cyrilzakka/clinical-trials huggingface dataset:
Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis

The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.

This is a Phase 3, randomized, masked, sham-controlled, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham injection procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.

Qualified subjects will be randomized to receive two suprachoroidal injections of CLS-TA administered to the study eye or two sham injection procedures administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
* Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥ 300 microns)
* Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters read (20/40 Snellen equivalent), in the study eye

Exclusion Criteria:

* Any active ocular disease or infection in the study eye other than uveitis
* Intraocular pressure \> 22 mmHg or uncontrolled glaucoma in the study eye; subjects are not excluded if IOP ≤ 22 mmHg with no more than 2 IOP lowering medications.
* Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
* Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.
Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive

The Odisha State Malaria Control Program (India) has introduced 'malaria camps' where teams of health workers visit villages to educate the population, enhance vector control with long-lasting insecticide nets (LLINs) and indoor residual spraying (IRS), and perform village-wide screening with rapid diagnostic tests and treatment for malaria. The long-term goal of this project is to evaluate the effectiveness of malaria camps (MCs) by determining if they reduce malaria, and to characterize malaria transmission in MCs.

The persistently high malaria burden in the remote forested areas of Odisha, India has led to the introduction of 'malaria camps' by the Odisha State Malaria Control Program where teams of health workers visit villages to educate the population, enhance vector control with long-lasting insecticide nets (LLINs) and indoor residual spraying (IRS), and perform village-wide screening with rapid diagnostic tests and treatment for malaria. The camps appear to be very effective but this is hard to assess in the context of ongoing changes such as LLIN introduction. The long-term goal of this project is to evaluate the effectiveness of malaria camps (MCs) by determining if they reduce malaria, and to characterize malaria transmission in MCs. The major objective to achieve this is through a quasi-experimental study (i.e., pretest-post-test control group design) of the effectiveness of the intervention, to determine if MCs reduce the prevalence of clinical and asymptomatic malaria as detected by PCR. In the first year, villages will be assigned across three study arms: arm 1 to receive new MCs; arm 2 is a control with no MCs but with standard malaria control; and arm 3 consists of villages already in receipt of MCs to study longer term effects. In the second year, both arm 1 and arm 2 villages will receive the intervention (i.e., a non-randomized stepped-wedge design). MC effectiveness will be evaluated from epidemiologic surveys and PCR detection of malaria prevalence with and without MCs.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent by individuals greater than 17 years old, or consent by a parent/guardian of children 1-6 years old, or assent of individuals from 7-17 years old along with consent from his or her parent or legal guardian.
* A complete understanding of study procedures/protocols, as delineated in the consent and assent forms and information sheets.
* Individuals have the ability and are willing to comply with study procedures for the entire length of the study.

Exclusion Criteria:

* Individuals less than 12 months or more than 69 years of age will be excluded.
* Persons who do not understand the study or are physically unable to make monthly visits.
Is the Daytime Sleepiness Based on Epworth Sleepiness Scale a Good Way to Assess Taiwanese With Suspected Obstructive Sleep Apnea.

This observational survey with retrospective follow-up is designed to study the daytime sleepiness based on Epworth Sleepiness Scale a good way or not to assess Taiwanese with suspected obstructive sleep apnea.

Daytime sleepiness (DS) is a complicated clinical problem, often indicating a serious underlying physiological abnormality and associated with higher prevalence of comorbid conditions such as diabetes, myocardial infarction, and stroke. Daytime sleepiness is also the cardinal symptoms of obstructive sleep apnea. How to identify the high risks patients with obstructive sleep apnea for further polysomnography is a difficult problem for doctors in out-patient department. Different methods have been proposed for measuring sleepiness and the Epworth sleepiness scale (ESS) is the measure of sleepiness most commonly used in sleep research and clinical settings.

However, whether Epworth sleepiness scale is a good tool with high predictive value of obstructive sleep apnea is not evaluated in the population of Taiwanese. This observational study is set up to document these practices.

Eligibility Criteria:
Inclusion Criteria:

* patients with polysomnography during 2016/1/1-2019/12/31

Exclusion Criteria:

* age under 20 year-old
* incomplete polysomnography
* incomplete chart information
* patients with narcolepsy
* patients with previous diagnosed with obstructive sleep apnea, including already patients with obstructive sleep apnea under treatment
Cardiovascular Risk Factors of Medical and Septic Complications After Laparoscopic Bariatric Surgery

A prospective, observational study of all morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) was performed. We evaluated preoperative comorbidities and cardiovascular risk factors, and the appearance of postoperative complications up to 90 days after surgery.

This study aimed to identify potential cardiovascular risk factors for postoperative medical and septic complications after bariatric surgery.

A prospective, observational study of all morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) was performed. We evaluated preoperative comorbidities and cardiovascular risk factors, and the appearance of postoperative complications up to 90 days after surgery.

Evaluated cardiovascular risk factors include age, the presence of tobacco habit, preoperative diagnosis of T2D, hypertension, dyslipidemia, cardiopathies (including arrhythmias, ischemic cardiopathy or congestive cardiac failure), strokes, Charlson index and analytical parameters of the lipid (triglycerids, total cholesterol and the subfractions High Density Lipoproteins (HDL-cholesterol) and Low Density Lipoproteins (LDL-cholesterol) and glycemic profile (fasting glucose and glycated hemoglobin). Cardiovascular risk factors, such as the Framingham risk score, were analyzed.

Primary outcomes were the appearance of medical and septic postoperative complications. Medical complications include cardiovascular complications (new onset or impairment of acute heart infarction, arrhythmias, cardiac failure or stroke), respiratory complications (pneumonia or respiratory failure) and acute renal failure. Septic complications include, urinary tract infections, incisional or organ/space surgical site infection (SSI), pneumonia or bacteriemia of other origin.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40 Kg/m2
* BMI \>35 Kg/m2 associated with obesity-related comorbidities

Exclusion Criteria:

* ASA IV
Quality of Life in Patients With Rectal Cancer Receiving Total Mesorectal Excision With or Without Stoma

The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer.

In most cases it is recommended that patients after low anterior resection with TME and neoadjuvant chemoradiotherapy for rectal cancer need a temporarily diverting stoma. Recent evidence suggests that this is not always necessary. The decision for or against a stoma is made by the surgeon in charge and is based on an algorithm of risk factors for anastomotic leakage. Many patients receive an adjuvant chemotherapy postoperative. This may influence the quality of life e.a. due to mucositis and urge incontinency or the stoma itself.The objective of this pilot study is to establish the basis for a randomized controlled trial. The long-term goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with TME and neoadjuvant chemoradiotherapy leads to a better quality of life without increasing morbidity and mortality in patients with rectal cancer. All patients scheduled for low anterior resection of the rectum for rectal carcinoma will be invited to participate and prospectively enrolled into the study.

Eligibility Criteria:
Inclusion Criteria:

* age older than 18,
* low anterior resection and TME due to rectum carcinoma after standardized neoadjuvant combined chemo- and radiotherapy and receiving adjuvant postoperative chemotherapy,
* German speaking patient who is capable to fill in the questionnaire,
* signed informed consent

Exclusion Criteria:

* age younger than 18,
* preoperative stoma,
* not German speaking
* inability to fill in the questionnaire,
* no standardized chemo- and radiotherapy
Hemodynamic Implications of Transcatheter Tricuspid Valve Repair in HFpEF Patients

The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation. Changes in right- and left-ventricular function as well as the interventricular dependence will be analysed on a multimodal basis including pressure-volume loop analysis and cardiac magnetic resonance imaging.


Eligibility Criteria:
Inclusion Criteria:

* Severe tricuspid regurgitation with need for interventional treatment approach as decided by an interdisciplinary heart team.
* Signs and symptoms of left-sided heart failure.
* Left-ventricular ejection fraction ≥50%
* Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure \[PCWP\] or left-ventricular end-diastolic pressure ≥15 mmHg)

Exclusion Criteria:

* Concomitant relevant mitral valve regurgitation with need for concomitant interventional treatment
* Moderate aortic stenosis.
* Pregnancy
* Contraindication to perform cardiac magnetic resonance imaging.
* Conditions rendering patient unable to give informed consent to the study protocol.
Oral Tranexamic Acid Versus Diosmin for Treatment of Menorrhagia in Women Using Copper IUD

To compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in women having Intra Uterine Contraceptive Device (IUD) and suffer from menorrhagia.


Eligibility Criteria:
Inclusion Criteria:

* Women complaining from an menorrhagia secondary to a current copper IUD use.
* Age: 20-40years.
* Menorrhagia , will be defined as a PBAC-Score greater than 100.
* No systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
* No other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
* No drugs decreasing blood coagulation.
* Well fitted IUD not misplaced.

Exclusion Criteria:

* Age \<20y and \>40y.
* Irregular menstrual cycle.
* Presence of systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases.
* Presence of other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps).
* Taking drugs decrease blood coagulation.
* Misplaced IUD.
Comparison of Cardiac Index and Stroke-volume-index Measured by Pulmonary Artery Catheter, FloTrac® and Argos® in Cardiac Surgery Patients.

A comparison of cardiac performance determined by stroke-volume-index measured by different mechanisms in patients during and after cardiac surgery:

1. Pulmonary artery catheter
2. Flo Trac
3. Argos Monitor Investigations will be done in theater and on ICU in ventilated and spontaneously breathing patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient after cardiac surgery with pulmonary artery catheter

Exclusion Criteria:

* Hemodynamic instability, no consent
Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter

The investigators propose a single center prospective study that will assess two different strategies for measuring Fractional Flow Reserve (FFR) in patients undergoing clinically-indicated coronary angiography in whom FFR measurement is indicated. FFR will be measured with a non-side hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) and with a side-hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) to determine, whether measurements obtained with an engaged side-hole guide catheter are more accurate as compared with those obtained with the engaged non-side hole catheter.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing a clinically indicated coronary catheterization
* Need FFR of a coronary artery lesion
* Agree to participate and able to provide informed consent

Exclusion Criteria:

* Significant difficulty advancing the pressure measuring guidewire into the coronary artery
* Severe chronic obstructive pulmonary disease
* Severe ostial disease (\>70% diameter stenosis within 5 mm from the coronary artery ostium)
Trial Investigating the Characteristics of Knismesis - a Lever to Explore Allodynia in Neuropathic Pain

Also known as a "moving itch", knismesis is a mildly annoying sensation caused by a light movement on the skin, such as from a crawling insect. Its underlying mechanism rely on spatial summation, i.e. amplification of the signal due to summation of stimulated fields, like it is for dynamic allodynia in neuropathic pain. This physiological study aims at determining the physical factors of the cutaneous stimulation inducing knismesis as well as the effect of confounding factors. The main area of exploration will be the back, because of its size and the possibility to blind the participant. The information collected, along with animal data in surrogate models, would help to better understand neuropathic pain in the future.

This is a physiological proof-of-concept, also aiming to validate a functional exploration model in healthy volunteers. Each participant will undergo a battery if psychometric then psychophysics tests, presented sequentially. However, most of the main study tests (knismesis) will be admistered in a random order (crossover). The primary endpoint is to characterise, in the healthy human, the physical determinants of the cutaneous stimulation inducing knismesis: length of the pathway, speed, direction, intensity, continuity break of the contact, hairiness, body site, or distraction by other cutaneous stimuli. The secondary endpoint is to study the relationship between the individual sensitivity to spatial summation (knismesis) and other individual sensitivities or profiles.

Eligibility Criteria:
Inclusion Criteria:

- Ability to answer French questionnaires.

· BMI between 19 and 30 kg/m2 at inclusion.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Natural intolerance to tickling.
* Any cutaneous, ocular or neurological disease contraindicating the psychophysical tests.
* Any disease or medical history that could expose the subject to unacceptable risk during the study.
* Any medication intake within 7 days before testing.
* History of drug or alcohol abuse.
* Involvement in another concomitant research protocol.
* Major dorsal hairiness.
* Inability to undergo the tests.
* Legal protection.
* Concomitant involvement in another clinical research.
* Refusal to participate.
Robot Therapy in Pediatric Emergency

The investigators are evaluating if the use of humanoid robots is an optimal distraction strategy in order to produce positive emotional states and facilitate the diagnosis and to reduce treatment time in pediatric age in emergency situations.


Eligibility Criteria:
Inclusion Criteria:

* children between the ages of 3 and 10 with white, green and yellow triage code

Exclusion Criteria:

* Red triage code
* inadequate knowledge of the Italian language,
* yellow triage code in case of: headache for recent trauma with visual impairment; headache with neck rigidity or vomiting; indifference to the environment; dyspnea and increased respiratory work; intoxication by inhalation of toxic substances; significant trauma to the head with altered state of consciousness.
The Effect of Ankle Floss Band on Football Players

There is no study in the literature investigating the effects of ankle stimulation with the flossband soft tissue technique on balance and proprioception. The impact of flossband use on flexibility and static and dynamic balance in the lower extremities requires further research. It is likely that flossband, which has been found to enhance sports performance, also affects balance, proprioception, and performance. More research is needed to evaluate the benefits of flossband use on body movements and motor control. Therefore, the aim of this study is to evaluate the effects of flossband on balance, proprioception, and performance, given its known impact on sports performance.

Objective: The aim of the study is to investigate the effects of exercises with flossband on balance, proprioception, and physical performance in the ankle.

Materials and Methods: Thirty-six football players were included in the study. As this was a serial group design the same football players were included in both the study group and the control group. There was a 72-hour break between the interventions for the study group and the control group. The study began with the study group. The study group received Flossband application while the control group received foam roller bandage application. The same exercises were conducted alongside both interventions. Measurements were taken before and after the interventions and exercises. Ankle dorsiflexion range of motion was evaluated using the weight-bearing lunge test, static balance using a smartphone application, dynamic balance using the Y-balance test, and proprioception using the joint position sense test. Additionally, the hop test was used to assess jumping performance.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 25 years old.
* Engaged in regular football training for at least 3 years.

Exclusion Criteria:

* History of fractures and surgeries in the lower extremities.
* Diagnosed with other ankle and lower extremity problems.
* Presence of pain in the ankle and lower extremities.
* Systemic conditions such as deep vein thrombosis and embolism.
* Experience of pain during any measurement.
Propafenone Versus Amiodarone in Septic Shock

Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few prospective trials done on cardiology patients. The papers on 1c class antiarrhythmics do not take into consideration a complex haemodynamic assessment using echocardiography. The authors have recently presented a retrospective study on SV arrhythmias in septic shock patients demonstrating favourable effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.

Primary aim is to verify the conclusions of the retrospective study, i.e. efficacy and safety of propafenone, in a prospective blinded randomized trial performed in two large intensive care units. Secondary aims are to monitor the electromechanics of left atrium in patients with SV arrhythmias in septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock with a new onset SV arrhythmia
* LV systolic function normal to moderately reduced according to echocardiography.

Exclusion Criteria:

* Severe LV systolic dysfunction
* More than 1st degree AV block
* High dose vasopressor therapy with continuous noradrenaline \> 1.0 ug/kg.min
* Known intolerance to amiodarone or propafenone
* Absence of septic shock
* Chronic AF
* Dependence on pacemaker
* Status after MAZE procedure
Citicoline in Youth Alcohol Use Disorder

The goal of this study is to evaluate how citicoline, an over-the-counter supplement, versus a placebo pill (i.e., an inactive pill) affects the immune system, brain, and cognition in adolescents who may use alcohol.


Eligibility Criteria:
Inclusion:

Age 16 to 22.

Call study team for additional screening and information.