bioihbjkbjnl/mcl2 huggingface dataset:
Neoadjuvant Chemotherapy for Patients With Squamous Cell Carcinoma of the Penis
Condition: Penile Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Penile Neoplasms
Intervention: Ifosfamide; Paclitaxel (Taxol); Cisplatin
Intervention description: 1200 mg/m^2 By Vein Over 2 Hours on Days 1-3; 175 mg/m^2 By Vein Over 3 Hours on Day 1; 25 mg/m^2 By Vein Over 2 Hours on Days 1-3
Intervention MeSH terms: Paclitaxel; Cisplatin; Ifosfamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 14 Years
Healthy volunteers: No
Keywords: Genitourinary; Penile Cancer; Neoadjuvant Chemotherapy; Extirpative Surgery; TanyN2-3M0 Squamous Cell Carcinoma of the Penis; Cisplatin; Platinol-AQ; Platinol; CDDP; Ifosfamide; Ifex; Paclitaxel; Taxol

Summary:

      Primary Objective:

      -To evaluate the feasibility and efficacy of multimodality treatment (neoadjuvant
      chemotherapy prior to extirpative surgery) for clinical stage TXN2-3M0 squamous cell
      carcinoma of the penis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent must be obtained from each patient prior to study entry.

          2. Age >/= 14 years of age. Life expectancy greater than or equal to 6 months. PS </= 2
             (ECOG).

          3. Patients with histologically confirmed squamous cell carcinoma of the penis who
             present with clinical stage (T(subscript)xN(subscript)2-3M(subscript)0) disease based
             on the 1987-1992 TNM Staging System and meeting the additional clinicopathologic
             criteria as defined in the protocol (section 3.1).

          4. Patients must have adequate physiologic reserve as evidenced by: absolute neutrophil
             count (ANC) >/= 1,500/mm3(superscript) and platelet count >/= 100,000/mm3.
             Transaminases </= 2 times the upper limit of normal. Conjugated bilirubin </=
             1.5mg/dL. Creatinine clearance (either calculated or measured) of >/= 40ml/minute.

          5. No evidence of active ischemia on the EKG and, for patients with significant prior
             coronary artery disease history, an ejection fraction of more than 40%. No evidence of
             severe conduction abnormalities on EKG.

        Exclusion Criteria:

          1. Patients with uncontrolled infection or CNS disease.

          2. Distant metastasis (TNM stage M1, i.e., lung, bone, other visceral sites, lymph node
             metastasis above the aortic bifurcation).

          3. Patients with clinically negative inguinal examinations or those with palpable
             adenopathy not meeting pathological or clinical criteria (i.e., minimal nodal
             metastasis or false positive inguinal examination).

          4. Prior systemic chemotherapy for penile carcinoma.

          5. Prior radiation therapy to inguinal or pelvic lymph nodes.
Combination Chemotherapy and Alemtuzumab in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia
Condition: Recurrent Adult Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: alemtuzumab; asparaginase; methotrexate; dexamethasone; leucovorin calcium; mercaptopurine; vincristine
Intervention description: Given subcutaneously; Given IM; Given IV or orally; Given orally; Given IV; Given orally; Given IV
Intervention MeSH terms: Leucovorin; Dexamethasone; Methotrexate; Vincristine; Asparaginase; Mercaptopurine; Alemtuzumab; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MOAD; Methotrexate; Vincristine; L-asparaginase; Dexamethasone; Subcutaneous Campath

Summary:

      This phase II trial is studying how well giving combination chemotherapy together with
      alemtuzumab works in treating patients with relapsed or refractory acute lymphoblastic
      leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Giving more than one
      drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as
      alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer
      cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing
      substances to them. Giving combination chemotherapy together with alemtuzumab may kill more
      cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Refractory or relapsed acute lymphoblastic leukemia

               -  Must be in first relapse or have failed to achieve complete remission with 1
                  prior regimen

          -  Prior central nervous system (CNS) leukemia allowed provided cerebrospinal fluid is
             normal

          -  ECOG Performance status of 0-3

          -  Bilirubin normal

          -  Creatinine normal

          -  Human immunodeficiency virus (HIV) negative

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        Exclusion criteria:

          -  Hepatitis B positivity

          -  Bacterial or fungal infection

          -  Infection requiring treatment with antibiotics

          -  Active cytomegalovirus infection by molecular detection methods

          -  Known hypersensitivity to alemtuzumab or its components

          -  Pregnant or nursing

          -  Other malignancy within the past 5 years except adequately treated basal cell skin
             cancer or cervical carcinoma
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
Condition: Epilepsy; Dravet Syndrome; Lennox-Gastaut Syndrome
MeSH terms: Epilepsy; Brain Diseases; Epilepsies, Myoclonic; Lennox Gastaut Syndrome; Syndrome
Intervention: TAK-935; Placebo
Intervention description: TAK-935 tablets or mini-tablets.; TAK-935 placebo-matching tablets or mini-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: 141.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Drug Therapy; Brain Diseases; Central Nervous System Diseases; Tuberous Sclerosis; CDKL5 deficiency disorder; Dup15Q syndrome; Anoxic brain injury; Infantile spams; West syndrome; Cortical dysplasia; SCN1A; OV-935; Cholesterol 24S-hydroxylase inhibitor; Seizure; Anti-epileptic drug; Anticonvulsants; Nervous System Diseases; Drop seizure; Atonic seizure

Summary:

      The purpose of this study is to investigate the effect on the frequency of all seizures
      (convulsive and drop) in participants treated with TAK-935 compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female participants aged greater than or equal to (>=) 2 and less than or
             equal to (<=) 17 years

          2. Clinical diagnosis of DS or LGS

          3. Weight of >=10 kilogram (kg) at the Screening visit

          4. Currently taking 1 to 4 anti-epileptic drugs (AEDs) at a stable dose

          5. Failed to become and remain seizure free with trials of at least 2 AEDs

        Exclusion Criteria:

          1. Has been admitted to a medical facility and intubated for treatment of status
             epilepticus 2 or more times in the 3 months immediately prior to the screening visit

          2. Non-epileptic events that cannot be reliably distinguished from epileptic seizures

          3. Participation in a clinical study involving another study drug in the previous month
V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)
Condition: HPV Infections
MeSH terms: Papillomavirus Infections
Intervention: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501); Comparator: Placebo (unspecified)
Intervention description: V501; Gardasil, 0.5 ml injection in 3 dosing regimen; Placebo 0.5 ml injection in 3 dosing regimen
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: Female
Minimum age: 9 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent
      females
    

Eligibility criteria:

        Inclusion Criteria:

          -  Virginal Female Subject Aged 9 To 17 Years

        Exclusion Criteria:

          -  Male Subject
BEZ235 Phase II Trial in Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.
Condition: Pancreatic Neuroendocrine Tumors (pNET)
MeSH terms: Neuroendocrine Tumors; Adenoma, Islet Cell
Intervention: BEZ235 (Stage 1)
Intervention description: The investigational study drug used in this trial was BEZ235, which was supplied as 50mg, 200mg, 300mg, and 400mg solid dispersion sachets. Supply as 200mg and 50mg were provided for dose reduction. Patients were instructed to take the contents of one sachet of BEZ235 twice a day in the morning within 30 minutes after a light meal (breakfast).
Intervention MeSH terms: Dactolisib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: advanced pancreatic neuroendocrine tumor; BEZ235; pNET

Summary:

      This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC)
      versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET)
      after failure of mTOR inhibitor therapy.

      Study design: This was a Phase II, two-stage, multicenter study, where Stage 1 was a single
      arm, open label design and Stage 2 was planned to be a randomized, double-blind study.

      However, at the end of Stage 1, the futility was met and hence the Stage 2 was not initiated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unresectable or metastatic, histologically confirmed low or intermediate grade
             pancreatic neuroendocrine tumor with radiological evidence of disease progression
             since last treatment

          -  Refractory disease to treatment with mTOR inhibitor

          -  Measurable disease per RECIST Version 1.1 using Computed Tomography (CT) or Magnetic
             Resonance Imaging (MRI)

          -  Prior or concurrent therapy with SSA is permitted; a stable dose at least 2 months
             prior to study start and must continue on the stable dose while receiving study
             treatment; SSA is not considered as a systemic treatment.

          -  WHO PS ≤ 1

          -  Adequate bone marrow function or organ function

        Exclusion Criteria:

          -  Previous treatment with any PI3K or AKT inhibitor

          -  Discontinuation prior mTOR inhibitor therapy due to toxicity

          -  Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
             adenocarcinoid, goblet cell carcinoid and small cell carcinoma

          -  Radiotherapy, or major surgery within 4 weeks prior to study treatment start

          -  Hepatic artery embolization or cryoablation/ radiofrequency ablation of hepatic
             metastasis within 2 months of study treatment start.

          -  More than 3 prior systemic treatment regimens (including cytotoxic chemotherapy,
             targeted therapy, immunotherapy)
Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer
Condition: Esophagitis
MeSH terms: Esophagitis
Intervention: GC4419 (avasopasem manganese)
Intervention description: 90 mg, by 60-minute IV infusion, prior to each fraction of RT
Intervention MeSH terms: Manganese; Avasopasem manganese
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 (avasopasem
      manganese) administered intravenous (IV) for the reduction of radiation induced esophagitis
      in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage
      2B Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) treatable with
      chemoradiotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects scheduled to be treated with (definitive or adjuvant) radiation therapy in
             combination with chemotherapy once daily for Stage 3A/3B or post-operative Stage 2B
             NSCLC or limited stage SCLC

          2. Treatment plan for subjects show that 5 cm of the esophagus for at least one surface,
             is included in the 60 Gy isodose volume. Dose volume histograms show esophagus dose
             exposure meet V38>30% and/or V60>20%

          3. Age 18 years or older

          4. ECOG performance status ≤ 2

          5. Adequate hematologic, renal and liver function

          6. Use of highly effective contraception

        Exclusion Criteria:

          1. Metastatic disease

          2. Prior radiation therapy to the region of the study cancer

          3. Subjects not receiving chemotherapy

          4. Grade 2 or greater esophagitis at baseline

          5. Inability to provide information in the electronic symptom-reporting device

          6. Receiving any approved or investigational immunotherapy, targeted therapy, hormone
             therapy, or biologic therapy

          7. Participation in another clinical trial or use of another investigational agent within
             30 days of first does of GC4419

          8. Malignant tumors other than the current lung cancer within the last 5 years

          9. Previous diagnosis of pneumonitis

         10. Untreated, active infectious disease requiring systemic anti-infective therapy

         11. Untreated HIV or active hepatitis B/C

         12. Females who are pregnant or breastfeeding

         13. Known allergies or intolerance to chemotherapy and similar platinum-containing
             compounds

         14. Requirement for concurrent treatment with nitrates or other drugs that may create a
             risk for a precipitous decrease in blood pressure

         15. Clinically significant heart disease
To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
Condition: Keratoconjunctivitis Sicca
MeSH terms: Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes
Intervention: R348 Ophthalmic Solution, 0.2%; R348 Ophthalmic Solution, 0.5%; Placebo
Intervention description: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.; R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.; Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are
      safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A history of dry eye (based on the date of initial dry eye symptoms)

          -  Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms

          -  Corneal fluorescein staining score of at least 2 in the inferior region

        Exclusion Criteria:

          -  History of, or a concurrent clinically significant illness, medical condition (other
             than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality
             that, in the Investigator's opinion, could affect the conduct of the study.

          -  Use of ophthalmic cyclosporine within 45 days of Visit 1.

          -  Use of any topical ophthalmic steroid within 2 weeks of Visit 1.

          -  Have worn contact lenses or anticipate using contact lenses during the study.

          -  Have a condition or be in a situation that the Investigator feels may put the subject
             at significant risk, may confound the study results, or may interfere significantly
             with the subject's participation in the study.

          -  Have a history of alcohol or substance abuse that, in the judgment of the
             Investigator, may impair or risk the subject's full participation in the study.
Domperidone in Refractory Gastroparesis
Condition: Gastroparesis
MeSH terms: Gastroparesis
Intervention: Domperidone
Intervention description: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily
Intervention MeSH terms: Domperidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to prescribe oral domperidone for patients with
      gastroparesis who have failed or suffered adverse effects from standard medical therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Age 18 and older

          -  Symptoms or manifestations secondary to motility disorders of the upper GI tract.
             These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease
             that are refractory to standard therapy.

          -  Patients must have a comprehensive evaluation to eliminate other causes of their
             symptoms. This includes a history and physical examination. A recent (within 3 years)
             evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic
             series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin
             level.

          -  Patient has signed informed consent for the administration of domperidone that informs
             the patient of potential adverse events including:

               -  Increased prolactin levels

               -  Breast changes

               -  Extrapyramidal side effects

               -  Cardiac arrhythmias including QT prolongation (increased risk with the drugs
                  listed in the appendix)

        Exclusion Criteria:

          -  History of, or current, arrhythmias including ventricular tachycardia, ventricular
             fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are
             not necessarily excluded.

          -  Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged
             QTc (QTc>450 milliseconds for males, QTc>470 milliseconds for females)

          -  Clinically significant electrolyte disorders. These include significant hypokalemia,
             hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with
             treatment of these electrolyte abnormalities.

          -  Gastrointestinal hemorrhage or obstruction.

          -  Presence of a prolactinoma (prolactin-releasing pituitary tumor).

          -  Pregnant or breast feedings female.

          -  Known allergy to domperidone
Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Bosutinib; exemestane; Exemestane
Intervention description: 300 mg =(3x100mg) tablets once daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs; 25 mg tablet once daily; 25 mg - 1 tablet per day- once daily daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs
Intervention MeSH terms: Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bosutinib; Exemestane; postmenopausal; breast cancer

Summary:

      This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in
      combination with exemestane versus exemestane alone. This is a 2-part study consisting of a
      safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive
      bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety
      concerns arise, then future eligible subjects will be randomly assigned to the main phase of
      the study. They will either receive bosutinib daily combined with daily exemestane, or daily
      exemestane alone for a specified period of time. Subjects will be followed up for survival
      after treatment discontinuation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Woman aged 18 years or older.

          -  Confirmed pathologic diagnosis of breast cancer.

          -  Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to
             curative treatment with surgery or radiotherapy.

          -  Surgically sterile or postmenopausal woman.

          -  Documented ER+ and/or PgR+ and erbB2- tumor.

          -  Progression of locally advanced or metastatic disease during treatment with a
             nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6 months
             of discontinuation of) an adjuvant nonsteroidal AI.

        Exclusion Criteria:

          -  Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.

          -  More than 1 prior endocrine treatment for locally advanced or MBC.

          -  More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.

          -  Bone or skin as the only site of disease.