bioihbjkbjnl/mcl2 huggingface dataset:
Ovarian Cancer Vaccine for Patients Who Have Progressed During the CAN-003 Study
Condition: Epithelial Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: MUC1 Dendritic Cell Vaccine (Cvac)
Intervention description: The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).
Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cvac

Summary:

      The purpose of this trial is to assess the safety profile of Cvac for epithelial ovarian
      cancer patients who were enrolled in the Cvac clinical trial CAN-003 and are no longer
      eligible for study participation due to disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients ≥ 18 years old with histologically confirmed Stage III or IV
             epithelial ovarian, primary peritoneal, or fallopian tube cancer who were enrolled in
             CAN-003

          -  Able and willing to undergo mononuclear cell (MNC) collection (if required for
             patients who do not have available Cvac doses)

          -  Were enrolled in CAN-003 and met protocol criteria for progressive disease

          -  Wish to remain in the study and, in the investigator's judgment, the potential benefit
             of Cvac treatment outweighs the risk

          -  Must be non-pregnant and, if of childbearing potential, must use adequate birth
             control (hormonal or barrier method of birth control or abstinence) for the duration
             of the study and for 3 months after study completion

          -  Able to provide written informed consent

          -  White blood cell count (WBC) ≥ 3.0 K/μL, absolute neutrophil count ≥ 1.5 K/μL,
             hemoglobin ≥ 9.0 g/dL, and platelets ≥100,000/mm^3

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Other medical conditions which preclude study participation, in the opinion of the
             investigator

          -  Receiving treatment with any other investigational product
A Study of SYN-004 for the Prevention of C.Diff in Patients With a LRTI
Condition: Clostridium Difficile; Clostridium Infections
MeSH terms: Infections; Clostridium Infections
Intervention: SYN-004; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 413.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004
      Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in
      Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract
      Infection (LRTI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Expected minimum hospital stay of 5 days

          -  Expected ≥5 day course of intravenous (IV) ceftriaxone alone or in combination with a
             macrolide

          -  Clinical diagnosis of moderate to severe lower respiratory tract infection consisting
             of signs and symptoms of a lower respiratory tract infection and Pneumonia Severity
             Index (PSI/PORT) score for CAP of 90-130, inclusive. Evidence of a new or progressive
             infiltrate on chest x-ray is recommended.

        Exclusion Criteria:

          -  Presence of a diarrheal illness within 72 hours prior to randomization

          -  Current treatment for CDAD or ongoing active CDI, as evidenced by clinical signs of
             diarrhea along with the presence of toxin A and/or B (or their respective genes, tcdA
             and/or tcdB) of C. difficile in the stool

          -  Number of previous CDAD episodes >1 within 12 weeks of randomization and no C.
             difficile infection (CDI) within 4 weeks of randomization

          -  Use of antibiotics within 1 month of start of study drug except for the current
             illness.
18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma
Condition: Recurrent Adult Soft Tissue Sarcoma; Stage I Adult Soft Tissue Sarcoma; Stage II Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma
MeSH terms: Sarcoma
Intervention: fludeoxyglucose F 18; 18F-fluoromisonidazole; positron emission tomography; computed tomography; laboratory biomarker analysis
Intervention description: Undergo 18F FDG and 18F FMISO PET/CT scans; Undergo 18F FDG and 18F FMISO PET/CT scans; Undergo 18F FDG and 18F FMISO PET/CT scans; Undergo 18F FDG and 18F FMISO PET/CT scans; Correlative studies
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans
      to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue
      sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic
      procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to
      find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors
      predict how well a patient will respond to treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed intermediate- or high-grade soft tissue sarcoma

               -  Biopsy proven or highly suspicious primary or recurrent disease

               -  Tumor size ≥ 2 cm

          -  Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy

          -  Life expectancy ≥ 12 months

          -  Negative pregnancy test

          -  Willing to undergo PET scanning

          -  Willing to undergo possible urinary bladder catheterization (for patients with pelvic
             or proximal thigh tumors)

          -  Able to lie on the imaging table for up to 1.5 hours

          -  Weight ≤ 400 lbs

          -  Not pregnant
Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Fluconazole; Vancomycin; Neomycin; Ciprofloxacin; Polyethylene Glycol 3350; Promethazine; Fluconazole placebo
Intervention description: 400mg orally once daily (Day 1-14); 500mg oral suspension 4 times daily (Day 1-14); neomycin 1000 mg orally three times daily (Days 1-3); ciprofloxacin 750 mg orally twice daily (Day 4-14); 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2; PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).; Once daily
Intervention MeSH terms: Promethazine; Diphenhydramine; Vancomycin; Ciprofloxacin; Neomycin; Fluconazole; Polyethylene glycol 3350
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage
      and antibiotics with or without an antifungal) in the management of active Crohn's Disease
      (CD) that is refractory to conventional, immunosuppressive therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is capable of giving informed consent

          -  Males or females 18-75 years of age

          -  Normal kidney function (defined by normal serum creatinine [male: <1.27 mg/dL; female:
             <1.03 mg/dL])

          -  Normal aspartate aminotransferase [AST] (<41 U/L), alanine aminotransferase [ALT] (<63
             U/L), and alkaline phosphatase (<126 U/L)

          -  Active CD defined as HBI ≥ 7

          -  CRP > 5 mg/dL or hs-CRP > 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) > - - 350
             mcg/g (within one month of enrollment)

          -  Have been treated with one of the following therapies** for at least 8 weeks with
             primary nonresponse or an initial response, followed by loss of response [LOR]
             (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine,
             methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab,
             vedolizumab, or ustekinumab **These medications must have been administered at
             standard, therapeutic dosages.

        Exclusion Criteria:

          -  Known or suspected stricturing disease producing obstructive symptoms

          -  Active Clostridium difficile infection

          -  Unwillingness to provide informed consent

          -  Allergy or intolerance to the medications used in this study

          -  History of kidney disease

          -  History of liver disease

          -  Pregnant or lactating females

          -  Baseline QTc interval on EKG > 430 in males or > 450 in females

          -  Participants who, in the opinion of the investigator, may be non-compliant with study
             schedules or procedures
Prevention of Syncope Trial 6 - Atomoxetine in Vasovagal Syncope
Condition: Vasovagal Syncope
MeSH terms: Syncope; Syncope, Vasovagal
Intervention: Atomoxetine; Placebo
Intervention description: 40mg PO the night before and the morning of the study tilt table test.; oral placebo capsule designed to blind the atomoxetine intervention
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Study drug was encapsulated in opaque capsules by study personnel not involved in the day to day operations of the study.
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Objective: To determine if atomoxetine 40 mg bid (bis in die) in patients ≥18 years old with
      recurrent vasovagal syncope will better prevent syncope during tilt testing than placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1 or more syncopal spells in the year preceding enrolment

          -  More than -2 points on the Calgary Syncope Symptom Score

          -  Age ≥18 years with informed consent

        Exclusion Criteria:

          -  Other causes of syncope, such as ventricular tachycardia, complete heart block,
             orthostatic hypotension or hypersensitive carotid sinus syndrome

          -  Inability to give informed consent

          -  important valvular, coronary, myocardial or conduction abnormality or significant
             arrhythmia.

          -  hypertrophic cardiomyopathy

          -  a permanent pacemaker

          -  a seizure disorder

          -  hypertension defined as >150/90 mm Hg

          -  pregnancy

          -  glaucoma

          -  medications with known effects on blood pressure

          -  Known hypersensitivity to atomoxetine and derivatives
A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive Impairment
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Cognitive Dysfunction
Intervention: GRF6021; Placebo
Intervention description: GRF6021 for IV infusion; Placebo for IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinson's Disease; Dementia

Summary:

      This study will evaluate the safety, tolerability, and potential effects on cognition of
      GRF6021, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects
      with Parkinson's disease and cognitive impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Parkinson's Disease (PD), with at least 1 year of PD symptoms.

          -  Diagnosis of PD with mild cognitive impairment (PD-MCI) or probable or possible
             Parkinson's disease dementia according to Movement Disorder Society's Clinical
             Diagnostic criteria.

          -  Score on the Montreal Cognitive Assessment (MoCA) of 13-25.

          -  Modified Hoehn and Yahr Stages 1-4.

          -  Modified Hachinski Ischemic Scale (MHIS) score of 4 or less.

        Exclusion Criteria:

          -  History of blood coagulation disorders or hypercoagulability.

          -  Current use of anticoagulant therapy. Use of antiplatelet drugs (e.g., aspirin or
             clopidogrel) is acceptable.

          -  Prior hypersensitivity reaction to any human blood product or any IV infusion.

          -  Treatment with any human blood product, including transfusions and IV immunoglobulin,
             during the 6 months prior to screening.

          -  History of immunoglobulin A or haptoglobin deficiency; stroke, anaphylaxis, or
             thromboembolic complications of IV immunoglobulins.

          -  Heart disease, as evidenced by myocardial infarction, unstable, new onset or severe
             angina, or congestive heart failure in the 6 months prior to dosing

          -  Hemoglobin < 10 g/dL in women and < 11 g/dL in men.
Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: VOX; SOF/VEL; RBV
Intervention description: 100 mg tablet(s) administered orally once daily with food; 400/100 mg FDC tablet administered orally once daily with food; Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This primary objectives of the study are to evaluate the safety, tolerability, and efficacy
      of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ±
      ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals with chronic HCV infection

          -  HCV RNA ≥10^4 IU/mL at screening

          -  HCV genotype 1

          -  Cirrhosis determination; a liver biopsy may be required

          -  Screening laboratory values within defined thresholds

          -  Use of two contraception methods if female of childbearing potential or sexually
             active male

        Key Exclusion Criteria:

          -  Pregnant or nursing female

          -  Current or prior history of hepatic decompensation

          -  Hepatocellular carcinoma (HCC) or other clinically significant malignancy

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  History of clinically significant illness or any other medical disorder that may
             interfere with the individual's treatment, assessment or compliance with the protocol

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Condition: Fatty Liver, Nonalcoholic; NAFLD; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Digestive System Diseases; Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases; Gastrointestinal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: HTD1801; Placebo
Intervention description: HTD1801 tablets, 250mg; tablets manufactured to mimic HTD1801 tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses
      of HTD1801 to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of NASH as assessed by MRI

          -  Clinically documented diagnosis of T2DM

          -  Body mass index (BMI) >25 kg/m2

        Exclusion Criteria:

          -  Liver disease unrelated to NASH

          -  Poorly controlled T2DM or Type 1 Diabetes Mellitus

          -  History of alcohol or substance abuse or dependence

          -  Inability to undergo MRI for any reason

          -  History of significant cardiovascular disease
Acute Effects of Inhaled Treprostinil in Fontan Patients
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Intervention: Treprostinil; Placebo
Intervention description: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.; 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
Intervention MeSH terms: Treprostinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Congenital heart disease

Summary:

      In this pilot study investigators propose to explore the effects of a locally delivered
      inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood
      flow, venous pressure response and vascular function in stable Fontan patients. Investigators
      will also assess the effects of resting and acute rises in exercise induced systemic venous
      pressure on liver stiffness and will also assess whether treprostinil will attenuate the
      acute stiffness increase that investigators expect to see. This will be a prospective,
      randomized, double-blinded placebo controlled, crossover trial. Following recruitment and
      informed consent, each participant will undergo three study visits, including baseline
      testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and
      visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients age 18 years and older

          2. Single ventricle patients status post Fontan procedure

        Exclusion Criteria:

          1. Clinically unstable: these are patients who are experiencing new cardiovascular
             symptoms such as worsening shortness of breath, new onset arrhythmia, uncontrolled
             heart failure, or evidence of clinically significant cirrhosis or renal failure.

          2. Evidence of Fontan pathway or intra cardiac obstruction as identified on prior
             clinically indicated imaging studies (echocardiography and MRI);

          3. Evidence of left or right systemic ventricular systolic dysfunction with an Ejection
             fraction of <40% on either echocardiogram or MRI from previously documented clinical
             data;

          4. Presence of uncontrolled arrhythmias;

          5. Unable to perform exercise testing for any reason or if deemed by the PI or designee
             that exercise testing would not be in the best interest of the participant

          6. Currently pregnant and/or breastfeeding

          7. Patient unable to provide informed consent

          8. BMI > 30 mg/m2
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
Condition: Myocardial Infarction; Acute Coronary Syndromes; Unstable Angina
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; Angina, Unstable; Infarction
Intervention: Short Tirofiban; Eptifibatide; Long Tirofiban
Intervention description: 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.; 180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.; 25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
Intervention MeSH terms: Tirofiban; Eptifibatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 535.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a
      shortened infusion duration compared to label-dosing eptifibatide in patients undergoing
      percutaneous coronary intervention (PCI) is associated with a non-inferior composite rate of
      death, PCI-related myocardial infarction, urgent target vessel revascularization or
      in-hospital major bleeding within 48 hours following PCI or hospital discharge, whichever
      comes first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years of age

          -  Scheduled to undergo PCI with an FDA, approved or cleared device (stent or procedures
             such as balloon angioplasty, rotoblation, AngioSculpt, laser atherectomy,etc.) in one
             or more native coronary target lesions

          -  Written informed consent

        Exclusion Criteria:

          -  Primary PCI for STEMI as index procedure

          -  Prior STEMI within 48 hours before randomization

          -  Prior PCI within 30 days before randomization

          -  Planned staged PCI within the subsequent 24 hours after index PCI

          -  Use of abciximab within 7 days before randomization

          -  Use of tirofiban or eptifibatide within 12 hours before randomization

          -  Use of low-molecular weight heparin within 12 hours before randomization

          -  Use of bivalirudin within 12 hours before randomization