bioihbjkbjnl/mcl2 huggingface dataset:
Toradol to Reduce Ureteroscopic Symptoms Trial
Condition: Urinary Lithiasis; Kidney Diseases; Kidney Stone; Pain, Postoperative
MeSH terms: Kidney Diseases; Kidney Calculi; Urolithiasis; Urinary Calculi; Pain, Postoperative; Lithiasis
Intervention: Toradol
Intervention description: IV toradol
Intervention MeSH terms: Ketorolac Tromethamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 94.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Double blinded randomized controlled clinical trial to assess the impact of intraoperative
      Toradol on post-operative pain scores for patients undergoing ureteroscopy for urinary stone
      management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing Ureteroscopy for kidney stone management between age 18-80.

        Exclusion Criteria:

          -  Unable to provide consent

          -  Contraindications to Toradol
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Intervention: 21mg transdermal nicotine patch (Nicoderm CQ); 1mg nicotine nasal spray; placebo nasal spray
Intervention description: 21mg transdermal nicotine patch; two 0.5mg/sprays, one to each nostril (dose = 1mg) The nicotine nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital. It is similar in concentration to Nicotrol.; saline combined with capsaicin to mimic the brief nasal irritation from active nicotine spray The placebo nasal spray is formulated by the Investigational Drug Service at Yale-New Haven Hospital.
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: alcohol; nicotine; smoking cessation; smoking cessation medications

Summary:

      This study examines the effect of combined nicotine replacement therapy (transdermal patch +
      nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and
      self-administration behavior.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 21 and over

          -  Able to read and write in English

          -  Smoker

          -  Heavy drinker

        Exclusion Criteria:

          -  Any significant current medical or psychiatric conditions that would contraindicate
             the consumption of alcohol or nicotine

          -  Significant hepatocellular injury

          -  Positive test result at intake appointments on urine drug screens conducted for
             opiates, cocaine, or benzodiazepines

          -  Women who are pregnant or nursing

          -  Suicidal, homicidal, or evidence of severe mental illness

          -  Prescription of any psychotropic drug in the 30 days prior to study enrollment

          -  Blood donation within the past 8 weeks

          -  Individuals who are seeking treatment for drinking or smoking who have attempted to
             quit drinking or smoking within the past 3 months

          -  Specific exclusions for administration of nicotine nasal spray not specified above
             including nasal polyps, chronic nasal congestion, allergies, sinusitis

          -  Specific exclusions for administration of nicotine patch not specified above including
             history of dermatoses

          -  Reported sensitivity or allergies to pepper or pepper spray, peppermint, or prior
             adverse reaction to nicotine spray

          -  Participation within the past 8 weeks in other studies that involve additive blood
             sampling and/or interventional measures that would be considered excessive in
             combination with the current study
Adjuvant GVAX Vaccine Therapy in Patients With Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: GVAX pancreas vaccine
Intervention description: Given intradermally
Intervention MeSH terms: Pancrelipase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I pancreatic cancer; stage II pancreatic cancer; pancreatic neoplasm; adenocarcinoma of the pancreas; stage IIl pancreatic cancer; adjuvant therapy; cancer vaccine; GVAX

Summary:

      This is an open label, phase II trial study of adjuvant GVAX pancreas vaccine in patients
      with pancreatic cancer.
    

Eligibility criteria:

        1. Inclusion Criteria:

             A. previously vaccinated subjects must receive Gvax vaccine previously

             B. naïve and previously vaccinated subjects must meet the following criteria:

               -  have a history of surgically resected pathologic stage 1,2 or 3 adenocarcinoma of
                  the head, neck, tail, or uncinate of the pancreas

               -  received the last anti-cancer therapy at least 28 days ago.

               -  provide informed consent.

               -  have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

               -  have adequate hematologic function (Hemoglobin ≥ 9 gm/dl, Absolute neutrophil
                  count (ANC) ≥ 1500 #/cu mm, platelets ≥100,000 K/cu mm)

               -  have adequate renal function (Serum creatinine ≤ 2 mg/dL).

               -  have adequate hepatic function (Bilirubin ≤ 2.0 mg/dL, unless known Gilbert's
                  Syndrome; Aspartate Aminotransferase (AST), Alanine transaminase (ALT) and
                  amylase ≤ 2x upper limit of normal: Alk Phosphatase ≤ 5x upper limit of normal.)

               -  agree to use adequate birth control, if of childbearing potential.

          2. Exclusion criteria:

               -  radiographical evidence of pancreatic cancer disease recurrence

               -  documented history of autoimmune diseases including systemic lupus erythematosus,
                  sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis

               -  uncontrolled medical problems

               -  systemic steroid therapy within 28 days before vaccine administration

               -  anticipated need for systemic steroid therapy within 28 days after vaccine
                  administration

               -  evidence of active infections

               -  pregnant
A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone
Intervention: Parsaclisib
Intervention description: Parsaclisib at the protocol-defined dose.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Marginal zone lymphoma; phosphatidylinositol 3-kinase (PI3K)δ inhibitor; indolent (slow-growing) non-Hodgkin lymphoma B-cell lymphoma

Summary:

      The purpose of this study is to evaluate the safety and efficacy of two parsaclisib treatment
      regimens in participants diagnosed with relapsed or refractory marginal zone lymphoma (MZL)
      who are naive to or were previously treated with a Bruton's tyrosine kinase (BTK) inhibitor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, aged 18 or older (except in South Korea, aged 19 or older).

          -  Histologically confirmed marginal zone lymphoma, including extranodal, nodal, and
             splenic subtypes.

          -  Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
             as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse
             diameter and ≥ 1.0 cm in the longest perpendicular diameter.

          -  Participants with splenic MZL who do not meet the radiographically measurable disease
             criteria described herein are eligible for participation provided that bone marrow
             infiltration of MZL is histologically confirmed.

          -  Participants must be willing to undergo an incisional or excisional lymph node or
             tissue biopsy or provide a lymph node or tissue biopsy from the most recent available
             archival tissue.

          -  Eastern Cooperative Oncology Group performance status 0 to 2.

        Exclusion Criteria:

          -  Evidence of diffuse large B-cell transformation.

          -  History of central nervous system lymphoma (either primary or metastatic) or
             leptomeningeal disease.

          -  Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K
             inhibitor.

          -  Allogeneic stem cell transplant within the last 6 months, or autologous stem cell
             transplant within the last 3 months before the date of the first dose of study
             treatment.

          -  Active graft versus host disease.

          -  Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be
             eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody
             will be eligible if they are negative for HCV-RNA.
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
Condition: Chronic Sinusitis
MeSH terms: Sinusitis
Intervention: S8 Sinus Implant (mometasone furoate, 1350 mcg)
Intervention description: Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Bilateral in-office placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to assess the safety and performance of the steroid-releasing
      S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus
      obstruction.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 years of age or older

          -  Diagnosis of chronic sinusitis

          -  Prior bilateral total ethmoidectomy

          -  Recurrent sinus obstruction due to polyps grade 2 or higher

        Key Exclusion Criteria:

          -  Required use of mometasone furoate within 2 weeks prior to implant procedure

          -  Significant scarring or adhesions of the sinus
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: Elagolix; Placebo
Intervention description: Capsule administered orally; Capsule administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 118.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Polycystic Ovary Syndrome; Hormone; Elagolix

Summary:

      This study will assess the potential impact of elagolix on disordered pituitary and ovarian
      hormones in women with polycystic ovary syndrome (PCOS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with clinical diagnosis of PCOS.

          -  Participants with a body mass index (BMI) of 18.5 to 38 kg/m^2 at time of Screening.

        Exclusion Criteria:

          -  Participants with newly diagnosed medical condition requiring intervention that has
             not been stabilized at least 30 days prior to Baseline.

          -  Participants with a significant medical condition that require intervention during the
             course of study participation (such as anticipated major elective surgery).

          -  Participants with an unstable medical condition (including, but not limited to,
             uncontrolled hypertension, epilepsy requiring anti-epileptic medicine, unstable
             angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically
             significant infection or injury).
Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B
Condition: Chronic HBV Infection
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: GS-4774; OAV Regimen
Intervention description: Administered as a subcutaneous injection every 4 weeks for a total of 6 doses; Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hepatitis B (HBV); Oral antiviral (OAV); GS-4774

Summary:

      The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in
      adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with
      an oral antiviral (OAV) medication.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability to understand and sign a written informed consent form, which must be obtained
             prior to initiation of study procedures

          -  Currently taking an approved HBV oral antiviral medication

          -  Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6
             months)

          -  Virally-suppressed (HBV DNA below the lower limit of quantification (LLOQ) for ≥ 1
             year)

        Key Exclusion Criteria:

          -  Cirrhosis

          -  Inadequate liver function

          -  Co-infection with hepatitic C virus (HCV), HIV or hepatitic D virus (HDV)

          -  Evidence of hepatocellular carcinoma

          -  Significant cardiovascular, pulmonary, or neurological disease

          -  Females who are pregnant or may wish to become pregnant during the study

          -  Received solid organ or bone marrow transplant

          -  Use of another investigational agents within 3 months of screening

          -  Current alcohol or substance abuse judged by the investigator to potentially interfere
             with compliance

          -  History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease
             ulcerative colitis, autoimmune disease

          -  Known hypersensitivity to study drug, metabolites or formulation excipients

          -  Malignancy within 5 years prior to screening, with the exception of specific cancers
             that are cured by surgical resection (basal cell skin cancer, etc). Participants under
             evaluation for possible malignancy are not eligible.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Phase 2 Efficacy, Safety, and Tolerability Study of Natalizumab in Focal Epilepsy
Condition: Epilepsy, Focal Seizures, Partial Seizures
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Natalizumab; Placebo
Intervention description: As specified in the treatment arm.; As specified in treatment arms.
Intervention MeSH terms: Natalizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a 6-month randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of natalizumab as adjunctive therapy in the treatment of adult subjects with drug-resistant focal epilepsy. The placebo-controlled phase is followed by a 6-month open-label phase during which all subjects receive natalizumab.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Double-blind
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Drug Resistant Focal Epilepsy, Natalizumab, Seizure

Summary:

      The primary efficacy objective of the study is to determine if adjunctive therapy of
      natalizumab 300 mg intravenous (IV) every 4 weeks reduces the frequency of seizures in adult
      participants with drug-resistant focal epilepsy. The secondary efficacy objective is to
      assess the effects of natalizumab versus placebo in drug-resistant focal epilepsy on
      additional measures of seizure frequency.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have focal epilepsy diagnosed on clinical grounds and as applicable supported by
             electroencephalogram findings [Scheffer 2017] and brain imaging. Participants with
             multifocal epilepsy may be included if all other entry criteria are met.

          -  Must have a drug-resistant epilepsy defined as failure of adequate trials of 2 (or
             more) tolerated and appropriately chosen and used AEDs (whether as monotherapies or in
             combination) [Kwan 2010].

          -  Experiences 6 or more seizures during the 6-week prospective baseline period and is
             not seizure free for more than 21 consecutive days during the prospective baseline
             period

        Key Exclusion Criteria:

          -  Focal aware seizures without motor signs are the only seizure type.

          -  Diagnosis of generalized, combined generalized and focal, or unknown epilepsy

          -  Known progressive structural CNS lesion.

          -  History of seizures occurring in predominantly clustered patterns, as determined by
             the Investigator, over the 12 months prior to the Screening Visit (Week -6) or during
             the 6-week prospective baseline period, where individual seizures cannot be counted.

          -  History of status epilepticus within the previous 6 months.

          -  Known history or presence of non-epileptic seizures.

        NOTE; Other protocol defined Inclusion/Exclusion criteria may apply
Topical Use of Vancomycin in Reducing Sternal Wound Infection in Cardiac Surgery (SWI Trial)
Condition: INFECTION
MeSH terms: Infections; Communicable Diseases; Wound Infection
Intervention: Vancomycin; No Vancomycin
Intervention description: Topical prophylactic antibiotic; Placebo: Sterile water. No Vancomycin.
Intervention MeSH terms: Vancomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1037.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research is to determine if using the antibiotic vancomycin as a
      preventative topical (on the surface of the skin) treatment during open-heart surgery will
      reduce the risk of developing a sternal wound infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to sign Informed Consent and Release of Medical Information Form

          -  Age ≥ 18 years

          -  Undergoing cardiac surgery with complete sternotomy (including re-operations)

        Exclusion Criteria:

          -  Evidence of active infection (any culture positive or blood positive infection)

          -  Undergoing organ transplantation

          -  Patients with known hypersensitivity to vancomycin

          -  Pregnant or nursing women

          -  Mental impairment or other conditions that may not allow participant to understand the
             nature, significance, and scope of study
Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
Condition: Quality of Recovery; Same Day Surgery; Nausea and Vomiting, Postoperative; Vaginal Prolapse
MeSH terms: Uterine Prolapse; Vomiting; Prolapse; Postoperative Nausea and Vomiting
Intervention: Dexamethasone; Normal saline
Intervention description: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.; Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 51.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Quality of Recovery, Dexamethasone, Same day surgery

Summary:

      To the investigators knowledge there are no studies in the literature evaluating the effect
      of Dexamethasone administration on patients undergoing outpatient vaginal prolapse surgeries.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women over the age of 18

          2. Women scheduled for vaginal POP reconstructive surgery with or without concomitant
             anti-incontinence procedure and with or without hysterectomy

          3. ASA class 1-2

        Exclusion Criteria:

          1. Daily use of steroids, antiemetics in the month prior to surgery

          2. Chronic pain requiring daily opioid treatment

          3. History of allergy/intolerance to Dexamethasone

          4. ASA class 3

          5. Numerical Pain score of more than 4 at baseline

          6. Renal/Liver disease

          7. Diabetes mellitus

          8. Pregnancy

          9. Inability to answer questionnaires

         10. Any systemic infections

         11. Immuno compromised status

         12. Patients with planned overnight stay