bioihbjkbjnl/mcl2 huggingface dataset:
Vilazodone for Corticosteroid-Induced Memory Impairment
Condition: Memory Impairment
MeSH terms: Memory Disorders
Intervention: Vilazodone; Placebo; Hydrocortisone
Intervention description: Participants will be randomized to either vilazodone or placebo titrated as follows: 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days.; Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment
Intervention MeSH terms: Hydrocortisone; Vilazodone Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine whether vilazodone attenuates the memory and mood
      effects of corticosteroids on the human hippocampus in 24 healthy controls.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men and women age 18-50 years

          -  Education of ≥ 12 years and baseline RAVLT total words recalled score ≥ 35 (normal
             baseline memory)

          -  BMI between 18.5-30 (not underweight or obese)

        Exclusion Criteria:

          -  History of major psychiatric illness defined as major depressive disorder, bipolar
             disorder, posttraumatic stress disorder, panic disorder, schizoaffective disorder,
             schizophrenia, eating disorders, or drug/alcohol abuse/dependence or current tobacco
             use

          -  History of neurological disorders including seizures, brain surgery, multiple
             sclerosis, Parkinson's disease

          -  Taking CNS-acting medications within 30 days of study

          -  History of allergic reaction or medical contraindication to vilazodone or
             hydrocortisone

          -  Significant medical conditions (e.g., myocardial infarction, cancer, diabetes)

          -  Vulnerable population including pregnant or nursing women, the incarcerated, and
             severe cognitive disorders

          -  Baseline HRSD (Hamilton Rating Scale for Depression) > 7 or current suicidal ideation
             or history of suicide attempt

          -  History of systemic Corticosteroid (CS) use or recent (past 6 months) inhaled CS use
Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Fludeoxyglucose PET CT; Sodium Acetate C11 PET CT; Fludeoxyglucose PET MRI; Sodium Acetate C11 PET MRI
Intervention description: Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).; Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).; Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).; Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: positron emission tomography (PET); computerized tomography (CT); Magnetic resonance imaging (MRI); Fludeoxyglucose (F-18 FDG); C-11 acetate

Summary:

      Investigators are doing this study to determine which of four imaging techniques:
      Fludeoxyglucose Positron Emission Tomography (18 FDG PET) computerized tomography (CT), 18
      FDG PET Magnetic resonance imaging (MRI), C-11 acetate PET CT, and C-11 acetate PET MRI) is
      the best test for finding sites of active myeloma disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients being staged for multiple myeloma as follows: new diagnosis, high risk
             smoldering multiple myeloma, relapsed as defined by investigator

          -  Patients who have undergone standard of care workup

          -  300 pounds or less

          -  Can provide informed consent

          -  Scheduled for a clinically indicated F-18 FDG PET scan

          -  English speaking

        Exclusion Criteria:

          -  Pregnant, breast feeding

          -  Concurrent active non-multiple myeloma malignancy

          -  Contraindication to PET MRI

          -  Previous Type I or Type II Diabetes mellitus or a fasting blood glucose >150 mg/dl
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
Condition: Hernia; Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: 5x5cm bupivacaine collagen sponges
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: laparoscope for bupivacaine sponge (200 mg bupivacaine hydrochloride) placement in laparoscopic hernia repair.
Masking: None (Open Label)
Enrollment: 10.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess pain intensity for the first 72 hrs after aggravated movement (cough)
      following Laparoscopic Inguinal or Umbilical Herniorrhaphy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Man ≥18 years

          2. Has a planned unilateral inguinal herniorrhaphy (laparoscopy, transabdominal
             preperitoneal [TAPP] approach or totally extraperitoneal [TEP] approach) or
             laparoscopic umbilical herniorrhaphy to be performed according to standard surgical
             technique under general anesthesia.

          3. Willing to use opioid rescue analgesia.

        Exclusion Criteria:

          1. Has a known hypersensitivity to amide local anesthetics, opioids, or bovine products.

          2. Scheduled for bilateral inguinal herniorrhaphy.

          3. Undergone a prior herniorrhaphy at the location scheduled for repair.

          4. Undergone major surgery within 3 months of the scheduled herniorrhaphy.
A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib; sunitinib; erlotinib; placebo
Intervention description: erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity; Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity; erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity; Placebo daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
Intervention MeSH terms: Erlotinib Hydrochloride; Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small cell lung cancer; sunitinib; erlotinib; Phase 2

Summary:

      This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib
      alone in patients with advanced/metastatic lung cancer who have received previous treatment
      with a platinum-based regimen
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with locally advanced/metastatic non-small cell lung cancer

          -  Prior treatment with no more than 2 chemotherapy regimens including a platinum-based
             regimen

        Exclusion Criteria:

          -  Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial
             growth factor (VEGF) inhibitors or other angiogenic inhibitors

          -  History of or known brain metastases
Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Nosocomial Genotype 1 HCV Infection
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: LDV/SOF
Intervention description: Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 7977; 5885; GS-7977; GS-5885; SOF; LDV; Sofosbuvir; Ledipasvir; FDC

Summary:

      This study is to evaluate the antiviral efficacy, safety, and tolerability of
      ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial
      genotype 1 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) greater than or equal to 18 kg/m^2.

          -  HCV RNA greater than or equal to 1000 IU/mL at screening.

          -  Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from
             the screening visit.

          -  Screening laboratory values within predefined thresholds.

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male.

          -  Healthy according to medical history and physical examination with the exception of
             HCV diagnosis.

        Exclusion Criteria:

          -  Unstable cardiac disease including subjects with active angina pectoris and/or
             hospitalization for a cardiac condition within 24 weeks prior to screening.

          -  Prior exposure to an HCV NS5a inhibitor.

          -  Pregnant or nursing female.

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

          -  History of solid organ transplantation.

          -  Current or prior history of clinical hepatic decompensation.

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment, or compliance with the protocol.

          -  Known hypersensitivity to LDV, SOF, or formulation excipients.
Impact of Duloxetine on Male Fertility
Condition: Infertility, Male; Depression
MeSH terms: Infertility; Infertility, Male
Intervention: Duloxetine; Placebo
Intervention description: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week; Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Blinded, placebo-controlled, randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Participant, investigator, and outcomes assessor are all blinded to participant's assigned group.
Enrollment: 69.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators are conducting a placebo-controlled, randomized control trial with
      duloxetine in healthy, fertile men not previously on any antidepressants. Participants will
      be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will
      assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes
      measured will include semen parameters (sperm concentration, motility, morphology), hormone
      levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ)
      surveys.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men aged 18-65 years old;

          -  normal or borderline semen analysis (sperm concentration > 10 million/mL, sperm
             motility > 30%, sperm morphology > 3%);

          -  willing to engage in sexual activity (alone or with a partner) at least once per week
             for the duration of the study;

          -  capable of providing semen sample.

        Exclusion Criteria:

          -  Clinically detected varicocele;

          -  oligoasthenoteratospermia or azoospermia on semen analysis;

          -  ongoing attempts to initiate pregnancy;

          -  current sexual dysfunction (classified as moderate or worse on IIEF);

          -  history of seizure disorder;

          -  history of previous chemotherapy or radiation therapy;

          -  current psychiatric history or history of bipolar disorder;

          -  family history of bipolar disorder, depression, or suicide;

          -  use of any psychotropic medications or anticonvulsants;

          -  use of sleeping pills more than once per week;

          -  use of any hormonal medications on a daily or intermittent basis during the preceding
             3 months;

          -  use of medications which may affect hormone measures and/or sexual function;

          -  inability to read, follow instructions, or complete questionnaires in English;

          -  consumption of tobacco or illicit drugs;

          -  consumption of >2oz of alcohol daily.
Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
Condition: Total Parenteral Nutrition-induced Cholestasis
MeSH terms: Cholestasis
Intervention: Omegaven®
Intervention description: 10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 4 Weeks
Maximum age: 18 Years
Healthy volunteers: No
Keywords: PNALD; Cholestasis; Omegaven®; Short Bowel Syndrome

Summary:

      The purpose of this study is to determine whether the omega-3 fatty acid emulsion
      (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is
      effective in treating parenteral nutrition associated liver disease (PNALD) in children.

      The study hypothesis is that Omegaven® can be safely provided to children who are dependent
      on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until
      the child can take adequate nutrition by mouth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children 0-18 years of age

          -  Patients will be PN-dependent and expected to continue PN for at least 30 days

          -  Patients considered eligible for study participation must have PN-associated liver
             diseases . Other causes of liver disease (i.e., biliary atresia, galactosemia, alpha-1
             antitrypsin deficiency) will be excluded. A liver biopsy is not necessary for
             treatment

          -  Direct bilirubin > 2.0 mg/dl

          -  Signed patient informed consent

          -  Signed patient assent where applicable.

        Exclusion Criteria:

          -  Pregnancy

          -  Other causes of chronic liver disease (cystic fibrosis, biliary atresia, alpha-1
             antitrypsin deficiency)

          -  Signs of advanced liver disease including cirrhosis on biopsy, varices, ascites

          -  The patient is allergic to eggs/shellfish

          -  The patient has a severe hemorrhagic disorder

          -  The patient is enrolled in any other clinical trial involving an investigational agent
             (unless approved by the designated physicians on the multidisciplinary team)

          -  The parent or guardian or child unwilling to provide consent or assent.
Lenalidomide/Bortezomib/Dexamethasone for Multiple Myeloma (MM)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Bortezomib; Dexamethasone
Intervention MeSH terms: Dexamethasone; Lenalidomide; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Newly diagnosed

Summary:

      This research study is a Phase II clinical trial. Phase II clinical trials test the
      effectiveness of an investigational combination of drugs. The purpose is to learn whether the
      combination of drugs works in treating a specific cancer. "Investigational" means that the
      combination of drugs is still being studied. It also means that research doctors are trying
      to find out more about it. Examples of what they want to learn about are the safest dose to
      use, the side effects it may cause, and if the combination of drugs works for treating
      different types of cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented symptomatic myeloma, with organ damage related to myeloma

          -  Myeloma that is measurable either by serum or urine evaluation of the monoclonal
             component or by assay of serum free light chains

          -  Must commit to complete abstinence from heterosexual contact or begin two acceptable
             method of birth control, one highly effective method and one additional effective
             (barrier) method

        Exclusion Criteria:

          -  Eligible for autologous stem cell transplantation

          -  HIV positive on combination antiretroviral therapy

          -  Pregnant or breastfeeding

          -  Treated with any prior systemic therapy

          -  Primary amyloidosis or myeloma complicated by amyloidosis

          -  Receiving other investigational agents within 14 days of the start of this trial or
             during this trial

          -  Known brain metastases

          -  Poor tolerability or known allergy to any of the study drugs or similar compounds

          -  Intercurrent illness

          -  Previous history of another malignant condition except for basal cell carcinoma or
             stage I cervical cancer

          -  Inability to comply with an anti-thrombotic treatment regimen

          -  Peripheral neuropathy greater than or equal to grade 2
Efficacy and Tolerability of Topical LFX453 for External Genital Warts
Condition: External Genital Warts
MeSH terms: Warts; Condylomata Acuminata
Intervention: Investigational Treatment; Aldara
Intervention description: Applied twice daily for up to 12 weeks; Applied 3 times a week for 16 weeks
Intervention MeSH terms: Imiquimod
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: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: human papilloma virus (HPV), Genital Warts, Sexually transmitted disease (STD), viral disease

Summary:

      The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety,
      tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an
      additional open label arm using imiquimod 5%.

      During the study the patients received either LFX453, placebo or active comparator and the
      tolerability and safety was assessed continuously through local tolerability assessments and
      adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study
      biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken
      for safety, pharmacokinetics (PK), and biomarkers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Circumcised male 18-60 years

          -  Clinical diagnosis of external genital warts

          -  Agree to remain abstinent or to use condoms during intercourse for the duration of the
             study

          -  Agree to digital photographs of treated area

        Exclusion Criteria:

          -  Any treatment of genital warts within one month of treatment start

          -  HPV vaccination

          -  presence of warts larger than 200 mm2

          -  Genital herpes within one month of treatment start

          -  History of Bowenoid papulosis

          -  significant illness within 2 weeks of treatment start

          -  use of other investigational drugs

          -  known hypersensitivity to study drugs or constituents

          -  history of ECG abnormalities

          -  History of significant heart conditions

          -  Impaired renal function

          -  Abnormal liver function

          -  History of immunodeficiency disease

          -  Drug or alcohol abuse

          -  Immunosuppressive therapies

          -  Malignancies in the past 5 years

          -  hypertrophic scarring
SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults
Condition: Staphylococcal Infections
MeSH terms: Staphylococcal Infections
Intervention: Staphylococcus aureus 4-antigen vaccine; Placebo
Intervention description: a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm; a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a
      single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to <86
      years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Japanese male and female adults aged 20 to <86 years,

          2. Determined as healthy by the investigator (Subjects with preexisting chronic medical
             conditions determined to be stable may be included),

          3. Must be available for the 12 month duration of the study,

          4. Subjects must agree to use an acceptable method of birth control for 3 months after
             study vaccination (if the subject or the subject's partner are/is capable of having
             children).

        Exclusion Criteria:

          1. Any contraindication to vaccination or vaccine components, including previous
             anaphylactic reaction to any vaccine or vaccine-related components,

          2. Unstable or serious chronic medical condition that would increase the subject's risk
             of participation,

          3. Immune system suppression or treatment with medications that suppress the immune
             system,

          4. Receipt of blood products or immunoglobulins within the past 12 months,

          5. Any infection proven or suspected to be caused by S.aureus within the past 6 months,

          6. A staff member at this site nor a relative of those site staff members, nor a
             sponsor's employee directly involved in the conduct of this research study,

          7. Living in a nursing home, long-term care facility or other institution or requiring
             any types of nursing care,

          8. A pregnant or a breast feeding woman.