bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Creatine and Tamoxifen in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: creatine; tamoxifen
Intervention description: creatine monohydrate powder; Tamoxifen citrate capsules
Intervention MeSH terms: Tamoxifen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ALS; Lou Gehrig's Disease; Amyotrophic Lateral Sclerosis; Creatine; Tamoxifen; Selection Design

Summary:

      The purpose of the study is to evaluate the safety and efficacy of high dose creatine and two
      dosages of tamoxifen treatment in amyotrophic lateral sclerosis (ALS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Familial or sporadic ALS.

          -  Disease duration from diagnosis no greater than 36 months at Screening Visit.

          -  Aged 18 years or older.

          -  Capable of providing informed consent and complying with trial procedures.

          -  Vital capacity (VC) equal to or more than 50% predicted normal value for gender,
             height and age at the Screening Visit.

          -  Not taking, or on a stable dose of riluzole (50mg bid) for at least 30 days prior to
             the Screening Visit.

          -  Women must not be able to become pregnant for the duration of the study (e.g., post
             menopausal for at least one year, surgically sterile, or practicing adequate birth
             control methods) for the duration of the study. Women of childbearing potential must
             have a negative serum pregnancy test at the Screening Visit and be non-lactating.

        Exclusion Criteria:

          -  History of known sensitivity or intolerability to creatine monohydrate or tamoxifen
             citrate or to any other related compound.

          -  Prior exposure to creatine or tamoxifen within 30 days of the Screening Visit.

          -  Exposure to any investigational agent within 30 days of the Screening Visit.

          -  Use of coumarin anticoagulants (warfarin sodium), rifampin, aminoglutethimide,
             medroxyprogesterone, letrozole, or bromocriptine.

          -  Presence of any of the following clinical conditions: Clinical evidence of unstable
             medical or psychiatric illness at the Screening Visit; Screening aspartate
             aminotransferase (AST) > 3 times the upper limit of normal or serum creatinine > 1.5
             mg/dl (133 umol/L); Permanent assisted ventilation or mechanical ventilation; or
             Lactating or have a positive serum pregnancy test at the Screening Visit.

          -  History of any of the following: blood clots including deep vein thrombosis, pulmonary
             embolism, and stroke, cataracts, renal problems, endometrial cancer, uterine sarcoma,
             or diabetes mellitus.
Regimen Optimization Study
Condition: Kidney Transplantation
Intervention: Thymoglobulin; Belatacept; mycophenolate mofetil(MMF); Corticosteroids; Everolimus(EVL); Tacrolimus(TAC)
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Everolimus; Abatacept; Tacrolimus; Thymoglobulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress
      the immune system (called immunosuppressive regimens) to stop the immune system from
      attacking the transplanted kidney in order to limit damage to or the possibility of rejecting
      the transplanted kidney. The purpose of this study is to evaluate benefits and risks of two
      immunosuppressive regimens (belatacept with everolimus or tacrolimus with mycophenolate
      mofetil) following thymoglobulin induction and rapid corticosteroid withdrawal.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Men and women, aged 18 to 75

          -  Serologic test results are positive for past exposure to Epstein Barr Virus (EBV+)

          -  Diagnosed with end stage renal disease (ESRD) and scheduled to undergo transplantation
             of a non-HLA identical, living or standard criteria deceased donor kidney

        Exclusion Criteria:

          -  Primary cause of ESRD is: primary focal segmental glomerulosclerosis; or Type I or II
             membranoproliferative glomerulonephritis; or Hemolytic Uremic Syndrome / Thrombotic
             Thrombocytopenic Purpura

          -  Had a previous graft loss due to acute rejection

          -  At increased immunologic risk of graft loss due to panel reactive antibodies (PRA)
             >20% or need for desensitization therapy

          -  Scheduled to receive a: kidney from identical twin; or paired kidney; or kidney from a
             Cytomegalovirus(CMV) positive donor when recipient is CMV negative; or kidney from an
             extended criteria donor

          -  Have a body mass index (BMI) of > 35 kg/m2 for nondiabetics or > 30 kg/m2 for
             diabetics

          -  Diagnosed as Hepatitis B positive; or Hepatitis C positive; or HIV positive; or
             currently or previously active or inadequately treated latent
Safety and Efficacy of CollaRx® Bupivacaine Implant in Men After Open Laparotomy Herniorrhaphy
Condition: Herniorrhaphy; Postoperative Pain; Inguinal Hernia
MeSH terms: Hernia, Inguinal
Intervention: Bupivacaine Collagen Sponge; Placebo collagen Sponge
Intervention description: Drug: Bupivacaine Collagen Sponge; Drug: Placebo Collagen Sponge
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess pain intensity for the first 72 hrs after after aggravated movement
      (cough)following open laparotomy inguinal herniorrhaphy in patient who receive either the
      CollaRx Bupivacaine implant or a plain collagen sponge.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man ≥ 18 years

          -  Body mass index (BMI) ≥ 19 and ≤ 40 kg/m2.

          -  Has a planned unilateral inguinal herniorrhaphy (open laparotomy, tension free
             technique) to be performed according to standard surgical technique under general
             anesthesia.

        Exclusion Criteria:

          -  Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.

          -  Scheduled for bilateral inguinal herniorrhaphy.

          -  Undergone a prior herniorrhaphy on the side scheduled for repair.

          -  Undergone major surgery within 3 mos of the scheduled herniorrhaphy.

          -  Has cardiac arrhythmias or atrioventricular (AV) conduction disorders.

          -  Concomitantly uses antiarrhythmics (eg, amiodarone, lidocaine), propranolol, or
             strong/moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers (eg, macrolide
             antibiotics and grapefruit juice).

          -  Used long acting analgesics within 24 hours of surgery. Short acting analgesics such
             as acetaminophen may be used on the day of surgery but are subject to preoperative
             restrictions for oral intake.
Helping Olfaction and Nutrition On Renal Replacement
Condition: End Stage Renal Disease; Olfactory Disorders
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: Theophylline
Intervention description: The study medication will be provided by Foundation Care.
Intervention MeSH terms: Theophylline
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: End stage renal disease; Olfaction; Dialysis; Hemodialysis; Malnutrition

Summary:

      This clinical trial examines whether nasal theophylline administration can improve olfaction
      and nutrition in hemodialysis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ESRD requiring chronic outpatient hemodialysis

          -  Able to provide written consent

          -  Defects in smell identification and/or smell threshold detection as measured by
             "Scratch-and-sniff" University of Pennsylvania Smell Identification Test (UPSIT) and
             Smell Threshold Test

        Exclusion Criteria:

          -  Prior allergic reaction to theophylline

          -  Patients currently treated with theophylline for clinical indication

          -  Pregnancy or lactation

          -  ESRD patients on peritoneal dialysis

          -  Patients hospitalized at the time of study enrollment
Buspirone, Stress, and Attentional Bias to Marijuana Cues
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Intervention: Buspirone; Placebo
Intervention description: Buspirone is an anxiolytic compound marked by modulation of both 5-HT1A and D3 receptors. Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.; Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
Intervention MeSH terms: Buspirone
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: marijuana; attentional bias; stress; buspirone

Summary:

      This project has two primary goals. The first goal is to further scientific understanding
      about marijuana abuse by examining two recognized factors in marijuana use and relapse: (1)
      stress/anxiety and (2) atypical reactivity to marijuana-related stimuli (e.g., attentional
      bias). The second goal is to attenuate the influence of stress/anxiety and attentional bias
      to marijuana stimuli via administration of buspirone.

      Buspirone is uniquely suited to this project because it has effects on neurotransmitter
      systems known to modulate both stress/anxiety and attentional bias.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Marijuana substance use disorder based on a score of ≥ 13 on the Cannabis Use
             Disorders Identification Test - Revised (CUDIT-R)

          -  a score of ≥ 4 on the Cannabis Abuse Screening Test (CAST)

          -  meeting criteria for a marijuana substance use disorder based on the Structured
             Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders IV
             (DSM-IV)

        Exclusion Criteria:

          -  Current DSM-IV Axis I disorder other than marijuana use disorder

          -  serious medical illness requiring ongoing medical treatment, which could affect the
             central nervous system, or any other medical contraindication (e.g., renal,
             cardiovascular, pulmonary, blood) as determined by medical screening

          -  a positive pregnancy test or breast feeding (females)

          -  concomitant use of prescription medications that could affect the central nervous
             system

          -  active suicidal ideation or Beck Depression Inventory II score greater than 19

          -  positive urine drug screen for drugs other than marijuana or positive breath alcohol
             screen

          -  Shipley-2 test of cognitive aptitude score outside 2 SD units of the published
             composite score average

          -  smoking > 10 nicotine cigarettes per day / Fagerstrom Score > 4

          -  taking meds known to have significant drug interactions with buspirone.
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars in Subjects Undergoing Elective Abdominoplasty
Condition: Scar Prevention
Intervention: EXC 001; Placebo
Intervention description: Multiple intradermal injections of EXC 001 and placebo; Multiple intradermal injections of EXC 001 and placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Scarring; Cicatrix; Fibrosis; Pathologic Process

Summary:

      This study will compare how well EXC 001 works versus placebo in reducing the appearance of
      scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety
      of EXC 001 in healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have sufficient excess abdominal tissue to qualify for a standard
             elective abdominoplasty

          -  Subject has chosen to have an elective abdominoplasty

          -  Medically healthy with normal screening results

          -  Subjects must not be pregnant or lactating

        Exclusion Criteria:

          -  Females who are currently pregnant or pregnant during the 12 months prior to inclusion
             in the study, or lactating

          -  Participation in another clinical trial within 30 days prior to the start of the study

          -  Any other condition or prior therapy, which, in the opinion of the PI, would make the
             subject unsuitable for this study
Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
Condition: Proliferative Diabetic Retinopathy; Macular Edema
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Edema
Intervention: ranibizumab
Intervention description: Ranibizumab 0.5mg at baseline and then again at 30 days and/or 60 days after PRP as deemed appropriate by the Investigator.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Ranibizumab; Proliferative Diabetic Retinopathy; Macular Edema following Panretinal Photocoagulation; Safety and Efficacy; Intravitreal Injection

Summary:

      This is a randomized, open-label Phase II study evaluating the safety and efficacy of
      intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic
      Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-PRP protocol refraction, fluorescein angiography, and optical coherence tomography
             AND 7-14 day post-PRP OCT

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age 21 years or older

          -  Previously untreated PDR patients with high risk characteristics who develop edema
             within 7-14 days post PRP therapy. This edema, determined by a masked investigator,
             will be characterized as either increased foveal thickness (>10% increase from pre-PRP
             foveal thickness), and/or increased macular volume on OCT (>10% increase from pre-PRP
             macular volume).

        Exclusion Criteria:

          -  Pregnancy (positive pregnancy test) prior to enrollment in the study

          -  Any other condition that the investigator believes would pose a significant hazard to
             the subject if the investigational therapy were initiated.

          -  Participation in another simultaneous medical investigation or trial

          -  Pre-PRP clinically significant diabetic macular edema (CSME) that would make the
             patient eligible for macular laser prior to PRP

          -  Neovascularization of the iris or neovascular glaucoma

          -  Increased central foveal thickness for any other reason

          -  Concurrent macular diseases that could confound the results of this study

          -  Prior vitrectomy in the study eye

          -  Prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab,
             bevacizumab or triamcinolone acetonide
Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in HER-2 Positive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Herceptin; Navelbine; Taxotere; Carboplatin
Intervention description: One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.; Weekly injections given starting week 3 and ending week 14; Given every three weeks starting week 3 and ending on week 14; Given every three weeks starting week 3 and ending on week 14
Intervention MeSH terms: Carboplatin; Docetaxel; Trastuzumab; Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HER-2 Positive Breast Cancer; herceptin; navelbine; taxotere; carboplatin; Early stage Breast Cancer

Summary:

      The purpose of this study is to find out what effects the preoperative combination therapies
      of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early
      stage HER-2 positive breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with stage II or III breast cancer

          -  HER-2 positive tumors

          -  Older than 18 years of age

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of greater or equal to 1.

          -  ANC > 1,500/mm3

          -  Hemoglobin > 9gm/dl

          -  Platelets > 100,000mm3

          -  Creatinine < 2mg/dl

          -  Glucose < 200mg/dl

          -  Bilirubin < 1.5 x ULN

        Exclusion Criteria:

          -  Previous treatment with herceptin, taxanes, doxorubicin or other anthracycline-type
             therapy, navelbine, or platinum-based therapy.

          -  Pregnant or breast-feeding women

          -  Serious illness, or medical or psychiatric condition

          -  Uncontrolled infections

          -  Active or severe cardiovascular or pulmonary disease

          -  Patients with left ventricular ejection fraction < 50%

          -  Peripheral neuropathy of any etiology that exceeds grade 1

          -  Prior history of malignancy

          -  Uncontrolled diabetes
Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Ribavirin; Pegylated Interferon Alfa 2a; Placebo; Telaprevir
Intervention description: tablet; Solution for injection; tablet; tablet
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 334.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon
      Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C
      virus (HCV) ribonucleic acid (RNA) levels
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA

          -  Have been infected with Hepatitis C virus for greater than (>) 6 months

          -  Seronegative for hepatitis B surface antigen and human immunodeficiency virus 1 and 2

          -  Must agree to use 2 methods of contraception, including 1 barrier method, during and
             for 24 weeks after the completion of the study (unless the subject is a female of
             documented non-child-bearing potential)

          -  Female subjects must have a negative pregnancy test at all visits before the first
             dose.

        Exclusion Criteria:

          -  Received any approved or investigational drug or drug regimen for the treatment of
             hepatitis C.

          -  Any medical contraindications to Peg-IFN-alfa-2a or Ribavirin therapy

          -  Any other cause of significant liver disease in addition to hepatitis C; this may
             include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis,
             autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis
             or primary biliary cirrhosis.

          -  Diagnosed or suspected hepatocellular carcinoma.

          -  Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a
             liver biopsy taken within 2 years before Study start.

          -  Alcohol/drug abuse or excessive use in the last 12 months.

          -  Participation in any investigational drug study within 90 days before drug
             administration or participation in more than 2 drug studies in the last 12 months
             (exclusive of the current study).
Combined Spinal-Epidural Temperature and Duration of Action
Condition: Pain
Intervention: combined spinal epidural
Intervention description: Combined Spinal Epidural
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Combined spinal epidural duration; labor pain

Summary:

      The hypothesis is that a combined spinal-epidural drug at refrigerated temperature will have
      a shorter period of pain relief than that maintained at room temperature. The temperature of
      the dose of medication will be measure with an infrared thermometer immediately prior (within
      5 minutes) to administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >/= 18 years of age not allergic to medications used to treat labor pain </= 6cm
             cervical dilation visual pain score >/=3

        Exclusion Criteria:

          -  <18 years of age > 6 cm cervical dilation non-English speaking subjects