cyrilzakka/clinical-trials huggingface dataset:
Study of Cardiac MRI in Patients With Left-Sided Breast Cancer Receiving Radiation Therapy

This is a pilot study to determine if there are changes in heart function following completion of radiation therapy for breast cancer as measured by cardiac magnetic resonance imaging (cardiac MRI) scans. Additional purposes of this study are to assess cardiac side effects from radiation treatment, evaluate cardiac MRI changes by radiation technique, and compare quality of life questionnaires.

As part of this study, participants will have a cardiac MRI at baseline and a follow-up cardiac MRI within 1 year after completion of standard radiation therapy for left-sided breast cancer. The cardiac MRI scans will be evaluated to determine if there are changes in cardiac function within 1 year after radiation treatment.

Patients will be asked to complete a questionnaire before and after treatment that asks about their health and any symptoms they may be having.

Physical exams and any other standard of care service or treatment will be at the discretion of the treating physician.

Eligibility Criteria:
Inclusion Criteria:

* Left-sided breast cancer stage I-III.
* Indications for adjuvant regional nodal and breast or chest wall radiation therapy (RT).
* Women and men are allowed.
* Must be at least 18 years old at time of consent.

Exclusion Criteria:

* Pregnant and/or breastfeeding women or patients of child-producing potential not willing to use contraception while on study.
* Prior history of cardiovascular disease per physician discretion.
* Stage 0 and IV breast cancer.
* Prior radiation therapy to chest.
* Concurrent trastuzumab per physician discretion.
Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial

The purpose of this study is to evaluate the safety and performance of the ELS to treat urinary stones. The ELS is intended to break urinary stones into small fragments that can pass during or after the procedure with less or no discomfort. Eligible patients are male or females, age 21 or older, with a single urinary stone in the ureter. Participants will undergo the ELS procedure and then be evaluated 30 days later for the presence or absence of urinary stone fragments on a CT scan. Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged \>=21 Years
* Provides written informed consent
* One urinary stone within the ureter, size \>=5 mm and \<=10 mm
* Stone is indicated for Shock Wavve Lithotrips Per AUA 2016 guidelines
* Urinary stone is present on a CT scan within past 14 days

Exclusion Criteria:

* Anatomic presentations that would preclude obtaining an acoustic window for the ultrasound treatment
* Medical Expulsion Therapy (e.g., Flomax)
* Non-calcium based stones (e.g., uric acid stones)
* Untreated UTI
* Presence of abnormal skin conditions in the area to be treated
* Coagulation abnormality
* Inability to lay still for 30 minutes
* Pregnant
* Abnormal Kidney Function
* Any genitourinary history or procedure that has altered anatomy (e.g. urinary tract reconstruction)
Role of Metabolites in Nicotine Dependence (2) - 5

The purpose of this study is to determine the effects of varying doses of cotinine on cigarette self-administration.

Previous studies have shown that cotinine, a metabolite of nicotine, antagonizes some of the effects of nicotine. One study showed that nicotine eliminates some of the beneficial effects of the nicotine patch in reducing withdrawal symptoms. The purpose of this study was to examine the effects of cotinine. The results generally showed no effects on self-administration of cigarettes, although higher serum nicotine levels were observed on the highest doses of cotinine compared to placebo or lower doses of cotinine.

Eligibility Criteria:
Inclusion Criteria:

Male/Female subjects ages 21-45 yrs. inclusive, with a smoking history of at least 1 pack of cigarettes daily for at least 1 year. Subject must be in good health as verified by medical history, screening examination, and screening laboratory tests. Subject must provide written informed consent to participate in the study and be motivated to stop smoking for a short term.

Exclusion Criteria:

History of myocardial infarction, angina pectoris, sustained or episodic cardiac arrhythmias, symptomatic peripheral vascular disease, peptic ulcer disease or any other medical condition which the physician or investigator deems inappropriate for participation. Insulin-dependent diabetes. Pregnant or lactating, or not using adequate birth control methods. Requirement of any form of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history). Chronic use of systemic steroids or antihistamines. Skin sensitivity which would preclude use of a transdermal system. Abuse of alcohol or any other recreational or prescription drug. Use of any other tobacco products including smokeless tobacco and nicotine products. Previous use of transdermal nicotine system. Inability to fulfill all scheduled visits and examination procedures throughout the study period.
Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)

The purpose of this study is to determine whether Timolol 0.5% Gel Forming Solution is safe and effective in promoting wound healing of infantile ulcerated hemangiomas compared with standard conservative management with topical antibiotic.

Ulceration is the most common complication associated with infantile hemangiomas. Ulceration and the delay in wound healing places patients at risk for infection, bleeding, pain and permanent scarring. Currently, the care of ulcerated hemangiomas is extremely difficult and patients are often subject to multiple treatment modalities.

In the past two years, the leading advance in the treatment of hemangiomas has been the use of the non-selective, oral beta-blocker propranolol to arrest growth and promote involution of hemangiomas. Recent literature also suggests beta-blockers may have a role in helping ulcerated wounds re-epithelialize.

The use of a topical non-selective beta-blocker on isolated ulcerated hemangiomas may promote early healing and reduce the number of complications associated with ulceration. Investigation is needed to explore the safety and tolerability of applying a topical beta-blocker on an ulcerated hemangioma and whether topical beta-blockade may be more efficacious than conservative care with topical antibiotics.

In this study, infants will be randomized to either receive a topical antibiotic (topical mupirocin 2% ointment twice per day) or a topical beta-blocker (Timolol 0.5% Gel Forming Solution) according to a dose-escalation schedule. Subjects will be seen in clinic on day 7, day 14, 1 month and 2 months into therapy and 1 month after therapy is completed. Photographs and safety and efficacy measurements will be taken at each visit to assess response to therapy.

Eligibility Criteria:
Inclusion Criteria:

* Infants weighing between 4-12kg
* Infants with corrected gestational age 44 weeks - 8 months of age
* Infant with an ulcerated hemangioma
* Informed consent

Exclusion Criteria:

* Ulceration larger than 16cm2
* Ulcerated hemangioma with active bleeding or infection at time of enrollment
* Disease threatening hemangioma meeting criteria for oral propranolol
* Previous treatment with topical/oral corticosteroid or propranolol
* Medical history of congenital heart disease with decreased cardiac output, stroke/cerebral vasculopathy, active reactive airway disease or metabolic disorder
* History of an allergic reaction to Mupirocin or Timolol
* Currently taking medication that would interact with beta-blockers
Barrett's Esophagus & Gastroesophageal Reflux Disease

This is a study of Barrett's Esophagus (BE) and Gastroesophageal Reflux Disease (GERD). It aims to look at the long term efficacy of evidence-based cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal resection and surveillance endoscopy with biopsy. Additionally, biological analyses will be performed in hopes of identifying biomarkers associated with the progression of BE to esophageal cancer.

Barrett's esophagus (BE) is a known premalignant condition of the esophagus, predisposing to the development of esophageal adenocarcinoma. BE represents a change in the lining (mucosa) of the esophagus which is known to be produced as a result of chronic gastroesophageal reflux. The current standard of care for patients with BE includes serial performance of upper endoscopy with multiple biopsies, performed at designated time intervals. However, the emergence of new technologies for the management of this condition has made the care of these patients non-uniform, and subject to biases of individual treating physicians.

The protocol at The Valley Hospital and Blumenthal Cancer Center aims to standardize the management of patients with Barrett's esophagus, with and without dysplasia, using evidence-based, cutting edge diagnostic and therapeutic algorithms and techniques such as radiofrequency ablation, endoscopic mucosal resection, and surveillance endoscopy with biopsies. If biopsies suggest the development of carcinoma or high grade dysplasia surgical removal of the esophagus is recommended. This study aims to look at the long-term efficacy of these procedures. In addition, data regarding clinical outcomes will be collected as well as blood, tissue and surgical specimens for proteomic analysis in hopes of identifying biomarkers associated with the progression of dysplasia to adenocarcinoma. Although patients will ultimately make their own informed decisions regarding the management of their BE, this protocol serves to unify physician recommendations, and allows for the collection and interpretation of data.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 18 to 85.
* Patient must have Barrett's Esophagus. Patients may be enrolled based on previous endoscopy reports and/or pathology reports. It is not necessary that each patient have endoscopy for the sole purpose of enrollment.
* Must agree to allow their clinical information to be collected, stored, analyzed and reported.
* Must allow portions of their biopsy/surgical specimens to be collected, stored, analyzed and reported.
* Must agree to fill out patient questionnaires in conjunction with the research study assistant assigned to this protocol (either in person or via telephone contact) at designated timepoints.

Exclusion Criteria:

* Intestinal metaplasia of the cardia, without an esophageal columnar lining.
* Unable to provide informed consent.
* Unable or unwilling to undergo endoscopic procedures.
Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis

Study the cervical spinal cord and brain over time to assess changes and differences in subjects with amyotrophic lateral sclerosis.

Investigators will study cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant compared to ALS patients who have not had a stem cell transplant. Investigators intend to determine cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant and compare these to corresponding measures in amyotrophic lateral sclerosis(ALS) patients who have not had a stem cell transplant.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Subjects with amyotrophic lateral sclerosis -

Exclusion Criteria:

1. Do not have opportunistic central nervous system infection
2. Do not have a history of head injury
3. Do not have cerebrovascular disease
4. Do not have a contraindication for MRI(e.g. cardiac pacemaker, ferromagnetic or metallic implants).
5. Must not be pregnant -
Evaluating the Implementation of a Comprehensive Multilevel Virtual Oncology Program Among Veterans Diagnosed With Lung, Colorectal, Prostate, and Breast Cancers in the US Department of Veterans Affairs

The purpose this pragmatic trial to test the effectiveness of an existing, ongoing clinical service, the VA National TeleOncology program (NTO), a multilevel telehealth population health management program. The primary aims are to study the intervention and determine its effectiveness on telehealth engagement, clinical quality, and healthcare cost outcomes across levels of Social Determinants of TeleHealth (SDTH) with the goal of promoting health equity.

Study staff will use the Veterans Health Information Systems and Technology Architecture (VistA), the VA health information technology system, to identify eligible patients at VA sites based on listed inclusion and exclusion criteria. Patient records will be observed of Veterans with a new cancer diagnosis of the lung, prostate, breast, or colon and a telehealth visit utilizing the VA National TeleOncology Service (NTO).

Eligibility Criteria:
Patients Inclusion Criteria:

1. A Veteran
2. Aged 18 years or older
3. Newly diagnosed with lung, prostate, breast, or colon cancer within 3 months of telemedicine visit
4. Engaged in an oncology visit during the 36-month analysis period at a Veterans Affairs Medical Center (VAMC) location.

VAMC Providers and Staff Inclusion Criteria:

1. Provider or staff member at one of the VAMC locations including physicians, nurse practitioners, physicians' assistants, and nurses caring for Veterans
2. Providers or staff members having helped provide care for at least 5 Veterans with cancer in the previous 6 months at a VAMC location

Patients Exclusion Criteria:

1. Veterans who have not seen any providers in the VA within the past year
2. Patients previously diagnosed with lung, prostate, breast, or colon cancer
3. Pregnant patients

VAMC Providers and Staff Exclusion Criteria:

1. Providers or staff members who do not help treat Veterans with specified cancers in oncology at the VA
On Demand Contraception: Ulipristal Acetate Plus a COX-2 Inhibitor at Peak Fertility

This is an exploratory prospective study investigating if addition of a COX-2 inhibitor can increase efficacy of ulipristal in disrupting ovulation at peak fertility.

This is an exploratory prospective study investigating if addition of a COX-2 inhibitor can increase efficacy of ulipristal in disrupting ovulation at peak fertility. We will compare the proportion of women with ovulatory disruption after taking the study medications with those women's own placebo cycles and also to previously established/published rates of ovulatory disruption of ulipristal alone.9 Given the established efficacy of ulipristal during the follicular time period as well as the theoretical mechanism of meloxicam to disrupt cumulus-oocyte expansion is a late step in ovulation, we hypothesize that this medication could emerge as the best candidate for an oral on-demand contraceptive option.

Eligibility Criteria:
Inclusion Criteria:

Women, aged 18-38

* English speaking
* Able to consent, literate
* Access to smart phone throughout study
* History of regular menses
* Documented baseline cycle with ovulation
* Not currently using or needing hormonal contraception
* Not currently using or needing regular NSAIDS
* Able to commit to frequency of study visits

Exclusion Criteria:

* Currently or recently (\<2months) pregnant
* Currently or recent (\<2months) breastfeeding
* Current or recent (\<2months) use of hormonal medication
* Regular NSAID use
* Known cardiac risk factors (e.g. personal history of obesity, HTN, cardiac disease, diabetes)
* BMI \> 30, as some studies have shown decreased efficacy of ulipristal in obese women37
* Allergy or previous unacceptable side effects with study medications
To Identify and Evaluate the Predictive Factors for Depression in Patients Diagnosed With Multiple Sclerosis

This is an observational, non controlled, multicentric, prospective study planned to be conducted in 350 subjects diagnosed with multiple sclerosis (MS) in 20 centres of Argentina to identify the predictive factors leading to depression. The incidence of depression symptoms and its influence in the evolution of the disease are unknown in the Argentinean population. Early diagnosis of depression symptoms allows the specific treatment of them and can also delay the rich apparition of the disease. This study intends to quantify the incidence of these symptoms and also aims to evaluate which are the predictive factors of the apparition of the depression.

Multiple sclerosis is a chronic, demyelinating disease of the central nervous system and is considered to be one of the most common cause of neurological disability in young adults. The clinical and pathophysiological characteristics of the disease lead to the association of several conditions over time, among which the depression and/or the depression symptoms are one of the most important ones. The underlying mechanism of depression is not clear and the etiology of depression is considered to be multifactorial and especially associated to the psychosocial stress, to the presence of focal demyelinating lesions and to the immune malfunction. Several scales like Beck Depression Inventory Fast Screen (BDI FS), Mini Mental State Examination (MMSE), Hamilton Depression Rating Scale (HDRS) have been used to objectify the presence of depression symptoms in subjects with MS.

OBJECTIVES

Primary objective:

* Identification of the predictive factors for the development of depression symptoms in subjects with MS in Argentina

Secondary objective:

* Evaluation of the proportion of subjects that develop depression symptoms during the follow up

The subjects will be managed with the clinical and therapeutic elements that the treating doctors considered appropriate, without modifying their decisions due to the subjects' inclusion into the study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 65 years of both sexes
* Subjects with established MS diagnosis according to the revised Mc Donald criteria - 2005 in any of its clinical forms
* Subjects with signed informed consent
* Subjects wiling to follow the study procedure

Exclusion Criteria:

* Subjects with diagnosis of depression at the moment of the initial evaluation
* Subjects receiving antidepressant drugs at the moment of the initial evaluation
* Subjects with moderate or severe cognitive impairment
* Antecedents of any other psychiatric disease
* Subjects that were receiving or have received any experimental treatment during the 6 months before the inclusion
A Study of Pancreatic Cancer in Xenografts From Liver Metastases

This is a feasibility study to perform image-guided liver biopsies in 25 patients who have pancreatic cancer with liver metastasis (cancer in the pancreas that has spread to the liver). This will contribute with samples for the bio-bank (bank of tumors) and develop xenografts (human tumors growing in mice) for further analysis of genes.

This study might bring a better understanding of the metastatic pancreatic cancer and evaluate the differences between the metastatic and the primary pancreatic cancer (the type that does not have metastasis).

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years old
* Pancreatic cancer with liver metastasis
* No contraindication to image-guided biopsy of liver metastasis, including uncontrolled bleeding diathesis, uncontrolled malignant pain, inability to lie supine etc) and no significant hepatic dysfunction.
* Provide written informed consent
* ECOG 0,1 or 2

Exclusion Criteria:

* Inability to lie supine for more than 30 minutes
* ECOG 3 or more
* Serious medical risk factors involving any of the major organ systems or including uncontrolled bleeding diathesis, uncontrolled malignant pain, inability to lie supine etc) and no significant hepatic dysfunction.
Neuro-rehabilitation Training Effects on Motion and Quality of Life After Acute Stroke and Post Stroke

High intensity motion improves motor functions and quality of life in a neurologist. The investigators want to improve the clinical condition and quality of life of post-STROKE participants with a special sensory motor and visual motor agility therapy.

High intensity motion improves engine function and quality of life in a neurologist. With special sensory motor and visual motility, investigaters want to improve the clinical condition and quality of life of STROKE participants.

The investigaters randomly select participants who only perform the rehabilitation treatment have performed. The other group that will receive the study's control group will receive the traditional rehabilitation physiotherapy treatment.

The investigaters assess the condition and quality of life of the patients. (EQ5-D, Barthel index, MRS test) The ivestigaters examine the functional movement and equilibrium variables of patients. (6MWT, Berg balance test, postgraduation) After that, participants are undergoing a 4-week intensive rehabilitation treatment. All participants are in post stroke.

Primary Hypothesis will be changes in life-quality tests (EQ5-D, Barthel index, MRS test). Functional tests show progress 6MWT, Berg balance test and postural control testing with posturography. The results are compared and evaluated among the groups.

The expected hypothesis is that visual and acoustic stimulation produces a better physical state at higher intensity.

Eligibility Criteria:
Inclusion Criteria:

* post stroke
* 6MWT : 120\>
* minimum after stroke 2 weeks

Exclusion Criteria:

* Sever heart problem
* sever demeanor
* alcoholism
* drug problems
Study of SARS-CoV2 Virus (COVID-19) Seroprevalence Among Lyon-Bron Military Health Schools Personnel

Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a global pandemic in March 2020. The clinical presentation is highly variable, ranging from asymptomatic forms to acute respiratory distress and even death. Transmission is by droplet route, with an R0 of approximately 3.

Rapidly, population protection measures were put in place by governments, including the confinement of all persons whose functions were not considered essential and the closure of educational institutions.

Health care institutions are places at risk of Covid-19 transmission and hospital staff are particularly exposed, either through direct contact with patients, contact with exposed persons or through the environment. In order to protect personnel, hygiene measures were immediately recalled and reinforced.

During the period of containment, the majority of students from the Lyon-Bron Military Medical Schools were sent as reinforcement in Army Training Hospitals and in the Military Reanimation Unit (Mulhouse). Some students developed symptomatic forms of SARS-Cov-2 infection, documented by positive PCR, during Operation Resilience or on their return from the mission.

The Lyon-Bron Military Medical Schools staff, exposed both to the initial phase of the epidemic and to national protection measures, represent an extremely interesting population for understanding the epidemiological dynamics of the virus.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* personnel of the Military Health Schools of Lyon-Bron
* working at the Military Health Schools of Lyon-Bron during the COVID-19 crisis

Exclusion Criteria:

* under 18
* contraindication to blood sampling