cyrilzakka/clinical-trials huggingface dataset:
Phosphoproteomic Patterns as a Novel Biomarker for Aurora and Polo-like Kinase Inhibitors in Non-Small Cell Lung Cancer

The investigators have characterized in preclinical Non-Small Cell Lung Cancer (NSCLC) models the proteomic expression profile associated with exposure to Aurora and Polo-like kinase inhibitors. The identification of proteomic expression patterns in patients with NSCLC would be an important step in defining the possible role of these agents as potential targeted therapies for this clinically important disease. This study proposes to evaluate resected non-small cell lung cancer specimens for these proteomic expression profiles.


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing or who have undergone thoracic surgery for presumed lung cancer
* Wedge resection, lobectomy, bilobectomy, segmentectomy and pneumonectomy thoracic surgical operations are permitted.
* Age ≥ 18 years.
* Subject meets criteria for thoracic surgery as determined by the thoracic surgeon.
* Able to provide written informed consent.

Exclusion Criteria:

* Subjects undergoing or who have undergone thoracic surgery for metastatic disease from other primary sources such as colorectal cancer, sarcoma, melanoma, breast cancer, bladder cancer, prostate cancer, esophageal cancer, pancreatic cancer, or gastric cancer will be excluded.
* Subjects who have received prior preoperative lung cancer anticancer therapy will be excluded.
Safety and Efficacy Study of Nimotuzumab Plus Neoadjuvant and Concurrent Chemoradiotherapy to Treat Oropharynx and Hypopharynx Cancer

The purpose of this study is to evaluate the efficiency and safety of adding nimotuzumab to neoadjuvant and concurrent chemoradiotherapy in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Locoregionally advanced squamous cell carcinoma of the head and neck(LA-SCCHN) poses one of the most complex management challenges. This stage of disease is still potentially curable, but requires combined-modality therapy. Recent studies have showed that induction chemotherapy（neoadjuvant）reduced the 3-year distant relapse rate. Concurrent chemoradiotherapy(CCRT), on the other hand, has demonstrated a significant and consistent benefit in local control rates, but its impact on distant failure is inconsistent. Nimotuzumab is a novel EGFR-targeting monoclonal antibody that has the potential.to be used as a single agent or as a radio- and chemotherapy sensitizer for the treatment of SCCHN. Thus, investigators conducted a randomized, multicenter phaseⅡ study to compare the efficiency and safety of adding nimotuzumab to neoadjuvant and CCRT with neoadjuvant and CCRT in the treatment of patients with locoregionally advanced squamous cell carcinoma of the oropharynx and hypopharynx.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form
* Histologically confirmed locally advanced (stages III and IVb), squamous cell carcinoma of the oropharynx and hypopharynx
* The tumor mass had to be measurable
* Karnofsky performance status ≥70
* Life expectancy estimated than 6 months
* Hematologic: WBC≥4×109 /L , plateletes≥100×109 /L, haemoglobin ≥100 g/L；
* Hepatic: AST/ALT\<1.5 times upper limit of normal (ULN)；serum bilirubin\<1.5 times ULN;
* Renal: Creatinine\<1.5 times ULN；

Exclusion Criteria:

* Known distant metastases
* Primary tumor and nodes received surgery(except of biopsy)
* Received other anti EGFR monoclonal antibody treatment
* Previous chemotherapy or radiotherapy
* Participation in other interventional clinical trials within 1 month
* Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix)
* History of serious allergic or allergy
* History of Serious lung or heart disease
* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
Effect of Upper Extremity Aerobic Exercise Training on Exercise Capacity Patients With Chronic Heart Failure

Heart failure is a cardiac structural or functional disorder that, despite normal filling pressures, leads to inability to deliver enough oxygen to meet the metabolic needs o tissue. Heart failure is a serious chronic condition that affects a large proportion of the adult population in the world causing high mortality, leading to exercise intolerance and reduced health-related quality of life. Patients included in the cardiac rehabilitation program slow down disease progression, hospitalization decreases, quality of life improves and health expenditures decrease. Despite the frequent use of upper extremities in daily living activities, studies investigating the effect of upper extremity aerobic training on daily living activities, functional exercise capacity and other outcomes are limited. No studies have investigated the effect of upper extremity aerobic exercise training on physical activity level, functional and maximal exercise capacity and other measures in patients with heart failure.

It has been reported that exercise capacity in peak arm exercise is almost 30% lower in heart failure patients. For this reason intolerance to arm exercise is a significant problem in heart failure patients and may contribute to a decrease in performance in activities of daily living. Considering the fact that developments in these patients are caused by vasculature functional adaptation the extremity skeletal muscle and applied limbs, upper extremity exercises may be useful to reduce exercise intolerance during activities requiring continuous arm movement.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of chronic heart failure diagnosed at rest below 40% of the left ventricular ejection fraction and class 1-3 according to the New York Heart Association classification
* Optimal medical treatment at least 30 days and clinically stable

Exclusion Criteria:

* Patients with unstable angina pectoris
* Decompensated heart failure
* Primary pulmonary hypertension
* Complex ventricular arrhythmia
* Contraindication to cardiopulmonary exercise testing
* Patients who have had myocardial ischemia in the past 3 months
* Ischemic cerebrovascular events
* Second and third degree atrioventricular block
* Thrombus detected in the left ventricle
* Uncontrolled insulin dependent diabetes mellitus
* Uncontrolled hypertension
* Renal insufficiency
* Acute infection
* Aortic stenosis
* Acute pulmonary embolism
* Mental, musculoskeletal, neurological, or systemic illness that will prevent exercise.
Oncologist-Initiated Cancer Genetic Testing for Pancreatic Cancer Patients

Pancreatic cancer (PC) has a dismal prognosis. Approximately 10% of PC patients carry a germline pathogenic variant in a cancer susceptibility gene, whose identification can lead to better treatments for the patient and participation in cancer prevention programs for their family members. Conventional genetic testing for PC patients is based on the family history of cancer, and may take up to six months from the point of meeting with the treating physician to receiving the results from a genetic counsellor. The median overall survival for these patients is 6 - 12 months, which may prevent them from having the genetic testing in the first place, or from receiving further targeted treatments. Patients with PC need a more comprehensive knowledge of their disease for better treatment planning. This includes genetic testing in absence of family history of cancer.

The investigators designed a one year study to assess the feasibility of medical oncologist initiated cancer genetic testing for all newly diagnosed PC patients unselected by family history.

For patients with negative genetic testing, no further testing will be ordered after the disclosure of results. Patients with positive genetic testing results will be informed and referred to Cancer Genetics Clinic. The investigators expect to enroll 100 patients in 1 year. Patients will be asked to complete satisfaction questionnaires according to the Satisfaction with Genetic Counseling Scale in multiple time points (pre-testing, post-testing, at 6 months and at 12 months). Designated oncologists will be asked to evaluate the process using the Oncologist Satisfaction Survey after every five counseled patients.

Three primary objectives will include 1) assessment of the turnaround time for genetic testing results; 2) assessment of patient satisfaction; 3) assessment of oncologist's satisfaction. Secondary objectives will include assessment of association between genetic testing results and types of treatment and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* • Newly diagnosed exocrine pancreatic cancer

  * Patient consents to blood draw and genetic testing
  * Treating oncologist at Odette Cancer Centre
  * No conditions that would prevent patients from completing the study-related questionnaires or understanding the consent process
  * Valid phone number
  * Email address to send link to online family history questionnaire
  * Treating physician agrees to complete the referrals

Exclusion Criteria:

* Patient declines genetic testing
* Blood transfusion within the past month
* Allogenic bone marrow transplantation
* History of comprehensive panel genetic testing
Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma

The purpose of this study is to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients.

The successful treatment of melanoma with immune checkpoint inhibitors, such as anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and Programmed cell death protein 1 (PD-1) antibodies, has altered our thinking and approach to immunotherapy for solid tumors. Despite these advances, only a portion of patients experience a durable response suggesting that there is room for improvement via enhanced immunomodulatory approaches. Anti-CTLA-4 (Ipilimumab) significantly improves overall survival and achieves long-lasting complete responses in some melanoma patients, the number of patients that achieve durable clinical benefit is limited and could be improved by a combined immunomodulatory approach. The objectives of this study are to assess the safety and efficacy of combined treatment with Ipilimumab and all-trans retinoic acid (ATRA) in melanoma patients. We hypothesize that combined treatment with Ipilimumab and ATRA will improve patient responses, increase tumor antigen-specific T cell responses, and decrease immunosuppressive myeloid-derived suppressor cells (MDSCs) in melanoma patients compared to patients treated with Ipilimumab alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 year.
* Patients diagnosed with advanced melanoma.
* Patients that are considered candidates for ipilimumab therapy.
* Patients able to understand and willing to sign a written informed consent documents.
* Patients willing to have regular blood draws, one before treatment and four during or after treatment.

Exclusion Criteria:

* Patients under the age of 18.
* Patients with Stage I or II, melanoma who are not candidates for Ipilimumab.
* Patients that have received systemic treatments within four weeks prior to the beginning of treatment.
* Women that are pregnant or nursing.
* Patients taking immunosuppressive medications.
* Patients with active autoimmune disease.
* Patients with known sensitivity to retinoic acid derivatives.
* Patients with aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin \> 2.5 × ULN.
Myopia Control With Simultaneous Vision Approach

To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.

The investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. It comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.

Eligibility Criteria:
Inclusion Criteria:

* Age 8-13 years
* Myopia (SE) between -1D to -5D
* Astigmatism less than or equal to -1D
* Anisometropia: less than or equal to 1.25D
* aided VA (monocular): 0.00 log MAR or better
* willingness to wear contact lens constantly
* availability for follow-up for at least 2.5 years
* parents' understanding and acceptance
* willing to provide refractive status of grandparents

Exclusion Criteria:

* Severe ocular or systemic allergies
* Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
* Ocular or systemic condition that might affect refractive development
* Strabismus at distance or near
* Prior use of bifocal or progressive lenses
* Prior use of rigid gas permeable lenses and Ortho-K lenses
A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe AD

The primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneous using devices for injection at home.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 at Day 1.
* Diagnosis of AD according to American Academy of Dermatology (AAD) Consensus Criteria (2014) that has been present for at least 12 months.
* History of inadequate response to Topical Corticosteroids (TCS) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]).
* Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™) score ≥ 3 at screening and pre-randomization.
* Eczema Area and Severity Index (EASI) score ≥ 16 at initial at screening and pre-randomization.
* ≥ 10% body surface area (BSA) of AD involvement at screening and pre-randomization.

Exclusion Criteria:

* Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization.
* Treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization:

  1. Systemic corticosteroids
  2. Non-biologic, non-targeted systemic immunosuppressants
  3. Oral or Topical Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization:

  1. Topical phosphodiesterase 4 (PDE4) inhibitors
  2. Other topical immunosuppressive agents (not including TCS/TCI)
  3. Combination topical agents containing any of the above components
A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia

The main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.


Eligibility Criteria:
Inclusion Criteria:

* Participant must meet the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (NIA-AA) criteria for probable AD dementia.
* MMSE score of 20 to 26 inclusive at screening visit.
* For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5 or 1, with the memory box score ≥0.5 at screening.
* Evidence of amyloid pathology.
* The participant must have a reliable study partner with whom he/she cohabits or has regular contact.

Exclusion Criteria:

* Significant and/or current neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, repetitive head trauma, serious infection of the brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease.
* Participants with any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessment, or affect the participant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded.
* Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
* Congenital QT prolongation.
* Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
* A corrected QT (QTcF) interval measurement \>470 milliseconds (men and women) at screening (as determined at the investigational site).
* History of malignant cancer within the last 5 years.
* History of vitiligo and/or current evidence of post-inflammatory hypopigmentation.
* Calculated creatinine clearance \<30 milliliters per minute (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening.
* Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Verification of the Efficacy/safety of the Intratympanic Drug Delivery for Hearing Loss

This study is a prospective, randomized pilot study. To verify an efficacy and safety of the Intratympanic drug delivery vehicle, patients who have not responded to the existing standard treatment will be enrolled. Hearing test, endoscopy of tympanic membrane and CT scans will be conducted after intratympanic treatment for evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Sudden hearing loss, ototoxic hearing loss, noise-induced hearing loss, meniere's disease patients with 25dB HL in pure tone audiometry
* Patients whose hearing has not been restored after standard treatment
* Patients do not participate in clinical trials within 6 months

Exclusion Criteria:

* Patients with retrocochlear lesion
* Patients with history of hypersensitivity to the ingredients of this drug
* Patients with end-stage renal disease, end-stage liver disease, cardiovascular surgery, progressive brain tumor, progressive palsy and progressive stroke, etc. severe brain disease or cancer.
Efficacy of Two Therapeutic Techniques for the Treatment of Acromioclavicular Dislocations

The aim of this study is to compare two therapeutical procedures for the grade III acromioclavicular dislocations, either open reduction and internal fixation with a coracoclavicular device (MINAR-STORZ ) or non operative treatment.

For these purpose we have designed an interventional, prospective, parallel assignment, opened and randomized study.

Acromioclavicular dislocations are one of the most frequent traumatic lesions of the scapular girdle. They represent the 40-50% of the sport related shoulder injuries.

There are different grades of dislocations being classified by Altman- Rockwood in 6 types. There is consensus for non operative treatment in types 1 and 2 and for surgical treatment in types 4, 5 and 6.

For type 3 both therapeutic techniques are accepted with no high scientific evidence studies supporting either of them.

During de 70's, surgical treatment was recommended for all these lesions but in the early 90´s surgeons´s preferences changed into the non-operative treatment. Now a day, treatment is decided according to the surgeon experience and the functional demands of the patient.

The aim of this study is to compare the results of non-operative treatment and open reduction and internal fixation with a coracoclavicular reconstruction device (MINAR-STORZ) in grade III acromioclavicular dislocations.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years.
* Grade III acromioclavicular dislocation.
* Signed informed consent.

Exclusion Criteria:

* Any condition that may impair the functional recovery or the patient collaboration with the rehabilitation program (cognitive disability, neurological pathology, tumoral disease...).
* Previous acromioclavicular osteoarthritis.
* Previous acromioclavicular lesions.
* Concomitant lesions in the ipsilateral limb or in the contralateral shoulder.
* Polytraumatized patients.
* Any disease or condition the investigator finds decisive for exclusion.
The Association of B-7 Lung Ultrasound Pattern With the Development of Postoperative Pulmonary Edema

The objective of this proposal is to conduct a randomized controlled study to examine the association between the increase in extravascular lung water as determined by lung ultrasound and the development of radiologic pulmonary edema as diagnosed by chest roentgenogram in patients undergoing major elective open intra-peritoneal surgeries under general endotracheal anesthesia.

This study will be conducted at the University of Alabama at Birmingham's post- anesthesia care unit (PACU). A total of 60 patients will be randomly selected from the 5th and 7th floor surgical suite daily display boards and enrolled in the study. A preoperative and postoperative Point of Care (POCUS) lung U/S exam and Point of Care (POCUS) transthoracic echo will be performed with a Sonosite Edge II bedside U/S machine (approved by UAB Biomedical and Clinical Engineering Dept-#9365) in the pre-anesthesia holding area before the surgical procedure, and after the end of the procedure in the post- anesthesia care unit (PACU). EVLW will be defined as B-line score ≥7 before and after the surgical procedure. Pulmonary edema will be defined by the official radiology report on a chest X ray in the first 72 hrs postoperatively. Pre and Post Op POCUS Pulmonary Capillary Wedge Pressure (PCWP) will be obtained via Trans-thoracic bedside Ultrasound measuring Mitral Valve Inflow (E) Velocity and Early Diastolic Lateral Mitral Annulus Velocity/Tissue Doppler Imaging (E'). A 5-1Mhz Phased Array Probe will be used to obtain images. The PCWP data obtained will be used to correlate with EVLW findings. Ultrasound windows for PCWP measurements will be obtained using the Apical 4-chamber View and/or modified Subcostal View.-

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age, undergoing major elective intraperitoneal surgeries expected to be in hospital for 72 hours

Exclusion Criteria:

* Patients \< 18 years
* Pregnant females
* Cardiac EF 40% on last pre-operative echo
* Prisoners