bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Placebo; Ritalin LA 20 mg; Ritalin LA 30 mg
Intervention description: Placebo Comparator: Placebo; Ritalin LA (a racemic mixture of d- and l-thre-Methylphenidate Hydrochloride (MPH), extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg.; Ritalin LA (a racemic mixture of d- and l-thre-Methylphenidate Hydrochloride (MPH), extended release hard capsules) taken orally once daily in doses of 60, or 80 mg.
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 725.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Attention Deficit /Hyperactivity Disorder, hyperactivity

Summary:

      This study will evaluate efficacy and safety of methylphenidate hydrochloride extended
      release compared to placebo in adult patients with childhood-onset attention
      deficit/hyperactivity disorder (ADHD).
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in
             childhood

          2. Female patients of childbearing potential must be practicing an acceptable method of
             contraception.

        Exclusion criteria:

          1. Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2

          2. History of alcohol or substance abuse within the last six months.

          3. History of seizures or use of anticonvulsant medication.

          4. Any psychiatric condition that requires medication or may interfere with study
             participation.

          5. Pre-existing cardiovascular disorders including severe hypertension, heart failure,
             myocardial infraction, etc.

          6. Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic
             disorder

          7. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma

          8. Diagnosis or family history of Tourette's syndrome

          9. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular
             abnormalities including vasculitis or stroke

        Other protocol-defined inclusion/exclusion criteria may apply
Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mesalamine; Placebo
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to investigate the efficacy of mesalamine for the induction of
      clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will
      receive 4 g extended release granules (sachet) once daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects aged 18 to 75 years

          -  Mild to moderate UC

        Exclusion Criteria:

          -  Disease limited to proctitis <15 cm

          -  Short bowel syndrome

          -  Prior colon resection surgery

          -  History of severe/fulminant UC

          -  Evidence of other forms of inflammatory bowel disease

          -  Infectious disease (including human immunodeficiency virus [HIV], hepatitis B virus
             [HBV], or hepatitis C virus [HCV])

          -  Intolerant or allergic to aspirin or salicylate derivatives

          -  Use of rectal formulations (5-aminosalicylic acid [5-ASA], steroids) within ≤7 days

          -  Women who are pregnant or nursing

          -  History or known malignancy

          -  History of bleeding disorders, active gastric or active duodenal ulcers, autoimmune
             diseases, or mental/emotional disorders, that would interfere with their participation
             in the trial
D Mannose in Recurrent Urinary Tract Infections
Condition: Recurrent Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Recurrence
Intervention: D Mannose; trimethoprim/sulfamethoxazole
Intervention description: 1 gr. every 8 hours; one cp b.i.d. for 5 days. Then one week of antibiotic every 4 weeks for the following 23 weeks
Intervention MeSH terms: Trimethoprim; Sulfamethoxazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 22 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: recurrent urinary tract infections; D Mannose; cystitis; antibiotic treatment

Summary:

      Background- In recurrent urinary tract infections (RUTIs) usual prophylactic antibiotic
      regimes do not change the long term risk of recurrence.

      Objective- D-Mannose is a sugar, it sticks to E. coli bacteria, the aim of the study was to
      evaluate its efficacy in the treatment and prophylaxis of recurrent UTIs.

      Design, setting and participants- : In this crossover trial female patient were eligible for
      the study if they had recurrent UTIs, that is three ore more episodes during the preceding 12
      months. Suitable patients were randomly assigned to antibiotic treatment with
      trimethoprim/sulfamethoxazole or to a regimen of oral D Mannose for 24 weeks, and received
      the other intervention in the second phase of the study.

      Outcome measurements and statistical analysis- The time to recurrence of UTI, bladder pain
      (VAS p) and urinary urgency (VAS u) were evaluated at the end of antibiotic therapy and at
      the and of 24 weeks fo D Mannose. The results for quantitative variables were expressed as
      mean values and SD as they were all normally distributed (Shapiro-Wilk test). T-test for
      paired data was used to analyze differences of time of recurrence, VAS pain, Vas urgency and
      number of voidings between treatment. Data analysis was performed with STATA statistical
      package (release 11,1, 2010, Stata Corporation, College Station, Texas, USA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years old or older

          -  3 or more culture documented urinary tract infections in the preceding 12 months

          -  Patients who had not taken antimicrobials within 4 weeks and were not pregnant or
             contemplating pregnancy.

        Exclusion Criteria:

          -  Patients with evidence of upper urinary tract infection, such as temperature higher
             than 38 °C, flank/lumbar pain or tenderness.
Safety and Efficacy of Olanzapine in the Long-term Treatment for Bipolar I Disorder, Depressed
Condition: Bipolar I Disorder
MeSH terms: Depression
Intervention: Olanzapine
Intervention description: 5-20 mg/day, oral, daily
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bipolar

Summary:

      To assess the efficacy and safety of olanzapine in the long-term treatment for patients with
      bipolar I disorder, depressed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must be aged 18 to less than 75 years.

          2. Each patient must be reliable, have a level of understanding sufficient to perform all
             tests and examinations required by the protocol, and must understand the nature of the
             study and have provided informed consent.

          3. All female patients must test negative for pregnancy.

          4. Females of breast-feeding potential must agree not to breastfeed an infant during the
             study and for 1 month following the last dose of study drug.

          5. Male patients who are not surgically sterilized must agree to use a reliable method of
             birth control during the study and for 1 month following the last dose of study drug.

          6. Patients must fulfill the diagnostic criteria for bipolar I disorder, most recent
             episode depressed, as defined in the Diagnostic and Statistical Manual of Mental
             Disorders Fourth Edition, Text Revision (DSM-IV-TR).

          7. Patients must have experienced, in the opinion of the investigator, at least one
             previous manic or mixed episode, as defined in the DSM-IV-TR.

          8. Patients must have a current Young Mania Rating Scale (YMRS) Total score =<8.

        Exclusion Criteria:

          1. Is investigator site personnel directly affiliated with this study or their immediate
             families.

          2. Is a Lilly employee.

          3. Has previously completed or withdrawn from this study or any other study investigating
             olanzapine.

          4. Is pregnant or nursing.

          5. Has a serious, unstable illness such that death is anticipated within 1 year or
             intensive care unit hospitalization for the disease is anticipated within 6 months.
Long-Term Study of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder (AD/HD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine hydrochloride
Intervention description: 0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 228.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The study is long-term extension study to evaluate long-term safety and efficacy of
      Atomoxetine in Japanese pediatric patients with Attention-Deficit/Hyperactivity Disorder
      (AD/HD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who met all of the disease diagnostic and study criteria at Visit 2 of
             previous placebo-controlled study, completed the study

          -  Patients wish to enter into this study

        Exclusion Criteria:

          -  Patients whose families anticipate a move outside the geographic range of the
             investigative site, or who plan extended travel inconsistent with the recommended
             visit interval
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Mirikizumab
Intervention description: Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Initially double-blind (until original, pivotal studies AMAK [NCT03482011] and AMAJ [NCT03535194] are locked and unblinded), then open-label.
Enrollment: 1936.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IL-23; Interleukin-23; Psoriasis

Summary:

      The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of
      mirikizumab in participants with moderate-to-severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have completed the last visit of an eligible study period of
             originating study.

          -  Participant must be willing to follow the birth control measures during and after
             study treatment if woman of childbearing potential.

        Exclusion Criteria:

          -  Participant must not have an unstable or uncontrolled illness, including but not
             limited to a cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal,
             endocrine, hematologic, or neurologic disease or abnormal lab results, that the study
             investigator thinks makes it unsafe or inappropriate for the participant to
             participate in this study.

          -  Participant must not have stopped taking mirikizumab during a previous study or if the
             study investigator thinks restarting mirikizumab would create an unacceptable risk to
             the participant.
BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: pixantrone, cyclophosphamide, vincristine, rituximab, prednisone; Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Intervention description: Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day); Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Gemcitabine; Etoposide; Vincristine; Vinorelbine; Pixantrone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pixantrone; Non-Hodgkins lymphoma

Summary:

      BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows
      reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural
      similarities with mitoxantrone as well as general similarities with anthracyclines (such as
      the tricyclic central quinoid chromophore).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed aggressive [de novo or transformed] NHL according to REAL/WHO
             classification.

          -  At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI
             and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be
             followed for response as target lesion.

          -  Relapse after 2 or more prior regimens of chemotherapy

          -  ECOG performance status of 0, 1, or 2

          -  Adequate hematologic, renal and hepatic function

          -  LVEF ≥50% determined by MUGA scan

        Exclusion Criteria:

          -  Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450
             mg/m²

          -  Prior allogenic stem cell transplant

          -  Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell
             lymphoma

          -  Active CNS lymphoma or HIV-related lymphoma.

          -  Any chemotherapy, radiotherapy, or other anticancer treatment (including
             corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks
             before randomization

          -  Pregnant women or nursing mothers
Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: ezetimibe and atorvastatin; atorvastatin; Placebo (unspecified)
Intervention description: ezetimibe 10 mg and atorvastatin 10 mg daily for 12 weeks; Atorvastatin 20 mg daily for 6 weeks, and up-titrated to atorvastatin 40 mg daily for an additional 6 weeks; Placebo (unspecified) daily for 12 weeks
Intervention MeSH terms: Atorvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1053.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      A 12 week clinical trial in patients 65 years of age and older with hypercholesterolemia at
      high risk for coronary heart disease to study the effects of atorvastatin and ezetimibe given
      in combination and two higher doses of atorvastatin on lipid lowering.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is age 65 or older

          -  Patient is willing to maintain cholesterol lowering diet

          -  Patient has hyperlipidemia with LDL level greater than 70 mg/dl or 100 mg/dl depending
             on their CHD risk category

        Exclusion Criteria:

          -  A condition which, in the opinion of the investigator, would pose a risk to the
             patient or interfere with participation in the study

          -  Patient is unlikely to be compliant in taking study medication

          -  Patient with chronic or unstable medical condition

          -  Patient is taking unstable doses of medication

          -  Patient drinks more than 2 alcoholic drinks per day

          -  Patient has elevations in certain laboratory values (CK, AST, ALT)
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: tapentadol (CG5503) ER; oxycodone CR; placebo
Intervention description: 50, 100, 150, 200, 250 mg twice daily for 15 weeks; 10, 20, 30, 40, 50 mg twice daily for 15 weeks; matching placebo twice daily for 15 weeks
Intervention MeSH terms: Oxycodone; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 981.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Low Back Pain; Chronic Pain; Pain Assessment; Tapentadol

Summary:

      The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety
      of orally administrated tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250
      mg twice daily in patients with moderate to severe chronic pain of the lower back, in
      comparison with placebo and Oxycodone Controlled Release (CR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and non-pregnant, non-lactating women having a diagnosis of Lower Back Pain (LBP)
             of non-malignant origin present for at least 3 months

          -  Patients taking analgesic medications for at least 3 months prior to screening and/or
             dissatisfied with their current therapy

          -  Patients requiring opioid treatment must be taking daily doses of opioid-based
             analgesic, equivalent to < 160 mg of oral morphine

          -  Baseline score of =5 on an 11-point numerical rater scale, calculated as the average
             pain intensity during the last 3 days prior to randomization.

        Exclusion Criteria:

          -  History of alcohol and/or drug abuse in Investigator's judgement

          -  History of significant liver insufficiency

          -  chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past
             3 months

          -  Life-long history of seizure disorder or epilepsy

          -  History of malignancy within past 2 years, with exception of basal cell carcinoma that
             has been successfully treated

          -  Uncontrolled hypertension

          -  Patients with severely impaired renal function

          -  Patients with moderate to severly impaired hepatic function or with laboratory values
             reflecting inadequate hepatic function
Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
Condition: Kidney Neoplasms
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: Axitinib (AG-013736); Sorafenib
Intervention description: axitinib will be given at a starting dose of 5 mg BID with continuous dosing; sorafenib will be given at a dose of 400 mg BID continuous dosing
Intervention MeSH terms: Sorafenib; Axitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 492.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Axitinib in First & Second Line Treatment of Patients With Metastatic Renal Cell Cancer

Summary:

      The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in
      delaying tumor progression in patients with metastatic renal cell cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented metastatic renal cell cancer with a component of clear cell
             histology.

          -  Evidence of measurable disease.

          -  Patients with mRCC must have received no prior systemic first-line therapy or must
             have progressive disease per RECIST (version 1.0) after one prior systemic first line
             regimen for metastatic disease containing sunitinib, cytokine(s), or both.

        Exclusion Criteria:

          -  Prior treatment for metastatic renal cell cancer with more that one systemic first
             line therapy.

          -  Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.