cyrilzakka/clinical-trials huggingface dataset:
Assessing the Atraumatic Technique in Ophthalmic Patients

This study is conducted to determine the efficacy of the cannula atraumatic technique as an alternative to the traditional needle penetrating technique to minimize the incidence of accidental globe penetration and/ or perforation, as the plastic part of the cannula is blunt and is difficult to perforate the normal globe being marble-like in consistency.

A prospective comparative single blinded randomized controlled clinical study was held in the operating theatre at Research institute of ophthalmology, on adult patients with age group between 18- 80 years of both sexes undergoing anterior, posterior segment or plastic surgeries. two techniques were used in comparison: the atraumatic technique, using a 20 or 22-gauge cannula advanced in the inferior-temporal peribulbar space after local infiltration. The skin and the conjunctiva will be pierced by the cannula and advanced for only 0.5 cm, then the cannula will be advanced blindly. Supplementation using the other sites (medial canthus and superior nasal) as needed.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients
2. Both
3. patients going to do anterior, posterior segment surgery or cornea surgeries.

Exclusion Criteria:

1. Pediatric population
2. Mentally retarded patients
3. Patients having Problems to lie flat, refused to take regional
4. Patients with communication problems as; language barrier, deaf and mute.
5. Patients with bleeding diathesis.
Determining the Safe Dosage of Ascorbic Acid Used in the Treatment of Occluded Totally Implanted Central Venous Catheter

The hypothesis of the study is to evaluate whether ascorbic acid is able to clear totally implanted central venous catheter

Totally implanted catheter is often occluded and thrombolytic drugs are usually used to restore permeability. In Brazil, the ascorbic acid has been used successfully by a service specialist in cancer treatment. However, no literature on international research that evaluates the efficacy and safety of this procedure. That was why it was decided to develop this research.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of partial or complete obstruction of the totally implanted central venous catheter;
* No signs of inflammation in the area of the port.

Exclusion Criteria:

* Use of oral anticoagulants or intravenous administration in the last seven days;
* Diagnostic and / or suspected infection in the totally implanted central venous catheter;
* Rupture, displacement or fissure of the totally implanted central venous catheter;
* Presence of thrombosis in the vein where the catheter is inserted.
Observational Study of Drowning Patient's Emergency Care in Its Pre-hospital Phase.

According to the 9th edition of "NOYADES" survey, 1480 drownings accidents occurred in France in 2021, of which 146 (i.e. nearly 10%), were in the Var department. These patient's care involve in first place the Emergency Medical Service (EMS).

To date, there is no recommendation from French or European academic societies of emergency medicine formalising pre-hospital care of these patients (except for the specific case of cardiac arrest). This absence of recommendation therefore favours heterogeneity of practices.

Within a three-year period from 2019 to 2022, this retrospective observational study aims to provide an inventory of pre-hospital practices by the EMS in the Var department and to describe drowning patients' characteristics as well as their outcome, according to the initial regulation and the type of care. These data could help for pre-hospital care management.

Eligibility Criteria:
Inclusion Criteria:

1. Drowning patient
2. Aged 18 years old or over
3. Patient treated by pre-hospital care from the emergency medical services 83 (SAMU 83) between 1st January 2019 and 30th September 2022.

Exclusion Criteria:

1. Diving accident
2. Patient opposition to participate in the study
A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Study (FE 999905 CS07) of Zomacton in Children With Growth Hormone Deficiency

This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No investigational medicinal product will be administered in connection with this follow-up study. Eligible patients will attend one visit in this follow-up study.


Eligibility Criteria:
Inclusion Criteria:

* Previous participation in trial FE 999905 CS07 and presence of anti-hGH antibodies at any post-dosing visit throughout the 12-month treatment period
* Signed informed consent and obtained assent according to local rules and practice
* Information on medical history, concomitant medications, and growth hormone therapy since completion of trial FE 999905 CS07

Exclusion Criteria:

* There are no pre-defined exclusion criteria in this study
Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism

The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with congenital hyperinsulinism.

This is an open-label, pilot study , to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cells, increases fasting blood glucose levels in subjects with congenital hyperinsulinism. Our overall hypothesis is that abnormal GLP-1 secretion resulting from dysfunctional nutrient sensing in intestinal L-cells plays a role in the dysregulated insulin secretion characteristic of this disorder, and that antagonism of the GLP-1 receptor will increase fasting blood glucose levels.

Aim 1. To evaluate the dose of exendin-(9-39) required to elevate fasting blood glucose levels in subjects with congenital hyperinsulinism due to KATP channel mutations.

Aim 2. To determine therapeutic plasma levels, plasma half-life and pharmacokinetics of exendin-(9-39) during an intravenous short-term infusion in subjects with congenital hyperinsulinism due to Adenosine triphosphate (ATP)-sensitive potassium channel (KATP) mutations.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with congenital hyperinsulinism

Exclusion Criteria:

* Acute medical illness
* History of other systemic chronic disease such as cardiac failure, renal insufficiency, hepatic insufficiency, chronic obstructive pulmonary disease, anemia, or uncontrolled hypertension
* Pregnancy
* Diabetes mellitus
* Use of medications that affect glucose metabolism, such as glucocorticoids, beta agonists, diazoxide and octreotide.
* Subjects will be eligible to participate 48 hrs after the last dose of octreotide and 72 hrs after last dose of diazoxide
Dynamic Strength Index-based Intervention in Basketball.

The goal of this randomized controlled trial will be to determine the effectiveness of the dynamic strength index (DSI) in optimizing training programs to improve physical performance proxies (sprinting, jumping, and CoD) in basketball players. Subjects will be randomly allocated to one of two groups: the intervention group and the control group. Measurement and intervention will occur during a 7-week in-season period, right before the play off starts. Throughout this period, all participants will engage in an average of 10 hours of basketball training per week, which will comprise 5 basketball sessions and 2 strength training sessions. In addition, they are anticipated to play 2 games weekly. A pre-test will be performed one week before the first training session, and post-tests will be performed in the week after the training sessions have finished. Athletes will perform both testing sessions at the same time of the day (± 2 hours). Each athlete will perform a 20-m sprint test, with timing gates positioned at every 5 m distance, a 505 CoD test, countermovement jump (CMJ), and isometric mid-thigh pull (IMTP). Based on CMJ peak force and IMTP peak force data, we will calculate DSI. Based on the average DSI value, the participants in the intervention group will be divided into two groups - strength group and ballistic group.


Eligibility Criteria:
Inclusion Criteria:

* Perform basketball training for at least 5 years
* Plays in professional regional, national or international league

Exclusion Criteria:

* Any musculoskeletal injury in the past 6 months
* Any neurological issues
* Any chronic non-communicable diseases
Study of Intravenous Ceftolozane/Tazobactam Compared to Piperacillin/Tazobactam in Ventilator-Associated Pneumonia

This is a Phase 3, multicenter, prospective, randomized, open-label, study to compare the safety and efficacy of intravenous (IV) ceftolozane/tazobactam with that of IV piperacillin/tazobactam in the treatment of ventilator-associated pneumonia (VAP) in adult participants .


Eligibility Criteria:
Key Inclusion Criteria:

* Participant has received mechanical ventilation for \> 48 hours
* Acute Physiology and Chronic Health Evaluation (APACHE) II score of 11-35
* Presence of a new or progressive infiltrate on chest x-ray
* Presence of clinical criteria consistent with VAP

Key Exclusion Criteria:

* History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics
* Known end stage renal disease or requirement for dialysis
The Effect of Fatigue on CPR

Background: This study, in contrast to the previous studies, generated a scenario of fatigue in an earthquake scenario and aimed to measure the effect of fatigue on the quality of cardiopulmonary resuscitation (CPR) performed by paramedics in a debris course.

Methods: The study was designed as a randomized controlled trial. The sample, consisting of 84 paramedic students, was randomly assigned as 42 control and 42 experimental groups. Fatigue was created in the participants by rehearsing the process of removing and transporting earthquake victims from the rubble through the prepared track. A personal information form and a CPR measurement form were used to obtain the data. The simulator was used to evaluate the accuracy of CPR. The collected data were analysed with the statistical program.

Introduction Cardiopulmonary Arrest (CPA) is among the leading cause of death worldwide. Each year, 375,000 people are reported to die in Europe and 250,000 in the United States due to CPA. Early diagnosis of arrest and Cardiopulmonary Resuscitation is life-saving. However, earthquakes, one of the deadliest disasters, are among the most challenging situations that people around the world have to face. The rate of rescue of survivors from earthquake or collapsed structures is reported to decrease by 50% following 24 hours. Therefore, the first 72 hours are crucial for search and rescue operations in disasters. In earthquakes, while some of the disaster victims experience arrest at the scene due to trauma, others experience arrest in early or late periods depending on the injury site and localization. Thus, search and rescue operations should be initiated quickly, effectively and swiftly in disaster areas. Properly and efficiently administered CPR is among the most crucial life-saving emergency medical care methods. In Turkey, paramedics are also deployed to National Medical Rescue Team (NMRT) units to support search and rescue activities and provide emergency medical care. Paramedics have difficulties in maintaining chest compressions in arrest cases, especially in challenging cases in tight spaces outside the hospital. Since chest compressions are considered the essential element of CPR, their quality is thought to be affected under harsh conditions. 2015 International Liaison Committee on Resuscitation (ILCOR) recommended the compression depth as 5-6 cm and stated that 1/3 of the sternum should be compressed owing to the body mass differences of the rescuers. However, effective CPR depends on many parameters such as the number of rescuers, elapsed time, physical characteristics and muscle strength of the rescuer, high level of fitness, fatigue, weight of the rescuer, physical fitness, having a higher maximum oxygen consumption, position of the rescuer, difficult and confined space rescues. This study aimed in this context, to measure the effects of fatigue on CPR using high-quality simulators.

Eligibility Criteria:
Inclusion Criteria:

* Being a paramedic student.
* Having taken a resuscitation course.

Exclusion Criteria:

* None
A Study To Evaluate The Safety, Pharmacokinetics/Pharmacodynamics (PK/PD) and Food Effect Of LC51-0255

1. To evaluate the safety and tolerability of LC51-0255 in healthy male subjects
2. To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in healthy male subjects
3. To evaluate bioavailability of LC51-0255

For safety and tolerability assessement, subjects will be monitored by collection of adverse events, physical exams, vital sign, 12-Lead ECG, Continuous ECG monitoring, Holter monitoring, blood chemistry and hematology panels, pulmonary function tests, optical coherence tomography (OCT) during the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 19\~45 years at screening.
* Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive)

Exclusion Criteria:

* History or Known presence of clinically relevant hepatic, gastrointestinal, pulmonary, psychiatric, endocrine, neurological, cancer, including solid tumors and hematological malignancies, cardiovascular, ophthalmological or other major systemic disease
* Exclusions Related to Laboratory Results: Platelet count \< 100,000/μL, Hgb \< 8.5 g/dL, Neutrophils \< 1.5 /μL, Absolute WBC count \< 3500/μL, Absolute lymphocyte count \< 800/μL
Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry

SAGE is an observational post market registry with the objective of characterizing long term outcomes after treatment of uterine fibroids with the Sonata System in real world clinical practice settings.

Patients whom have selected the CE-marked Sonata system for treatment of fibroids will be approached for study participation. Participation in the trial will consist of data collection in the form of questionnaires prior to and after the treatment at the following intervals: pre-procedure, 4 weeks, 1, 2, 3, 4 and 5 years following treatment.

The following data points will be collected: Length of stay, time to return to normal activities (Treatment Recovery Questionnaire), time to return to sexual activity (Treatment Recovery Questionnaire), change in fibroid symptom severity and quality of life (UFS-QOL), change in general health outcome (EQ-5D), work productivity and activity impairment (WPAI), subject satisfaction and overall treatment effect (Overall Treatment Effect and Satisfaction Questionnaire), pregnancy occurrence and outcome, non-medical re-intervention, adverse events related to the device/procedure.

Validated questionnaires are used where appropriate (UFS-QOL, E1-5D and WPAI). Double data entry will occur to ensure accurate capture of subject reported data. Monitoring will occur throughout the course of the trial to ensure adherence to the protocol.

As an observational trial, there are no pre-specified statistically powered endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Have selected Sonata for treatment of symptomatic uterine fibroids or is participating in the OPEN study (Evaluation of Uterine Patency Following Sonography-guided Transcervical Ablation of Fibroids, NCT02844920, protocol # CL04897) or has completed participation in the OPEN study within the last 14 months
* Speaks and reads a language for which questionnaires are available
* Are greater than or equal to 18 years of age at the time of enrollment
* Willing and able to read, understand and sign the informed consent form, to participate in the registry and to adhere to all registry study follow-up requirements

Exclusion Criteria:

* Any reason for which, in the opinion of the Investigator, the individual study patient is not appropriate or suitable for participation in the registry
Patient Empowerment for Major Surgery Preparation @ Home

Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program (based on physical activity, nutritional support and mental preparation) for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery

Prehabilitation programs essentially based on physical activity improvement may reduce postoperative complications after major surgery. We hypothesize that a multimodal program based on physical activity, nutritional support and mental preparation may not only improve postoperative recovery and reduce costs but also improve health status beyond postoperative period.

Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery.

Other outcomes will be measured : length of hospital stay, hospital readmissions, direct costs, health status at 1 and 6 months.

Moreover, the feasibility and adherence of Paprika program will be evaluated. Inter-data centres relating to the implementation of the same prehabilitation program will be compared with the consortium Paprika (Hospital Clinic of Barcelona, University of Cologne, University of Gdansk)

Eligibility Criteria:
Inclusion Criteria:

* Patient eligible to elective major surgery (digestive, orthopedic, vascular-thoracic, urologic)
* Age \> 70 years and/or American Society of Anesthesiologists (ASA) score 3-4
* or Unfit patient according to appropriate scores (Two among 3 scores (HAD, Physical activity score, nutritional score) below threshold). Unfit patients will be defined by at least 2 criteria if 'YES' answers: Physical activity: Less than 50% of WHO recommendations = less than 5000 steps/day or less than 75 min moderate activity/week or less than 12 min moderate activity/day Yes/No Malnutrition: BMI \< 20 kg/m2 if \< 70 years (or \<22 if \>70y) = undernutrition Yes/No or BMI\>25 kg/m2 (= overweight to obesity) or Loss of appetite? Mental evaluation HAD (Hospital Anxiety and Depression) \>8 for A or D score Yes/No
* Diagnosis:

Elective major surgery (digestive, orthopedic, vascular-thoracic, urologic)

- Regulatory aspects: Be legally able to give consent Patient affiliated to social security

Exclusion Criteria:

* Planned surgery (less than 4 weeks at inclusion)
* Urgent surgery
* Patient with, at baseline, good to excellent physical, nutritional, mental status as defined by appropriate scores.
* Patient considered not eligible to this program for physical or psychological reasons by the surgeon or the anesthetist
* Persons referred in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).
A Study of Simbrinza™ Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study is a retrospective chart review to assess the tolerability and efficacy of treatment with Simbrinza™ used for patients with Open-Angle Glaucoma or Ocular Hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Participants treated with Simbrinza™ for Intra-Ocular Pressure (IOP) lowering in at least one eye
* Participants who had at least one-follow-up visit with tolerablity and efficacy data after Simbrinza™ treatment initiation.

Exclusion criteria:

* Active ocular disease other than glaucoma or ocular hypertension
* History of any intraocular surgery or glaucoma laser surgery within 3 months.
Effect of Oral Supplementation With a Fibre Enriched Paediatric Sip Feed For Children With Acute Lymphocytic Leukemia

This is a randomised, controlled, open-label intervention study. It is hypothesized that supplementation with a fibre enriched sip feed will improve the nutritional status, gut microbiota and quality of life (QOL) of children with acute lymphoblastic leukemia, and may enhance their immune response. This could give them a better chance to finish their induction chemotherapy successfully with fewer side effects.

Study objectives:

Primary objective:

To evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed on the nutritional status of Egyptian children with acute lymphocytic leukemia (ALL) compared to standard dietary counseling.

Secondary objective:

To evaluate the effect of oral supplementation with a fibre supplemented paediatric sip feed on the gut microbiota and quality of life (QoL) of Egyptian children with ALL compared to standard dietary counseling.

Eligibility Criteria:
Inclusion Criteria:• Newly diagnosed male and female paediatric ALL patients presenting in the study period.

* Age should be above 2 years and children should be pre-pubertal.
* Hospitalized for the entire (6 week) intervention period.
* About to receive? induction chemotherapy.
* Able to tolerate oral feeding.
* Written informed consent from parents/guardian (and child, if applicable to local law).

Exclusion Criteria:

* ALL patients \< 2 years and those who show signs of puberty.
* ALL patients who cannot tolerate oral feeding and/or are on parenteral nutrition.
* ALL patients with a known history of cow's milk allergy/intolerance or galactosemia.
* ALL patients requiring a fibre-free diet.
* Investigator's uncertainty about the willingness or ability of the child/carer to comply with the protocol requirements.
* Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Lateral Prostate Capsule Sparing Versus Nerve Sparing Robot-assisted Radical Cystectomy-orthotopic Ileal Neobladder for Bladder Cancer in the Male

To compare the perioperative, functional, and oncologic outcomes between nerve sparing and lateral prostate capsule sparing robot-assisted radical cystectomy with orthotopic ileal neobladder in male patients with bladder cancer.

This study will enroll male patients with bladder cancer who will undergo robot-assisted radical cystectomy with orthotopic ileal neobladder. The patients will be distributed into two comparable groups according to surgical procedures: nerve sparing group and lateral prostate capsule sparing group. Patient demographics and pathologic, perioperative, functional, and oncologic outcomes will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Male patients aged 18 or older.
2. Patients those who are diagnosed with urothelial carcinoma.
3. Patients those who are without tumour in the bladder neck or urethra, and prostate cancer was ruled out by MRI and serum T-PSA\<2.5ng/ml.
4. Patients those who are capable of receiving radical cystectomy with orthotopic ileal neobladder.
5. Patients those who are able to cooperate and complete the follow-up.
6. Patients those who volunteer to participate in this study and sign the informed consens.

Exclusion Criteria:

1. Patients thsoe who are diagnosed distant metastasis before surgery.
2. Patients those who are diagnosed with other malignancies.
3. Patients those who had received pelvic radiotherapy or major pelvic operation.