cyrilzakka/clinical-trials huggingface dataset:
Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients

Hemodialysis patients have a rate of fatal arrhythmias that is 40 times greater than the general population, but the causes and types of fatal arrhythmias they experience is unclear. The purpose of this prospective observational cohort study is to capture and characterize occult arrhythmias which occur in hemodialysis patients over a 6 month period. After informed consent and baseline assessment, 30 adult hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device (REVEAL, Medtronic). Three followup visits will be scheduled to download device data and quantify the number of potentially malignant arrhythmias which occur in study subjects during the 6 month period. Additionally, captured events will be monitored remotely via regular patient initiated transmission of device data every 2 weeks. Any serious occult arrhythmias detected will be immediately acted upon with a predefined management algorithm. Descriptive data and simple proportions will be used to describe the incidence and types of arrhythmias among the study cohort. Risks of this study include 1) potential loss of patient confidentiality 2) risks related to insertion of device including pocket hematoma, device infection, pain and discomfort secondary to procedure. These will be minimized by strict security measures to protect each patient's protected health information (PHI), preprocedural screening and insertion of monitoring devices by highly trained operators, and frequent careful direct patient followup.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* ESRD receiving hemodialysis for at least 3 months

Exclusion Criteria:

* Inability to give informed consent
* Pre-existing implantable cardiac device (pacemaker or ICD) or imminent device implantation
* Imminent renal transplantation
* Life expectancy \< 1yr
* PT-INR or aPTT \> 1.7 upper limit of normal (ULN) or history of bleeding diathesis
* Unstable medical condition as deemed by primary nephrologist or study staff
* Known sustained ventricular tachycardia due to non-reversible cause.
* Active infection
* Known atrial fibrillation
* Women who are pregnant
Typing Proficiency Following Carpal Tunnel Release

This study will investigate how soon a patient's typing proficiency returns to their pre-operative levels following carpal tunnel release surgery. In order to determine this, patients will undergo typing tests at different time points that will record their typing accuracy and speed. The results will then be compared to determine on average how soon a person returns to their pre-operative baseline results.

Carpal tunnel syndrome is a condition in which the median nerve is compressed at the wrist. It causes such symptoms as numbness, tingling, weakness, muscle damage, and pain. If non-operative treatments do not work generally patients go on to carpal tunnel release surgery in which the transverse carpal ligament is released. After surgery patients usually return to work with no restrictions within six weeks. Patients often ask how soon they are able to return to typing after surgery, and what their typing ability will be like after surgery. Currently there are no studies that evaluate how long it takes for patient's typing skills to return to that of the pre-operative skill level. We would like to answer that question by comparing typing results from different time points including a baseline prior to surgery. We additionally seek to identify which patient characteristics are predictive of a faster return of typing proficiency.

An additional innovative aspect of this project is the use of a web-based typing test that will be used in the assessment of patient typing proficiency. We will additionally use a web-based model for the collection of our survey data.

Eligibility Criteria:
Inclusion Criteria:

* Patients set to undergo carpal tunnel release
* Patients who have a positive EMG test
* Patients must have access to a computer with internet access
* Patients must have an email account
* Patients must be between the ages of 20-70
* Patients that meet typing test requirements

  * Must type weekly
  * Typing proficiency of 30 wpm at time of pre-operative appointment
  * Must use all fingers when typing
  * Can read text in font Times New Roman size 14

Exclusion Criteria:

* People who cannot read or write
* People who do not meet inclusion criteria
* Patients who do not speak English
* Patients unwilling or unable to return for follow-up visits prescribed by the study protocol
* Patients who qualify for inclusion in the study, but refuse to participate.
* Patients with concurrent, ipsilateral confounding hand or upper extremity pathology such as trigger finger, ganglion cyst, painful arthritis, etc.
Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).

The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp examinations and posterior capsule opacification (PCO) grading.

Follow up will be up to 24 months postoperative.

Eligibility Criteria:
Inclusion Criteria:

* Cataractous eyes with no comorbidity
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Irregular astigmatism
* Age of patient \< 45 years
* Regular corneal astigmatism \> 0.75 D on study eye as measured by an automatic keratometer (regularity determined by the topography of the keratometry)
* Difficulty for cooperation (distance from their home, general health condition)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...)
* Any ocular comorbidity
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* Complicated surgery
Effects of Anesthesia on Immunity in Cancer

The aim of the study is a comparative study of the cellular immunity response of patients operated on for kidney cancer under total intravenous and inhalational anesthesia.

The severity of perioperative immunosuppression is directly proportional to the degree of surgical stress. A series of experimental and clinical studies indicate a different effect of certain types of anesthesia on immunity. It is believed that surgical stress itself opens an opportunity for the recurrence of oncological diseases precisely due to the immunosuppressive effect. The aim of present pilot clinical study is to test a hypothesis that total intravenous anesthesia as superior to inhalational anesthesia in term of its effects on cell immunity among patients with kidney cancer.

Eligibility Criteria:
Inclusion Criteria:

* Surgery for renal cancer
* Signed informed concent

Exclusion Criteria:

* Propofol or sevoflurane intolerance
* Contraindications for epidural anesthesia
* Renal failure
* Hepatic failure
* Congestive heart failure
* Previous hemotherapy
* Hematological diseases
Effectiveness of Using Tobacco Free Snuff in Reducing Negative Effects of Smokeless Tobacco Use

Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of smokeless tobacco (ST) include tooth abrasion, gum recession, mouth disease, loss of bone in the jaw, yellowing of teeth, and chronic bad breath. This study will assess the effectiveness of using tobacco free snuff in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.

Spit tobacco presents as many health risks to its users as smoking tobacco. Although a significant number of ST users recognize the importance of quitting, many either do not want to quit or feel it is impossible. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. However, approaches to help ST users reach this goal have not been studied. This study will assess the effectiveness of using tobacco-free snuff in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.

Participants will be randomly assigned to receive either treatment with tobacco-free snuff or treatment without it. All participants will be encouraged to reduce nicotine intake by 50% during the first four weeks and by 75% the following four weeks. Participants receiving the tobacco-free snuff will be asked to alternate the use of their usual brand of ST with tobacco-free snuff in order to achieve the targeted reduction. Participants not receiving the tobacco-free snuff will only be informed to try to cut down their tobacco use to the targeted reduction. Study visits will occur once weekly during the 8-week treatment period. Assessments will include vital signs, physiological measures related to tobacco use, and measures of motivation and self-efficacy to quit ST. The number of participants who either do not complete treatment, reduce nicotine intake, or quit completely will be assessed at the Week 8 study visit and at follow-up visits, which will be held at Weeks 12 and 26.

Eligibility Criteria:
Inclusion Criteria:

* Not interested in quitting smokeless tobacco use within 90 days of study entry
* Used smokeless tobacco at least six times a day for 6 months prior to study entry
* Agree to use an effective form of contraception throughout the study

Exclusion Criteria:

* Current use of tobacco or nicotine products other than ST
* Pregnant or breastfeeding
* Any unstable medical condition
* Use of any medication that may affect tobacco use or be affected by reduction of tobacco use
* DSM-IV diagnosis of any psychiatric disorders or substance abuse disorders within 6 months prior to study entry
* Use of any psychotropic medications within 6 months prior to study entry
Cardiovascular Risk Assessment and Dynamic Monitoring-based Prevention Trial

The CRITICALLY study is a cluster randomized trial that will evaluate the effectiveness of a risk-based dynamic monitoring strategy for the primary prevention of cardiovascular high-risk Chinese adults.

The objective of the study is to evaluate the effectiveness of a risk-based management strategy on cardiovascular risk scores (calculated by the 2019 WHO cardiovascular risk charts) in 24 months (Phase I) and the incidence of major adverse cardiovascular events in 60 months (Phase II). Totally 216 clinics in Yinzhou District, China will be randomized to the intervention or the control arms with usual care. The interventions supported by the web-based decision support system include (1) cardiovascular risk assessment, (2) dynamic risk monitoring, and (3) regular visits by the general practitioner every three months. Only usual care will be provided in the control arm. The primary outcome is the change in cardiovascular risk scores for Phase I and the incidence of the composite endpoint of coronary heart disease, stroke, heart failure and all-cause mortality for Phase II. If the comprehensive strategy is proven effective, it could provide evidence for the primary prevention of cardiovascular diseases using digital health technology.

Eligibility Criteria:
Inclusion Criteria:

* Residents in the Yinzhou District have a unique health ID;
* Aged 40 to 79 years at the baseline enrollment;
* With high risk of cardiovascular disease evaluated by the 2019 WHO laboratory-based risk models (10-year risk≥10%);

Exclusion Criteria:

* Have a history of coronary heart disease, stroke or heart failure;
* Patients with a diagnosis of cancer;
* Refused to provide written informed consent
A Study of Effect of LY3556050 on Metformin in Healthy Participants

The main purpose of this study is to evaluate how much Metformin gets into the bloodstream and how long the body takes to get rid of it when it is administered orally in combination with LY3556050 in healthy participants. Iohexol will be administered to evaluate kidney function. Each enrolled participant will remain in the study for up to 7 weeks including the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical evaluation
* Participants with body weight of at least 50 kilograms (kg) or more and have a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²)
* Have an ECG at screening considered to be within acceptable limits by the investigator
* Male participants who agree to use contraception and female participants of child bearing potential who agree to use contraception and women not of child bearing potential may participate.

Exclusion Criteria:

* Women who are lactating
* Have known allergies or contraindications to LY3556050, metformin, iodine, iohexol, or other contrast agents, related compounds or any components of their formulation, or history of significant atopy
* Have a history, or ECG findings, of clinically significant bradycardia, heart block, tachycardia, sick sinus syndrome/sinoatrial block, first-degree AV block, or second- or third-degree AV block, bundle branch block or other tachy- or brady-arrhythmias; o rhave any other abnormality in the 12-lead ECG that, in the opinion of the investigator, confounds assessment of QT interval or increases the risks associated with participating in the study
* Have active or a history of gastritis or peptic ulcer disease
Half-Dose Flu Vaccine Study in Healthy Adults

It appears likely that there will be a delay and possibly a reduction in the amount of influenza vaccine available for the 2000-2001 influenza season. One possible way of increasing the availability of influenza vaccine for this year is to use a half-dose in healthy adults. The objective of this study is to determine if the immune system responds to a half-dose the same way it responds to a whole dose. This study will use the currently approved inactivated influenza vaccine in healthy adults ages 18 to 49 years old.

If the immune response to the half-dose is not significantly different than the immune response generated to the whole dose, this could be a strategy to extend the amount of vaccine that could be available in this age group.

Eligible subjects will be randomized to receive a single intramuscular injection of either a half-dose or a whole dose of a currently approved influenza virus vaccine in their arm. Prior to vaccination, subjects will have one tube of blood drawn. Subjects will be given a 3-day diary card to record any symptoms they may experience and asked to return for a second and final visit approximately 21 days following vaccination. A second blood draw will be done.

Eligibility Criteria:
Inclusion Criteria:

Volunteers may be eligible for this trial if they:

* Are able to and have given informed consent.
* Are able to understand and comply with all study procedures and to complete study diary.
* Are aged 18 to 49 years.
* Are female, and are not pregnant.
* Are available for all study visits.

Exclusion Criteria:

Volunteers will not be eligible for this trial if they:

* Are allergic to eggs or egg products.
* Have a current chronic medical condition for which influenza vaccine is normally recommended.
* Have received experimental vaccines or medications within 30 days of study entry.
* Have received parenteral immunoglobulin within 30 days of study entry.
Study to Analyze the Efficacy of Chronic Intake With a β-alanine Supplement in Recreational Cyclists

Randomized, controlled, double-blind, single-center, controlled clinical trial with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) to measure the efficacy of 28-day consumption of a sustained-release beta alanine on the physiological efficacy of physical performance in recreational cyclists.

Subjects meeting the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).

The product to be consumed is beta alanine. Participants will consume the product for 28 days. They will have to take 4 intakes every three hours, the first intake being two hours after waking up.

The study subjects will have to make 2 visits to the laboratory. Physical performance and physiological changes will be evaluated with a 10-minute time trial. The first test will be performed without product consumption and the second after 28 days of consumption.

Eligibility Criteria:
Inclusion Criteria:

* Male cyclists with more than two years of cycling experience.
* Perform tests without fatigue.
* Road bike training at least twice a week.

Exclusion Criteria:

* Participants with chronic illness.
* Have a long-term injury that prevents you from training in the previous month.
* Inability to understand informed consent.
* Have consumed beta alanine in the three years prior to the start of the study.
* Consumption of other supplements that may alter performance.
Comparison of Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia

To compare the effect of two different protocol of fluid therapy in sever preeclamptic patients under spinal anesthesia : Hemodynamic and kidney function .


Eligibility Criteria:
Inclusion Criteria:

* more than 36 weeks gestation
* singleton pregnant women planned for elective caesarian section

Exclusion Criteria:

* patient refusal.
* psychiatric disorders.
* parturient \<36 weeks gestation, twins, abnormal cardiotocography (CTG) tracing.
* absolute contraindications for spinal anesthesia (patients refusal, raised intracranial pressure, hypovolemic states, abnormal coagulopathy).
Bariatric Surgery and Pharmacokinetics of Amlodipine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on amlodipine.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Novel Imaging Markers in SPMS

This pilot study takes the innovative approach of using ultrasmall superparamagnetic iron oxide (USPIO) nanoparticle enhanced MRI to measure activity of the innate immune system within MS lesions. Activity of innate immunity has been hypothesized as one of the critical pathologic processes underpinning neurologic worsening in progressive MS. As such, in the short term this project proposes to investigate USPIO uptake in SPMS lesions as a promising in vivo imaging biomarker for chronic-active lesions, as distinguished from chronic-inactive lesions.


Eligibility Criteria:
Inclusion Criteria:

1. Adults age 35 to 65 years
2. Clinically diagnosed with secondary progressive multiple sclerosis (SPMS) (2017 McDonald Criteria)
3. Worsening 25 foot walk time (worsening SPMS cohort) over the preceding 2 years.
4. Ambulatory with ability to walk at least 20 meters without rest, with or without aid
5. Ability and willingness to attend study visits and complete the study

Exclusion Criteria:

1. Clinically diagnosed with relapsing remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), clinical isolated syndrome (CIS), or radiologically isolated syndrome (RIS)
2. Clinical MS relapse and/or new MRI lesion(s) within the preceding 2 years
3. Positive pregnancy test
4. Gadolinium contrast allergy
5. Acute or chronic kidney disease with eGFR \<30 ml/min/1.73m2
6. Pacemaker or other MRI contraindications per American College of Radiology guidelines
7. Intravenous iron sensitivity
8. Serum ferritin and transferrin saturation above age-adjusted upper limit of normal (if serum ferritin is above normal, but transferrin saturation is normal, the subject is NOT excluded)
IRIS Alfa Clinical Trial A Monocentric, Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device.

To perform a safety study on the prototype IRIS vitrectomy device.

to determine the safety and effectiveness of the device.

Eligibility Criteria:
Inclusion Criteria:

* Patients that are scheduled for vitrectomy surgery, regardless of the indication
* Both vitrectomy-only and combined phaco-vitrectomy surgeries
* Primary or repeat vitrectomy
* General or local anesthesia, or combination
* All ages
* Informed consent (from parents in patients \<18 years old)

Exclusion Criteria:

* Unable to obtain informed consent from patient (or from parents in children)
* No post-operative 8 week visit is anticipated
Neuro-cognitive Function 1 Year Post ICU Discharge Among VV ECMO Survivors

In the past three years, in the general intensive care unit in Meir medical center, 25 patients were treated with ECMO, of which two patients were treated with VA ECMO and the rest with VV ECMO. 70% of the patients survived to hospital discharge.

ECMO is indicated as a rescue therapy for patients in critical condition suffering from severe cardiac and/or respiratory failure that does not respond to conservative treatment. It can be used as a bridge to recovery or to heart/lung transplantation. ECMO was introduced in the late seventies of the pervious century. Between the years 2006-2011, partly due to the outbreak of the flu epidemic (H1N1), a 433% increase was observed in the use of ECMO worldwide in adults. In light of the outbreak of the Covid-19 epidemic in recent years, another significant increase has been observed.

There are short-term and long-term complications of ECMO. Short-term complications include bleeding, thrombosis, hemolysis, HIT, renal and neurological injuries, associated infections, and technical-mechanical problems. Long-term complications include significant physical and psychological consequences that may adversely affect the patient's daily function, especially executive function.


Eligibility Criteria:
Inclusion Criteria: All patients treated with VV ECMO who survived to hospital discharge between 2021-2023 -

Exclusion Criteria:

-
Effect of AIN457 on Ozone-induced Airway Neutrophilia Compared to Placebo and Corticosteroid in Healthy Subjects

This study will assess the ability of AIN457 to attenuate the increase in airway neutrophils that is seen following ozone exposure. Healthy subjects will be treated with AIN457, placebo, or oral corticosteroid and the response to a subsequent ozone exposure will be evaluated.


Eligibility Criteria:
Inclusion criteria:

* Healthy subjects
* Normal sputum neutrophil levels at screening
* Ozone responsive

Exclusion criteria:

* Smokers
* Prior treatment with antibody treatment or immunosuppressive agent
* Presence or history of a major chronic inflammatory autoimmune disease
* History of severe hypersensitivity to any biological agents (antibody or soluble receptor), a history of serious allergic reaction, collagen disease, neurological disease (including demyelinating disease).

Other protocol-defined inclusion/exclusion criteria may apply