bioihbjkbjnl/mcl2 huggingface dataset:
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation
Condition: CML
Intervention: nilotinib
Intervention description: Nilotinib will be provided as 150 mg capsules. Patients will take nilotinib 300mg twice daily on study and dose modifications to 450mg once daily is permitted per protocol.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CML, chronic myeloid leukemia, stop, niotinib, discontinue, imatinib, switch, MR4.5, undetectable, bcr-abl

Summary:

      To evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in
      patients who achieve MR4.5
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosis of CML

          -  Treated with at least 1 year of imatinib

          -  Bcr-Abl level by PCR must be less than or equal to 0.1% and greater than 0.0032% by
             PCR reported on the International scale confirmed during screening

          -  Written informed consent obtained prior to any screening procedures performed

        Exclusion Criteria:

          -  T315I mutation

          -  Prior imatinib failure or had accelerated phase or blast crisis CML

          -  Impaired cardiac function

          -  Pregnant or lactating women
A Study to Evaluate SAGE-547 in Participants With Severe Postpartum Depression
Condition: Severe Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: SAGE-547; Placebo
Intervention description: Administered as intravenous infusion.; Administered as intravenous infusion.
Intervention MeSH terms: Brexanolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 21.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of
      the efficacy, safety, and pharmacokinetics of SAGE-547 Injection in adult female participants
      diagnosed with severe postpartum depression.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant either must have ceased lactating at Screening; or if still lactating at
             Screening, must have already fully and permanently weaned their infant(s) from
             breastmilk; or if still actively breastfeeding at Screening, must agree to cease
             giving breastmilk to their infant(s) prior to receiving study drug.

          -  Participant had a major depressive episode that began no earlier than the third
             trimester and no later than the first 4 weeks following delivery, as diagnosed by
             Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).

          -  Participant was less than or equal to (<=) six months postpartum.

          -  Participant must be amenable to intravenous therapy.

        Key Exclusion Criteria:

          -  Active psychosis.

          -  Attempted suicide associated with index case of postpartum depression.

          -  Medical history of seizures.

          -  Medical history of bipolar disorder.

        Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/exclusion
        criteria may apply.
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Capecitabine; Exemestane; Everolimus
Intervention description: Capecitabine, tablets for oral use, 1250 mg/m² twice daily for 2 weeks followed by one week rest (3-week-cycle) (locally supplied); Exemestane, tablets for oral use, 25 mg per day in (locally supplied); Everolimus, 5 mg tablets for oral use, 10 mg (2 x 5 mg) per day (centrally supplied)
Intervention MeSH terms: Capecitabine; Everolimus; Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 309.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Everolimus; Exemestane; Capecitabine; locally advanced; metastatic; breast cancer; breast cancer positive for human epidermal growth factor receptor 2; HER2; HER2 positive; breast cancer progression; estrogen-receptor positive breast cancer; ER

Summary:

      This was a three-arm, randomized, open label, multi-center phase II study investigating the
      combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg
      daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with
      estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or
      progression on letrozole or anastrozole.
    

Eligibility criteria:

        Key Inclusion Criteria:

        - Women with locally advanced, recurrent, or metastatic breast cancer along with
        confirmation of estrogen-receptor positive (ER+). Measurable disease defined as at least
        one lesion ≥ 10 mm by CT or MRI that can be accurately measured in at least one dimension
        (CT scan slice thickness ≤ 5 mm) OR • Bone lesions: lytic or mixed (lytic + blastic) in the
        absence of measurable disease as defined above.

        Key Exclusion Criteria:

        - Patients who received more than one chemotherapy line. Patients with only non-measurable
        lesions other than lytic or mixed (lytic and blastic) bone metastasis.Previous treatment
        with exemestane, mTOR inhibitors, PI3K inhibitors or AKT inhibitors.
Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)
Condition: Adjunctive Treatment of Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Pimavanserin; Placebo
Intervention description: Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.; Placebo, taken as two tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
Intervention MeSH terms: Pimavanserin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the efficacy of pimavanserin compared to placebo when given adjunctively to a
      selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor
      (SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and an
      inadequate response to antidepressant therapy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients, aged 18 years and above

          2. A clinical diagnosis of major depressive disorder (MDD)

          3. Is being treated with one of the following SSRI or SNRI antidepressants as
             monotherapy:

               -  Citalopram

               -  Escitalopram

               -  Paroxetine

               -  Fluoxetine

               -  Sertraline

               -  Duloxetine

               -  Venlafaxine

               -  Desvenlafaxine

               -  Venlafaxine XR

          4. Has a history of inadequate response to antidepressant treatments

        Exclusion Criteria:

          1. Patient has a psychotic disorder other than MDD

          2. Patient has current evidence of a serious and/or unstable neurologic, cardiovascular,
             respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder,
             including cancer or malignancies, which would affect the patient's ability to
             participate in the program

          3. Patient has a history or symptoms of long QT syndrome

        Patients will be evaluated at screening to ensure that all criteria for study participation
        are met. Patients may be excluded from the study based on these assessments (and
        specifically if it is determined that their baseline health and psychiatric condition do
        not meet all pre-specified entry criteria).
Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas
Condition: Glioblastoma; Glioma
MeSH terms: Glioblastoma; Glioma
Intervention: Selinexor
Intervention description: One cycle is 28 days (4 weeks).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GBM; Glioblastoma; selinexor; KPT-330; Karyopharm; brain tumor; brain cancer; Glioma; Astrocytoma; Oligodendrogliomas; Oligo-astrocytomas

Summary:

      This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral
      selinexor in participants with recurrent gliomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed GBM (including all histologic variants) at first diagnosis
             with radiographic evidence of recurrent disease after treatment with radiotherapy and
             temozolomide;

          -  18 years of age or older

          -  Participants enrolling in the medical arm (Arms B, C and D) must be on a stable or
             decreasing dose of corticosteroids (or none) for at least 5 days prior to the baseline
             MRI;

          -  Measurable disease (according to RANO guidelines)

          -  Surgical arm (Arm A) must be predicted pre-operatively to have sufficiently sized
             tumor to be resected and provide tissue samples for exploratory assessments.

        Exclusion Criteria:

          -  Markedly decreased visual acuity if attributed to other causes than GBM.

          -  Known active hepatitis A, B, or C

          -  Participants with coagulation problems and medically significant bleeding in the month
             prior to start of treatment (e.g., peptic ulcer, epistaxis, spontaneous bleeding).
             Prior history of DVT or PE is not exclusionary.

          -  Participants must not have significantly diseased or obstructed gastrointestinal
             tract, malabsorption, uncontrolled vomiting or diarrhea, or inability to swallow oral
             medications.

          -  Prior treatment with bevacizumab or other direct VEGF/ VEGFR inhibitors. For any
             question of the definition of a direct VEGF/VEGFR inhibitor, consult Sponsor.

          -  Arms C and D only: body surface area < 1.2 m².

          -  < 24 days from prior temozolomide, < 6 weeks from nitrosourea, < 4 weeks from other
             chemotherapy or investigational agents prior to start of treatment within study.
A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer
Condition: Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: brivanib (active)
Intervention description: Tablet, Oral, Brivanib 800 mg, once daily, until progression
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the
      growth of advanced liver cancer. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of hepatocellular carcinoma (HCC) ≥ 2cm based on:

          -  Biopsy OR

          -  Radiological evidence of HCC by contrast-enhanced CT scan or contrast-enhanced AND

          -  Blood test positive for Hepatitis B or C AND

          -  Alpha fetoprotein above > 400 mg/L

          -  Not appropriate for curative surgery

          -  Screening Blood Pressure <150/100 mmHg, Left Ventricular Ejection Fraction (LVEF) >50%

        Exclusion Criteria:

          -  Heart Attack within 12 months, uncontrolled chest pain within 6 months

          -  Ascites resistant to diuretic medication therapy

          -  Portal-systemic encephalopathy

          -  Portal hypertension with bleeding esophageal or gastric varices within the past 2
             months

          -  Deficiency of sodium in the blood with sodium < 125 mEq/L

          -  Subjects with serious non-healing wounds, ulcers or bone fractures
Synergistic Pharmacologic Intervention for Prevention of ROP (SPIPROP Study)
Condition: Retinopathy of Prematurity
MeSH terms: Retinopathy of Prematurity
Intervention: Caffeine citrate; Ibuprofen; Ketorolac
Intervention description: Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose); Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days; Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days
Intervention MeSH terms: Ibuprofen; Ketorolac; Caffeine; Caffeine citrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Maximum age: 28 Weeks
Healthy volunteers: No

Summary:

      Phase 2, open-label, randomized, multi-center studies in infants and premature infants are
      necessary to determine treatment and preventative strategies for ROP. This study was designed
      to: a) target infants at the highest risk of ROP in a large number of centers with variable
      rates of ROP (all stages and severe ROP or stage 3+); and b) assess whether caffeine plus
      systemic or ophthalmic NSAID will decrease ROP among infants most at risk for ROP. The study
      is designed to determine whether the novel treatment regimens are safe and potentially
      effective for ROP prevention and to obtain requisite data for the development of a Phase III
      efficacy/safety randomized blinded trial. Since caffeine is used extensively in NICUs as
      standard of care for ELGANs, no placebo group is included.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neonates at high risk for ROP as outlined by the American Academy of Pediatrics,
             Section on Ophthalmology; American Association for Pediatric Ophthalmology and
             Strabismus; and American Academy of Ophthalmology (129) will be enrolled. Inclusion
             criteria are:

               1. all infants with a birth weight of less than 1250 grams;

               2. all infants with a gestational age of 28 weeks or less; and

               3. all infants who required oxygen therapy and ventilator support within the first 2
                  days of life.

        Exclusion Criteria:

          -  Exclusion criteria are:

               1. major congenital malformations and or chromosomal anomalies including
                  duct-dependent cardiac anomalies;

               2. maternal antenatal NSAID exposure <72 hours before birth;

               3. renal failure or oliguria defined as a urine flow rate <0.5 mL/kg/hour in the 8
                  hours prior to randomization. Anuria is acceptable if infant is less than 24
                  hours of life;

               4. platelet count <75,000.mm3;

               5. clinical bleeding such as oozing from puncture sites; and

               6. participation in other clinical drug trials while subject participates in this
                  study and for 7 days after last dose of study drug.
Translational Neuropsychopharmacology Research of Nicotine Addiction
Condition: Nicotine Dependence, Cigarettes
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline (VRN); N-Acetylcysteine (NAC); Placebo
Intervention description: VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.; NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment; Matched placebo
Intervention MeSH terms: Acetylcysteine; Varenicline; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will examine the effects of combining Varenicline (VRN) and N-acetylcysteine (NAC)
      on neural circuitry function and treating nicotine addiction. Healthy adult nicotine
      dependent cigarette smokers interested in quitting (n=110) will be randomized to one of four
      PBO-controlled conditions for 4 weeks: 1) VRN+NAC, 2) VRN+PBO, 3) NAC+PBO or 4) PBO+PBO.
      Following 1 week of medication, participants will be contingently reinforced for 3 days of
      smoking abstinence and be scanned using functional magnetic resonance imaging (fMRI)
      techniques, while nicotine deprived during a resting state and a cue-reactivity (CR) task.
      Participants will be followed over the next 3 weeks of treatment and clinical variables will
      be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 - 55

          2. Right Handed

          3. English fluency

          4. 20/20 vision with corrective lenses.

          5. Smoke ≥ 10 cigarettes/day for a minimum of two years and have an expired carbon
             monoxide (CO) concentration of ≥ 10 ppm (to confirm inhalation).

          6. Interest in quitting smoking or contemplating a quit attempt in the next 6 months

          7. If female, agreement to use birth control

        Exclusion Criteria:

          1. Past head injury or primary neurological disorder associated with MRI abnormalities,
             including dementia, MCI, brain tumors, epilepsy, Parkinson's disease, or demyelinating
             diseases

          2. Any physical or intellectual disability affecting completion of assessments

          3. Any contraindication to MRI

          4. Positive urine drug screen for illicit substances (such as marijuana or cocaine).

          5. Current or past psychosis

          6. Electroconvulsive therapy in last 6 months

          7. Use of antidepressant medications or other psychotropic medications in the last month.

          8. Positive urine pregnancy test or current breast feeding status
Follicle Stimulating Hormone (FSH) to Improve Testicular Development in Men With Hypogonadism
Condition: Hypogonadism; Kallmann Syndrome
MeSH terms: Kallmann Syndrome; Hypogonadism
Intervention: Testicular biopsy; gonadotropin releasing hormone (GnRH); follicle stimulating hormone (FSH)
Intervention description: Outpatient surgical procedure.; Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump titrated to reach normal serum testosterone levels); 75 IU subcutaneous injection daily for four months.
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Male reproduction hormones; Hypogonadotropic hypogonadism; FSH; LH; GnRH

Summary:

      Men with idiopathic hypogonadotropic hypogonadism (IHH, Kallmann Syndrome) may have small
      testicular size, low testosterone levels, no history of puberty, and infertility. These men
      lack a hormone called gonadotropin releasing hormone (GnRH) that stimulates the development
      and maturation of the testes. This study will investigate the impact of hormonal treatments
      on men with IHH. The goal of hormonal therapy is to maximize the potential fertility in these
      individuals.
    

Eligibility criteria:

        Inclusion Criteria

          -  no history of spontaneous puberty

          -  clinical hypogonadism

          -  infantile testes (< 3 ml)

          -  no reproductive hormone therapy except testosterone

          -  Complete absence of normal LH pulses during 12-hour baseline frequent blood sampling
             and serum testosterone < 100 ng/dl

          -  Normal testing of the anterior pituitary gland

          -  Negative MRI of the hypothalamic-pituitary area

        Exclusion Criteria

          -  Prior therapy with gonadotropins (FSH, hCG, or GnRH)
Adjunctive Therapeutic Treatment With Human Monoclonal Antibody AR-105 (Aerucin®) in P. Aeruginosa Pneumonia
Condition: Pseudomonas Aeruginosa Pneumonia
MeSH terms: Pneumonia; Pseudomonas Infections
Intervention: AR-105; Placebo
Intervention description: monoclonal antibody; matching placebo (+ SOC antibiotics)
Intervention MeSH terms: Anti-Bacterial Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pseudomonas aeruginosa; pneumonia

Summary:

      Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic
      of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia
      caused by P. aeruginosa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent

          -  ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only)

          -  pneumonia due to P. aeruginosa

          -  mechanically-ventilated

          -  intubated

          -  APACHE II score between 10 and 35

        Exclusion Criteria (main criteria):

          -  being moribund

          -  effective antibiotic therapy ≥48 hours

          -  immunocompromised

          -  underlying pulmonary disease that may preclude the assessment of a therapeutic
             response