bioihbjkbjnl/mcl2 huggingface dataset:
Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease
Condition: Thyroid Associated Ophthalmopathies; Thyroid-Associated Ophthalmopathy
MeSH terms: Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases
Intervention: teprotumumab; normal saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Thyroid Eye Disease, Graves Orbitopathy, Thyroid Associated; Ophthalmopathy

Summary:

      The primary objective of this study is to investigate the efficacy, safety, and tolerability
      of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months,
      in comparison to placebo, in the treatment of participants suffering from active TED.

      "Funding Source - FDA OOPD"
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Graves' disease associated with active TED and a clinical
             activity score of ≥ 4

          -  Fewer than 9 months from onset of TED

          -  No previous medical or surgical treatment, excluding local supportive measures and
             oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone
             or equivalent with at least 6 weeks between last administration of oral steroids and
             randomization

          -  Euthyroid or with mild hypo or hyperthyroidism defined as free thyroxine (FT4) and
             free triiodothyronine (FT3) levels less than 50% above or below the normal limits
             (every effort should be made to correct the mild hypo- or hyperthyroidism promptly)

        Exclusion Criteria:

          -  Optic neuropathy

          -  Corneal decompensation unresponsive to medical management

          -  Oral or IV steroid treatment for any non-TED reason in the preceding 3 months

          -  Poorly controlled diabetes

          -  Platelets < 100 x 10^9/L

          -  Hemoglobin concentration > 2 g/dL below the lower limit of normal
ZD4054 (Zibotentan) or Placebo Plus Chemotherapy in Patients With Advanced Ovarian Cancer
Condition: Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Hypersensitivity
Intervention: ZD4054 Zibotentan; Paclitaxel; Carboplatin; Placebo
Intervention description: 10 mg oral tablets once daily; 175mg/m2 IV on day 1 every 3 weeks; Carboplatin AUC of 5.0 IV on day 1 every 3 weeks; matching placebo for ZD4054 10 mg
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian; cancer; chemotherapy; sensitive; ZD4054

Summary:

      The purpose of this study is to compare progression-free survival in patients with advanced
      ovarian cancer treated with ZD4054 in combination with carboplatin+paclitaxel versus placebo
      in combination with carboplatin+paclitaxel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven diagnosis of: - Epithelial ovarian carcinoma - Fallopian tube
             carcinoma - Primary serous peritoneal carcinoma

          -  Radiologically documented measurable disease according to RECIST criteria assessed by
             Computerised Tomography (CT) or Magnetic Resonance Imaging MRI) or radiologically
             documented non-measurable (but evaluable) disease.

          -  Advanced disease not amenable to curative surgery or radiotherapy at the time of study
             entry with evidence of disease recurrence or progression at least 6 months following
             treatment cessation of first-line platinum- containing therapy

        Exclusion Criteria:

          -  Clinical evidence of central nervous system (CNS) metastases

          -  Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and
             mucinous carcinoma of the peritoneum

          -  Tumour of borderline malignancy
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: RG1507; erlotinib [Tarceva]
Intervention description: iv 9mg/kg weekly; 150mg oral daily
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive
      disease after deriving clinical benefit (defined as response or stable disease after 12
      weeks) from second or third line Tarceva monotherapy will determine the proportion of
      patients with progression-free survival at 12 weeks following combination therapy with R1507
      and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva
      (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints
      including overall survival, objective response rate, time to response, time to progressive
      disease and duration of response will also be evaluated. The anticipated time on study
      treatment is 1-2 years, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female patients >=18 years with histologically documented inoperable, locally
             advanced or metastatic (stage IIIB or IV) NSCLC;

          -  currently receiving Tarceva monotherapy and having failed at least one standard
             chemotherapy regimens;

          -  prior response or stable disease 12 weeks from start of Tarceva;

          -  documented progressive disease at enrollment;

          -  measurable disease according to the RECIST criteria;

          -  ECOG performance status 0-2;

          -  life expectancy >12 weeks.

        Exclusion Criteria:

          -  patients with active CNS lesions;

          -  prior treatment with agents acting via IGF-1R inhibition or EGFR targeting;

          -  administration with high doses of systemic corticosteroids;

          -  radiotherapy in the 4 weeks prior to study start;

          -  surgery or significant traumatic injury with in the last 2 weeks prior to study start.
Evaluate Esophageal Reinforcement With ACell MatriStem Surgical Matrix: A Degradable Biologic Scaffold Material
Condition: Esophageal Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: MatriStem PSM
Intervention description: All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Esophageal Reinforcement; ACell MatriStem; 13-178

Summary:

      The purpose of this study is to see if implanting MatriStem will lower the risk of one of the
      more common complications after stomach or esophagus surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient 18 years of age or older

          -  Pathologically confirmed Gastric, Gastroesophageal Junction (GEJ) or Esophageal,
             adenocarcinoma at either MSKCC or a participating site (biopsy may be performed at
             other institutions but slides must be confirmed at MSKCC or a participating site, as
             is routine care at our institution)

          -  Patient undergoing any resection requiring an anastomosis to the esophagus for
             curative intent. Including but not limited to esophagectomy or total gastrectomy.

          -  Subject is willing to provide written informed consent

          -  Subject is willing and able to comply with the follow-up regimen

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Intraoperative evidence of metastatic or locally-unresectable disease

          -  Patients with known sensitivity or allergy to porcine materials.

          -  Patients undergoing any resection requiring an anastomosis to the esophagus for
             palliative intent.
Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Cisplatin; Radiation Therapy; Mastectomy
Intervention description: (RECOMMENDED BUT NOT REQUIRED)
Intervention MeSH terms: Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Locally Advanced; Neoadjuvant

Summary:

      The purpose of this study is to determine whether Cisplatin when given with radiation therapy
      prior to surgery is effective in improving response to treatment in breast cancer patients.
      Tumor, blood and bone marrow samples will be collected in this study and will also help
      researchers determine if cisplatin is able to change tumor DNA so it cannot multiply itself
      and create more tumor cells, and cause the tumor cells to die.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be >= 18 years of age

          -  Patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.

          -  Tumor classified as clinically stage T2, T3 or T4 with any N (NX, N1, N2, or N3).

          -  Tumor does not express the following biomarkers: estrogen receptor, progesterone
             receptor, Her2/neu

          -  Adequate organ function defined as:

               -  Serum Creatinine <= 1.5 x upper limit of institutional normal.

               -  ALT, AST, ALK Phos <= 1.5 x upper limit of institutional normal.

               -  Bilirubin <= 1.5 x upper limit of institutional normal.

               -  Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.

        Exclusion Criteria:

          -  No evidence of distant metastasis present by CT, Bone scan, or physical exam. If the
             bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions
             should be further clarified by additional testing such as PET or MRI.

          -  No prior malignancies with the exception of curatively treated basal or squamous
             carcinoma of the skin or history of previous malignancies, treated with at least
             greater than 5 years disease free survival.

          -  Women of child bearing potential may not be currently pregnant or breastfeeding at
             time of registration and must agree to use adequate contraception.

          -  Karnofsky Performance Status of <= 70.

          -  Patients with known history neural deficiencies (e.g. peripheral neuropathy).

          -  Patients with a known hearing impairment (hearing loss or severe tinnitus).

          -  Male patients
A Study To Monitor Long-Term Treatment With PF-00547659
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: PF-00547659
Intervention description: 75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Active Crohn's disease; Anti-TNF Refractory; Immunosuppressant Refractory

Summary:

      This study provides open-label drug to eligible patients who have completed a prior study of
      PF-00547659. The primary endpoint for this study is long-term safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between 18 and 76 years of age.

          -  Subjects previously enrolled in study A7281006 who have completed the blinded 84 day
             (12 week) induction period or in study A7281008 who have completed Week 12 and have
             demonstrated a clinical response as defined by that protocol.

        Exclusion Criteria:

          -  Subjects that have completed Day 84 (Week 12) of a PF-00547659 study but have
             experienced serious event(s) related to the investigational product, an unstable
             medical condition, or any other reason, in the opinion of the investigator, would
             hinder entry or participation in this study.

          -  Subjects who are taking any dose of azathioprine, 6-mercaptopurine or methotrexate.
Efficacy Study of a Facemask Device to Treat Hypotension
Condition: Hypotension
MeSH terms: Hypotension
Intervention: Impedance Threshold Device; sham ITD
Intervention description: Active impedance threshold device; sham impedance threshold device
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: hypotension; hypovolemia; dehydration; sepsis; blood loss

Summary:

      The purpose of this study is to determine if the impedance threshold device (ITD) attached to
      a facemask can increase blood pressure in patients who present to the emergency department
      with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss,
      sepsis, or dehydration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Conscious patient

          -  Systolic blood pressure < 95 mmHg

          -  Hypotension caused by blood loss, sepsis, or dehydration

        Exclusion Criteria:

          -  Hypotension secondary to heart failure

          -  Complaints of chest pain

          -  History of heart failure

          -  Complaints of shortness of breath
Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Intervention: Rotigotine
Intervention description: Optimal dose after titration period
0.5 mg/24 h (2.5 cm^2)- 1 mg/24 h (5 cm^2)- 2 mg/24 h (10 cm^2)- 3 mg/24 h (15 cm^2)
1 patch /day
Intervention MeSH terms: Rotigotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: Rotigotine; Restless Legs Syndrome; RLS; Long-term; Adolescents

Summary:

      This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up
      study of monotherapy administration of rotigotine transdermal patch in adolescents with
      Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability of
      Rotigotine treatment in adolescents with RLS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Tolerated the first dose level of Rotigotine in a previous study in adolescents with
             Restless Legs Syndrome (RLS), without meeting withdrawal criteria

          -  Is expected to benefit from participation, in the opinion of the investigator

          -  Subject/legal representative is considered reliable and capable of adhering to the
             protocol, visit schedule, and study patch application/removal, according to the
             judgment of the investigator

        Exclusion Criteria:

          -  Previously participated in this study

          -  Is experiencing an ongoing serious adverse event (SAE) that is assessed to be related
             to Rotigotine by the investigator or sponsor

          -  Pregnant or nursing or is a female of childbearing potential who is not surgically
             sterile or does not consistently use 2 combined medically acceptable methods of birth
             control (including at least 1 barrier method), unless not sexually active

          -  Any medical or psychiatric condition that, in the opinion of the investigator, can
             jeopardize or would compromise the subject's ability to participate

          -  Active suicidal ideation as indicated by a positive response ("Yes") to either
             Question 4 or Question 5 of the "Since the Last Visit" version of the Columbia Suicide
             Severity Rating Scale (C-SSRS) of the final evaluation visit of the previous
             Rotigotine study
Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
Condition: HAART-induced Lipodystrophy and Metabolic Syndrome
MeSH terms: Lipodystrophy; Metabolic Syndrome; Syndrome
Intervention: r-metHuLeptin; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: leptin; lipodystrophy; insulin resistance; hyperlipidemia; metabolic syndrome

Summary:

      The purpose of this study is to examine whether replacing leptin to normal levels can reverse
      the changes in fat distribution, lipid profile, and other metabolic problems associated with
      highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in
      HIV patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years old

          -  Documented HIV infection

          -  Exposed to at least 6 months of cumulative highly active antiretroviral medications
             for HIV

          -  Developed fat depletion after starting HIV medications

          -  Low leptin level in the blood

          -  Fasting triglyceride level > 300 mg/dl

        Exclusion Criteria:

          -  Active infectious diseases, except HIV

          -  Diabetes prior to starting HIV medications

          -  Alcohol or drug abuse

          -  Triglyceride level > 1000 mg/dl

          -  Significant kidney, liver, or thyroid dysfunction

          -  Cancer or lymphoma

          -  Pregnancy or planning to become pregnant during the study
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: Phenobarbital; Clonidine
Intervention description: Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge.; Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.
Intervention MeSH terms: Clonidine; Phenobarbital
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 35 Weeks
Healthy volunteers: No

Summary:

      The purpose of this study is to compare clonidine versus phenobarbital as adjunctive therapy
      in those infants who have failed monotherapy with morphine sulfate for neonatal abstinence
      syndrome (NAS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants greater than or equal to 35 weeks gestation age

          -  Admitted to the neonatal intensive care unit

          -  Failed monotherapy with morphine sulfate therapy

        Exclusion Criteria:

          -  Neonatal abstinence syndrome due to iatrogenic causes

          -  Unable to take oral medications at any point during their treatment

          -  Infants in the custody of the Department of Child Protective Services with no legal
             guardian identified at the time of enrollment
A Study of Tarceva (Erlotinib) in Sequential Combination With Gemcitabine as First Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib [Tarceva]; gemcitabine; gemcitabine
Intervention description: 150mg po on days 15-28 of each 4 week cycle; 1250mg/m2/day on days 1 and 8 of each 4 week cycle; 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle
Intervention MeSH terms: Gemcitabine; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva
      and gemcitabine, and of gemcitabine monotherapy, as first line treatment of elderly patients,
      or patients with ECOG performance status of 2, with advanced non-small cell lung
      cancer.Patients will be randomized to receive either sequential gemcitabine 1250mg/m2/day on
      days 1 and 8 + Tarceva 150mg po on days 15-28 of each 4 week cycle, or gemcitabine
      monotherapy 1000mg/m2/day on days 1, 8 and 15 of each 4 week cycle. The anticipated time on
      study treatment is 3-12 months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=70 years of age or with ECOG PS of 2;

          -  advanced (stage IIIB or IV)non-small cell lung cancer;

          -  no prior systemic chemotherapy for advanced NSCLC or prior treatment with HER-axis
             targeted drugs.

        Exclusion Criteria:

          -  active brain metastasis or spinal cord suppression;

          -  unstable systemic disease.