cyrilzakka/clinical-trials huggingface dataset:
Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study

TAVI recipients exhibit a high burden of arrhythmic events early after the procedure. ECG continuous monitoring could be useful to diagnose and facilitate early implementation of specific therapeutic measures in these patients.

Prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device after hospital discharge. Following the TAVI procedure, continuous ECG monitoring will start just before hospital discharge and prolonged up to 4 weeks. There won't be any restriction regarding the type of valve and approach used for the TAVI procedure.

All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the diagnosis of the arrhythmic event.

Analyses of the CardioSTAT will be done at 2 and 4 weeks following hospital discharge. Clinical follow-up will be performed at 14 days (analysis of CardioSTAT® record), 28 days (analysis of CardioSTAT record), 1 year post-TAVI and yearly thereafter up to 5-year follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves.

Exclusion Criteria:

* Failure to provide informed consent.
* Prior or post-procedural pacemaker
* In-hospital death
* Logistic reasons precluding ECG monitoring within the 4 weeks after the procedure
* Participation in another continuous ECG monitoring post-TAVI trial
Lung Recruitment Maneuver for Predicting Fluid Responsiveness in Children

Lung recruitment maneuver induces a decrease in stroke volume, which is more pronounced in hypovolemic patients. The authors hypothesized that the changes of dynamic variables through lung recruitment maneuver could predict preload responsiveness in pediatric patients with lung protective ventilation


Eligibility Criteria:
Inclusion Criteria:

* pediatric patients undergoing general anesthesia under 6 years old

Exclusion Criteria:

* arrhythmia
* \<30%, ejection fraction
* lung disease
MRI Measurement of the Effects of Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopy

During laparoscopy, a surgical working space is obtained by creation of a pneumoperitoneum. Optimal surgical conditions are essential to ensure the patient's safety. A meta-analysis on studies comparing the influence of deep and moderate neuromuscular blockade (NMB) on the quality of the surgical space conditions during laparoscopy (1), showed that compared to moderate NMB, deep neuromuscular blockade improves the surgical space conditions, assessed by the Leiden-Surgical Rating scale, as reported by Martini and colleagues (2).

In this prospective cohort study, we will assess the influence of deep neuromuscular blockade on the surgical space, measured by magnetic resonance imaging (MRI) in patients scheduled for laparoscopic donor nephrectomy

Objective: To establish the influence of deep neuromuscular blockade (NMB) on the abdominal working space during laparoscopy.

Study design: A single center prospective cohort study

Study population: 10 adult patients (18 years or older), equally distributed by gender, scheduled for laparoscopic donor nephrectomy

Study procedures:

Induction of general anesthesia followed by intubation and creation of a pneumoperitoneum (12 mmHg).

Each patient will have a MRI scan during 3 stages:

Phase 1: No neuromuscular blockade (TOF ratio 1) Phase 2: moderate neuromuscular blockade(TOF 1-3). Phase 3: deep neuromuscular blockade (PTC 0-1)

Primary outcome:

The abdominal space measured by MRI: Skin - sacral promontory distance

Secondary outcome:

3D volume measurement of the abdominal cavity by MRI.

Eligibility Criteria:
Inclusion Criteria:

* scheduled for laparoscopic donor nephrectomy
* obtained informed consent

Exclusion Criteria:

* Unable to provide informed consent
* known or suspect allergy to mivacurium, rocuronium or sugammadex
* neuromuscular disease
* indication for rapid sequence induction
* Being unable to undergo MRI due to any reason (e.g. non MRI-compatible implants, epilepsy)
* BMI\>30 kg/m2
* American Society of Anesthesiologists (ASA) classification \>2
Screening to Improve Survival in AL Amyloidosis

The purpose of this study is to see whether certain genes may be linked with the development of AL amyloidosis in subjects 60 years of age or older with the blood disorders SMM and MGUS. A limited repertoire of immunoglobulin (Ig) variable region genes have been associated with AL amyloidosis. The clonal plasma cells of subjects with SMM and MGUS may express one of these Ig variable region genes indicating a risk of progression to AL amyloidosis and potentially enabling early diagnosis. We hope this study will help us begin to understand whether Ig variable region gene identification can be a useful tool for assessing a subject's risk of progression to AL amyloidosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients 60 years of age and older
* Diagnosed with λ LC MGUS or λ LC SMM
* dFLC greater than 23 mg/L and κ::λ free LC ratio below normal
* If the patient has an eGFR less than 50 mL/min/1.73m2, the κ::λ free LC ratio is inconsequential. The patient only needs to meet the age, dFLC, and λ LC MGUS or λ LC SMM diagnosis criteria in this case

Exclusion Criteria:

* Patients with κ LC MGUS or κ LC SMM
* Amyloid in the bone marrow or in other biopsies will not be included
* Patients younger than 60 years of age are not eligible
The Effects of Spasticity on Glucose Metabolism in Individuals With Spinal Cord Injury

Muscle atrophy may occur in individuals with spinal cord injury (SCI) as a result of diminished physical activity and alterations in glucose metabolism and body composition may be seen. In a few studies, it has been suggested that spasticity may have a positive impact on glucose metabolism by preventing muscle atrophy and alterations in body composition in individuals with motor complete SCI. Investigators aimed to assess the effects of spasticity on glucose metabolism and body composition in participants with complete and incomplete SCI.

Investigators plan a prospective clinical trial. Participants with SCI were included to study if times from injury were at least one year. Participants had an AIS grades of A-D with spasticity. We evaluated that participants with AIS A and B SCI were motor complete group, AIS C and D SCI were motor incomplete group. Spasticity was assessed with Modified Ashworth Scale (MAS) and spasms were assessed with Penn Spasm Frequency Scale (PSFS). Hip adductor and extensor spasticity, knee extensor and flexor spasticity and ankle plantar flexor spasticity were assessed by using MAS. Body composition was measured by dual-energy x-ray absorptiometry. All participants underwent a 75 gram (g) oral glucose tolerance test (OGTT). Insulin sensitivity was assessed by calculating Matsuda index and HOMA-IR. Investigators assessed the effects of spasticity on glucose metabolism and body composition in participants with SCI.

Eligibility Criteria:
Inclusion Criteria:

• Spinal cord injury AIS A,B,C,D

Exclusion Criteria:

* Other central nervous system diseases
* Significant complications that affect spasticity
* Joint contracture
* Diabetes mellitus
Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment

This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent
* Meeting the pre-defined Glomerular Filtration Rate (GFR) values

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product
* Drugs known to affect creatinine clearance including cimetidine within 14 days or 5 half-lives prior to the day of dosing of GZR4 and during this trial
* Individuals who routinely undergo dialysis or have a history of renal transplantation, hepatorenal syndrome, or acute kidney injury
Adenoma Detection Rate in Colonoscopy Performed With EndoRings

The study is designed to examine whether colonoscopy using an EndoRings cap has a higher adenoma detection rate than conventional colonoscopy. Secondary end-points is to compare completion rate, completion time, complication rate and detection of malignancies. Half of the patients will be randomised to colonoscopy using cap and the other half to no cap.

Colonoscopy is recognised as the standard method for finding and removing colorectal adenomas, which are precursors of most colorectal cancers. It has been shown that there is a direct correlation between adenoma detection rate and the risk of developing colorectal cancer subsequently. However, patients undergoing colonoscopy are still at risk of developing colorectal cancer, mainly because precursor lesions are missed during the procedure. This may be due to insufficient bowel preparation, difficulties in visualising flat lesions or the location of lesions behind haustral folds.

Improving the ADR can be achieved by different means; better training of endoscopists, improved bowel preparation, optimal sedation and medico technical developments. The technical improvements have mainly been in the optimising of image and improved scope thickness and flexibility, including devices that improve visualisation by increasing the exposed colonic surface . One of these new inventions is the EndoRings II Distal Attachment.

According to the Danish Colorectal Cancer Screening Database, the ADR of standard screening colonoscopy is between 34 and 67 % with a national average of 49 % of patients with detected adenomas. Due to the known adenoma miss rate in standard screening colonoscopies, it is important to increase the ADR on average as well as finding ways to improve ADR for centres with a lower than average ADR.

Eligibility Criteria:
Inclusion Criteria:

Patients meeting all the below listed criteria are eligible for inclusion in the trial:

1. Age between 50 - 74 years (age range of screening population)
2. Positive HemoCult home test from the Danish Colorectal Cancer Screening Programme
3. Ability to give informed consent to participation in the trial.

Exclusion Criteria:

Patients meeting one or more of the below listed criteria will be excluded from the trial:

1. History of colorectal cancer
2. History of Inflammatory Bowel Disease
3. Part of other control programme (e.g. HNPCC or adenoma control)
4. ASA =/\> 4 and/or necessity of general anaesthesia
5. Former surgery with removal of a part of the colon on either benign or malignant background
Open-Label Study of Safety of H1337 in Healthy Volunteers

The trial will evaluate the safety of one dose regimen of H-1337 \[1% twice daily (b.i.d.)\] in both eyes in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female subjects
* Subjects in good ocular and systemic health with clinically insignificant medical and ophthalmic history

Exclusion Criteria:

* Chronic or acute ophthalmic disease in each eye including but not limited to any form of glaucoma, retinal diseases, clinically significant cataract (primary or secondary)
* Recent intraocular surgery in either eye (within 6 months)

Note: Other inclusion/exclusion criteria apply.
EMS Prehospital Blood Culture Collection and Antibiotic Administration: A Two-Phase Pilot Project to Reduce Mortality in Patients With Severe Sepsis and Septic Shock

This study is designed to improve the outcomes for patients suffering from severe sepsis and septic shock (SS/SS) by decreasing the time from first medical contact to antibiotic administration. This is a stepwise study that aims to demonstrate the ability of paramedics to accurately obtain blood cultures prior to hospital arrival, administer a broad spectrum antibiotic and initiate IV fluid resuscitation in patients meeting predefined criteria for SS/SS.

This study is designed to improve the outcomes for patients suffering from severe sepsis and septic shock (SS/SS) by decreasing the time from first medical contact to antibiotic administration. This is a pilot project. This is a stepwise study that will build on previously published literature to demonstrate the ability of paramedics to accurately obtain blood cultures prior to hospital arrival, administer a broad spectrum antibiotic and initiate IV fluid resuscitation in patients meeting predefined criteria for SS/SS. The primary aim is to take processes that have been developed for use in this patient population during Emergency Department care and to advance these same processes "downrange" to initiate them prior to hospital arrival. Early antibiotic administration has been shown to decrease mortality in a time dependent fashion when implemented in hospitalized patients. The investigators hypothesize that initiating antibiotics prior to hospital arrival will improve morbidity and mortality while also addressing quality metrics that are publicly reported for this patient population.

This pilot study will be conducted in two consecutive phases, responding to the following aims.

Aim 1: Evaluate the feasibility that paramedics can obtain blood cultures from general patients prior to hospital arrival with a contamination rate that is statistically equivalent to that for blood cultures obtained in Emergency Department.

Aim 2 (primary aim): Investigate whether prehospital paramedic initiated broad spectrum antibiotics, administered after blood cultures are obtained, will result in improved mortality rates for patients, when compared to historical controls.

Eligibility Criteria:
Inclusion Criteria:

Phase 1 (blood culture contamination rate quantification phase)

1. Hemodynamically stable patients ≥18 years old being transported by Lakeview EMS to Lakeview Hospital who will have an intravenous access established as part of their routine prehospital care are eligible for this study.
2. English speaker

Phase 2 (blood cultures + antibiotics prehospital)

a. Patients with fever \>38oC + ≥2 qSOFA who are being transported to Lakeview Hospital that originate as a 911 call

Exclusion Criteria:

Phase 1:

1. Patients age \<18 years
2. Hemodynamic instability
3. Prisoners

Phase 2:

1. Documented allergy to Penicillin or inability to determine patient's medication allergies
2. Prisoners
3. Pregnant patients
4. Patients being transferred from one hospital to another
5. Non-English speakers
Protocol to Validate the Performance of the Mellitus Glycated CD59 ELISA for Gestational Diabetes Screening

Demonstrate effective performance of the Mellitus GCD59 Test (an ELISA) in screening for gestational diabetes mellitus (GDM)

Validate the performance of the Mellitus GCD59 ELISA as a screening test for GDM by evaluating its negative predictive value (NPV) and positive predictive value (PPV) to identify pregnant women at risk for GDM. Sensitivity and specificity of the Mellitus GCD59 ELISA will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Women 18 years of age or older at enrollment
2. Has an established viable singleton pregnancy
3. Is recommended for routine GDM screening between 24-28 weeks gestation
4. Has confirmed gestational age of 24-28 weeks at the Screening Visit
5. Is willing and able to provide documentation of informed consent

Exclusion Criteria:

1. Has diabetes before pregnancy or has already been diagnosed with GDM
2. Has contraindications for drinking oral glucose solution up to 100 g of sugar
3. Is taking metformin for any reason
4. Has any concomitant illness, disease or condition that, in the clinical judgment of the investigator, is likely to prevent the subject from complying with any aspect of the protocol, or that may put the subject at unacceptable risk
Evolution of the State of Health of Patients Undergoing Surgery for Osteoarticular Surgery

Osteoarticular surgery is frequently associated with the occurrence of moderate to severe postoperative pain. This pain can persist and become chronic post-surgical pain that is often debilitating. The transition between early postoperative pain and chronic pain is poorly understood, which complicates treatment.


Eligibility Criteria:
Inclusion criteria:

* Patient aged ≥18 years
* Underwent osteoarticular surgery between 01/01/2019 and 31/12/2022.
* Having been followed up with the administration of at least 1 QoR-15F questionnaire postoperatively
* Subject who has not expressed his opposition to the reuse of his data for scientific research purposes.

Exclusion criteria:

- Subject who expressed their opposition to participating in the study has
Dosing Flexibility Study in Patients With Rheumatoid Arthritis

During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.

Subjects with a stable methotrexate (MTX) dose enter the run-in period in which certolizumab pegol (CZP) will be administered at a dose of 400 mg (2 injections) at Weeks 0, 2, and 4 and at a dose of 200 mg with placebo (1 injection placebo, 1 injection CZP) at Weeks 6, 8, 10, 12, 14 and 16. The dose of MTX should be stable for at least 2 months prior to the Baseline visit and will remain stable throughout the trial, unless there is a need to reduce the dose for reasons of toxicity.

At the Week 18 visit, subjects who were ACR20 (American College of Rheumatology 20% Improvement) responders at Week 16 will be randomized in a double-blinded way to receive either 400 mg CZP given every 4 weeks and placebo given every 4 weeks given as two injections (alternating CZP and placebo every two weeks) plus MTX, 200 mg CZP and placebo administered every 2 weeks (one injection of each) plus MTX, or Placebo administered as two injections every 2 weeks plus MTX. Non-responders will be withdrawn from the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with established adult rheumatoid arthritis currently on Methotrexate for at least 3 months

Exclusion Criteria:

* All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
* Previous clinical trials participation and previous biological therapy that could interfere with the results of the present clinical trial
Pain Monitoring of Herniated Disc Surgery Patients With Oura Ring

The objective of this research study is to show whether data given by Oura ring could be used to objectively measure patients pain and well-being before and after disc surgery.

The study will consist of a total 30 disc prolapse patients. Patients are given Oura rings along with other treatment. Patients use Oura rings before and after disc surgery. Patients will also fill Beck Depression Inventory (BDI) and pain detect inquiries in the beginning and in the end of study. Patients symptoms will also be followed daily by electrical symptom diary.

Oura rings technology is based on photoplethysmography( PPG). PPG is a noninvasive method to detect blood volume changes in the microvascular bed of tissue. PPG waveform varies by respiration, sympathetic nervous system activity and thermoregulation. Oura ring gives information of patients activity level, calorie consumption, steps count, resting heart rate,heart rate variability, respiration rate, body temperature, sleep depth and quality of sleep.

Data collected with Oura ring after disc surgery will be compared to data collected before surgery.

Eligibility Criteria:
Inclusion Criteria:

* Upcoming herniated disc surgery, ability to give a written informed concent

Exclusion Criteria:

* Sleep apnea, Condition with irregular heart rate, lack of cooperation
Efficacy and Safety of Tripterygium Wilfordii in Patients With Rheumatoid Arthritis

Evaluation of oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of RA patients with clinical efficacy and safety.Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years with informed consent
* Diagnosed with rheumatoid arthritis as determined by meeting the 2010 ACR/EULAR classification criteria and has had rheumatoid arthritis for at least 6 weeks
* Swollen joint (SJC)≥3 and tender joint count(TJC)≥5
* ESR \>28 mm/hr or C-reactive protein \> 20 mg/L

Exclusion Criteria:

* Pregnant, lactating or further fertility requirements
* Previous treated with methotrexate or biologic DMARD.
* Active or chronic infection, including HIV, HCV, HBV, tuberculosis
* Patient with cancer
T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus

Type 1 diabetes is a condition that is caused in part by an abnormality of the immune system which occurs when T cells, which are part of the immune system, damage the insulin secreting cells (islet cells) in the pancreas. Although it is known that T cells are important mediators of the disease, progress in the development of reliable T cell assays has been modest. The purpose of this study is to learn which T cell assays are most reliable and reproducible so that the investigators can improve their understanding about how type 1 diabetes occurs.

The T Cell Validation Study is designed to determine the ability of T cell assays to identify differences in responses from participants with type 1 diabetes compared to normal control subjects, and to compare four different laboratory tests which examine T cells to determine whether the measurements are quantitatively reproducible.

Antibody assays that confirm the presence of type 1 diabetes will be evaluated including: Diabetes Biochemical Autoantibody Assay (anti-GAD65, anti-ICA512, anti-insulin) and Islet Cell Autoantibody testing; genetic testing (deoxyribonucleic acid \[DNA\] and human leukocyte antigen \[HLA\]) will also be done to learn more about the T cell assays.

The following T Cell Assays will be conducted in individuals with type 1 diabetes, as well as those without type 1 diabetes:

* Cellular Immunoblot Testing
* T Cell Proliferation Assay
* Tetramer Assay
* Cytokine ELISpot Assay

Eligibility Criteria:
Inclusion Criteria:

To be eligible, individuals with type 1 diabetes must be:

* Diagnosed with type 1 diabetes within one year of first study visit
* 8-35 years of age at time of first visit
* Weigh \> 40 kg (88 lbs) at time of first visit
* Individuals who will serve as control subjects who do not have type 1 diabetes cannot have a first degree or second degree relative with type 1 diabetes.

Exclusion Criteria:

Individuals must not:

* Have any major illness
* Be taking any steroid medications
* If female, should not be pregnant or breastfeeding.
E-health Literacy and Healthy Lifestyle Behaviors of University Students Studying Health Education in Turkey

The aim of this study is to examine the relationship between e-health literacy and healthy lifestyle behaviors of university students receiving health education in Turkey.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* being at least an associate degree student in the study area of health education

Exclusion Criteria:

* having any vision and hearing problems