bioihbjkbjnl/mcl2 huggingface dataset:
A Study of MabThera/Rituxan (Rituximab) in Combination With Fludarabine And Cyclophosphamide as Primary Therapy in Elderly Patients With Chronic Lymphocytic Leukemia
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Cyclophosphamide; Fludarabine; Rituximab
Intervention description: 150 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1-3 of each 28-day cycle for 6 cycles; 12.5 mg/m^2 IV on Days 1-3 of every 28-day cycle for 6 cycles; 375 mg/m^2 IV Day 0 of Cycle 1, 500 mg/m^2 IV Day 1 of Cycles 2-6. Each cycle was 28 days.
Intervention MeSH terms: Cyclophosphamide; Rituximab; Fludarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      This single arm, open-label study will assess the safety and efficacy of low dose fludarabine
      and cyclophosphamide in combination with standard dose MabThera/Rituxan (rituximab) as
      primary therapy in elderly patients (>/= 65 years) with chronic lymphocytic leukemia.
      Patients will receive six 28-day cycles of treatment with Mabthera/Rituxan (375 mg/m2
      intravenously [iv] Day 0 of cycle 1, 500 mg/m2 iv Day 1 of cycles 2-6), fludarabine (12.5
      mg/m2/d iv Days 1-3, cycles 1-6) and cyclophosphamide (150 mg/m2/d iv Days 1-3, cycles 1-6).
      Anticipated time on study treatment is 6 months, with a 30-month follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 65 years of age

          -  Previously untreated B-cell chronic lymphocytic leukemia (CLL)

          -  Binet stage C or active Binet stage A and B disease

        Exclusion Criteria:

          -  Prior treatment for CLL

          -  CLL with transformation (Richter's syndrome)

          -  Suspected or known central nervous system (CNS) involvement of CLL

          -  Impaired renal or hepatic function

          -  Human Immunodeficiency Virus (HIV) positivity, active hepatitis B/C or Hepatitis B
             Virus (HBV) surface antigen positive, or any active or uncontrolled infections

          -  Patients with anti-HBV core antibodies (past infection with HBV) but who are negative
             for Hepatitis B Virus Surface Antigen (HBVsAg) (either anti-HBS Ab positive or
             negative) and are positive for HBV- Deoxyribonucleic acid (DNA) by Polymerase chain
             reaction (PCR) analysis

          -  Concomitant diseases requiring chronic steroid administration

          -  Active second malignancy within the 2 years prior to study (except for non-melanoma
             skin cancer and in situ cervix or breast or prostate carcinoma)

          -  Eastern Cooperative Oncology Group (ECOG) performance status >/= 3
Safety Study of Nicardipine to Treat Cerebral Vasospasm
Condition: Cerebral Vasospasm
MeSH terms: Vasospasm, Intracranial
Intervention: Nicardipine hydrochloride; Preservative-free normal saline
Intervention description: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.; Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
Intervention MeSH terms: Nicardipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vasospasm; Subarachnoid hemorrhage; Aneurysmal subarachnoid hemorrhage; Nicardipine; Intrathecal; SAH; aSAH

Summary:

      The purpose of this study is to determine if intrathecal nicardipine is safe for the
      treatment of cerebral vasospasm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 18 years of age and older

          -  Subarachnoid hemorrhage documented on head CT

          -  Fisher Grade 3 or 4

          -  Hunt Hess Grade 1-5

          -  Cerebral aneurysm as definitive source of subarachnoid hemorrhage

          -  Cerebral aneurysm must be treated via open or endovascular techniques

          -  Presence of external ventricular drain

          -  Written informed consent obtained from subject or subject's legally authorized
             representative

        Exclusion Criteria:

          -  Absence or inability to have an external ventricular drain (coagulopathy)

          -  Non-aneurysmal subarachnoid hemorrhage (perimesencephalic)

          -  Untreated cerebral aneurysm

          -  Inability to be randomized prior to post-hemorrhage day 4

          -  Elevated intra-cranial pressures that would preclude external ventricular drain
             clamping for 30-60 minutes

          -  Inability to administer study medication (severe intra-ventricular hemorrhage,
             occluded external ventricular drain)

          -  Inability to obtain angiography (coagulopathy, renal failure)

          -  Pregnant

          -  Presence of a condition or abnormality that in the opinion of the Investigator would
             compromise the safety of the patient or the quality of the data
Evaluate Rituximab in Obtaining PCR (Polymerase Chain Reaction) Negative Leukapheresis Product in Patients With Relapsed Follicular Lymphoma
Condition: Non-Hodgkins Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Rituximab
Intervention description: 375 MG/M2 (milligram per meter squared) given IV (intravenously) weekly x 4-8 doses.
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: non-Hodgkins; lymphoma; stem cell transplant

Summary:

      Researchers hope to learn if adding rituximab with high doses of chemotherapy and stem cell
      transplantation will help patients get rid of their lymphoma cells from the bone marrow and
      stem cell collections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with biopsy-proven refractory CD20+ (cluster of differentiation antigen 20)
             Follicular lymphoma or transplant eligible mantle cell lymphoma in CR1 (complete
             remission 1) or later.

          -  Patients must be transplant eligible per KUCC BMT SOP (Kansas University Cancer Center
             Bone Marrow Transplant Standard Operation Procedures) with chemo-sensitive/marrow
             negative disease.

          -  Patients planning to harvest and hold may also be included as long as above criteria
             are met.

        Exclusion Criteria:

          -  Pregnancy

          -  Zubrod performance status greater than 2

          -  Life expectancy is severely limited by concomitant illness.

          -  Uncontrolled arrhythmias or symptomatic cardiac disease precluding transplantation

          -  Symptomatic pulmonary disease precluding transplantation

          -  Serum creatinine greater than 1.8 mg/dL

          -  Serum bilirubin greater than 2 X upper limit of normal, SGPT (serum glutamate pyruvate
             transaminase) greater than 3 times upper limit of normal

          -  Evidence of chronic active hepatitis or cirrhosis

          -  Unable to sign informed consent.

          -  Allergy to Rituximab
Safety and Efficacy of ATG003 in Patients With Wet Age-Related Macular Degeneration (AMD)
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Mecamylamine; Placebo
Intervention MeSH terms: Mecamylamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 343.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; Wet AMD

Summary:

      This is a Phase II randomized, double-masked study comparing the safety and efficacy of
      ATG003 (mecamylamine HCl) 1.0% and 0.3% ophthalmic solutions to placebo in patients with
      neovascular ("wet") age-related macular degeneration (NV-AMD).
    

Eligibility criteria:
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
Condition: Chronic Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: OBV/PTV/r; Sofosbuvir; Ribavirin (RBV)
Intervention description: Tablet; Tablet; Tablet
Intervention MeSH terms: Ritonavir; Ribavirin; Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus; Genotype 2; Chronic Hepatitis C; Genotype 3; Non-cirrhotic; Cirrhotic

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Ombitasvir
      (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV)
      in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV
      infection with or without Cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chronic HCV infection prior to study enrollment.

          2. Screening laboratory results from the central clinical laboratory indicating HCV
             genotype 2 or 3 infection only (no mixed genotype).

          3. Absence OR presence of cirrhosis.

          4. If cirrhotic, need to have compensated cirrhosis and absence of hepatocellular
             carcinoma (HCC)

        Exclusion Criteria:

          1. Positive screen for hepatitis B surface antigen or anti-human immunodeficiency virus
             antibody

          2. Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse.

          3. Current enrollment in another clinical study, previous enrolment in this study, or
             previous use of any investigational or commercially available anti-HCV therapy (other
             than interferon, pegIFN, RBV, and or SOF) including previous exposure to telaprevir,
             boceprevir, ABT-450, or ombitasvir (ABT-267).

          4. Subjects without cirrhosis: Any current or past clinical evidence of cirrhosis.

          5. Abnormal lab tests.

          6. Females who are pregnant or plan to become pregnant or breastfeeding, or males whose
             partners are pregnant or planning to become pregnant
Open Label Extension In Cancer Patients
Condition: Neoplasms; Bone Metastases
MeSH terms: Neoplasm Metastasis
Intervention: Anti-NGF AB
Intervention description: Solution for injection, 10 mg, one injection/8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer pain; NGF; open-label extension

Summary:

      To evaluate the safety and efficacy of anti-NGF AB in cancer patients with pain due to bone
      metastases who participated in the double-blind Study A4091003 and who wish to receive
      open-label therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has been
             diagnosed as having metastasized to bone;

          -  Karnofsky Performance Score ≥40% at Baseline;

          -  patients randomized and treated with intravenous study drug in double-blind Study
             A4091003.

        Exclusion Criteria:

          -  Patient was withdrawn from Study A4091003 for an adverse event or serious adverse
             event;

          -  Occurrence of any adverse event or condition during Study A4091003 or since
             termination from that study that, in the opinion of the Investigator, would put the
             patient at increased safety risk or should exclude the subject from participating in
             the open-label extension Study A4091029.
Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: olaparib; paclitaxel; carboplatin; paclitaxel; Drug: carboplatin
Intervention description: Tablets Oral BID; 175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle; AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle; 175mg/m2 iv for up to 6 cycles (18 weeks); AUC4 iv for up to 6 cycles (18 weeks)
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Olaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: Female
Minimum age: 18 Years
Maximum age: 125 Years
Healthy volunteers: No
Keywords: Poly(ADP ribose); polymerisation (PARP); Platinum sensitive; Advanced Serous Ovarian cancer; olaparib; PARP inhibitors; Platinum Sensitive Advanced Serous Ovarian Cancer

Summary:

      To compare the efficacy of olaparib in combination with paclitaxel and carboplatin (AUC4)
      when compared with carboplatin (AUC6) and paclitaxel alone in patients with advanced ovarian
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with serous ovarian cancer

          -  Patients who have received no more than 3 previous platinum containing treatments and
             were progression free for at least 6 months following the end of the last platinum
             treatment

          -  At least one lesion that is suitable for accurate repeated measurements

        Exclusion Criteria:

          -  Patients receiving any systemic anticancer chemotherapy, radiotherapy (except
             palliative) within two weeks from the last dose prior to study treatment

          -  Hypersensitivity to pre medications required for treatment with paclitaxel/carboplatin
Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Bepotastine besilate formulation; Fluticasone propionate; Bepotastine besilate-fluticasone propionate; Placebo Comparator
Intervention description: Nasal Spray; Nasal Spray; Nasal Spray; Nasal Spray
Intervention MeSH terms: Fluticasone; Xhance; Bepotastine besilate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 606.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a clinical study to evaluate the safety and efficacy of a bepotastine
      besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic
      rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of
      Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from
      baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom
      scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination
      nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared
      to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in
      screening period dosing with placebo nasal spray and then a 14-day treatment period where
      subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective
      and instantaneous scores for both nasal and ocular symptoms prior to each dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 12 years of age with a demonstrated history of Mountain Cedar
             pollen allergy

        Exclusion Criteria:

          -  No active nasal infection or nasal abnormality that would affect subject safety or
             symptom assessments
Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)
Condition: Acute Demylelinating Optic Neuritis
MeSH terms: Neuritis; Optic Neuritis
Intervention: Fingolimod 0.5mg/daily; Placebo
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Acute demyelinating optic neuritis; Optic neuritis

Summary:

      To evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with
      suspected acute demyelinating optic neuritis (ADON) receiving standard steroid treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical signs and symptoms of ADON in one eye (loss of vision, pain on movement,
             impairment of color vision)

          -  First episode of ADON

          -  Able to undergo treatment with IV steroids

        Exclusion Criteria:

          -  History of any unexplained eye or neurological symptoms lasting longer than 48 hours

          -  Optic neuritis in both eyes

          -  Concomitant condition in either eye, other than optic neuritis

          -  History of heart condition/disease

          -  Patients with uncontrolled diabetes mellitus

          -  Patients with liver conditions/disease

          -  Inability to undergo MRI

          -  Pregnant or nursing women

          -  Women of childbearing potential who are not using highly effective method of birth
             control

               -  Other protocol-defined inclusion/exclusion criteria may apply
Intravenous Milk Thistle (Silibinin-Legalon) for Hepatic Failure Induced by Amatoxin/Amanita Mushroom Poisoning
Condition: Amatoxin Poisoning; Amanita Poisoning; Mushroom Poisoning; Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; Poisoning; Mushroom Poisoning
Intervention: Silibinin
Intervention description: 20 mg/kg continuous IV is over 24 hours
Intervention MeSH terms: Silybin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Healthy volunteers: No
Keywords: amatoxin; amanita; mushroom poisoning; hepatic failure; milk thistle; Silibinin; Legalon

Summary:

      Legalon® SIL will be administered to patients with amatoxin poisoning diagnosed by history,
      gastrointestinal symptoms, elevated liver enzymes, and/or diagnostic assay (should one become
      available). Patients may or may not also demonstrate abnormalities in bilirubin and/or
      creatinine. Treatment consists of a 5 mg/kg loading dose followed by 20 mg/kg/day via
      continuous infusion. The treating physician is expected to administer supportive therapy of
      his/her choosing but consistent with best practices. Legalon® SIL will be stopped when
      coagulopathy is no longer present, and when liver function tests have returned significantly
      towards the normal range. Patients will be followed 7-14 days after the end of Legalon® SIL
      therapy with follow up lab studies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed Informed Consent(s) for clinical trial participation (due to the potential
             critical status of the subject upon presentation, consent may need to be obtained from
             Legally Authorized Representative (LAR) per sites consenting policy and ICH/GCP
             guidance) Signed Informed Consent for Clinical Trial participation

          2. History of eating foraged mushrooms

          3. Gastrointestinal symptoms suggestive of amatoxin poisoning (cramping abdominal pain,
             nausea, vomiting, and / or watery diarrhea) usually 24-48 hours after of mushroom
             ingestion

          4. Liver function tests suggestive of amatoxin poisoning: AST or ALT above the
             institutions upper limit of normal after mushroom ingestion

        Exclusion criteria:

        1. Evidence of significant medical illness or any other abnormal laboratory finding that,
        in the Investigator's judgment, will substantially increase the risk associated with the
        subject's participation in, and completion of the study or could preclude the evaluation of
        the subject's response.
A Clinical Trial To Evaluate PF-05089771 On Its Own And As An Add-On Therapy To Pregabalin (Lyrica) For The Treatment Of Pain Due To Diabetic Peripheral Neuropathy (DPN)
Condition: Diabetic Neuropathy, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: PF-05089771 150 mg; Matched placebo for PF-05089771 150 mg and pregabalin 300 mg; Pregabalin 300 mg; PF-05089771 150 mg + Pregabalin 300 mg
Intervention description: PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.; Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.; Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.; PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of PF-05089771 as a
      monotherapy and as an add-on to pregabalin for the treatment of painful diabetic peripheral
      neuropathy (DPN)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged 18 years to 80 years.

          -  Diagnosis of Type 2 diabetes mellitlus (T2DM) with current glycosylated hemoglobin A1c
             (HbA1c) levels of ≤ 11% at Screening and on a stable antidiabetic medication regimen
             for at least 30 days prior to randomization.

          -  Presence of ongoing pain due to DPN for at least 6 months.

          -  Willing to discontinue protocol-specified prohibited pain medications for DPN
             throughout the duration of the study.

        Exclusion Criteria:

          -  Painful neuropathies or painful conditions other than DPN that may confound evaluation
             of pain due to DPN during the study.

          -  Subjects who have failed previously on pregabalin (at the recommended label dose and
             for adequate duration) due to lack of efficacy.

          -  Subjects with any clinically significant medical or psychiatric conditions or
             clinically significant laboratory test abnormalities.

          -  Pregnant women, lactating mothers, men with partners currently pregnant, women
             suspected of being pregnant, and women who wish to be pregnant during the course of
             the clinical study.