cyrilzakka/clinical-trials huggingface dataset:
Estimation of Vascularization After Treatment of Deep Rectovaginal Endometriosis Node by Rectal Shaving

Indocyanine green is a dye, using in surgery to bring out the intraoperative evaluation of tissue perfusion.

After intravenous injection of indocyanine green, using a near infrared light, the vascularisation becomes fluorescent.

In endometriosis disease, the treatment of recto vaginal node can be complicated by rectovaginal fistula.

An abnormal vascularisation related to the surgery would be a risk factor of post operative fistulas.

The aim of this study is to evaluate the rectal and vaginal vascularisation during the treatment of a recto vaginal endometriosis nodule with rectal shaving, using indocyanine green fluorescence.

Investigators are going to inject, at the end of a rectal shaving, a bolus of 0,2mg/kg of indocyanine green after dilution (2,5mg/ml). With de SPIES system (KARL STORZ GmbH \& Co. KG, Tuttlingen, Germany), the vascularisation would be imediately fluorescent. Investigators are going to estimate the vascularization of the rectal serosa and mucosa where the nodule was located.

If a vaginal resection has been performed, investigators are going to estimate the vascularization of the vaginal scar.

To estimate de vascularization, investigators are going tu use a scale with a score between 0 and 4.

After the surgery, the post-operative follow-up with be the same as usual after a Rectal Shaving.

Eligibility Criteria:
Inclusion Criteria:

* Patients above the age of 18 year
* Patients with endometriosis recto vaginal node
* Patients with operative indications of rectal shaving, with or without vaginal resection
* Patients who have accepted to participate

Exclusion Criteria:

* minors patients
* Patients under guardianship or wardship
* Patients who refused the participation
* Iodine allergy
* Pregnant woman
* Patients during lactation
A Pilot Study of the Effect of Individualized Clinical Management Among Parent/Child Dyads on Continuity of Care and Interaction

this project aims to collect retrospective data on the conitinuity/disconitnuity rate for child care in the child psychiatry unit of the université hospital of Besançon, France.


Eligibility Criteria:
Inclusion Criteria:

* Family having with a first consultation request submitted from 2015
* Children aged \< 10 years old at the time of the first consultation
Endovascular Treatment of Peripheral Artery Disease

The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must sign the informed consent form prior to the index-procedure.
2. Patient is older than 18 years.
3. Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime.
4. Patient suffers from intermittent claudication (Rutherford 2-3) or critical limb ischemia (Rutherford 4-5).
5. Target lesion is an occlusion or diameter stenosis is ≥70% by visual estimate.
6. Target lesion is located in the common and external iliac artery, in the common and superficial femoral artery, popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery) .

Exclusion Criteria:

1. Patients with Rutherford 0, 1 and 6.
2. Patient is pregnant.
3. Patients with serum creatinine \>2.0 mg/dL or renal dialysis.
4. Patient has an acute thrombus or aneurysm in the target arteries.
5. Patient has a life expectancy of \<12 months.
6. Patient with bypass that involves the target arteries.
7. Patient has a target lesion that cannot be crossed with a guidewire.
8. Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
9. Patient has scheduled elective non-vascular procedures within 3 months after index-procedure. Vascular procedures are allowed within 3 months after the index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted.
10. Contraindication for anti-thrombotic therapy (coagulopathy, ...).
11. Patient has a known intolerance to anti-thrombotic medication or contrast agents.
A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Participants With Advanced Breast Cancer

This is an open-label, multi-center, non-randomized study of the safety and tolerability of the combination of T-DM1 plus docetaxel for the treatment of participants with metastatic breast cancer (MBC) and of T-DM1 plus docetaxel with or without pertuzumab, for the treatment of participants with locally advanced breast cancer (LABC). The study comprises an initial dose finding (feasibility) part to determine the maximum tolerated dose (MTD) of T-DM1 and docetaxel, followed by an extension part aiming to consolidate the safety and efficacy of the recommended docetaxel/T-DM1 combination regimen.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (ECOG performance status of 2 will be allowed if only due to debilitating bone disease)
* HER2-positive metastatic or locally advanced breast cancer

For MBC participants:

* Documented metastatic or inoperable locally advanced (without meeting LABC criteria) disease, amenable for treatment with docetaxel
* History of disease progression within 3 months prior to study entry

For LABC participants:

* Newly diagnosed locally advanced breast cancer, Stage IIA-IIIC (American Joint Committee on Cancer \[AJCC\] staging system)

Exclusion Criteria:

* Significant cardiac disease
* Inadequate bone marrow, liver or renal function

For MBC participants:

* Participants must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases
* Brain metastases that are untreated, symptomatic or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastasis within 2 months of the first study treatment.

For LABC participants:

* Clinically or radiologically detectable metastasis (M1 disease)
* Participants for whom surgery as primary intent procedure is the best option to treat their disease
* Participants must not have received any systemic or loco-regional anti-cancer therapy for the treatment of locally advanced disease
Personal Protective Equipment Comfort and User Attitude During COVID-19

There are studies in the literature that evaluate the attitude, behavior and comfort level of students who do internships in different disciplines (medicine, pharmacy) towards the use of protective equipment. However, no study evaluating physiotherapy and rehabilitation students was found. Therefore, the present study aims to investigate the behaviors and attitudes regarding the use of personal protective equipment of physiotherapy and rehabilitation department students who are interning in the Covid-19 pandemic.

A total of 250 participants, who are physiotherapy and rehabilitation intern students in Turkey, will be included in the present study. Data collection will be carried out using an online survey. The online survey link will be shared via social media accounts and via mail. The questionnaire created through Google forms will be delivered to the participants via the link. The link will be active in the data collection process. Before the participants start the questionnaire, they will be asked whether they were willing to participate. The socio-demographic characteristics (age, gender, weight, height) and health status (presence of chronic disease and drugs used) will be questioned. In addition, the information about the institution where the internship was held and the duration of the internship, internship hours, time spent at the internship will be collected. Personal Protective Equipment Comfort and User Attitude Evaluation Form will be used to evaluate participant's thoughts, attitudes and behaviors towards the use of personal equipment also physical complaints, comfort level due to personal protective equipment.

Eligibility Criteria:
Inclusion Criteria:

* The participants included in this study will be aged over 18 years, men or women, an intern student actively during Covid-19 pandemic and able to use computer and have an internet connection

Exclusion Criteria:

* Participants excluded from the study if they not able to understand and read Turkish as a language, do not use protective equipment with their own choice; do internship in a different discipline other than physiotherapy and rehabilitation.
Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion

This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 year or older
* Confirmed Implant of the Transloc 3D Fusion System
* Did not have Transloc device removed or another manufacturer device implanted post Transloc
* Does not have other manufacturer's titanium or metal implant
* Patient may be included with prior allograft implant
* Willing to participate and give written consent
* Must have or planned CT post ≥1 year per standard of care

Exclusion Criteria:

* Patient is younger than 18 years
* Patient is unable to sign the Informed Consent
* Implant of other manufacturer's titanium or alternative metal implant
* Revision with another manufacturer's implant
* Fracture or unresolved trauma of implant side after implantation of TransLoc
* Patient unwilling to participate in Patient Satisfaction Survey
* Patient has not returned for Standard of Care follow-up
Impact of Sleeve Gastrectomy on Balance and Cognitive Function

Purpose of the study:

Purpose of study is to determine the effect of sleeve gastrectomy on balance and cognitive function in Saudi Arabia.

Aim of study:

To investigate if there is any change of balance and cognitive function disturbance after sleeve gastrectomy on participant.

Research hypothesis:

Sleeve gastrectomy have no impact on balance and cognitive function.

Inclusion criteria:

The participant will be selected according to the following criteria: 1.History of sleeve gastrectomy within 1 to 5 years.

2. Their age between (20-60 years). 3.Ability to walk without any assistive device. 4.All participant should be able to understand all requested instructions

Exclusion criteria:

The participant will be excluded if they have:

1. Any cognitive disturbances.
2. Disease that may affect balance (Spinal stenosis, peripheral polyneuropathy, vestibular impairment).
3. Gastrectomy operation less than 1year.
4. Pregnancy.

Material:

1. Introduction survey (willingness of participant) to recruit sittable participant.
2. Assessment form survey to collected data and result (include MOCA and App-coo application)


Eligibility Criteria:
Inclusion Criteria:

-

The participant will be selected according to the following criteria:

1. History of sleeve gastrectomy within 1 to 5 years.
2. Their age between (20-60 years).
3. Ability to walk without any assistive device.
4. All participant should be able to understand all requested instructions

Exclusion Criteria:

-

The participant will be excluded if they have:

1. Any cognitive disturbances.
2. Disease that may affect balance (Spinal stenosis, peripheral polyneuropathy, vestibular impairment).
3. Gastrectomy operation less than 1year.
Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia

The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).

Fludarabine is currently approved for treatment of relapsed Chronic Lymphocytic Leukemia. Studies have shown that drugs in combination with fludarabine have shown more effectiveness than fludarabine alone. The addition of ofatumumab to fludarabine-cyclophosphamide combination offers potentially a more effective therapy, without additional toxicity.

The objective of this study was to determine the effect of ofatumumab added to fludarabine and cyclophosphamide in patients with Chronic Lymphocytic Leukemia who have responded previously to therapy but later develop progressive disease and require additional therapy.

Eligibility Criteria:
Key Inclusion Criteria:

* confirmed and active CLL requiring treatment
* at least one previous treatment for CLL and having achieved a complete or partial remission/response but after a period of 6 or more months, shows evidence of disease progression
* fully active at a minimum or fully capable of selfcare and up and about more than 50% of waking hours
* age 18yrs or older
* signed written informed consent

Key Exclusion Criteria:

* diagnosis of refractory CLL (failure to achieve a complete or partial remission/response or disease progression within 6 months of last anti-CLL treatment
* abnormal/inadequate blood values, liver and kidney function
* certain heart problems, serious significant diseases, AIHA, other current cancers or within the last 5 years
* active or chronic infections
* use of drugs to suppress allergic or inflammatory responses (glucocorticoids)
* CLL transformation
* CLL central nervous system involvement
* current participation in other clinical study
* inability to comply with the protocol activities
* lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception
Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human Lung

The purpose of this research study is to test the ability of Mucinex, an oral, over-the-counter, FDA approved expectorant) to stimulate the clearance of inhaled particles from the subject's lungs (called "mucociliary clearance"). The study will also monitor the metabolism of the drug by the subject's body.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non smoker
* BMI 19-29
* Normal lung function

Exclusion Criteria:

* Pregnant
* Smokers
* Any illness
Does Tamsulosin Facilitate Semi-rigid Ureteroscopic

Ureteric calculi are one of the most common reasons for frequent Urolithiasis. The estimated prevalence is 8-13% of all calculi.

Medical expulsive therapy (MET) is recommended by the European Association of Urology (EAU) (2013) for 5-10 mm ureteric stones to facilitate stone passage. For MET, alpha blockers, mainly tamsulosin, have shown efficacy in several randomized controlled trials. The underlying pathophysiology of this therapy is supported by the presence and distribution of adrenoreceptors in the ureter. Blocking the action of alpha-1 receptors by pharmacological agents (alpha blockers), such as alfuzosin, terazosin, doxazosin, and, most typically, tamsulosin, results in the relaxation of the ureteric smooth muscle.

Ureteroscopy (URS) is the most commonly performed procedure for the treatment of ureteral calculi, with a high (\>90%) stone-free rate after a single treatment. Advancing a rigid ureteroscope into a non-dilated ureter may be difficult and cause complications. Ureteric dilatation may provide access to stones, but not in all cases, and ureteral mucosal injury up to perforation might occur.

Based on the role of alpha blockers, mainly tamsulosin, in MET of ureteric calculus, the investigator will attempt to extend the use of alpha blockers prior to URS for procedural ease. the investigator will conduct a prospective, randomized double-blind study to evaluate whether alpha blockers facilitate the negotiation of the ureteroscope if administered preoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Lower ureteral stone.
* Age: 18 - 75 years.
* normal renal function.
* single sided ureteral stone with normal other kideny.
* sign the informed consent.
* Be willing/able to adhere to follow up visits.

Exclusion Criteria:

* Upper and middle ureteral stones.
* renal impairment.
* Age \< 18 years or 75 \< years.
* female who were pregnant
* bilateral ureteric stone or solitary kidney.
* urinary tract infection need drainage.
Comparison of Visual Acuity Performed in Office Versus In Residence

GoCheck has developed and deployed a home-based visual acuity test that may be used in-office or in residence. The test methodology utilizes modified ATS and ETDRS protocols with Sloan optotypes, crowding bars and sophisticated algorithms. The objective of this study is to determine if the results of the GoCheck visual acuity test performed in an office setting correlate to the same testing when implemented in the residence

To address the increasing needs for remote patient assessment, GoCheck has developed and deployed a home-based visual acuity test that may be used in-office or in residence, to meet the changing needs of providers visit time allocation, as well as presenting a standardized form of visual acuity centered around clinically-validated approaches.

The test methodology utilizes modified ETDRS design features with HOTV or Sloan optotypes (based on age), crowding bars, and displays 3 optotypes at a time (arranged vertically) to accommodate smaller screen sizes, but still significantly shortens testing time as opposed to displaying only a single optotype at a time.

The application may be used to screen children old enough to comprehend the test, typically around age 4 through adulthood, during their primary care, or school-based visits, and now, in the home. The purpose of home vision testing is to provide actionable insights into the status of an individual's vision without the need for an in-office visit. The testing results will be able to used by the physician to help determine if additional interventions are necessary.

The objective of this study is to determine if the results of the GoCheck visual acuity test performed in an office setting correlate to the same testing when implemented in the residence.

Eligibility Criteria:
Inclusion Criteria:

1. Ages four (4) to twenty(20) years, inclusive
2. Corrected visual acuity range of 20/16 to 20/100
3. Manifest or cycloplegic refraction within prior six (6) months
4. Ability to comprehend and complete the VA test with age appropriate optotypes

Exclusion Criteria:

1. No access to smartphone
2. Inability to read, write, and/or understand English
3. Inability to provide written informed consent or have consent conferred on patient's behalf
4. Subjects from populations otherwise deemed ineligible/unable to provide informed consent and/or participate in studies (detention, correction, rehabilitation, psychiatric residents, etc.)
5. Current pregnancy
6. Any ocular pathology defect(s) except amblyopia, strabismus or refractive error or history of nystagmus.
Patient Tolerability and Efficacy of Bowel Preparation With Split Dose Picosalax vs. Split Dose PEG

Introduction: Colonoscopy is an important tool for colon cancer screening. Proper colon cleansing is essential to ensure adequate mucosal examination. Timing of bowel preparation administration is now recognized as an important component for achieving superior cleansing. Multiple randomized controlled trials and meta-analyses have found split-dosing to be superior than day-before dosing. Objective: This study aims to compare two types of bowel preparations in split-doses to assess for differences in patient tolerability, as well as efficacy of colon cleansing. Methods: This is a prospective, single-blinded, randomized-controlled trial. Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will be randomly assigned to receive either a split-dose polyethylene glycol (PEG) or picosalax (P/MC) bowel preparation. Patient tolerability will be examined through questionnaires. The endoscopist performing the colonoscopy will use two standardized bowel preparation scoring systems to evaluate the quality of the cleansing. The investigators propose that P/MC will be superior to PEG in patient tolerability and non-inferior in bowel cleansing effects.


Eligibility Criteria:
Inclusion Criteria:

* All male and non-pregnant female patients between ages 18 and 75 years old who require outpatient colonoscopy

Exclusion Criteria:

* ileus or bowel obstruction, previous colorectal surgery, ascites, recognized renal impairment, defined as GFR less than normal in 3 months prior to enrollment, active inflammatory bowel disease, insulin dependent diabetes, pregnancy, or recent (\<6 months) myocardial infarction or unstable angina
Efficacy and Safety of Prunus Mume Extract on Improvement of Constipation

The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Prunus Mume Extract on Improvement of Constipation. The investigators measured Improvement of Constipation parameters , including Colonic Transit Time, number of bowel movement, defecation time, stool type, color and stool amounts per defecation, and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 19-40 years old
* Subject who have functional constipation by ROME IIII criteria
* Subject who have over 36 hour colonic transit time
* Able to give informed consent

Exclusion Criteria:

* Subject who have Irritable bowel syndrome by ROME IIII criteria
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.
Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E

To determine the time course of development of resistance to atevirdine mesylate ( U-87201E ) in patients with HIV isolates showing in vitro resistance to zidovudine ( AZT ). To determine the genotype changes in HIV reverse transcriptase associated with in vitro AZT resistance to U-87201E. To determine the genotype and phenotype effects of treatment with a nondideoxynucleoside agent on the alterations of the HIV-1 population associated with in vitro AZT resistance. To determine whether serial passage of patient pre-drug HIV isolates in the presence of U-87201E will generate the resistant mutants that may subsequently emerge in the patients.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Enrollment on protocol RV-43 (AZT resistance study).
* Development of a primary RV-43 study endpoint-opportunistic infection.
* HIV isolate with an AZT IC50 \> 50 times that of the sensitive type strain.
* Able to swallow tablets without difficulty.
* Normal QTc interval on EKG.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Clinically significant hypersensitivity to piperazine type drugs (Antepar, Stelazine).
* Severe uncontrollable diarrhea or vomiting or known malabsorption.
* Symptomatic hyperlipidemia.

Concurrent Medication:

Excluded:

* Other experimental drugs.
* AZT, ddI, ddC, foscarnet, immunomodulators or other agents with primary antiretroviral activity (exemptions by principal investigator permitted).

Patients with the following prior conditions are excluded:

History of clinically significant cardiovascular disease or nervous system or muscle disease, including seizures, peripheral neuropathy, dementia, or motor dysfunction.

Prior Medication:

Excluded:

* Experimental drugs within 4 weeks prior to study entry.