cyrilzakka/clinical-trials huggingface dataset:
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System

The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment. All subjects will be asked to complete the urine test by following the application guidance,including providing a urine sample and scanning the urine strip after placing it on the Color-Board. The user will also complete a questionnaire to collect information regarding the use of the Velieve U.S. device. Following the usability test performed by the lay user, the subject's urine sample will be tested by the professional user using the comparator device.

The use of the Velieve U.S. device will be evaluated for identified risks. Additionally, measurable usability criteria for specific, critical steps will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females 18-80 years of age;
* Subjects who are healthy or:
* Subjects with a medical condition that normally present with an abnormal concentration of Leukocytes, Nitrites and Blood: (examples of such conditions include the following):

  * Urinary tract infection (UTI)
  * Patients with suspected or known occult blood in urine
  * Pregnant women
  * Other relevant conditions
* Subjects with any pathological findings which might be identified by the urine test (according to the physician discretion)
* Subject is capable and willing to provide informed consent;
* Subject has facility with both hands;
* Subject is capable and willing to adhere to the study procedures.
* Subject is familiar with the use of a smartphone
* Subject is capable of comprehending and following instructions in English

Exclusion Criteria:

* Subject has dementia.
* Subject has mental disorders.
* Subject cannot collect urine in a receptacle.
* Subject is visually impaired (cannot read the user manual).
* Any additional reason the study physician believes disqualifies the subject from participating in the study.
Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System

This purposed of this study is to ascertain if the implementation of remote patient management systems utilizing American Heart Association (AHA) guideline-based heart failure protocols and educational content can improve the management of patients with congestive heart failure.

This prospective, comparative study uses a pre-post test design to ascertain if the implementation of remote patient management systems utilizing AHA guideline-based heart failure protocols and educational content can successfully address the following objectives:

* validate the suitability of the Intel Health Guide to deploy AHA guideline-based patient care protocols and health content to patients managing congestive heart failure
* confirm that the AHA protocols as deployed on the HGS are supportive for clinicians following the AHA guidelines in a telehealth environment
* validate and verify that the data intended to be collected was effectively collected
* measure patient and provider satisfaction with use of the system

Eligibility Criteria:
Inclusion Criteria:

* Patient has a diagnosis of Heart Failure NYHA and is currently in functional class II- IV status.
* Patient has been hospitalized for an episode of acute HF decompensation within the last 30 days.
* Patients with other co-morbidities such as atrial fibrillation, diabetes, coronary artery disease, COPD, hypertension, may be included in this evaluation. These conditions shall be documented during enrollment.
* Have telephone line or broadband internet availability to connect Intel® Health Guide.
* Are physically and mentally capable to complete the monitoring process or have a caregiver capable of assisting in the use of the Intel® Health Guide.
* Will be willing and able to sign an informed consent form to participate in this evaluation for a duration of 60 days.
* Live within a reasonable distance (30 miles or less) from the institution.

Exclusion Criteria:

* Have a life expectancy of less than six months.
* Live in a nursing home or other multi-member assisted living facility.
* Intend to be away from their home for more than 2 weeks (14 days) total during the 60 days.
* Are unable to read English at a minimum 5th grade level.
* Do not live within a reasonable distance (30 miles or less) from the institution.
The Contributions of the Multidisciplinary Management of Prosthesis Knee Infections in a Reference Center: A Retrospective Study About 52 Cases.Skin Coverage in a Reference Center: A Retrospective Study About 52 Cases

Acute and chronic infection of knee joint prosthesis can have several outcomes, the most feared of which is trans-femoral amputation. In order to save the limb while maintaining function, the management of these infections involves several specialists. Orthopedic surgeons are on the front line for carrying out bacteriological samples as well as for changing the material when necessary. The infectiologists coordinate this care by supervising each of the interventions by an antibiotic therapy adapted to the germs and by ensuring the occurrence of adverse events related to the treatment. Plastic surgeons intervene when the skin cover of the knee is deemed to be precarious or when there is an identified loss of substance that could affect the prognosis of the prosthesis. The main objective of our study is to evaluate the success rate of skin coverage and functional recovery for patients cured of their infection. The secondary objective is the identification of risk factors for skin coverage in this population.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a prosthesis knee infection whose management requires skin covering plastic surgery
* Surgical procedures performed at the Croix Rousse Hospital

Exclusion Criteria:

* none
Vafseo Outcomes In-Center Experience

This trial is an investigator-initiated, multi-center, randomized (1:1), open-label, active-controlled, pragmatic study of the safety of vadadustat administered three times per week for the treatment of anemia in in-center hemodialysis patients with End Stage Kidney Disease (ESKD). This study will obtain long-term safety data in a large sample of subjects receiving in-center hemodialysis to support adoption of three times per week vadadustat dosing.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients greater than or equal to 18 years of age.
* Receiving outpatient in-center hemodialysis at least three times per week for end-stage kidney disease.
* Currently prescribed or eligible for erythropoiesis-stimulating agent based on approved facility policy
* Understands the procedures and requirements of the study and provides written informed consent and authorization for protected health information disclosure.

Exclusion Criteria:

* Contraindication to receive vadadustat or any of its known constituents per USPI.
* Cirrhosis or active, acute liver disease. Concomitant use of any hypoxia-inducible factor prolyl-hydroxylases or OAT1/OAT3 inhibitors (probenacid, rifampicin, gemfibrozil, or teriflunomide).
* Unable to comply with study requirements or in the opinion of a healthcare provider or a member of the central study team, not clinically stable to participate in the study.
* Pregnant at time of consent (per subject self-report).
Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia

There is a long debate whether monopoloar or blunt dissection should be adopted in TEP to minimise the chance of seroma formation. This study aims at study the effect on seroma formation (and pre-peritoneal drain output) by 2 techniques in randomised controlled trial.

There is a long debate whether monopoloar or blunt dissection should be adopted in TEP to minimise the chance of seroma formation. This study aims at study the effect on seroma formation (and pre-peritoneal drain output) by 2 techniques in randomised controlled trial.

all male and female patients presented with first occurrence, unilateral inguinal hernia anticipated for laparoscopic TEP are included into study after informed consent. Patients are randomized into "diathermy-preferred" (DP) group and "blunt dissection-preferred" (BDP) group just before commence of operation after general anaethesia. Surgeons are instructed to use monopolar energy as main dissection method for whole operation if possible (DP), where as blunt dissection is the preferred choice in BDP group but it is allowed to use monopolar energy if needed. Total energy time is measured by a specially designed device attaching to the monopolar pedals as accurate as to millisecond (ms). Pre-peritoneal drains are inserted for drainage and removed 23 hours after operation. Energy time, drainage output, ultrasonic seroma sizes at day 1, day 6, 1 month post-operations, recurrence are compared between 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 and below 90
* Male or female patients
* Unilateral inguinal hernia
* First occurrence hernia
* Consent to laparoscopic hernioplasty for inguinal hernia

Exclusion Criteria:

* inguino-scrotal hernia
* Recurrent inguinal hernia
* Incarcerated hernia
* Bilateral inguinal hernia
* Bleeding tendency
* On anti-platelet agent or anti-coagulant
* Significant co-morbidies
* Patients with pacemaker
* Decline or not consent to
Comparison of Two Initial Evaluation Scales of the Severity of Brain Injury Adults Patients on the Neurological Outcome at 6 Months

Prospective cohort study. Any patient with potential cerebral injured (medical or traumatic) will be included in the study, regardless of its severity, history, the presence of anticoagulant or antiagrégant.

The collection should be done as soon as possible, in the reception of vital emergencies or in the urgencies. The collection consists of the realization of a Glasgow score and a scale of Kremlin-Bicêtre for all patients by completing a standardized collection sheet. The collection of GCS and Kremlin-Bicêtre must be did at the same time. The collection sheet is filled by medical personnel trained.

The future of the patient is informed at 6 months using the Glasgow Outcome Scale- Extended, which will be made during a following consultation or by phone. Additional data will be collected on the folder (ventilation time, days of hospitalization, mortality).


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years or more
* Potentially Victim of a cerebral injury whatever the level of severity
* Having a calculation of GCS and KBS on arrival at the hospital (emergency room)
* Affiliated to a social security scheme or benefiting through a third person.

Exclusion Criteria:

* Pregnant women
* Patients who refusing to participate in research
* Patients undergoing enhanced protection (persons deprived of liberty by a judicial or administrative decision, adults under legal protection).
Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy

This a study aiming to compare treatment with tamsulosin versus placebo in patients undergoing endoscopic treatment for urolithiasis. The main outcome is the rate of stone free patients.

Endoscopic treatment of urolithiasis has increased during the last several years. Adrenergic receptors have been described mainly in the distal ureter. Blockage of adrenergic receptors has been associated to a decrease in ureteral resistance. In this study the investigators hypothesized that alpha blockers are associated to a decrease in ureteral resistance with an increase in successful endoscopic management of urolithiasis.

Only patients with urolithiasis undergoing to endoscopic treatment are offered to participate. Patients are randomized between placebo arm or tamsulosin 0.4 mg/day. Demographic characteristics, stones characteristics and information related to surgery are recorded. Main study outcome is stone free rate and successful insertion of semirigid ureteroscope 8,0 - 9,8 Fr. All patients are follow-up for 30 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with urolithiasis undergoing to endoscopic ureterolithotomy

Exclusion Criteria:

* Patients with previous ureteral catheter

  * Patients with allergy to tamsulosin
  * Patients currently in treatment with tamsulosin for other disease different than ureterolithiasis
  * Multiple ureterolithiasis
  * Patients with impairment of their mental status

    * Patients with open surgeries in the affected ureter or urinary diversion
    * Pregnancy
Human Versus Computer-based Predictions of Long Allograft Survival

The clinical decision-making after kidney transplantation is mainly driven by patient individual assessment. However, this task remains difficult and uncertain due to the integration of complex and numerous parameters. We aim to evaluate and compare the ability of transplant physicians to predict long term allograft survival compared with a computer-based survival prediction algorithm (iBox system).

400 kidney transplant recipients among the cohort of 4,000 patients from the Paris Transplant Group prospective kidney transplant cohort (NCT03474003) were randomly selected. We generated an anonymized electronic health record for each included patient including a total of 60 classical kidney transplant prognostic parameters comprising baseline transplant and recipient characteristics, together with post-transplant parameters including allograft function, proteinuria, histology, diagnoses, and immunological profile collected during the first-year post-transplant. The time of risk evaluation for the human and the iBox system were at 1-year post transplant and the death censored allograft survival predictions made at 7 years after risk assessment. We enrolled transplant physicians at various stages of their careers (residents, fellows and seniors) to assign death censored graft survival probabilities at 7 years post risk assessment. The physicians were blinded to the actual patient outcome (allograft failure) and the iBox predictions. The physicians-based predictions will then be compared with the iBox system, a validated computer-based kidney survival prediction system.

Eligibility Criteria:
Inclusion Criteria:

* transplant evaluation available at one year post-transplant

Exclusion Criteria:

* no
A Real-World Study in China for the TECNIS Eyhance™ Intraocular Lens

This is a prospective and retrospective, single-center, single-arm, open-label clinical study of the TECNIS Eyhance™ IOL. The study will enroll up to 100 subjects from a single site in China. All subjects will be followed for 12 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients at least 22 years of age
2. Have/had a cataract in one or both eyes, with planned phacoemulsification with intraocular lens implantation or a history of implantation with TECNIS Eyhance intraocular lens
3. Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with study visits
4. Voluntary participation indicated by the study informed consent form (ICF) signed by the patient or legal guardian.

Exclusion Criteria:

1. Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
2. Planned monovision correction (one eye designated for near correction).
3. Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the course of the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).
Screening Women With Prior HPV for Anal Neoplasia

The goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in HIV uninfected women with a history of lower genital tract neoplasias and cancers.

This single arm trial will enroll 300 HIV uninfected women with a history of genital neoplasia (ie., cervical intraepithelial neoplasia grade 2-3, vaginal intraepithelial neoplasia grade 2-3 or vulvar intraepithelial neoplasia grade 2-3) or early stage cervical or vulvar cancer to evaluate the test characteristics of anal cancer screening tests (cytology, HPV testing and high resolution anoscopy) and determine the prevalence and incidence of anal high-grade squamous intraepithelial lesions in this population. Participants will undergo evaluation at baseline and then at 12 and 24 months. The investigators will also measure the acceptability of anal cancer screening in this previously unstudied group. The trial is expected to run from 2021-2027.

Eligibility Criteria:
Inclusion Criteria:

* Women with a history of pathologically proven high-grade genital HPV-associated neoplastic disease (cervical intraepithelial neoplasia 2+, vulvar intraepithelial neoplasia 2+, or vaginal intraepithelial neoplasia 2+, or history of non-metastatic cervical, vaginal or vulvar cancer)
* Documented HIV seronegativity
* Aged 35 years and older
* Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston
* English or Spanish speaking

Exclusion Criteria:

• prior history or high resolution anoscopy
A Trial Comparing - Robotic Assisted Versus Laparoscopic Partial Nephrectomy For Small Renal Masses

A prospective, randomized, controlled trial including patients who are diagnosed with a small renal mass (\<4 cm) amenable to resection using either RALPN or LPN.

Small renal masses (SRM) \<4cm are increasingly being discovered incidentally on imaging. The standard of care for management of SRMs is partial nephrectomy whenever feasible. In the last 10 years, a minimally invasive laproscopic approach has largely supplanted open surgery for the treatment of SRMs. Robot-assisted laparoscopic partial nephrectomy (RALPN) has emerged as an alternative to laparoscopic partial nephrectomy (LPN) and has been able to bridge the technical difficulties of LPN. The big question about the role and cost of RALPN in comparison to LPN especially in Canadian healthcare for SRMs still remains unanswered.

The objective of this proposed study is to conduct a randomized controlled trial to determine whether RALPN is better than LPN for the management of patients with SRMs. The primary outcomes will be warm ischemia time and secondary outcomes will be estimated glomerular filtration rate (eGFR), estimated blood loss, complication rate, length of hospital stay, positive surgical margin rate and cost comparison of these two techniques.

Eligibility Criteria:
Inclusion Criteria:

1. Patients at least 18 years of age and capable of giving informed consent
2. Patients scheduled for treatment of a renal tumor suitable to undergo LPN /RALPN
3. Patients with SRMs (tumor(s) ≤ 4 cm)

Exclusion Criteria:

1. Large tumors \> 4.0cm
2. Unable to have a general anesthetic
3. Unable to comply with post-operative follow-up protocol
4. Uncorrectable bleeding diathesis
5. Tumors unsuitable for LPN/RALPN technique
6. Evidence of metastatic disease
7. Prior surgery on the affected kidney
8. Ectopic or malrotated kidney
9. Mental health condition that precludes informed consent
A Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens

The rigid scleral contact lens with optical multi-focal design adopted in this study can focus the light in part of the optical area on the front of the retina to form myopic defocus, in order to delay the axial changes in children and adolescents with ultra-high myopia. In this study, RGP was used as a control, and a multicenter, randomized, controlled trial was conducted to verify the safety and effectiveness of multifocal scleral contact lenses for the correction of ultra-high myopia in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

1. Be able to understand and sign the informed consent when accompanied by parents or guardians.
2. Age from 8 years old to15 years old.
3. The equivalent spherical lens of both eyes after ciliary muscle paralysis is -5.00D to -20.00D, the astigmatism is ≤-3.50D.
4. Willing to wear hard contact lenses, and able to wear only the hard contact lenses provided by the study as required and ensure adequate wearing duration.

(6) Best corrected visual acuity of both eyes ≥ 0.8.

Exclusion Criteria:

(1) Allergic or intolerant to rigid contact lens or its care products or ciliary muscle paralysis drugs.

Strabismus and/or amblyopia. (3) Those who have worn hard contact lenses in the past 30 days are using atropine, defocus frame lens, bifocal lens or progressive lens, acupuncture, etc. for myopia treatment.

(4) Any clinically significant active eye disease, such as glaucoma, uveitis, chorioretinitis, central retinal artery or vein occlusion, and so on.

(5) Patients with systemic diseases that may affect the wearing of hard contact lenses, such as hyperthyroidism, diabetes, mental illness, and so on.

(6) are using drugs that affect their eye health. (7) History of eye injury or surgery. (8) Incapacitated or unable to follow the visitor as required. (9) Other conditions not suitable for inclusion as judged by the investigator.
Effect of 3 Years of Exercise on Development of Atrial Fibrillation

This is a substudy of "Generation 100". In that study, 4000 healthy persons between 70 and 75 will be randomised to a moderate intensity training group, a high intensity training group or control group, with 3 years of exercise. The investigators will follow these persons and register all who develop atrial fibrillation during these 3 years, and at follow-up after ended intervention to see if there is differences in the number of persons who develop atrial fibrillation in the 3 groups.


Eligibility Criteria:
Inclusion Criteria:

* Participating in the "Generation 100" study

Exclusion Criteria:

-
Comparative Analysis of Outcome Between Extravesical and Transvesical Repair for Vesico-vaginal Fistula

In patients with vesicovaginal fistula, transvesical and extravesical repair will be compared in terms of operative time, complications and recurrence rates.


Eligibility Criteria:
Inclusion Criteria:

* all patients with Vesicovaginal fistula

Exclusion Criteria:

* uretrovaginal fistula