bioihbjkbjnl/mcl2 huggingface dataset:
Actual Human Use of Methotrexate (MTX) Subcutaneously Administered Via the VIBEX™ MTX Auto-Injector Device
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: VIBEX MTX
Intervention description: Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the usability of the VIBEX MTX device for SC
      self-injection of methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients >18 years of age, diagnosed with Rheumatoid Arthritis

        Exclusion Criteria:

          -  Pregnant females

          -  Any other clinically significant disease or disorder which, in the opinion of the
             investigator might put the subject at risk
ET-01 in Subjects With Lateral Canthal Lines
Condition: Lateral Canthal Lines; Crow's Feet
Intervention: botulinum toxin, Type A; Vehicle
Intervention description: topical liniment; Vehicle Formulation
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: sequential, dose escalating study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  25 - 65 years of age

          -  minimal to moderate Crow's Feet wrinkles at rest

          -  moderate to severe Crow's Feet wrinkles on contraction

          -  willingness to refrain from any product affecting skin remodeling

          -  female subjects must be not pregnant and non-lactating-

        Exclusion Criteria:

          -  history of adverse reactions to any prior botulinum toxin treatments

          -  history of vaccination or non-response to any prior botulinum toxin treatments

          -  botulinum toxin treatment in the prior 6 months

          -  present or history of neuromuscular disease, eyelid ptosis, muscle weakness,
             paralysis, or "dry eye"

          -  history of peri-ocular surgery, brow lift or related procedures

          -  procedures affecting the lateral canthal region in the prior 12 months

          -  application of topical prescription medication to the treatment area

          -  female subjects who are pregnant or are nursing a child
Feasibility of One-Step Sentinel Lymph Node (SLN) Biopsy With Radiolabeled Methylene Blue (IND 70,627)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Methylene blue
Intervention description: 1 mC1
Intervention MeSH terms: Methylene Blue
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Breast cancer; diagnostic; lymph nodes

Summary:

      The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary
      lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage 0,I, II breast cancer

          -  Clinical node status N0, N1

          -  No know allergy to iodine, lymphazurin or methylene blue dyes

        Exclusion Criteria:

          -  Patient cannot be pregnant or nursing

          -  Prisoners will not be eligible

          -  Women under the age of 18 will not be eligible

          -  Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes
Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: degarelix
Intervention description: Degarelix was given as subcutaneous injections.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 189.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing
      six different doses. The patients participating in the trial were treated with degarelix
      every month for a year. During the treatment the patients had to visit the clinic for
      investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone,
      follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed
      throughout the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent prior to any study related procedures

          -  Proven prostate cancer in need for endocrine treatment, except for neoadjuvant
             hormonal therapy, but including patients with a rising PSA further to prostatectomy or
             radiotherapy

          -  ECOG score to be equal to or above 2

          -  Testosterone level within age-specific normal range

          -  PSA value equal to or above 2 ng/ml

          -  Life expectancy of at least 6 months

        Exclusion Criteria:

          -  Previous or current hormonal treatment of prostate cancer

          -  Recent or current treatment with any drugs modifying the testosterone level

          -  Candidate for curative treatment such as prostatectomy or radiotherapy

          -  History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or
             Quincke's Oedema

          -  Hypersensitivity towards any component of degarelix or mannitol

          -  Cancer disease within the last 5 years except for prostate cancer and some skin
             cancers

          -  Signs of liver impairment shown as elevated serum ALT or serum bilirubin

          -  Known hepatic disease

          -  Other laboratory abnormalities that judged by the investigator would interfere with
             the patients participation in the trial or the evaluation of the trial results

          -  Clinically significant disorder including excessive alcohol or drug abuse that may
             interfere with trial participation or influence the conclusion of the trial as judged
             by the investigator

          -  Mental incapacity or language barrier precluding adequate understanding or cooperation

          -  Having received an investigational product within the last 12 weeks preceding the
             trial

          -  Previous participation in this trial
A Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients With Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Intervention: AMG 714; Placebo; Placebo Gluten Challenge; Gluten Challenge
Intervention description: AMG 714 administered by subcutaneous injection; Matching placebo to AMG 714 administered by subcutaneous injection; Gluten-free cookies (Finnish rusks); Gluten-containing cookies (Finnish rusks), 1-2 g gluten per serving
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: celiac; gluten; Interleukin 15 (IL-15); AMG 714; gluten challenge

Summary:

      This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of
      the effects of gluten exposure in adult patients with celiac disease during a gluten
      challenge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of celiac disease by intestinal biopsy at least 12 months prior to screening

          -  On a gluten-free diet for at least 12 months

          -  Negative celiac serology

          -  Avoidance of pregnancy

        Exclusion Criteria:

          -  Severe complications of celiac disease, such as refractory celiac disease

          -  Celiac symptoms

          -  Other concomitant autoimmune disease

          -  Chronic, active gastrointestinal disease

          -  Infections, concomitant diseases

          -  Prohibited medications
A Pilot Study, Evaluating the Efficacy of Regulatory T-cell Suppression by Ontak in Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Ontak
Intervention description: One dose of Ontak 9 mcg/Kg IV over 30 minutes times 3 doses. 1 dose every other day
Intervention MeSH terms: Denileukin diftitox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Denileukin diftitox; Metastatic Pancreatic Cancer; Ontak; Regulatory T-cell

Summary:

      This study is designed to determine the duration of T reg suppression in patients with
      metastatic pancreatic cancer receiving Ontak. The goal is to define the optimal time for
      future dendritic cell vaccine administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients and nonpregnant, nonlactating female patient > 18 years old

          -  Histologic diagnosis of pancreatic cancer with distant disease seen on CT or MRI with
             no prior chemotherapy or radiotherapy for a least 4 weeks

          -  Karnofsky performance status equal to or greater than 70%

          -  Life expectancy of at least 3 months.

          -  No uncontrolled pain

          -  No symptoms of bowel obstruction

          -  Women with child bearing potential must agree to use adequate contraceptives. If she
             should become pregnant she needs to inform the treating physician

          -  Ability to give informed consent

        Exclusion Criteria:

          -  Positive serologic testing for HIV, AIDS, human T-cell lymphotrophic virus type 1,
             hepatitis B, or hepatitis C.

          -  Hemoglobin <9g/dL; hematocrit <27%; platelets <100,000/ U/L without transfusion
             support

          -  Creatinine > 1.8 mg/dL

          -  Serum albumin < 2.0 mg/dL

          -  AST > 3X ULN; ALT > 3X ULN

          -  Bilirubin > 1.8

          -  Uncontrolled angina, arrhythmias, bronchospasm, hypertension, or hypercalcemia.

          -  Corticosteroid use within 28 days

          -  Chemotherapy or radiation within 28 days

          -  Bacteremia or other signs of active systemic infection

          -  History of autoimmune disease
Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Trizivir; Lamivudine/Zidovudine; Lopinavir/Ritonavir; Nevirapine
Intervention description: 300 mg abacavir sulfate/150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily; 150 mg lamivudine/300 mg zidovudine tablet taken orally twice daily; 400 mg lopinavir/100 mg ritonavir tablet taken orally twice daily; 200 mg tablet taken orally daily for the first 14 days before receiving 200 mg tablet taken orally twice daily
Intervention MeSH terms: Ritonavir; Lopinavir; Lamivudine; Zidovudine; Nevirapine; Lamivudine, zidovudine drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 730.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Treatment Naive; MTCT; HIV Seronegativity

Summary:

      Anti-HIV drug regimens have dramatically improved the rates of prevention of mother-to-child
      transmission (MTCT) of HIV in developed countries. However, little is known of the
      effectiveness of such regimens in developing countries, such as Botswana. This study will
      determine whether Trizivir (TZV), a single pill containing abacavir sulfate, lamivudine, and
      zidovudine (ABC/3TC/ZDV), or lopinavir/ritonavir (LPV/r) and lamivudine/zidovudine (3TC/ZDV)
      is more effective in reducing HIV-1 viral load and preventing MTCT among HIV infected
      pregnant women in Botswana.
    

Eligibility criteria:

        Inclusion Criteria for Mothers:

          -  HIV-infected

          -  At least at 26th week of pregnancy (treatment group) or 18th week of pregnancy
             (observational group) but not beyond the 34th week of pregnancy

          -  Able to complete study visits until at least 6 months postpartum

          -  Citizen of Botswana

        Exclusion Criteria for Mothers:

          -  Taken ARVs for more than 1 week, other than ZDV, during current or prior pregnancy.
             Women who have received single-dose NVP in a prior pregnancy are not excluded.

          -  Certain abnormal laboratory values

          -  Plan to formula feed

          -  Known fetal abnormalities that suggest the fetus will not survive to 6 months of
             gestational age

          -  Known allergy or medical contraindication to any of the study drugs

          -  Require certain medications

          -  Previous participation in the "Prevention of Milk-Borne Transmission of HIV-1C in
             Botswana" (Mashi) study

          -  Currently incarcerated
Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: LX1031 High Dose; LX1031 Low Dose; Placebo
Intervention description: A high dose of LX1031; daily oral intake for 28 days; A low dose of LX1031; daily oral intake for 28 days.; Matching placebo dosing with daily oral intake
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX1031
      versus a placebo control in subjects with non-constipating irritable bowel syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged 18-70 years old

          -  Documented diagnosis of IBS (IBS-diarrhea or IBS-mixed) based upon Rome III criteria

          -  Abdominal pain/discomfort at least 2 days per week during the screening and run-in
             periods

          -  Normal structural evaluation of the colon within 5 years prior to screening

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  Inability to discontinue current drug therapy for IBS, except for bulking agents,
             through the duration of the study

          -  Use of anticholinergic antidepressants, opioid pain medications, or any drugs that
             affect bowel motility

          -  Lactose intolerance

          -  Major psychological disorder

          -  Significant nicotine or caffeine use (>10 cigarettes and/or six 8 ounce cups of coffee
             per day, respectively)
Treatment of Cognitive Impairment in Men With Schizophrenia (MK5757-005)(COMPLETED)
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Intervention: MK5757; Comparator: Placebo
Intervention description: This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 25 mg capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 MK5757 50 mg capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days; This is a 2 period, cross-over study. In each of the two treatment periods, each patient will receive the following: Days 1 and 28 MK5757 one placebo capsules three times a day (tid). Days 2 through 14 and Days 29 through 42 two MK5757 placebo capsules tid. Study drug is taken 3 times daily. Each treatment period is 14 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: Male
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study is to evaluate the safety and efficacy of the study drug compared to placebo in
      the treatment of cognitive impairment in men with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male between 21 and 55 years of age

          -  Duration of the illness must be longer than 1 year

          -  Patient's current antipsychotic medication regimen must be stable

          -  Patient is negative for selected drugs of abuse at Screening

          -  Must be in a stable living arrangement for at least 3 months prior to screening (not a
             homeless shelter)

        Exclusion Criteria:

          -  Patient has mental retardation

          -  Undergone Electroconvulsive Therapy (ECT) treatment within 6 months prior to screening

          -  Has suicidal attempts or ideation within the last 12 months

          -  Patient has a history of alcohol/drug dependence within 1 year or alcohol/drug abuse
             within 12 months of starting the study
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Normal saline (Placebo); botulinum toxin Type A (200U); botulinum toxin Type A (50U); botulinum toxin Type A (200U); botulinum toxin Type A (100U); botulinum toxin Type A (200U); botulinum toxin Type A (200U)
Intervention description: Placebo injection on Day 1 and botulinum toxin Type A injection 200 U > Week 12; injection into the detrusor; botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor; botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor; botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U > 12 weeks; injections into the detrusor
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to explore the effectiveness and safety of several doses of
      botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord
             injury

          -  Inadequate response to anticholinergic medication used to treat overactive bladder

        Exclusion Criteria:

          -  History or evidence of pelvic or urologic abnormality

          -  Previous or current diagnosis of bladder or prostate cancer

          -  Urinary tract infection at time of enrollment
A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection
Condition: Chronic Hepatitis C; Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/ritonavir (r); ABT-530; Ribavirin (RBV)
Intervention description: Tablet; Tablet; Tablet
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C; HCV; Interferon Free; Chronic Hepatitis C; Hepatitis C virus; Hepatitis C Genotype 3

Summary:

      The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and
      ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female (of non-child bearing potential) between 18 and 70 years of age with
             Body Mass Index ≥18 to <38 kg/m2.

          -  Chronic HCV genotype 3 infection prior to study enrollment and has never received
             antiviral treatment for HCV.

          -  Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.

          -  Sexually active males must be sterile, have male partners only, or agree to use two
             effective forms of birth control for 7 months after stopping study drug.

        Exclusion Criteria:

          -  History of severe, life-threatening or other significant sensitivity to any drug.

          -  Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human
             Immunodeficiency virus antibody (HIV Ab).

          -  Prior therapy for the treatment of HCV.

          -  Any current or past clinical evidence of cirrhosis.

          -  Any cause of liver disease other than chronic HCV-infection.

          -  HCV genotype co-infection with any other HCV genotype.

          -  Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.