cyrilzakka/clinical-trials huggingface dataset:
Implementation of SGLT-2 Inhibitors in Patients with Heart Failure Through a New Digital Strategy

The implementation of new medical therapies and guidelines, is a long and complex process that takes up to 10 years on average. This prolonged process is a global challenge and is mainly due to the complexity of cross-institutional patient care, involving primary care, out-patient clinics, nursing homes and patient associations.

The main objective of this clinical trial is to determine whether a new digital strategy that employs official digital letters to inform and invite patients to evaluate their eligibility for new therapies, specifically the sodium-glucose co-transporter-2 (SGLT-2) inhibitor for heart failure patients, can facilitate and optimise the implementation. The aim is to increase the number of eligible patients with heart failure who start taking SGLT-2 inhibitors and reduce the time it takes to initiate treatment compared to the current process. Ultimately, this approach may improve patient outcomes.

The study is a prospective, multicenter, two-armed, randomised clinical trial that will be coordinated from the Department of Cardiology, Herlev-Gentofte Hospital. The primary objective of the study is to determine whether a new digital strategy can be implemented to introduce novel medical therapies, specifically sodium-glucose co-transporter-2 (SGLT-2) inhibitors to heart failure patients. The aim is to increase the number of eligible patients who initiate therapy and to reduce the time taken to initiate therapy compared to the current process. The study will recruit patients with a registered diagnosis of heart failure residing in The Capital Region of Denmark and Roskilde, who have not yet been started on SGLT-2 inhibitor therapy. Patient identification and recruitment will be carried out through Danish nationwide registries, using their personal identification number (CPR-number), which is also linked to a secure digital mailbox where all official letters from public authorities are sent to Danish citizens. Patients will be randomly assigned (1:1) to receive a digital letter containing evidence-based information about the newly approved heart failure therapy option, SGLT-2 inhibitors. The letter will also invite recipients to be evaluated by a heart failure specialist for potential initiation of the therapy. Outcome measures will be obtained from Danish nationwide registers at pre-specified time points and in collaboration with the Danish Health Data Authority.

Eligibility Criteria:
Inclusion Criteria:

1. Registered diagnosis of heart failure within the last 10 years
2. Living in the Capital Region of Denmark or Roskilde
3. Age ≥20 years

Exclusion Criteria:

1. Redeemed prescription of a SGLT-2 inhibitor after 2015
2. Type 1 diabetes
3. History of diabetic ketoacidosis
4. Chronic kidney disease in long term dialysis
5. Living in a nursing home
6. Dementia
7. Cancer diagnosis within the last year (except prostate cancer and non-melanoma skin cancer)
8. Exemption from the public digital mailbox system
Mortality and Related Risk Factors After Hip Arthroplasty

The patients who underwent hip arthroplasty in our hospital from January 2017 to December 2020 were reviewed. The perioperative data were collected, and then the mortality was calculated and the risk factors were analyzed.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing hip arthroplasty in Renji Hospital during 2017.1-2020.12

Exclusion Criteria:

* Patients who did not undergo surgery after admission Age \< 18 years Patients undergoing the second operation
Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin

The radial approach for a coronary angiography has became popular in several centers because of its simplicity and fewer complications. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. Several strategies have been used to decrease the incidence of RAO (heparin, patent hemostasis, etc). Nitrates in intra-arterial have been widely studied in prevention of this spasm. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of RAO. The hypothesis that use of nitroglycerin at the start of catheterization would have the same effect was not tested.

Transradial access (TRA) has been increasingly adopted for diagnostic and interventional cardiovascular procedures in many centers worldwide. This is largely driven by the evidence supporting an unequivocal reduction in access site-related complications associated with TRA compared with transfemoral access, as well as reduction in cost and increased patient comfort. The radial artery occlusion (RAO) is the main inconvenient and impose a limitation of future use of the radial artery as an access site for catheterization in the future. RAO is the most commun complication of transradial access, and its incidence continues to reach up to 12%.

Nitrates in intra-arterial have been widely studied in prevention of this spasm. Nitroglycerin binds to the surface of endothelial cells and undergoes two chemical reductions to form nitric oxide (NO). The nitric oxide then moves out of the endothelial cell and into an adjacent smooth muscle cell, where it promotes the formation of cyclic guanosine monophosphate (cGMP), which then promotes muscle relaxation. Current data show that nitroglycerin intra-arterial at the end of the procedure reduce the incidence of radial artery occlusion.

A big sheath to artery size ratio could reduce the incidence of RAO, so the main objective of this study is to evaluate whether administration of nitroglycerin at the start of a transradial procedure may preserve the patency of the radial artery; as well, confirm if nitroglycerin administration just before sheet removal helps to keep the radial artery patency.

Eligibility Criteria:
Inclusion Criteria:

* Indication for cardiac catheterization;
* Suitable candidates for transradial approach;
* Use of 5 or 6 French sheath in the procedure;
* Signed informed consent.

Exclusion Criteria:

* Unable to tolerate nitrates or known allergy to nitrates;
* Use of any nitrate, by any route of administration, up to 1 hour before the procedure;
* ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;
* Intubated patients (on mechanical ventilation);
* Complications before or during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke);
* Prior inclusion in this trial.
Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization

A randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization in healthy adult men and women

The purpose of this randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover study was to evaluate the effect of therapeutic and supra-therapeutic doses of eslicarbazepine acetate on the placebo corrected time-matched change from baseline using individually corrected QT (QTcI) interval durations in adult healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Be a healthy male or female 18 to 45 years of age. Women were required to be postmenopausal (more than 12 months since last period); surgically sterile (hysterectomy or tubal ligation at least 6 months prior to enrollment); using an intrauterine device; or double barrier (i.e. diaphragm or spermicide plus male condom) non-hormonal contraceptive therapy for the duration of the trial and were required to have a negative pregnancy test at screening and upon each check-in to the study facility.
* Have a BMI within the range of 18-30 kg/m2.
* Be able to communicate effectively with the study personnel.
* Have no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit and on each admission to the clinic.
* Have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction.
* Be nonsmokers defined as not having smoked in the past 6 months.
* Be adequately informed of the nature and risks of the study and give written informed consent prior to study entry.

Exclusion Criteria:

* Known hypersensitivity or allergy to moxifloxacin, eslicarbazepine acetate or related compounds such as carbamazepine, oxcarbazepine, or licarbazepine.
* Women who were pregnant or breast feeding.
* Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or placed the subject at increased risk.
* A sustained supine systolic blood pressure \> 140 mmHg or \<100mm Hg or a diastolic blood pressure \> 95 mmHg at screening or baseline.
* A resting ECG heart rate of \<50 bpm or \>100 bpm.
Moral Injury Symptom Scale/Moral Injury Outcome Scale

The purpose of this research is to validate the moral injury symptom scale clinician version short form and the Moral Injury Outcome Scale in nurses. Participants will be recruited in accordance with AdventHealth Policy # 400.120: Selection and Enrollment of AdventHealth Employees, Physicians, and Volunteers for research Studies. Employee participants will be assured participation in this study will not affect performance evaluation or employment-related decisions by peers or supervisors. No employees will be recruited by a direct supervisor. Recruitment of potential employees as participants will occur without coercion by the Principal Investigator (PI), by bulletin board advertisements, or through a third party unassociated in a power/supervisory relationship with the employee (i.e., researchers from Center for Whole-Person Research).


Eligibility Criteria:
Inclusion Criteria:

1. Currently working as a registered nurse (Licensed Practical Nurse, Registered Nurse, Assistant Nurse Manager, Nurse Manager, Nurse Educator) at identified hospital within the state of Florida
2. Access to computer or mobile device to complete the survey
3. Ability to read and understand English

Exclusion Criteria:

1. Any employee at identified hospitals who is not a licensed nurse
Investigation of the Efficacy of Different Treatment Approaches on Sexual Health in Healthy Women

Sexual health is one of the important factors affecting the quality of life and general health of individuals.

Sexual life, with its personal and social aspects, is an inseparable part of the human being in general. It is one of the most important factors in human life and happiness, especially in family life.

Sexuality positively integrates and enriches the somatic, emotional, intellectual and social aspects of individuals, and develops a personality, communication and love.

The concepts of sexuality and sexual health have long been considered taboo. This situation negatively affects rehabilitation strategies. Studies are known to have sexual problems in women more than men.

There are many factors that affect sexual function. In the etiology of female sexual dysfunction; neurogenic, vascular, hormonal, musculogenic and psychogenic factors are included. If female sexual dysfunction causes distress, it negatively affects women's quality of life. The repetition of problems related to sexual response, pain, orgasm and desire, which cause interpersonal problems and discomfort, creates a complex problem.

Pelvic floor muscles are known to play an important role in sexual function as they are responsible for involuntary rhythmic contractions during orgasm and vaginal sensation during intercourse. Studies have reported that pelvic floor disorders affect one-third of adult women and significantly reduce their quality of life. Different treatment methods applied to the pelvic floor muscles increase the level of muscle strength and muscle activation. Increasing pelvic floor muscle strength affects individuals' sexual life positively and reduces the problems encountered. Conservative treatment modalities include exercises for the pelvic floor muscles, functional electrical stimulation, and surface electromyography. Exercise practices are one of the important approaches that strengthen the pelvic floor muscles.

These exercise approaches can be given in the form of home exercise applications, as well as device-assisted applications.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18 and over
* Having an active sex life

Exclusion Criteria:

* Latex allergy
* Other allergies in the pelvic area
* Vaginal or urinary tract infection
* Gynecological cancer
Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis

Primary Objective:

To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of participants with Idiopathic Pulmonary Fibrosis (IPF).

Secondary Objectives:

To evaluate the efficacy of 2 dose levels/regimens of SAR156597 compared to placebo on IPF disease progression.

To evaluate the safety of 2 dose levels/regimens of SAR156597 compared to placebo in participants with IPF.

The total study duration of study was expected up to 68 weeks (screening period of 4 weeks, treatment period of 52 weeks, and 12 weeks of follow up).

Eligibility Criteria:
Inclusion criteria :

* Adult male or female participants.
* Documented diagnosis of IPF according to the current 2011 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ American Latin Thoracic Association (ATS/ERS/JRS/ALAT) guidelines.
* Signed written informed consent.

Exclusion criteria:

* Age less than or equal to 40 years.
* IPF disease diagnosis greater than 5 years.
* Forced vital capacity (FVC) less than (\<) 40 percent (%) of predicted value.
* Carbon monoxide diffusing lung capacity (DLCO) corrected for hemoglobin \<30% of predicted value.
* Severe chronic obstructive bronchitis as characterized by forced expiratory volume in 1 second /forced vital capacity (FEV1/FVC) \<0.70.
* Need for 24 hours of oxygen therapy or oxygen saturation \<88% after 10 minutes breathing ambient air at rest.
* Known diagnosis of significant respiratory disorders other than IPF.
* Pulmonary artery hypertension requiring a specific treatment.
* Currently listed and/or anticipated for lung transplantation within the next 6 months (on an active list).
* History of vasculitis or connective tissue disorders.
* Known human immunodeficiency virus or chronic viral hepatitis.
* Participants with active tuberculosis or incompletely treated latent tuberculosis infection.
* Use of any cytotoxic/immunosuppressive agent including but not limited to azathioprine, cyclophosphamide, methotrexate, and cyclosporine within 4 weeks prior to screening.
* Use of any cytokine modulators (etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab, rituximab) within 12 weeks or 5 half-lives of screening (24 weeks for rituximab and 24 months for alefacept).
* Use of any investigational drug within 1 month of screening, or 5 half-lives, if known ( whichever was longer), or within 12 weeks for stem cell therapy.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Hand Hygiene Before Non-sterile Glove Use

The importance of healthcare worker hand hygiene in decreasing bacterial transmission between patients is well documented. Healthcare workers may don non-sterile gloves in routine care of patients, particularly for those patients known or suspected to harbor epidemiologically important microorganisms. Governing bodies currently recommend performing hand hygiene prior to donning gloves and after glove removal. The importance of hand hygiene post glove removal is well shown, however few studies exist to show utility of hand hygiene prior to donning gloves. In fact, data suggests that glove use is an impediment to hand hygiene and may reduce compliance with hand washing. In light of this and the fact that no evidence exists that washing hands BEFORE glove use is important, the aim of the study is to asses the utility of routine hand hygiene prior to donning non-sterile gloves before a patient contact.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare worker engaging in direct patient contact on Contact Precautions (e.g. expected glove use)
* \>= 18 years of age

Exclusion Criteria:

* Visibly soiled hands requiring hand washing (cannot randomize)
* Non-compliance with glove use as indicated for care of patient on Contact Precautions
Sitagliptin in Prevention of Type 2 Diabetes Mellitus

The hypothesis is, in subjects with persistent impaired glucose tolerance(IGT) , sitagliptin will decrease the conversion rate to diabetes as compared to a placebo in three years.

The DPP-4 inhibitor Sitagliptin may be a suitable preventive agent in subjects with IGT or IFG on account of observed functional improvements in islet cell function and potential protective effect on beta cell mass.

Objectives of the study

1. Primary objectives :

   - To test whether the DPP4 inhibitor Sitagliptin is effective in preventing conversion of IGT to diabetes when compared with a placebo.
2. Secondary objectives:

   * To assess rates of reversal from IGT to Normal Glucose Tolerance (NGT) in IGT patients administered Sitagliptin
   * To assess the effect of Sitagliptin on measure of beta cell function and insulin resistance in patients with IGT.

Study design

Double blind placebo controlled, parallel group study - three years follow up .

Subjects with IGT in the age group of 30-55 years (n=900) will be identified by screening with a standard OGTT. Selected subjects will be randomized to the control arm using placebo and the two study arms using Sitagliptin. At baseline all group will receive a standard advice on lifestyle modification. The dose of sitagliptin will be 100 mg/d. The subjects will be reviewed at 6 monthly intervals and repeat OGTT will be done annually.

Proforma containing details of anthropometry, occupation, physical activity, diet habits, details of medications, regularity of treatment and biochemical investigations will be filled up at each interview.

Investigations:

Initial Screening

1. Demographic data
2. Height, weight, waist and hip measurements.
3. Details of family history of diabetes, hypertension and cardiovascular diseases.
4. History of any other major illness.
5. History of blood pressure and measurements.
6. Details of education and occupation.
7. Diet habits will be analyzed by dietician.
8. Details of physical activity will be assessed by a questionnaire.

Laboratory investigations:

1. Initial OGTT
2. Plasma glucose and HbA1c.
3. Lipid profile
4. Liver function tests
5. Serum amylase and serum lipase
6. Plasma insulin
7. 12 lead ECG.

Review analysis:

1. Review will be done with all clinical and biochemical assessment annually.
2. Evaluation of adherence to prescription will be done at 6 monthly intervals.

Eligibility Criteria:
Inclusion Criteria:

Subjects with IGT in the age group of 30-55 years (n=900) will be identified by screening with a standard OGTT.

Exclusion Criteria:

1. Known diabetes
2. Pregnant women
3. Alcohol abuse
4. Transferable jobs.
5. Subjects with major illness like cancer, hepatic or cardiac diseases.
Effect of Systemic Hypoxia and Hyperoxia on Retinal Oxygen Saturation

Adequate perfusion and oxygenation is essential for the function of the inner retina. Although it is known that oxygen tension is very well autoregulated in the retina, the physiological mechanisms behind this regulation process are not fully explored. The development of new instruments for the non-invasive measurement of oxygen tension in retinal vessels now allows for the more precise investigation of these physiological processes. The current study seeks to evaluate the retinal oxygen saturation in healthy subjects while breathing different oxygen mixtures to achieve a hypoxic and a hyperoxic state.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years
* Nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropy \< 3 Dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study (except oral contraceptive)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence of any form of anemia
* Blood donation during the previous 3 weeks
* Pregnancy
EFFECTS OF CORE STRENGTHENING WITH RESISTIVE VERSUS NON-RESISTIVE DIAPHRAGMATIC TRAINING ON CORE ENDURANCE IN LOWER CROSS SYNDROME

This study is a randomised control trial and the purpose of this study is to determine the effects of core strengthening on trunk endurance after core strengthening with resistive versus non-resistive diaphragmatic training in lower cross syndrome.

The purpose of this study is to determine the effects of core strengthening on trunk endurance after core strengthening with resistive versus non-resistive diaphragmatic training in lower cross syndrome.

Core stability of young adults (age: 19-30 years) will be determined using McGill's muscular endurance test battery:

1. Flexor endurance test
2. Extensor endurance test
3. Right lateral endurance test
4. Left lateral endurance test Scores will be taken three times for each test; the average of each text will be noted for each participant.

Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will be allocated to either of the groups through a sealed opaque envelope method. McGill's Torso Muscular Endurance Test Battery will be used and baseline and post-intervention scores will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-30 years
* Both genders
* Positive modified Thomas test
* Positive prone hip extension strength test
* Positive trunk flexion strength test
* Tight erector spinae
* Asia pacific BMI normal and overweight (18.5-24.9 Kg/m2)
* Local intermittent lumbar pain
* Mild to moderate pain (NPRS 1-6)
* Painless movement and activity
* Pain only produced by sustained loading in relevant position, which is then relieved on moving from that posture

Exclusion Criteria:

* Shoulder pain
* Acute flare LBP
* Centralization and peripheralization of pain (21)
* Intermittent pain at limited end range (21)
* Leg symptoms when walking, eased in flexion (Signs of stenosis) (21)
* Pain due to repetitive movement (21)
* Paresthesia/numbness (21)
* Structural deformity (Kyphosis, lordosis, scoliosis, spondylosis, spondylolysis, spondylolisthesis)
* Curve reversal (21)
* Pregnancy
* Post surgery
* Degenerative and inflammatory spinal diseases