bioihbjkbjnl/mcl2 huggingface dataset:
Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM)
Condition: Obesity; Glucose Homeostasis; Postmenopausal Symptoms
Intervention: Bazedoxifene/Conjugated Estrogens (BZA/CE); Placebo Oral Tablet
Intervention description: Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.; Daily placebo tablet
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 17.0
Sex: Female
Minimum age: 50 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The goal of this pilot clinical study is to perform a randomized placebo-controlled study to
      assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens
      (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women.
      The recruitment will be performed at Tulane Health Sciences Center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-menopausal women (<5y since final menstrual period) with age between 50-60y

          -  Symptomatic (hot flashes, vaginal dryness) or asymptomatic

          -  BMI 26-45 kg/m2 (Overweight, Obesity I and Obesity II)

          -  Fasting glucose <125mg/dl

          -  Triglycerides <200mg/dl

          -  Normal mammogram within past 12 months

          -  Physician clearance

        Exclusion Criteria:

          -  Amenorrhea from other causes (Hyperandrogenemia and anovulation)

          -  type 2 and type 1 diabetes

          -  Medications: diabetes or diabetic drugs, dyslipidemia, estrogen/progestin therapy,
             antidepressants and antipsychotics, antiretroviral (HIV), oral steroids, weight loss
             drugs

          -  ≤ 3 month washout of birth control pill (often prescribed for postmenopausal symptoms)

          -  Hysterectomy (partial or complete)

          -  Contraindications to estrogen treatment (unusual vaginal bleeding, blot clots, hepatic
             disease, bleeding disorder, past/present history of breast or uterine cancer,
             pregnant, breastfeeding)
Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)
Condition: Bone Infection; Joint Infection
MeSH terms: Infections; Communicable Diseases; Arthritis, Infectious
Intervention: Antibiotics
Intervention description: The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.
Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines.
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1054.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: oral; intravenous; antibiotics; bone; joint; infection

Summary:

      The study will compare the outcomes of treating bone and joint infections with 6 weeks of
      intravenous antibiotics with 6 weeks of oral antibiotic treatment. The trial is of antibiotic
      "strategy" rather than of individual antibiotics. The study will be open label, but the
      primary outcome will be proven failure of infection treatment, determined by pre-established
      objective criteria for treatment failure. The null hypothesis tested is that there will be no
      difference in treatment failure rates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is willing and able to give informed consent for participation in the study. Has a
             bone and joint infection one of the following categories;

               1. Native osteomyelitis.

               2. Native joint septic arthritis.

               3. Diabetic foot infection with osteomyelitis.

               4. Prosthetic joint associated infection.

               5. Discitis/ spinal osteomyelitis/ epidural abscess

          -  Has had at least 48 hours, but not more than 7 days, of IV antibiotic therapy already
             given after definitive surgical management.

          -  Has a clinical diagnosis of bacterial infection (caused by any organism excepting
             mycobacteria).

          -  Is clinically stable in the opinion of the study clinicians, has no further
             interventions to treat acute infection required or planned.

        Exclusion Criteria:

          -  Has Staph aureus bacteraemia.

          -  Has suspected bacterial endocarditis.

          -  Has suspected mediastinal infection.

          -  Has suspected central nervous system infection.
Treatment of Smoking Lapses and Relapses
Condition: Smoking Cessation
MeSH terms: Recurrence
Intervention: nicotine patch, experimental use; nicotine patch, labeled use
Intervention description: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch.; nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 701.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nicotine dependence; smoking cessation; lapse; relapse; tobacco; nicotine patch; nicotine replacement therapy; NRT

Summary:

      Many smokers who try to stop smoking with nicotine medications (NM) such as gum, lozenge and
      patch, go back to smoking (i.e., a slip or lapse). Currently, labeling on many NM products
      tells smokers who lapse while using NM to stop NM. However, some studies suggest it is safe
      to continue NM upon a lapse and that doing so dramatically increases success at quitting. The
      investigators will test this by doing a randomized trial in which all treatment and measures
      are done from home with paper, phone or computer surveys. The investigators will recruit
      smokers who want to quit, provide them with 10 weeks of nicotine patch treatment and 5 weeks
      of counseling. One group will be asked to stop use of the patch if they lapse and the other
      group will be asked to continue use of the patch if they lapse. The investigators will
      compare the groups on their success at quitting and side-effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 18 years old

          -  daily smoker of 10 or more cigarettes per day for at least 1 year

          -  state they plan to probably or definitely quit smoking in the next month

          -  have a home or cell phone

          -  willing to use nicotine patch

          -  good command of written and spoken English

          -  weigh at least 100 pounds

          -  US citizen or permanent resident alien

        Exclusion Criteria:

          -  use of non-cigarette tobacco in the last month

          -  use of a smoking cessation medication or smoking cessation counseling in the last
             month

          -  medical contraindication to use of patch

          -  other person in household already in our study

          -  previously a participant in the study

          -  currently pregnant or breast feeding

          -  plan to become pregnant in the next 6 months

          -  regularly works the overnight shift

          -  use of electronic cigarettes in the last month
Subcutaneous Rehydration Compared to Intravenous Rehydration
Condition: Dehydration
MeSH terms: Dehydration
Intervention: recombinant human hyaluronidase
Intervention description: 150 Units in 1 mL
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 30 Days
Maximum age: 10 Years
Healthy volunteers: No
Keywords: pediatric; hylenex; subcutaneous infusion; hyaluronidase; rHuPH20; recombinant human hyaluronidase

Summary:

      Randomized (1:1 ratio) study of subcutaneous (SC) versus intravenous (IV) fluid rehydration
      in mildly to moderately dehydrated pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children of either gender from one month to ≤10 years of age.

          -  Patients with mild or moderate dehydration

          -  Healthy child except for the underlying etiology for dehydration

          -  Pre-dehydration body weight ≥ 5th percentile for age

          -  Parents or legal guardian(s) available to provide informed consent.

        Exclusion Criteria:

          -  Severe dehydration

          -  Shock or life-threatening situation (life expectancy < 10 days).

          -  Requirement for IV access for any indication other than for treatment of dehydration.

          -  Indwelling IV catheter, except for one intended only for collection of clinical
             laboratory specimens.

          -  Any condition precluding SC infusion or infusion site evaluation

          -  Any reason (prior to study enrollment) for a hospital admission or an extended stay in
             the ED for other than dehydration.

          -  Known hypersensitivity to hyaluronidase or hylenex.

          -  Known hyponatremia (< 130 milliequivalents per liter [mEq/L]) or hypernatremia (> 155
             mEq/L).

          -  Known hypokalemia (< 3.0 mEq/L).

          -  Any medical condition likely to interfere with the patient's ability to fully complete
             all protocol-specified interventions, the ability to undergo all protocol-specified
             assessments, or likely to prolong the patient's need for medical attention beyond that
             required for treatment of dehydration.

          -  Participation in an investigational drug or device study within 30 days prior to
             enrollment in this study.
Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Brexpiprazole
Intervention description: Oral brexpiprazole tablets as adjunctive therapy to ADT
Intervention MeSH terms: Brexpiprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MDD; Depression; Brexpiprazole

Summary:

      The clinical trial will investigate the effect of brexpiprazole on the concept of life
      engagement in participants with Major Depressive Disorder (MDD) with a current depressive
      episode.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants (outpatients) between the regional age of majority (18 or
             19 years of age) to 65 years of age, inclusive, at the time of informed consent.

          -  Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE)
             as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
             (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an
             inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs
             in their current MDE, including current ADT.

          -  Participants with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the
             screening and baseline visits, if separate.

        Exclusion Criteria:

          -  Participants currently or previously treated with brexpiprazole including participants
             who received brexpiprazole in any prior clinical trial.

          -  Participants with a concurrent DSM-5 diagnosis of the following will be excluded:

               -  Schizophrenia or schizoaffective disorder

               -  Bipolar I or bipolar II disorder

               -  Post-traumatic stress disorder

               -  Dementia

               -  Eating disorder

               -  Borderline personality disorder

               -  Antisocial personality disorder

          -  Participants with a suicidality score of 3 based on Inventory of Depressive
             Symptomatology Self-Report (IDS-SR) suicidality item 18 or participants who, in the
             opinion of the investigator, presents a serious risk of suicide.
Spironolactone After Liver Transplant
Condition: Transplant, Liver
Intervention: Spironolactone
Intervention description: spironolactone 25 mg up to 50 mg
Intervention MeSH terms: Spironolactone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  liver transplant

        Exclusion Criteria:

          -  dual organ transplant
Beta Blockade in in Traumatic Brain Injury
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Intervention: Propranolol
Intervention MeSH terms: Propranolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is test the effect of beta-adrenergic blockade on mortality in
      patients with traumatic brain injury with the hypothesis being that the addition of beta
      blockade to the treatment regime of this patient population will lower mortality and supress
      the catecholamine surge that accompanies traumatic brain injury as compared to those who do
      not receive beta blockade.

      Half the patients will be randomized to receive propranolol and half will be randomized to
      receive no beta blocker.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ages 18 and older with isolated traumatic brain injury as defined by Glasgow
             Coma Scale score 12 or less with documented injury on head CT and limited injury to
             the rest of the body. (Abbreviated Injury Scale (AIS) must be < or = 3 from other body
             areas.)

        Exclusion Criteria:

          -  Subjects <18 years of age, prisoners, those on beta-blockers as home medication, those
             who are pregnant, those with severe liver disease, those taking vasopressors, those
             with acute coronary syndrome, and those with severe injury to another body region (AIS
             >3).

          -  Subjects who cannot be enrolled within 48 hours of admission following acute
             resuscitation will not be enrolled into this study.
Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Nilotinib
Intervention description: A daily dose of 300 mg was given to all participants as two 150 mg capsules BID. The prescription of study drug was not study dependent and followed medical needs of the participant only. The study treatment was administered for 24 months.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 171.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Chronic Myeloid Leukemia; Nilotinib; Molecular Response; MR4.5

Summary:

      The main purpose of this study was to evaluate the rate of deep molecular response (MR4.5)
      after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase
      chronic myeloid leukemia (CML) using EUTOS (European Treatment and Outcome Study for
      CML)-standardized laboratories. All participants received nilotinib 300 mg twice daily (BID).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Patients with newly diagnosed (within 6 months) Philadelphia chromosome positive CML
             in chronic phase

          -  Patients must be previously untreated for CML with the exception of 6 months treatment
             with hydroxyurea and a maximum of 6 weeks treatment with imatinib

          -  Adequate end organ function

          -  Normal serum levels ≥ lower limit of normal (LLN) of potassium, magnesium, total
             calcium corrected for serum albumin or phosphorus, or correctable to within normal
             limits with supplements, prior to the first dose of study medication.

        Key Exclusion Criteria:

          -  Known impaired cardiac function like long QT syndrome, history of myocardial
             infarction or unstable angina in the past 12 months.

          -  Patients who are pregnant or breast feeding.

        Other inclusion/exclusion criteria might apply
The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity
Condition: Rotavirus Infection; Vaccine Response Impaired; Vaccine Virus Shedding
MeSH terms: Rotavirus Infections
Intervention: Rotarix, dose 1; Rotarix, dose 2; Placebo (for Rotarix dose 2)
Intervention description: Rotarix, dose 1; Rotarix, dose 2; Sterile water to provide volume equivalent as a second dose of Rotarix
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Maximum age: 15 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rotavirus; Oral vaccines; Vaccine underperformance; Vaccine shedding

Summary:

      Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines
      work remarkably well in high-income countries, but for unclear reasons they underperform in
      low-income countries. A double-blind, randomized control trial will be performed to evaluate
      whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can
      improve immune responses among infants in Dhaka, Bangladesh.

      Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6
      and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum
      rotavirus-specific IgA responses to determine vaccine immunogenicity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Generally healthy infant (as determined by medical officers)

          2. Age 0-7 days at enrolment

          3. Mother willing and able to provide signed informed consent

          4. Mother willing to allow infant to be vaccinated according to study schedule

          5. Mother willing to allow biological specimens, including blood, stool, and saliva, to
             be collected from infant according to study protocol

          6. Mother willing and able to adhere to study schedule

        Exclusion Criteria:

          1. Obvious congenital malformation

          2. Birth weight (if known) or enrolment weight (if birth weight unknown) < 2000 gm

          3. Known immunocompromising condition in infant

          4. Enrolment in other vaccine research trials

          5. Other household member enrolled in this study
An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 197.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will generate safety data on Nivolumab given by itself in treatment of advanced
      Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related
      side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with
      Nivolumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced or Metastatic renal cell carcinoma (RCC)

          -  Predominant clear cell histology:

               1. At least 1 but no more than 2 prior systemic anti vascular endothelial growth
                  factor (anti-VEGF) treatments

               2. No more than 3 total prior systemic treatment regimens in the advanced or
                  metastatic setting

               3. Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are
                  eligible

          -  Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor

          -  Brain metastases allowed if asymptomatic, without edema, and not receiving
             corticosteroids or radiation

          -  Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)

          -  All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed

        Exclusion Criteria:

          -  Subjects with any active autoimmune disease or a history of known autoimmune disease

          -  History of severe hypersensitivity reaction to other monoclonal antibodies

          -  Prior malignancy, active within the last 3 years, except for locally curable cancers
             which have been apparently cured

          -  Known HIV or AIDS-related illness

          -  Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic
             infection

        Other protocol-defined inclusion/exclusion criteria apply