bioihbjkbjnl/mcl2 huggingface dataset:
Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen
Condition: Esophageal; Gastrooesophageal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: jevtana
Intervention description: Cabazitaxel 25mg/m2, IV every 21 days until progression
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: esophageal cancer; gastroesophageal cancer; gastric cancer

Summary:

      The purpose of this study is to evaluate the effectiveness of Cabazitaxel, as well as safety
      and side effects for patients with advanced gastroesophageal cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients are required to have histologically or pathologically confirmed metastatic
             gastric or esophageal adenocarcinoma.

          -  Patients must demonstrate relapse or progression after at least one prior line of
             chemotherapy for metastatic disease.

          -  Patients must have measurable disease by CT scan or MRI

          -  Absolute neutrophil count ≥ 1,500/uL, platelet ≥ 100,000/uL and Hgb > 8.0 g/dl.

          -  Total bilirubin ≤ upper institutional limit of normal (ULN), and AST or ALT ≤ 3x ULN;
             if liver metastases then AST or ALT < 5x ULN

          -  Peripheral neuropathy must be ≤ Grade 1

          -  Creatinine < 2 x ULN

          -  ECOG performance status 0 to 2

          -  Minimum life expectancy of 12 weeks.

          -  Age older than 18 years.

          -  Voluntary, signed written informed consent.

          -  Women of childbearing potential must have a negative pregnancy test Men and women of
             childbearing potential must be willing to consent to using effective contraception
             while on treatment and for at least 3 months thereafter.

        Exclusion Criteria:

          -  History of severe hypersensitivity reaction to Cabazitaxel or other drugs formulated
             with polysorbate 80.

          -  Patients with known, untreated brain metastasis

          -  Any uncontrolled severe, intercurrent illness.

          -  Women who are breast-feeding.

          -  Patients who have undergone major surgery, chemotherapy, or radiotherapy within the
             last 3 weeks.

          -  Patients on concurrent anticancer therapy
A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP)
Condition: Progressive Supranuclear Palsy
MeSH terms: Supranuclear Palsy, Progressive
Intervention: Placebo; ABBV-8E12
Intervention description: Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.; Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr. For participants in Cohort 2, ABBV-8E12 doses may have been decreased after the evaluation by the Data Monitoring Committee of available safety, tolerability and pharmacokinetic data.
Intervention MeSH terms: Tilavonemab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 378.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: PSP; Steele-Richardson-Olszewski syndrome; Tauopathy

Summary:

      The purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics
      of ABBV-8E12 in participants with progressive supranuclear palsy (PSP).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female participant with age 40 years or greater at the time of signed consent

          -  Meets the criteria for possible or probable progressive supranuclear palsy (PSP;
             Steele-Richardson-Olszewski Syndrome)

          -  Presence of PSP symptoms for less than 5 years

          -  Participant is able to walk 5 steps with minimal assistance (stabilization of one arm
             or use of cane/walker)

          -  Participant has an identified, reliable, study partner (e.g., caregiver, family
             member, social worker, or friend)

        Key Exclusion Criteria:

          -  Participants who weigh less than 44 kg (97 lbs) at screening

          -  Mini-Mental State Examination (MMSE) score less than 15 at screening

          -  Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)

          -  Participant resides at a skilled nursing or dementia care facility, or admission to
             such a facility is planned during the study period

          -  Evidence of any clinically significant neurological disorder other than PSP

          -  The participant has a history of or currently has schizophrenia, schizoaffective
             disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental
             Disorders, 5th Edition (DSM-V) or International Classification of Diseases (ICD-10)
             criteria

          -  Participant has had a significant illness or infection requiring medical intervention
             in the past 30 days
Clevidipine Bolus Administration in the Treatment of Hypertensive Patients Undergoing Cardiac Surgery (SPRINT)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: clevidipine
Intervention description: Clevidipine (0.5mg/mL in 20% lipid emulsion) was administered as an IV bolus (<5 sec) by rapid injection for Bolus 1 and for Bolus 2, if second bolus dose was administered, directly into a peripheral venous catheter followed by a normal saline flush (10mL).
Intervention MeSH terms: Clevidipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; Antihypertensive Agent; Calcium Channel Blocker

Summary:

      This study was designed to evaluate the pharmacodynamics of a bolus dosing regimen of
      clevidipine, a vascular-selective L-type calcium channel antagonist, for the management of
      blood pressure in cardiac surgery patients, as well as to evaluate the efficacy, safety and
      pharmacokinetics of clevidipine after bolus administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Require elective cardiac operation involving the use of cardiopulmonary bypass

          -  Age 18 years or older

          -  A history or hypertension and/or expected to require perioperative antihypertensive
             therapy in the opinion of the investigator

          -  Written informed consent

          -  Pre-anesthesia baseline SBP ≥140 mm Hg just prior to bolus, measured using an arterial
             line

        Exclusion Criteria:

          -  Receiving either intravenous vasopressor or intravenous vasodilatory therapy in the 72
             hours prior to dosing

          -  Critical left main coronary artery stenosis

          -  Critical aortic valve (<0.5 cm3) or mitral valve (<1.0 cm3) stenosis

          -  Acute myocardial infarction within the prior 14 days

          -  Fully paced cardiac rhythm

          -  Known or suspected aortic dissection

          -  Requiring preoperative intra-aortic balloon pump counterpulsation therapy

          -  Contraindication to transesophageal echocardiography

          -  Positive pregnancy test or breast feeding

          -  Intolerance or allergy to calcium channel blockers

          -  Allergy to soybean oil or egg lecithin

          -  Any condition(s) that in the Investigator's opinion would warrant exclusion from the
             study or prevent the patient from completing the study

          -  Participation in other clinical research studies involving the evaluation of other
             investigational drugs or devices within 30 days of enrollment
Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.
Condition: Anemia
MeSH terms: Anemia
Intervention: Peginesatide
Intervention description: Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Anemia; Drug Therapy; Peritoneal Dialysis.

Summary:

      The purpose of this study is to determine the efficacy and safety of peginesatide injection
      for maintenance treatment of anemia in participants on peritoneal dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient was a man or woman and 18 to 90 years of age, inclusive.

          2. The patient had CKD and had been on peritoneal dialysis for ≥3 months before
             enrollment.

          3. The patient was on stable SC epoetin (alfa or beta) maintenance therapy continuously
             prescribed for a minimum of 8 weeks prior to enrollment.

          4. The patient had 4 consecutive Hb values with a mean ≥10.0 and ≤12.0 g/dL during the
             screening period, with the difference between the mean of the first confirmed (2
             consecutive) Hb values and the mean of the last confirmed (2 consecutive) Hb values
             being ≤1.0 g/dL.

          5. The patient had 1 ferritin level ≥100 ng/mL within 4 weeks before enrollment.

        Exclusion Criteria:

          1. The patient had known bleeding or coagulation disorder.

          2. The patient had known hematologic disease or cause of anemia other than renal disease
             (e.g., pure red cell aplasia, homozygous sickle-cell disease, thalassemia, multiple
             myeloma, hemolytic anemia, and myelodysplastic syndrome).

          3. The patient had received a recent course of intensive iron replacement (i.e., more
             than 500 mg IV in the 28 days before enrollment).

          4. The patient had advanced chronic congestive heart failure defined by New York Heart
             Association Class III or IV.

          5. The patient had a known history of seizure disorder or received antiepileptic
             medication for a seizure disorder within 6 months before enrollment.

          6. The patient had a scheduled kidney transplant. (Note: patients who were currently on a
             transplant waiting list were not excluded unless there was an identified donor).
Safety, Efficacy and PK/PD of QGE031 vs. Placebo in Patients With Active Bullous Pemphigoid Despite Oral Steroid Treatment
Condition: Bullous Pemphigoid
MeSH terms: Pemphigoid, Bullous
Intervention: QGE031; Placebo
Intervention description: QGE031 will be evaluated at various dose levels and regimens, based on the impact on disease of the next highest dose level and regimen.; Placebo will be used to control for normal variability in disease severity.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: bullous pemphigoid; QGE031

Summary:

      To evaluate the safety and efficacy of QGE031 versus placebo in patients with bullous
      pemphigoid. Efficacy will be assessed as a reduction of disease activity. How QGE031 is
      broken down by the body and the impact it has on different blood and tissue markers will also
      be explored.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with bullous pemphigoid

          -  Stable dose of prednisone at or above 10mg per day but no greater than 1 mg/kg/day

          -  Weigh between 40-120kg

          -  total IgE level up to 5000 IU/mL

        Exclusion Criteria:

          -  Use of rituximab within 1 year

        Other protocol-defined inclusion/exclusion criteria may apply
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: ChimeriVax™-JE vaccine; JE-VAX® vaccine
Intervention description: 0.5 mL, subcutaneously; 1.0 mL, subcutaneously
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese encephalitis; ChimeriVax™-JE; JE-VAX®

Summary:

      The purpose of this study is to determine non-inferiority in seroconversion and to compare
      the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous
      virus strain and several wild types strains after completion of vaccination course.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent obtained.

          -  Aged ≥18 to <49 years.

          -  In good general health.

          -  Available for the study duration, including all planned follow-up visits.

          -  Females must have negative pregnancy test and be using adequate form of contraception

        Exclusion Criteria:

          -  Clinically significant abnormalities on laboratory and vital sign assessments.

          -  Anaphylaxis or other serious adverse reactions

          -  Administration of another vaccine within 30 days of study treatment period.

          -  Physical examination indicating any significant medical condition.

          -  Intention to travel out of the area prior to the study visit on Day 56.

          -  Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or
             positive for Hepatitis B Surface Antigen.

          -  Pregnancy.

          -  Excessive alcohol consumption, drug abuse.

          -  Involvement in another clinical study within 60 days preceding the screening visit and
             during study treatment period.
A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device
Condition: Asthma
MeSH terms: Asthma
Intervention: 75 µg indacaterol maleate (LB); 75 µg indacaterol maleate (PoS); 37.5 µg indacaterol maleate (PoS); placebo to indacaterol (LB); placebo to indacaterol (PoS)
Intervention description: 75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.; 75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.; 37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.; Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.; Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
Intervention MeSH terms: Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma; Indacaterol; QAB149

Summary:

      This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two
      different formulations of indacaterol maleate, both administered via the Concept1 device. The
      study aims to determine whether the novel formulation has a similar clinical profile as the
      established formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients with asthma

          -  Aged 18 or above

          -  Patients using inhaled corticosteroid (with or without long acting beta agonist)

          -  Patients who demonstrate an increase in FEV1 after inhaling a short acting beta
             agonist

        Exclusion Criteria:

          -  Asthma exacerbations in previous 6 months

          -  COPD or other pulmonary disease

          -  Excessive use of short acting beta agonists
Behavioral Economic Analysis of Demand for Marijuana
Condition: Marijuana Smoking
MeSH terms: Marijuana Abuse; Marijuana Use
Intervention: Smoked marijuana cigarettes: High THC dose (6% THC)
Intervention description: Smoked marijuana cigarettes (High THC dose [6% THC])
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 133.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This laboratory study will employ a multi-session experimental design to examine the
      behavioral economic demand for marijuana, by studying effect of marijuana administration
      (High THC) on demand for marijuana, and marijuana smoking topography. The study will recruit
      100 non-treatment seeking marijuana users who smoke marijuana at least twice weekly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  marijuana use at least 8 times in the past month on average and at least monthly for
             the past 6 months

          -  English-speaking

          -  negative urine toxicology screen for drugs other than marijuana

          -  non-treatment seeking

          -  purchase of marijuana at least twice in the past 6 months to confirm familiarity with
             the construct to be measured

        Exclusion Criteria:

          -  positive pregnancy test

          -  nursing

          -  inability to use contraception during the study

          -  poor physical health

          -  positive breath alcohol concentration

          -  diagnosis of a current affective disorder, psychosis, and panic disorder

          -  self-report of past serious adverse reaction to marijuana

          -  current psychotropic drug use

          -  smoking more than 20 tobacco cigarettes per day

          -  inability to abstain from marijuana for 15 hours

          -  body mass index outside 18.5-30 kg/m2 range
Bolus of Saline in Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: Normal saline
Intervention description: intravenous administration of 500cc of 0.9% NaCl over 30 minutes
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Maximum age: 110 Years
Healthy volunteers: No

Summary:

      This study is a non-randomized, Phase 2 clinical trial designed to assess optical cerebral
      blood flow (CBF) response to bolus normal saline. Subjects will have had an ischemic stroke
      within 96 hours of enrollment. The study intervention will be a one hour monitoring session.
      There will be a 15 minute baseline measurement period, followed by intravenous administration
      of 500cc of 0.9% NaCl over 30 minutes, and finally 15 minutes of monitoring post-bolus. All
      study measurements will cease after 1 hour. Subjects will be followed during their
      hospitalization for 7 days or until discharge, whichever is sooner, to monitor for adverse
      events and to collect clinical information.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Acute ischemic stroke in the territory of the anterior, middle, or posterior cerebral
             artery territory on either side of the brain

          -  Study intervention can be initiated within 96 hours of symptom onset

          -  Willingness and ability to sign informed consent by patient or legally acceptable
             surrogate decision-maker

        Exclusion Criteria:

          -  Infarct limited to the brainstem and/or cerebellum with no involvement of the cerebral
             hemispheres

          -  Bi-hemispheric infarction or acute infarct in the contra-lateral hemisphere within the
             past 30 days

          -  Symptoms of active congestive heart failure (dyspnea, orthopnea, increased oxygen
             requirement)

          -  Exacerbation of congestive heart failure, requiring hospitalization, within the past
             30 days or severe systolic dysfunction with a known ejection fraction <20%

          -  End stage renal disease requiring hemodialysis or a creatinine clearance <20
             ml/min/1.73 m2

          -  Hemicraniectomy or other skull defect that would interfere with monitoring

          -  Pregnant women are excluded. Women of child-bearing age must have a negative pregnancy
             test prior to enrollment

          -  Participation in another clinical trial

          -  Any other illness or condition that the investigator feels would pose a hazard to the
             subject from participation in the study