bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials
Condition: Hepatitis B Virus; HBV
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Entecavir; Lamivudine
Intervention description: Tablets, Oral, 1.0 mg, once daily; Oral, 100 mg, daily
Intervention MeSH terms: Lamivudine; Entecavir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1053.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to provide entecavir to participants who have completed another
      entecavir trial without achieving virologic response or who relapsed during postdosing
      follow-up.
    

Eligibility criteria:

        Key inclusion criteria:

          -  Age of 16 years and older

          -  Receipt of entecavir or lamivudine in a previous entecavir study.

        Participants who were, based on their response to entecavir:

          -  Virologic nonresponders at Week 48

          -  Partial virologic responders who became nonresponders during the second year of
             treatment

          -  Partial virologic responders at Week 96

          -  Complete responders who relapsed during postdosing follow-up

               -  Decompensated liver disease in AI463-048 that met 1 or more of the following
                  criteria:

          -  Nonresponse to adefovir after at least 24 weeks of treatment

          -  Partial response to adefovir after 96 weeks of treatment

          -  Complete response to adefovir after relapsing during postdosing follow-up

          -  Demonstrated intolerance to adefovir

               -  Except for those participants enrolled from AI463-048, compensated liver disease.

        Key exclusion criteria:

          -  HIV coinfection

          -  Receiving nephrotoxic or hepatotoxic agents

          -  Ongoing opportunistic infections

          -  Hemoglobin level <11.0 g/dL except for those enrolled from AI463-048

          -  Platelet count <70,000 mm^3 except for those enrolled from AI463-048

          -  Absolute granulocyte count <1,500 cells/mm^3

          -  Recent history of pancreatitis (within 24 weeks prior to first dose of therapy)

          -  Current evidence of ascites requiring paracentesis, hepatic encephalopathy, or
             variceal bleeding, except for those enrolled from AI463-048

          -  Known history of allergy to nucleoside analogues.
Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)
Condition: Acute Cough
MeSH terms: Respiratory Tract Infections; Cough
Intervention: Gefapixant; Placebo
Intervention description: Gefapixant 45 mg will be administered orally.; Placebo tablet matching gefapixant will be administered orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant
      (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good general health

          -  Susceptible to human rhinovirus type 16 (HRV-16)

          -  Male or non-pregnant and non-breast feeding female

          -  If female of reproductive potential, agrees to use 1 form of acceptable birth control

        Exclusion Criteria:

          -  Donated blood within 56 days or donated plasma within 7 days prior to dosing

          -  History of significant multiple and/or severe allergies

          -  Recent history of respiratory tract infection

          -  History of cancer

          -  Body mass index <18 kg/m^2 or ≥40 kg/m^2

          -  History of major surgery or loss of 1 unit of blood

          -  History of allergic reaction to sulfonamides

          -  Received medications within 14 days prior to randomization

          -  Significantly abnormal laboratory tests at Screening

          -  Current smoker, smoked within 5 years of Screening, or significant past smoking
             history

          -  History of alcohol or drug abuse
A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Intervention: N-Acetylcysteine; placebo; Contingency Management
Intervention description: 1200 mg twice daily for 8 weeks; 2 capsules twice daily for 8 weeks; rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 116.0
Sex: All
Minimum age: 13 Years
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will
      reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is
      hypothesized that marijuana dependent adolescents who are treated with NAC will use less
      marijuana during treatment when compared to adolescents who receive a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 13-21 years

          -  Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking
             marijuana cessation treatment

        Exclusion Criteria:

          -  Allergy or intolerance to NAC

          -  Pregnancy or lactation

          -  Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if
             taken with NAC) within 14 days of study participation

          -  Current enrollment in treatment for cannabis dependence

          -  Current substance dependence, other than cannabis or nicotine

          -  Significant medical or psychiatric illness that may place the participant at increased
             risk in the judgement of the study physician
Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer
Condition: Esophageal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms; Esophageal Neoplasms
Intervention: Cetuximab,Paclitaxel, Carboplatin
Intervention description: IV treatment for 6 weeks
Intervention MeSH terms: Paclitaxel; Carboplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: esophageal cancer; gastroesophageal cancer; gastric cancer

Summary:

      Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction
      and Gastric Cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients are required to have pathologically confirmed adenocarcinoma or squamous cell
             carcinoma of the esophagus, gastroesophageal junction, or stomach.

          -  Patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric
             lymphadenopathy.

          -  There must be no evidence of distant organ metastases.

          -  No prior radiation for gastric or esophageal cancer.

          -  Patients must be > 18 years of age, and nonpregnant

          -  Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2 x upper
             limit normal (ULN) and bilirubin < 1.5 x ULN, and AST < 3 x ULN.

          -  ECOG performance status 0-2.

          -  Patients must not have significant infection or other coexistent medical condition
             that would preclude protocol therapy.

          -  Female patients, must either be not of child bearing potential or have a negative
             pregnancy test within 7 days of starting study treatment. Patients are considered not
             of child bearing potential if they are surgically sterile (they have undergone a
             hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are
             postmenopausal. Pregnant or lactating females are not eligible.

          -  All patients must sign informed consent

        Exclusion Criteria:

        Any of the following criteria will make the patient ineligible to participate in this
        study:

          -  Acute hepatitis or AIDS.

          -  Active or uncontrolled infection.

          -  Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
             unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
             congestive heart failure, and cardiomyopathy with decreased ejection fraction.

          -  Prior therapy which specifically and directly targets the EGFR pathway.

          -  Prior severe infusion reaction to a monoclonal antibody.

          -  Any concurrent chemotherapy not indicated in the study protocol or any other
             investigational agent(s).
High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Intervention: glucarpidase; leucovorin
Intervention description: IV dose based on weight, two doses given for 5 minutes, 24 hours apart; IV or po given every 6 hours
Intervention MeSH terms: Leucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 7.0
Sex: All
Minimum age: 8 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: osteosarcoma; high dose methotrexate; leucovorin

Summary:

      The purpose of this study is to demonstrate whether use of glucarpidase facilitates
      administration of the next cycle of chemotherapy as scheduled and improves safety and
      tolerability of HDMTX given with LV
    

Eligibility criteria:

        Inclusion Criteria:

          -  osteosarcoma

          -  eligible to receive 2 sequential cycles of HDMTX-LV

        Exclusion Criteria:

          -  prior administration of glucarpidase

          -  progression of disease while on previous MTX treatment
Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty
Condition: Acute Blood Loss Anemia; Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee; Hemorrhage
Intervention: Tranexamic Acid; Placebo
Intervention description: Topical tranexamic acid (2g/100mL 0.9% saline); 100mL 0.9% sterile saline
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tranexamic Acid; Blood transfusion; Total knee arthroplasty

Summary:

      This study aims to assess postoperative blood loss and transfusion rates in total knee
      replacement after one-time administration of topical tranexamic acid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult patients over age eighteen

          -  Primary unilateral total knee arthroplasty at Henry Ford Hospital (Detroit, Michigan,
             United States) and Henry Ford West Bloomfield Hospital (West Bloomfield, Michigan,
             United States)

        Exclusion Criteria:

          -  patient history of venous thromboembolic disease or coagulopathy

          -  use of anticoagulant medications within 7 days of surgery

          -  history of arterial embolic disease

          -  history of Class III or IV heart failure

          -  renal failure

          -  intraoperative cardiovascular, pulmonary, orthopaedic, or anesthetic complication (MI,
             intraoperative fracture, vasopressor support, emergent intubation).
A Study of TAK-994 in Adults With Narcolepsy
Condition: Narcolepsy Type 1 (NT 1)
MeSH terms: Narcolepsy
Intervention: TAK-994; Placebo
Intervention description: TAK-994 tablets.; Placebo-matching tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      Adults with narcolepsy who have completed the TAK-994-1501 study will be able to take part in
      this study.

      The main aim of this study is to check if participants have side effects from TAK-994.

      Participants will take one of 3 different TAK-994 dose for 8 weeks.

      Then, half the participants will continue with their dose of TAK-994 and half will take a
      placebo. In this study, a placebo will look like a TAK-994 tablet but will not have any
      medicine in it. Participants will take TAK-994 or placebo for 4 weeks.

      Participants will visit the clinic for a final check-up 2 weeks after their last dose of
      TAK-994 or placebo.

      The study doctors will check for side effects from TAK-994 and placebo throughout the study.

      Participants will continue to record any narcolepsy symptoms as they did in Part B of the TAK
      994-1501 study.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Participant with a diagnosis of Narcolepsy Type 1 (NT1) who has completed TAK-994-1501
        Part B before enrollment (which will occur immediately following the final TAK-994-1501
        assessments), and for whom the investigator has no clinical objection they be enrolled.

        Exclusion Criteria:

        1. Participant has a clinically significant moderate or severe ongoing AE related to the
        study drug from the prior study.
A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease
Condition: Perianal Crohn's Disease
MeSH terms: Crohn Disease
Intervention: BLI-1300 low dose; BLI-1300 high dose; placebo
Intervention description: topical ointment; topical ointment; topical ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crohn's disease; perianal; inflammatory bowel disease; fistula

Summary:

      This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is
      designed to determine the effects of BLI-1300 ointment on perianal pain associated with
      active Perianal Crohn's Disease (PCD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects must give written informed consent.

          -  Male or female subjects, 18 years of age.

          -  Confirmed diagnosis of Crohn's Disease.

          -  Subject must have a 3 month documented history of perianal Crohn's Disease (PCD) and
             with clinical evidence of active PCD.

          -  Subject must have a Crohn's Disease Activity Index (CDAI) total score of ≤ 350 at
             Visit 2.

          -  Subjects must have a qualifying perianal pain score at Visits 1 and 2.

        Exclusion Criteria:

          -  Women of childbearing potential who are not using adequate contraception.

          -  Women who are pregnant or breastfeeding.

          -  Subjects on unstable regimens of Crohn's therapy (e.g. tumor necrosis factor (TNF)
             inhibitors, immunosuppressants, steroids).

          -  Subjects taking strong analgesics that could interfere with pain measurements.
             Subjects with a perianal abscess requiring incision and drainage.

          -  Subjects with anal stenosis.

          -  Subjects with fistulae outside the immediate perianal area.

          -  Subjects who have had abdominal surgery for Crohn's disease within the past 12 weeks.

          -  Subjects who have had significant anorectal surgery for Crohns disease within the past
             8 weeks.
A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Intervention description: Atezolizumab was given as 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Intervention MeSH terms: Atezolizumab; Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant
      atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant
      therapy consisted of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy
      consisted of up to 12 months of atezolizumab in participants who demonstrate clinical benefit
      with neoadjuvant therapy. All participants who undergo surgery entered a surveillance period,
      which consisted of standardized blood sample collection and Chest CT Scans, for up to 2
      years. All participants were monitored for disease recurrence and survival for up to 3 years
      after last dose of study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically documented Stage IB, II, IIIA, or selected IIIB, including T3N2 or T4
             (by size criteria, not by mediastinal invasion) NSCLC

          -  Adequate pulmonary and cardiac function

          -  Available biopsy of primary tumor with adequate samples

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by
             virtue of N3 disease

          -  Any prior therapy for lung cancer within 3 years.

          -  Prior treatment with anti-PD-1 or PD-L1 therapies

          -  History or risk of autoimmune disease
Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-118 Lotion; Tazorac Cream; IDP-118 Vehicle Lotion; IDP-118 Vehicle Cream
Intervention description: Lotion; Cream; Lotion; Cream
Intervention MeSH terms: Tazarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety and Efficacy of IDP-118 Lotion in the Treatment of Plaque Psoriasis
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female, of any race, at least 18 years of age (inclusive).

          -  Freely provides both verbal and written informed consent.

          -  Has an area of plaque psoriasis appropriate for topical treatment that covers a Body
             Surface Area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms,
             soles, axillae, and intertriginous areas are to be excluded in this calculation.

          -  Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
             radiation (natural and artificial) for the duration of the study.

          -  Has a clinical diagnosis of psoriasis at the Baseline visit with an (IGA) Investigator
             Global Assessment score of 3 or 4. (The face, scalp, palms, soles, axillae and
             intertriginous areas are to be excluded in this assessment, if psoriasis is present.)

        Key Exclusion Criteria:

          -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
             psoriasis, as determined by the investigator.

          -  Presents with psoriasis that was treated with prescription medication and failed to
             respond to treatment, even partially or temporarily, as determined by the
             investigator.

          -  Presents with any concurrent skin condition that could interfere with the evaluation
             of the treatment areas, as determined by the investigator.

          -  Is pregnant, nursing an infant, or planning a pregnancy during the study period.

          -  Has received treatment with any investigational drug or device within 60 days or 5
             drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently
             participating in another clinical study with an investigational drug or device.