
      placebo.

      This study will enroll approximately 100 adult patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject aged 18 years and older.

          -  Moderate to severe atopic dermatitis.

        Exclusion Criteria:

          -  Clinically significant impairment of renal or hepatic function.

          -  History of hypersensitivity to any substance in Oral DS107 or placebo capsules.

          -  Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline).

          -  Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources
             and/or is planning a trip to sunny climate.
Evaluate the Efficacy and Safety of Activated T-lymphocyte Cell Therapy in Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Activated T lymphocyte
Intervention description: Intravenous dripping of 200 ml (109~2 1010 lymphocytes/60 kg adult) for 1 hour.
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
Maximum age: 75 Years
Healthy volunteers: No
Keywords: advanced pancreatic cancer

Summary:

      Phase 2 Clinical trial to Evaluate the efficacy and safety of activated T-lymphocyte
      ("Immuncell-LC") cell therapy in Gemcitabine refractory advanced pancreatic cancer
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject who signed the written consent form by themselves, protectors or legal
             representatives prior to the clinical trial after the person in charge explained fully
             about objectives, procedure and the characteristics of the study drug.

          2. Patient aged 18 to 75

          3. Patient with pathologically-confirmed, advanced pancreatic cancer

          4. ECOG scale (ECOG-PS) ≤2 (Appendix 4. Performance status scale/score)

          5. Patient with anticipated survival period of more than 3 months

          6. Patient with progressed disease after Gemcitabine-based primary anti-cancer
             chemotherapy

          7. Patient whose blood test, renal function test and liver function test results meet the
             following conditions.

        Exclusion Criteria:

          1. Patient with the medical history of immunodeficiency or autoimmune disease that could
             be aggravated by immunotherapy (examples: rheumatoid arthritis, systemic lupus
             erythematosus, vasculitis, multiple sclerosis, adolescent Insulin-Dependent Diabetes
             Mellitus, etc.)

          2. Confirmed immunodeficient patient

          3. Patient with the history of cancer other than skin cancer, local prostate cancer or
             carcinoma in situ of cervix within the last 5 years of the start of study

          4. Patient who has received systemic anti-angiogenic agent

          5. Patient who has received a chemotherapy other than Gemcitabine based chemotherapy

          6. Obvious myocardial failure or uncontrolled arterial hypertension

          7. Patient who has experienced serious allergy (judged by the investigator)

          8. Patient with serious psychological disease (judged by the investigator)

          9. Pregnant woman, breast-feeding woman or woman who want to be pregnant during the trial
             period

         10. Patient who has participated in another clinical trial within the last 4 weeks of the
             start of study
Comparison of Loss of Resistance Techniques
Condition: Pain Relief
Intervention: Air; Saline
Intervention description: 3 mls used for identifying epidural space; 3 mls of saline used to identify epidural space
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 356.0
Sex: Female
Healthy volunteers: No
Keywords: Quality of pain relief with 2 different methods of identifying epidural space

Summary:

      The purpose of this study is to determine whether there is a difference in success outcome of
      the combined spinal epidural labor analgesia between air versus saline when used to identify
      the epidural space.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant females weighing less than or equal to 250 lbs

          -  Request for neuraxial labor analgesia

        Exclusion Criteria:

          -  ASA physical status greater than II
A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY3209590; Insulin Degludec
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 399.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if the study drug LY3209590 is safe and effective in
      participants with type 2 diabetes that have already been treated with basal insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria
             treated with basal insulin and up to 3 of the following oral antihyperglycemic
             medication (OAM):

               -  dipeptidyl peptidase-4 (DPP-4) inhibitors

               -  sodium-glucose cotransporter (SGLT-2) inhibitors

               -  biguanides

               -  alpha-glucosidase inhibitors

               -  sulfonlyureas

          -  HbA1c value of 6.5% to 10%, inclusive

          -  Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive

        Exclusion Criteria:

          -  Type 1 diabetes mellitus or latent autoimmune diabetes

          -  Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6
             months prior to screening

          -  Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New
             York Heart Association Class III or IV heart failure, or cerebrovascular accident
             (stroke)

          -  Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver
             disease

          -  Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m2

          -  Active or untreated malignancy

          -  Chronic (>14 days) systemic glucocorticoid therapy
Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension
Condition: Hypercholesterolemia; Hypertension
MeSH terms: Hypertension; Hypercholesterolemia
Intervention: ETC-1002; Placebo
Intervention description: ETC-1002 capsules taken once daily; Placebo capsules taken once daily
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: LDL; Cholesterol

Summary:

      This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo
      in participants with hypercholesterolemia and hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg

          -  or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg

          -  Fasting LDL-C between 100 and 220 mg/dL

          -  Fasting triglycerides less than 400 mg/dL

          -  Body mass index (BMI) between 18 and 45 kg/m2

        Exclusion Criteria:

          -  Known or suspected secondary hypertension or history of malignant hypertension

          -  Taking more than two anti-hypertension medications at the first visit

          -  History or current clinically significant cardiovascular disease

          -  History or current type 1 diabetes or type 2 diabetes
A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Aliskiren 150 mg; Furosemide 60 mg; Placebo for Aliskiren; Aliskiren 300 mg
Intervention description: Aliskiren 150 mg tablet; Furosemide 60 mg commercially-available tablets; Matching placebo for aliskiren 150 mg and 300 mg; Aliskiren 300 mg tablet
Intervention MeSH terms: Furosemide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Heart failure,; aliskiren,; furosemide,; diuretic efficacy,; interaction

Summary:

      This study assessed the interaction between single and multiple doses of aliskiren (150 mg
      and 300 mg) and furosemide (60 mg) in patients with heart failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Systolic or diastolic heart failure, diagnosed with either NYHA functional class II to
             III at least 3 months prior to screening and on stable medication for at least 12
             weeks.

          -  Patients must have met either of the criteria at screening:

          -  Documented left ventricular ejection fraction (LVEF) greater than 20% but lower than
             40% OR

          -  Patients with a documented LVEF greater than 40% and with a history of NT-pro-BNP>
             400pg/mL (or BNP > 100pg/mL) within 12 months of screening.

        Exclusion Criteria:

          -  Treatment with Angiotensin Receptor Blockers (ARBs), aldosterone receptor antagonists
             and diuretics (other than furosemide) within 3 weeks of first dose and during the
             study. Beta blockers were permitted provided the dose was stable for at least 3 weeks
             before the first dose and remains so throughout the study.

          -  Hypertrophic cardiomyopathy (HCMP).

          -  If a subject is currently treated with furosemide, the dose must be stable for at
             least 3 weeks before the first dose and the dose must not exceed 60 mg daily

          -  Stable heart failure requiring treatment with both an ACE inhibitor and an ARB or
             Current acute decompensated heart failure.

          -  Mean sitting systolic blood pressure ≥160 mmHg and/or mean sitting diastolic blood
             pressure ≥ 100mmHg and/or secondary forms of hypertension.

          -  Persistent sitting systolic blood pressure <90 mmHg.

          -  History of angioedema.

        Other protocol-defined inclusion/exclusion criteria may apply
A Study of Cariprazine in Patients With Chronic Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Cariprazine
Intervention description: Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 61 Years
Healthy volunteers: No

Summary:

      This is an outpatient study to evaluate the long-term safety, tolerability, and
      pharmacokinetics of cariprazine in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed the double-blind treatment period of the lead-in study
             RGH-MD-16 (NCT 00694707)

          -  Patients who have responded to double-blind treatment in the lead-in study as defined
             as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative
             Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S)
             score of ≤ 3.

          -  Patients eligible to continue as outpatients based on the opinion of the Principal
             Investigator.

          -  Patients must have a caregiver to ensure treatment compliance.

        Exclusion Criteria:

          -  Patients with clinically significant abnormalities on physical examination,
             laboratory, vital signs, and/or electrocardiogram (ECG).
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
Condition: Alagille Syndrome
MeSH terms: Liver Diseases; Alagille Syndrome; Syndrome
Intervention: LUM001 (Maralixibat)
Intervention description: Dosing of LUM001 also known as Maralixibat (MRX) with the objective of achieving optimal control of pruritus at a dose level that is tolerated by the participant and up to a maximum daily dose of 560 micrograms per kilogram (mcg/kg).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this extension study is to determine the long-term safety and tolerability of
      an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who
      have completed participation in a core LUM001 treatment protocol. Efficacy will be assessed
      by evaluating the effect of LUM001 on pruritus, biochemical markers of pruritus, as well as
      biochemical markers of cholestasis and liver disease.
    

Eligibility criteria:

        Participation for an individual patient is expected to be approximately 72 weeks.

        Patients who complete 72 weeks of treatment may be eligible to receive treatment for up to
        52 weeks during the follow-up treatment period and patients who completed the 124 weeks of
        treatment may be eligible to enter the additional long-term follow-up period.
Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Condition: Opioid Abuse
MeSH terms: Opioid-Related Disorders
Intervention: 40/0mg taken first; 80/0mg taken first; 40/240mg taken first; 80/480mg taken first; 0/0mg taken first
Intervention description: 8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses; 8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses; 8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses; 8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses; Placebo All arms taken with a 48 hour washout between doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Matching white tablets
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Abuse Liability; Abuse Prevention; Abuse Resistance; Abuse Deterrence

Summary:

      The primary objective of this study is to compare the relative abuse potential of two
      different doses of orally administered Acurox Tablets to orally administered
      immediate-release (IR) oxycodone HCl tablets in non-dependent recreational opioid users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female between 18 and 55 years old.

          -  Subject is in generally good health, including no history of pulmonary disease, and
             has a body mass index (BMI) within 18-33 kg/m2.

          -  Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12
             months, and at least 1 within the past 12 weeks) who is NOT physically dependent on
             opioids (per Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text
             Revision [DSM-IV-TR]); is able to speak, read, and understand English; and will
             provide written informed consent.

          -  Subject has a minimum of a 6th grade reading level as determined by the Investigator
             or by the Rapid Estimation of Adult Literacy in Medicine (REALM).

        Exclusion Criteria:

          -  History or current diagnosis of substance dependence (except nicotine and caffeine)
             and/or alcohol abuse according to the criteria of DSM-IV-TR.

          -  History or current diagnosis of neurological, hepatic, renal, endocrine,
             cardiovascular, gastrointestinal, hematologic, pulmonary, or metabolic disease.

          -  Known allergy or history of hypersensitivity to oxycodone HCl, other opioids, or any
             component of Acurox Tablets.