bioihbjkbjnl/mcl2 huggingface dataset:
Ursodeoxycholic Acid (UDCA) for Hepatic Sarcoidosis
Condition: Hepatic Sarcoidosis, Elevated Alkaline Phosphatase
MeSH terms: Sarcoidosis
Intervention: Ursodeoxycholic Acid
Intervention description: weight-based dosing
Intervention MeSH terms: Ursodeoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will act as their own controls by undergoing a six-month initial observational period prior to initiating the six-month UDCA intervention
Masking: None (Open Label)
Masking description: All subjects will receive appropriately dosed UDCA after six months of observation
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatic sarcoidosis; elevated alp

Summary:

      This study aims to (1) evaluate efficacy of UDCA in improving liver function and quality of
      life; (2) monitor safety, tolerability of UDCA, as well as progression of hepatic sarcoidosis
      and liver disease, in patients diagnosed with hepatic sarcoidosis. A minimum of 10 subjects
      will be followed for 12 months. For all subjects, initial 6 months will be observational; in
      subsequent 6 months, UDCA will be administered. Visits will occur every 3 months and involve
      routine blood collection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Systemic sarcoidosis with evidence of liver involvement as denoted by any of the
             following:

               -  Elevated liver-specific alkaline phosphatase

               -  Granulomas on liver biopsy

               -  Hepatomegaly on imaging

               -  Portal Hypertension (via imaging or endoscopy)

          2. Stable dose of immunosuppressant, if taking (no dose variation for 6 months)

          3. If cirrhotic, absence of hepatocellular carcinoma as indicated by imaging within 6
             months of screening

        Exclusion Criteria:

          1. Female who is pregnant, planning to become pregnant during the study, or breastfeeding

          2. Clinically significant abnormalities, co-morbidities, or recent alcohol/drug abuse
             that make the subject an unsuitable candidate

          3. Concurrent liver disease including hepatitis B, hepatitis C, alcohol-related liver
             disease, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing
             cholangitis

          4. Currently on UDCA

          5. Prior intolerance to UDCA

          6. Receipt of any investigational product within a time period equal to 10 half-lives of
             the product, or 6 weeks (whichever is longer), to study drug administration

          7. Current evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy,
             or ascites). In the event potential participant is post-transplant, no evidence of
             hepatic decompensation since transplantation
REVEAL: Reduction of Infarct Expansion and Ventricular Remodeling With Erythropoietin After Large Myocardial Infarction
Condition: Acute ST Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction; Ventricular Remodeling
Intervention: Epoetin alfa
Intervention description: Randomized
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 223.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Acute Myocardial Infarction; Left Ventricular Remodeling; Cardiac Magnetic Resonance Imaging; Endothelial Progenitor Cells; Infarct Size

Summary:

      The purpose of this study is to evaluate whether erythropoietin can help limit the damage to
      the heart in patients with acute heart attacks.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

        Age greater than 21 years

        Acute ST-elevation myocardial infarction

        Referral for primary or rescue angioplasty

        Revascularization procedure within 8 hours from the onset of ischemic symptoms

        TIMI (Thrombolysis in myocardial infarction) flow grade 0 or 1 in the culprit coronary
        artery at the beginning of coronary angiography

        Successful revascularization of infarct-related artery

        EXCLUSION CRITERIA:

        Clinical indication for erythropoietin

        STEMI (ST-elevation myocardial infarction) due to occlusion of a branch vessel

        Any history of prior MI, PCI (Percutaneous coronary intervention), CABG (Coronary artery
        bypass graft), cardiomyopathy, myocarditis, or CHF (congestive heart failure)

        Hypersensitivity to human albumin, mammalian cell-derived products, or erythropoietin

        Hematocrit greater than 42% in men or greater than 40% in women at the time of study drug
        administration

        Uncontrolled hypertension at the time of study drug administration

        Cardiogenic shock

        Need for coronary surgical revascularization as determined at the time of the index
        coronary catheterization

        History of hypercoagulable disorder, thromboembolic event, or venous thrombosis

        History of stroke or TIA (transient ischemic attack)

        History of seizures

        Contraindication to MRI

        Pregnancy or nursing mother
A Study of Safety and Efficacy of Vaniprevir Administered With Pegylated-Interferon and Ribavirin in Japanese Participants With Chronic Hepatitis C Infection (7009-016)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Vaniprevir; Pegylated Interferon (peg-IFN); Ribavirin; Comparator: Placebo
Intervention description: Vaniprevir oral capsule administered twice daily (200, 600 or 1200 mg/day) for 28 days; Open-label peg-IFN alfa-2a subcutaneous injection (sourced locally) administered weekly, 180 micrograms, for 6 weeks; Open-label ribavirin (sourced locally) administered orally twice daily, 600 to 1000 mg/day, for 6 weeks; Placebo to vaniprevir oral capsule twice daily for 28 days
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The study evaluates safety and efficacy of vaniprevir (MK7009), when administered with
      Pegylated-Interferon (peg-IFN) and Ribavirin, in Japanese patients with Hepatitis C
      infection. The primary hypotheses are that 1.) the proportion of patients achieving rapid
      viral response (RVR) in one or more of the vaniprevir treatment groups is superior to that in
      the placebo group, when each is administered concomitantly with pegylated interferon
      (peg-IFN) α-2a and ribavirin; and 2.) vaniprevir at the studied doses is well tolerated
      compared with placebo, when each is administered concomitantly with peg-IFN α-2a and
      ribavirin for 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has chronic genotype 1 Hepatitis C infection

        Exclusion Criteria:

          -  Has not tolerated previous course of peg-IFN and ribavirin

          -  Has HIV

          -  Has Hepatitis B

          -  Has a history of clinically significant medical condition that may interfere with the
             study (e.g., stroke or chronic seizures or major neurological disorder) or is
             contraindicated for treatment with peg-IFN and ribavirin
A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Drug: 99mTc-MIP-1404
Intervention description: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: Male
Minimum age: 21 Years
Healthy volunteers: No
Keywords: PROSTATE CANCER; HIGH-RISK; PROSTATECTOMY SURGERY; NEWLY DIAGNOSED

Summary:

      This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and
      performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic
      lymph node cancer. Comparative performance characteristics between MIP 1404 imaging and MRI
      were also assessed, as judged by histopathology results.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male aged 21 years or older.

          -  Ability to provide signed informed consent and willingness to comply with protocol
             requirements.

          -  Biopsy confirmed presence of adenocarcinoma of the prostate gland.

          -  At high-risk for metastatic disease by a stage of cT3, cT4, or a total nomogram score
             of greater than or equal to 130.

          -  Scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection.

          -  Agree to use an acceptable form of birth control for a period of 7 days after the
             99mTc MIP-1404 injection.

        Exclusion Criteria:

          -  Participating would significantly delay the scheduled standard of care therapy.

          -  Administered a radioisotope within 5 physical half lives prior to study drug
             injection.

          -  Have any medical condition or other circumstances that, in the opinion of the
             investigator, would significantly decrease obtaining reliable data, achieving study
             objectives or completing the study.

          -  Have a contraindication for MR imaging.
A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Ligelizumab
Intervention description: QGE031 240 mg s.c. q4w
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: QGE031; chronic; spontaneous; Urticaria; CSU; adults; Safety; ligelizumab

Summary:

      A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4
      weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study
      CQGE031C2201
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients eligible for inclusion in this study have to fulfill all of the following
             criteria:

               1. Written informed consent must be obtained before any assessment is performed.

               2. Patients who complete the treatment epoch in study CQGE031C2201 and complete at
                  least Visit 203 (Week 32 of the follow-up epoch, ≥16 weeks after last injection)
                  and present with active disease as defined by UAS7 ≥12.

               3. Patients must not have any missing eDiary entries in the 7 days prior to Visit
                  301 (patients are allowed to repeat until this criterion is met).

               4. Willing and able to complete a daily symptom eDiary for the duration of the study
                  and adhere to the study visit schedules.

        Exclusion Criteria:

        Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous
        urticaria

          -  Evidence of parasitic infection

          -  Any other skin diseases than chronic spontaneous urticaria with chronic itching

          -  Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or
             epinephrine

          -  History of anaphylaxis

          -  History or current diagnosis of ECG abnormalities indicating significant risk of
             safety for patients participating in the study

          -  History of hypersensitivity to any of the study drugs or its components of similar
             chemical classes

          -  Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion
             criteria may apply
A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
Condition: Liver Cancer; Hepatocellular Cancer
MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular
Intervention: individualized Stereotactic Body Radiation Therapy (SBRT)
Intervention description: The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase II trial to characterize the safety and efficacy of individualized
      stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment
      or who have primary hepatocellular carcinoma (HCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  over age 18

          -  life expectancy of at least 12 weeks

          -  Zubrod performance status of ≤2.

          -  biopsy proven hepatocellular carcinoma (HCC)

          -  liver metastases

          -  a discrete hepatic tumor(s) as defined by the Barcelona46 criteria - for cirrhotic
             patients, (1) 2 imaging studies showing hypervascular tumor > 2cm, or (2) single
             imaging study showing hypervascular tumor > 2cm with AFP ≥ 400 ng/mL

          -  a discrete hypervascular tumor present on two consecutive imaging studies (CT or MRI)
             with documented growth of > 1cm in diameter

          -  adequate organ function

          -  women and men not interested in pregnancy

          -  must be recovered from the effects of any prior surgery, radiation therapy,
             chemotherapy and the effects of Radiofrequency Ablation (RFA) or Transcatheter
             Arterial Chemo Embolization (TACE)

          -  minimum of 6 weeks following their last surgical procedure, radiation and
             chemotherapy.

        Exclusion Criteria:

          -  cannot be eligible for a curative liver resection

          -  uncontrolled ascites clinically evident on physical exam

          -  known allergy to IC-Green

          -  known allergy to intravenous iodinated contrast agents

          -  patients with poor venous access

          -  patients with metastatic cancer with normal liver function who have not undergone
             previous liver directed therapy and a single tumor < 6 cm in size.
An 8-Week Refractory Chronic Cough Study (MK-7264-021)
Condition: Refractory Chronic Cough
MeSH terms: Cough
Intervention: Gefapixant; Placebo (for gefapixant)
Intervention description: Gefapixant tablets administered by mouth twice daily for 8 weeks; Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This was an 8-week randomized, parallel, double-blind, placebo-controlled study of gefapixant
      (AF-219) in participants with refractory chronic cough.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women and Men between 18 and 80 years of age inclusive

          -  Have refractory chronic cough

          -  Women of child-bearing potential must use 2 forms of acceptable birth control

          -  Have provided written informed consent.

          -  Are willing and able to comply with all aspects of the protocol.

        Exclusion Criteria:

          -  Current smoker

          -  Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) < 60%

          -  History of upper respiratory tract infection or recent significant change in pulmonary
             status within 4 weeks of the Baseline

          -  History of opioid use within 1 week of the Baseline Visit

          -  Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2

          -  History of concurrent malignancy or recurrence of malignancy within 2 years prior to
             Screening (not including participants with <3 excised basal cell carcinomas)

          -  Screening systolic blood pressure (SBP) >160 mm Hg or a diastolic blood pressure (DBP)
             >90 mm Hg

          -  Significantly abnormal laboratory tests at Screening

          -  Clinically significant abnormal electrocardiogram (ECG)

          -  Pregnant or Breastfeeding

          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with trial participation or
             investigational product administration or may interfere with the interpretation of
             trial results and, in the judgment of the Investigator or Sponsor, would make the
             participants inappropriate for entry into this trial
Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section
Condition: Nausea; Vomiting; Cesarean Section
MeSH terms: Nausea; Vomiting
Intervention: Ephedrine [Synonyms: Ephedra, Ephedrinum]; Saline Placebo
Intervention description: 25 mg, IM (in the muscle), one time; 0.5 mL, IM (in the muscle), one time
Intervention MeSH terms: Ephedrine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Nausea; Vomiting; Cesarean Section

Summary:

      The purpose of this research study is to investigate if the incidence of nausea and vomiting
      that subjects experience during and after a Cesarean section can be reduced by giving a shot
      of the drug ephedrine into the thigh muscle at the time of spinal anesthesia administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be pregnant with a single baby

          -  Must be at term in their pregnancy (estimated gestational age of at least 38 weeks)

          -  Must be scheduled for an elective Cesarean section

          -  Must be between 60-70" tall

          -  Must be free of severe systemic disease (ASA class I or II)

        Exclusion Criteria:

          -  Contraindication to spinal anesthesia

          -  Any allergy to any of the medications included in the study

          -  History of pregnancy-induced hypertension or preeclampsia

          -  History of preexisting hypertension

          -  Diabetes mellitus

          -  Hyperemesis gravidum

          -  Previous perioperative nausea and vomiting

          -  History of motion sickness

          -  Women carrying a fetus with a known abnormality will also be excluded from the study
Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Influenza Vaccine GSK1247446A; FluarixTM
Intervention description: Single dose, intramuscular injection; Single dose, intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 678.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine; Influenza

Summary:

      The purpose of this study is to evaluate the immunogenicity and the safety of a second
      vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in
      elderly aged 60 years and above
    

Eligibility criteria:

        Inclusion Criteria:

          -  A male or female age 60 years or older at the time of the revaccination, who
             previously participated in 107192 & 107214 clinical trials.

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol

          -  Written informed consent obtained from the subject.

          -  Free of an acute aggravation of the health status as established by clinical
             examination before entering into the study.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) within 30 days
             preceding the administration of the study vaccine, or planned use during the study
             period.

          -  Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional
             abnormality, as determined by physical examination or laboratory screening tests.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within 3 months prior to the first vaccine dose.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or
             4 weeks (for live vaccines) prior to enrolment in this study. Planned administration
             of a vaccine not foreseen by the study protocol up to 30 days after vaccination.

          -  History of hypersensitivity to a previous dose of influenza vaccine.

          -  History of confirmed influenza infection within the last 12 months.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine(s)

          -  Acute disease at the time of enrolment.