bioihbjkbjnl/mcl2 huggingface dataset:
A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Aliskiren; Amlodipine; Hydrochlorothiazide
Intervention description: 300 mg tablet; 5 mg tablet; 12.5 mg and 25 mg capsule
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 564.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Essential hypertension; High blood pressure

Summary:

      This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide
      in participants with essential hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients 18 years of age or older

          -  Male or female participants are eligible.

          -  Mean sitting diastolic blood pressure (msDBP) and mean sitting systolic blood pressure
             (msSBP) Requirements:

               -  For newly diagnosed/untreated participants, msDBP ≥ 100 and < 120 millimeters of
                  mercury (mmHg), and/or msSBP ≥ 160 and < 200 mmHg at Visit 1 and Visit 2.

               -  For previously treated participants, msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥
                  160 and < 200 mmHg at Visit 2, Visit 3, or Visit 4.

          -  For participants requiring tapering off their previous antihypertensive medication,
             they must meet the above criteria and completely discontinue all antihypertensive
             treatment prior to entering the treatment phase of the study.

          -  Participants who are eligible and able to participate in the study, and who consent to
             do so after the purpose and nature of the investigation has been clearly explained to
             them (written informed consent).

        Exclusion Criteria:

          -  Inability to discontinue all prior antihypertensive medications safely for a period of
             1 week to 4 weeks as required by the protocol.

          -  Participants on three antihypertensive drugs with msDBP ≥ 110 mmHg and/or msSBP ≥ 180
             mmHg at Visit 1.

          -  Participants on four or more antihypertensive drugs at Visit 1.

          -  Participants with an msSBP ≥ 200 and msDBP ≥ 120 mmHg anytime during the washout
             period of the study Visit 1-4 must be discontinued from the study.

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human chorionic gonadotropin (hCG) laboratory test (>= 5 milli-international
             units per milliliter mIU/mL).
Subdissociative Dose Ketamine for Treatment of Acute Pain in Subjects With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain; Acute Pain
Intervention: Ketamine; Placebo
Intervention description: sub-dissociative ketamine; Normal Saline
Intervention MeSH terms: Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a prospective, randomized controlled trial which will be conducted to determine
      whether sub-dissociative dose ketamine (SDDK) can improve pain control in subjects with
      chronic pain syndrome presenting to the emergency department with exacerbation of their
      chronic pain. The investigators also aim to determine whether use of SDDK can reduce the
      amount of subsequent opioid pain medications required for adequate pain relief in this
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult subjects over the age of 18 with chronic pain* presenting to the emergency
             department with exacerbation of their chronic pain as their primary complaint

          -  Subjects who are willing and able to provide informed consent. *Chronic pain defined
             as greater > 3 months of symptoms and an initial VAS pain score > 70

        Exclusion Criteria:

          -  History of overt psychosis, severe hypertension as defined by Systolic Blood Pressure
             > 180 mm Hg or Diastolic Blood Pressure >110 mm Hg, unstable angina, Coronary Artery
             Disease, Congestive Heart Failure, porphyrias, thyroid disease, seizure disorder,
             inability to provide informed consent: dementia, non-English/Spanish speakers,
             subjects in custody, suicidal, or clinically intoxicated.
Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol (NEB); Metoprolol (MET)
Intervention description: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.; Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: safety and tolerability study; hypertension; beta-blockers

Summary:

      The purpose of this study is to evaluate long-term safety,tolerability and blood pressure
      effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be
      given alone or in combination with other drugs that are commonly used in the treatment of
      hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of previous nebivolol study

          -  Stage 1-2 Hypertension (HTN) at baseline of first study

        Exclusion Criteria:

          -  Recent myocardial infarction or stroke

          -  Contraindications to beta blocker therapy
Randomized Safety Study of CVT-301 Compared to an Observational Control Group
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: CVT-301; Observational cohort
Intervention MeSH terms: Levodopa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 408.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; OFF episodes

Summary:

      This study is a 12-month, open-label, randomized, multicenter study which will evaluate the
      safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in
      Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will
      include a concurrent observational cohort of PD patients managed using the usual standards of
      care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has signed and dated an Internal Review Board/Independent Ethics Committee
             (IRB/IEC)-approved informed consent form before any protocol-specific screening
             procedures are performed.

          -  Women of child-bearing potential must use protocol-defined contraceptive measures and
             must have a negative serum human chorionic gonadotropin (hCG) test at screening. These
             patients must be willing to remain on their current form of contraception for the
             duration of the study.

          -  Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as
             defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria,
             diagnosed after the age of 30 years.

          -  Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn
             and Yahr scale for staging of PD severity.

          -  Patients who have experienced motor fluctuations for a minimum of 2 hours of average
             daily OFF time per waking day (excluding early morning OFF time) by self-report and
             confirmed by the PD Diary (on 3 consecutive days) during the screening period.

        Exclusion Criteria:

          -  Patients who have dyskinesia of a severity that would significantly interfere with
             their ability to participate or perform study procedures.

          -  Pregnant or lactating females or females wishing to become pregnant.

          -  Patients who have any known contraindication to the use of levodopa (LD), including a
             history of malignant melanoma or a history of narrow-angle glaucoma.

          -  Patients who have had previous surgery for PD (including but not limited to deep brain
             stimulation [DBS] or cell transplantation).

          -  Patients with a history of psychotic symptoms requiring treatment, or suicide ideation
             or attempt within the prior 12 months.
Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
Condition: Cervical Ripening; Induction of Labor; Multiparity
Intervention: Oxytocin
Intervention MeSH terms: Oxytocin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Study Purpose: The purpose of this study is to determine the optimal method for induction of
      labor in multiparous women who present with an unfavorable cervix.

      Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in
      place will result in more rapid labor courses, without increasing morbidity or increasing the
      need for operative delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 years

          -  Gestational age > 34 + 0/7 weeks

          -  Prior spontaneous vaginal delivery

          -  Clinical or U/S EFW of <4500 grams

          -  Singleton gestation

          -  Cervical dilation <2 cm

        Exclusion Criteria:

          -  Any contraindication to cervical ripening balloon, pitocin, or vaginal delivery

          -  Placenta within 2 cm of cervical os

          -  Placental abruption, chorioamninoitis, or systemic infection prior to induction

          -  Rupture of membranes prior to induction ->1 prior C/S
A Long-term Trial of OPC-34712 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: OPC-34712
Intervention description: orally administered once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To investigate the safety and efficacy of long-term administration of OPC-34712 in patients
      with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 18 years or older (at time of informed consent) diagnosed with
             schizophrenia based on DSM-IV-TR diagnostic criteria

          -  Outpatients who are receiving an oral antipsychotic treatment (other than clozapine),
             who are considered to require maintenance therapy using antipsychotics, and for whom
             monotherapy with OPC-34712 is considered feasible

        Exclusion Criteria:

          -  Female patients who are breastfeeding or who have a positive pregnancy test (urine)
             result prior to receiving investigational medicinal product

          -  Patients who are diagnosed with a disease other than schizophrenia (schizoaffective
             disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder,
             anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on
             current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder
             (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
HELIOS-A: A Study of Vutrisiran (ALN-TTRSC02) in Patients With Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis)
Condition: Amyloidosis, Hereditary; Transthyretin Amyloidosis
MeSH terms: Amyloid Neuropathies, Familial; Amyloidosis, Familial; Amyloidosis
Intervention: Patisiran; Vutrisiran
Intervention description: Patisiran will be administered by IV infusion.; Vutrisiran will be administered by SC injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of vutrisiran (ALN-TTRSC02)
      in participants with hereditary transthyretin amyloidosis (hATTR amyloidosis). Participants
      will receive vutrisiran subcutaneous (SC) injection once every 3 months (q3M) or the
      reference comparator patisiran intravenous (IV) injection once every 3 weeks (q3w) during the
      18 month Treatment Period. This study will use the placebo arm of the APOLLO study
      (NCT01960348) as an external comparator for the primary and most other efficacy endpoints
      during the 18 Month Treatment Period. Following the 18 Month Treatment Period, all
      participants will be randomized to receive vutrisiran SC injection once every 6 months (q6M)
      or q3M in the Randomized Treatment Extension (RTE) Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of 18 to 85 years of age (inclusive);

          -  Has a diagnosis of hATTR amyloidosis with transthyretin (TTR) mutation;

          -  Has adequate neurologic impairment score (NIS);

          -  Has adequate polyneuropathy disability (PND) score;

          -  Has adequate Karnofsky Performance Status (KPS).

        Exclusion Criteria:

          -  Had a prior liver transplant or is likely to undergo liver transplantation during the
             study;

          -  Has known other (non-hATTR) forms of amyloidosis or leptomeningeal amyloidosis;

          -  Has New York Heart Association heart failure classification >2;

          -  Clinically significant liver function test abnormalities;

          -  Has known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B
             virus (HBV) infection;

          -  Received an experimental drug within 30 days of dosing;

          -  Received prior TTR-lowering treatment;

          -  Has other known causes of neuropathy.
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Matching Placebo for Upadacitinib; Upadacitinib
Intervention description: Matching placebo tablets; Upadacitinib tablets
Intervention MeSH terms: Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 624.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Upadacitinib; Crohn's Disease; Efficacy; Safety

Summary:

      The objective of this study is to evaluate the efficacy and safety of upadacitinib compared
      to placebo as induction therapy in participants with moderately and severely active Crohn's
      disease (CD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CD for at least 3 months prior to Baseline.

          -  Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
             abdominal pain (AP) score.

          -  Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's
             disease (SES-CD) on an endoscopy confirmed by a central reader.

          -  Demonstrated an inadequate response or intolerance to any biologic therapy for
             infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.

          -  If female, participant must meet the contraception recommendations.

        Exclusion Criteria:

          -  Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

          -  Participant not on stable doses of CD related antibiotics, oral aminosalicylates,
             corticosteroids or methotrexate (MTX).

          -  Participant with the following ongoing known complications of CD: abscess (abdominal
             or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or
             any other manifestation that might require surgery while enrolled in the study.

          -  Participant with ostomy or ileoanal pouch.

          -  Participant diagnosed with conditions that could interfere with drug absorption
             including but not limited to short gut or short bowel syndrome.

          -  Screening laboratory and other protocol pre-specified analyses show abnormal results.
Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes
Condition: Transcatheter Aortic Valve Replacement
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Acetylsalicylic Acid (ASA); Clopidogrel; Rivaroxaban (Xarelto, BAY59-7939); Vitamin K antagonist (VKA)
Intervention description: 10mg OD (once-daily); 75-100mg OD; 75mg OD; In case of NOAF, 20/15 mg OD (once-daily); In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines
Intervention MeSH terms: Aspirin; Vitamin K; Rivaroxaban; Clopidogrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1653.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TAVR; TAVI; Transfemoral aortic valve implantation

Summary:

      To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR,
      compared to an antiplatelet-based strategy, is superior in reducing death or first
      thromboembolic events (DTE).

      To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an
      antiplatelet-based strategy, following TAVR.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful TAVR (Transcatheter Aortic Valve Replacement) of an aortic valve stenosis
             (either native or valve-in-valve)

               -  By iliofemoral or subclavian access

               -  With any approved/marketed device

        Exclusion Criteria:

          -  Atrial fibrillation (AF), current or previous, with an ongoing indication for oral
             anticoagulant treatment

          -  Any other indication for continued treatment with any oral anticoagulant (OAC)

          -  Known bleeding diathesis (such as but not limited to active internal bleeding,
             clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin
             level < 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history
             of intracranial hemorrhage or subdural hematoma)

          -  Any ongoing absolute indication for dual antiplatelet therapy (DAPT) at time of
             screening that is unrelated to the TAVR procedure

          -  Clinically overt stroke within the last 3 months

          -  Planned coronary or vascular intervention or major surgery

          -  Severe renal impairment (eGFR < 30 mL/min/1.73 m2) or on dialysis, or post-TAVR
             unresolved acute kidney injury with renal dysfunction stage 2 or higher

          -  Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic
             disease associated with coagulopathy
An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: rFVIIIFc
Intervention description: Administered as specified in arm description
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: Male
Maximum age: 5 Years
Healthy volunteers: No
Keywords: prophylaxis treatment; Hemophilia A; Hemophilia; episodic treatment

Summary:

      The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in
      previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives
      were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding
      episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of
      bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune
      tolerance induction (ITI) in participants with inhibitors.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability of the participant's legally authorized representative (e.g. their parent or
             legal guardian) to understand the purpose and risks of the study and provide signed
             and dated informed consent and authorization to use confidential health information in
             accordance with national and local participant privacy regulations.

          -  Weight >=3.5 kg at the time of screening.

          -  Severe hemophilia A defined as less than (<) 1 IU/dL (<1%) endogenous FVIII documented
             in the medical record or as tested during the Screening Period.

        Key Exclusion Criteria:

          -  Any exposure to blood components, factor VIII replacement products, including
             commercially available rFVIIIFc at any time prior to or during screening.

          -  History of positive inhibitor testing. A prior history of inhibitors was defined based
             on a patient's historical positive inhibitor test using the local laboratory Bethesda
             value for a positive inhibitor test (ie, equal to or above lower level of detection).

          -  History of hypersensitivity reactions associated with any rFVIIIFc administration.

          -  Other coagulation disorder(s) in addition to hemophilia A.

          -  Any concurrent clinically significant major disease that, in the opinion of the
             Investigator, would make the participant unsuitable for enrollment.

          -  Current systemic treatment with chemotherapy and/or other immunosuppressant drugs.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.