bioihbjkbjnl/mcl2 huggingface dataset:
Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B
Condition: Hemophilia A With Inhibitor; Hemophilia B With Inhibitor
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Coagulation Factor VIIa variant
Intervention description: Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD,
      efficacy and safety of a daily subcutaneous [SC] treatment regimen with MarzAA for bleeding
      prophylaxis in 12 adult subjects with hemophilia A or B with an inhibitor and history of
      frequent spontaneous bleeding episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe congenital hemophilia A or B with an inhibitor.

          -  History of frequent spontaneous bleeding episodes.

          -  Male, age 18 or older.

          -  Affirmation of informed consent with signature confirmation before any trial-related
             activities.

        Exclusion Criteria:

          -  Receiving prophylaxis treatment.

          -  Previous participation in a clinical trial evaluating a modified rFVIIa agent.

          -  Known positive antibody to FVII or FVIIa detected by central laboratory at screening.

          -  Have a coagulation disorder other than hemophilia A or B.

          -  Significant contraindication to participation.
Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease
Condition: Hyperphosphataemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: PT20; Placebo
Intervention description: Modified ferric oxide adipate tablets; Placebo tablets matched to each PT20 dose arm
Intervention MeSH terms: Iron
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Dialysis Dependent Chronic Kidney Disease

Summary:

      The main purpose of this study is to see whether PT20 can help people with a high level of
      phosphate in their blood (called Hyperphosphatemia) that are being treated with dialysis for
      kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women aged 18 90 years

          -  Subject must have a stable dialysis prescription for at least 28 days prior to start
             of Screening.

          -  Subject must have the most recent serum phosphate measurement, taken during the 28
             days prior to the start of Screening, of ≥ 4.0 mg/dL and ≤ 8 mg/dL.

        Exclusion Criteria:

          -  Subject's most recent historical pre-dialysis serum bicarbonate value within 14 days
             prior to the start of Screening (Visit 1) is < 18 mg/dL.

          -  Subject has, in the opinion of the investigator, severe chronic lung disease and/or
             carbon dioxide retention.
A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Lasmiditan; Placebo
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Lasmiditan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 846.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of lasmiditan in the acute treatment of a
      migraine attack in Japanese adult participants with or without aura.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with migraine with or without aura fulfilling the International
             Classification of Headache Disorders (ICHD)-2.

          -  History of disabling migraine for at least 1 year.

          -  Migraine Disability Assessment Test (MIDAS) score ≥11.

          -  Migraine onset before the age of 50 years.

          -  History of 3-8 migraine attacks per month and <15 headache days per month during the
             past 3 months.

        Exclusion Criteria:

          -  Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets.

          -  History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing
             the patient at increased risk of seizures.

          -  History of recurrent dizziness and/or vertigo including benign paroxysmal positional
             vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders.

          -  History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or
             neuropathy).

          -  History of orthostatic hypotension with syncope.
Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet)
Condition: Pain Management
Intervention: Morphine Sulfate; Oxycodone; Acetaminophen
Intervention description: 15mg PO morphine sulfate; 10mg Oxycodone; 650 mg Acetaminophen
Intervention MeSH terms: Acetaminophen; Morphine; Oxycodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      Oxycodone and Hydrocodone are the most commonly used oral opioid analgesics in the emergency
      department and in outpatient settings. Both medications have a very high potential for abuse
      due to the prominence of the euphoric effect (abuse liability) and relative lack of "bad "or
      "negative" effects (likeability). The highly addictive properties of these medications lead
      to recurrent ED visits for repetitive dosing and prescribing that may lead to abuse, misuse,
      development of dependence and addiction, and, most importantly, death due to overdose. In
      contrast, several research papers demonstrated that administration of MSIR results in similar
      analgesic efficacy to Oxycodone and Hydrocodone but with significantly less euphoric and
      rewarding associated effects. In addition, consumption of large doses of MSIR leads to
      dysphoria, vomiting and sedation ("negative effects"). To the investigators' knowledge, there
      are no randomized controlled trials in the ED that directly compared analgesic efficacy of
      MSIR to Percocet
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 18-64,

          -  present to the Emergency department with moderate-to-severe acute pain that warrants
             an oral opioid analgesic.

          -  pain score is above 5 and are deemed to require oral opioid at the discretion of the
             attending physician.

          -  Painful conditions will include but will not be limited to acute
             traumatic/non-traumatic musculoskeletal pain, renal colic pain, dental pain.

        Exclusion Criteria:

          -  age <18, age >64,

          -  subjects who received long acting opioids within 24 hours of presenting to ED

          -  received short acting analgesics within 4 hours,

          -  chronic pain,

          -  pregnant patients,

          -  patient refusal,

          -  altered mental status,

          -  known allergy to either morphine or oxycodone or acetaminophen,

          -  history of substance and opioid abuse,

          -  unstable vital signs, acute psychosis or incarceration.

          -  subjects who received long acting opioids within 24 hours of presenting to ED;

          -  chronic pain"
LEE011 for Patients With CDK4/6 Pathway Activated Tumors (SIGNATURE)
Condition: Tumors With CDK4/6 Pathway Activation
MeSH terms: Neoplasms
Intervention: LEE011
Intervention description: Study drug was provided in 200 mg and 50 mg hard gelatin capsules to be taken orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solid malignancy; Hematologic malignancy; Mutations; Amplifications; Signature; CDK4; CDK6; CDK4/6; Cyclin D1; CCND,; Cyclin D3; p16 mutation; CDKN2A; LEE011; Breast cancer; Ovarian cancer; Lymphoma; Mesothelioma; Pancreatic neuroendocrine; Leukemia; Tumor

Summary:

      The purpose of this signal seeking study was to determine whether treatment with LEE011
      demonstrates sufficient efficacy in CDK4/6 pathway activated solid tumors and/or hematologic
      malignancies to warrant further study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient had a confirmed diagnosis of a select solid tumor (except breast cancer
             (however, triple negative was included), liposarcoma, CRPC, melanoma and teratoma) or
             hematological malignancy (except mantle cell lymphoma).

          -  Patient must have been pre-identified as having a tumor with CDK4 amplification or
             mutation, CDK6 amplification or mutation, Cyclin D1 (CCND1) amplification, Cyclin D3
             (CCND3) amplification, or p16 (CDKN2A) mutation

          -  Patient had received at least one prior treatment for recurrent, metastatic and /or
             locally advanced disease and for whom no standard therapy options are anticipated to
             result in a durable remission.

          -  Patient had progressive and measurable disease as per RECIST 1.1. or other appropriate
             hematological guidelines.

          -  Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

        Exclusion Criteria:

          -  Patients had received prior treatment with LEE011.

          -  Patient had clinically significant resting bradycardia (heart rate < 50 at rest),
             tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval > 109
             msec, or QTcF > 450 msec.

          -  Patients had primary CNS tumor or CNS tumor involvement

          -  Patient had received chemotherapy or anticancer therapy ≤ 4 weeks prior to starting
             study drug
Safety and Efficacy of TOP1630 for Dry Eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: TOP1630 Ophthalmic Solution; Placebo to TOP1630 Ophthalmic Solution
Intervention description: Bilateral ocular drug administration; Bilateral ocular drug administration
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In subjects with Dry Eye Syndrome:

      The primary objective of this study is to compare the safety and tolerability of TOP1630
      Ophthalmic Solution to placebo.

      The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to
      placebo for the treatment of the signs and symptoms of dry eye syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age;

          -  Provide written informed consent;

          -  Have a reported history of dry eye;

          -  Have a history of use of eye drops for dry eye symptoms;

        Additionally for Part 2

        Symptoms of dry eye syndrome including:

          -  Ocular discomfort

          -  Conjunctival redness

          -  Tear film break up time

          -  Schirmer test score

        Signs of dry eye syndrome including:

        Conjunctival staining score

        Exclusion Criteria:

          -  Have any clinically significant slit lamp findings at entry visit ;

          -  Be diagnosed with an ongoing ocular infection;

          -  Have any significant ocular lesion that could interfere with assessment of safety or
             efficacy or prevent study conduct in the opinion of the PI;

          -  Have any planned ocular and/or lid surgeries over the study period;

          -  Have an uncontrolled systemic disease;

          -  Be a woman who is pregnant, nursing or planning a pregnancy;

          -  Be a woman of childbearing potential who is not using an acceptable means of birth
             control;

          -  Have a known allergy and/or sensitivity to the test article or its components;

          -  Have a condition or be in a situation which the investigator feels may put the subject
             at significant risk, may confound the study results, or may interfere significantly
             with the subject's participation in the study;
Analyzing Female Trauma Exposed Responses to a Medication
Condition: Stress Disorders, Post-traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: GSK561679; Placebo
Intervention description: GSK561679, oral administration, 350mg/day, 6 week administration; Placebo compound treatment for comparison with IP
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Stress disorders, Post-traumatic; Sleep

Summary:

      This purpose of this study is to look at the safety of the experimental drug GSK561679 as
      well as its effects on PTSD symptoms, thinking and memory, startle reaction, stress hormones,
      and mental health symptoms in comparison to placebo (an inactive substance).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female between 18-65 years of age

          -  Able to provide consent and willing to participate in research

          -  PTSD duration of illness at least 3 months

          -  Negative Urine toxicology test

          -  Agrees to use protocol-defined effective birth control method

        Exclusion Criteria:

          -  Subject is currently participating in another clinical trial in which she is or will
             be exposed to an investigational or non-investigational drug or device, or has done so
             within the preceding month for studies unrelated to PTSD, or 1 month for studies
             related to PTSD

          -  Subject has a documented history of hepato-biliary disease including a history of, or
             positive laboratory results for hepatitis

          -  Subject requires ongoing treatment with medications that are prohibited per protocol

          -  Subject has a stool positive for occult blood.

          -  Pregnancy or lactation
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
Condition: Cognitive Disorders; Delirium; Acute Kidney Injury
MeSH terms: Delirium; Acute Kidney Injury; Renal Insufficiency; Postoperative Cognitive Complications; Cognitive Dysfunction; Cognition Disorders
Intervention: Ketamine; Propofol
Intervention description: Ketamine used for induction; Propofol for induction
Intervention MeSH terms: Ketamine; Propofol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 75 Years
Healthy volunteers: No

Summary:

      Ketamine is a commonly used anesthetic medication which is used for induction of anesthesia
      as well as as an analgesic. It has been shown to have anti-inflammatory properties which may
      decrease post-operative complications following cardiac surgery with cardiopulmonary bypass
      that are thought to associated with inflammation. Some studies have shown that ketamine does
      decrease these complications when compared with anesthetics that are not commonly used in our
      cardiac anesthesiology practice. Propofol is another commonly used anesthetic medication
      which is used for induction of anesthesia. Ketamine has not been compared with propofol for
      potential to reduce post-operative complications associated with the inflammatory process.
      This study aims to see if ketamine will reduce the incidence of cognitive dysfunction,
      delirium, and renal dysfunction in comparison with propofol. In addition, the hemodynamic
      impact of ketamine compared propofol will be investigated.
    

Eligibility criteria:

        Scheduled to undergo cardiac surgery.

        Inclusion criteria:

          -  age greater than or equal to 75 years presenting for cardiac surgery at the Mayo
             Clinic in Rochester, Minnesota;

          -  schedule to undergo complex cardiac surgery. Complex cardiac surgery will be defined
             as surgery involving more than one heart valve, redo-sternotomy procedures, or
             combined valvular and CABG procedures.

        Exclusion criteria will include:

          -  left or right ventricular assist device implantation or explantation,

          -  procedures not requiring cardiopulmonary bypass,

          -  active infection or sepsis, severe hepatic disease or ascites,

          -  pre-operative renal dysfunction including a baseline creatinine equal to or greater
             than 1.5 mg/dL or requiring dialysis,

          -  immunosuppressive medication use (including steroid use),

          -  immunodeficiency syndrome,

          -  known neurologic or psychiatric disorder, or

          -  use of drugs for psychosis.
Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide; Leuprolide; Dutasteride
Intervention MeSH terms: Leuprolide; Dutasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate cancer; prostatectomy; neoadjuvant

Summary:

      The purpose of this study is to determine if enzalutamide is an effective therapy in treating
      localized prostate cancer prior to prostatectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to provide informed consent

          -  18 years of age or older

          -  Histologically confirmed adenocarcinoma of the prostate

          -  Must be a candidate for radical prostatectomy and considered surgically resectable

        Exclusion Criteria:

          -  Stage T4 prostate cancer by clinical or radiologic evaluation

          -  Treatment with an investigational agent within 4 weeks prior to randomization

          -  Received therapy for other neoplastic disorders within 5 years

          -  Hypogonadism or severe androgen deficiency
Telephone Administered Psychotherapy for the Treatment of Depression for Veterans in Rural Areas
Condition: Depressive Disorder; Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Telephone cognitive behavioral therapy
Intervention description: An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cognitive-Behavioral Therapy; Telephone psychotherapy; Clinical Trial; Primary Care Clinic; Treatment for Depression

Summary:

      The purpose of this study is to examine the efficacy of telephone-administered
      cognitive-behavioral therapy (T-CBT) in treating major depression among veterans served by
      community-based outpatient clinics (CBOCs) in the Veteran's Integrated Service Network (VISN)
      21, which serves rural areas in Northern California and (VISN) 12, which serves rural areas
      surrounding the Hines, IL VA Hospital.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a DSM-IV diagnosis of Major Depressive Disorder as assessed using the MINI

          -  Has a telephone

          -  Able to speak and read English

          -  At least 18 years of age

          -  Able to give informed consent

          -  Must be registered at a VA community-based, outpatient clinic (CBOC) at VA Eureka or
             VA Ukiah or VA Santa Rosa, or VA Manteno, or VA Elgin, or VA La Salle

        Exclusion Criteria:

          -  Has a hearing, voice or visual impairment that would prevent participation in T-CBT

          -  Meets criteria for dementia

          -  Is diagnosed with Psychotic Disorder, Bipolar Disorder, substance abuse with clinical
             consensus, or current severe PTSD.

          -  Is currently receiving psychotherapy or planning to receive psychotherapy during the
             20-week treatment phase of the study

          -  Has a history of suicide attempts or is at high risk for suicide.