cyrilzakka/clinical-trials huggingface dataset:
Screening for Barrett's Esophagus in Otolaryngology Patients

The purpose of this project is to develop an accurate method to identify patients that suffer from acid reflux, but may not present with classic reflux symptoms (such as heart burn). Additionally, it is the purpose of this project to utilize the Unsedated Small-caliber Endoscopy (USE) to assess the prevalence of Barrett's esophagus in a population of patients with laryngopharyngeal reflux (LPR) symptoms and to define normal patterns of LPR. Laryngopharyngeal reflux (LPR) is when a small amount of stomach contents and acid are pushed up through the esophagus and may affect the vocal cords and upper respiratory tract.

It is suspected that patients with LPR symptoms may have a prevalence of Barrett's esophagus similar to that found in a population with typical reflux symptoms. We propose to systematically test this hypothesis using the USE.

This project is designed to improve the methods of identifying patients with a form of acid reflux that is often undetected, and thus untreated. If this project is successful then more patients with Barrett's esophagus will be identified; furthermore, screening and treatment for this pre-cancerous condition will be improved.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Prior anti-reflux surgery, laryngeal surgery, trauma to larynx Esophageal diverticulum Pregnancy Anticoagulation therapy Esophageal varices ENT malignancy History of recurrent epistaxis
My Lifestyle Intervention of Food and Exercise

Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest among women with a history of breast cancer (stages 1-3) who are also overweight or obese. The purpose of this study is to compare a tailored nutrition, physical activity, and behavioral weight management program for breast cancer survivors against a widely available commercial weight management program. We hypothesize that an intervention tailored to the unique psychological, nutritional and physical needs of breast cancer survivors will provide superior physiological and psychological benefits compared to an existing commercial program.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 21 to 65
* History of stage 1, 2, or 3 breast cancer
* Completed primary treatments (chemotherapy, radiation, and/or surgical treatment) for breast cancer (with or without maintenance therapy) within the last 3 months to 5 years of providing consent
* Be willing/able to attend groups and assessments in Gainesville or Jacksonville
* BMI of 27 to 45 kg/m2
* Weight-stable, i.e., not lost/gained ≥ 10 lbs in the preceding 6 months, or since the end of primary treatment

Exclusion Criteria:

* History of bariatric surgery
* Pregnant, lactating, or planning on becoming pregnant in next 12 months.
* Irritable bowel syndrome
* Serious infectious disease
* Chronic malabsorption syndrome
* Uncontrolled angina within the past 6 months
* History of musculo-skeletal or chronic lung diseases that limit physical activity
* Serum creatinin \> 1.5 mg/dL
* Uncontrolled or insulin-dependent diabetes (i.e., hemoglobin A1c\< 10 g/dL, fasting serum triglycerides \> 400 mg/dL; oral medications are not exclusionary)
* At-rest blood pressure \> 140/90 mg/Hg
* Myocardial infarction
* Stroke
* Congestive heart failure
* Chronic hepatitis
* Cirrhosis
* Chronic pancreatitis
* History of solid organ transplantation
* Cancer treatment within past 5 years (other than for breast cancer)
* Any other physical condition (other than history of breast cancer) deemed likely to limit 5-year life expectancy or significantly interfere with individuals' ability to participate in a lifestyle intervention involving eating and physical activity changes.
* Use of antipsychotic medications, monoamine oxidase inhibitors, systemic corticosteroids, human immunodeficiency virus or tuberculosis antibiotics, chemotherapeutics medications, or weight-loss medications.
* Significant psychiatric disorder
* Illicit drug use or excessive use of alcohol (i.e., \> 2 drinks/day)
* Currently participating in Weight Watcher's or another weight loss program
* Currently participating in another research study
* Unable to read English at the 5th grade level
* Unable/unwilling to provide informed consent
* Unwilling to receive random assignment to TLI or CWLP
EPO906 Therapy in Patients With Advanced Melanoma

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.


Eligibility Criteria:
Inclusion Criteria

The following patients may be eligible for this study:

* Patients with advanced metastatic melanoma defined as poor prognosis Stage III melanoma and Stage IV disease, which has been histologically or cytologically confirmed with at least one measurable lesion not including bone metastases (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
* Patients with poor prognosis Stage III melanoma must have locally advanced unresectable disease that is measurable (repeat histological or cytological confirmation is not necessary at the time of study entry if previous results are available and there is no question in the investigator's opinion as to the diagnosis)
* Must have a life expectancy of greater than three (3) months
* Prior immunotherapy with interferon alpha in the adjuvant setting is permitted, but must have been completed \> 4 weeks prior to treatment
* Prior vaccine therapy is permitted, but must have been completed \> 4 weeks prior to treatment
* Patient has no major impairment of hematological function (red blood cell transfusions and repeat evaluations for study entry are allowed).

Exclusion Criteria

The following patients are not eligible for this study:

* Patients with choroidal ocular melanoma
* Patients with symptomatic CNS metastases or leptomeningeal involvement
* Patients with renal or hepatic dysfunction
* Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
* Patients with severe cardiac insufficiency
* Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
* Patients who have received any investigational compound or anti-melanoma vaccine within the past 28 days or those who are planning to receive other investigational drugs while participating in the study
* Patients who had received radiotherapy within the last 4 weeks to a site which will be the reference for disease assessment (however, new or progressive lesions in the previously irradiated fields of these patients may be used for disease assessment and patients must have recovered from the side effects of radiotherapy)
* Patients receiving chemotherapy within the last four weeks
* History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
* Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
* HIV+ patients
* Pregnant or lactating females.
The PRIME Study: A Randomized, Controlled, Prospective Study

To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively.

A Randomized, Controlled, Prospective Study design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, TID 1 week, BID 1 week, and QD 1week, following bilateral RLE surgery. All eyes will receive topical moxifloxacin QID for one week and topical Ilevro QD for 4 weeks. Moxifloxacin and Ilevero are used in post-op regardless of the research. Post-operative evaluations to be performed on Day 1, Day 7, and 1 Month.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient who is planned to undergo bilateral RLE surgery with BCVA 20/30 or better
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria:

* Patients under the age of 22 or above the age of 75
* Patients who are pregnant (must be ruled out in a women of child-bearing age with pregnancy test).
* Patients with active infectious ocular or extraocular disease.
* Patients actively treated with local or systemic immunosuppression including systemic corticosteriods
* Paitents with know hypersensitivity to Dexamethasone
* Patients with severe disease that warrants critical attentino, deemed unsafe for the study by the investigator
* Patients with a history of ocular inflammation or macular edema
* Patients with allergy or inability to receive intracameral antibiotic
* Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) grater than 1,200 mg/day
* Patient with a corticosteriod implant (i.e. Ozurdex).
* Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes
Assessment of Stent Strut Coverage and Endothelial Function After Drug-Eluting Stents

The purpose of this study is to compare coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker level.


Eligibility Criteria:
Inclusion Criteria:

* Significant coronary de novo lesion (\> 70% by quantitative angiographic analysis)
* Patients with stable or acute coronary syndrome considered for coronary revascularization
* Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion Criteria:

* Contraindication to anti-platelet agents
* Ostial lesion within 5 mm from ostium
* Different DES in other vessel simultaneously
* Creatinine level 2.5 mg/dL
* Left main stenosis more than 50%.
* vein graft lesion
* Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
* Life expectancy 1 year
* Reference vessel \< 2.5 mm or \> 4.0 mm diameter by visual
* Long lesion that require more than three stents
Efficacy on Volume Reduction and Tolerance of Progressiv' Medical Compressive Therapy (MCT) V0322 BC in Patients With Chronic Venous Oedema

Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on studies carried prior to CEAP classification (2004). Item C3 of this classification relates to patients suffering from chronic venous disease and permanent oedema. Literature mentions only one study in which volume reduction in venous-induced oedema was primary endpoint. Indeed, 240 patients showed a 46.7 ± 8.2 ml reduction (SEM) after 12 weeks with a Class 2 compression sock (15-20 mm Hg at ankle). Volume is an accurate and reproducible quantitative measure considered nowadays as being gold standard when objectifying oedema variation. It is therefore particularly relevant in a C3-patient trial (CEAP classification).

The main objective of the current study is to evaluate the clinical effect of Progressiv' MCT on volume reduction in permanent CVI-oedema after 3 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and above
* Permanent chronic oedema of venous origin (C3 based on CEAP classification) confirmed by Doppler or Duplex ultrasound examination with reflux and/or obstruction on superficial, deep or perforator veins
* Pitting oedema
* Have given and signed written informed consent
* Registered with or benefiting from health insurance (Mandatory for France)

Exclusion Criteria:

* Use of compression therapy in the last 5 days before inclusion
* Common contraindications for MCT (arteriopathy, decompensated heart failure, infectious dermatitis
* Isolated lipoedema
* Isolated lymphoedema (Kaposi- Stemmer sign
* Severe systemic disease (heart failure, renal failure, hepatic failure, thyroid dysfunction untreated, malnutrition with hypo-proteinemia ...)
* Known hypersensitivity to any component of MCT
* Important limitation of ankle movement requiring a specific therapy
* Following treatment initiated or dose-modified 1 month prior to inclusion: NSAID, corticosteroids, calcium blockers, ACE inhibitors, Angiotensin II inhibitors, vasoconstrictors or vasodilators
* Hormonal treatment initiated or dose-modified 1 month prior to inclusion
* Diuretic and/or phlebotonic treatment initiated or dose-modified 1 month prior to inclusion
* Pregnancy, breast feeding, planning to become pregnant, or not using any form of contraception
* Patient linguistically or psychologically unable to understand the information given or who refuses to give his/her consent in writing
* Participation in another clinical trial
* Deprived of liberty for administrative, medical and legal reasons
* May not be compliant with the constraints imposed by the protocol
Clinical Study to Assess the Influence of a Saw Palmetto Preparation in Patients With Benign Prostatic Hyperplasia (BPH) and Sexual Dysfunctions

Assessment in an open trial if a standardized saw palmetto preparation has a positive influence on sexual dysfunctions in patients with BPH and sexual dysfunctions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with BPH and sexual dysfunctions (erectile dysfunction or decrease in libido)
* IPSS \> 4
* BSFI, sexual drive questions \< 5

Exclusion Criteria:

* Lack of libido which is due to a psychic disease or a depressive mood -Excessivly strong lack of libido in the judgement of the investigator within the last two months
* Patients with severe vascular disorders (microangiopathies)
* Patients with known neuropathies
* Severe diabetes mellitus
* Patients with hypertension who are for less than two months on a stable antihypertensive medication
* Known bad compliance of the patient
Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults

1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.
2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (ELISA) in a healthy adult population.


Eligibility Criteria:
Inclusion Criteria:

* Adult men or women aged 18 to 49 years inclusive.
* Able and willing to provide written informed consent to participate.
* Healthy, as determined by medical history, physical examination, and vital signs.
* Willing to receive the unlicensed (VAX102) vaccine given as an i.m. or s.c. injection.
* Willing to provide multiple blood specimens collected by venipuncture.
* Females should avoid becoming pregnant during the course of the study
* Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of the first and preceding receipt of the second (booster) vaccination.
* Must exhibit comprehension of the study requirements; expressed availability for the required study period and expect to reside in the study area during the entire study period, and ability to attend scheduled visits.

Exclusion Criteria:

* Persons under 18 years old or 50 years or older.
* Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease.
* Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination.
* Persons who have had a prior serious reaction to influenza vaccine.
* Persons with a history of anaphylactic-type reaction to injected vaccines.
* Persons with a history of drug or chemical abuse in the year preceding the study.
* Persons who received an influenza vaccine for the current influenza season or those who plan to receive an influenza vaccine while participating in the study.
* Persons who received any other vaccine within one week prior to enrollment (may delay enrollment).
* Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment).
* Persons currently participating in another research study involving any study medications (medicines or vaccines).
Optimizing Gastrointestinal Procedure Appointments

This project will address the question:

Does an "enhanced" IVR-T protocol differ in effectiveness from the standard IVR-T protocol in reducing missed appointments and late cancellations for GI endoscopy? Hypothesis: The enhanced IVR-T protocol will be more effective.

This study will be a randomized trial over a 6-month period (March 8 through September 7, 2019) in 3 GI endoscopy clinics (Franklin, Rock Creek, and Lone Tree). All members currently receive a text reminder 7 days prior to their procedure, which rolls over to a telephone reminder if the text cannot be delivered or the member's phone is not text-enabled. Members will be randomized either to receive this standard IVR-T protocol (control) or to receive an enhanced reminder (intervention) protocol.

Randomization: Beginning in March 8, 2019, a randomization algorithm will be used in the Structured Query Language program that manages the IVR relational database to assign each visit for a procedure at all three sites to control or intervention. Since members with multiple procedures on different days during the study period could receive control or intervention for different visits, the statistical analysis will be limited to the first randomized appointment during the project period. Randomization will be stratified by clinic site.

Eligibility Criteria:
Inclusion criteria:

* Members scheduled for any GI procedure (upper endoscopy, colonoscopy, or both), with or without anesthesia, at all three clinical sites (Franklin, Rock Creek, Lone Tree) will be included if their procedure is scheduled ≥ 2 days prior to the procedure. The IVR-T protocol will be adapted based on the wait time between appointment scheduling and the date of the procedure.
* Members with all clinical indications (screening, diagnosis, or surveillance), will be included.

Exclusion criteria:

* KPCO members who request not to participate in research or not to receive IVR-T or email outreach
* KPCO members in the "break the glass" or "code pink" protocols.
* Members whose procedure is scheduled \< 2 days prior to the procedure.
Methylnaltrexone Use for Opioid-induced Postoperative Constipation

The purpose of this study is to determine whether the routine use of methylnaltrexone in the post-operative pediatric spinal fusion patient will decrease the incidence of constipation.

Methylnaltrexone will be given to pediatric patients post-operative from spinal fusion surgery on post-operative day number 3 and then again on postoperative day number 4, if no laxation achieved. Various outcome measures, safety and efficacy of the drug will be observed and recorded.

Eligibility Criteria:
Inclusion Criteria:

* spinal fusion surgery
* current opioid use
* 12 years of age and older
* no or inadequate bowel movement by post-operative day 3

Exclusion Criteria:

* known or expected mechanical bowel obstruction
* known or suspected lesions of the GI tract
* unexpected transfer to ICU
* unexpected return to the operating room
* patient or parent refusal of methylnaltrexone
* incomplete data concerning time to laxation
Comparison of the Efficacy and Tolerability of Femal Versus Placebo

Femal, a food supplement based on pollen extracts introduced in Europe in 1999, is a non-estrogenic alternative to hormone replacement therapy in women with vasomotor symptoms.

Patients with prior breast cancer, spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flashes per week) will be included.

Patients who are on tamoxifen or anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry.

Patients on SSRI or SNRI antidepressant therapy are excluded. Eligible patients will be randomly assigned to either Femal (2 cp/day) or placebo (2 cp/day) for 3 months (double-blind study).


Eligibility Criteria:
Inclusion Criteria:

- patients with a history of breast cancer, in spontaneous or iatrogenic menopause or who are premenopausal with ovarian function suppressed by GNRH analogue and experiencing severe vasomotor symptoms (at least 20 hot flushes per week).

Patients who are on tamoxifen or aromatase anti-estrogen or aromatase inhibitor therapy are eligible if started at least 2 months prior to study entry

Exclusion Criteria:

* Patients on SSRI or SNRI antidepressant therapy are excluded
Clinical Study of Released Unitron RIC and BTE Hearing Aid Models

Participants will wear two sets of Unitron released hearing aids (RIC and BTE) programmed based on a prescriptive approach and will perform a standardized speech discrimination test in noise in both aided conditions as well as in unaided condition.

During this study each participant will be asked to complete three randomized conditions of the HINT testing: unaided, aided with RIC, and aided with BTE. The investigators will be assessing their speech intelligibility in noise in each condition, during the same appointment to determine the SNR-50 (the Signal-to-Noise ratio necessary for a participant to recognize the speech material correctly 50 percent of the time).

Eligibility Criteria:
Inclusion Criteria:

* Adults (18+ years) with hearing impairment (N2 - N6 hearing loss).
* Healthy outer ear.
* Symmetrical hearing loss.
* Ability to answer questions and repeat sentences.
* Informed consent as documented by signature.
* Willingness to wear different style of hearing aids.
* Willingness to wear a binaural fitting.
* Willingness to wear closed domes.
* Willingness to adhere to COVID protocols including correct mask use, completing screening for each visit

Exclusion Criteria:

* Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational product).
* Limited mobility/not able to come to scheduled visits.
* Inability to produce reliable hearing test result.
* Visible congenital or traumatic deformity of the outer ear.
* History of active drainage from the ear in the previous 90 days.
* Abnormal appearance of the eardrum and ear canal.
* Acute or chronic dizziness.
* Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz.
* Known psychological problems.