cyrilzakka/clinical-trials huggingface dataset:
Dasatinib Combination Therapy With the Smoothened (SMO) Inhibitor BMS-833923 in Chronic Myeloid Leukemia (CML)

The purpose of the study is to determine the safety and tolerability of the combination of BMS-833923 plus dasatinib in patients with chronic myeloid leukemia.


Eligibility Criteria:
Key Inclusion Criteria

* Age ≥18 years
* Diagnosis of chronic myeloid leukemia (CML) and cytogenetic positive for the Philadelphia chromosome (Ph+), documented Ph+ cells on bone marrow assessment (BMA) ≤6 weeks prior to treatment
* Either chronic-phase CML, with \<15% blasts in peripheral blood and bone marrow, or advanced-phase CML, including Ph+ acute lymphoblastic leukemia (ALL) (\> 5% blasts) or hematologic progression with ≥15% blasts not in complete cytogenetic remission
* Resistance or suboptimal response to imatinib, dasatinib, or nilotinib and no known T315I/A Abl-kinase mutation.

Key Exclusion Criteria

* Known Abl-kinase T315I or T315A mutation
* CCyR at baseline
* Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
* Uncontrolled or significant cardiovascular disease
* Grade 3 or higher peripheral blood counts
* Serum calcium or phosphate below the lower limit of normal
* Baseline hypomagnesemia and amylase or lipase at least Grade 1 or higher
* Reduced renal function, defined as serum creatinine level \>3\*upper limit of normal
* Prior therapies for CML or Ph+ ALL permitted, with the following restriction:

  * Therapy permitted with corticosteroids, hydroxyurea, or anagrelide prior to starting treatment and during the first 4 weeks on study
  * 6 months or longer after stem cell transplantation
  * 28 days or longer after any investigational agent
  * 7 days or longer after any standard chemotherapy agent
  * Concomitant use of medications with a known risk of causing Torsades de Pointes
  * Concomitant use of strong inhibitors of the CYP3A4 isoenzyme
Immediate Effect Analysis of Vocal Techniques

The objective of this clinical and experimental study was to verify the immediate effect of vocal techniques: vibration, nasal sound and articulation in women without vocal complaints.

Vocal techniques have been used, but few studies had as their aim to effectively verify its use and effect produced in voice and the larynx. The objective of this clinical and experimental study was to verify the immediate effect of vocal techniques: vibration, nasal sound and articulation. Material and method: 32 female subjects with normal to mild dysphonia participated in the research, with ages from 20 to 45 years. All subjects were submitted to realization of vocal techniques of vibration of the lips, articulation and nasal sounds for twenty minutes. The subjects were submitted to record the voice and laryngostroboscopic exams for perceptual analysis and laryngostroboscopic exams before and after the use of vocal techniques.

Eligibility Criteria:
Inclusion Criteria:

* female subjects
* with normal voices or slightly altered voice
* without vocal complaints

Exclusion Criteria:

* subject with altered voices of moderate and severe grades
* with lesions in the vocal folds; fusiform or double gap on the phonation
* subjects with neurological disorders
* subjects who had been treated earlier speech by voice changes and / or surgery in the larynx
Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)

This is a prospective study in which a process of identifying and improving a reduction of functional capacity in COVID-19 survivors \>50 years old.

The overall goal of this study to identify the feasibility and value of risk-guided medical therapy and exercise intervention in COVID-19 survivors.

Participants enrolled in this study will be randomized to a cardio-COVID disease management plan (CC-DMP) that involves the use of VO2 testing and surveillance imaging to detect reduced functional capacity and subclinical left ventricular dysfunction (LVD), clinical review to ensure optimal risk factor control and cardio-protection and exercise intervention. The program will be delivered over a period of 24 months.

The outcome from this study will show that subclinical LVD is common among COVID-19 survivors, and a CC-DMP is feasible in reducing HF risk factors in this sub group of survivors.

Eligibility Criteria:
Inclusion Criteria:

1. History of COVID-19 infection
2. Live within a geographically accessible area for follow-up

Exclusion Criteria:

1. Valvular stenosis or regurgitation of \>moderate severity
2. History of previous heart failure (baseline New York Heart Association (NYHA) classification \>2)
3. Inability to acquire interpretable images (identified from baseline echo)
4. Contraindications to beta blockers or angiotensin-converting enzyme inhibitors
5. Oncologic (or other) life expectancy \<12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial
6. Already taking both angiotensin converting enzyme inhibitors/ angiotensin receptor blockers and beta blockers, or intolerance (or allergy) to both.
7. Mobility impairment that would impact participants' ability to perform exercise
8. Unable to provide written informed consent to participate in this study
ISIS 2503 in Treating Patients With Metastatic and/or Locally Recurrent Colorectal Cancer

RATIONALE: ISIS 2503 may kill cancer cells by inhibiting a gene that promotes the development and growth of cancer.

PURPOSE: Phase II trial to study the effectiveness of ISIS 2503 in treating patients who have metastatic and/or locally recurrent colorectal cancer.

OBJECTIVES: I. Determine the response rate, duration of response, and time to progression in patients with metastatic and/or locally recurrent adenocarcinoma of the colon or rectum treated with ISIS 2503, an antisense inhibitor of H-ras. II. Determine the safety profile of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive ISIS 2503 IV continuously for 14 days. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven metastatic and/or locally recurrent adenocarcinoma of the colon or rectum that is not expected to be cured with standard therapy Patients who previously underwent definitive surgical resection and subsequently develop metastatic disease should have diagnosis reconfirmed with new histologic or cytologic specimen if: More than 5 years have elapsed since primary surgery OR Primary tumor was stage I or II At least 1 measurable lesion (2 cm or more in widest diameter) by CT or MRI scan No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dl Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No underlying disease state associated with active bleeding No active infection requiring therapy No second malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy with or without radiotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy to nonindicator lesion allowed and recovered See Chemotherapy Surgery: See Disease Characteristics Other: No concurrent approved cancer therapy or other experimental therapy
Evaluating the Effectiveness of a Multi-level Health-Related Social Needs Initiative

The goal of this study is to evaluate the effectiveness of a multi-level health-related social needs (HRSN) initiative among adult patients diagnosed with type 2 diabetes, plus hypertension or hyperlipidemia. The multi-level initiative includes HRSN data collection, training and tools for health care professionals, care coordinator support, and community resources. Patients with type 2 diabetes plus hypertension or hyperlipidemia will be screened for HRSN as part of the primary care clinic intake process to assess if patients have any social needs (like difficulty with getting food, housing, or transportation). If patients screen positive for having social needs, then patients will be offered support, which can include help from primary care providers with adjusting a patient's disease management plan, referrals to care coordinators to provide additional assistance in addressing social needs, and information about community organizations that offer resources for social needs. The initiative will be integrated as a system change across VUMC adult primary care practices.

The investigators will use a prospective, single-arm clinical trial to evaluate effects on clinical outcomes for 12 months. Data will be extracted from the EHR on adult patients diagnosed with type 2 diabetes, and either hypertension or hyperlipidemia. The investigators hypothesize that the initiative will reduce the impact of HRSN on clinical outcomes over the study period. The investigators will also administer surveys to a subgroup of patients to examine trends in self-reported psychosocial and behavioral measures over the course of the initiative.


Eligibility Criteria:
ELIGIBILITY CRITERIA FOR EHR DATA EXTRACTION

Inclusion Criteria:

* 18 years of age or older
* Completed the health-related social needs (HRSN) screener as part of a primary care visit
* Diagnosed with type 2 diabetes, plus hypertension and/or hyperlipidemia as reflected by ICD-10 billing codes
* Receive care at one of six partner Vanderbilt University Medical Center primary care clinics: South One Hundred Oaks, North One Hundred Oaks, Green Hills, Hillsboro Medical Group, Melrose, Bellevue

ELIGIBILITY CRITERIA FOR PATIENT SURVEYS (subset of EHR data)

Inclusion Criteria:

* 18 years of age or older
* Completed the HRSN screener as part of a primary care visit
* Diagnosed with type 2 diabetes, plus hypertension and/or hyperlipidemia as reflected by ICD-10 billing codes
* Receive care at one of six partner Vanderbilt University Medical Center primary care clinics: South One Hundred Oaks, North One Hundred Oaks, Green Hills, Hillsboro Medical Group, Melrose, Bellevue
* English-speaking

Exclusion Criteria:

* Blindness
* Hearing impairment
* Conditions that would interfere with survey completion (e.g., significant dementia, active psychosis or mania)
* Being near the end of life (hospice or home hospice)
Grapiprant (ARY-007) and Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 NSCLC Adenocarcinoma

This study will be conducted in adult participants diagnosed with NSCLC who have been previously treated for a minimum of 12 weeks with any PD-1 or PD-L1 checkpoint inhibitor. This is a phase 1b/2, multi-center, open label study designed to assess safety and tolerability of grapiprant in combination with pembrolizumab, to determine the recommended phase 2 dose (RP2D) with pembrolizumab, and to evaluate disease response with grapiprant based on investigator assessments. Pharmacokinetics, pharmacodynamics and response biomarkers will also be assessed.


Eligibility Criteria:
Key Inclusion Criteria:

* Male and female adult patients at least 18 years of age on day of signing informed consent
* Histologically confirmed non-small cell lung cancer (NSCLC) adenocarcinoma
* Advanced (stage IIIb) disease that is not amenable to curative intent treatment with concurrent chemoradiation and metastatic (stage IV) patients
* Progressed clinically and/or radiographically per RECIST v1.1 after receiving a PD-1 or PD-L1 antagonist for a minimum of 12 weeks
* Measurable disease per RECIST v1.1
* Disease that can be safely accessed via bronchoscopic, thoracoscopic or percutaneous biopsy for multiple core biopsies and participant is willing to provide tissue from newly obtain biopsies on study in a subgroup of patients
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Adequate organ function
* Highly effective birth control
* Able to swallow and absorb oral tablets

Key Exclusion Criteria:

* Current use of NSAIDs, COX-2 inhibitors
* Known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS gene alteration
* No history of smoking (≤100 cigarettes lifetime)
* History of severe hypersensitivity reactions to a PD-1/L1 antibody
* Received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment or 5 half-lives, whichever is shorter
* Received prior radiotherapy within 2 weeks of start of study treatment
* Has received a live vaccine within 30 days prior to the first dose of study treatment
* Taking strong CYP3A4 or P-glycoprotein inhibitors or inducers
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
* Known additional malignancy that is progressing or has required active treatment within the past 3 years (with some permitted exceptions)
* Known active CNS metastases and/or carcinomatous meningitis
* Active autoimmune disease that has required systemic treatment in past 2 years
* History of pneumonitis that required steroids or has current pneumonitis
* Has an active infection requiring systemic therapy
* Recent or current GI ulcer, colitis or non-immune colitis
* Known history of human immunodeficiency virus (HIV) infection, or known active Hepatitis B, or Hepatitis C virus infection
* Has had an allogeneic tissue/solid organ transplant
* Clinically significant (i.e.active) cardiovascular disease
Computer-Delivered Intervention for Individuals With Obesity and Elevated Anxiety Sensitivity

The proposed study will design and evaluate a computerized-delivered single-session anxiety sensitivity reduction program (i.e., Anxiety Sensitivity Training; AST). The AST will be designed to achieve three primary aims: (1) provide psycho-educational information on AS and its consequences, (2) present psycho-educational information on the relationship between AS and obesity-related health behavior correlates, and (3) offer concrete, evidence-based strategies to facilitate motivation to change their obesity-related lifestyle behaviors.

The primary goal of the research study is to investigate the efficacy of a brief, computer-delivered transdiagnostic intervention that addresses anxiety sensitivity to reduce emotional eating, eating expectancies, food cravings, binge eating, perceived barriers to engage in physical activity, anxiety/depressive symptoms, severity of daily fatigue and increase perceived benefits to engage in physical activity, exercise self-efficacy, willingness to use adaptive coping strategies, and perceived physical health functioning. To address this aim, the investigator's will implement a randomized controlled trial that will employ a longitudinal experimental design and involve five stages: (a) online pre-screener; (b) baseline survey consisting of a pre-intervention assessment (eligibility) and random assignment to a one-session computer-delivered intervention (Active versus Control); (c) 1-week follow-up survey; (d) 2-week follow-up survey; (e) 1-month follow-up survey.

Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index of at least 30
* Endorse elevated anxiety sensitivity defined as an ASI-3 score of 17 or greater

Exclusion Criteria:

* Any anticipated matters that would interfere with participating in the study
* Not being fluent in English
A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736 (Durvalumab), in patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer. MEDI4736 will be investigated in patients who have received at least two prior treatment regimens including one platinum-based chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* Aged at least 18 years.
* Documented evidence of NSCLC (stage IIIB/IV disease)
* Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC
* World Health Organisation (WHO) Performance Status of 0 or 1
* Estimated life expectancy of more than 12 weeks
* Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3))

Exclusion Criteria:

* Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
* Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).
* Active or prior autoimmune disease or history of immunodeficiency
* Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
* Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
* Any unresolved toxicity CTCAE \>Grade 2 from previous anti-cancer therapy.
* Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE \>Grade 1
* Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
Evaluation and Control of WAG in PACU Within Patient and Caregiver Breathing Zone

The purpose of this study is to evaluate anesthetic gas in the PACU within patient and caregiver breathing zones.

The purpose of this single-center, multi-arm, randomized controlled study is to evaluate use of the ISO-Gard mask in patients immediately following a surgical procedure in which inhaled anesthetic is used as the primary modality of anesthesia, for the following: 1) measure the waste anesthetic gas emanating from patient during the immediate one hour post-operative recovery period in the PACU; 2) measure waste anesthetic gas within PACU caregiver's breathing zone; and 3) determine the efficacy of the ISO-Gard mask in reducing caregiver's exposure to waste anesthetic gas in the PACU.

Subjects who will receive either Sevoflurane or Desflurane inhaled anesthetic will be enrolled in this study. Subjects will be randomized to receive either the ISO-Gard scavenging mask or a traditional supplemental oxygen mask post operatively; all other elements of the subjects' care will be in accordance with the institution's standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18-120 years of age.
* Patients requiring inhaled anesthetic agents as part of their anesthesia during surgery (Sevoflurane or Desflurane)
* Patients with following outpatient procedures scheduled for a duration of greater than 2 hours per the operating room schedule:

  1. . Bariatric procedures
  2. Robotic surgery cases
  3. Orthopedic
  4. Gynecological procedures
  5. ENT
  6. Plastic
* Not documented as terminally ill
* Subject expected to remain in PACU for at least one hour
* Subject or legally authorized representative has provided written informed consent prior to the procedure using a form that is approved by the Institutional Review Board (IRB).

Exclusion Criteria:

* Patients are/were given/planned to be given total IV anesthetics during surgery
* Any patient that is not expected to tolerate a mask in PACU
* Subject has already been enrolled in study
* Subject is an employee of the Investigator or has involvement in other studies under the direction of investigator or study site
* Women who are pregnant
* End of anesthetic gas administration in PACU bay greater than 45 minutes
Computer Assisted Family Intervention to Treat Self-Harm Disparities in Latinas and Sexual/Gender Minority Youth

This study is designed to refine and test the efficacy of a computer assisted culturally informed and flexible/adaptive intervention for Latino adolescents for whom self-harm behaviors are a health disparity-specifically, Latinas and sexual/gender minority youth.

This study enhances an original Computer Assisted Culturally Informed and Flexible Family-Based Treatment for Adolescents (CA CIFFTA) to directly address key targets related to self-harm behavior (e.g., depression, emotion dysregulation, LGBT, culture-related stressors, and trauma-related stressors); (b) refines the technological aspects of CA CIFFTA for web-based delivery; and (c) tests the preliminary efficacy of the new intervention and its delivery system in a randomized trial of 100 Hispanic adolescents and their parents. The investigators seek to reduce risk for repeated self-harm by showing treatment effects on depression, emotion regulation, substance use, and family functioning. Participants are randomly assigned to CA CIFFTA or Treatment-As-Usual and treatment covers a four month period.

Eligibility Criteria:
Inclusion Criteria. The adolescent must:

* be 11 to 18 years old;
* self-report an act of self-harm in the past 6 months,
* meet criteria for cut-off on two of the four underlying/maintaining factors (depression, emotion dysregulation, family conflict, substance use), and
* live with at least one parent-figure who agrees to participate in assessments and treatment Participants should be willing and able to participate fully in the protocol (e.g., to accept assignment to either condition, to provide sufficient locator information for follow-up, to allow their treatment sessions to be recorded for fidelity/process assessment and supervision).

Exclusion Criteria. Youth who:

* have a history of DSM V Developmental Disorders, Elective Mutism, Organic Mental Disorders, Schizophrenia, Delusional Disorder, Psychotic Disorder, and Bipolar Affective Disorder.
* are actively in crisis and reporting current ideation with a specific plan and with means to complete the plan.
Intravitreal Injections by Nurses and Physicians Compared

Anti-VEGF agents are given for a variety of previously untreatable eye diseases. The last years indications for their use and consequently the number of patients needing treatment, have been increasing. Most patients require multiple injections. This has resulted in many eye departments administering thousands of injections per year, also at St Olavs University Hospital Trondheim. To cope with this increase in workload, it would be helpful if injections would be given not only by the physicians but also by the nurses. This study's objective is to compare efficiency, patient satisfaction and cost per patient of injections given by nurses and physicians.


Eligibility Criteria:
Inclusion Criteria:

* referred to the eye clinic for treatment of age related macular degeneration, diabetes retinopathy or retinal vein occlusion with anti-vascular endothelium growth factor
* Ability to provide written informed consent
* ability to comply with study assessments for the full duration of the study

Exclusion Criteria:

-