bioihbjkbjnl/mcl2 huggingface dataset:
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant
Condition: End Stage Liver Disease; Hepatitis C
MeSH terms: Hepatitis C; Liver Diseases; End Stage Liver Disease
Intervention: Treatment with Direct Acting Antiviral tablet
Intervention description: HCV Treatment for 12 Weeks
Intervention MeSH terms: Antiviral Agents
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV; Epclusa; ESLD

Summary:

      This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to
      HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV
      transmission upon transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient is Age ≥ 18 years

          -  Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver
             transplant

          -  HCV naïve

          -  Able to sign informed consent

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Human immunodeficiency virus (HIV) positivity

          -  Need for dual organ transplant

          -  Any contra-indication to liver transplantation per center protocol
Immunologic Basis of Anti-IgE Therapy (Study II: On Patients With Asthma)
Condition: Asthma; Allergic Rhinitis; Atopic Dermatitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Dermatitis
Intervention: Omalizumab; Placebo
Intervention description: Xolair (Omalizumab) will be given by subcutaneous injection according to Ige level and weight calculation.; Placebo, given by subcutaneous injection.
Intervention MeSH terms: Omalizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to look at measures that will help scientists understand the way
      Omalizumab, an FDA-approved anti-allergy medication, works.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild or moderate persistent asthma

          -  Allergic rhinitis

          -  Atopic dermatitis

        Exclusion Criteria:

          -  Other lung diseases

          -  Blood clotting disorder

          -  Pregnant or lactating women
Immune Intervention With Rituximab to Preserve Beta Cell Function in Early Onset Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: rituximab
Intervention description: anti-CD20 monoclonal antibody 125mg/m^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)
Intervention MeSH terms: Rituximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 120.0
Sex: All
Minimum age: 8 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: type 1 diabetes; age; course of disease; autoantibodies; C-peptide levels

Summary:

      Transient elimination of B lymphocytes with anti-CD20 monoclonal antibody would decrease
      immune-mediated destruction of beta cells and result in preserved beta-cell function in
      patients with type 1 diabetes of recent onset.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of type 1 diabetes

          -  The age of subjects between 8 and 70 years old

          -  Course of disease within 12 months

          -  Presence of at least one type of detectable islet autoantibody [zinc transporter 8
             antibody(ZnT8A),glutamic acid decarboxylase antibody(GADA),protein tyrosine
             phosphatase-2 antibody(IA-2A),insulin autoantibody(IAA)]

          -  Fasting C-peptide levels of at least 0.2 pmol/mL

        Exclusion Criteria:

          -  Confirmed diagnosis of type 2 diabetes

          -  Severe chronic or acute complications of diabetes

          -  Severe infection or damage to the immune response

          -  Presence of chronic latent infection in vivo

          -  Viral hepatitis B patients whose hepatitis B virus(HBV)DNA > log10^5

          -  Liver and kidney dysfunction, alanine aminotransferase(ALT), aspartate
             aminotransferase(AST), and creatinine more than 2 times the upper limit of normal

          -  Hypotension, systolic blood pressure(SBP) ≤ 90mmHg, diastolic blood pressure(DBP) ≤
             60mmHg

          -  Patients with rheumatoid arthritis

          -  Allergic to any component of this drug

          -  Pregnancy, breast-feeding women

          -  Use of other immunosuppressive agents 3 months before selected
Terconazole Vaginal Suppository vs Fluconazole for the Treatment of Severe Vulvovaginal Candidiasis
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Intervention: Terconazole Vaginal Suppository; Fluconazole
Intervention description: Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days; orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Intervention MeSH terms: Fluconazole; Terconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 140.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No

Summary:

      The objectives of this study were to demonstrate comparable safety and efficacy of
      Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with
      severe vulvovaginal candidiasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Vulvovaginal candidiasis infection is diagnosed, the symptoms evaluated using a
             numerical rating system based on severity (absent=0; mild=1; moderate=2; severe=3)
             with a minimum VVC Composite Signs/Symptoms score of 7

          -  Subject completes the informed consent process

          -  Subject agrees to take study medication when scheduled

          -  Subject complies with all clinical trial instructions. Commits to all follow-up visits

          -  Subject agrees to abstain from sexual intercourse from the time of randomization
             through the first seven days immediately following treatment

        Exclusion Criteria:

          -  had any other sexually transmitted disease or gynaecological abnormality requiring
             treatment

          -  had a disease known to predispose to candidiasis such as diabetes mellitus, or were
             receiving antibiotics or corticosteriods

          -  had used antifungal medication in the week before entry; or

          -  were expected to menstruate within seven days of the start of treatment

          -  infected more than one candida species
The Effect of Upneeq (Oxymetazoline Hydrochloride 0.1%) on Eyelid Position, Eye Redness, and Eye Appearance
Condition: Ptosis, Eyelid; Conjunctiva Inflamed; Eye Manifestations
MeSH terms: Blepharoptosis; Eye Manifestations; Conjunctivitis
Intervention: Oxymetazoline hydrochloride 0.1% ophthalmic solution; Placebo
Intervention description: One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye.; One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye.
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the research is to see if Upneeq ( oxymetazoline 0.1% ophthalmic solution) has
      an effect on eyelid position, eye redness, or patient-perceived appearance of the eyes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults age 18 and above able to provide informed consent to participate

          -  Subject with stable ocular health, defined as no ocular conditions requiring ongoing
             topical therapy or recent surgical intervention

        Exclusion Criteria:

          -  Adults unable to consent

          -  Individuals less than 18 years of age

          -  Prisoners

          -  Pregnant women.

          -  Known contradictions or sensitivities to study medication (oxymetazoline)

          -  Ocular surgery within the past 3 months or refractive surgery within the past six
             months

          -  Grossly abnormal lid margins, anatomical abnormalities, previous eyelid or orbital
             surgery

          -  Variable ptosis or eyelid position (e.g., myasthenia gravis, thyroid eye disease, or
             blepharospasm)

          -  Any ocular or systemic condition that, in the opinion of the investigator, would
             confound study data, interfere with the subject's study participation, or affected the
             subject's safety or trial parameters

          -  Presence of an active ocular infection

          -  Prior (within 5 days of beginning study treatment) use of eye whiteners (eg,
             vasoconstrictors), decongestants, antihistamines (including over the counter and
             herbal topical ophthalmic medications), phenylephrine dilating drops, any other
             topical ophthalmic agents

          -  Inability to sit comfortably for 15 - 30 minutes
Randomized Trial of Wound Infiltration With Extended-release Bupivacaine Before Laparoscopic or Robotic Hysterectomy
Condition: Pain, Postoperative; Surgical Procedure, Unspecified
MeSH terms: Pain, Postoperative
Intervention: Liposomal Bupivacaine; Bupivacaine HCl
Intervention description: pre-incision infiltration with liposomal bupivacaine; pre-incision infiltration with bupivacaine HCl
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 64.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Laparoscopy; Robotic Surgical Procedures; Hysterectomy; Anesthetics, Local; Bupivacaine; Pain, Postoperative

Summary:

      The investigators are studying ways to improve pain control after surgery. One way to
      decrease pain is to inject incisions with a numbing medicine (local anesthetic) while in the
      operating room. There is an FDA approved extended-release version of a commonly used local
      anesthetic (bupivacaine) that can last for 4 days instead of 6 hours. The investigators are
      studying whether using the extended-release medication (Exparel) will give better pain relief
      after laparoscopic and robotic-assisted hysterectomies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Benign indication for surgery

          2. Planned multiport laparoscopic or robotic assisted hysterectomy

          3. Non-pregnant

          4. Able to provide informed consent

          5. Owns smartphone or computer with internet access

          6. Willing to provide contact phone number and accept SMS text messages

          7. Ability to speak and read English (because texts and online surveys will be in English
             only)

        Exclusion Criteria:

          1. Planned additional procedures (e.g. incontinence surgery, prolapse repair or bowel
             surgery)

          2. Contraindication to study drug

               1. Severe Hepatic disease

               2. Severe Kidney disease

               3. Current use of monoamine oxidase inhibitors

               4. Current use of tricyclic antidepressants

          3. History of substance or alcohol abuse within the past 2 years
Clinical Outcomes Mandible: Buffered 1% vs. Non-Buffered 1% Lidocaine
Condition: Anesthesia, Local
Intervention: Lidocaine
Intervention description: Efficacy for mandibular molar and canine anesthesia
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Masking description: double blind
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: lidocaine, mandible

Summary:

      Assess the clinical impact of Buffered 1% lidocaine with epinephrine as compared to the
      Non-buffered 1% lidocaine with epinephrine in dental and oral surgical procedures.
    

Eligibility criteria:

        Inclusion Criteria:

        Age 18-30 years American Society Anesthesiologists I,II

        Exclusion Criteria:

        Allergy to lidocaine class of anesthetic drugs Local anesthetic drug use in past week
        Current symptoms in teeth or oral mucosa
Effectiveness, Safety, and Health-Related Outcomes of NUEDEXTA® in Nursing Home Patients With Pseudobulbar Affect (PBA)
Condition: Pseudobulbar Affect (Involuntary Laughing and/or Crying)
Intervention: NUEDEXTA®
Intervention description: NUEDEXTA® only
Intervention MeSH terms: Quinidine; Dextromethorphan
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: PBA; involuntary crying; involuntary laughing

Summary:

      6 month study of NUEDEXTA ® (Dextromethorphan Hydrobromide and Quinidine Sulfate) for the
      treatment of Pseudobulbar Affect (PBA) in Nursing Home Patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of a neurological disorder affecting the brain (e.g. Alzheimer's and other
             dementias, stroke, Trauma Brain Injury, Multiple Sclerosis, Amyotrophic Lateral
             Sclerosis, Huntington's disease, Parkinson's disease) of at least 3 months duration
             prior to baseline and which is not rapidly progressing

          -  Diagnosis of Pseudobulbar Affect (PBA)

          -  A Center for Neurologic Study-Lability Scale (CNS-LS) score of 13 or greater at
             Baseline

          -  Minimum Data Set (MDS) information for patient available within 60 days prior to
             Baseline

          -  Informant who is willing to comply with study procedures

        Exclusion Criteria:

          -  Patients who have received NUEDEXTA® in the past 1 year

          -  Patients with the diagnosis of Severe Depressive Disorder that would interfere with
             the conduct of the study

          -  Patients who have a history of schizophrenia spectrum and other psychotic disorders

          -  Patients with co-existent clinically significant or unstable systemic diseased that
             could confound the interpretation of the safety results of the study (e.g.,malignancy,
             poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal
             or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or
             unstable valvular heart disease)

          -  Patients with myasthenia gravis
Study of Nivolumab for Advanced Cancers in India
Condition: Non-Small Cell Lung Cancer (NSCLC); Non-Small-Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Kidney Cancer; Kidney Neoplasms; Renal Cancer; Renal Neoplasms
MeSH terms: Lung Neoplasms; Neoplasms; Carcinoma, Non-Small-Cell Lung; Kidney Neoplasms
Intervention: Nivolumab
Intervention description: specified dose on specified days
Intervention MeSH terms: Nivolumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study of nivolumab in participants with advanced Non-Small Cell Lung Cancer or
      Kidney Cancer in India.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior
             chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

          -  Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to
             randomization

        Exclusion Criteria:

          -  Participants with untreated, symptomatic central nervous system (CNS) metastases

          -  Participants with carcinomatous meningitis

          -  Participants with active, known or suspected autoimmune disease

          -  Participants with a condition requiring systemic treatment with either corticosteroids
             or other immunosuppressive medications

          -  Other active malignancy requiring concurrent intervention

        Other protocol defined inclusion/exclusion criteria could apply
Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.
Condition: Clostridium Difficile
MeSH terms: Clostridium Infections
Intervention: Bezlotoxumab
Intervention description: Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group compared to concurrent and historical control groups
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: clostridium difficile; diarrhea

Summary:

      This study will examine whether the human monoclonal antibody, bezlotoxumab administered
      AFTER acute Clostridioides difficile (C.diff) has resolved, but during a period of subsequent
      antibiotic therapy, will eliminate the high risk of C. diff relapse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  C diff diagnosed within 90 days

          -  Receipt of high-risk antibiotics for C diff (e.g. Beta-lactams, carbapenems) in an
             inpatient setting

          -  Age 60 years and older

        Exclusion Criteria:

          -  Receipt of current C.diff active antibiotics (oral vancomycin, fidaxomycin,
             metronidazole, tigecycline/ doxycycline, nitazoxanide, rifamycin) within 72hrs.

          -  Not Expected to survive 8 weeks

          -  Prior or planned fecal microbiota transplant or Bezlotoxumab use

          -  Congestive heart failure (a potential risk of Bezlotoxumab)
Fibrinolysis Compared to Thoracoscopy for Pleural Infection
Condition: Pleural Infection; Empyema; Pleural Diseases; Parapneumonic Effusion
MeSH terms: Infections; Communicable Diseases; Empyema; Pleural Diseases
Intervention: tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase); Medical Thoracoscopy
Intervention description: Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose; Medical thoracoscopy will be performed as per standard protocols.
Intervention MeSH terms: Plasminogen; Tissue Plasminogen Activator
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this prospective randomized clinical trial is to compare two currently
      accepted standard-of-care treatment strategies: Medical thoracoscopy as compared to
      instillation of intrapleural tissue Plasminogen Activator (TPA) and human recombinant
      Deoxyribonuclease (DNase) for the management of empyema or complicated parapneumonic effusion
      (CPPE) in adults.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects >18 years old with:

        Evidence of empyema or complex parapneumonic effusion

        Exclusion Criteria:

        Age <18 years Pregnancy Inability to give informed written consent Previous thoracic
        surgery or thrombolytic therapy for pleural infection Medical thoracoscopy cannot be
        performed within 48 hours Hemodynamic instability or severe hypoxemia Non corrected
        coagulopathy Homogeneously echogenic effusion on pleural ultrasonography
Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide; Abiraterone; Placebo for Enzalutamide; Prednisone
Intervention description: 160 mg by mouth once daily; 1000 mg by mouth once daily; Sugar pill manufactured to mimic Enzalutamide 40 mg capsule; 5 mg by mouth twice daily
Intervention MeSH terms: Prednisone; Prednisolone; Abiraterone Acetate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 509.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if continued treatment with Enzalutamide is
      effective in patients with metastatic prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men with metastatic castration-resistant prostate cancer

          -  Progressive disease on androgen deprivation therapy

          -  Patients must agree to continue androgen deprivation therapy with a GnRH
             agonist/antagonist throughout the study or have had a prior bilateral orchiectomy

          -  ECOG performance score ≤ 1

          -  Estimated life expectancy of ≥ 12 months

        Exclusion Criteria:

          -  Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone, or
             enzalutamide for the treatment of prostate cancer

          -  Prior participation in a clinical trial of an investigational agent that inhibits the
             androgen receptor or androgen synthesis (unless the treatment was placebo)

          -  History of brain metastasis, active leptomeningeal disease or seizure

          -  Severe cardiovascular or hepatic disease

          -  Pituitary or adrenal dysfunction