bioihbjkbjnl/mcl2 huggingface dataset:
A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer
Condition: Small Cell Lung Carcinoma
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: figitumumab; Cisplatin (Or Carboplatin); Etoposide; Cisplatin (Or Carboplatin); Etoposide
Intervention description: Figitumumab (20 mg/kg); Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5; Etoposide (100 mg/m2 IV on Days 1, 2 and 3); Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5; Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
Intervention MeSH terms: Cisplatin; Carboplatin; Etoposide; Etoposide phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Small Cell Lung Cancer; Extensive stage disease; SCLC; IGF-1R inhibitor

Summary:

      This study will summarize the safety of patients receiving figitumumab combined with
      etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or
      carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung
      Cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of extensive stage disease Small Cell Lung Cancer
             (SCLC), with tumor biopsy sample required.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Total IGF-1 > or
             = 120 ng/ml

        Exclusion Criteria:

          -  Any prior systemic therapy for Small Cell Lung Cancer (SCLC)

          -  HbA1c > or = 5.7%
Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency
Condition: Central Adrenal Insufficiency; Mifepristone
MeSH terms: Adrenal Insufficiency
Intervention: Mifepristone
Intervention description: Mifepristone is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor.
Intervention MeSH terms: Mifepristone
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Insulin Tolerance Test

Summary:

      The researchers propose the use of mifepristone as an alternative way to test for Central
      Adrenal Insufficiency (CAI). They want to assess the feasibility of recruitment and the
      efficacy of the purposed method.
    

Eligibility criteria:

        Inclusion Criteria (1 of the following):

          -  Completed insulin tolerance testing (ITT) at University of Michigan from 2012 to
             present.

          -  Are scheduled to complete ITT.

          -  Are clinically suspected to have adrenal insufficiency but have not undergone ITT.

        Exclusion Criteria:

          -  Female patients who are of child-bearing potential (defined as a sexually mature woman
             who has not undergone hysterectomy, bilateral oophorectomy bilateral salpingectomy or
             bilateral tubal ligation/occlusion, at least 12 weeks prior to screening, or who has
             not been naturally postmenopausal for at least 24 consecutive months prior to study
             enrollment) and not using non-hormonal contraception.

          -  Female patients not willing to use non-hormonal contraception for one month following
             treatment.

          -  Women who are pregnant or breast feeding.

          -  Patients with an existing diagnosis of adrenal insufficiency who are on any
             glucocorticoid replacement other than oral hydrocortisone or prednisone.

          -  Patients on medications that are strong CYP3A

          -  Patients taking other medications metabolized by CYP3A

          -  Patients who have a history of QT prolongation and patients with any recent abnormal
             electrocardiogram (ECG).
Clinical Trial in 22q13 Deletion Syndrome(Phelan-McDermid Syndrome)
Condition: 22q13 Deletion Syndrome; Phelan-McDermid Syndrome
MeSH terms: Chromosome Disorders; Syndrome; Chromosome Deletion
Intervention: Insulin-Like Growth Factor-1 (IGF-1); Normal saline
Intervention description: IGF-1 and placebo will each be administered for 3 months with a four-week washout period in between. IGF-1 will be administered for 3 months subcutaneously.; Saline solution will be administered for three months subcutaneously.
Intervention MeSH terms: Mitogens; Mecasermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: SHANK3; IGF-1; Autism

Summary:

      The purpose of this study is to pilot the use of Insulin-Like Growth Factor-1 (IGF-1)
      treatment in 22q13 Deletion Syndrome (Phelan-McDermid Syndrome) caused by SHANK3 gene
      deficiency in order to evaluate safety, tolerability, and efficacy. IGF-1 is an injection
      under the skin that contains human IGF-1. IGF-1 is approved by the FDA under the brand name
      Increlex for the treatment of children with short stature due to primary IGF-1 deficiency. It
      is being used off-label in the current study and is not FDA approved, nor has it yet been
      studied in humans for the treatment of SHANK3 deficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  5 to 12 years old

          -  pathogenic deletions or mutations of the SHANK3 gene

          -  stable medication regimens for at least three months prior to enrollment

        Exclusion Criteria:

          -  closed epiphyses

          -  active or suspected neoplasia

          -  intracranial hypertension

          -  hepatic insufficiency

          -  renal insufficiency

          -  cardiomegaly / valvulopathy

          -  history of allergy to IGF-1 or any component of the formulation (mecasermin)

          -  history of extreme prematurity (<1000 grams) with associated early neo-natal
             complications, e.g. intra-cerebral hemorrhage, prolonged hypoxia, prolonged
             hypoglycemia

          -  patients with comorbid conditions deemed too medically compromised to tolerate the
             risk of experimental treatment with IGF-1
Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease Progression
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Disease Progression
Intervention: 18F-DTBZ AV-133
Intervention description: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: 18F-DTBZ AV-133 imaging

Summary:

      A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of
      age may be eligible for this study. Candidates are screened with a medical history and
      physical examination, and blood test.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female age 20 years to 80 years.

          2. Patients should be fulfilled Criteria of diagnosis of Parkinson disease of "possible"
             or "probable" PD1.

          3. Patients who provide a written informed consent prior to study entry. If the patient
             is incapable of informed consent, the caregiver may consent on behalf of the patient
             (the patient must still confirm assent)

        Exclusion criteria:

          1. Significant recent (within 6 months) history of neurological (including stroke and
             brain trauma) or psychiatric disorder.

          2. Alcohol or substance abuse.

          3. History or presence of QTc prolongation. (>500msec)

          4. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep
             brain stimulation.

          5. Unable to stay still in the MRI or PET scanner for 30 minutes.

          6. Pregnancy and breast feeding.

          7. Hepatic dysfunction with liver function test (alanine aminotransferase [ALT] and
             aspartate aminotransferase [AST]) of > 3x the upper limit of normal
A Multicenter Assessment of ALD403 in Chronic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: ALD403; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 665.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Migraine Disorders; ALD403

Summary:

      The purpose of this study is to assess ALD403 in the prevention of migraine headache in
      chronic migraineurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year

          -  During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days
             were assessed as migraine days with at least 5 migraine attacks as recorded in the
             eDiary

          -  Headache eDiary was completed on at least 22 of the 28 days prior to randomization

        Exclusion Criteria:

          -  Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional
             pain syndrome) or any pain syndrome that requires regular analgesia

          -  Psychiatric conditions that are uncontrolled and untreated, including conditions that
             are not controlled for a minimum of 6 months prior to screening.

          -  History or diagnosis of complicated migraine (ICHD-III beta version, 2013), chronic
             tension-type headache, hypnic headache, cluster headache, hemicrania continua, new
             daily persistent headache, migraine with brainstem aura, sporadic and familial
             hemiplegic migraine

          -  Unable to differentiate migraine from other headaches

          -  Subject has received botulinum toxin for migraine or for any other medical/cosmetic
             reasons requiring injections in the head, face, or neck within 4 months prior to
             screening.

          -  Have any clinically significant concurrent medical condition

          -  Receipt of any monoclonal antibody treatment within 6 months of screening (within or
             outside a clinical trial)

          -  Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway
Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL
Condition: Lymphoma, Mantle-Cell
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: CpG-MCL vaccine; PF-3512676; Vaccine-primed T-cells; Autologous hematopoietic stem cell transplant (HSCT); Rituximab; Standard induction chemotherapy; Cyclophosphamide; Filgrastim
Intervention description: CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection.; PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs. PF-03512676 acts as an agonist of human Toll-like receptor 9, leading to activation of antigen-presenting cells and a cascade of antitumor immune reactions.; Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells.; Regular medical procedure; 375 mg/m² by infusion; Patient-specific, regular medical care treatment as determined by treating oncologist; Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC); Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
Intervention MeSH terms: Cyclophosphamide; Rituximab; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Mantle cell lymphoma (MCL) is a sub-type of non-Hodgkin's lymphoma (NHL) which is generally
      considered incurable with current therapy. Participants will receive an autologous vaccine
      against their individual lymphoma after undergoing stem cell transplantation. This
      vaccination may prolong the time which patients will stay in remission from their disease.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Newly-diagnosed with mantle cell lymphoma (MCL) with accessible disease site for
             excisional biopsy, OR have sufficient peripheral blood tumor to leukapherese ≥ 1.5 x
             10e9 lymphoma cells in a single session

          -  Medically appropriate by standard clinical criteria to receive rituximab and standard
             induction chemotherapy and high-dose chemotherapy with autologous hematopoietic cell
             transplant (AHCT)

          -  HIV-negative

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status, OR Karnofsky performance
             scale 50 to 100%

          -  Capable of providing informed consent

        EXCLUSION CRITERIA

          -  Currently receiving immunosuppressive medications

          -  Severe psychological or medical illness

          -  Pregnant or lactating

          -  Unable to safely complete the study, at the discretion of the principal investigator
Ondansetron Versus Aprepitant Plus Ondansetron for Emesis
Condition: Hematologic Diseases; Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia
MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Hematologic Diseases
Intervention: Ondansetron; Aprepitant
Intervention description: 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.; 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
Intervention MeSH terms: Ondansetron; Aprepitant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hematologic Disorder; Acute myelogenous leukemia; AML; High-risk myelodysplastic syndrome; HR-MDS; Chronic Myelogenous Leukemia; CML; Ondansetron; Zofran; Aprepitant; Emend; L 754030; MK 869; Emesis; Nausea; Vomiting

Summary:

      The goal of this clinical research study is to compare the effectiveness of receiving a
      combination of ondansetron and aprepitant to receiving ondansetron alone in helping to
      prevent nausea and/or vomiting in patients with Acute myeloid leukemia (AML) or high-risk
      (HR) Myelodysplastic syndromes (MDS) who are receiving cytarabine. The safety of this drug
      combination will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients greater than or equal to 18 years of age.

          2. Patients with a diagnosis of acute myelogenous leukemia, high-risk myelodysplastic
             syndrome, chronic myelogenous leukemia in blast crisis or acute undifferentiated
             leukemia who will receive chemotherapy with regimens containing high-dose cytarabine
             (greater or equal 1g/m^2/d for at least 3 days).

          3. Patients must sign an informed consent indicating they are aware of the
             investigational nature of this study, in keeping with the policies of the hospital.

        Exclusion Criteria:

          1. Patients with emesis or grade 2 or 3 nausea present less than or equal to 24 hours
             before chemotherapy.

          2. Patients with ongoing emesis due to any organic etiology

          3. Patients with known hypersensitivity to the study drug or to 5-HT3 receptor
             antagonists

          4. Patients receiving pimozide, terfenadine, astemizole, or cisapride
A Study of TRV130 for the Treatment of Pain After Abdominoplasty
Condition: Pain
Intervention: TRV130; Morphine; Placebo
Intervention description: Rescue: Ibuprofen, oxycodone; Rescue: Ibuprofen, oxycodone; Rescue: Ibuprofen, oxycodone
Intervention MeSH terms: Morphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain; abdominoplasty; PCA

Summary:

      The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with
      placebo in patients with acute postoperative pain following abdominoplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >=18 and <=65 years of age.

          -  Plans to undergo an abdominoplasty procedure with no additional collateral procedures.

          -  Is able to understand and comply with the procedures and study requirements, and to
             provide written informed consent before any study procedure.

        Exclusion Criteria:

          -  ASA Physical Status Classification System classification of P3 or worse.

          -  Has surgical or post-surgical complications.

          -  Has clinically significant medical conditions or history of such conditions that may
             interfere with the interpretation of efficacy, safety, or tolerability data obtained
             in the trial, or may interfere with the absorption, distribution, metabolism, or
             excretion of drugs.

          -  Has previously participated in another TRV130 clinical study.
Efficacy and Safety of RX-10045 Ophthalmic Solution for Ocular Inflammation and Pain in Cataract Surgery
Condition: Inflammation; Pain; Cataract
MeSH terms: Cataract; Inflammation
Intervention: RX-10045
Intervention description: topical therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the efficacy and safety of 2 concentrations
      of RX-10045 ophthalmic solution, 0.05% and 0.1%, compared to placebo for the treatment of
      ocular inflammation and pain in subjects undergoing cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unilateral cataract surgery (phacoemulsification or extracapsular extraction) with
             posterior chamber intraocular lens implantation in the capsular bag.

        Exclusion Criteria:

          -  Any additional surgical procedures at the time of the cataract surgery

          -  Refractive surgery in the study eye within the past 2 years

          -  History or presence of noninfectious inflammatory ocular disease (e.g., episcleritis,
             scleritis, uveitis) in either eye

          -  Intraocular pressure of > 21 mm Hg in either eye

          -  Proliferative or severe nonproliferative diabetic retinopathy in either eye

          -  Neovascular/wet age-related macular degeneration in either eye
Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: Euphrasia-based homeopathic therapy; Cyclosporin solution
Intervention description: ophthalmic solution; 1 drop both eyes twice daily; Cyclosporin solution; 1 drop both eyes twice daily
Intervention MeSH terms: Cyclosporine; Lubricant Eye Drops; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Dry Eye Syndromes; Lacrimal Apparatus Diseases

Summary:

      The purpose of this study is to determine whether a homeopathic therapy in combination with
      cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment
      of dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of moderate to severe dry eye syndrome with or without Sjögren's syndrome

          -  receiving treatment with topical cyclosporine (Restasis)

          -  experience one or more moderate dry eye-related symptoms, including dryness, foreign
             body sensation, burning, blurred vision, photophobia, and soreness or pain

        Exclusion Criteria:

          -  history of ocular disorder including non-dry eye ocular inflammation, glaucoma,
             contact lens use

          -  trauma or surgery, including punctal plug insertion within the prior 3 months

          -  any uncontrolled systemic disease or significant illness

          -  use of topical ophthalmic medications that could affect dry eye syndrome

          -  pregnancy, lactation, or considering a pregnancy
Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)
Condition: HIV Infections; Acquired Immunodeficiency Syndrome
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Intervention: Comparator: MK0518; MK0518; MK0518; Placebo
Intervention description: MK0518 oral tablets 200 mg b.i.d, for 24 weeks; MK0518 oral tablets 400 mg b.i.d, for 24 weeks; MK0518 oral tablets 600 mg b.i.d, for 24 weeks; Placebo to MK0518, oral tablet b.i.d, for 24 weeks
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 179.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the safety and efficacy of different doses of an investigational
      drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral
      therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid
             (RNA) values that are within ranges required by the study

          -  Patient must be currently on antiretroviral therapy (ART)

        Exclusion Criteria:

          -  Patient less than 18 years of age

          -  Additional exclusion criteria will be discussed and identified by the study doctor