cyrilzakka/clinical-trials huggingface dataset:
Virtue® Male Incontinence Sling Study

This study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product.


Eligibility Criteria:
Inclusion Criteria:

* Male subject at least 18 yrs old with an estimated life expectancy of more than 5 years
* Confirmed SUI (stress urinary incontinence) through medical history, urodynamics, and/or physical exam
* Subject has completed urodynamics, uroflow, post-void residual and cystoscopy per protocol within 12 months prior to implant
* Subject has intrinsic sphincter deficiency due to one of the following: post-TURP (trans-urethral resection of the prostate), simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
* Subject is willing to have the Virtue male sling implanted and is able and willing to completed all f/u visits and procedures as indicated in protocol
* Subject agrees to the provisions of the study and has provided written informed consent as approved by the local ethics committee of the respective site

Exclusion Criteria:

* Subject is unable or unwilling to sign the Informed Consent Form and/or comply with provisions of the study
* Subject has active urogenital infection or active skin infection in region of surgery
* Subject has serious bleeding disorders
* Subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury,CVA (cerebrovascular accident), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
* Subject has previous implant to treat SUI
* Subject has undergone radiation, cryosurgery, or brachytherapy to treat prostate or other pelvic cancer with 6 months or is likely to undergo radiation therapy within the next 6 months
* Subject has active urethral or bladder neck stricture disease requiring continued treatment
* Subject has urge predominant incontinence
Efficacy of an Oral Formula in Prevention of Anti-cancer Therapy Side Effects

Anti-cancer treatment is often inducing side-effects that can affect the compliance to the treatment protocol and quality of life of the patients. The researchers will study if the nutritional intervention with the product could abrogate the undesired effects in a preventive manner.


Eligibility Criteria:
Inclusion Criteria:

* Patient with GI neoplasm
* Patient that must start a (new) line of chemotherapy with at least 2 cycles
* Age \> 18 ans
* Exclusively orally fed
* Life expectancy more than 3 months
* Intravenous 5FU-based chemotherapy with 2 or 3-week cycles
* Hematological toxicities from previous chemotherapies terminated or \<= 2

Exclusion Criteria:

* Positive HIV status
* Pregnant or lactating woman
* Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study
* Patient having diarrhoea of grade \> 1 for more than 2 weeks before the inclusion
* State of sub occlusion, chronic inflammatory diseases of the digestive tract, radiation enteropathy
* Sepsis
* Concomitant radiotherapy, except analgesic radiotherapy
A Study to Evaluate Nivolumab in Patients With Unresectable Advanced/Metastatic Gastric Cancer and Gastroesophageal Junction Cancer

The purpose of this study is to collect and evaluate real-world data to enhance understanding of the effectiveness, and treatment patterns of first-line nivolumab treatment in patients with unresectable advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC) in China


Eligibility Criteria:
Inclusion Criteria:

* Participants aged ≥ 18 years at date of first administration of nivolumab
* Confirmed diagnosis of unresectable advanced or metastatic Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC) (histologically or cytologically)
* Participants newly received nivolumab as first-line (1L) treatment between 15 June 2018 and 30 June 2023
* Participants with at least one tumor assessment after index date except for death or discontinuation due to Adverse Events

Exclusion Criteria:

* Participants with primary malignancies other than unresectable advanced or metastatic GC/GEJC
* Participants who participate in an interventional clinical trial in or before 1L nivolumab treatment for advanced/metastatic GC/GEJC
* Participants with known HER2 status positive
* Participants who investigator deems inappropriate for inclusion, for example clinical data was incomplete
Systemic Treatment Alone Versus Systemic Treatment Plus Radiotherapy in Oligometastatic Renal Cell Carcinoma

To evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.

Various institutions are attempting to use locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, accompanied by a few metastases. Research findings have indicated that high-dose locoregional radiotherapy can suppress disease progression, potentially prolonging the interval for additional systemic therapy; however, whether the addition of locoregional radiotherapy in cases of renal cell carcinoma with oligometastases demonstrates superior oncologic outcome compared to standard systemic therapy alone has yet to be established. Therefore, a randomized phase III study is being conducted to evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with metastatic renal cell carcinoma classified within the ESTRO/EORTC classification system as having ≤ 5 metastases, ≤ 3 metastatic organs, and meeting criteria for new, recurrent, or induced metastases.
2. Patients aged 20 to 80 years.
3. Patients with individual metastases ≤ 5 cm in longest diameter.
4. Patients with primary tumors surgically removed or scheduled for surgery.
5. Patients histologically diagnosed with clear cell carcinoma.
6. Patients with ECOG performance status 0-1.
7. Patients with normal major organ function and bone marrow function meeting specific criteria: WBC ≥ 2,000/μL, neutrophils ≥ 1,000/μL, platelets ≥ 50,000/μL.
8. Patients who understand the contents of the informed consent form, voluntarily consent to participate in the study, and sign the informed consent form.
9. Patients who agree to use contraception from the time of signing the consent form until 1 year after the last standard systemic therapy.
10. Breastfeeding women who agree to stop breastfeeding for at least 5 months after the last standard systemic therapy.
11. Patients with visible tumors outside the scope of tumor removal surgery (surgical therapy) for metastatic lesions.

Exclusion Criteria:

1. Patients with total bilirubin \> 3.6 mg/dL.
2. Patients with AST \>160 U/L, ALT \> 165 U/L.
3. Patients unable to maintain position for partial nephrectomy radiotherapy.
4. Patients with a history of radiotherapy to metastatic renal cell carcinoma or surrounding areas.
5. Patients with confirmed brain, peritoneal, or pleural metastases.
6. Patients diagnosed with another solid tumor and treated within 2 years or with residual lesions.
7. Patients who do not consent to participate in the study.
8. Pregnant patients.
Comparison of Two Strategies for Glycemic Control in Acute Ischemic Stroke

The purpose of this prospective randomized controlled trial was to compare intensive insulin therapy with a carbohydrate restrictive strategy in patients with acute ischemic stroke evaluating the outcome through the Glasgow Outcome Scale Extended, hospital mortality and NIHSS during the ICU stay.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with acute ischemic stroke defined as: Abrupt onset of focal neurologic deficit
* No evidence of intracranial hemorrhage at non-contrasted CT scan.

Exclusion Criteria:

* Age below 18
* Pregnancy
The Natural History Study of Patients With Sanfilippo Disease(s) (MPS3)

The natural history study of patients with Sanfilippo disease(s) (MPS3)

This is a natural history study of patients with Sanfilippo Disease (MPS3). Patients will be followed over the course of 6 months in which they have blood and urine collected, hearing assessment, complete questionnaires and are evaluated by the Principal Investigator.

Eligibility Criteria:
Inclusion Criteria:

1. IRB - approved informed consent/assent signed by subject and/or parent(s) or legal guardian(s).
2. Genetically confirmed diagnosis of MPS III disease Genomic DNA analysis demonstrating a homozygous or compound heterozygous pathogenic variants in SGSH (type A), NAGLU (type B), HGSNAT (type C), or N- acetylglucosamine-6-sulfatase GNS (type D).
3. Male or female; five years of age and older
4. Negative urine pregnancy test at screening for female subjects with child-bearing potential

Exclusion Criteria:

1. Unwilling or unable to follow protocol requirements as per principal investigator
2. Any serious or chronic medical illness, including significant cardiac or severe debilitating pulmonary disease as determined by the investigator.
3. Any medical condition that, in the opinion of the PI, would place a subject at undue risk
4. Inability to cooperate for clinical and safety data collection
5. Use of genistein or Miglustat within one week of the study
6. Evidence of hepatitis B or hepatitis C infection upon serological testing at screening
7. Currently participating in another interventional drug trial or has completed an interventional trial less than one month prior to the screening visit
Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature

Study to assess the efficacy and safety of oral potassium citrate on the Prevention of nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. Premature infants of both sexes born at the Hospital Clinic of Barcelona.
2. Corrected gestational age below 32 weeks and lower birth weight 1500gr.
3. Survivors at 7 days old.
4. Clinically stable, in the opinion of the investigator, at the time of inclusion.
5. That, properly informed, parents and / or legal guardians give written consent to allow the participation of the infant in the study and submit to the tests and examinations that it entails

Exclusion Criteria:

1. Renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis.
2. Chronic renal failure (serum creatinine\> 1.5 mg / dL or an increase of 0.3 mg / dL / day and / or oliguria defined as diuresis \<0.5 mL / kg / hour after the first day of life)
3. Treatment with furosemide or dexamethasone
4. Addison's disease.
5. Persistent severe metabolic alkalosis.
6. Impossibility of oral feeding.
Remote Patient Management for Cardiac Implantable Electronic Devices

This is a pilot study to assess barriers, evaluate and implement a patient oriented CIED management model incorporating advanced technological innovation to promote a paradigm shift to patient-centered care involving remote CIED monitoring and programming. The advancement in technology is very important as it addresses several potential gaps and barriers in the care of patients with CIEDS:

1. Long, expensive travel for patients
2. Morbidity to patients due to delay in receiving appropriate treatment
3. Efficiency in health care delivery
4. Patient satisfaction

Canada is a country with a diverse geography, of which 19% of the inhabitants are in communities classified as 'rural', but many may still have long distances to travel to reach a health care facility. This results in challenges in uniform delivery of health care throughout the country. There are 25,000 pacemaker (PM) implants and 7000 implantable defibrillator (ICD) implants yearly in Canada, with approximately 120 000 patients living with these devices. The recommended follow-up for these devices are based on consensus and position statements, with the majority of patients requiring at least yearly visits to a specialized device clinic during the lifetime of their device. During the life of these patients, many issues may arise, such as atrial or ventricular arrhythmias that may result in syncope, stroke or sudden death, need for increased monitoring resulting from device advisories, or minor programming adjustments to improve device performance, or simply the need for enhanced surveillance as the device battery depletes and replacement is anticipated.

While remote monitoring technology is currently available and has permitted surveillance and device assessment from any patient location accessible to a landline or mobile phone, the use has been inconsistent in Canada. In addition, new technology has become available that not only permits surveillance, but also remote programming of these devices. The incorporation of remote programming capability, along with automatic recalibration of device settings, allows us to develop a new paradigm of remote patient management where after the patient receives their device, they would remain in the care of their local health team and no longer require travel to the specialized 'hub' clinics for follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with an implanted pacemaker/cardiac resynchronization therapy with a pacemaker(CRT-P) capable of remote patient management would be eligible for the study that will be followed by the site where the implantation occurred OR patients with an implanted defibrillator/CRT-D capable of remote patient management where the patients reside in a community OUTSIDE of the site where the implantation occurred. The device may be de novo, existing or a patient undergoing a pulse generator change that now has remote patient management capabilities.
2. Able to provide consent.
Cue-Reward Learning and Weight Gain in Youth

The objective of the study is to compare children at low risk for obesity (two healthy weight parents) to children at high risk for obesity (two overweight parents) in their response rate to food taste and in their rate of learning using fMRI.

The primary aim of this project is to conduct an adequately powered study that compares children at low risk for obesity to children at high risk for obesity on their brain responses to food tastes during a pavlovian learning task. Seven assessment visits will be conducted at three separate time points; baseline, 1-year follow up, and 2-year follow up. Assessments will include anthropometry, interviews, computer tasks, questionnaires, and an fMRI scan. This program of research tests a novel hypothesis regarding overeating and the development of obesity in children, and could provide critical data on individual vulnerabilities to overeating for further research. Furthermore, this study could provide mechanisms for intervention with regards to cue-reward learning in children, to ultimately prevent obesity in youth.

Eligibility Criteria:
Inclusion Criteria:

* Healthy weight children between the ages of 8 and 11 Years
* BMI 5-75th percentile
* Child must be right-handed
* Child must be willing to participate in an fMRI scan
* Either two biological parents who are overweight/obese or no biological parents that are overweight/obese
* One biological parent willing to bring child to assessment visits
* Child and participating parent Fluent in English for speaking, reading, and writing
* Child must like cheese pizza and chocolate milkshake

Exclusion Criteria:

* Child overweight (BMI≥85th percentile)
* Child diagnoses of a serious chronic physical disease (e.g., diabetes) for which physician supervision of diet and exercise prescription are needed
* Child who is taking medications that may impact brain responses (can take kids who are stable on meds)
* Child with MRI contraindications (presence of metallic foreign object or device in body, piercings that cannot be removed, tattooed permanent makeup that contain metal, braces, head trauma, claustrophobia, use of Bigen permanent hair dye)
* Child with an active eating disorder (reported on EDE interview) or with first degree relative with Anorexia Nervosa or Bulimia Nervosa
* Cognitive impairment or disability determined through parent and child self-report measures, and parent reported child individual education plan
* Vision problems uncorrectable with lenses
* Food allergies related to cheese pizza, chocolate milkshake, or the snack foods used in the study
* Menarche in female participants at time of enrollment
* Children scoring within the midpubertal range or higher based on the Pubertal Development Scale
The Exploratory Study About the Effect of Using Double Filtration Plasmapheresis (DFPP) Removing Inflammatory Cytokines, Lipids and Toxic Metal Ions in Peripheral Blood in Adults

This study investigates whether using Double Filtration Plasmapheresis (DFPP) could improve the overall health of adults through removing inflammatory cytokines, lipids and toxic metal ions from peripheral blood. It's also postulated that DFPP could boost immune cells through removing certain inflammatory cytokines and blood lipids.

In this study, 3 groups of subjects will be recruited based on the indications of using DFPP. Estimated 100 sub-healthy subjects will be enrolled in the Group A (inflammatory cytokine group), the inflammatory cytokine panel will be tested at baseline, immediately and 1, 3, 6 months after using DFPP. Similarly estimated 100 subjects with elevated blood lipid or cholesterol will be enrolled in Group B (lipids group), the lipid panel will be tested at the same timeline as Group A. Estimated 50 subjects who are likely to have toxic metal ions accumulated (eg. using make-up for long term, working exposure) will be enrolled in Group C (toxic metal ions group), the specific metal ions will be tested before and after using DFPP. Tests related to immune cells will also be conducted in Group A and B at baseline, immediately and 1, 3, 6 months after using DFPP.

Eligibility Criteria:
Inclusion Criteria:

* Male/females of 18 to 85 years of age. For Group B, subjects should have elevated blood lipid or cholesterol, which could be a. hyperlipidemia; b. higher than the normal range but not high enough to be diagnosed as hyperlipidemia. Able to provide written Informed Consent. Able to follow verbal and written study directions.

Exclusion Criteria:

* Have sever liver and kidney dysfunction. Have cardiopulmonary insufficiency. Have solid or blood tumor. Pregnancy or breastfeeding women.
Optimizing Behavioral Healthcare Delivery Through Technology

The goal of this randomized controlled clinical trial is to determine the feasibility, acceptability, and preliminary efficacy of an artificial intelligence platform )שׁ( for behavioral health in facilitating better clinical outcomes for adult patients receiving outpatient therapy.

The main question\[s\] it aims to answer are:

* whether an AI platform designed for behavioral healthcare would be feasible and acceptable to patients and therapists.
* whether the depression and anxiety outcomes of adults receiving outpatient cognitive-behavioral therapy (CBT) in a community-based clinic would be superior among patients whose therapists used an AI-based platform to support clinical decision making and administrative tasks compared to patients receiving treatment-as-usual (TAU).

Participants will receive CBT for depression or anxiety and complete standardized assessments. Participants will be followed for the first two months of therapy.

The need for scalable delivery of mental health care services that are efficient and effective is now a major public health priority. Artificial intelligence (AI) tools have the potential to improve behavioral healthcare services by helping clinicians collect objective data on patients' progress, streamline their workflow, and automate administrative tasks.

The goal of this study is to determine the feasibility, acceptability, and preliminary efficacy of an AI platform for behavioral health in facilitating better clinical outcomes for patients receiving outpatient therapy.

This open randomized clinical trial will compare an AI platform provided by Eleos Health to treatment-as-usual (TAU) during the first 2 months of therapy. The study will be conducted at a community-based clinic in the U.S. Participants will be adults referred for outpatient, individual cognitive behavioral therapy for a main diagnosis of a depressive or anxiety disorder. Patients will be randomized to receive either therapy provided with the support of an AI platform developed by Eleos Health or TAU at the same clinic.

Data analysis will be carried out based on intention-to-treat principle. The primary outcomes include the feasibility and acceptability of the AI platform. Secondary outcomes include changes in depression (Patient Health Questionnaire-9) and anxiety (Generalized Anxiety Disorder-7) scores as well as treatment attendance and satisfaction.

Findings of this study will inform the optimization of future trials and services offered to individuals seeking mental health support in the U.S.

Eligibility Criteria:
Inclusion Criteria:

1. Older than 18 years old.
2. Presenting for an outpatient CBT for a depressive or anxiety disorder.

Exclusion Criteria:

1. Age \<18.
2. individuals who are medically unstable for outpatient treatment.
3. a severe mental health condition that might interfere with treatment compliance (e.g., psychotic depression, psychosis, active substance dependence).
Echocardiographic Assessment of the Right Ventricle in Healthy Subjects During Stress Test in the Mexican Population

The echocardiographic indices of the right ventricle function vary significantly with demographic and anthropometric of each population factors and are associated with poor prognosis in several cardiovascular diseases.

This study aims to investigate exercise-induced changes in echocardiographic indices of the right ventricle function in healthy volunteers and establish the reference values to the Mexican population.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men or women
* Age ≥18 years and \< 45.
* No history or symptoms of cardiovascular or lung disease
* No cardiovascular risk factors, that is, arterial systemic hypertension, smoking, diabetes, dyslipidemia
* No ongoing or previous cardio or vasoactive treatment
* Normal ECG
* Normal physical examination
* Able to use the semi-supine exercise bicycle
* Able to give informed consent

Exclusion Criteria:

* Tricuspid regurgitation more than mild
* Poor acoustic window.
* Professional sports activity
* Pregnancy
* Obesity (body mass index \[BMI\], ≥30 kg/m2).
* No knowledge of serum lipid or glucose levels at any time
* Inability to provide consent