bioihbjkbjnl/mcl2 huggingface dataset:
A Dose Ranging Study Of PF-00868554 In Combination With PEGASYS And COPEGUS In Patients With Chronic Hepatitis C Genotype 1 Infection
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: PF-00868554; PF-00868554; PF-00868554; Placebo
Intervention description: 500 mg BID administered as 5x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks.; 300 mg BID administered as 3x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks; 200 mg BID administered as 2x100 mg tablets for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks; Placebo administered for 4 weeks in combination with standard of care; standard of care continued for an additional 44 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to further assess the potency of PF-00868554, an HCV polymerase
      inhibitor, in subjects chronically infected with HCV by evaluating the antiviral activity of
      PF-00868554 in combination with current standard of care therapy, pegylated
      interferon-alpha2a (PEGASYS) and ribavirin (COPEGUS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment naive (no prior treatment with IFN-a +/- RBV regimens.

          -  Subjects who have discontinued IFN-a containing regimens after <2 weeks of therapy due
             to tolerability issues are considered treatment naive.

          -  HCV RNA > 100,000 IU/mL at screening.

          -  Genotype 1.

          -  A diagnosis of chronic HCV infection for at least 6 months.

        Exclusion Criteria:

          -  Evidence of acute or chronic infection with HIV or HBV.

          -  Exposure within the previous three months to an investigational anti-HCV agent.

          -  Evidence of severe or decompensated liver disease.

          -  Subjects with liver disease unrelated to HCV infection.
A Phase 2 Study Of PF-00232798 In HIV Positive Patients
Condition: HIV
Intervention: PF-00232798; PF-00232798; PF-00232798; PF-00232798; PF-00232798; PF-00232798
Intervention description: Solution, 20 mg. once daily, 10 days; Solution, 150 mg. once daily, 10 days; Solution, 5 mg. once daily, 10 days; Solution, 40 mg. once daily, 10 days; Solution, 300 mg. once daily, 10 days; Solution, 400 mg. once daily, 10 days
Intervention MeSH terms: PF 232798
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Treatment Experienced; Treatment Naive

Summary:

      To assess the viral load response, safety, tolerability and pharmacokinetics of multiple oral
      doses of PF 00232798 in HIV-positive patient volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Asymptomatic HIV-1 infected male patients between the ages of 18 and 55 years
             inclusive.

          -  Patients with CCR5 tropic virus as determined by the Monogram PhenoSense Entry assay.

        Exclusion Criteria:

          -  Patients who have received any experimental drug within the past four months (prior to
             the first dosing day of the study) or who have previously received another CCR5
             antagonist.

          -  Patients with evidence of decompensated liver disease.
TXA and Corona Virus 2019 (COVID19) in Outpatients
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Tranexamic acid tablets; Placebo oral tablet
Intervention description: Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos; 2 tablets p.o. three times per day x 5 days
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blind comparison
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Pharmacy prepares 5 day packs of medications that are coded
Enrollment: 5.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      A controlled trial of the drug tranexamic acid (TXA) in outpatients who were recently
      diagnosed with COVID-19. It is hypothesized that TXA will reduce the infectivity and
      virulence of the virus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Positive COVID-19 test

          -  Outpatient

          -  Age >/= 19 y.o.

        Exclusion Criteria:

          -  Allergic reaction to tranexamic acid

          -  History of hypercoagulation disorders (deep venous thrombosis, pulmonary
             thromboembolism)

          -  Ongoing anticoagulation

          -  History of GI bleeding

          -  History of Seizures

          -  Cardiac or other vascular stents

          -  History of severe renal disease

          -  History of intracranial hemorrhage
Study to Evaluate Safety, Efficacy of Botulinum Toxin Type A in Patients With Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: botulinum toxin type A; botulinum toxin type A Formulation 2; Normal Saline
Intervention description: Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.; Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.; Intramuscular injections of placebo (normal saline) into the affected muscles for treatment cycle 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Study is to investigate the use of the Toronto Western Spasmodic Torticollis Rating Scale
      (TWSTRS) scale in a cervical dystonia population treated with botulinum toxin type A, and
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of cervical dystonia

        Exclusion Criteria:

          -  Current or previous botulinum toxin treatment of any type for any condition
Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: GSK239512; Placebo
Intervention description: Histamine H3 Antagonist; Placebo to match GSK239512
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: H3 Antagonist; Schizophrenia; double blind; Histamine; randomised; placebo controlled; Cognition

Summary:

      This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512
      compared to placebo in patients with schizophrenia
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of Schizophrenia

          2. No acute exacerbation of symptoms requiring hospital admission or step up care in the
             previous six months.

          3. Not on any symptomatic treatment for cognition

        Exclusion Criteria:

          1. Poses a significant homicidal or suicidal risk or evidence of previous homicidal or
             suicidal risk.

          2. Co-morbid psychiatric or significant physical illness

          3. Alcohol or drug abuse or dependence.
CerviPrep for Applying Topical Gemcitabine to the Cervix in Treating Patients With Primary Endometrial, Cervical, or Ovarian Epithelial Cancer
Condition: Cervical Cancer; Endometrial Cancer; Ovarian Cancer
MeSH terms: Uterine Cervical Neoplasms; Endometrial Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: topical gemcitabine hydrochloride; therapeutic conventional surgery
Intervention description: Gemcitabine 100 mg/m2 will be administered as a single dose, directly to the cervix via the CerviPrep™ device.; hysterectomy
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent cervical cancer; cervical cancer; endometrial carcinoma; ovarian epithelial cancer; recurrent ovarian epithelial cancer; recurrent endometrial carcinoma

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Using the CerviPrep™ drug delivery device to apply topical gemcitabine to the cervix may be
      an effective way to kill more tumor cells.

      PURPOSE: This phase II trial is studying how well CerviPrep™ works in applying topical
      gemcitabine to the cervix in treating patients with primary endometrial cancer, cervical
      cancer, or ovarian epithelial cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary endometrial or cervical cancer

          -  Scheduled to undergo abdominal hysterectomy as part of surgical staging and/or
             treatment

          -  Gynecologic Oncology Group (GOG) performance status 0-2

          -  Absolute neutrophil count (ANC) ≥ 1,500 cells/mm³

          -  Platelet count ≥ 100,000 cells/mm³

          -  Creatinine ≤ 2.5 mg/dL

          -  Serum Aspartate aminotransferase (AST) or Alanine transaminase (ALT) ≤ 3 times upper
             limit of normal

          -  Total bilirubin ≤ 2.0 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        Exclusion Criteria:

          -  Serious medical condition or psychiatric illness that places the patient at an
             unacceptable risk for study participation or precludes signing the informed consent

          -  Known allergic reaction or hypersensitivity to gemcitabine hydrochloride

          -  Prior radiotherapy to the whole abdomen or pelvis

          -  More than 28 days since prior standard or experimental anticancer therapy

          -  No other concurrent anticancer agents
Envarsus XR in Lung Transplant
Condition: Lung Transplant
Intervention: Extended-Release Tacrolimus; Immediate-Release Tacrolimus
Intervention description: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.; Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Patients undergoing a lung transplant will be enrolled. All patients will undergo lung
      transplantation with standard post-operative management, including triple immunosuppression.
      As soon as the patient is deemed appropriate to take medications via the oral route, they
      will be converted from IR tacrolimus to Envarsus XR. Patients will be followed per site's
      standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

        Prospective arm:

          -  Age ≥ 18 years

          -  Received a lung transplant at NYU Langone Health

          -  Be able to convert to Envarsus XR within the first month post-transplant

          -  Able and willing to provide informed consent

        Historical control:

          -  Age ≥ 18 years

          -  Received a lung transplant at NYU Langone Health

          -  Completed one year from transplant on IR tacrolimus

        Exclusion Criteria:

        Prospective arm:

          -  Contraindication to tacrolimus due to allergic or adverse reactions

          -  Pregnant or nursing women

          -  Multi-organ transplant recipient

        Historical control:

          -  Contraindication to tacrolimus due to allergic or adverse reactions (not including
             chronic kidney disease)
Radiation Therapy Alone for the Treatment of Stage 1 and 2 Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma
Condition: Ann Arbor Stage I Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Extranodal Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone
Intervention: Radiation Therapy
Intervention description: Undergo radiation therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Healthy volunteers: No

Summary:

      This trial studies the side effects of radiation therapy used alone, and if it can achieve a
      high cure rate in the treatment of patients with MALT lymphoma. Radiation therapy uses high
      energy sources to kill cancer cells and shrink tumors. This treatment may improve the
      patient's lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with newly diagnosed stage 1 and 2 MALT lymphoma are eligible for this study

          -  Patients with Helicobacter (H.) pylori positive gastric MALT lymphoma are recommended
             to have treatments with antibiotics prior to enrollment to this protocol

          -  Patients who failed other treatment modalities (e.g. chemotherapy, antibiotics therapy
             etc) are also eligible as far as they never had stage 3 or 4 disease during the course
             of the disease or disease progression to the opposite side of the diaphragm (as the
             time course of the response to antibiotic therapy can be very variable among patients,
             sometimes requiring more than one year for complete response, failure to antibiotic
             therapy can be very variable among patients, sometimes requiring more than one year
             for complete response, failure to antibiotic treatment will be defined as no response
             or progression of the disease documented by endoscopy and biopsy)

          -  Patients who have had stage 4 diseases due to bilateral parotid gland or ocular/ocular
             adnexal involvement or due to multiple sites within Waldeyer's ring will still be
             eligible

        Exclusion Criteria:

          -  Patients who had previous radiation dose to the site of the current primary disease
             which would lead to violation of known radiation tolerance limit of that particular
             site if treated again

          -  Patients with MALT lymphoma of the skin whose lesions are separated by more than 5 cm
             will be ineligible

          -  Previous or concurrent malignancy in any form would not be an exclusion criterion.
             However, patients who receive chemotherapy for concurrent malignancy will be excluded
             from statistical analysis

          -  Low blood cell counts would not be exclusion criteria as far as the patient is willing
             to accept supportive measures such as transfusions, filgrastim and epoetin
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Capecitabine; Exemestane; Everolimus
Intervention description: Capecitabine, tablets for oral use, 1250 mg/m² twice daily for 2 weeks followed by one week rest (3-week-cycle) (locally supplied); Exemestane, tablets for oral use, 25 mg per day in (locally supplied); Everolimus, 5 mg tablets for oral use, 10 mg (2 x 5 mg) per day (centrally supplied)
Intervention MeSH terms: Capecitabine; Everolimus; Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 309.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Everolimus; Exemestane; Capecitabine; locally advanced; metastatic; breast cancer; breast cancer positive for human epidermal growth factor receptor 2; HER2; HER2 positive; breast cancer progression; estrogen-receptor positive breast cancer; ER

Summary:

      This was a three-arm, randomized, open label, multi-center phase II study investigating the
      combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg
      daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with
      estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or
      progression on letrozole or anastrozole.
    

Eligibility criteria:

        Key Inclusion Criteria:

        - Women with locally advanced, recurrent, or metastatic breast cancer along with
        confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least
        one lesion ≥ 10 mm by CT or MRI that can be accurately measured in at least one dimension
        (CT scan slice thickness ≤ 5 mm) OR • Bone lesions: lytic or mixed (lytic + blastic) in the
        absence of measurable disease as defined above.

        Key Exclusion Criteria:

        - Patients who received more than one chemotherapy line. Patients with only non-measurable
        lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment
        with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors.
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
Condition: Chronic HBV Infection
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: GS-4774; OAV Regimen
Intervention description: Administered as a subcutaneous injection every 4 weeks for a total of 6 doses; Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hepatitis B (HBV); Oral antiviral (OAV); GS-4774

Summary:

      The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in
      adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with
      an oral antiviral (OAV) medication.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability to understand and sign a written informed consent form, which must be obtained
             prior to initiation of study procedures

          -  Currently taking an approved HBV oral antiviral medication

          -  Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6
             months)

          -  Virally-suppressed (HBV DNA below the lower limit of quantification (LLOQ) for ≥ 1
             year)

        Key Exclusion Criteria:

          -  Cirrhosis

          -  Inadequate liver function

          -  Co-infection with hepatitic C virus (HCV), HIV or hepatitic D virus (HDV)

          -  Evidence of hepatocellular carcinoma

          -  Significant cardiovascular, pulmonary, or neurological disease

          -  Females who are pregnant or may wish to become pregnant during the study

          -  Received solid organ or bone marrow transplant

          -  Use of another investigational agents within 3 months of screening

          -  Current alcohol or substance abuse judged by the investigator to potentially interfere
             with compliance

          -  History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease
             ulcerative colitis, autoimmune disease

          -  Known hypersensitivity to study drug, metabolites or formulation excipients

          -  Malignancy within 5 years prior to screening, with the exception of specific cancers
             that are cured by surgical resection (basal cell skin cancer, etc). Participants under
             evaluation for possible malignancy are not eligible.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype
Condition: Alpha1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Intervention: VX-864; Placebo
Intervention description: Tablets for oral administration.; Placebo matched to VX-864 for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-864 in PiZZ
      subjects.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects must have a PiZZ genotype confirmed at screening

          -  Plasma AAT levels indicating severe deficiency at screening

        Key Exclusion Criteria:

          -  History of a medical condition that could negatively impact the ability to complete
             the study

          -  Solid organ, or hematological transplantation or is currently on a transplant list

          -  History of use of gene therapy or RNAi therapy at any time previously

        Other protocol defined Inclusion/Exclusion criteria may apply