bioihbjkbjnl/mcl2 huggingface dataset:
One-year, Open Extension to Evaluate the Treatment of Patients With Castration-Resistant Prostate Cancer With YONSA™
Condition: Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: abiraterone acetate with Methylprednisolone
Intervention description: YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Abiraterone Acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an open-label, single-arm, multi-center extension study to evaluate safety in
      patients with mCRPC of YONSA 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid).
      Patients will have successfully completed an 84-day treatment with abiraterone acetate in a
      previous trial. Results from the final visit of the previous study will be used to determine
      patient's eligibility for this study. Patients in this study will be eligible to receive
      open-label YONSA with methylprednisolone for up to 12 months. Pharmacodynamic parameters of
      serum testosterone and PSA levels will be monitored. Disease progression will be assessed by
      PCWG2 criteria.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful completion of 84 days of treatment with YONSA in Churchill Pharmaceuticals
             clinical trial, CHL-AA-201

          -  Last dose of YONSA or Zytiga within 45 days prior to treatment in this study

          -  Written informed consent obtained prior to any study-related procedure being performed

          -  Has in the investigator's opinion, the potential to gain clinical benefit with YONSA
             treatment

          -  Ongoing therapy with a GnRH agonist or antagonist AND serum testosterone level <50
             ng/dL at screening

          -  Life expectancy of at least 9 months at screening

          -  Subject is willing and able to comply with all protocol requirements assessments

          -  Agrees to protocol-defined use of effective contraception.

        Exclusion Criteria:

          -  Serious concurrent illness, including psychiatric illness, that would interfere with
             study participation

          -  Inability to swallow tablets whole

          -  Known hypersensitivity to YONSA, methylprednisolone, or any excipients in study
             medications

          -  Moderate to severe hepatic impairment (Child-Pugh Classes B and C)
A Study to Evaluate SAGE-217 in Participants With Essential Tremor
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Intervention: SAGE-217; SAGE-217; Placebo
Intervention description: SAGE-217 Oral Solution; SAGE-217 Capsules; SAGE-217 matching placebo capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Tremor

Summary:

      This study is a three-part, multicenter, Phase 2a study to evaluate the efficacy, safety,
      tolerability, and pharmacokinetics of SAGE-217 in adult participants with essential tremor.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral
             postural tremor and kinetic tremor, involving hands and forearms, that is visible and
             persistent and the duration is >5 years prior to screening.

        Key Exclusion Criteria:

          -  Participant has presence of abnormal neurological signs other than tremor or Froment's
             sign.

          -  Participant has presence of known causes of enhanced physiological tremor.

          -  Participant has concurrent or recent exposure (14 days prior to admission visit) to
             tremorogenic drugs.

          -  Participant has had direct or indirect trauma to the nervous system within 3 months
             before the onset of tremor.

          -  Participant has historical or clinical evidence of tremor with psychogenic origin.

          -  Participant has convincing evidence of sudden tremor onset or evidence of stepwise
             deterioration of tremor.
Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
Condition: Pharmacokinetics; Renal Impaired; Healthy Volunteer
MeSH terms: Renal Insufficiency
Intervention: LCZ696A; LCZ696A
Intervention description: once daily administration of 400 mg LCZ696 for 5 days
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: LCZ696; pharmacokinetics

Summary:

      An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and
      its metabolites in subjects with severe renal impairment compared to matched healthy subjects
      with normal renal function
    

Eligibility criteria:

        Inclusion Criteria:

        -

        Exclusion Criteria:

        -
Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors
Condition: Hypertension; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Hypertension
Intervention: lisinopril; losartan potassium; laboratory biomarker analysis; benazepril hydrochloride; ramipril
Intervention description: Given orally; Given orally; Correlative studies; Given orally; Given orally
Intervention MeSH terms: Losartan; Ramipril; Lisinopril; Benazepril
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help
      lower blood pressure.

      PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril,
      ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed solid tumor malignancy
             AND hypertension, defined as a systolic pressure > 130 OR a diastolic pressure > 80

          -  Patients cannot be on active chemotherapy or radiation therapy; start of treatment
             with ACE-I or ARB must occur at least four weeks after the last dose of chemotherapy
             or radiation therapy

          -  Creatinine < 2.5

          -  Potassium < ULN

          -  Ability to understand and the willingness to sign a written informed consent document

          -  HIV positive patients are eligible to participate in this study

        Exclusion Criteria:

          -  Patients who are pregnant or nursing due to significant risk to the fetus/infant

          -  Patients who are unable to take oral medications

          -  Patients who are currently taking an ACE-Inhibitor or ARB
Heliox-Powered Albuterol Therapy in the Treatment of Children Admitted With Acute Asthma Exacerbation
Condition: Status Asthmaticus
MeSH terms: Status Asthmaticus
Intervention: Helium-oxygen-driven albuterol nebulizer; Oxygen
Intervention description: Subjects will be treated with continuous albuterol nebs with Heliox; Subjects will be treated with continuous albuterol nebs in oxygen
Intervention MeSH terms: Albuterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 24 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Status asthmaticus; Asthma; Helium; Children

Summary:

      The purpose of this study is to investigate whether heliox-powered albuterol nebulizer
      therapy will result in reduced inpatient length of stay in children hospitalized with acute
      asthma exacerbations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 2 -18 years;

          -  Previous history of asthma;

          -  Hospital admission for acute asthma exacerbation;

          -  Clinical asthma score greater than or equal to 3

        Exclusion Criteria:

          -  Less than 2 years old or over 18 years old;

          -  Known allergy or hypersensitivity to ß-agonists;

          -  Require mechanical ventilation (invasive or non-invasive);

          -  Require FiO2 >0.4;

          -  Failure to obtain informed consent;

          -  Enrollment in another investigational drug or asthma protocol;

          -  Incipient respiratory failure including but limited to respiratory acidosis(pCO2>60
             torr), altered mental status and/or excessive work of breathing.
Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas
Condition: Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: Selinexor (KPT-330)
Intervention description: Oral tablet or suspension at 60, 80, 100 or 120 mg per patient-specific body surface area category. Dosing will occur twice weekly in 28-days cycle.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous; SCC; Carcinoma; KPT-330; SINE; Selinexor; Karyopharm; Karyopharm Therapeutics; Lung; Head; Neck; Esophageal

Summary:

      Open-label, multi-center, single-arm, Phase 2 study of oral selinexor in patients with SCC of
      the head and neck (HN-SCC; Cohort 1), lung (L-SCC; Cohort 2), or esophagus (E-SCC; Cohort 3)
      who have relapsed or have metastasis following chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  confirmed SCC of the head and neck, lung, or esophagus

          -  1 to 2 prior therapies

          -  measurable disease at screening and documented progression within the past 6 weeks

        Exclusion Criteria:

          -  patients requiring total parenteral nutrition

          -  unstable cardiovascular function

          -  substantially impaired gastrointestinal function

          -  Symptomatic brain metastases

          -  another malignancy within 3 years except adequately treated in situ carcinoma of any
             type, basal or non-melanomatous skin cancer
Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant
Condition: Allogeneic Stem Cell Transplant; Viral Infection
MeSH terms: Infections; Communicable Diseases; Virus Diseases
Intervention: Viral Specific T-cells (VSTs)
Intervention description: VSTs will be infused into stem cell transplant recipients
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this research study is to learn more about the use of viral specific
      T-lymphocytes (VSTs) to prevent viral infections that may happen after allogeneic stem cell
      transplant. Allogeneic means the stem cells come from another person. VSTs are cells
      specially designed to fight viral infections that may happen after a stem cell transplant
      (SCT).

      Stem cell transplant reduces your ability to fight infections. Viral infections are a common
      problem after transplant and can cause significant complications. Moreover, treatment of
      viral infections is expensive and time consuming, with families often administering prolonged
      treatments with intravenous anti-viral medications, or patients requiring prolonged
      admissions to the hospital. The medicines can also have side effects like damage to the
      kidneys or reduction in the blood counts, so in this study we are trying to find a way to
      prevent these infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recipient must be at least 21 days after stem cell infusion

          -  Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other
             steroid equivalent

        Exclusion Criteria:

          -  Patients who have developed viral infection or reactivation will be ineligible for
             prophylactic infusions of VSTs

          -  Active acute GVHD grades II-IV

          -  Uncontrolled relapse of malignancy

          -  Infusion of ATG or alemtuzumab within 2 weeks of VST infusion. Additionally, in
             patients who received alemtuzumab as part of their conditioning regimen, alemtuzumab
             levels will be collected in the second week following stem cell infusion. The level
             must be less than, or equal to, 0.15 prior to infusion of VSTs. In patients with level
             greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is
             obtained. They would become eligible for prophylactic VST infusion at that point if
             there is still no evidence of viral infection at that time.
Acute Effects of Inhaled Treprostinil in Fontan Patients
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Intervention: Treprostinil; Placebo
Intervention description: A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.; 3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
Intervention MeSH terms: Treprostinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Congenital heart disease

Summary:

      In this pilot study investigators propose to explore the effects of a locally delivered
      inhaled pulmonary vasodilator (inhaled treprostinil) on exercise performance, pulmonary blood
      flow, venous pressure response and vascular function in stable Fontan patients. Investigators
      will also assess the effects of resting and acute rises in exercise induced systemic venous
      pressure on liver stiffness and will also assess whether treprostinil will attenuate the
      acute stiffness increase that investigators expect to see. This will be a prospective,
      randomized, double-blinded placebo controlled, crossover trial. Following recruitment and
      informed consent, each participant will undergo three study visits, including baseline
      testing (visit 1), followed by two sets of exercise and vascular function tests (visit 2 and
      visit 3) at CCHMC. Twenty-six patients will be enrolled in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients age 18 years and older

          2. Single ventricle patients status post Fontan procedure

        Exclusion Criteria:

          1. Clinically unstable: these are patients who are experiencing new cardiovascular
             symptoms such as worsening shortness of breath, new onset arrhythmia, uncontrolled
             heart failure, or evidence of clinically significant cirrhosis or renal failure.

          2. Evidence of Fontan pathway or intra cardiac obstruction as identified on prior
             clinically indicated imaging studies (echocardiography and MRI);

          3. Evidence of left or right systemic ventricular systolic dysfunction with an Ejection
             fraction of <40% on either echocardiogram or MRI from previously documented clinical
             data;

          4. Presence of uncontrolled arrhythmias;

          5. Unable to perform exercise testing for any reason or if deemed by the PI or designee
             that exercise testing would not be in the best interest of the participant

          6. Currently pregnant and/or breastfeeding

          7. Patient unable to provide informed consent

          8. BMI > 30 mg/m2
Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo to Ertugliflozin; Ertugliflozin 1 mg; Ertugliflozin 5 mg; Ertugliflozin 25 mg; Sitagliptin 100 mg; Placebo to Sitagliptin; Metformin
Intervention description: Tablet(s), 1 or 2, matching placebo to 1-mg, 5-mg and/or 25-mg tablets, once daily for 84 days; Tablet, 1 mg, once daily for 84 days; Tablet(s), 1 or 2, 5-mg tablets once daily for 84 days; Tablet, 25 mg, once daily for 84 days; Tablet, 100 mg, once daily for 84 days; Tablet, matching placebo to 100 mg, once daily for 84 days; Participants continued pre-study stable doses of metformin during the run-in and treatment periods of the study (maximum dose up to 2500 mg/day or 3000 mg/day where the maximum metformin dose per the local country product labels was 3000 mg/day).
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Ertugliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 375.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Phase 2; safety and efficacy study with ertugliflozin (PF-04971729, MK-8835); Type 2 diabetes mellitus

Summary:

      MK-8835-016 (B1521006) is designed to evaluate the safety and efficacy of an investigational
      drug, ertugliflozin (MK-8835, PF-04971729) in participants with Type 2 diabetes mellitus.
      Participants in the study will receive 1 of 6 treatments for 12 weeks including 1 treatment
      with an approved drug (sitagliptin) for the treatment of Type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with type 2 diabetes on stable doses of background medicines for
             management of the diabetes; aged 18-70 years; body mass index between 23-45 kg/m^2

        Exclusion Criteria:

          -  Participants with type 1 diabetes, heart attack or stroke in last 6-months,
             uncontrolled blood pressure, significant kidney disease
Topical Capsaicin for Cyclical Vomiting
Condition: Cyclical Vomiting
MeSH terms: Vomiting
Intervention: Capsaicin 0.1% Cream; Placebos
Intervention description: Topical application; placebo cream
Intervention MeSH terms: Capsaicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Identical appearing placebo cream used for control
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the
      relieve of nausea and vomiting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  suspected cyclical vomiting syndrome / cannabinoid hyperemesis

          -  active severe nausea or vomiting in the emergency department

        Exclusion Criteria:

          -  pregnant women, children < 18 years, no prior history of similar symptoms, suspected
             surgical or infectious cause of symptoms, suspected hepatitis or pancreatitis, allergy
             to capsaicin or hot peppers, chronic use of prescription antiemetic in prior 24 hours,
             abdominal pain alone (without nausea or vomiting)
Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis
Condition: Nonallergic Irritant Rhinitis
MeSH terms: Rhinitis
Intervention: Capsaicin; Placebo
Intervention MeSH terms: Ethanol; Capsaicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nonallergic irritant rhinitis; nasal congestion; rhinorrhea

Summary:

      The proposed study seeks to investigate the effect of intranasal capsaicin treatment in
      patient with Non-allergic irritant rhinitis (NAIR), as well as evaluate optical rhinometry
      (ORM) as a means to quantify symptomatic improvement in NAIR patients during and after
      treatment.
    

Eligibility criteria:

        Inclusion criteria:

          -  Non-allergic irritant rhinitis (NAIR) patients as defined by history (symptoms of
             nasal congestion, rhinorrhea, nasal itching or sneezing upon exposure to nasal
             irritants)

          -  Patients with positive optical rhinometer (ORM) response with intranasal challenge
             with 0.5 millimolar (mM) capsaicin as described by Lambert et al 2012

          -  Confirmed negative skin prick test to common allergens (which rules out allergic
             rhinitis)

        Exclusion Criteria:

          -  History of sinonasal surgery

          -  Chronic rhinosinusitis

          -  Inflammatory or granulomatous diseases

          -  Asthma

          -  Allergic rhinitis

          -  Immunocompromised state

          -  Radiation to the head and neck

          -  Intranasal steroid use >4 wks

          -  Intranasal or systemic antihistamine x 3 days

          -  Intranasal or systemic decongestants x 3 days