bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation
Condition: Cytokines
Intervention: G-CSF, GM-CSF administered at extremities; G-CSF and GMCSF administered at abdomen
Intervention description: Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete.; Injection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete.
Intervention MeSH terms: Lenograstim; Sargramostim; Mitogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether or not the injection site of cytokines, or
      growth factors, has an effect on peripheral blood stem cell collection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for
             relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with
             myeloma. All patients must meet criteria for transplantation.

        Exclusion Criteria:

          -  Patients with active, invasive/systemic fungal infection.

          -  Patients who are pregnant or lactating females.

          -  Patients with active CNS malignant disease or life expectancy limited by diseases
             other than the disease for which the patient is being transplanted.

          -  Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.
Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout
Condition: Gout
MeSH terms: Gout
Intervention: Placebo; Febuxostat; Febuxostat; Febuxostat
Intervention description: Febuxostat placebo-matching tablets, orally, once daily for up to 4 weeks.; Febuxostat 40 mg, tablets, orally, once daily for up to 4 weeks.; Febuxostat 80 mg, tablets, orally, once daily for up to 4 weeks.; Febuxostat 120 mg, tablets, orally, once daily for up to 4 weeks.
Intervention MeSH terms: Febuxostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Uric Acid; xanthine oxidase; tophi; Drug Therapy

Summary:

      The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in
      reducing serum urate levels in subjects with gout.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hyperuricemia (serum uric acid ≥8.0 mg/dL).

          -  Must meet American College of Rheumatology criteria for gout.

          -  Must have adequate renal function (serum creatinine <1.5 mg/dL).

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating from Screening throughout the
             duration of the study.

        Exclusion Criteria:

          -  History of xanthinuria

          -  Alcohol consumption >14/week

          -  Has a history of significant concomitant illness.

          -  Has active liver disease.

          -  Has a body mass index greater than 50 kilogram per meter² (kg/m²)

          -  Any other significant medical condition that would interfere with the treatment,
             safety or compliance with the protocol, as defined by the investigator.
Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Macrobeads in Subjects With Castration-Resistant Prostate Cancer Resistant to Taxanes (Docetaxel, Cabazitaxel) and Evidence of Disease Progression on Androgen-axis Inhibition and/or Immunotherapy in the Form of Sipuleucel-T
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Adenocarcinoma; Carcinoma, Renal Cell; Disease Progression
Intervention: Cancer Macrobead placement in abdominal cavity
Intervention description: 8 macrobeads per kilogram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a clinical research study of an investigational (FDA IND-BB 10091) treatment of
      subjects with castration-resistant prostate cancer resistant to Taxanes (docetaxel,
      cabazitaxel) and evidence of disease progression on androgen-axis inhibition and/or
      immunotherapy in the form of sipuleucel-T.

      The treatment is being evaluated for its effect on tumor growth. It consists of the placement
      (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA
      macrobeads). The cells in the macrobeads produce substances that have been shown to slow or
      stop the growth of tumors in experimental animals and veterinary patients. It has been tested
      in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II
      studies in patients with colorectal, pancreatic or prostate cancers are in progress.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cancer of prostate

          -  Evidence of metastasis

          -  Failed available therapies

          -  Resolution of any toxic effects of previous therapies

          -  Performance status (ECOG PS) 0-2

          -  Adequate hematologic, coagulation (INR 2-3max), hepatic and renal function

          -  Life expectancy of 12 months

          -  Agrees to contraceptive use while on study if sexually active

          -  Sign informed consent document

        Exclusion Criteria:

          -  Any condition presenting an unacceptably high anesthetic or surgical risk

          -  HIV positive

          -  Cognitive impairment such as to preclude informed consent

          -  Other surgical treatment, chemotherapy and radiation within four weeks of baseline

          -  Inadequate hematologic, coagulation (INR >3), hepatic, renal function

          -  Hepatic blood flow abnormalities and/or large-volume ascites

          -  Concurrent cancer of any other type except skin cancer (excluding melanoma)

          -  History of allergic reactions to mouse antigens

          -  Active infection, congestive heart failure, unstable angina, serious cardiac
             arrhythmias, psychiatric illness, difficult social situations not permitting reliable
             participation, active bleeding
A Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T-Cell Lymphoma (NKTCL), Nasal Type
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell
Intervention: Daratumumab
Intervention description: Participants will receive daratumumab 16 mg/kg as intravenous infusion.
Intervention MeSH terms: Daratumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the clinical efficacy and safety of daratumumab in
      relapsed or refractory natural killer/T-cell lymphomas (NKTCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented as histologically confirmed extranodal natural killer/T-cell lymphomas
             (NK/T)-cell lymphoma, nasal type according to the World Health Organization (WHO)
             classification and the pathology report will be verified by the Sponsor

          -  Failed at least 1 line of chemotherapy and who, according to treating physician or
             investigator, is not candidate to receive other treatment modalities

          -  At least 1 measurable site of disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2 and
             life expectancy greater than or equal to (>=) 3 months

        Exclusion Criteria:

          -  Received daratumumab or other antiCD38 therapies previously

          -  Previous allogenic stem cell transplant or autologous stem cell transplantation within
             12 weeks before the first administration of the study drug

          -  Clinical symptoms of central nervous system involvement

          -  Known chronic obstructive pulmonary disease, known moderate or severe persistent
             asthma within the past 2 years, or uncontrolled asthma of any classification

          -  Clinically significant cardiac disease, including:Myocardial infarction within 6
             months before the first study agent administration, or unstable or uncontrolled
             disease/condition related to or affecting cardiac function (eg, unstable angina,
             congestive heart failure, New York Heart Association Class III-IV); Uncontrolled
             cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE] [most
             recent version] Grade 3 or higher) or clinically significant ECG abnormalities;
             Screening 12-lead ECG showing a baseline QT interval as corrected QTc >470 msec

          -  Seropositive for human immunodeficiency virus

          -  Seropositive for hepatitis B or hepatitis C

          -  Abnormal laboratory values according to protocol defined parameters at screening
An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP)
Condition: Progressive Supranuclear Palsy (PSP)
MeSH terms: Supranuclear Palsy, Progressive
Intervention: ABBV-8E12; Placebo solution for IV infusion on Day 15
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.; 0.9% NaCl injection/solution for infusion 500 mL; 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.
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: 142.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Tauopathy; Steele-Richardson-Olszewski Syndrome; PSP

Summary:

      The purpose of this study was to assess the long-term safety and efficacy of ABBV-8E12
      (tilavonemab) in participants with progressive supranuclear palsy (PSP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant completed the 52-week treatment period in Study M15-562 (NCT02985879)

          -  In the opinion of the investigator, the participant was compliant during participation
             in Study M15-562 (NCT02985879)

          -  Participant has an identified, reliable, study partner (e.g., caregiver, family
             member, social worker, or friend)

        Exclusion Criteria:

          -  Participants who weigh less than 44 kg (97 lbs) at the time of study entry

          -  Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI)

          -  Participant has any significant change in his/her medical condition that could
             interfere with the subject's participation in the study, could place the subject at
             increased risk, or could confound interpretation of study results

          -  More than 8 weeks have elapsed since the participant received his/her last dose of
             study drug in Study M15-562 (NCT02985879)

          -  Participant is considered by the investigator, for any reason, to be an unsuitable
             candidate to receive ABBV-8E12 or the participant is considered by the investigator to
             be unable or unlikely to comply with the dosing schedule or study evaluations
A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: pertuzumab; paclitaxel; gemcitabine; carboplatin
Intervention description: Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks; 175 mg/m2 IV every 3 weeks for 6 cycles; 1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles; Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine; Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of pertuzumab in combination with
      carboplatin-based standard chemotherapy in patients with platinum-sensitive recurrent ovarian
      cancer. The anticipated time on study treatment is 3-12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically confirmed ovarian, primary peritoneal, or fallopian tube cancer;

          -  only 1 previous regimen, which must be platinum-based;

          -  platinum-sensitive disease which is defined by a progression-free interval of greater
             than 6 months after completion of platinum-based chemotherapy.

        Exclusion Criteria:

          -  previous radiotherapy;

          -  previous treatment with an anti-cancer vaccine or any targeted therapy;

          -  major surgery or traumatic injury within 4 weeks of study;

          -  history or evidence of central nervous system metastases.
Guadecitabine Extension Study
Condition: Acute Myeloid Leukemia; Myeloid Dysplastic Syndrome
Intervention: Guadecitabine
Intervention description: Guadecitabine
Intervention MeSH terms: Guadecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Guadecitabine

Summary:

      This is a multicenter, open-label extension study for participants who participated in a
      previous Astex-sponsored guadecitabine clinical study [including but not limited to
      SGI-110-01 (NCT01261312), SGI-110-04 (NCT02348489), SGI-110-06 (NCT02920008), and SGI-110-07
      (NCT02907359)].
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previous participation in an Astex-sponsored guadecitabine clinical trial [including
             but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT03603964), SGI-110-05,
             SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)], in which the participant was
             treated with guadecitabine and was still on active treatment with guadecitabine at the
             time of database close for the prior study.

          2. Participant is considered to be benefitting from guadecitabine treatment in the
             opinion of the treating investigator.

          3. Able to understand and comply with the study procedures, understand the risks involved
             in the study, and provide written informed consent before any study-specific
             procedure.

          4. Women of child-bearing potential (according to recommendations of the Clinical Trial
             Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a
             negative pregnancy test at screening. Women of child-bearing potential and men with
             female partners of child-bearing potential must agree to practice 2 highly effective
             contraceptive measures while receiving treatment with guadecitabine and for at least 3
             months after completing treatment and must agree not to become pregnant or father a
             child while receiving study treatment and for at least 3 months after completing
             guadecitabine treatment.

        Exclusion Criteria:

          -  1. Any participant who, in the opinion of the investigator, may have other conditions,
             organ dysfunction, or have safety data from their prior study participation that
             suggest that the risks of continuing treatment with guadecitabine may outweigh the
             benefits.
Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open-Angle; Hypertension, Ocular
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: NCX 470; Latanoprost 0.005%
Intervention description: NCX 470 Ophthalmic Solution; Latanoprost 0.005% Ophthalmic Solution
Intervention MeSH terms: Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 656.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The objective of this clinical study is to evaluate the safety and efficacy of NCX 470
      ophthalmic solution in lowering intraocular pressure (IOP) in patients with ocular
      hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic
      solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic
      solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of open-angle glaucoma or ocular hypertension in both eyes

          -  Qualifying IOP at 3 time points throughout the day at 2 visits following washout of
             IOP-lowering medication, if applicable

          -  Qualifying best-corrected visual acuity (BCVA) using the Early Treatment of Diabetic
             Retinopathy Study (ETDRS) protocol in each eye

          -  Ability to provide informed consent and follow study instructions

        Exclusion Criteria:

          -  Pigmentary or pseudoexfoliative glaucoma

          -  Narrow anterior chamber angles or disqualifying corneal thickness in either eye

          -  Clinically significant ocular disease in either eye

          -  Previous complicated surgery or certain types of glaucoma surgery in either eye

          -  Incisional ocular surgery or severe trauma in either eye within the past 6 months

          -  Uncontrolled systemic disease
Study to Assess Efficacy and Safety of Lanreotide Autogel 120 MG in Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction
Condition: Intestinal Obstruction
MeSH terms: Intestinal Obstruction
Intervention: Lanreotide Autogel
Intervention description: 120mg administered via deep subcutaneous injection at Day 0 and Day 28.
Intervention MeSH terms: Lanreotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the efficacy of Lanreotide Autogel 120 mg for the relief of vomiting due to
      inoperable malignant intestinal obstruction in patients without nasogastric tube (NGT) and to
      assess the efficacy of lanreotide Autogel 120 mg on removal of nasogastric tube without the
      recurrence of vomiting in patients with an inoperable malignant intestinal obstruction with a
      nasogastric tube.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent before any study related procedure

          -  Male and female patients age 18 years or older at time of enrollment

          -  Diagnosis of intestinal obstruction of malignant origin

          -  In case of peritoneal carcinomatosis, confirmation by CT or MRI scan within the 3
             months preceding the inclusion in the study

          -  Confirmed as inoperable after surgical advice

          -  Patient with a nasogastric tube OR presenting with 3 or more episodes of vomiting /
             24h in the last 48 hours

          -  Estimated life expectancy 1 month or more

        Exclusion Criteria:

          -  Operable obstruction or subobstruction

          -  Bowel obstruction due to a non-malignant cause

          -  Signs of bowel perforation

          -  Prior treatment with somatostatin or any other analogue within the previous 60 days

          -  A known hypersensitivity to any of the study treatments or related compounds

          -  Previous participation in this study

          -  Is likely to require treatment during the study with drugs that are not permitted by
             the study protocol

          -  Has abnormal baseline findings, any other medical condition(s) or laboratory findings
             that, in the opinion of the Investigator, might jeopardise the subject's safety