bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Uracyst to Treat Interstitial Cystitis/Painful Bladder Syndrome
Condition: Interstitial Cystitis; Painful Bladder Syndrome
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome; Pain
Intervention: 2% sodium chondroitin sulfate; Placebo
Intervention description: Weekly 20 mL Intravesical instillation; The identical buffer used in Uracyst for the same administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 98.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bladder Pain; GAG replacement therapy; IC/PBS

Summary:

      A new device for interstitial cystitis is compared to inactive control to determine if it is
      safe and effective. The study lasts approximately 7 weeks with a 19-week follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are a female, 18 years or older

          -  Have been diagnosed with IC/PBS

          -  Are willing to provide written informed consent and authorization to disclose after
             being fully informed of the risks of participation

        Exclusion Criteria:

          -  Are lactating females

          -  Have previously received investigational products or devices within 30 days of
             screening

          -  Have previously received Uracyst

          -  Are currently receiving therapy with Interstim®

          -  Have any other condition/disease which, in the opinion of the investigator, could
             compromise subject safety or confound the interpretation of study results

          -  Are unable or unwilling to comply with protocol requirements
Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
Condition: Congenital Heart Defect; Surgery-Induced Tissue Adhesions; Hemorrhage
MeSH terms: Heart Defects, Congenital; Hemorrhage; Tissue Adhesions
Intervention: CoSeal Surgical Spray Group
Intervention description: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
Patients weighing < 3kg will receive 1ml of CoSeal
Patients weighing 3-10kg will receive 1-2ml of CoSeal
Patients weighing >10kg will receive 2-4ml of CoSeal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 35.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the
      effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on
      the formation of mediastinal and pericardial adhesions in children undergoing staged surgical
      reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn
      Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated
      by drainage post-operatively through surgical site drainage output.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have an acceptable surrogate capable of giving consent on the subject's behalf.

          -  Pediatric patients ages 0 - 17

          -  Have a cardiac disease which requires staged cardiac surgery and resternotomy

          -  Non-emergent state or emergent state with sufficient time to educate and consent

        Exclusion Criteria:

          -  An immune system disorder

          -  Unplanned reoperation

          -  Known hypersensitivity to components in CoSeal

          -  Patients undergoing reoperation less than 3 months after the primary surgery
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
Condition: Urinary Tract Infection; Vesicoureteral Reflux
MeSH terms: Urinary Tract Infections; Gastroesophageal Reflux; Vesico-Ureteral Reflux
Intervention: Sulfur hexafluoride type-a lipid microspheres
Intervention description: Used as a contrast to enhance renal ultrasound
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 8 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal
      ultrasound.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent

          -  Age more than or equal to 8 years

          -  Patient with history of urinary tract infection (UTI) and history of Voiding
             Cystourethrogram (VCUG) for vesicoureteral reflux

          -  Candidate for Dimercaptosuccinic acid (DMSA) scan or scan for renal scar

          -  Demonstration of renal scarring by DMSA scan or renal ultrasound without contrast

        Includes healthy volunteers

        Exclusion Criteria:

          -  Age less than 8years

          -  Allergy to contrast or related products

          -  Cardiac shunt/ congenital heart anomalies

          -  Abnormal baseline ECG

          -  Open heart surgery

          -  Evidence of retinopathy

          -  Patient in intensive care

          -  Unable to comply with study requirement

          -  History of emphysema

          -  Unable to maintain oxygen saturation of 92% on at room air

          -  Pregnancy and lactation
SGI-110 in the Treatment of Advanced Hepatocellular Carcinoma (HCC)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: SGI-110
Intervention description: SGI-110 will be administered by subcutaneously (SC) on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity
Intervention MeSH terms: Guadecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Phase 2 open-label, single-arm, non-randomized study in the treatment of advanced
      hepatocellular carcinoma (HCC) patients who failed prior treatment with sorafenib using a
      Simon's 2-stage design. A set minimum number of patients must demonstrate disease control at
      16 weeks to proceed to Stage 2. At Stage 2, a set number of patients must have disease
      control at 16 weeks to declare that SGI-110 is of interest in the treatment of advanced HCC
      after failure of prior sorafenib.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older

          2. Histological or cytological confirmed hepatocellular carcinoma with advanced stage
             disease

          3. Received prior sorafenib treatment, and showed evidence of disease progression, which
             is defined as Investigator verified radiologic progression, or intolerance of prior
             systemic therapy, which is defined as having had clinically significant adverse events
             that persisted despite one or more dose reductions or interruptions

          4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          5. Acceptable organ function

          6. Signed an approved informed consent

        Exclusion Criteria:

          1. Known hypersensitivity to SGI-110

          2. Adequate washout of prior radiation, chemotherapy or other locoregional therapy

          3. Abnormal left ventricular ejection fraction

          4. Uncontrolled ischemic heart disease or a history of congestive cardiac failure

          5. Known brain metastases

          6. Clinically evident ascites

          7. Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points

          8. Prior malignancy, except for adequately treated basal cell or squamous cell skin
             cancer, in situ cervical cancer, non-metastatic prostate cancer with normal
             prostate-specific antigen (PSA) or other cancer from which the subject has been
             disease free for at least three years

          9. Known history of human immunodeficiency virus (HIV)
A Safety and Effectiveness Study of Intraspinal Gabapentin (MDT2004) for the Treatment of Chronic Pain
Condition: Chronic Intractable Pain
MeSH terms: Pain, Intractable
Intervention: Intraspinal Gabapentin
Intervention description: Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs.
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and minimum effective dose of
      intraspinal gabapentin when delivered through an implanted drug infusion system.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic pain below the neck present for a minimum of one year.

          -  Diagnosis of at least one of the following:

               -  back pain with or without leg pain,

               -  post-herpetic neuralgia,

               -  complex regional pain syndrome (CRPS) 1 or 2,

               -  diabetic neuropathy,

               -  or a general neuropathic condition; medically stable and able to undergo surgery
                  for implantation of the drug infusion system.
Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes
Condition: Infertility
MeSH terms: Infertility
Intervention: ultrasound guided aspiration of hydrosalpingeal fluid
Intervention description: Under deep sedation, the retrieval of oocytes is done and then an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . If there are bilateral hydrosalpinges, the process is repeated on the opposite side.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Maximum age: 37 Years
Healthy volunteers: No
Keywords: Infertility; Hydrosalpinx; IVF-ET

Summary:

      The aim of this study is to determine whether the ultrasound guided aspiration of
      hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with unilateral or bilateral hydrosalpinges visible by ultrasound

          -  Age between 18 - 37 years

          -  Period of infertility > 1 year

          -  Body mass index between 19-29

          -  Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and
             prolactin concentrations

          -  Normal recent semen analysis (according to World Health Organization criteria)

        Exclusion Criteria:

          -  Uterine fibroid requiring surgical removal

          -  Endometriosis

          -  Male factor of infertility requiring ICSI

          -  Previous IVF cycles

          -  History of recurrent miscarriage

          -  Endocrinologic disorders

          -  Presence of systemic disease contraindicating pregnancy
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF; RBV
Intervention description: SOF administered orally once daily; RBV oral solution or capsules will be administered orally in a divided daily dose based on weight
Intervention MeSH terms: Ribavirin; Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study will have two parts as follows:

      The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and
      confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric
      participants. The PK Lead-in Phase will also evaluate the safety and tolerability of 7 days
      of dosing of SOF+ribavirin (RBV) in HCV-infected pediatric participants.

      The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate SOF
      dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the
      Treatment Phase with no interruption of study drug administration. The Treatment Phase will
      evaluate the antiviral efficacy, safety, and tolerability of SOF+RBV for 12 or 24 weeks in
      pediatric participants with genotype 2 or 3 HCV infection, respectively.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Consent of parent or legal guardian required

          -  Chronic HCV infection genotype 2 or 3

          -  Screening laboratory values within defined thresholds

          -  PK Lead-in only: all individuals must be treatment naive

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol

          -  Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus

          -  Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)

          -  Pregnant or nursing females

          -  Known hypersensitivity to study medication

          -  Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Mirikizumab
Intervention description: Administered IV and SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Interleukin-23 (IL-23) antibody; IL-23p19; Pediatric

Summary:

      This study was designed to evaluate how the body processes and removes mirikizumab. The study
      also evaluated safety and disease response in pediatric participants with UC taking
      mirikizumab. The study lasted about 52 weeks and included up to 18 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants weighing >10 kg

          -  Participants must have a diagnosis of ulcerative colitis for at least 3 months before
             the planned start date for the study medications

          -  Participants must have moderately to severely active UC as defined by a Modified Mayo
             Score (MMS) within 14 days before the first dose of study treatment

          -  Participants must have evidence of UC extending proximal to the rectum

          -  Participants must have demonstrated an inadequate response to, a loss of response to,
             or an intolerance to corticosteroids, immunomodulators, Janus kinase inhibitor
             (JAK-inhibitor) or to biologic therapies for UC

        Exclusion Criteria:

          -  Participants must not have a current diagnosis of Crohn's disease, inflammatory bowel
             disease-unclassified (indeterminate colitis), ulcerative proctitis, or primary
             sclerosing cholangitis

          -  Participants must not have had surgery to remove part of their colon

          -  Participants must not have current evidence of toxic megacolon

          -  Participants must not have received any of the following for treatment of UC:
             cyclosporine or thalidomide within 30 days of screening; corticosteroid enemas,
             corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within
             1 week of screening endoscopy

          -  Participants must not have had an inadequate response to Interleukin-12 p40 subunit
             antibody (anti-IL12p40) (e.g. ustekinumab) or had prior exposure to anti-IL-23p19
             antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab)
t-PA Prophylaxis to Prevent Catheter-associated Thrombosis and Infection
Condition: Central Venous Catheter Thrombosis; Central Venous Catheter Associated Bloodstream Infection
MeSH terms: Infections; Communicable Diseases; Sepsis; Thrombosis; Upper Extremity Deep Vein Thrombosis
Intervention: alteplase (recombinant t-PA); Heparin
Intervention description: Medication administered to dwell in central venous catheter; Medication administered to dwell in central venous catheter
Intervention MeSH terms: Heparin; Tissue Plasminogen Activator
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Centralized pharmacy will prepare and blind the study drug (t-PA) and the control (heparin)
Enrollment: 20.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to test feasibility of concept, consent and enrollment
      rates, and mechanics of study designed to assess if intra-catheter dwells of tissue
      plasminogen activator (t-PA) is effective in decreasing the rate of clinically diagnosed
      central line associated blood stream infection (CLABSI) or venous thromboembolism (VTE) in
      central venous catheters (CVC) compared to standard of care heparin dwell.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 0 - ≤ 18 years old

          -  PICU admission

          -  CVC placed within 72 hours of enrollment (tunneled such as peripherally inserted
             central catheter (PICC), Broviac or Hickman, or untunneled) and in place during
             hospitalization

        Exclusion Criteria:

          -  Pregnancy

          -  Non-English-speaking subjects and/or parent/guardian

          -  Platelet count < 20,000

          -  Active CVC infection-defined as positive blood culture from the in -situ CVC at time
             of enrollment

          -  Current radiographically confirmed VTE

          -  Currently receiving treatment doses of anticoagulation (heparin infusion >15U/kg/hr,
             enoxaparin injections >=2mg/kg/day or >=60mg/day)

          -  CVC diameter <1.9 Fr

          -  Current or previous diagnosis of Heparin Induced Thrombocytopenia or allergy to
             heparin or t-PA

          -  Med-a-port catheters
ZACtima FASlodex Trial in Postmenopausal Advance Breast Cancer Patients Instead of ZACtima FASlodex Trial
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: ZD6474 (Vandetanib at the dose of 100 mg); Placebo to match ZD6474 (Vandetanib at the dose of 100 mg); Fulvestrant; ZD6474 (Vandetanib at the dose of 300 mg); Placebo to match ZD6474 (Vandetanib at the dose of 300 mg)
Intervention description: 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first; Placebo of 300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first; All patients will receive fulvestrant Loading Dose (LD). The Loading Dose regimen is 500mg (2 injections) at day 1, followed by 250mg at day 14, 28 and every 28 days thereafter.; 300 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first.; Placebo of 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: No
Keywords: ZD6474; Vandetanib; Zactima; Fulvestrant; Faslodex; Breast Cancer; Advanced, Metastatic; Hormone Receptor Positive; Post-Menopausal Patients; post-menopausal women with hormone receptor positive advanced breast cancer

Summary:

      The primary objective is to assess the event-free survival defined as the time from
      randomisation to progression, death without progression, loss to follow up, whichever
      occurred first..
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post menopausal women with locally advanced or metastatic breast cancer

          -  Patients may have either measurable or non-measurable disease, as defined by RECIST
             criteria

          -  One previous hormone therapy or one previous chemotherapy for advanced disease are
             allowed (patients who have stable but evident disease after chemotherapy are eligible)

          -  estrogen receptor positive ER+ and/or progesterone receptor positive PR+ on primary or
             secondary tumour

        Exclusion Criteria:

          -  Hormone receptor negative tumours (ER and PR negative)

          -  Presence of life-threatening metastatic visceral disease

          -  Significant cardiovascular event (e.g. myocardial infarction, superior vena cava [SVC]
             syndrome, New York Heart Association [NYHA] classification of heart disease ³2) within
             3 months before entry, or presence of cardiac disease that in the opinion of

          -  History of arrhythmia or QTc with Bazett's correction unmeasurable or ≥ 480 msec on
             screening ECG