bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
Condition: Migraine; Migraine With Aura; Migraine Without Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Intervention: Dihydroergotamine
Intervention description: Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Intervention MeSH terms: Dihydroergotamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 482.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: dihydroergotamine; dihydroergotamine mesylate; migraine

Summary:

      Study STS101-003 is a multi-center, multiple dose (PRN), open-label, 12-month study to
      evaluate the safety and tolerability of STS101 (dihydroergotamine nasal powder) in the acute
      treatment of migraine.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or females, 18-65 years of age at the time of Screening Visit

          -  Subject has at least 1-year history of migraines (with or without aura), according to
             the

          -  International Classification of Headache Disorder, 3rd Edition (ICHD3)

        Key Exclusion Criteria:

          -  Pregnant or breast-feeding women

          -  Women of child-bearing potential not using or not willing to use highly effective
             contraception.

          -  Diagnosis of headache conditions other than migraine with or without aura, including
             diagnosis of basilar or hemiplegic migraines or cluster headache.

          -  History of coronary artery disease, coronary artery vasospasm (including
             Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular
             disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina
             pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary
             intervention, or cardiac surgery.

          -  History of cerebrovascular disease, including but not limited to stroke, transient
             ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.

          -  Diagnosis of major depression with current symptoms, psychosis, alcohol abuse or
             dependence, drug abuse or dependence, major psychiatric conditions (e.g.
             schizophrenia, psychosis or Bipolar disorder), dementia. Other significant
             neurological or psychiatric disorders (including other pain syndromes or risk of
             suicide) that in the opinion of the investigator might interfere with study
             participation and assessments or subject safety.

          -  Any clinically significant symptoms or conditions, including but not limited to
             central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic
             or gastrointestinal conditions or history of such conditions that, in the opinion of
             the investigator might interfere with study assessments or safety of participant.
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Condition: Cytomegalovirus (CMV)-Positive Recipients; Allogeneic, Hematopoietic Cell Transplant (HCT)
MeSH terms: Cytomegalovirus Infections
Intervention: ASP0113; Placebo
Intervention description: Intramuscular injection; Intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ASP0113; Cytomegalovirus (CMV); Hematopoietic Cell Transplant (HCT)

Summary:

      The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as
      measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD)
      through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT
      will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is a CMV-seropositive HCT recipient

          -  Participant is planned to undergo either of the following:

               -  Sibling Donor Transplant

               -  Unrelated Donor Transplant

          -  Participant has one of the following underlying diseases:

               -  Acute myeloid leukemia (AML)

               -  Acute lymphoblastic leukemia (ALL)

               -  Acute undifferentiated leukemia (AUL)

               -  Acute biphenotypic leukemia

               -  Chronic myelogenous leukemia (CML)

               -  Chronic lymphocytic leukemia (CLL).

               -  A defined myelodysplastic syndrome(s) (MDS)

               -  Primary or secondary myelofibrosis

               -  Lymphoma (including Hodgkin's)

        Exclusion Criteria:

          -  Participant has active CMV disease or infection or has received treatment for active
             CMV disease or infection within 3 months (90 days) prior to transplant

          -  Participant has a modified hematopoietic cell transplant comorbidity index (HCT-CI)
             score ≥ 4

          -  Participant has received a prior HCT and has residual Chronic Graft-versus-host
             Disease (cGVHD)

          -  Participant who is scheduled to have a cord blood transplant or a haploidentical
             transplant

          -  Participant has a platelet count of less than 50,000 mm3 within 3 days prior to
             randomization (platelet transfusions are allowed)

          -  Participant has aplastic anemia or multiple myeloma
A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]; Epoetin
Intervention description: 0.6 micrograms/kg every 2 weeks; As prescribed, iv, 3 times weekly
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will evaluate the efficacy of intravenous Mircera treatment for the
      correction of anemia in patients with chronic kidney disease who are on dialysis. Patients
      will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin
      3 times per week i.v. according to approved treatment recommendations. The anticipated time
      on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic renal anemia;

          -  maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and
             during screening period.

        Exclusion Criteria:

          -  previous therapy with epoetin within 8 weeks prior to screening;

          -  overt gastrointestinal bleeding within 8 weeks before screening or during screening
             period;

          -  RBC transfusions within 8 weeks before screening or during screening period;

          -  active malignant disease except non-melanoma skin cancer.
Cardiovascular Safety of Xenon in General Anaesthesia, in Patient With Cardiovascular Risk in Non Cardiac Surgery
Condition: Elevated Cardiac Risk; Coronary Arteries Disease Risk
MeSH terms: Coronary Artery Disease
Intervention: Xenon; Sevoflurane
Intervention MeSH terms: Sevoflurane
Phase: Phase 3
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Xenon; Cardiac safety; Cardiovascular risk; Non cardiac surgery; Atherosclerotic vascular surgery

Summary:

      The Primary Objective is to show non inferiority in cardiac safety (i.e myocardial
      necrosis-MN- assessed by positive cardiac Troponin I -cTnI- ultrasensitive assay) of a Xenon
      based general anesthesia procedure in patients with elevated cardiac risk scheduled for
      atherosclerotic vascular surgery (i.e patient with Coronary Arteries Disease risk) when
      compared to sevoflurane based general anesthesia procedure, postoperatively up to 3 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Scheduled for atherosclerotic vascular elective surgery with presumed fast-track,

          -  Cardiac ischaemic risk supported by:

               -  History of myocardial infarction older than 1 month and/or

               -  Documented Stable angina (asymptomatic ± medical treatment) and/or

               -  History of coronary revascularisation, and/or

               -  Surgical Risk Index ("Lee" index) ≥ 3.

               -  Written informed consent

        Exclusion Criteria:

          -  Unstable angina within the last 30 days,

          -  Non controlled arterial Hypertension .

          -  Severe Cardiac heart Failure (NYHA IV)

          -  Severe Chronic Obstructive Pulmonary Disease

          -  Patient already randomized in another ongoing clinical trial

          -  Patient with recent myocardial infarction (M.I) (less than one month )

          -  Patient already included in a clinical trial

          -  History of hypersensitivity to study drugs( i.e Xenon, propofol, sevoflurane,
             desflurane, isoflurane)

          -  Malignant hyperthermia

          -  Documented Elevated intracranial pressure

          -  Preeclampsia or eclampsia

          -  Pregnancy and lactation

          -  Presumed uncooperativeness or legal incapacity
Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone
Condition: Schizophrenic Disorders
MeSH terms: Schizophrenia
Intervention: Quetiapine XR; Risperidone
Intervention description: Oral, once daily, tablets of 400 mg to 800 mg; Oral, once daily, tablets of 2 mg to 6 mg
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 798.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; SWNK

Summary:

      The trial is designed to assess the long term subjective well-being in schizophrenic
      outpatients treated with quetiapine XR (extended release) or oral risperidone at flexible
      dose in a naturalistic setting over a period of one year. Secondary outcome measures have
      been selected for helping in the differentiation of the compared atypical antipsychotics. The
      primary objective of this study is to demonstrate the non-inferiority of quetiapine XR to
      risperidone assessed at month 6 in terms of responder rate using the self-report instrument
      SWN-K
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treated for symptomatic schizophrenia (DSM-IV-TR codes: 295.10, 295.20, 295.30,295.60,
             295.90) or schizoaffective disorder (DSM-IV-TR code:295.70) or schizophreniform
             disorder (DSM-IV-TR code: 295.40). Patients with co-morbid depressive symptoms may be
             enrolled

          -  Patient with first episode of the above mentioned disease (item 3) or patient
             requiring a medication change for clinical reasons (effectiveness, tolerability,
             compliance, patient preference), i.e. switch from typical to atypical neuroleptics,
             switch from other atypical neuroleptics, excluding patients treated with risperidone
             or quetiapine at the time of enrolment.

        Exclusion Criteria:

          -  Patients with a baseline SWN-K total score of >75

          -  Patients with previous treatment with risperidone or quetiapine may be enrolled if
             change of treatment has not been dictated by major lack of tolerability and efficacy
             and if date of last dose has been at least 3 months prior to enrolment.
Long Term Safety of Clopidogrel in Neonates/Infants With Systemic to Pulmonary Artery Shunt Palliation
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Intervention: Clopidogrel; placebo
Intervention description: Form: reconstituted solution using Clopidogrel powder
Route: oral or enteric
Frequency: once daily
Dose: daily dose adjusted for weight; Form: reconstituted solution using matching placebo powder
Route: oral or enteric
Frequency: once daily
Dose: daily dose adjusted for weight
Intervention MeSH terms: Clopidogrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 12 Months
Healthy volunteers: No
Keywords: cyanotic congenital heart disease; shunt palliation; thrombosis; clopidogrel

Summary:

      This study is the extension of the CLARINET study [NCT00396877 -EFC5314] in neonates or
      infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery
      shunt.

      The primary objective was to assess the safety up to 18 months of age of the extended use of
      Clopidogrel 0.2 mg/kg/day in patients for whom the shunt was still in place at one year of
      age.

      The secondary objective was to assess the efficacy on the occurrence of shunt thrombosis
      requiring intervention or any death.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients randomized in the CLARINET study,

          -  Still receiving the study drug,

          -  Palliative systemic-to-pulmonary artery shunt still in place at 1 year of age,

          -  Investigator's decision to continue based on his/her judgment of the expected benefit
             / risk of continuing treatment with study drug,

          -  Signed informed consent to participate in the long-term safety study.
Actual Use Study of Tamsulosin in Men
Condition: Urological Manifestations
MeSH terms: Urological Manifestations
Intervention: tamsulosin hydrochloride
Intervention MeSH terms: Tamsulosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1117.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An actual use study to assess how men who respond to advertisements about urinary symptoms
      use tamsulosin in a simulated Over the Counter (OTC) setting including following "stop use
      and ask a doctor if" and "ask a doctor before use" statements and if they take the medication
      according to the label instructions, also assess any reported adverse events during simulated
      OTC use.
    

Eligibility criteria:

        Inclusion criteria:

          -  Men, 18 years of age and older, with bothersome urinary symptoms

          -  Able to speak, read and understand English

          -  Subject or anyone in their household is not currently employed by a marketing or
             marketing research company, advertising agency or public relations firm, a pharmacy or
             pharmaceutical company, a manufacturer of medicines, a managed care or health
             insurance company, as a certified or licensed healthcare professional or in a
             healthcare practice

          -  Has not participated in any clinical trial in the last 12 months

          -  Willing to sign an informed consent/HIPPA form and willing and able to provide contact
             information

        Exclusion criteria:

          -  Allergy to tamsulosin hydrochloride or sulpha drugs

          -  Report current use of a medication listed on the "Do not use" section of the Drug
             Facts Label (DFL)

          -  Choose not to purchase the study product

          -  Do not provide consent or sign HIPPA form

          -  Do not provide contact information
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection
Condition: Graft Rejection
Intervention: everolimus; mycophenolate mofetil; cyclosporine; corticosteroids
Intervention description: Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments.; Mycophenolate mofetil supplied as 500 mg tablets.; Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm.; Corticosteroids standard dose.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 721.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Everolimus; heart transplant; heart disease; transplantation; heart IVUS assessment at 12 months; rate of graft loss; acute rejection episodes; survival

Summary:

      This trial was to examine the impact of everolimus and reduced dose of cyclosporine on
      efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in
      heart transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female cardiac recipients 18-70 years of age undergoing primary heart
             transplantation.

          -  The graft must be functional at time of randomization.

        Exclusion Criteria:

          -  Patients who are recipients of multiple solid organ transplants or tissue transplants
             or have previously received organ transplants.

          -  Patients who are recipients of ABO incompatible transplants.

        Other protocol-defined inclusion/exclusion criteria may apply.
CORAL XT - Open-label Extension Trial of the CORAL Trial
Condition: Pain; Neoplasms; Chronic Pain
MeSH terms: Chronic Pain
Intervention: Cebranopadol
Intervention description: Film-coated tablet; strengths: 200, 400, or 600 µg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer-related pain; cebranopadol

Summary:

      The purpose of this trial was to find out how well cebranopadol is tolerated and how often,
      and which, adverse reactions occur when it is taken every day for a longer period of time. In
      addition, information was collected how cebranopadol affects pain and well-being in patients
      suffering from cancer-related pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent signed indicating that the participant understands the purpose of and
             procedures required for the trial and is willing to participate in the trial.

          -  Participants must be at least 18 years of age at the Enrollment Visit.

          -  Women of childbearing potential must have a negative pregnancy test at enrollment and
             must not be lactating at the Enrollment Visit.

          -  Participants must be willing to use medically acceptable and highly effective methods
             of birth control.

          -  Participants who have completed treatment in KF6005/07 and are still in need of
             around-the-clock pain analgesia with strong opioids.

        Exclusion Criteria:

          -  The participant has a clinically significant disease or condition other than cancer
             which in the investigator's opinion may affect efficacy or safety assessments.

          -  Known to or suspected of not being able to comply with the protocol and the use of
             cebranopadol.

          -  Participants taking forbidden concomitant medications or not being able to follow the
             rules of use of concomitant treatment.

          -  History of torsade de pointes and/or presence of risk factors for torsade de pointes
             (e.g., heart failure, hypokalemia, bradycardia).

          -  Concurrent participation in another trial (except participation in KF6005/07) or
             planning to be enrolled in another clinical trial (i.e., administration of
             experimental treatment in another clinical trial) during the course of this trial, or
             previous participation in this trial.

          -  Employees of the sponsor, investigator, or trial site or family members of the
             employees, sponsor, or investigator.