bioihbjkbjnl/mcl2 huggingface dataset:
Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
Condition: Advanced Malignant Neoplasm; Dermatologic Complication
MeSH terms: Neoplasms
Intervention: Doxycycline; Management of Therapy Complications; Placebo; Questionnaire Administration; Spironolactone; Sunscreen; Therapeutic Hydrocortisone
Intervention description: Given PO; Moisturizer given topically; Given topically; Ancillary studies; Given topically; Given topically; Given topically
Intervention MeSH terms: Doxycycline; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Spironolactone; Sunscreening Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well giving spironolactone works in preventing
      rash in patients with cancer that has spread to other places in the body and are receiving
      panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor
      (EGFR) inhibitor-induced skin rash.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled to start panitumumab or cetuximab; patients must not have been on the EGFR
             agent prior to randomization

          -  Ability to reliably apply topical spironolactone/placebo twice a day to the face

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  For study 2 only, patients must be willing to avoid sun exposure for one month from
             registration

          -  Creatinine =< 1.5 x upper limit of normal (UNL)

          -  For Study 2 only, ability to apply topical creams to the entire face and body

        Exclusion Criteria:

          -  Prior allergic reaction or severe intolerance to spironolactone

          -  Any rash at the time of randomization

          -  Cutaneous metastases

          -  Any other disorder that may predispose to hyperkalemia in the opinion of the treating
             oncologist

          -  Use of topical corticosteroids at the time of study or their anticipated use in the
             next 8 weeks; (it is acknowledged that patients may be starting these agents
             pre-emptively as part of this protocol)

          -  For study 2 only, previous intolerance of sunscreen or any of the other components of
             the Modified Preemptive Therapy Regimen (a moisturizer or oral doxycycline)
Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Intervention: KAE609; Coartem
Intervention description: Exploration of different doses of KAE609 to establish safety profile.; Control Arm
Intervention MeSH terms: Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomized to KAE609 and Coartem in parallel treatment arms. Increasing doses of KAE609 (single dose and multiple dose) were evaluated in dose escalated manner in sequential cohorts
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: uncomplicated Plasmodium falciparum Malaria.

Summary:

      KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in
      sequential cohorts with increasing doses.This study aims to determine the maximum safe dose
      of the investigational drug KAE609 in malaria patients.
    

Eligibility criteria:

        KEY Inclusion Criteria:

          1. Male and female patients ≥ 18 years with a body weight ≥ 45 kg.

          2. Microscopic confirmation of acute uncomplicated P. falciparum using by Giemsa-stained
             thick film.

          3. P. falciparum parasitaemia of 500 to 50 000 parasites/µL.

          4. Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history
             of fever during the previous 24 hours.

          5. Written informed consent must be obtained before any study assessment is performed. If
             the patient is unable to write, then a witnessed consent according to local ethical
             standards is permitted.

        KEY Exclusion Criteria:

          1. Mixed Plasmodium infections.

          2. Signs and symptoms of severe malaria according to World Health Organization (WHO) 2016
             criteria (WHO 2016).

          3. Known liver abnormalities, liver cirrhosis (compensated or decompensated), known
             active or history of hepatitis B or C (testing not required), known gallbladder or
             bile duct disease, acute or chronic pancreatitis.

          4. Clinical or laboratory evidence of any of the following:

          5. AST/ALT > 1.5 x the upper limit of normal range (ULN), regardless of the level of
             total bilirubin

          6. AST/ALT > 1.0 and ≤ 1.5 x ULN and total bilirubin is > ULN

          7. Total bilirubin > 2 x ULN, regardless of the level of AST/ALT

          8. History of photodermatitis/increased sensitivity to sun.

          9. Pregnant or nursing (lactating) women.

         10. Known disturbances of electrolyte balance, e.g. hypokalemia, hypocalcemia or
             hypomagnesemia.

         11. Moderate to severe anemia (Hemoglobin level <8 g/dL).

        Other protocol-defined inclusion/exclusion criteria may apply
Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant
Condition: A/Vietnam/H5N1 Influenza Virus
MeSH terms: Influenza, Human; Influenza in Birds
Intervention: 7.5 mcg H5N1 (stored as monobulk); 15 mcg H5N1 (stored as monobulk); 90 mcg H5N1 (stored as monobulk); 90 mcg H5N1 (stored in vials); MF59; MF59 (stored as monobulk)
Intervention MeSH terms: MF59 oil emulsion
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 422.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to assess the usability of long-term stored H5N1 antigen
      and adjuvant. The study is designed to assist in stockpile management by assessing the
      safety, reactogenicity, and immunogenicity long-term stored influenza A/Vietnam/H5N1 vaccine
      when administered with or without MF59® adjuvant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or nonpregnant female

          -  Provide written informed consent prior to study-related procedures

          -  Stable health status

          -  Access to consistent and reliable means of telephone contact

          -  Able to understand and comply with planned study procedures

          -  Agree to stay in contact with site, and no plans to move from study area for study
             duration

        Exclusion Criteria:

          -  Allergic to eggs, other vaccine components, or squalene-based adjuvants

          -  Women with positive pregnancy test within 24 hours of vaccination, or are
             breastfeeding

          -  Females of childbearing potential who refuse acceptable birth control, if sexually
             active, have not used birth control for 2 months prior to study entry

          -  Have immunosuppression or use anticancer chemotherapy or radiation therapy within
             preceding 36 months

          -  Have an active neoplastic disease or history of hematologic malignancy

          -  Have long term use (≥14 consecutive days) of glucocorticoids (>20 mg/day) or high-dose
             inhaled steroids (>800 mcg/day) within preceding 6 months

          -  Diagnosis of schizophrenia, bipolar disease, or major psychiatric diagnosis

          -  Have been hospitalized for psychiatric illness, attempted suicide or deemed danger to
             self or others within past 10 years
A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment
Condition: Cerebrospinal Fluid Leaks
MeSH terms: Cerebrospinal Fluid Leak; Intracranial Hypotension
Intervention: TISSEEL
Intervention description: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CT fluoroscopy; epidural patching; spontaneous intracranial hypotension

Summary:

      The goal of this randomized controlled trial (RCT) is to compare the efficacy of CT
      fluoroscopy-guided targeted epidural patching for treatment of imaging-confirmed spinal CSF
      leaks to that of a simulated procedure without patching material in patients with spontaneous
      intracranial hypotension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients meeting International Classification of Headache Disorders 3rd Edition
             (ICHD-3) criteria for a diagnosis of SIH (Table 1) who have had a contrast-enhanced
             brain MRI and a myelogram confirming the presence of a CSF leak will be recruited from
             the Duke Radiology spine intervention clinic [25]

        Exclusion Criteria:

          -  recent (i.e., < 2 weeks) blood patch

          -  contraindication or inability to undergo the procedure

          -  inability to provide informed consent

          -  expected inability to complete follow-up assessment

          -  a contraindication to receiving contrast material (precluding an epidurogram)

          -  contraindication to receiving fibrin glue (i.e., allergy).
Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Enzalutamide; Fulvestrant
Intervention description: 160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.; 500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Female
Minimum age: 18 Years
Maximum age: 101 Years
Healthy volunteers: No
Keywords: ER+/Her2 - breast cancer; Preoperative Fulvestrant; Enzalutamide

Summary:

      This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant
      plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced
      AR+/ER+/Her2- BC who will have local surgery after ~4 months on treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ER+ Her2- breast cancer

          -  Stage at least T2 or greater

          -  Planned to get local surgery

          -  Postmenopausal, or if pre- or peri- menopausal, then will need to have concurrent
             ovarian suppression.

          -  At least 18 years of age

          -  Not on anticoagulants

          -  PS 0-2

          -  Able to swallow study drug and comply with study requirements

          -  ANC >1000/uL, platelets >75,000/uL at screening visit

          -  Total bilirubin < 1.5 times upper limit of normal (ULN) at the screening visit unless
             an alternate nonmalignant etiology exists (eg, Gilbert's disease)

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 times ULN or <
             5 times ULN if patient has documented liver metastases

          -  Creatinine < 1.5 times ULN

          -  INR < 1.5 times ULN, or if on warfarin, can safely transition off for biopsy

          -  Willing to donate blood for research at 4 time points

          -  Willing to undergo core biopsies for research at study entry and at ~4 weeks.

          -  Willing to donate tissue to research from the surgical specimen

          -  Written informed consent obtained prior to biopsies and blood samples

        Exclusion Criteria:

          -  Current or previously treated brain or leptomeningeal metastases

          -  History of seizures

          -  Prior treatment with an anti-androgen (abiraterone, ARN-509, bicalutamide,
             enzalutamide, ODM-201, TAK-448, TAK-683, TAK-700, VT-464).

          -  Systemic estrogens or androgens within 14 days before initiating therapy. Vaginal
             estrogens are allowed if necessary for patient comfort.
The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Intervention: N-acetyl-l-cysteine
Intervention description: 1200 mg BID x 4 weeks
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: uncontrolled; neuropathic pain

Summary:

      This study will test whether treatment with N-acetyl-L-cysteine (NAC) is safe and decreases
      pain in patients with chronic neuropathic pain. The investigators hypothesize that NAC will
      be a useful adjunct to opioid treatment in chronic neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years old

          -  non-cancer neuropathic pain

          -  stable dose of opioids for pain

          -  using breakthrough pain meds

          -  still with persistent pain per VAS

        Exclusion Criteria:

          -  pregnant or nursing

          -  serious medical or psychiatric illness (including uncontrolled hypertension)

          -  active stomach ulcer, history or seizures or asthma

          -  breakthrough pain meds other than opioids

          -  using illicit drugs
PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
Condition: Chronic Kidney Disease Requiring Hemodialysis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: PA21; PA21; PA21; PA21; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 183.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hemodialysis; Hyperphosphatemia

Summary:

      To investigate dose-response efficacy and safety in hemodialysis patients with
      hyperphosphatemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 20 or older, regardless of gender.

          -  Receiving stable maintenance hemodialysis 3 times a week.

          -  Patients not having changed their phosphate binder agent dose, for 4 weeks or more
             before their observation period start.

        Exclusion Criteria:

          -  Patients having history of a pronounced brain / cardiovascular disorder.

          -  Patients having severe gastrointestinal disorders.

          -  Patients having severe hepatic disorders.
Screening Protocol for Preliminary Eligibility Determination for Adoptive Cell Therapy Trials
Condition: Neoplasms
Intervention: Screening Platform
Intervention description: Eligible participants who qualify as per this screening protocol may be referred to evaluate adoptive cell therapy in participants with various malignancies, on a separate treatment trial. No study treatment will be administered in this screening study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No
Keywords: Adoptive T-cell therapy; Hematologic Malignancy; Human leukocyte antigen; Screening study; Solid Tumors; T-cell receptors

Summary:

      This screening study is intended to determine preliminary eligibility of participants who may
      be potential candidates for GlaxoSmithKline's Adoptive T-cell therapy studies by screening
      for appropriate biomarkers. No treatment intervention will occur as part of this screening
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of locally advanced high-risk
             eligible tumor types .

          -  Participant must be greater than or equal to (>=)18 years of age (or >=10 years of age
             with synovial sarcoma or myxoid/round cell liposarcoma [MRCLS])

          -  Participants with life expectancy of greater than 6 months

          -  Performance status: Eastern Cooperative Oncology Group 0-1.

        Exclusion Criteria:

          -  Any prior treatment with oncology cell and/or gene therapy (unless agreed in advance
             with Sponsor)

          -  Prior malignancy not in complete remission.

          -  Clinically significant systemic illness

          -  Serious active infections or significant cardiac, pulmonary, hepatic or other organ
             dysfunction,

          -  Prior or active demyelinating disease

          -  Previous New-York Esophageal Antigen-1 (NY-ESO-1)-specific T cells, NY-ESO-1 vaccine,
             or NY-ESO-1 targeting antibody.

          -  Previous allogeneic hematopoietic stem cell transplant within the last 5 years or
             solid organ transplant.
Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy
Condition: IGA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Intervention: Fostamatinib 150 mg; Fostamatinib 100 mg; Placebo
Intervention description: Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks; Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks; Placebo tablet twice daily by mouth, over the course of 24 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: IGA Glomerulonephritis; Nephritis, IGA Type

Summary:

      The purpose of this study is to determine whether fostamatinib is safe and effective in the
      treatment of IgA Nephropathy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Renal biopsy findings consistent with IgA nephropathy

          -  Treatment with an Angiotensin Converting Enzyme inhibitor (ACEi) and/or an Angiotensin
             II Receptor Blocker (ARB) for at least 90 days at the maximum approved (or tolerated)
             dose

          -  Proteinuria > 1 gm/day at diagnosis of IgA nephropathy and Proteinuria > 0.50 gm/day
             at the second Screening Visit

          -  Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other
             anti-hypertensive agents

        Exclusion Criteria:

          -  Recent use of cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab.

          -  Use of > 15 mg/day prednisone (or other corticosteroid equivalent).
Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and BLOCK Trial
Condition: Cardiac Arrest; Sudden Cardiac Death; Ventricular Fibrillation; Tachycardia, Ventricular
MeSH terms: Heart Arrest; Tachycardia; Death, Sudden, Cardiac; Ventricular Fibrillation; Tachycardia, Ventricular; Death
Intervention: Epinephrine; Metoprolol
Intervention description: Epinephrine (1 mg) IV additional doses; Metoprolol 5 mg IV (up to two times only) instead of epinephrine additional doses
Intervention MeSH terms: Metoprolol; Epinephrine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiac arrest; Sudden Cardiac Death; Ventricular Fibrillation; Pulseless Ventricular Tachycardia; Cardiopulmonary resuscitation

Summary:

      The purpose of this research study is to evaluate the effectiveness of metoprolol, a "beta
      blocker," in treating patients in the hospital with a cardiac arrest. It will be given
      intravenously (given into a vein). The subjects who will take part in this study are 18 years
      of age or older, are experiencing a cardiac arrest in the hospital, and are in a life
      threatening situation. Patients who develop a cardiac arrest require prompt electrical
      defibrillation (electrical shocks) to restore the normal beating rhythm of the heart. In
      patients who do not respond to electrical defibrillation, current standard of care recommends
      the use of medications which have been shown to be of unknown benefit. Some people recover
      from a cardiac arrest, but many people do not. We want to learn whether giving metoprolol
      will improve survival of patients with a cardiac arrest. A total of 100 patients will be
      enrolled in the study. Patients will receive either the standard of care with the drug
      epinephrine or the standard of care plus metoprolol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients age > 18 years of age who develop an in-hospital VF or pVT arrest which
             persists after three or more precordial shocks.

          -  Patients who develop an in-hospital cardiac arrest due to asystole or PEA which
             subsequently converts to VF or pVT will be included.

        Exclusion Criteria:

          -  Pediatric patients

          -  Pregnancy

          -  Age < 18 years of age

          -  Patients who develop VF or pVT in the emergency room, operating room or surgical
             intensive care unit.