bioihbjkbjnl/mcl2 huggingface dataset:
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
Condition: Other Acute Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Indomethacin; Indomethacin; Indomethacin; Placebo
Intervention description: capsules, 40 mg, TID; capsules, 40 mg, BID; capsules, 20 mg, TID; capsules
Intervention MeSH terms: Indomethacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 373.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and
      effective for the treatment of postoperative bunionectomy pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female between 18 and 65 years of age

          -  For women of child-bearing potential: a woman who is not pregnant and not nursing, and
             who is practicing an acceptable method of birth control

          -  Has undergone primary, unilateral, first metatarsal bunionectomy with no additional
             collateral procedures

          -  Patient must be willing to stay at the study site ≥ 72 hours

        Exclusion Criteria:

          -  Patient has hypersensitivity, allergy, or clinically significant intolerance to any
             medications to be used in the study, or related drugs

          -  Patient has a current disease or history of a disease that will impact the study or
             the patient's well-being

          -  Patient has used or intends to use any of the medications that are prohibited by the
             protocol

          -  Patient has a history of drug or alcohol abuse or dependence, or patient has a
             positive urine drug screen or alcohol breathalyzer test

          -  Patient has taken another investigational drug within 30 days prior to screening
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Enoxaparin overlapping with and followed by VKA
Intervention description: During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.; Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 hr before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.
Intervention MeSH terms: Enoxaparin; Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4833.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority
      program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with
      confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein
      Thrombosis (DVT) (Einstein-PE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed acute symptomatic proximal PE with or without symptomatic DVT

        Exclusion Criteria:

          -  Legal lower age limitations (country specific)

          -  Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
             current episode of DVT and/or PE

          -  Other indication for VKA than DVT and/or PE

          -  The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from
             36 hours to a maximum of 48 hours.
Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Intervention: Somatropin; Somatropin
Intervention description: Doubled dosage with respect to the pre-enrollment (in-label) dosage; In-label dosage
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Maximum age: 14 Years
Healthy volunteers: No

Summary:

      Multi-center, randomized, controlled, open-label, phase III study comparing the effects of
      two different dosages of somatropin treatment (in-label or doubled) after 12 and 24 months of
      treatment, on height velocity in early pubertal children with growth hormone deficiency
      (GHD). The study will be conducted in Italy. Approximately 26 subjects will participate in
      this study, distributed as 13 in the in-label dosage group (group A) and 13 in the doubled
      dosage group (group B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Height velocity (cm/y) less than 25th percentile at the time of diagnosis.

          -  diagnosis of GHD

          -  Replacement therapy at label dosage (from 0.025 to 0.035 mg/kg/day) must be started at
             least 1 year before the enrolment in this study, but at most 3 years before enrolment

          -  Bone age less than 12 years for girls and less than 14 years for boys. This assessment
             should be made by the central reader of bone ages, based on the x-ray taken at Visit
             0.

          -  Informed consent obtained from either both of the subject's parents or legal
             representative.

        Exclusion Criteria:

          -  Pubertal clinical stage less than 2 and greater than 3 according to Tanner score (for
             male subjects a volume of testicle greater than 15 mL).

          -  Any evidence of active malignancy. In case of previous surgical removal of both
             diencephalic and hypophysial masses, an MRI, performed within six months before
             enrollment into the study, must exclude the growth of residual tumoral tissue.

          -  Any known chronic disease such as diabetes mellitus, hepatic disease (defined by
             elevated liver enzymes 3-fold the upper limit of normal ranges), renal disease with
             creatinine levels greater than 130 micromol/L, or congestive heart failure.

          -  Glucocorticoid therapy in supra physiological doses (inhaled corticoids will be
             accepted if below 3 puffs/day, for no more than 10 days consecutively).

          -  Current or previous therapy with any therapy that may directly influence growth,
             including growth hormone releasing hormone, estrogens and anabolic steroids.
An Open Label Trial of ALD403 (Eptinezumab) in Chronic Migraine
Condition: Migraine Disorder
MeSH terms: Migraine Disorders
Intervention: ALD403 (Eptinezumab)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between 18 and 65 years of age, inclusive, who were diagnosed with
             migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months
             before screening.

        Exclusion Criteria:

          -  Receipt of any monoclonal antibody treatment (within or outside a clinical trial)
             within 6 months before screening.

          -  Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low
             back pain, complex regional pain syndrome).

          -  Psychiatric conditions that are uncontrolled and/or untreated, including conditions
             that are not controlled for a minimum of 6 months prior to screening. Patients with a
             lifetime history of psychosis, mania, or dementia are excluded.

          -  History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic
             tension-type headache, hypnic headache, cluster headache, hemicrania continua, new
             daily persistent headache, or sporadic and familial hemiplegic migraine.
Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Amlodipine
Intervention description: Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks
Intervention MeSH terms: Amlodipine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 134.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects
      who will be able to enter a long-term study after completing the parent study "A double-blind
      comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension
      for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who had completed the preceding study A0531085, Phase III study, who the
             investigator judged to be able to further treatment of long term administration in
             terms of efficacy and safety

          -  Patients who had a treatment compliance rate of at least 80%

        Exclusion Criteria:

          -  The patient who met the discontinuation criteria in the preceding study A0531085
GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.
Condition: HIV; Infectious
MeSH terms: Communicable Diseases; Infections
Intervention: darunavir; ritonavir
Intervention description: 600mg bid for 48 wks; 100mg bid for 48 wks
Intervention MeSH terms: Ritonavir; Darunavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 429.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; AIDS; Immunodeficiency Virus, Human; Females; Women; PREZISTA; darunavir; TMC114; Protease Inhibitor

Summary:

      The purpose of this study is to evaluate any differences in the effectiveness, safety, and
      tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg
      twice a day on virologic response (defined as a viral load (VL) of < 50 copies/mL) over a
      48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV)
      agents will also be administered and will be chosen by the Investigator based on resistance
      testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV infection

          -  Plasma HIV-RNA >= 1000 copies/mL

          -  Must be able to comply with protocol requirements

        Exclusion Criteria:

          -  No prior use of PREZISTA (darunavir), TMC125, enfuvirtide, or tipranavir

          -  No currently active AIDS defining illness, Category C conditions according to the
             Center for Disease Control [CDC] Classification System for HIV Infection (1993) with
             the following exceptions, which must be discussed with the Sponsor prior to
             enrollment: stable cutaneous Kaposi's Sarcoma, Wasting syndrome due to HIV infection

          -  Not currently using an investigational drug

          -  Not pregnant or breastfeeding

          -  No Grade 3 or 4 laboratory abnormality as defined by DAIDS (Division of AIDS, National
             Institute of Allergy and Infectious Diseases).
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Simultaneous Pancreas-Kidney Transplants
Condition: Pancreas Transplantation; Kidney Transplantation
Intervention: Enteric-coated mycophenolate sodium (EC-MPS)
Intervention description: Experimental
Intervention MeSH terms: Mycophenolic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Keywords: Simultaneous Pancreas-Kidney Transplantation; mycophenolate; GI problems

Summary:

      Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in
      gastrointestinal (GI) complications in some patients. This study will assess if a switch from
      MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or
      health-related quality of life outcomes and determine the proportion of pancreas-kidney
      transplant recipients who experience any GI complaints under MMF-based immunosuppressive
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received simultaneous pancreas-kidney (SPK) transplant at least 3 months prior to
             study enrollment

          -  Receiving immunosuppressive regimen that includes MMF in combination with other
             immunosuppressive drugs (i.e., a calcineurin inhibitor, a mTOR inhibitor, steroids at
             least for three months at time of study enrollment)

          -  Receiving MMF for at least 1 month prior to enrollment; maximal MMF dose 2000 mg/d.

        Exclusion Criteria:

          -  Patients with any known hypersensitivity to mycophenolic acid, mycophenolate sodium,
             mycophenolate mofetil or other components of the formulations (e.g. lactose; see also
             SCP of EC-MPS)

          -  If applicable, GI symptoms assumed or known to be induced by other drugs or infections
             (e.g. oral biphosphonates induced, infectious diarrhea)

          -  Acute rejection < 1 month prior to study enrollment

        Other protocol-defined inclusion/exclusion criteria may apply.
Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: sunitinib malate; sorafenib
Intervention description: sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability.; sorafenib tablets at starting dose of 400 mg PO twice daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sorafenib dosing interruptions and/or reductions are allowed based on patient tolerability.
Intervention MeSH terms: Sorafenib; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1075.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sunitinib; phase 3; randomized; hepatocellular; liver

Summary:

      The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally
      once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients
      with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A
      and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be
      given until disease progression, occurrence of unacceptable toxicity, or other withdrawal
      criteria are met. After discontinuation of study treatment, patients will be followed up in
      order to collect information on further antineoplastic therapy and survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-confirmed diagnosis of hepatocellular carcinoma

          -  presence of measurable disease by radiographic imaging

          -  Child-Pugh class A

          -  ECOG PS 0 or 1

          -  adequate organ function.

        Exclusion Criteria:

          -  Prior treatment with any systemic treatment for hepatocellular carcinoma

          -  prior local treatment within 4 weeks from entry

          -  presence of clinically relevant ascites

          -  severe hemorrhage <4 weeks of starting study treatment

          -  known HIV or serious acute or chronic illness

          -  current treatment on another clinical trial

          -  pregnancy or breastfeeding
Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Condition: Open-angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: AR-13324 Ophthalmic Solution 0.02%; Timolol Maleate Ophthalmic Solution 0.5% BID; Placebo
Intervention description: 1 drop once daily (QD), PM, OU; 1 drop BID, AM/PM, OU; 1 drop QD, AM, OU
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 708.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate ocular hypotensive efficacy and safety of Netarsudil (AR-13324) Ophthalmic
      Solution compared to Timolol Maleate Ophthalmic Solution.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older

          2. Diagnosis of open angle glaucoma or ocular hypertension in both eyes

          3. Post-washout intraocular pressure >20mmHg and <30mmHg in 1 or both eyes at 2
             qualification visits

          4. Corrected visual acuity equivalent to 20/200

          5. Able to give informed consent and follow study instructions

        Exclusion Criteria:

          1. Clinically significant ocular disease

          2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure
             or narrow angles

          3. Unmedicated intraocular pressure ≥30mmHg

          4. Use of more than 2 ocular hypotensive medications within 30 days of screening

          5. Known hypersensitivity to any component of the formulation

          6. Previous glaucoma surgery or refractive surgery

          7. Ocular trauma within 6 months prior to screening

          8. Any ocular surgery or non-refractive laser treatment within 3 months prior to
             screening

          9. Recent or current ocular infection or inflammation in either eye

         10. Used ocular medication in either eye of any kind within 30 days of screening

         11. Mean central corneal thickness >620µm at screening

         12. Any abnormality preventing reliable applanation tonometry of either eye

         13. Clinically significant abnormalities in lab tests at screening

         14. Known hypersensitivity or contraindication to beta-adrenoceptor antagonists

         15. Clinically significant systemic disease

         16. Participation in any investigational study within 60 days prior to screening

         17. Used any systemic medication that could have a substantial effect in intraocular
             pressure within 30 days prior to screening

         18. Women who are pregnant, nursing, planning a pregnancy or not using a medically
             acceptable form of birth control
Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Intervention: Simvastatin 20 mg daily; Folic acid 2 mg + vitamin B12 1 mg daily; Simvastatin 80 mg daily; Placebo
Intervention description: Simvastatin 20 mg tablet once daily; Folic acid 2 mg + vitamin B12 1 mg tablet once daily; Simvastatin 80 mg tablet once daily; Placebo vitamin B12/folic acid tablet once daily
Intervention MeSH terms: Folic Acid; Vitamin B 12; Hydroxocobalamin; Simvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12064.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Myocardial infarction; Coronary heart disease; Cholesterol; Stroke

Summary:

      SEARCH is a randomised, double-blind, multi-centre United Kingdom (UK) trial of 12,064
      patients with myocardial infarction (MI) prior to study entry which aims to demonstrate
      whether a more intensive cholesterol lowering regimen using 80 mg simvastatin daily produces
      a larger and worthwhile reduction in cardiovascular events compared with a standard 20 mg
      daily regimen and whether reducing blood homocysteine levels with a daily dose of folic acid
      2 mg + vitamin B12 1 mg compared with matching placebo produces a worthwhile reduction in
      vascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior myocardial infarction

          -  Statin therapy indicated

          -  No clear indication for folic acid

        Exclusion Criteria:

          -  No clear contraindication to study treatments

          -  Screening plasma total cholesterol <3.5 mmol/l in patient already on statin therapy,
             or <4.5 mmol/l in patient not on statin therapy

          -  Chronic liver disease

          -  Severe renal disease or evidence of renal impairment

          -  Inflammatory muscle disease

          -  Concurrent treatment with fibrates or high-dose niacin

          -  Concurrent treatment with cyclosporin (or condition likely to result in organ
             transplantation and the need for cyclosporin), nefazodone, methotrexate, systemic
             azole antifungal or systemic macrolide antibiotics

          -  Child bearing potential

          -  No other predominant medical problem (other than coronary heart disease [CHD]) which
             might limit compliance with 5 years of study treatment