cyrilzakka/clinical-trials huggingface dataset:
Comparison of Surveillance Colonoscopy Techniques in Patients With IBD

We propose a randomized controlled study to determine the detection rates of neoplasia with high definition colonoscopy alone, high definition dye spraying chromoendoscopy or High definition iSCAN virtual chromoendoscopy in patients with long standing colitis (8 years from diagnosis except primary sclerosing cholangitis when surveillance starts at diagnosis) CD or UC.

We hypothesized that these novel endoscopic techniques using High definition colonoscopy with virtual chromoendoscopy -iScan 2 and 3 may be superior to high definition colonoscopy alone and similar to using dye spraying chromoendoscopy for detection of dysplasia and neoplasia in patients with long standing IBD.

We will aim to demonstrate if we can avoid dye spraying during the procedure and save expense and considerable time.

In addition, we can hope to produce evidence and inform the way in which we perform surveillance colonoscopy especially without large number of multiple random biopsies but only few targeted" smart and intelligent" biopsies using high definition colonoscopy with iSCAN technique as is already the European practice in several centres.


Eligibility Criteria:
Inclusion Criteria:

Clinical and histological diagnosis of UC or colonic CD-extensive or pancolitis.

UC -CD Disease duration 8 years from diagnosis UC-CD with associated primary sclerosing cholangitis from diagnosis Ulcerative Colitis Activity Index Mayo score 0-1 (inactive disease) Crohn's disease Activity Index - Harvey Bradshaw score \<4 (dysplasia detection requires quiescent inflammatory bowel disease)

Exclusion Criteria:

Known intraepithelial neoplasia or colorectal cancer or other neoplasia Coagulopathy which may prevent biopsies Pregnancy Inability to obtain informed consent
A Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer

This clinical trial studies whether a patient navigation (PN) intervention can be used to improve risk management among women at high risk of breast cancer. Women with a family history of breast cancer have a higher lifetime risk of developing it. Risk management can benefit women at high risk of breast cancer and can include surveillance routines, preventative surgeries, and medications that can dramatically lower the risk of breast cancer and allow early detection. Although risk management can benefit women at high risk of breast cancer, only a small amount actually use it. PN is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN intervention in this study is designed to help give women the information and support they need to make choices about their breast cancer risk that they feel good about, which may improve risk management.

PRIMARY OBJECTIVE:

I. Test the feasibility of the PN intervention and of recruiting participants to a randomized controlled trial of the intervention.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive links to informational websites on breast cancer risk and risk management options on study. Participants also receive phone calls from a single patient navigator and discuss breast cancer risk and risk-management options once a month for 8 months. Participants may choose to receive additional patient navigator phone calls as needed on study.

ARM II: Participants receive links to informational websites on breast cancer risk and risk management options on study.

After completion of study intervention, participants are followed for up to 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Are non-Hispanic Black or non-Hispanic white
* Identify as women
* Are between 18 and 75 years old
* Have been identified as at potentially high risk by a population-based risk screening program
* Have never been diagnosed with breast or ovarian cancer
* Are early in their risk-management adoption process, defined as currently identifying with stage 0 (never heard of it) or 1 (haven't decided) of the risk-management adoption pathway (R-MAP) in relation to at least one of the four risk-management actions recommended for all high-risk women: attending genetic counseling appointment, having a personalized risk assessment, undergoing annual clinical breast exams, and considering chemoprevention
* Who do not believe cancer can be prevented and/or have not received risk-management guidance from a specialist
Hemodynamic Repercussions of Noninvasive Ventilation

The noninvasive ventilation (NIV) is a method of ventilatory support that does not require artificial airway. Its application is associated with complex hemodynamic repercussions, therefore is important to identify them for safety and effectiveness of the technique application.

The main objective of this research is to evaluate the hemodynamic repercussions using doppler echocardiography in healthy volunteers submitted a different values of positive end expiratory pressure (PEEP) by the following ventilatory modes: Continuous positive airway pressure (CPAP) and Bilevel.

The study hypothesis is that the positive end expiratory pressure (PEEP) may cause hemodynamic repercussions as: reduction of the ventricles pre-load, left ventricle after load, cardiac output and reduction in the diameter of the superior vena cava, due to the increase in the intrathoracic pressure and pulmonary volumes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Age between 18 and 40 years old
* Non smoker

Exclusion Criteria:

* Clinical signs or symptoms of any disease decompensation
* History of blood pressure variations by autonomic dysfunction
* Sense of claustrophobia
* Smoker
Using Smart Phone Technology to Support PrEP Uptake and Adherence

This is a single arm pilot study of a new smartphone app to support adherence to PrEP medication for HIV prevention in public clinics in Virginia.

Testing the impact of a smart phone application's impact on PrEP uptake and adherence.

The app features daily medication reminders, daily mood and stress evaluations, a community message board for social support, and patient-provider secure, HIPAA compliant private messaging between patients and clinic providers. Participants will be recruited from VDH clinics. We will evaluate the adherence and uptake rates of PrEP among study participants. Usage data will be collected from the application, and from participant surveys at 30 day, 3 month, and 6 month study timepoints. Surveys will include questionnaires on medication adherence, empathy of providers, experiences with the app, stigma and disclosure attitudes, and social support, along with mental health screening. The study will be analyzed as a prospective one arm study by comparing baseline to 3M and 6M surveys, along with examining and characterizing app usage across time.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* one or considering being on PrEP for HIV prevention
* Patient at a VDH or VDH funded clinic
* ability to read at a 5th grade reading level

Exclusion Criteria:

* HIV positive individuals
* Persons under the age of 18
Analgesia Nociception Index Guided Remifentanil Administration During Propofol Anesthesia for Laparoscopic Surgery

The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint : lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?

The Physiodoloris (MetroDoloris, Lille, France) monitor, CE marqued, uses the ECG signal in order to compute the Analgesia Nociception Index (ANI) which has been shown to measure the relative parasympathetic tone, and hence to reflect the analgesia/nociception balance during general anesthesia. The primary endpoint of this randomized multicenter study is to measure whether there is a benefit to use the ANI in order to adapt remifentanil administration during propofol anesthesia for laparoscopic surgery. Primary endpoint is: lesser proportion of patients presenting with at least one episode of hemodynamic reactivity, hypotension or bradycardia in the ANI guided group vs control group ?

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic cholecystectomy or gynecological laparoscopic surgery
* ASA I or II
* adult patient
* body mass index between 17 and 33 kg/m2

Exclusion Criteria:

* pregnancy
* arrhythmia
* pace maker
* diabetes mellitus
* dysautonomia
* treatment with beta blocking agents
Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay

This study is aimed to evaluate the performance of the Micromedic CD24 assay in identifying colorectal adenoma using Western blot and ELISA assays. These assays are designed to detect CD24 protein in peripheral blood leukocytes (PBL). Elevated levels of CD24 may be indicative of colorectal adenoma (inclusive of optically detectable early adenoma to late adenoma, and cancer).


Eligibility Criteria:
Inclusion Criteria:

* Subject is 50 years old and above
* Subject is asymptomatic and referred for regular recommended screening colonoscopy or subject is referred due to suspicion of colon cancer, prior to beginning of any treatment (enriched population)
* Subject signed the informed consent

Exclusion Criteria:

* Subject has been previously diagnosed with any type of cancer
* Subject has been previously diagnosed with a colorectal abnormality such as colorectal adenoma, hyperplastic polyp or carcinoma
* Blood sample was not collected on the day of colonoscopy and prior to colonoscopy
* Subject has first degree family history of colorectal cancer
* Subject has active infection or inflammation as determined clinically at screening
* Subject is currently taking medications related to the previous exclusion criteria
* Subject has participated in, or is participating in, any investigational drug or device study within 30 days prior the date of colonoscopy and any additional study required test
* Pregnant or lactating woman
Enhancing Physical Therapy Best Practice for Improving Walking After Stroke

The aim of this study is to assess the effect of implementing best practices into current stroke rehabilitation physical therapy on walking outcomes. Participants will also be provided an activity monitor to help them track and target their walking practice to determine if this can improve walking ability.

This multi-site study will have each site start in usual care with participants consented to collecting outcome measures. The twelve inpatient stroke units include: Kelowna General Hospital, Nanaimo Regional General Hospital, Glenrose Rehabilitation Hospital, Saskatoon City Hospital, Wascana Rehabilitation Centre, Joseph Brant Hospital, Bruyère Hospital, Freeport Grand River Hospital, CIUSSS-de-l'Estrie-CHUS Centre de réadaptation de l'Estrie, Centre interdisciplinaire de recherche en réadaptation et intégration sociale, Dr. Everett Chalmers Regional Hospital, and Queen Elizabeth Hospital. Each site will randomly switch over to Enhanced Usual Care (best practice implementation) where all physical therapists at the site will be educated on delivery of best practice for locomotor retraining. The specific therapy activities are at the discretion of the physical therapist; however, physical therapists must work towards thirty minutes of weight-bearing/stepping activity at greater than forty percent heart rate reserve. Participants will continue to be consented to collecting outcome measures. Additionally, participants will be given and trained to use activity watches to monitor their own progress.

Eligibility Criteria:
Inclusion Criteria:

* Admitted by inpatient or day stroke rehabilitation
* Improved walking is a rehabilitation goal
* Within 12 weeks post hemorrhagic or ischemic CVA with hemiparesis (confirmed by medical chart or motor assessment)
* Able to ambulate at least 5 steps. May use assistive and/or orthotic device and maximum one person assist
* Overground walking speed slower than normal
* Able to understand and follow directions
* Greater than or equal to 19 years of age
* Medically stable

Exclusion Criteria:

* Pre-stroke health included a serious gait disorder or disease that affected ambulation (musculoskeletal conditions, amputation, surgery/arthroplasty in the last 6 months, etc.)
* Pre-stroke health included a neurological condition (such as Parkinson's disease or Multiple Sclerosis) or other serious medical condition (active cancer, uncontrolled diabetes)
* Excessive pain in the body/joint preventing participation in an exercise intervention
* Participating in an experimental drug field study
* Participating in another formal exercise rehabilitation clinical trial
* Expected to receive \<2 weeks daily in-/out- patient rehabilitation
Surgical Outcome of Two-port Laparoscopic Myomectomy

Study Objective: To evaluate the surgical outcome of laparoendoscopic two-sites myomectomy (LETS-M) and compare the difference between an experienced surgeon and three trainees.

Design: A retrospective study. Setting: A university hospital and a tertiary care center. Patients: 204 women underwent LETS-M

Laparoscopic myomectomy (LM) is an alternative and advanced technique that can take the place of traditional open surgery and achieve the goal of minimally invasive operation for women who wish to preserve the uterus. However, LM is considered a time-consuming procedure, requiring more suturing and knot-tying, and is better performed for woman with an appropriate uterine size by experienced surgeons.

Laparoendoscopic two-sites myomectomy (LETS-M) is a novel setting for LM on a two-port basis, using the umbilical glove port, three trocars, and conventional laparoscopic equipment.

Between January 2015 and September 2019, the medical records of women with uterine myoma managed by LETS-M were retrospectively reviewed.

The review of the chart records consisted of a detailed history, such as age, body mass index (BMI), gravidity, parity, marital status, sexual experience, previous abdominal surgery, and hospital stay after the surgery. All women received preoperative ultrasound for their uterine myoma assessment, including the location, type, size, number, and accompanying pathology, such as an ovarian tumor. The myoma locations were identified during the operation and classified into fundal wall myoma, anterior wall myoma, posterior wall myoma, and cervical myoma. The myoma type classification was based on the International Federation of Gynecology and Obstetrics (FIGO) leiomyoma subclassification system. We measured the weight of the specimen after finishing the surgery. The operation time was defined as the period from the incision to the closure of the skin. Any intraoperative blood loss less than 50mL or minimal blood loss on operation note was recorded as 50 milliliters in this study. Excessive blood loss was defined as more or equal to 500 milliliters in the operation. The postoperative pain scale was evaluated by a visual analog scale (VAS) on the first and second postoperative days.

Eligibility Criteria:
Inclusion Criteria:

* Women older than 20 years old and had not reached menopause
* Symptomatic uterine myomas, such as hypermenorrhea, infertility, a mass effect-related urinary frequency, and constipation.

Exclusion Criteria:

* Dominant symptoms with active pelvic or urinary tract infection
* A history of pelvic radiotherapy
* A preexisting or suspicious malignant pelvic tumor
* Pathologies other than uterine myoma noted during the operation
Ocular, Vascular, and Genetic Findings in AMD Patients

Observation of findings associated with AMD

Explorational observation of ocular, vascular, and genetic findings in patients diagnosed with AMD

Eligibility Criteria:
Inclusion Criteria:

1. At least 55 years of age at the time of consent
2. Able to understand and provide written informed consent
3. Sufficiently clear ocular media, adequate pupillary dilation, and adequate fixation to permit quality fundus imaging
4. Able to cooperate with ophthalmic visual function testing and anatomic assessments
5. Diagnosed with late-stage AMD in at least one eye. (if both eyes of an eligible subject meet inclusion criterion, the more advanced eye will receive primary eye assignment)
6. Willing to have protocol specified genetic testing
7. Willing to have head coil MRI/A (with contrast if deemed necessary)

Exclusion Criteria:

Ocular

1. History of any retinal disease other than AMD in either eye
2. Spherical equivalent refractive error demonstrating \>6 diopters of myopia or an axial length \>26 mm in the study eye
3. History of vitrectomy in the study eye
4. Any intraocular surgery (including lens replacement surgery) in the study eye, within 90 days of enrollment
5. History of endophthalmitis
6. Trabeculectomy or aqueous shunt or valve in the study eye
7. Aphakia or absence of the posterior capsule in the study eye (Note: Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet \[YAG\] laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 90 days prior to enrollment)
8. Presence of advanced guttae or visually significant keratopathy that would cause scattering of light or alter visual function in the study eye
9. History of idiopathic or autoimmune-associated uveitis in either eye
10. Active inflammation or infection, including conjunctivitis, keratitis, or scleritis in either eye
11. GA secondary to a condition other than AMD (e.g., Stargardt's disease, cone rod dystrophy, or toxic maculopathies such as Plaquenil maculopathy) in either eye

    Non-Ocular
12. Use of any investigational product or investigational medical device (i.e., not approved by FDA for the specific use) within 90 days prior to screening or anticipated use during the study
13. Women of childbearing potential who are pregnant or unwilling to use effective contraception for the duration of the study
14. Acute or serious illness, in the opinion of the site investigator
15. History of kidney failure or gadolinium toxicity
Crux Biomedical Evaluation of the Crux Inferior Vena Cava Filter System 3 ("RETRIEVE 3")

The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a permanent or temporary risk of Pulmonary Embolism.
* Patient must provide informed consent At least one of the following conditions -
* Proven PE
* Recurrent PE despite adequate
* Contraindication to anticoagulation
* Inability to achieve/maintain therapeutic anticoagulation
* Iliocaval DVT
* Large, free-floating proximal DVT
* Massive PE treated with thrombolysis/thrombectomy
* Chronic PE treated with thrombectomy
* Protection during thrombolysis for iliocaval DVT
* PE with limited cardiopulmonary reserve
* Poor compliance with anticoagulation medication
* High risk of injury worsening on anticoagulation
* Multi-trauma patient with high risk of PE
* Surgical patients at high risk of PE
* Medical condition with high risk of PE Patients with a documented vena cava diameter of 17-28mm Patient has IVC anatomy suitable for infra-renal placement Patient is willing to be available for the appropriate follow up

Exclusion Criteria:

* Age \<18 years old
* Patient has any one of the following conditions:

  * Renal vein thrombosis
  * IVC thrombosis extending to the renal veins
  * Duplicate IVC
  * Gonadal vein thrombosis
  * Requires supra-renal placement
* Vena cava diameter of 17-28mm
* Uncontrolled infectious disease
* Risk of aseptic PE
* Uncontrolled coagulopathy
* Existing inferior vena cava filter implant
* Life expectancy less than 6 months
* Pregnant or planning a pregnancy in the next 6 months
* Condition that inhibits radiographic visualization of the IVC
* Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol
* Known hypersensitivity to contract which cannot be pretreated
* Access vessels preclude same insertion of delivery system
* Participation in another drug or device trial
* Unable or unwilling to cooperate with study procedures or required follow-up visits
Comparison of Sphincter Preservation Surgery and Abdominoperineal Resection (APR): Prospective Clinical Trial

Sphincter preservation surgery in low rectal cancer has been increased due to better understanding of tumor biology and advances in surgical technology. Furthermore, a majority of patients prefer sphincter preservation rather than living with permanent colostomy. But it is not clear whether sphincter preservation is directly related with better quality of life. There have been many studies comparing sphincter preservation surgery and abdominoperineal resection in many aspects including oncologic and functional outcomes, and the quality of life. However, the conclusion remains controversial because of the different results between studies.

This prospective study was designed to compare the quality of life after sphincter saving surgery and abdominoperineal resection. Because of ethical issues, it is difficult to conduct as a randomized trial. On the basis of tumor location, extent, and preoperative anal function, patient will be attributed to two different operative method groups. On the assumption that 10% of the patients are lost to follow-up at 1 year, at least 74 patients undergoing APR and 220 patients undergoing SPS will be recruited. The study will be continued until the target sample size will be achieved.

Eligibility Criteria:
Inclusion Criteria:

* Low rectal cancer (5cm from anal verge by surgeon's digital rectal exam / rigid rectoscopy)
* Patient who understands and accepts to sign the informed consent form
* Confirmed preoperative colonoscopic biopsy (adenocarcinoma)
* Proper bone marrow function
* Proper renal function
* Proper liver function
* No severe comorbidity

Exclusion Criteria:

* Metastatic lesion detected in preoperative assessment
* Previous history of cancer disease. (except patients with skin cancer)
* Severe heart disease, congestive heart disease.
* Severe lung disease, respiratory failure.
* Mental illness.
* Invasion to prostate, bladder and combined resection needed (partial or radical.• Legally prohibited for clinical trial.
* Pregnancy or breast feeding.
* Previous disease or disability expected to influence the assessment of postoperative quality of life.
Prospective Registry of the Current Status of Care for Patients With Coronary Artery Disease

The study will estimate the current status of care for participants with coronary artery disease


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with discharge diagnosis as coronary artery disease (including atherosclerosis or non-athrosclerosis)

Exclusion Criteria:

* None