bioihbjkbjnl/mcl2 huggingface dataset:
First Study of Secukinumab in Pre-filled Syringes in Subjects With Chronic Plaque-type Psoriasis: Response at 12 Weeks
Condition: Moderate to Severe Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: secukinumab 150 mg; secukinumab 300 mg; placebo
Intervention description: After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period; After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period; Subjects who were on placebo at Week 52 cannot continue in the extension treatment period
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      The purpose of this study is to demonstrate efficacy of secukinumab at Week 12 based on PASI
      and IGA response rates versus placebo in subjects with moderate to severe chronic plaque-type
      psoriasis.
    

Eligibility criteria:

        Inclusion criteria:

          -  Moderate and severe plaque-type psoriasis diagnosed for at least 6 months.

          -  Severity of psoriasis disease meeting all of the following three criteria:

        Psoriasis Area and Severity Index (PASI) score of 12 or greater, Investigator's Global
        Assessment (IGA) score of 3 or greater, Total body surface area (BSA) affected of 10% or
        greater.

        -Inadequate control by prior use of topical treatment, phototherapy and/or systemic
        therapy.

        Exclusion criteria:

          -  Current forms of psoriasis other than chronic plaque-type psoriasis (for example,
             pustular, erythrodermic, guttate).

          -  Current drug-induced psoriasis.

          -  Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor.

          -  Significant medical problems such as uncontrolled hypertension, congestive heart
             failure or a condition that significantly immunocompromises the subject.

          -  Hematological abnormalities.

          -  History of an ongoing, chronic or recurrent infectious disease, or evidence of
             untreated tuberculosis.

          -  History of lymphoproliferative disease or history of malignancy of any organ system
             within the past 5 years.

          -  Pregnant or nursing (lactating) women. Other protocol-defined inclusion/exclusion
             criteria may apply
A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALKS 3831
Intervention description: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Safety

Summary:

      The primary objective of this study is to evaluate the long-term safety and tolerability of
      ALKS 3831 in subjects with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Agrees to use an acceptable method of contraception for the duration of the study

          -  Subject has completed the 24-week treatment period in the antecedent study,
             ALK3831-A303, within 7 days

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Subject is currently taking medications that are contraindicated with olanzapine use
             or exhibit drug-interaction potential with olanzapine

          -  Subject has a positive test for drugs of abuse at study entry

          -  Subject is pregnant, planning to become pregnant, or breastfeeding during the study

          -  Additional criteria may apply
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Condition: ERCP; Pancreatic Diseases; Bile Duct Diseases
MeSH terms: Pancreatic Diseases; Bile Duct Diseases
Intervention: Drotaverine hydrochloride; Hyoscine-N-butylbromide
Intervention description: Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP; Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Intervention MeSH terms: Drotaverin; Scopolamine; Butylscopolammonium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 650.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: ERCP; Drotaverine hydrochloride; Hyoscine-N-butylbromide

Summary:

      The aim of the present study was to evaluate the use of drotaverine hydrochloride versus
      hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing ERCP above the age of 18 years

        Exclusion Criteria:

          -  Patient with Billroth II gastrectomy

          -  Known previous sphincterotomy

          -  Active acute pancreatitis before ERCP

          -  Ongoing acute cholangitis before ERCP

          -  Hypotension (systolic blood pressure < 100 mmHg)

          -  Second-degree and third-degree atrioventricular block

          -  Heart failure

          -  Glaucoma

          -  Obstructive uropathy

          -  Impaired renal function (serum creatinine > 133μmol/L)

          -  Pregnant or breastfeeding women
Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
Condition: Parkinson's Disease Dementia
MeSH terms: Parkinson Disease; Dementia
Intervention: Rivastigmine capsule; Rivastigmine transdermal patch
Intervention description: Rivastigmine capsules orally twice a day. Target dose 12 mg/day.; Rivastigmine patch once a day in the morning, worn for 24 hours. Target dose 10 cm^2/day delivering 9.5 mg over a 24 hour period.
Intervention MeSH terms: Rivastigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 583.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's disease dementia; cholinesterase inhibitor; rivastigmine

Summary:

      The purpose of this study is to provide long-term safety data for rivastigmine capsule and
      transdermal patch treatments, in particular the effect of rivastigmine on worsening of the
      underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately
      severe dementia associated with PD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of idiopathic Parkinson's disease, according to the UK Parkinson's disease
             Society Brain Bank criteria

          -  Diagnosis of Parkinson's disease dementia according to Diagnostic and Statistical
             Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, with onset of symptoms
             of dementia at least 2 years following the first diagnosis of idiopathic Parkinson's
             disease

          -  Mini Mental State Examination score of ≥10 and ≤ 26 (at Screening Visit only)

        Exclusion Criteria:

          -  An advanced, severe, or unstable disease of any type that may interfere with the
             primary and secondary variable evaluations

          -  A score of 5 (wheelchair bound or bedridden) in the "on"-state on the Modified Hoehn
             and Yahr Staging (UPDRS Part V)

          -  A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD

          -  A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12
             or folate deficiency) that is verified by the investigator to be the cause of
             dementia.

          -  A current diagnosis of probably vascular dementia according to the National Institute
             of Neurological Disorders and Stroke and the Association International pour la
             Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria

          -  A current diagnosis of a major depressive episode according to DSM-IV criteria

          -  A history of stereotaxic brain surgery for Parkinson's disease

          -  A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar
             to rivastigmine or to other cholinergic compounds

        Other protocol-defined inclusion/exclusion criteria may apply.
Omarigliptin (MK-3102) Clinical Trial - Add-on to Oral Antihyperglycemic Agent Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-3102-015)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Omarigliptin; Matching placebo to omarigliptin
Intervention description: Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).; Matching placebo to omarigliptin 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 585.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study will examine the safety and efficacy of the addition of omarigliptin in Japanese
      participants with type 2 diabetes mellitus who have inadequate glycemic control on
      diet/exercise therapy and oral antihyperglycemic agent monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has type 2 diabetes mellitus

          -  Has inadequate glycemic control on diet/exercise therapy and oral antihyperglycemic
             agent monotherapy

        Exclusion Criteria:

          -  History of type 1 diabetes mellitus or a history of ketoacidosis

          -  History of any of the following medications: Thiazolidinediones (TZD) (for
             participants whose basal medication is not TZD) and/or insulin within 12 weeks prior
             to study participation, omarigliptin anytime
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock
Condition: Sepsis
MeSH terms: Shock, Septic
Intervention: Drotrecogin alfa (activated); Placebo
Intervention description: 24 microgram/kilogram/hour, intravenous, 96 hours (hr); 0.9% sodium chloride, intravenous, 96 hours
Intervention MeSH terms: Drotrecogin alfa activated
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1696.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sepsis; Septic shock

Summary:

      The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated)
      treatment provides significant mortality reduction improvement in patients with septic shock
      compared with placebo treatment in patients receiving the current standard of care for septic
      shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in
      reducing 28-day mortality in patients with septic shock and concomitant severe protein C
      deficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 18 years or older

          -  Must have evidence of infection

          -  Must have systemic inflammatory response syndrome (SIRS)

          -  Must have vasopressor-dependent septic shock

        Exclusion Criteria:

          -  Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the
             start of study drug

          -  Have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of
             the study drug infusion

          -  Have single organ dysfunction and recent surgery (within 30 days of study entry)

          -  Have had surgery performed within the 12-hour period immediately preceding the study
             drug infusion, or are postoperative with evidence of active bleeding, or have planned
             or anticipated surgery during the infusion period

          -  Are not expected to survive 28 days given their preexisting uncorrectable medical
             condition
A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)
Condition: Refractory Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461
Intervention description: samidorphan + buprenorphine administered sublingually
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label
Masking: None (Open Label)
Enrollment: 175.0
Sex: All
Minimum age: 18 Years
Maximum age: 72 Years
Healthy volunteers: No
Keywords: Alkermes; Major depressive disorder; Depression; ALKS 5461

Summary:

      This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive
      treatment for refractory MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed study ALK5461-217

          -  Be willing to abide by the contraception requirements as outlined in the study
             protocol

          -  Be willing and able to follow the study procedures and visits as outlined in the
             protocol

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Pregnant, planning to become pregnant, or breastfeeding

          -  A positive urine drug test for drugs of abuse

          -  Poses a current suicide risk

          -  Additional criteria may apply
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Intervention: Tranexamic acid injection; Normal saline placebo
Intervention description: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section; 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This trial will be an open-label, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive TXA 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby.
Masking: Double (Participant, Care Provider)
Enrollment: 1226.0
Sex: Female
Healthy volunteers: No
Keywords: Postpartum hemorrhage; Tranexamic acid; Caesarean section; Prevent

Summary:

      This study seeks to determine if the using tranexamic acid prophylactically at caesarean
      section will prevent postpartum haemorrhage which is a major cause of maternal mortality in
      Zimbabwe and globally.
    

Eligibility criteria:

        Inclusion Criteria: Women undergoing elective or emergency caesarean section with:

          -  Estimated gestational age of 37 weeks or more

          -  Live intrauterine foetus

          -  Elective or emergency caesarean delivery

          -  Signed informed consent

        Exclusion Criteria:

          -  History of coagulopathies or conditions predisposing them to thromboembolic phenomena,

          -  seizure history,

          -  autoimmune disease,

          -  placental abruption,

          -  placenta praevia,

          -  abnormally adherent placentae if identified on prenatal ultrasound,

          -  eclampsia or HELLP syndrome,

          -  known hypersensitivity to TXA,

          -  planned general anaesthesia,

          -  caesarean delivery for the second twin or second/third triplet(s) after vaginal birth
             of the first twin,

          -  poor understanding of English/Shona languages,

          -  those who have received anticoagulants in the week before delivery

          -  persons-under-investigation for Coronavirus disease (COVID-19) and confirmed COVID-19
             positive women
Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation
Condition: Open-Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Tafluprost 0.0015%
Intervention description: Eye drops, 0.015 mg/ml, once daily to affected eye(s)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ocular hypertension

Summary:

      The objective of this study is to investigate the pharmacodynamics (as expressed in
      intraocular pressure [IOP]) of two formulations of tafluprost 0.0015% eyedrops (preserved and
      unpreserved) in patients with open-angle glaucoma or ocular hypertension.

      The primary aim of this study is to show that IOP reduction between the two formulations is
      equivalent at the end of the 4 week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or more

          -  A diagnosis of open angle glaucoma or ocular hypertension

          -  Prior use of prostaglandin(s)

          -  Intra ocular pressure of 22-34 mmHg in at least one eye

        Exclusion Criteria:

          -  Females who are pregnant, nursing or planning a pregnancy, or females of childbearing
             potential who are not using a reliable method of contraception

          -  Previous participation in any clinical trial in which tafluprost was an
             investigational drug or use of contact lenses at screening or during the study

          -  Presence of any abnormality or significant illness that could be expected to interfere
             with the study
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease
Condition: Advanced Stage Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine
Intervention description: Rotigotine trans-dermal patches once daily:
20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours)
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 395.0
Sex: All
Minimum age: 31 Years
Healthy volunteers: No
Keywords: Rotigotine; Neupro®

Summary:

      The objective of this open-label extension is to assess the safety and tolerability of
      long-term treatment of the rotigotine patch in subjects with advanced-stage idiopathic
      Parkinson's disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed four months of maintenance treatment in the SP515
             (NCT00244387) double-blind trial

        Exclusion Criteria:

          -  Subjects who had an ongoing serious adverse event from SP515 (NCT00244387)
             double-blind trial that was assessed as related to study medication
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma
Condition: Recurrent Glioblastoma
MeSH terms: Glioblastoma; Recurrence
Intervention: Cediranib; Cediranib; Lomustine Chemotherapy; Placebo Cediranib
Intervention description: 30 mg/day, oral, until progression; 20 mg/day, oral, until progression; 110 mg/m2 / Q6W, oral, until progression; Oral, until progression
Intervention MeSH terms: Cediranib; Lomustine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 423.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Cancer; Tumour; Advanced Solid Tumour; GBM; Glioblastoma

Summary:

      The purpose of this study is to see how effective cediranib is in treating a brain tumour
      called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an
      approved oral chemotherapy that belongs to the class of drugs called alkylating agents.
      Cediranib is a new drug that has not yet been approved for this disease. This study will
      compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo
      ("inactive substance") to see whether the combination or cediranib alone will be more
      effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmation of recurrent glioblastoma

          -  Life expectancy ≥ 12 weeks

          -  Received only one prior systemic chemotherapy regimen and this regimen must contain
             temozolomide

        Exclusion Criteria:

          -  Patients on enzyme-inducing anti-epileptic drugs within 3 weeks prior to randomisation

          -  Poorly controlled hypertension

          -  Previous anti-angiogenesis (eg bevacizumab, sorafenib, sunitinib) therapy