cyrilzakka/clinical-trials huggingface dataset:
Removal of Uremic Toxins With Nocturnal Dialysis Versus Standard Dialysis

Dialysis patients, who decide to switch from standard dialysis (3 times 240-270 min/week) to nocturnal dialysis (3 times 480 min/week), will be followed. In parallel a control group with patients staying on standard dialysis will be followed. The study will last 30 weeks. During this period blood samples (pre- and post-dialysis: 10 times; inlet and outlet of dialyzer: 3 times) will be collected on predetermined time points. Concentration of several uremic retention solutes will be determined.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years

Exclusion Criteria:

* pregnancy
Study of the Relationship Between Body Composition, Insulin Resistance and HDL Levels

Approximately 20 million people in the United States have some form of kidney failure. People with kidney failure have an increased chance of having low levels of high density lipid (HDL), so called "good cholesterol." Patients who are overweight or obese also have low levels of HDL. The investigators are trying to find out whether causes of low HDL are the same in people who are overweight and in patients with kidney failure so that in the future doctors can better treat low HDL cholesterol levels. People with low levels of HDL are more likely to have heart attacks and strokes and are more likely to lose kidney function. This study hope to learn more about how kidney failure causes low HDL cholesterol levels.

This study is not a treatment or outcome trial.This is a single center cross sectional analysis of body composition and lipoprotein level and structure among patients with graded levels of renal failure in comparison to control subjects. To study the relationship between HDL cholesterol and both body composition and insulin resistance measured as homeostatic model assessment (HOMA) among a cohort of non diabetic non-proteinuric patients with advanced chronic kidney disease (CKD) compared to non diabetic subjects having normal kidney function. Renal patients chosen will be with advanced CKD stage 3, Stage 4, and stage 5 - which is end stage renal failure (ESRD) and on hemodialysis. Fasting blood will be taken for the evaluation of baseline lipid and renal function, and blood glucose level to make sure that there is no recent evidence of diabetes. Body compositions will be measured with 2 established methods: DEXA and whole body bio-impedance spectroscopy (BIS). Fat mass and analysis will be estimated so as to provide a relationship between adiposity, insulin resistance, residual renal function and HDL levels and structure.

Eligibility Criteria:
Inclusion Criteria:

* self report of stable body weight during the past six months;
* BMI 18-40 kg/m2; Hemodialysis dependent for at least 3 months, prevalent ESRD (end stage renal disease) cohort;
* GFR \> 15 \< 44 ml/min (CKD cohort);
* GFR \> 60 ml/min (Control cohort).

Exclusion Criteria:

* Diabetes Mellitus (American Diabetes Association definition: fasting glucose \>120 mg/dl);
* Evidence of liver disorder, ie; hepatitis
* Evidence of thyroid disorders
* HIV by medical history (HIV test will not be performed)
* Renal transplant recipient
* Oral contraceptive/ hormone replacement therapy
* Systemic use of systemic or inhaled corticosteroids in the past month
* Contraindication to systemic anticoagulation (heparin administration is necessary to measure levels of LPL, HL);
* Hemoglobin \< 8.5 g/dl (anemia);
* Current, within 2 months use of any hypolipidemic or anti-diabetic agents;
* Patients treated with a fibric acid derivative or niacin in the past 4 weeks;
* Urinary protein excretion of greater than 0.5 grams per day;
* Any other condition that, in the opinion of the investigators, would put the subject at risk.
Intramedullary Fixation of Humerus Fractures

The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.

The study will include 20 patients who have an acute mid shaft diaphyseal humeral fracture due to injury. The patients will undergo lateral and AP X- ray evaluation of the fracture. Following General anesthesia, closed reduction of the fracture will be performed. It will be followed by nail insertion, percutaneously, according to standard surgical techniques, with the help of the insertion handle. Following insertion the nail will be locked both distally and proximally using interlocking screws. The nail and screws insertion will be monitored by fluoroscopy. Patients will remain under follow up for 6 months following the procedure. In the follow up sessions the fracture will be evaluated by fluoroscopy or X-ray for correct bone alignment, callus formation, and fracture union.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old.
* Mid shaft diaphyseal fracture
* Acute fracture

Exclusion Criteria:

* Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes.
* Ongoing infection in fracture site.
Safety of Local Dental Anesthesia in Patients With Cardiac Channelopathies

Patients with cardiac channelopathies needing restorative dental treatment will be included in two sessions of the study, using local dental anesthetic: lidocaine 2% with epinephrine and lidocaine 2% without vasoconstrictor. The safety of the use of two cartridges (3.6 mL) will be evaluated. The patients will be their own control and will be assessed by Holter monitoring for 28 hours, blood pressure measurement and anxiety measuring.

Patients of Heart Institute of the University of São Paulo with inherited cardiac channelopathies will be included, considering the criteria for inclusion and non-inclusion, after reading and signing the informed consent.

They will undergo dental restorative treatment in two sessions, in the morning period, with an interval of at least seven days (wash-out) between them, and the patients will be their own control.

In the first session, after randomization, patients will receive lidocaine 2% without vasoconstrictor (LSA) or lidocaine 2% with 1: 100,000 epinephrine (LCA) (cross-over), resulting in two conditions: with adrenaline and without adrenaline.

The randomization of the anesthetic solution will be performed by the main researcher, being blind to the performer researcher and to the patient.

The injected volume will be 3.6 mL (2 cartridges) of the anesthetic solution, using blocking technique of the inferior alveolar nerve.

The patients will be monitored by Holter for 28 hours starting one hour before the procedure, for registration and analysis of cardiac electrical activity during the two sessions. Blood pressure will be monitored with digital sphygmomanometer and anxiety will be measured with Facial Image Scale, both on three occasions: at the beginning of the baseline periods, before starting application of anesthesia and at the end of the proceedings. The results will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

* Patients with any channelopathies below, kept on optimal drug therapy, with or without ICD:

Brugada Syndrome, Long QT Syndrome and Catecholaminergic Polymorphic Ventricular Tachycardia

* Dental caries or unsatisfactory restorations in the mandible, indicating restorative dental treatment

Exclusion Criteria:

* Patients allergic to lidocaine
* Patients undergoing ICD therapy for less than three months
* Patients with recurrent syncope in the last three months
* Patients with sustained arrhythmias documented for less than 3 months
* Have received epinephrine in the last 24 hours
An Open-Label Study of Vascazen in Cardiac Rehab Patients With Deficient Blood Omega-3 Fatty Acid Levels

The investigators aim to test the hypothesis that dietary supplementation with VASCAZEN will correct omega-3 deficiency in cardiac rehab patients and improve biochemical risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (\> or = 18 years of age)
* Enrolled in Cardiac Rehabilitation clinic with documented cardiovascular disease as assessed by the principle investigator
* Has had cardiovascular examination within the past 2 months

Exclusion Criteria:

* Subjects who refuse to provide written consent
* Subjects with medical conditions, as determined by the principal investigator, which prevented them from study participation
* Subjects with a known bleeding or clotting disorder
* Subjects with known allergies to fish
* Subjects with an implantable cardiac defibrillator
* Subjects with a heart transplant
* Female subjects who are currently taking hormone replacement therapy
* Subjects who are pregnant or planning on becoming pregnant
* Subjects currently taking Omega-3 fatty acid supplements (either under medical supervision or self-administered)
Cost Effectiveness Analysis of an Ancillary Study of the REMOTEV Study

The implications of the medico-economic impact are essential in the choice of first-line therapists. The economic impact is an important criterion to recommend the privileged use of Direct Oral Anticoagulants (AOD) in first intention.


Eligibility Criteria:
Inclusion criteria

* Major patient whose age is ≥18 years
* Patient with a diagnosis of MTEV: pulmonary embolism or deep vein thrombosis diagnosed by the diagnostic reference methods according to the recommendations
* Major patient included in the REMOTEV registry
* Patient having accepted that his data recorded in the REMOTEV register be re-used for research and publication purposes

Criteria of non-inclusion

* Refusal to participate in the REMOTEV register
* Patient who refused to have his data reused for research and publication purposes
* Pregnant woman
* Subjects under safeguard of justice Subject under guardianship or curatorship
A Comparison of Single Port and Four Port Laparoscopic Gallbladder Removal

New minimally invasive surgical treatments are often outpatient procedures with low complication rates, promising fast recovery. The traditional physician-reported outcomes such as complication rates, blood loss, and hospital stay are not useful to guide treatment recommendations for one or the other minimally invasive procedure. This study aims to apply patient-reported outcomes developed within the NIH framework for cancer research and chronic disease treatment to the comparative effectiveness research in minimally invasive procedures for benign disease.

To establish a pathway for comparative effectiveness using patient reported outcomes in minimally invasive surgery, we propose to use a readily available and easily reproducible model: cholecystectomy. Each year in the United States, approximately 750,000 patients undergo a cholecystectomy. Patients clearly prefer the laparoscopic approach over the open procedure to abdominal surgery. Initial survey data suggest that patients may also prefer even less invasive approaches.

Currently, the standard operative procedure for a patient with symptomatic gallstone disease is a laparoscopic cholecystectomy performed under general anesthesia with four small abdominal incisions. Although postoperative pain and cardiopulmonary and wound complications are much less compared to open cholecystectomy, considerable cost is generated from lost productivity in days off of work after the surgical procedure related in part to pain and the physiologic response to the stress of the operative procedure. Anecdotal data suggest that fewer incisions, especially fewer transabdominal incisions, translate into less pain, less need for narcotic pain medication and faster recovery, but randomized trial data are needed. We propose to compare the effectiveness of the novel single-port cholecystectomy with laparoscopic cholecystectomy, the current standard of care.

Eligibility Criteria:
Inclusion criteria for this study are:

1) patients undergoing cholecystectomy in an elective setting for symptomatic gallstone disease.

Exclusion criteria for the study are:

1. Patients \<18 years of age
2. Pregnant patients
3. Patients with ASA-class \>3
4. Patients undergoing treatment for chronic pain with opiates
5. Patients with biopsy proven gallbladder cancer
6. Patients who cannot provide consent for the study
7. Patients not willing to participate in the study
8. Prisoners/Institutionalized individuals
VitalConnect VitalPatch ECG Interpretation/Arrhythmia Detection

Subjects in this study will wear the VitalPatch with the added ECG Interpretation and arrhythmia detection features which will expedite the identification of patients whose condition may rapidly deteriorate as well as eliminate the majority of non-actionable alarms.

This project intends to validate, through comparative study, the output of new technologies (ECG Interpretation and arrhythmia detection) to the VistaCenter platform, aiming to replace current telemetry monitoring equipment. The new technology, through the previous Mercy pilot study, has demonstrated greater accuracy in the detection of ventricular tachycardia patterns and other dysrhythmias/arrhythmias, as well as, reducing the volume of false alarms resulting in the mitigation of alarm fatigue experienced by bedside staff and monitor technicians.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old,
* No skin trauma to the site where the patch will be applied
* No known allergies to hydrocolloid or silicone based adhesives
* Admitted to Mercy Hospital Washington Cardiac Unit on the 5th floor and have been placed in one of the assigned rooms and require cardiac/telemetry monitoring as ordered by their physician

Exclusion Criteria:

* Pacemaker or Implanted Defibrillator (ICD)
* Pregnancy
* Adults unable to provide informed consent
* Individuals who cannot read and understand English
* Prisoners
* Not recommended for use in MRI
MIMS® Retrospective Chart Review

This is a post-market clinical follow-up, retrospective chart review of MIMS® surgical procedures conducted during time period between Sep 2023 and May 2025.


Eligibility Criteria:
Inclusion Criteria:

1. Eye treated with MIMS® Device as a standalone procedure
2. MIMS® surgery was performed between 27 Sep 2023 and 30 April 2024
Validation of a Smartwatch in Persons With Multiple Sclerosis

The study is designed to validate the accuracy of steps detected by a commercially available smartwatch in persons with multiple sclerosis. Specifically, the investigators examine whether a smartwatch can detect steps accurately during slow, comfortable and fast overground walking. The total steps counted by the smartwatch will be compared to those counted by an accelerometer commonly used in clinical studies and the actually walked steps.

Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system. It is one of the most common neurological diseases in young adulthood. The main symptoms of MS are gait and mobility impairments, which also determine the severity of the disease. Currently, subjective clinical functional tests are commonly used to evaluate therapy outcomes. Due to advancing mechanization, body-worn accelerometers have been established as a potential instrument for the objective detection of mobility in clinical research. The accuracy of these devices for determining the mobility is therefore essential. However, current studies, especially in people with altered gait, show large deviations in step detection accuracy.

In the present study we want to investigate: i) whether a commercially available smartwatch (Polar M600) counts steps in persons with multiple sclerosis (pwMS) accurately and ii) whether it counts steps as accurately as an accelerometer commonly used in clinical research (ActiGraph wGT3X-BT). In addition, the accuracy of the step detection by the algorithms of the manufacturer of the two devices (Polar M600 and ActiGraph wGT3X-BT) will be compared with an own-developed algorithm.

For this purpose, 63 pwMS with low to severe functional restriction (EDSS: 0 - 6.5) will participate in this validation study. The validation protocol consists of three walking tests with different walking velocities. During these three conditions the participants will wear the Polar M600 on the wrist and the ActiGraph wGT3X-BT with a belt over the hip. In the first walking test, the subjects will complete 250 steps with comfortable walking velocity (CWV). After a sufficient break, the participants will be randomly assigned to either a fast walking velocity condition (FWV: CWV + 20%) followed by a sufficient period of rest and a slow walking velocity condition (SWV: CWV - 20%) or vice versa. Each of the walking tests with modified walking velocity also consists of 250 steps. To analyze the accuracy of step detection, the measured steps of the devices will be compared with the actually walked 250 steps.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis with Expanded Disability Status Scale between 0 - 6.5
* Ability to walk 250 steps with or without an assistive device

Exclusion Criteria:

* Clinically relevant cardiovascular or orthopaedic disease
* Severe polyneuropathy
* Cognitive impairment
Consistency of LGE-MRI Fibrosis and EAM Low-voltage Area

This study aims to:

1. Assess the consistency of LGE-MRI bi-atrial fibrosis and electroanatomical mapping of bi-atrial low voltage region
2. To evaluate the electroanatomical characteristics of different types of fibrosis (dense fibrosis, patchy fibrosis, etc.) in different locations of the left and right atrium;
3. To explore the correlation between preoperative and postoperative bi-atrial fibrosis and long-term recurrence in patients with atrial fibrillation.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent;
2. Atrial fibrillation was diagnosed and catheter ablation was proposed

Exclusion Criteria:

1. Left atrial thrombus or left atrial appendage thrombus;
2. Severe chronic obstructive pulmonary disease (FEV1/ FVC\<70%, FEV1\<50% predicted value);
3. Absolute contraindications of anticoagulation therapy;
4. Currently pregnant;
5. Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR\<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.);
6. refuse to participate in the study;
7. other physical or mental incapacity to participate in the study.
Effectiveness of Smartphone Application for Adherence Support (Vuka+)

This is a Type I Hybrid effectiveness-implementation trial to evaluate an HIV Pre-Exposure Prophylaxis (PrEP) medication adherence, persistence and social support app (Vuka+) for adolescent girls and young women (AGYW) in South Africa. This 6-month, 2-arm effectiveness and implementation trial (standard of care \[SOC\] vs. intervention app) will assess acceptability, feasibility and effectiveness. In addition, we will gather information on intervention delivery and barriers and facilitators for real-world delivery to inform future implementation and scale up.

We will recruit 330 AGYW, aged 15-24 from the surrounding community, PrEP clinics and service providers in Cape Town, South Africa. If AGYW qualify for enrollment, they will be offered daily Truvada as PrEP. Participants will then be randomized 1:1 at baseline to SOC counselling and the Vuka+ intervention app or SOC counselling only (control). All participants will receive their regularly scheduled PrEP clinical care visits. At baseline, 1-, 3- and 6-month follow-up visits, participants will complete biobehavioral surveys, undergo HIV testing and pregnancy testing, and provide a urine (month 1 and 6) and DBS sample (months 1, 3 and 6) for tenofovir assessment. Intervention arm participants will also have the following study activities: install the intervention app on their phones at baseline study visit and be asked to use the intervention app for at least 5-10 minutes daily for 6 months. During this time, they will be prompted by the app to complete daily activities or health and wellness readings and to complete a weekly brief assessment related to their PrEP use. At follow-up study visits, intervention arm participants will complete an additional set of questions evaluating their app use experience and a subsample of participants will complete an in-depth qualitative exit interview to assess their app use experience, acceptability of the intervention and their evaluation of the app's content.

Eligibility Criteria:
Inclusion Criteria:

* Assigned female at birth
* Age 15-24 years
* Healthy and weight at least 35kg
* Sexually active (had a male sexual partner in the past 6 months)
* Consistent access to a smartphone
* HIV-negative (clinic test)
* PrEP naive or no PrEP use in the past 6 months
* Eligible to start oral PrEP

Exclusion Criteria:

* Unable to currently start PrEP
* Abnormal laboratory, medical, physical, or social finding which could impact study participation, by investigator discretion
* Unwilling or unable to provide informed consent
* Participating in another PrEP trial
* Unwilling to provide at least 2 forms of contact for follow-up
* Taking renal toxic medications
* Sexual partner known to be HIV-positive
Discharge Planning Assessment of Family Needs

It is well established within pediatric and neonatal medicine that social and traditionally "non-medical" aspects of the home environment and conditions after discharge influence neonatal health both in the acute and long-term setting. Government programs and laws exist that are designed for the provision of basic pediatric health needs. Unfortunately, deficits in obtaining those services lead to preventable poor health outcomes. Hospital social workers and discharge planners are able to identify appropriate services, while lawyers are experts in ensuring those rights and services are actually obtained and delivered.

West Side Health of CCHS has implemented a medical-legal partnership along the pathways advocated by the Medical Legal Partnership for Children as part of their clinical care services. Before implementing a similar system in the NICU, a needs assessment will be performed first.

The purpose of this study is to determine what the health care team (physicians, nurses, social workers, discharge planners, etc) through our discharge planning practice establishes as the legal needs. We will collect information which is normally collected by the health care team as a part of their usual care and assessment for discharge planning. The families will not be approached directly by study staff.


Eligibility Criteria:
Inclusion Criteria:

* Infants admitted to the NICU
* Length of stay \> 6 days
* Discharge to home

Exclusion Criteria:

* Length of stay \</= 6 days
* Discharge to another hospital
Registry of Patients Treated With Plerixafor (Mozobil®) for Haematopoietic Stem Cell Mobilization Before Autologous Transplantation

The aim of this registry is to provide information, in day-to-day practice, on Plerixafor prescription modalities in France, over a 13-month period in order to address the health authorities' request.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with Plerixafor for autologous transplantation between November 2011 and November 2012
* Patients who have been informed and who have given their written consent for the access to their medical file

Exclusion Criteria:

* Patients already included in a Plerixafor ongoing clinical trial.