cyrilzakka/clinical-trials huggingface dataset:
Temocillin Versus a Carbapenem as Initial Intravenous Treatment for ESBL Related Urinary Tract Infections

TEMO-CARB is a phase 3, randomized, controlled, multicentre, open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection (UTI) due to extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae.

Urinary tract infections are among the most common bacterial infections that are treated in the community by an empirical antibiotic treatment regimen. Enterobacteriaceae are the most common bacteria involved in urinary tract infection. Since 2006, extended-spectrum beta-lactamase (ESBL) producing enterobacteriaceae have spread in France, as elsewhere. Finding therapeutic alternatives to carbapenems in infections caused by ESBL producing enterobacteriaceae is imperative. Although temocillin, 6-α-methoxy derivative of ticarcillin has been suggested as a potential alternative to carbapenem therapy for ESBL related infections, it was not investigated in accordance with current standard. The hypothesis to test in this study is that temocillin is not inferior to a carbapenem as initial intravenous treatment of urinary tract infections caused by ESBL producing enterobacteriaceae.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years)
* Hospitalized patient with clinically significant monomicrobial UTI
* Complicated UTI due to ESBL producing enterobacteriaceae (pyelonephritis, prostatitis or renal abscess) requiring parenteral antimicrobial therapy
* Susceptibility to temocillin and carbapenem as evidenced by testing results
* For woman able to procreate: negative pregnancy test and use of an effective method of contraception (abstinence, oral contraceptives, intra-uterine device, diaphragm with spermicide and condom). All forms of hormonal contraception are acceptable
* Signed informed consent by patient himself (able or under curatorship) or his legal representative (patient unable to give his consent or under tutorship)
* Patient affiliated to the social security system

Exclusion Criteria:

* Patient infected with a bacteria which is not an ESBL-producing enterobacteriaceae.
* Polymicrobial infection.
* Hypersensitivity and/or previous intolerance to carbapenem or temocillin, or penicillins or any other beta-lactam.
* Patient with a contraindication to any of the drugs to be used in research
* Patient presenting another site of infection than urinary (except onset of bacteraemia from urinary tract origin due to Gram negative bacteria).
* Woman who is pregnant, breastfeeding, or expecting to conceive at any time during the study (pregnancy test will be conducted for woman without menopause).
* Palliative care of life expectancy \< 90 days.
* Ongoing empirical treatment of the urinary tract infections with carbapenem or temocillin \> 24 hours before randomization
* Delay in randomization \> 48 hours after identification of ESBL producing enterobacteriaceae in urinary and/or blood culture.
* Participation in other clinical trial for the infection.
Reliability and Validity of the French Version of the Virtual Reality Sickness Questionnaire

This is a multicenter, controlled, non-randomized interventional clinical study, with minimal risks and constraints, aimed at verifying the reliability of the French version of the VRSQ questionnaire (VRSQ-F) and the validity of the VRSQ-F score by comparing it with the SSQ score.


Eligibility Criteria:
Inclusion Criteria:

For Healthy people :

* Men or women aged 18 to 65
* Person affiliated to a social security scheme
* Healthy person with no particular medical condition
* Having given their consent to participate in the research

For patients :

* Men or women aged 18 to 65
* Persons affiliated to a social security scheme
* People undergoing regular rehabilitation, walking or in a wheelchair, who can use a virtual reality solution as part of their care.
* Having given their consent to take part in the research

Exclusion Criteria:

* Vestibular and cardiac pathologies, and major visual disorders not compatible with virtual reality rehabilitation
* Cognitive and language disorders
* Persons under legal protection
* Pregnant women
* MSSQ greater than 15
* People suffering from photosensitive epilepsy
* Persons under the influence of medication that may impair drugs or alcohol
* Participant with an implanted medical device that may be affected by radio waves emitted by compatible third-party equipment (e.g. : Pacemaker)
Prevalence of Acute Injuries in Amateur and Elite Mountain Bikers

The investigators intented to assess the prevalence of acute injuries in amateur and elite mountain bikers.

In order to assess the prevalence of acute injuries in amateur and elite mountain bikers a questionnaire was created in accordance to existing literature. The questionnaire was translated in several languages by bilingual people familiar with mountain biking. The questionnaire focussed on demographic data, training volume, number of races per year, number of injuries since practising mountain biking, wearing of protective gear items and accident mechanism. The survey was conducted during the Swiss Epic Mountain Bike Event in 2017. All riders were asked to voluntarily participate in the survey.

Eligibility Criteria:
Inclusion Criteria:

* mountain bikers participating in the Swiss Epic Mountain Bike Event in 2017

Exclusion Criteria:

* non-participators, non-mountain bikers in the Swiss Epic Mountain Bike Event in 2017
Comparative Study Between Lumbar Foraminal Stenosis Treatment Modalities

The goal of this clinical trial is to compare the clinical and radiological outcome of two different interventional techniques in lumbar foraminal stenosis decompression. The main questions it aims to answer are:

Does minimally invasive techniques give better results than conventional techniques?

Participants will:

Undergo minimally invasive intervention using unilateral biportal endoscopy for lumbar foraminal stenosis decompression Undergo lumbar fusion for lumbar foraminal stenosis decompression Keep a diary of their symptoms and improvement of these symptoms

Lumbar foraminal stenosis decompression will be done using two different techniques:

1. Conventional Open Lumbar fusion By laminectomy and facetectomy and fixation with screws and rods ± interbody cage
2. Minimally invasive (Unilateral Biportal Endoscopy) Basic spine surgery instruments, 0° and 30° angled 4-mm diameter endoscopes commonly used in joint arthroscopic surgery, a radiofrequency catheter, Arthroscopic burr, and a shaver.

Surgical approach to the foraminal area Two portals are created to perform this surgery. Water is infused through the endoscope through the viewing portal, and the working portal had an additional purpose as a portal for water outflow. The proximal and distal portals are created 2 cm lateral from the pedicle level on the C-arm anteroposterior image. Each incision for the portals is 0.8 cm in length, which is adequate for instrument and endoscope insertion. For the left side foramen, the proximal and distal portals are used as the viewing and working portals, respectively, and vice versa for the right foramen. After the endoscope insertion through the viewing portal, we secure a space for the lower transverse process around the lateral surface of the facet joint. A radiofrequency catheter or a shaver is used to secure the space, and a radiofrequency catheter is used to control active bleeding.

Decompression of foraminal stenosis After a sufficient working space is obtained, the cranial 50% of the superior articular process of the thickened facet joint is removed using an arthroscopic burr or an osteotome. After removing the superior articular process, the ligamentum flavum around the foramen is removed using a curette and a Kerrison punch. After completion of flavectomy, nerve root and epidural fat are identified. If herniated disc material is found preoperatively, additional discectomy is performed usually from the axilla of the root. Surgery is confirmed to be completed after achieving an amount of free space concordant with the diameter of the nerve root in the foraminal zone, and then a drain tube is inserted.

Eligibility Criteria:
Inclusion Criteria:

* All Patients with degenerative lumbar foraminal stenosis, diagnosed in outpatient clinic.
* Patients (age \>18 )

Exclusion Criteria:

* Deformity.
* Infection of vertebrae.
* Tumor of vertebrae.
* Instability.
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis

This is a randomized control trial aimed to decreased radiation-induced vaginal stenosis in patients with endometrial or cervical cancer treated with post-operative external beam radiation therapy with or without brachytherapy. The intervention is an enhanced vaginal dilator model, including a silicone band placed at the desired depth of dilator insertion. The new model will be compared against the traditional vaginal dilator model used as our institutional standard of care. We hypothesize the enhanced model will improve adherence, correct use and efficacy of vaginal dilator use.

Pelvic radiotherapy and vaginal brachytherapy play an integral role in managing gynecological malignancies, including endometrial and cervical cancer. Radiation-induced vaginal stenosis is a well recognized complication of radiation therapy and can result in painful, inadequate pelvic exams and sexual dysfunction. Current recommendations to prevent and manage vaginal stenosis include regular use of vaginal dilators, with our institutional recommendation being three times weekly for 10 minutes. Compliance varies among studies but is generally perceived to be low. Limited literature exists regarding ways to improve adherence and correct use of vaginal dilators. The goal of this study is to enhance the standard vaginal dilator model to improve patient outcomes. Eligibility includes women with endometrial or cervical cancer treated with post-operative external beam radiation therapy with or without brachytherapy. Patients will be randomized to either the standard vaginal dilator or an enhanced model. The enhanced dilator model includes the addition of a silicone band placed at the desired depth of vaginal dilator insertion, aimed to aide in correct insertion length. The primary aim of the study is patient adherence to vaginal dilator use. Secondary aims include vaginal length, CTCAE v5.0 grading scale for vaginal stricture, sexual function, self-reported comfort with use, and discomfort during office pelvic exams. Outcomes will be obtained based on physician reporting and patient surveys. All analyses will be completed by a biostatistician in the Clinical Research Office using SAS version 9.4.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of endometrial or cervical cancer
* Undergoing external beam radiation therapy with or without brachytherapy
* English-speaking

Exclusion Criteria:

* History or current presence of fistula
Coronary Sinus Reducer Objective Impact on Symptoms, MRI Ischaemia and Microvascular Resistance

ORBITA-COSMIC is a randomised, double-blinded, placebo controlled trial of the coronary sinus reducer (CSR). The investigators will compare the effects of CSR versus placebo on myocardial perfusion on MRI, exercise time and symptoms in 50 participants with refractory angina and ischaemia.


Eligibility Criteria:
Inclusion Criteria:

* Stable coronary artery disease (CAD) not eligible for percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG)
* Evidence of ischaemia on stress perfusion CMR
* Angina - Canadian Cardiovascular Society Class II-VI on maximal medical therapy

Exclusion Criteria:

* Age\<18 years
* Pregnancy
* Inability to consent
* Recent acute coronary syndrome (3 months)
* Recent revascularisation (6 months)
* Permanent pacemaker or defibrillator leads in the right heart
* Severe left ventricular impairment (\<25%)
* Indication for cardiac resynchronisation therapy (CRT)
* Right atrial pressure ≥15mmHg
* Life expectancy \<1 year
* Severe renal impairment (eGFR\<15)
* Contraindication to CMR
* Contraindication to adenosine
* Ischaemia isolated to inferior wall
* Ongoing participation in a separate interventional study
Supine Daoyin in the Treatment of AECOPD

The purpose of this study was to evaluate the clinical efficacy and safety of supine daoyin in the treatment of AECOPD.

Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease with high incidence rate, high mortality rate and high disability rate. Among the people over 40, the prevalence rate is 10.1%, while the prevalence rate in China is 13.7%. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a major event that affects the natural course of COPD. In particular, most patients with AECOPD have poor prognosis, higher morbidity and mortality, and lower quality of life. Pulmonary rehabilitation can improve the clinical symptoms of AECOPD patients, increase exercise tolerance, delay the decline of lung function, and improve the quality of life. In recent years, the clinical research on the rehabilitation of patients with AECOPD is still in the exploratory stage, which needs to be supported by clear evidence.

This is a multicenter, randomized controlled trial to evaluate the clinical efficacy and safety of supine daoyin in the treatment of AECOPD. After admission, the patients were randomly divided into two groups, rehabilitation group and control group, 114 cases in each group. After routine treatment, the patients began to recover when they reached the initial rehabilitation standard, and recovered until they reached the discharge standard. The primary outcomes are the length of hospital stay due to acute exacerbation and clinical symptom score. The secondary outcomes include activities of daily living, dyspnea score, 6-minute walking distance, lower limb muscle strength, mechanical ventilation and quality of life. Safety will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. A confirmed diagnosis of AECOPD.
2. Age between 40 and 80 years.
3. mMRC score ≥ 3.
4. Barthel index\<50.
5. With the informed consent signed.

Exclusion Criteria:

1. Patients with severe cognitive impairment, dementia and various psychosis.
2. Combined with severe arthritis and other osteoarthritis affecting the movement.
3. Dyskinesia due to neuromuscular diseases.
4. Long term bedridden for various reasons.
5. Participating in other trials.
The Dose Finding Study of DAOIB Added to tDCS for AD

This is a 26-week randomized, double-blind, placebo-controlled trial. We will enroll patients with aMCI or mild AD. All patients will receive 2 weeks of tDCS (5 sessions per week, 10 sessions in total) during the first 2 weeks of the study, and will also be allocated randomly to either of 4 treatment groups for 24 weeks: (1) Dose A group; (2) Dose B group; (3) Dose C group; (4) placebo group. We will assess the patients every 8 weeks during the treatment period (weeks 0, 10, 18, and 26). We hypothesize that augmentation with certain dose of DAOIB will yield better effect than tDCS alone in improving the cognitive function, global functioning and quality of life in patients with aMCI or mild AD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Alzheimer's disease or mild cognitive impairment
* MMSE between 10-26
* CDR 1 or 0.5

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major depressive disorder
* Major physical illnesses
* Severe visual or hearing impairment
Scouting Nutrition and Activity Program

The purpose of the study was to evaluate the effectiveness of an intervention designed to prevent obesity by improving the environmental characteristics of Girl Scouts troop meetings.

Girls and parents affiliated with Girl Scouts Juniors programs completed a questionnaire prior to the beginning of an intervention program, and again after the program. Children responded to previously validated questionnaire items assessing demographics, parent-child connectedness, parent-child physical activity, screen time usage, family meal-time environment, consumption of fruits and vegetables, soda, and fast food. Parents completed a similar questionnaire, assessing demographics, parent-child connectedness, parent-child physical activity, family mealtime environment, parenting style and parenting practices. Children were also assessed on height and weight to characterize their risk for overweight status. Questionnaires and environmental observations were used to assess the effectiveness of an intervention designed to improve the family meal-time environment at home, as well as helping to assess the relationships between parental factors and family health-related behavior.

Eligibility Criteria:
Inclusion Criteria:

* Girls had to be attending members of Girl Scouts in one of our included troops.
* The troop needed to be a registered Girl Scouts Juniors troop, consisting of girls primarily in the 4th and 5th grades.
* To be officially registered, the troop leaders were required to complete Girl Scout leader training and pass a criminal background check.
* To be included, the troops also needed to meet at least twice per month, have meeting facilities capable of allowing physical activity and food preparation.
* Also, troops needed to have initial agreement of leaders and parents for the troop to participate in a research study.

Exclusion Criteria:

* An inability to speak or read English.
* Troops not primarily composed of Girl Scouts Juniors, not regularly meeting during the study period, or not having leader and parental consensus approval for troop participation.
Clinical Trial for a Outpatient Clinical Management of Urgent Laparoscopic Appendectomy

The aim of this study is to evaluate the safety and efficacy of outpatient management of uncomplicated acute appendicitis. For this purpose, a randomized clinical trial was designed. Selected patients who have undergone surgery for acute appendicitis are randomized into two groups. One group with hospitalization and another group without admission.

The aim of this study is to evaluate the efficacy and safety of outpatient management of laparoscopic appendicectomy in uncomplicated acute appendicitis.

This was a single center randomized controlled clinical trial consisting in 2 treatment groups. Patients were recruited in University Hospital of Tarragona Joan XXIII of Spain.

All patients admitted in the emergency department at University Hospital of Tarragona Joan XXIII with acute appendicitis diagnosis were likely to enter in the study. All patients who accomplished at least 4 over 5 of the Saint-Antoine criteria were included. The 5 criteria were: Leukocytosis lower than 15.000; C-Reactive protein lower than 30mg; Body mass index lower than 30kg/m2; appendicular diameter lower than 10mm and no radiological sign of complication.

All patients who met the inclusion criteria and none of the exclusion criteria were admitted to the study for emergency surgery.

In order to avoid the biases a unique anesthetic and surgical protocol were established for both groups.

Once Laparoscopic appendicectomy was performed the patients were randomly assigned to the hospitalization group or outpatient group.

Patients in the hospitalization group were admitted in the hospitalization ward. Patients in the outpatient group were referred to the day-surgery unit where they were discharged according to ALDRETE criteria.

The primary endpoint was the length of hospital stay (LHS). The length of hospital stay was calculated from the day and hour of admission in the surgical area to the day and hour of discharge, based on the hours of hospital stay. Secondary endpoints included the failures of the outpatient management, readmissions and the hospitals cost.

Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* meet at least 4 over 5 Saint Antoine criteria
* ASA classification (American Society of Anesthesiologists) less than or equal to 3
* patients who live accompanied in a home at a maximum distance of 30 minutes from the hospital and an adequate cognitive capacity.

Exclusion Criteria:

* pregnancy or breastfeeding
* complicated Acute Appendicitis
* surgical management performed in more 90 minutes.
Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients

Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.


Eligibility Criteria:
Age Limits: and Adults

Inclusion Criteria:

1. Male or female patients, at least 1 month of age.
2. Patients who require PN for at least 5 days/week.
3. Patients who receive 80% or more of their total energy requirements as PN at enrollment and who are expected to receive 80% or more of their total energy requirements as PN for at least 56 days.
4. Written informed consent. In case of pediatric patients, informed consent must be obtained from parent(s) or legal representatives. If possible, the assent of the pediatric patient must also be obtained (according to local law).

Exclusion Criteria:

1. Use of any other lipid injectable emulsion than SMOFlipid within 6 months prior to study participation
2. Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of SMOFlipid.
3. Hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration \>250 mg/dL in infants or \>400 mg/dL in older pediatric and adult patients).
4. Inborn errors of amino acid metabolism.
5. Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support).
6. Hemophagocytic syndrome.
7. Liver enzymes (either AST, or ALT, or GGT) exceeding 2 x upper limit of normal range
8. Direct bilirubin exceeding 2 x upper limit of normal range
9. INR exceeding 2 x upper limit of normal range and patient not receiving oral anticoagulants.
10. Any known hepatic condition outside of IFALD that will increase direct bilirubin ≥2.0 mg/dL.
11. Clinically significant abnormal levels of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate).
12. Active bloodstream infection demonstrated by positive blood culture at screening.
13. Severe renal failure (eGFR \<15 ml/min per 1.73 m2) including patients on renal replacement therapy.
14. Abnormal blood pH, oxygen saturation, or carbon dioxide.
15. Pregnancy or lactation.
16. Participation in another interventional clinical study.
17. Unlikely to survive longer than 56 days.
Effects of Hydrolyzed Collagen and Vitamin C on Explosive Performance

Determine whether supplementation with a combined dose of 20 g of hydrolyzed collagen and 50 mg vitamin C, along with a power training exercise program, increases rate of force development (RFD) and performance in athletes


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male athletes between 18-30 years of age
2. Currently participating in sport
3. \<3 musculoskeletal injuries in the past year
4. No health or dietary restriction that would be affected by the supplementation protocol

Exclusion Criteria:

1. History of more than 3 musculoskeletal injuries within the past 12 months
2. Health, dietary restriction or diet that would be affected by the supplementation protocol
3. Willing to eat similar dietary pattern the day before baseline testing and each exercise testing/intervention day