bioihbjkbjnl/mcl2 huggingface dataset:
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Condition: Feeding; Difficult, Newborn; Growth Failure; Necrotizing Enterocolitis; Sepsis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing; Premature Birth; Birth Weight; Failure to Thrive
Intervention: Lactobacillus reuteri; Placebo
Intervention description: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day; Oil drops without Lactobacillus reuteri
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 134.0
Sex: All
Minimum age: 1 Day
Maximum age: 3 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Probiotics; Lactobacillus reuteri; Prematures; Enteral feeding; Motility; Necrotizing enterocolitis; Sepsis; Weight

Summary:

      Mortality and incidence of severe complications is still high among extremely premature
      infants. Common causes of severe complications in this population are poor nutrition,
      necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common
      problem resulting in prolonged need for intravenous lines and poor nutrition.

      The aim of the study is to evaluate whether supplementation with the probiotic bacterium
      Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight
      increases feeding tolerance to breast milk and thereby improves nutrition, increases growth
      and reduces serious complications and mortality in this population. Beyond this, possible
      mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Birth weight < 1000 g

          -  Gestational age: v23+0-V27 +6.

          -  Age < 72 hours at inclusion.

          -  Signed informed consent by parents.

        Exclusion Criteria:

          -  Fatal or complex congenital malformation at inclusion time.

          -  Chromosomal defect at inclusion time.

          -  No realistic hope of survival at inclusion time.

          -  Gastrointestinal malformation at inclusion time.

          -  Participation in another study which aims to influence nutrition, growth, feeding
             tolerance or necrotizing enterocolitis.
Phase II Dasatinib Study in Advanced Breast Cancer
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Dasatinib
Intervention description: An initial dose of 50 mg PO BID; following 4 weeks of treatment, dose adjustment will be based on inhibition of phosphorylation of FAK and paxillin per biopsy assessment, as well as toxicity assessment.
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Breast Cancer; Breast cancer; Dasatinib; Inoperable Stage III Breast Cancer; Metastatic Breast Cancer; Stage IV Breast Cancer

Summary:

      The purpose of this study is to find out if dasatinib will safely reduce the size or spread
      of your tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Measurable Stage IV or inoperable Stage III advanced breast cancer.

          -  There is no limit on the number of prior therapies.

          -  At least 3 weeks since prior chemotherapy, biological or hormonal therapy.

          -  At least 2 weeks since surgical biopsy.

          -  At least 3 weeks since major (open thoracic/abdominal/cardiac) surgery.

          -  No central nervous system (CNS) metastases except solitary brain metastasis

          -  No cardiac dysfunction

          -  left ventricular ejection fraction (LVEF) ≥ 50% as determined by multiple gated
             acquisition scan (MUGA)/echocardiogram

          -  Adequate blood counts

          -  Normal liver and kidney function

          -  Negative serum pregnancy test.

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Pregnant or breast feeding.

          -  Prior treatment with dasatinib.

          -  Bone as the only site of disease.

          -  Significant gastrointestinal bleeding

          -  Septicemia, infection, acute hepatitis, hypokalemia, or hypomagnesemia
A Comparison of Ketamine Infusion Versus Placebo in Opioid Tolerant and Opioid Naive Patients After Spinal Fusion
Condition: Spinal Fusion
Intervention: Ketamine; Saline
Intervention description: 0.12 mg/kg/hr of ketamine post surgery; Saline will be administered at the same rate as the ketamine infusion.
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 129.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The aim of the proposed study is to examine the effectiveness of low dose postoperative
      ketamine infusion as an analgesic adjuvant to morphine pca in opioid tolerant and opioid
      naïve patients after major spine surgery. Primary endpoints of the study are to determine the
      effectiveness of postoperative ketamine infusion in for the reduction of postoperative pain
      and opioid requirements.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult and teenage (>/=16) male or female who will undergo surgery for multilevel (>4
             level) spinal fusion from a posterior approach with general anesthesia, and who are
             fluent English speakers such that they can complete the pain score and satisfaction
             questionnaires whose scores are a critical outcome variable.

          -  If female, subject is non-lactating and is either:

          -  Not of childbearing potential

          -  Of childbearing potential but is not pregnant at time of baseline as determined by
             pre-surgical pregnancy testing.

          -  Subject is ASA physical status 1, 2, or 3.

        Exclusion Criteria:

          -  anxiety

          -  psychiatric disorder

          -  Allergy or sensitivity to ketamine or dilaudid

          -  Deemed un-acceptable by study team

          -  Cognitively impaired (by history)

          -  Subject requires chronic antipsychotic medication

          -  Subject known to be in liver failure

          -  Subject for whom opioids or ketamine are contraindicated

          -  Patients with narrow angle glaucoma

          -  Patients with a history of psychosis
Stereotactic Radiosurgery and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Intervention: radiation therapy; stereotactic radiosurgery
Intervention description: No more than 2 weeks later, patients undergo conventional radiotherapy once daily, 5 days a week, for 6 weeks.; stereotactic radiosurgery to high-risk areas of active tumor determined by MR-spectroscopy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Summary:

      RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and
      cause less damage to normal tissue. Radiation therapy uses high-energy x-rays to kill tumor
      cells. Giving stereotactic radiosurgery together with radiation therapy may kill more tumor
      cells.

      PURPOSE: This phase II trial is studying how well giving stereotactic radiosurgery together
      with radiation therapy works in treating patients with glioblastoma multiforme.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed grade IV malignant glioblastoma multiforme

               -  Diagnosis by surgical biopsy or resection within the past 5 weeks

          -  Post-operative diagnostic contrast-enhanced MRI scan with MR spectroscopy must be
             performed prior to initiating study treatment

               -  High-risk area of active tumor without margin by MR spectroscopy

                    -  Meets the following criteria for radiosurgery:

                         -  Maximum diameter ≤ 40 mm

                         -  Located > 5 mm from the optic nerve or chiasm

                         -  Does not involve the brainstem

          -  No multifocal or recurrent malignant glioma

        PATIENT CHARACTERISTICS:

        Performance status

          -  Karnofsky 50-100%

        Life expectancy

          -  At least 3 months

        Hematopoietic

          -  Not specified

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Other

          -  Not pregnant

          -  Negative pregnancy test

        PRIOR CONCURRENT THERAPY:

        Chemotherapy

          -  At least 6 weeks since chemotherapy

          -  Concurrent chemotherapy allowed

        Endocrine therapy

          -  Concurrent steroids allowed, but at the smallest therapeutic dose possible

        Radiotherapy

          -  No prior in-field radiotherapy to the head and neck

        Surgery

          -  See Disease Characteristics

          -  Recovered from prior surgery or any post-operative complication

        Other

          -  Concurrent antiseizure medications allowed
Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Intervention: Degarelix mid-luteal, 2.5 mg; Placebo
Intervention description: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.; Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 85.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Assisted Reproductive Technology (ART); oocyte donors undergoing controlled ovarian hyperstimulation for assisted reproductive technologies

Summary:

      The main purpose of this clinical research study is to investigate if degarelix can
      synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the
      lining of the womb.
    

Eligibility criteria:

        Inclusion Criteria

          -  Signed Informed Consent Form, prior to screening evaluations

          -  In good physical and mental health

          -  Pre-menopausal females between the ages of 18-35 years (both inclusive) at the time of
             randomisation

          -  Regular menstrual cycles of 26-35 days duration (both inclusive), presumed to be
             ovulatory

          -  Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive)

          -  Willing to donate the retrieved oocytes

          -  Willing to use an adequate barrier method of contraception from informed consent to
             Day hCG injection +7 and to use an adequate barrier or hormonal method of
             contraception from Day hCG injection +7 to the end-of-study visit

        Exclusion Criteria

          -  Abnormal karyotype

          -  Any known clinically significant systemic disease (e.g., insulin dependent diabetes)

          -  Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or
             kidney) which can compromise participation in the study

          -  Diagnosed with polycystic ovarian syndrome or endometriosis stage III/IV

          -  Diagnosed as "poor responder"

          -  History of recurrent miscarriage (defined as three consecutive spontaneous losses
             before weeks 24 of pregnancy)

          -  Pregnancy or lactation

          -  Use of any investigational drug during 3 months prior to start of the current COH
             cycle

          -  Previous participation in the study

          -  Hypersensitivity to any trial product
SER-109 Versus Placebo to Prevent Recurrent Clostridium Difficile Infection (RCDI)
Condition: Clostridium Difficile
MeSH terms: Clostridium Infections
Intervention: SER-109; Placebo
Intervention description: SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.; Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study will involve administering the study drug as a single dose of study drug or
      placebo. This study is designed to demonstrate the superiority of the experimental drug
      versus placebo in adult patients with recurrent CDI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent, indicating that the patient understands the purpose of and
             procedures required for the study. Patients who are unable to provide informed consent
             will not be included in the study.

          2. Male or female patients ≥ 18 years.

          3. ≥ 3 episodes of CDI within the previous 9 months, inclusive of the current episode
             with documentation of ≥ 2 episodes.

        Exclusion Criteria:

          1. Female patients who are pregnant, breastfeeding, lactating, or planning to become
             pregnant during the study.

          2. Known or suspected toxic megacolon and/or known small bowel ileus.

          3. Active irritable bowel syndrome with diarrhea within the previous 12 months.

          4. Major gastrointestinal surgery (eg, significant bowel resection or diversion) within 3
             months before enrollment (this does not include appendectomy or cholecystectomy) or
             any history of total colectomy or bariatric surgery.

          5. History of inflammatory bowel disease (ulcerative colitis, Crohn's disease,
             microscopic colitis) with diarrhea believed to be caused by active inflammatory bowel
             disease in the past 24 months.

          6. Admitted to or expected to be admitted to an acute care facility or intensive care
             unit for medical reasons (not just boarding). Patients discharged from an acute care
             facility before Day 1 or residing in nursing homes or rehabilitation facilities may be
             enrolled.

          7. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for
             active malignancy (patients on maintenance chemotherapy may only be enrolled after
             consultation with medical monitor).
A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion
Condition: Brain Contusion
MeSH terms: Brain Contusion; Contusions
Intervention: BIIB093; Placebo
Intervention description: Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Intervention MeSH terms: Glyburide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96
      when compared to placebo.

      The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status,
      functional outcomes, and treatment requirements, to further differentiate the mechanism of
      action of BIIB093 on contusion expansion by examining differential effects on hematoma and
      edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to
      placebo.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of brain contusion with lesions within the supratentorial brain
             parenchyma totaling >3 mL in volume per Investigator assessment of baseline
             non-contrast computed tomography scan (NCCT) at Screening.

          -  A score of 5 to 15 on the Glasgow Coma Scale (GCS).

          -  Functionally independent, in the opinion of the Investigator, prior to index head
             injury.

        Key Exclusion Criteria:

          -  In the judgment of the Investigator, participant is likely to have supportive care
             withdrawn within 24 hours.

          -  Indication for immediate evacuation of IPH or DC.

          -  Clinical signs of brainstem herniation, in the opinion of the Investigator.

          -  NCCT or magnetic resonance imaging (MRI) evidence of penetrating brain parenchyma.
             Cerebrospinal fluid leak in isolation is not exclusionary unless evidence of
             parenchymal penetration by an external force (e.g., blunt object, bullet, or depressed
             skull fracture).

          -  Any presence of midbrain or posterior fossa injury as assessed by imaging and clinical
             examination.

          -  Presence of concomitant spinal cord injury as assessed by imaging and clinical
             examination.

          -  Life-threatening or nonsurvivable polytrauma, per Investigator's judgment.

          -  Use of novel oral anticoagulants (NOACS; including direct thrombin inhibitors such as
             dabigatran, or Factor Xa inhibitors such as rivaroxaban or apixaban), in preceding 3
             days prior to the injury, if known.

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
Condition: Bladder, Neurogenic
MeSH terms: Urinary Bladder, Neurogenic
Intervention: tamsulosin hydrochloride
Intervention description: oral
Intervention MeSH terms: Tamsulosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: tamsulosin; pediatric; neurogenic bladder

Summary:

      Aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and
      evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in
      children with a neuropathic bladder, over the course of 12 months of active treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neuropathic bladder secondary to known neurological disorder

          -  Elevated detrusor leak point pressures (LPP) ≥40 cm H2O confirmed by two measurements
             at baseline

        Exclusion Criteria:

          -  Clinically significant abnormalities as determined by the investigator

          -  A history of relevant orthostatic hypotension, fainting spells or blackouts
Dabigatran Etexilate in Patients With Mechanical Heart Valves
Condition: Heart Valve Diseases
MeSH terms: Heart Valve Diseases
Intervention: warfarin 1mg; dabigatran etexilate intermediate dose; dabigatran etexilate low dose; warfarin 5mg; dabigatran etexilate high dose; warfarin 3mg
Intervention description: comparator warfarin; active treatment (medium); active treatment (low); comparator warfarin; active treatment (high); comparator warfarin
Intervention MeSH terms: Warfarin; Dabigatran
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 328.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical
      heart valve.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients aged 18-75

          2. Patients who have received a bileaflet mechanical heart valve

        Exclusion criteria:

          1. Prior valve surgery

          2. Uncontrolled hypertension

          3. severe renal impairment

          4. active liver disease

          5. increased risk of bleeding