bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab 3 mg/kg IV; Ipilimumab 1 mg/kg IV; Nivolumab 1 mg/kg IV; Ipilimumab 3 mg/kg IV; Nivolumab 6 mg/kg IV
Intervention description: Followed by Nivolumab monotherapy; Followed by Nivolumab monotherapy; A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to ~ 480mg.
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 387.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate two different dose combinations of nivolumab and
      ipilimumab in the treatment of melanoma.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Subject must have been diagnosed with stage III or/and stage IV histologically
             confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that
             is unresectable or metastatic

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Subject has not been treated by systemic anticancer therapy for unresectable or
             metastatic melanoma

        Exclusion Criteria:

          -  Subjects with active brain metastases or leptomeningeal metastases

          -  Subjects with ocular melanoma

          -  Subjects with active, known or suspected autoimmune disease

        Other protocol defined inclusion/exclusion criteria could apply
An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Nivolumab; Elotuzumab; Pomalidomide; Dexamethasone
Intervention description: Specified dose on specified days, IV (intravenous); Specified dose on specified days, IV; Specified dose on specified days, PO (by mouth); Specified dose on specified days, PO
Intervention MeSH terms: Dexamethasone; Nivolumab; Pomalidomide; Elotuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of several combination
      therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized
      (assigned by chance) to receive either:

      Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone
      OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone.

      Enrollment is closed for all groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Refractory or relapsed and refractory multiple myeloma

          -  Measurable disease

          -  Have received ≥ 2 lines of prior therapy which must have included an immune modulatory
             drug (IMiD) and a proteasome inhibitor alone or in combination

        Exclusion Criteria:

          -  Solitary bone or extramedullary plasmacytoma disease only

          -  Active plasma cell leukemia

        Other protocol defined inclusion/exclusion criteria apply
Efficacy and Safety of Tolvaptan in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease
Condition: Chronic Kidney Disease; Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Renal Insufficiency, Chronic; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Tolvaptan (OPC-41061); Placebo
Intervention description: Tolvaptan tablets (15 or 30 mg) will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later.; Matching placebo tablets will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1370.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Autosomal Dominant Polycystic Kidney Disease

Summary:

      The purpose of the study is to determine whether tolvaptan is effective and safe for the
      treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney
      disease (ADPKD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects with eGFR between 25-65 mL/min/1.73m2 (if aged 18 to55) or
             eGFR between 25-44 mL/min/1.73m2 (if aged 56 to <66)

          -  Tolvaptan naïve

          -  Diagnosis of ADPKD by modified pei-Ravine criteria 1) 3 cysts per kidney by sonography
             or 5 cysts by CT or MRI with family history of ADPKD or 2) 10 cysts per kidney by any
             radiologic method and exclusion of other cystic kidney diseases if without family
             history

        Exclusion Criteria:

          -  Women of childbearing potential who do not agree to practice 2 different methods of
             birth control or remain abstinent during the trial and for 30 days after the last dose
             of Investigational medicinal product (IMP)

          -  Women who are breast-feeding and/or who have a positive pregnancy test prior to
             receiving IMP

          -  Need for chronic diuretic use

          -  Hepatic impairment or liver function abnormalities other than that expected for ADPKD
             with typical cystic liver disease

          -  Advanced diabetes, evidence of additional significant renal disease, renal cancer,
             single kidney, recent renal surgery or acute kidney injury

          -  Contraindications to required trial assessments

          -  Medical history or medical findings inconsistent with safety or compliance with trial
             assessments
Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Placebo; Idalopirdine
Intervention description: Once daily, matching placebo capsules, orally; Once daily, encapsulated tablets, orally
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 858.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic
      treatment of patients with mild-to-moderate Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a knowledgeable and reliable caregiver.

          -  The patient is an outpatient.

          -  The patient has probable AD.

          -  The patient has mild to moderate AD.

          -  Stable treatment with donepezil.

          -  The patient, if a woman, must have had her last natural menstruation ≥24 months prior
             to baseline, OR be surgically sterile.

          -  The patient, if a man, agrees to protocol-defined use of effective contraception if
             his female partner is of childbearing potential, OR must have been surgically
             sterilised prior to the screening visit.

        Exclusion Criteria:

          -  The patient has evidence of any clinically significant neurodegenerative disease, or
             other serious neurological disorders other than AD.

          -  The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition,
             Text Revision (DSM-IV-TR) Axis I disorder other than AD.

          -  The patient has evidence of clinically significant disease.

          -  The patient's donepezil therapy is likely to be interrupted or discontinued during the
             study.

          -  The patient is currently receiving memantine or has taken memantine within 2 months
             prior to screening.

        Other inclusion and exclusion criteria may apply.
Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
Condition: Fluoride Varnish and Oral Health Promotion; Usual Care
Intervention: Fluoride varnish; Oral health education; Dental services delivered by the Indian Health Service.
Intervention description: Fluoride varnish will be administered by the COHS quarterly for 2 years.; Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
Intervention MeSH terms: Fluorides; Fluorides, Topical
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2060.0
Sex: All
Minimum age: 3 Years
Maximum age: 5 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An intensive intervention of specially trained paraprofessionals, called community oral
      health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish
      and oral health promotion education, compared to usual care, will reduce decayed, missing,
      and filled tooth surface measures at 2 years for children in American Indian Head Start
      Programs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children ages 3-5 enrolled in Head Start Centers on a Southwest Indian Reservation and
             having a primary caregiver (preferably mother, or the child's legal guardian as
             documented by the HSC)

          -  American Indian, as defined by the tribe, or

          -  Children of other racial/ethnic groups who are in the Head Start classes on the
             Reservation

          -  Parent/caregiver able to read, understand, and sign the study consent form, and

          -  Willing and able to follow the study procedures and instructions

        Exclusion Criteria:

          -  Allergy to any of the components of the fluoride varnish

          -  Ulcerative gingivitis

          -  Stomatitis

          -  Other conditions resulting in disrupted or irritated oral mucosa

          -  Any other conditions or findings that, in the opinion of the investigators, would
             interfere with or preclude participation in the study.
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
Condition: Pulmonary Hypertension, Familial Persistent, of the Newborn
MeSH terms: Hypertension, Pulmonary; Persistent Fetal Circulation Syndrome; Hypertension
Intervention: placebo; iv sildenafil
Intervention description: IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.; loading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum 48 hours and maximum of 14 days.
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 0 Days
Maximum age: 4 Days
Healthy volunteers: No
Keywords: persistent pulmonary hypertension; newborn; neonates; iv sildenafil; hypoxic respiratory failure and at risk of persistent pulmonary hypertension of the newborn

Summary:

      This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide
      treatment and reduce the failure rate of available treatments for persistent pulmonary
      hypertension of the newborn.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neonates with persistent pulmonary hypertension of the newborn

          -  Age <=96 hours and >=34 weeks gestational age

          -  Oxygenation Index >15 and <60

          -  Concurrent treatment with inhaled nitric oxide and >=50% oxygen

        Exclusion Criteria:

          -  Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary
             resuscitation

          -  Expected duration of mechanical ventilation <48 hours

          -  Profound hypoxemia

          -  Life-threatening or lethal congenital anomaly
Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases
Condition: Spinal Metastases
MeSH terms: Neoplasm Metastasis
Intervention: single-fraction SRS; high-dose hypofractionated SRS; Quality of Life Measures
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stereotactic Radiosurgery (SRS); Single-Fraction; Hypofractionated; Spinal surgery; 14-233

Summary:

      The purpose of this study is to find out whether giving one higher dose of radiation is as
      good at treating the tumor in the patient's spine after surgery as giving three lower doses
      of radiation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically diagnosed metastatic cancer (Diagnosis made or confirmed at MSKCC for
             MSKCC participants. Institutional pathologic determination accepted from participating
             multicenter sites.)

          -  Age ≥18 years

          -  Life expectancy ≥3 months

          -  ECOG ≤ 3

          -  Spinal surgery carried out with the goal of spinal cord decompression and spinal
             stabilization within 8 weeks

          -  Post-operative CT myelogram or MRI perfusion with evidence of separation of tumor and
             the spinal cord It should be noted that patients with multiple lesions will be
             eligible as long as there are no overlapping fields of radiation, including at various
             time frames.

        Exclusion Criteria:

          -  Primary spine tumor

          -  Age < 18

          -  Pregnancy

          -  Lack of adequate (≥ 2 mm) separation between the spinal cord and the tumor on
             post-operative CT myelogram or MRI perfusion

          -  Radiosensitizing chemotherapy (taxol, taxotere, cisplatin, gemcitabine,
             5-fluorouracil) given within one week of radiation treatment
0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka
Condition: Anesthesia
Intervention: Exparel; 0.25% bupivacaine
Intervention description: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty; 0.25% bupivacaine in patients undergoing total knee arthroplasty
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 25.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Total Knee arthroplasty; bupivacaine; anesthesia

Summary:

      Total knee and hip replacements are some of the most common orthopedic procedures that
      require aggressive postoperative pain management. This management helps us to improve
      clinical outcomes such as participation in early physical therapy, hospital discharge, and
      patient satisfaction. Based on the recent anatomical evidence and the investigator's
      knowledge of the complexity of the knee joint innervation the investigator proposes a new
      regional anesthesia technique that provides a complete sensory blockade and better analgesia
      while preserving the quadriceps strength and avoiding the potential for foot drop caused by
      inadvertent blockade of the common peroneal nerve.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing unilateral total knee replacement due to OA or rheumatoid
             arthritis

          -  Ages 40- 80 years old

          -  American Society of Anesthesiologists class I-III

        Exclusion Criteria:

          -  Refusal or absolute medical contraindication to peripheral nerve block

          -  refusal or absolute medical contraindication to spinal anesthesia

          -  conversion of spinal anesthesia to general anesthesia is obtained

          -  inability to cooperate

          -  allergy to any drug used in this study

          -  daily intake of opioids (tramadol, morphine, oxycodone, methadone, fentanyl)

          -  alcohol dependence or use of any illegal drugs within the last month

          -  inability to perform the mobilization test and timed up and go (TUG) test
             pre-operatively
68Ga-PSMA-11 PET in Patients With Prostate Cancer
Condition: Prostate Cancer; Prostate Adenocarcinoma
MeSH terms: Prostatic Neoplasms
Intervention: Ga-PSMA-11
Intervention description: The PSMA Sterile Cold Kit, is a kit comprising all needed materials (lyophilized PSMA for PSMA reconstitution, elution vial for Ga and ancillary materials for transfer between vials) to perform a room-temperature radiolabelling of PSMA-11 with Ga. Ga is not part of the kit and should be provided in the form gallium chloride solution following the requirements of the relevant local regulations. PSMA-11 radiolabelled with Ga is administered in patients with prostate cancer recurrence after radical treatment.
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: Male
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Newly Diagnosed

Summary:

      Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically proven prostate adenocarcinoma

          -  Age ≥ 18 years

          -  Patients already diagnosed with prostate cancer: Primary Staging: intermediate and
             high-risk patients per NCCN guidelines

          -  Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or
             radiation therapy (external beam or brachytherapy):

             a. Post radical prostatectomy (RP) - AUA recommendation i. PSA greater than or equal
             to 0.2 ng/mL measured more than 6-13 weeks after RP and confirmed by a second
             determination of a PSA level of >0.2 ng/mL b. Post-radiation therapy - ASTRO-Phoenix
             consensus definition i. Nadir + greater than or equal to 2 ng/mL rise in PSA

          -  Ability to understand a written informed consent document, and the willingness to sign
             it.

        Exclusion Criteria:

          -  Unable to lie flat, still or tolerate a PET/CT scan, or any other condition that would
             preclude PET/CT imaging.

          -  Patients with any medical condition or circumstance that the investigator believes may
             compromise the data collection or lead to a failure to fulfil the study requirements.

          -  Patients with known hypersensitivity to the active substance or to any of the
             excipients of the investigational product.
A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals); Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray; Placebo
Intervention description: Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.; Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.; Placebo nasal spray administered once daily (4 actuations) for 14 days.
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 727.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Rhinitis; Seasonal Allergic Rhinitis; Fluticasone furoate; Equivalence; Hay fever

Summary:

      This study compared the safety and efficacy of a generic fluticasone furoate (Lek
      Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal
      allergic rhinitis. Additionally both the test and the reference formulations were tested for
      superiority against a placebo nasal spray.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of
             2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in
             season at the time the study is being conducted.

          -  Signed informed consent (assent) form.

          -  Documented positive allergic skin test to local pollen.

          -  An average score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS)
             with a minimum score of at least 2 for "nasal congestion" and at least 4 on the
             reflective Total Ocular Symptom Score (rTOSS).

        Exclusion Criteria:

          -  History of asthma that required chronic therapy (with the exception of occasional
             acute or mild exercise induced asthma).

          -  Some other past and concomitant medical conditions, prohibited medications.

          -  Upper respiratory tract infection or any untreated infections.

          -  Patient has started immunotherapy/changed the dose.

          -  Any known allergy to any of the components of the study nasal spray.