bioihbjkbjnl/mcl2 huggingface dataset:
Diagnostic Imaging for Clear Cell Renal Cell Carcinoma
Condition: Clear Cell Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Ioflupane I123
Intervention description: 185 MBq ioflupane I123 will be administered at one single occasion to the study subjects A one time dose of DaTSCAN is given via intravenous injection of 185 MBq Ioflupane (I123) .
The patient takes potassium iodine tablets prior to the DatSCAN injection to protect the thyroid gland. At the time of the DaTSCAN examination, the patient is injected intravenously at slow rate with 185MBq DaTSCAN solution.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diagnosis; Imaging

Summary:

      The main objective is to study whether imaging detection of the biomarker DAT can be used to
      detect kidney tumors identified by computer tomography (CT), which are pathologically
      assesses as being of the clear cell subtype.
    

Eligibility criteria:

        Inclusion Criteria:

          -  suspected kidney cancer diagnosis

          -  suspected spread of the cancer

          -  patient is scheduled for surgery alternatively biopsy of kidney tumor

          -  patient is 18 years or older

          -  the patient has given their consent to participate in the study

          -  female patients of reproductive age displays negative pregnancy test

        Exclusion Criteria:

          -  known or suspected allergy to Ioflupane or sodium acetate or acetic acid or ethanol

          -  patient suffers from moderate to severe renal impairment and exhibits glomerular
             filtration rate (GFR) <40

          -  patient is medicated for Parkinson's disease

          -  patient is medicated with any of the following medications: amphetamine, benzatropine,
             buproprion, cocaine, mazindol, methylphenidate, phentermine, sertraline, levodopa,
             dexamphetamine, lisdexamphetamine, modafinil, moclobemid, venlafaxine

          -  patient is pregnant

          -  breastfeeding

          -  patient suffers from mental inability unwillingness or language difficulties resulting
             in difficulty in understanding the meaning of taking part in the study
Assessment of LBR-101 In Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: LBR-101 High Dose; LBR-101 Low Dose; Placebo
Intervention description: Subcutaneously Administered LBR-101 Monthly x 3; Subcutaneously Administered LBR-101 Monthly x 3; Subcutaneously Administered Placebo (Vehicle) Monthly x 3
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Headache; Migraine; Chronic Migraine

Summary:

      The purpose of the study is to determine whether monthly subcutaneous administration of
      LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic
      migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 18 to 65 years of age.

          -  A signed and dated informed consent document indicating that the subject has been
             informed of all pertinent aspects of the study including any known and potential risks
             and available alternative treatments.

          -  Chronic migraine meeting the diagnostic criteria listed in the International
             Classification of Headache Disorders (ICHD-III beta version, 2013)

          -  Body Mass Index (BMI) of 17.5 to 37.5 kg/m2, and a total body weight between 50 kg and
             120 kg inclusive.

          -  Demonstrated compliance with the electronic headache diary during the run-in period
             headache data on a minimum of 22/28 days (80% diary compliance)

        Exclusion Criteria:

          -  Onset of chronic migraine after the age of 50 years.

          -  Subject has received onabotulinum toxin A for migraine or for any medical or cosmetic
             reasons requiring injections in the head, face, or neck during the 6 months prior to
             study entry.

          -  Subject is using medications containing opioids (including codeine) or barbiturates
             (including Fiorinal®, Fioricet®, or any other combination containing butalbital) on
             more than 4 days per month for the treatment of migraine or for any other reason.

          -  Failed > 2 medication categories or > 3 preventive medications (within two medication
             categories) due to lack of efficacy for prophylactic treatment of episodic or chronic
             migraine after an adequate therapeutic trial

          -  Treatment with an investigational drug or device within 30 days of study entry or any
             prior exposure to a monoclonal antibody targeting the CGRP pathway.
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-692 as an Adjunctive Treatment in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: CTP-692; Placebo
Intervention description: Administered as powder for oral solution.; Administered as powder for oral solution.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the safety and efficacy of 3 different doses of
      CTP-692 administered once daily (QD) for 12 weeks to adult participants with schizophrenia on
      stable dopaminergic antipsychotic medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physician confirmed diagnostic and statistical manual-version 5 (DSM-V5) diagnosis of
             schizophrenia for the past 2 years

          -  Patients with clinically stable schizophrenia with residual symptoms defined as
             positive and negative syndrome scale (PANSS) total score of 70-110

          -  Patients currently treated with one antipsychotic medication

        Exclusion Criteria:

          -  Patients who, in the opinion of the Investigator, have a history of antipsychotic
             treatment resistance

          -  Patients currently taking clozapine

          -  History of meeting DSM-V5 criteria for moderate to severe alcohol or substance use
             disorder (other than nicotine or caffeine) within the 6 months before the first
             Screening Visit

          -  Patients with positive blood screen for human immunodeficiency virus (HIV) antibody
             and/or hepatitis B virus surface antigen

          -  Patients with history of renal disease or those taking medications to treat renal
             disease
Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer
Condition: Carcinoma, Non-small-cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib and bexarotene
Intervention description: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
Intervention MeSH terms: Erlotinib Hydrochloride; Bexarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tarceva; targretin; non-small cell lung cancer; Carcinoma, non-small cell lung cancer; NSCLC

Summary:

      The purpose of this study is to learn about the effects of two new anticancer drugs,
      erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung
      cancer.

      Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of
      non-small-cell lung cancer (NSCLC). Bexarotene is approved by the FDA for the treatment of
      cutaneous T-cell lymphoma. This combination of drugs is experimental.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced NSCLC

          -  Prior chemotherapy or radiotherapy is allowed.

        Exclusion Criteria:

          -  Hepatic or renal dysfunction
A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; PF-00299804
Intervention description: Continuous oral dosing at 150 mg daily.; Continuous oral dosing at 45mg daily
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Lung cancer; advanced; second or third line

Summary:

      This study will compare PF-00299804 given orally on continuous schedule to the approved drug,
      erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy;
      patients will be randomized to receive one of these drugs, and followed for efficacy and
      tolerance of each.
    

Eligibility criteria:

        Inclusion Criteria:

          -  advanced measurable Non-Small Cell Lung Cancer (NSCLC);

          -  progressed after 1-2 prior chemotherapy;

          -  Eastern Cooperative Oncology Group (ECOG) 0-2;

          -  tissue available for future KRAS/ EGFR testing

        Exclusion Criteria:

          -  prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;

          -  active or untreated Central Nervous System (CNS) metastases;
Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention
Condition: Heart Catheterization
Intervention: dabigatran 110 mg; dabigatran 150 mg; unfractionated heparin
Intervention description: comparison of different dabigatran dosages with unfractionated heparin; comparison of different dabigatran dosages with unfractionated heparin; comparison of different dosages dabigatran with unfractionated heparin
Intervention MeSH terms: Heparin; Calcium heparin; Dabigatran
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To assess whether two doses of dabigatran etexilate (110 mg twice daily (b.i.d) and 150 mg
      twice daily (b.i.d)) as compared to unfractionated heparin (UFH), both in addition to a
      standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of
      elective percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion criteria:

          -  patients between 18 and 85 years

          -  due to undergo elective PCI

          -  informed consent obtained

        Exclusion criteria:

          -  PCI lesion specific conditions

          -  class III or IV congestive heart failure

          -  severe hypertension

          -  increased bleeding risk

          -  thrombolytic therapy within 24 hours preceding randomization
A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes
Intervention: PF-04449913; Low dose ARA-C (LDAC); PF-04449913; Decitabine; PF-04449913; Daunorubicin; Cytarabine; PF-04449913; Daunorubicin; Cytarabine; PF-04449913; Low dose ARA-C (LDAC)
Intervention description: PF-04449913 administered orally and continuously for 28-days.; Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.; PF-04449913 administered orally and continuously for 28 days.; Decitabine given at 20 mg/m2 over 1 hour infusion for 5-days; PF-04449913 administered orally and continuously for 28 days; Daunorubicin given using 60 mg/m2 for 3-days; Cytarabine 100 mg/m2 on days 1 through 7; PF-04449913 administered orally and continuously for 28 days; Daunorubicin given using 60 mg/m2 for 3-days; Cytarabine 100 mg/m2 on days 1 through 7; PF-04449913 administered orally and continuously for 28 days (if randomized to receive PF-04449913); Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
Intervention MeSH terms: Cytarabine; Decitabine; Daunorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 255.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hedgehog Inhibitor; Acute Myeloid Leukemia; Myelodysplastic syndrome; Intensive chemotherapy; LDAC; glasdegib

Summary:

      This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute
      Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents
      used to treat these diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the WHO
             2008 Classification and previously untreated.

          -  Patients with AML (arising from an antecedent hematologic disease [AHD]) or MDS who
             may have had one prior regimen with commercially available agents for the treatment of
             their prior hematologic disease. The patients may not have had a prior therapy for
             their AML.

          -  AML patients include de novo AML, AML evolving from MDS or other AHD and AML after
             previous cytotoxic therapy or radiation (secondary AML)

          -  For a diagnosis of AML, a bone marrow blast count of 20% or more is required.

          -  For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have
             10-19% bone marrow blasts

          -  Adequate Organ Function

          -  ECOG Performance Status 0, 1, or 2

        Exclusion Criteria:

          -  AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic
             translocation.

          -  Patients with known active uncontrolled central nervous system (CNS) leukemia.
A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012)
Condition: Contraception
MeSH terms: Uterine Hemorrhage
Intervention: Nomegestrol acetate (NOMAC); Etonogestrel (ENG); Ethinyl estradiol (EE); Estradiol (E2)
Intervention description: Daily release of 500, 700, or 900 μg.; Daily release of 75, 100, 120 or 125 μg; Daily release of 15 μg; Daily release of 300 μg
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Etonogestrel; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 666.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial was to identify at least one next generation ring (NGR)
      that demonstrates inhibition of ovulation (which was considered confirmed if in the subset of
      participants ovulation was observed in less than 15% of the participants at any time during
      the 3 treatment cycles of the study) and cycle control that was non-inferior to NuvaRing®, as
      judged by the incidence of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3. The
      primary hypothesis was that at least 1 of the 6 NGRs would show inhibition of ovulation and
      cycle control during Treatment Cycle 3 that is non-inferior to NuvaRing®, as judged by the
      incidence of BTB-S.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) ≥18 and ≤35

          -  Regular cycles from 24 to 35 days in length, with an intra-individual variation of ±3
             days permitted within this range

          -  Good physical and mental health

        Exclusion Criteria:

          -  Diabetes mellitus with vascular involvement

          -  Presence of a severe or multiple risk factor(s) for venous or arterial thrombosis

          -  Severe dyslipoproteinemia

          -  Severe hypertension

          -  Presence or history of pancreatitis associated with severe hypertriglyceridaemia

          -  Presence or history of severe hepatic disease

          -  Undiagnosed vaginal bleeding

          -  Known or suspected pregnancy

          -  Participation in another investigational drug study within 30 days prior to screening
             visit

          -  History of malignancy ≤5 years, except for adequately treated basal cell or squamous
             cell skin cancer, or in situ cervical cancer

          -  Documented abnormal cervical smear result in 6 months prior to screening visit

          -  Sterilization using a fallopian tube occlusion device (e.g., Essure method)

          -  Sex hormone therapy within 2 months prior to screening visit for purpose other than
             contraception, or injectable hormonal contraception within 6 months prior to screening
Percutaneous Image Guided Video-Assisted Thoracic Surgery (VATS) Resection of Lung Lesions
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Video-Assisted Thoracic Surgery (VATS) wedge resection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: lung nodule; lung cancer; lung mass

Summary:

      This is a phase II protocol to determine the safety and feasibility of Intraoperative CT
      fluoroscopy guidance for lung resection for small nodules.
    

Eligibility criteria:

        Inclusion Criteria:

          -  peripheral lung nodules < 3cm in size

          -  Surgical candidate

        Exclusion Criteria:

          -  Non surgical candidate
Concurrent Carboplatin and Reduced Dose Craniospinal Radiation for Medulloblastoma and Primitive Neuroectodermal Tumor (PNET)
Condition: Metastatic Medulloblastoma; High Risk Supratentorial PNET; Metastatic PNET
MeSH terms: Medulloblastoma; Neuroectodermal Tumors, Primitive
Intervention: Carboplatin; Vincristine; 24 Gy
Intervention description: Administered concurrently with craniospinal radiation.; Administered concurrently with craniospinal radiation.; Craniospinal radiation.
Intervention MeSH terms: Carboplatin; Vincristine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 3 Years
Maximum age: 25 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to study the efficacy of the combination of reduced dose
      craniospinal radiation (reduced from standard of care dosing at 36 Gy to 24 Gy) with
      concurrent carboplatin and vincristine administration for metastatic classical histology
      medulloblastomas and high-risk supratentorial PNETs and metastatic PNETs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 3 years and less than 25 years

          -  Patients with classic histology or desmoplastic histology metastatic medulloblastoma
             by histological diagnosis and by head and spine MRI.

          -  Patients with high-risk supratentorial, non-metastatic, PNET

          -  Patients with metastatic PNET

          -  Newly diagnosed patients who have not received prior therapy, with the exception of
             one short course of emergent chemotherapy in newly presenting patients with
             neurological compromise per provider decision

          -  Only patients who are expected to survive at least 6 weeks will be eligible for this
             study.

        Exclusion Criteria:

          -  Patients who are pregnant may not be treated on this study

          -  Patients with anaplastic histology
Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Neratinib; Trastuzumab; Paclitaxel
Intervention description: Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.; Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.; Paclitaxel - 80 mg/m² IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Intervention MeSH terms: Paclitaxel; Trastuzumab; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 479.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ErbB-2 positive advanced breast cancer; HKI-272; Neratinib; Nerlynx; HER2; PB-272; metastatic breast cancer

Summary:

      This study is investigating the effects of an experimental drug (neratinib) in combination
      with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women
      who have not received previous treatment for erbB-2-positive locally recurrent or metastatic
      breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors
      and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will
      also compare the safety of the two regimens and as well as the quality of life of subjects
      receiving either regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ErbB-2 positive locally recurrent or metastatic breast cancer

          -  Eastern Cooperative Oncology Group (ECOG) 0-2

          -  Measurable disease

          -  Availability of tumor tissue for HER2 status confirmation

        Exclusion Criteria:

          -  Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent
             or metastatic disease

          -  Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or
             adjuvant setting

          -  Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant
             therapy

          -  History of heart disease

          -  History of gastrointestinal disease