bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Oxytocin on Obstructive Sleep Apnea Induced Changes in Sleep
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: Oxytocin Intranasal Spray; Placebo Intranasal Spray
Intervention description: In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.; The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: All members of the research team except the IP dispensing staff will be blinded for the duration of the research study. Once all the subjects have finished in the research study, and all data is data-locked, the outcomes assessor will then unblind the research data for the statistical analysis.
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sleep Apnea; Oxytocin Nasal Spray

Summary:

      In human volunteers intranasal administration of oxytocin significantly increases
      parasympathetic and decreases sympathetic cardiac control. OSA is a very prevalent disease
      with high cardiovascular risk factors, yet this disease remains very poorly treated.

      This proposal, based on the current literature and new basic science results detailed above
      on the role of oxytocin in cardiovascular control, will test if oxytocin administration
      improves adverse cardiovascular events during the recurrent nocturnal apneas in patients with
      OSA. This project will lay the groundwork and provide preliminary data to obtain NIH funding
      to test this important hypotheses more thoroughly and in larger clinical trials.

      This study will explore if intranasal oxytocin has any positive cardiovascular benefits in
      patients with sleep apnea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 18 years old or older of any ethnic background

          -  Subjects that have recently undergone a standard "in the sleep-lab" diagnostic
             polysomnography (per standard of care medical guidelines), or the "at home" diagnostic
             test, and have been diagnosed with OSA

        Exclusion Criteria:

          -  Pregnant or Breastfeeding women

          -  Women of Child Bearing Potential who are not willing to undergo methods to prevent
             pregnancy

          -  Subjects who are on medications that affect cardiac autonomic function (eg. Beta
             Blockers)

          -  Active smokers

          -  Subjects who are unable to read or answer questions in the English language
Brain Stimulation and Aphasia Treatment
Condition: Aphasia
MeSH terms: Aphasia
Intervention: Activa Dose II Real tDCS; Activa Dose II Sham tDCS
Intervention description: 20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions); 20 minutes of sham stimulation per treatment day (15 total sessions)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 25 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Aphasia; Brain; Stimulation; Communication; Stoke; Post; Phase II Clinical Trial; Treatment; tDCS; Fridriksson

Summary:

      The purpose of this study is to assess the changes in language processing of patients with
      chronic, post-stroke aphasia following the application of brain stimulation. The brain
      stimulation the investigators administer is called transcranial direct current stimulation
      (tDCS). It involves passing a weak electrical current through the brain between two
      electrodes in the form of damp sponges. One sponge will be placed over a specified area on
      the damaged left hemisphere, while the other sponge will be placed on the right scalp.
      Computer-controlled speech-language treatment will be administered during the application of
      tDCS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must be willing and able to give informed consent.

          2. Patients must be willing and able to comply with study requirements.

          3. Patients must be between 25- and 80-years of age.

          4. Patients must be native English speakers.

          5. Patients must be pre-morbidly right-handed.

          6. Patients must have sustained a one-time ischemic stroke in the left-hemisphere.

          7. Patients must be greater than 6-months post-stroke.

          8. Patients must have an aphasia diagnosis as confirmed by the Western Aphasia
             Battery-Revised.

          9. Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.).

         10. Patients must achieve at least 65% accuracy on naming task during screening -

        Exclusion Criteria:

          1. History of brain surgery

          2. Seizures during the previous 12 months

          3. Sensitive scalp (per patient report)

          4. Able to overtly name more than an average of 140 out of 175 items during the
             pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3.

          5. Unable to overtly name at least an average of 5 out of 80 items during the
             pre-treatment functional magnetic resonance imaging (fMRI) sessions during Visits 2 or
             3.
Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS topical product
Intervention description: treatment daily for 28 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal
      Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to
      SevereScalp Psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating females 12-17 years of age.

        Exclusion Criteria:

          -  Females who are pregnant, nursing, planning to become pregnant during the duration of
             the study, or if of child-bearing potential and sexually active and not prepared to
             use appropriate contraceptive methods to avoid pregnancy.
Envarsus XR in Lung Transplant
Condition: Lung Transplant
Intervention: Extended-Release Tacrolimus; Immediate-Release Tacrolimus
Intervention description: Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.; Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Patients undergoing a lung transplant will be enrolled. All patients will undergo lung
      transplantation with standard post-operative management, including triple immunosuppression.
      As soon as the patient is deemed appropriate to take medications via the oral route, they
      will be converted from IR tacrolimus to Envarsus XR. Patients will be followed per site's
      standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

        Prospective arm:

          -  Age ≥ 18 years

          -  Received a lung transplant at NYU Langone Health

          -  Be able to convert to Envarsus XR within the first month post-transplant

          -  Able and willing to provide informed consent

        Historical control:

          -  Age ≥ 18 years

          -  Received a lung transplant at NYU Langone Health

          -  Completed one year from transplant on IR tacrolimus

        Exclusion Criteria:

        Prospective arm:

          -  Contraindication to tacrolimus due to allergic or adverse reactions

          -  Pregnant or nursing women

          -  Multi-organ transplant recipient

        Historical control:

          -  Contraindication to tacrolimus due to allergic or adverse reactions (not including
             chronic kidney disease)
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
Condition: Cardiomyopathy, Hypertrophic; Cardiomyopathy, Hypertrophic, Familial
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Cardiomyopathy, Hypertrophic, Familial; Hypertrophy
Intervention: Perhexiline; Use of bioanalytical assay to monitor plasma levels of perhexiline
Intervention description: Period 1 (Weeks 1-8) and Period 2 (Weeks 9-16): dose titrated to two different plasma levels of perhexiline; The bioanalytical assay is the device under investigation. It will be used to monitor plasma levels of perhexiline. The data obtained from this analysis will be used to guide dose adjustments of perhexiline.
Intervention MeSH terms: Perhexiline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label, 2 period, dose escalation study of perhexiline in symptomatic patients with hypertrophic cardiomyopathy
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertrophic cardiomyopathy; heart failure; cardiopulmonary exercise testing; 6 minute walk test; perhexiline; carnitine palmitoyltransferase; mixed ion channel effects; late sodium current inhibitor; calcium channel inhibition

Summary:

      The purpose of this study is to evaluate the effect of perhexiline on exercise performance
      (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe
      heart failure following dosing for 16 weeks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Hypertrophic cardiomyopathy with symptoms of moderate-to-severe heart failure

          -  Left ventricular hypertrophy with maximum LV wall thickness ≥ 15 mm

          -  Left ventricular ejection fraction ≥ 50%

          -  Able to perform exercise testing but unable to exceed 75% of the predicted
             age-adjusted maximum level

        Key Exclusion Criteria:

          -  CYP2D6 Poor Metabolizer (PM) status

          -  History of a known chronic liver disease

          -  ALT, AST, alkaline phosphatase, or LDH > 1.5 x upper limit of normal

          -  Total Bilirubin > 2.0 x upper limit of normal

          -  Severe LV outflow obstruction

          -  Asymptomatic patients or cardiomyopathy-related criteria as per protocol

          -  QT interval related criteria as per protocol
Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: systemic chemotherapy; axillary lymph node dissection; neoadjuvant therapy; sentinel lymph node biopsy; therapeutic conventional surgery; ultrasound imaging
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 756.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy
      before surgery may make the tumor smaller and reduce the amount of normal tissue that needs
      to be removed.

      PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and
      axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage
      IIIB breast cancer.
    

Eligibility criteria:

        Eligibility Criteria:

          1. ≥ 18 years old

          2. ECOG/Zubrod Performance Status 0-1

          3. Female. Note: Men are excluded from this study because the number of men with breast
             cancer is insufficient to provide a statistical basis for assessment of effects in
             this subpopulation of people with breast cancer.

          4. Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding
             inflammatory breast cancer).

          5. FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time
             of diagnosis and prior to preoperative chemotherapy.

          6. Preoperative chemotherapy must be completed or planned for patient. NOTE: Patients
             enrolling on studies involving preoperative chemotherapy (through cooperative groups
             or institutional studies) may be eligible for this study, provided sentinel node
             surgery prior to preoperative chemotherapy was not required in the other studies.

          7. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or
             treatment of hidradenitis.

          8. No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of
             axillary status.
A Study of Atezolizumab in Participants With Programmed Death - Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab
Intervention description: 1200 mg IV every 3 weeks
Intervention MeSH terms: Atezolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 667.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in
      participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer
      (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3
      weeks as long as participants are experiencing clinical benefit as assessed by the
      investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration
      attributed to disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants greater than or equal to 18 years of age

          -  Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC

          -  Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens

          -  PD-L1-positive tumor status as determined by an immunohistochemistry (IHC) assay based
             on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by
             a central laboratory

          -  Measurable disease, as defined by RECIST version 1.1

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3
             weeks prior to initiation of study treatment; the following exception are allowed:

        Hormone-replacement therapy or oral contraceptives tyrosine-kinase inhibitors (TKIs)
        approved for treatment of NSCLC discontinued >7 days prior to Cycle 1, Day 1

          -  Central nervous system (CNS) disease, including treated brain metastases

          -  Malignancies other than NSCLC within 5 years prior to randomization, with the
             exception of those with negligible risk of metastases or death and treated with
             expected curative outcome

          -  History of autoimmune disease

          -  History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced
             pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT
             scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted

          -  Active hepatitis B or hepatitis C

          -  Human Immunodeficiency virus (HIV) positive

          -  Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic
             antibody or pathway-targeting agents
OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Dexamethasone; Placebo Vehicle
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone
      insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the
      treatment of the signs and symptoms of dry eye disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Had a known history of dry eye disease

          -  Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye

        Exclusion Criteria:

          -  History of intraocular inflammation in either eye

          -  Use of the anti-inflammatory or immunomodulating agents ocular or systemic for the
             duration of the study

          -  Uncontrolled glaucoma or is on medications to treat glaucoma

          -  History of IOP spikes in either eye

          -  Active epiphora
A Phase 2 Evaluation of TRC105 In Combination With Bevacizumab in Patients With Glioblastoma
Condition: Glioblastoma; Glioblastoma Multiforme
MeSH terms: Glioblastoma
Intervention: TRC105; Bevacizumab
Intervention description: 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle; IV
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: A total of 6 initial patients were treated with 10 mg/kg of TRC105 monotherapy. All patients progressed within 2 months of initiating treatment, reflecting the rapid progression. Due to the lack of activity in this disease setting with TRC105 alone, the study was amended to treat patients with 10 mg/kg TRC105 weekly in combination with 10 mg/kg bevacizumab every two weeks.
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of TRC105 in patients with
      recurrent or progressive glioblastoma after prior antiangiogenic therapy (including anti-VEGF
      therapy)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histologically confirmed glioblastoma, recurrent after prior
             external-beam fractionated radiotherapy and temozolomide chemotherapy.

          2. Patients with documented radiographic progression following bevacizumab therapy for
             treatment of glioblastoma.

          3. Patients with up to 3 prior recurrences are allowed.

          4. Karnofsky performance status ≥ 70%.

          5. Age ≥ 18 years old.

          6. Normal organ function

        Exclusion Criteria:

          -  Patients who have had previous treatment with TRC105.

          -  Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or
             intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting
             study drug, or patients who have had minor procedures, percutaneous biopsies or
             placement of vascular access device ≤ 1 week prior to starting study drug, or who have
             not recovered from side effects of such procedure or injury

          -  Patients with cirrhosis, or active viral or nonviral hepatitis.

          -  Patients with active bleeding or pathologic conditions that carry a high risk of
             bleeding,(i.e. hereditary hemorrhagic telangiectasia).

          -  Patients who are currently receiving anticoagulation treatment

          -  Patients unwilling or unable to comply with the protocol