bioihbjkbjnl/mcl2 huggingface dataset:
Ambrisentan in Single Ventricle
Condition: Hypoplastic Left Heart Syndrome; Hypoplastic Right-sided Heart Complex
MeSH terms: Univentricular Heart; Hypoplastic Left Heart Syndrome; Dextrocardia
Intervention: Ambrisentan; Placebo
Intervention description: Once daily oral dosing
Intervention MeSH terms: Ambrisentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 24 Months
Maximum age: 120 Months
Healthy volunteers: No
Keywords: Single ventricle

Summary:

      Purpose: To evaluate the pharmacokinetics, bioavailability and hemodynamic efficacy of
      ambrisentan after Fontan surgical palliation of single ventricle heart defects.

      Study activities and population group: Children undergoing Fontan surgical palliation for
      single ventricle defects will be eligible for the study. Up to 20 subjects will be enrolled
      (16 ambrisentan, 4 placebo) and will receive 3 days (3 doses) of ambrisentan starting on
      post-operative day #1 upon returning from the operating room. Ambrisentan plasma levels will
      be obtained at specified time points during treatment. Post-operative monitoring lines will
      be used to measure effects of ambrisentan on hemodynamics and pulmonary / systemic
      endothelial function.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 24 months; ≤120 months.

          2. History of congenital heart disease with severe hypoplasia of a right or left
             ventricle.

          3. Undergoing Fontan surgery as part of standard clinical care.

          4. Availability and willingness of the parent/legally authorized representative to
             provide written informed consent and, as appropriate, assent from the child.

        Exclusion Criteria:

          1. History of serious adverse event related to ambrisentan administration.

          2. History of ambrisentan exposure within 48 hours of the study.

          3. Presence of pulmonary venous obstruction.

          4. Treatment with cyclosporin.

          5. Any of the following - as determined by the attending physician

               -  Significant hemodynamic instability

               -  Sepsis.

               -  Need for ECMO support.

          6. Renal failure defined as serum creatinine > 2 times higher than the upper limit of
             normal.

          7. Liver dysfunction defined as alanine aminotransferase or aspartate aminotransferase >
             3 times higher than the upper limit of normal.

          8. Thrombocytopenia defined as a platelet count < 50 000 cells/µL.

          9. Leukopenia defined as white blood cells < 2500 cells/µL.

         10. Anemia defined as hemoglobin < 8mg/dL.

         11. Atrial hypertension (mean LA pressure > 12mm Hg).
A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
Condition: Cystitis, Interstitial
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: Tanezumab; Tanezumab; Tanezumab; Tanezumab; Placebo
Intervention description: 1 mg dose given subcutaneously twice at an 8-week interval.; 2.5 mg dose given subcutaneously twice at an 8-week interval.; 10 mg dose given subcutaneously twice at an 8-week interval.; 20 mg dose given subcutaneously twice at an 8-week interval.; Placebo dose given subcutaneously twice at an 8-week interval.
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Randomized double blind placebo-controlled parallel-group dose-range finding interstitial cystitis efficacy pain urinary symptoms safety

Summary:

      In a previous study in patients with interstitial cystitis/ painful bladder syndrome
      (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS,
      as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab
      was well tolerated. In this study, the hypothesis being tested is that tanezumab will show
      efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety
      will also be assessed at different dose levels
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months
             with moderate to severe pain and a micturition frequency greater than 7 per day.

          -  Patients who have been on stable oral medicines for interstitial cystitis/ painful
             bladder syndrome for at least 3 months. Other therapies might need to be stopped.

        Exclusion Criteria:

          -  Patients on certain recent treatments for interstitial cystitis/ painful bladder
             syndrome.

          -  Body mass index (BMI) of >39 kg/m2.

          -  History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal
             antibody or IgG-fusion protein.

          -  Patients with peripheral neuropathy.

          -  Patients with Type I or type II diabetes mellitus who have an HbA1c > 8.0%.
Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: Vehicle; ANT-1207
Intervention description: Vehicle for ANT-1207 liniment formulation without active ingredient.; Botulinum toxin Type A topical liniment (ANT-1207).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 145.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment
      of primary axillary hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ages 18 - 70 years of age

          -  diagnosis of primary axillary hyperhidrosis

          -  HDSS score of ≥3

          -  threshold sweat production/axilla in 5 minutes as measured gravimetrically

          -  willingness to shave underarms prior to each study visit

        Exclusion Criteria:

          -  botulinum toxin treatment in the prior 6 months

          -  signs of infection in the axilla

          -  skin affliction in the axilla requiring medical treatment

          -  oral anticholinergic treatment

          -  use of antiperspirants, deodorants, powders, or lotions

          -  use of axillary depilatories or axillary epilation

          -  history of surgery or other interventions for axillary hyperhidrosis

          -  female subjects who are pregnant or are nursing a child
Efficacy and Systemic Safety of Netarsudil 0.01%, 0.02%, 0.04% Relative to Placebo in Subjects With Open-angle Glaucoma or Ocular Hypertension in Japan
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Netarsudil Ophthalmic Solution 0.01%; Netarsudil Ophthalmic Solution 0.02%; Netarsudil Ophthalmic Solution 0.04%; Netarsudil Ophthalmic Solution Placebo
Intervention description: Topical sterile ophthalmic solution; Topical sterile ophthalmic solution; Topical sterile ophthalmic solution; Topical sterile ophthalmic solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 215.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Glaucoma; Ocular Hypertension; Open-Angle Glaucoma

Summary:

      Test ocular hypotensive efficacy and systemic safety of netarsudil 0.01%, 0.02%, 0.04%
      relative to placebo in subjects with open-angle glaucoma or ocular hypertension in Japan
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be 20 years of age or older

          2. Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in both eyes. (OAG
             in one eye and OHT in the fellow eye is acceptable)

          3. BCVA 0.1 or better in decimal unit using Landolt-C chart or its equivalent

          4. Able and willing to give signed informed consent and following study instructions

        Exclusion Criteria:

          1. Clinically significant ocular diseases

          2. Pseudoexfoliation or pigment dispersion component glaucoma, history of narrow angle
             closure glaucoma or narrow angles

          3. Previous glaucoma intraocular surgery

          4. Refractive surgery in either eye

          5. Ocular trauma

          6. Ocular infection or inflammation

          7. Known hypersensitivity to benzalkonium chloride or excipient of netarsudil ophthalmic
             solution

          8. Cannot demonstrate proper delivery of the eye drop

          9. Clinically significant abnormalities in screen lab tests

         10. Clinically significant systemic disease

         11. Participation in any investigational study within 30 days of screening

         12. Women of child-bearing potential who are pregnant, nursing, planning a pregnancy or
             not using a medically acceptable form of birth control
DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
Condition: SARS-CoV-2
Intervention: DUR-928; Placebo
Intervention description: IV infusion; IV infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3:1 randomization DUR-928:placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects
      infected with SARS-CoV-2
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized with moderate, severe, or early critical COVID-19 illness diagnosed by
             RT- PCR

          -  Acute liver injury (including acute on chronic liver disease) or acute kidney injury
             or moderate COVID-19 pneumonia

        Exclusion Criteria:

          -  Critical COVID-19 illness (MAP < 60 mm Hg, on mechanical ventilator for ≥ 5 days)

          -  On maintenance hemodialysis or peritoneal dialysis

          -  Child Pugh C cirrhosis

          -  Hepatorenal syndrome

          -  Ascites and/or hepatic encephalopathy

          -  History of end stage renal disease or CKD with eGFR < 15 mL/min/1.73m2

          -  Women who are pregnant or breast feeding

          -  Receipt of other concomitant experimental therapies
Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System
Condition: Thyroid Carcinoma; Radioactive Iodine Level
MeSH terms: Carcinoma; Thyroid Neoplasms
Intervention: Artificial Tears
Intervention description: Self-Administered - utilizing eye drop preservative free vials
Intervention MeSH terms: Lubricant Eye Drops
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to explore whether administration of preservative free
      artificial tears will decrease the level of detectable radioiodine in the tears and
      nasolacrimal duct system of patients undergoing radioiodine therapy for thyroid carcinoma and
      thus decrease the risk of developing radioactive iodine associated nasolacrimal duct
      obstruction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Radio-iodine therapy for thyroid cancer

          -  Radioiodine therapy ≥100mCi

          -  Patient wears soft contacts on both eyes

        Exclusion Criteria:

          -  Use of eye drops, other than artificial tears

          -  History of periocular trauma with tear duct involvement/lacrimal gland trauma

          -  History of lacrimal drainage disease: canaliculitis, dacryocystitis

          -  Prior radiotherapy

          -  Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)

          -  Medical conditions that predispose to NLD stenosis

               -  Sarcoid

               -  Granulomatosis with polyangiitis

               -  Chronic lymphocytic leukemia
Open-Label Extension Study of Recombinant Human Arylsulfatase A (HGT-1111) in Late Infantile MLD
Condition: Late Infantile Metachromatic Leukodystrophy
MeSH terms: Leukodystrophy, Metachromatic
Intervention: HGT-1111
Intervention description: Patients currently dosed with 100 U/kg or 200 U/kg will continue this treatment. Patients dosed with 50 U/kg will be equally randomized to treatment on 100 U/kg or 200 U/kg. The dose will be adjusted every 6-week to account for changes in body weight.The infusion length will be dependent on the dose. Infusion of 100 U/kg will be diluted in 50 ml isotonic sodium chloride and infused over 30 minutes. Infusion of 200 U/kg will be administered in the same manner except for an infusion time of 60 minutes.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 3 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: Metazyme; Late Infantile Metachromatic Leukodystrophy

Summary:

      This is a multi-center, open-label, extension study of patients with late infantile MLD who
      have previously completed clinical study HGT-MLD-048 (NCT00633139), defined as the completion
      of all Week 52 procedures. This group of patients will be offered ongoing treatment with
      HGT-1111 in this protocol. One infusion will be given every other week until the product is
      commercially available, the patient discontinues, or the study is terminated by the Sponsor,
      provided no safety issues have emerged.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject's legally authorized guardian(s) must provide signed, informed consent prior
             to performing any study-related activities (Trial-related activities are any
             procedures that would not have been performed during normal management of the subject)

          2. Completion of study HGT-MLD-048 (NCT00633139)

          3. The subject and his/her guardian(s) must have the ability to comply with the protocol

        Exclusion Criteria:

          1. Spasticity so severe to inhibit transportation

          2. Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal
             disease or other medical condition that, in the opinion of the Investigator, would
             preclude participation in the trial

          3. Any other medical condition or serious intercurrent illness, or extenuating
             circumstance that, in the opinion of the Investigator, would preclude participation in
             the trial
A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Intervention: Rabeprazole; Rabeprazole; Rabeprazole; Placebo
Intervention description: Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.; Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.; Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.; Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Intervention MeSH terms: Rabeprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 338.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: dyspepsia; rabeprazole; Japan

Summary:

      The purpose of this study is to assess the efficacy and safety of rabeprazole compared to
      placebo in Japanese subjects with Functional Dyspepsia.
    

Eligibility criteria:

        Inclusion criteria:

        -Participants diagnosed as Functional Dyspepsia according to Rome III criteria.

        Exclusion criteria:

          -  Participants with neuropsychiatric disorder.

          -  Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and
             serious constipation.
A Research Study to Characterize the Pharmacodynamics and Safety of Repeat Dose SP-102
Condition: Lumbosacral Radicular Pain
Intervention: SP-102
Intervention description: Injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: lumbosacral radicular pain; sciatica; leg pain

Summary:

      This is an open-label, single-arm, repeat dose study to characterize the pharmacodynamics and
      safety/tolerability of SP-102 administered by epidural injection.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Able and willing to read, write, and understand the English language and provide
             English language written informed consent prior to beginning any study procedures.

          -  Age 18 to 70 years (inclusive) at the Screening Visit.

          -  A diagnosis of lumbosacral radicular pain (sciatica).

          -  Agrees to follow study-specific medication requirements.

          -  If sexually active and a female of child-bearing potential or a male capable of
             bearing a child, agrees to use an effective method of birth control during the study.

          -  Has reviewed all study specific materials and has, in the opinion of the Investigator,
             the abilities to understand and appropriately complete all study procedures.

        Main Exclusion Criteria:

          -  Has radiologic evidence of a condition that would compromise study outcomes.

          -  Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention
             while in the study.

          -  Has been diagnosed with insulin dependent diabetes mellitus.

          -  Presence of any other disorder, condition or circumstance (including secondary gain)
             that, in the opinion of the Investigator, has the potential to prevent study
             completion and/or to have a confounding effect on outcome assessments.

          -  Use of any investigational drug and/or device within 30 days, or is scheduled to
             receive an investigational drug other than blinded study drug during this study.

          -  Has a body mass index ≥40 kg/m2.
Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer; Efficacy
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: cisplatin, dexamethasone,vitamin B12, folic acid; cisplatin, gemcitabine
Intervention description: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment; cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
Intervention MeSH terms: Folic Acid; Vitamin B 12; Dexamethasone; Cisplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC)
      cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient
      administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences
      based on histologic type. The investigators want to research some biomarkers that can predict
      clinical outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chemotherapy-naive patients with histologically or cytologically confirmed
             adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to
             curative treatment or stage IV

          2. With at least one unidimensionally measurable lesion according to the Response
             Evaluation Criteria in Solid Tumors;

          3. with an Eastern CooperativeOncology Group performance status of 0 or 1,

          4. At least 18 years of age

          5. adequate bone marrow reserve and organ function including calculated creatinine
             clearance 45 mL/min based on the standard Cockcroft and Gault formula.

          6. Prior radiation therapy was permitted if it was completed at least 4 weeks before
             study treatment

          7. patients had fully recovered from its acute effects.

        Exclusion Criteria:

          1. peripheral neuropathy > National Cancer Institute Common Toxicity Criteria grade 1

          2. progressive brain metastases,

          3. uncontrolled third-space fluid retention before study entry.

          4. Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or
             if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.