cyrilzakka/clinical-trials huggingface dataset:
Enhanced Recovery in Laparoscopic Cholecystectomy

The study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis.

Laparoscopic cholecystectomy (LC) is the most common surgical procedures in the world. Elective LC is commonly performed as one-day surgery, while in an emergency setting of acute cholecystitis the in-hospital stay averages 4.5 days. Causes of prolonged rehabilitation period are often associated with severe pain syndrome, dyspepsia and postoperative complications. The complications rate after LC is about 6% and has no tendency to decrease. The implementation of enhanced recovery after surgery (ERAS) programs may potentially reduce stress-associated complications and improve the quality of rehabilitation. A few retrospective studies examined their advantages and setbacks in the treatment of acute cholecystitis with encouraging results. The aim of this randomized control study is to evaluate the modified ERAS program for patients with acute cholecystitis.

Eligibility Criteria:
Inclusion Criteria:

* Grade I and II acute cholecystitis according to Tokyo Guidelines 2013 classification (TG13)
* ASA I and II.

Exclusion Criteria:

* Severe acute cholecystitis (Grade III on TG13);
* Patient's refusal to participate;
* The language barrier;
* Transfer to the intensive care unit after surgery;
* ASA class ≥ III;
* Conversion to open procedure;
* Biliary hypertension detected during preoperative examination or intraoperatively.
A Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets

Phase I, randomised, open label, 3-period crossover study in healthy male subjects to investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the safety and tolerability of AZD8931.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria:

* Use of any prescribed or non-prescribed medication (including analgesics, herbal remedies, vitamins and minerals) during the two weeks prior to the first administration of investigational product
* Administration of another investigational medicinal product in the 3 months before the start of dosing in this study
* Definite or suspected clinically relevant personal history of adverse drug reactions, or drug hypersensitivity
Resveratrol and Serum Apo A-I

Although much effort has been done to lower LDL-cholesterol concentrations, there is still a substantial risk for cardiovascular disease (CVD). Another strategy to lower the risk for CVD is elevating the HDL-cholesterol (HDL-C). Both in vitro and in vivo studies showed that elevating HDL-C or apolipoprotein A-I (Apo A-I) levels protect against CVD. However, despite many initiatives, no new widely applicable intervention strategies with proven efficacy have been developed.

Epidemiologic studies have shown that a higher polyphenol intake is associated with a lower risk for CVD. Resveratrol, a polyphenol, could, through several beneficial mechanisms, exert a positive effect on formation of atherosclerotic plaques and thus on developing CVD. It has been shown in animals that resveratrol elevates PPAR-alpha activity. This may lead to elevated apo A-I and HDL-C levels in the blood. However, these effects are not shown in human intervention studies.


Eligibility Criteria:
Inclusion Criteria:

* aged between 45 and 70 years
* HDL-C \<1.0 mmol/L (men)
* HDL-C \<1.3 mmol/L (women)
* serum total cholesterol \<8.0 mmol/L
* plasma glucose \<7.0 mmol/L
* BMI between 25 - 35 kg/m2
* non-smoking
* willingness to abstain from resveratrol rich products from two weeks prior to the study and the duration of the study:

  * grapes and grape juice
  * wine (red and white)
  * all berries
  * peanuts
  * peanut butter
  * soy (products)
  * pomegranate

Exclusion Criteria:

* unstable body weight (weight gain or loss \>3 kg in the past 3 months)
* indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus
* use of medication or a medically-prescribed diet known to affect serum lipid or glucose metabolism
* Active cardiovascular disease (for instance congestive heart failure) or recent (\<6 months) event, such as acute myocardial infarction or cerebro-vascular accident
* not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
* men: consumption of \>21 glasses of alcohol-containing drinks per week women: consumption of \>14 glasses of alcohol-containing drinks per week
* abuse of drugs
* pregnant or breastfeeding women
* participation in another biomedical study within 1 month prior to the screening visit
* having donated blood (as blood donor) within 1 month prior to the screening visit or planning to do so during the study
* impossible or difficult to puncture as evidenced during the screening visits
The Use of Transcranial Focused Ultrasound for the Treatment of Depression and Anxiety

The purpose of this open label study is to evaluate longer term tolerability and early efficacy of transcranial ultrasound in the treatment of patients with refractory depression and anxiety.

The present study is designed as an open label study of patients with refractory depression and anxiety to evaluate longer term tolerability and early efficacy of transcranial ultrasound treatment. Baseline and outcome measures in this study utilize validated tests that are appropriate for repeated measures which are not affected by practice effects. For patients with refractory depression, the target will be the subgenual cingulate (Brodmann's area 25) through a trans temporal scalp window. For patients with anxiety, the target will be the amygdala. Targeting will include reference to scalp fiducials based on the obtained MRI and Doppler waveform confirmation will be obtained because of the ability of TCD to record Doppler signal from the posterior cerebral artery that runs medial to the mesial temporal lobe.

On the day of the ultrasound appointment, patients will undergo ten to thirty minutes of transcranial ultrasound treatment. The sonification device will be aimed at the subgenual cingulate or amygdala, depending on the predetermined condition. Targeting will include reference to scalp fiducials based on the obtained MRI; confirmation of target accuracy will either be obtained by Doppler waveform confirmation or optical tracking technology which co-registers patient neuroimaging with real space. Patients will undergo 8 total sessions of focused ultrasound. Patients will be evaluated at baseline and upon final ultrasound treatment using the same measures obtained upon entry. Safety and any adverse events will be monitored closely.

Eligibility Criteria:
Inclusion Criteria for Depression:

* Diagnosis of Major Depressive Disorder
* Score greater than 13 on the Beck Depression Inventory
* Failure to remit with 3 antidepressants
* At least 18 years of age

Inclusion Criteria for Anxiety:

* Diagnosis of Generalized or Acute Anxiety Disorder
* Score greater than 15 on the Beck Anxiety Inventory
* Failure to remit with 3 anxiolytics
* At least 18 years of age

Exclusion Criteria for Depression \& Anxiety:

* Cognitive decline clearly related to an acute illness
* Subjects unable to give informed consent
* Subjects who would not be able to lay down without excessive movement in a calm environment sufficiently long enough to be able to achieve sleep
* Recent surgery or dental work within 3 months of the scheduled procedure.
* Pregnancy, women who may become pregnant or are breastfeeding
* Advanced terminal illness
* Any active cancer or chemotherapy
* Any other neoplastic illness or illness characterized by neovascularity
* Macular degeneration
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
* Advanced kidney, pulmonary, cardiac or liver failure
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.

The project will improve scientific knowledge regarding a recent law applying potentially to every french driver. It will give for the first time an indication on the impact of alerting treatments on driving risks. It will reinforce the links between different research environments (sleep physiopathology, clinical research, cognitive neurosciences, drivers supervision, virtual reality, pharmacology) among the "Réseau Eveil Sommeil Attention et Transports" (RESAT) network.

Excessive daytime sleepiness is responsible of 20% of traffic accidents and 2/3 of truck accidents on French Freeways. Since the publication of a new law (2005 december 28th - Official Journal) regulating fitness to drive, the Maintenance of Wakefulness Test (MWT) is now mandatory to evaluate driving skills of patients suffering of excessive daytime sleepiness. The MWT has shown a good predictability of driving handicap on simulators in patients suffering from obstructive sleep apnea syndrome. Nevertheless no study has proven yet the predictability of the MWT regarding real and simulated driving in patients suffering from hepatic encephalopathy. Furthermore, even if therapeutic drugs significantly improve MWT scores there is no data available concerning the impact of these drugs on fitness to drive. Lactulose, a treatment of hepatic encephalopathy, has not been tested as a counter measure to driving impairment. This lack of knowledge is a major handicap to evaluate driving skills of treated patients suffering from excessive daytime sleepiness. The main objective of our project is to test the predictive value of the MWT on real and simulated driving performances in untreated and treated sleepy patients suffering from hepatic encephalopathy.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis proved by histologic or clinico-biologics criteria, whatever its severity, its stability defined by a child stable score (variation \< 2 points for the last month) without any other disease which could be responsible of excessive daytime sleepiness
* driver's licence since at least 2 years
* driving more than 2000 Km/year
* registered to French national health and pensions organization
* having given their written light agreement in order to participate in the study.

Exclusion Criteria:

* Night workers
* neurologic disease
* recent strong complication (\< 30 days)
* recent antibiotics or lactulose intake
* substance abusers (alcohol)
* hepatoma more than 5 cm
* disorder associated which engaged life prognostic in a short time
* glycemia fasted \> 8 mmol/l
* haemoglobin \< 10g/l
* neurologic or psychiatric disorders associated which affect superiors functions,
* hepatic encephalopathy stage 3 or 4
* having participated in a clinical study during the last 6 months
* drugs abusers
* unable to drive.
Fluid Responsiveness Prediction Using Extra Systoles

Fluids are generally administered to patients in order to improve circulation. However, fluids do not always improve circulation and fluids have side effects. Unfortunately, it is difficult to predict whether fluid administration improves the circulation, i.e. it is difficult to predict fluid responsiveness The overall aim of this observational study is to investigate if analysis of spontaneously occuring extra systoles can give the answer: The second beat in the extra systole - the post ectopic beat - is a normal sinus beat but it has experienced the compensatory pause, i.e. this beat is associated with increased filling time and in turn associated with increased filling. As such, the post ectopic beat shows how the heart responds to increased filling. Therefore, the hypothesis of this study is that the hemodynamic response to the increased filling at the post ectopic beat (compared with sinus beats) can predict fluid responsiveness


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for a 500 ml volume expansion
* Patients without atrial fibrillation
* Patients equipped with ECG, arterial pressure and non-invasive cardiac output monitoring

Exclusion Criteria:

* Changes in anesthetic, vasoactive or inotropic drugs during the study period (30 minutes before fluid infusion initiation to end of fluid infusion).
* Changes in positive end-expiratory pressure the study period
* Changes in bed positioning the study period
* Infusion time with crystalloids exceeding 30 minutes
* Infusion time with colloids exceeding 75 minutes
Magnetic Resonance Imaging Study on Young and Middle-aged Patients With Cervical Spondylotic Pain

Cervical and shoulder pain in young adults is commonly caused by intervertebral disc degeneration, bulge or herniation. Disc degeneration includes the synthetic and degradative imbalance of myxoid matrix, degeneration of annulus collagen, and decrease of water content in nucleus pulposus. A few patients with cervical degeneration had moderate to severe pain, but there are no obvious abnormalities in the shape and signal of the disc with routine MRI, which may be related to the early discal degeneration. In most cases, the pain could be relieved by non-surgical treatment due to mild decreased proteoglycan and slight abnormality of water diffusion, but these changes cannot be clearly demonstrated by routine MRI. Therefore, it is necessary to rely on sensitive MRI techniques to reflect the abnormal microstructure in the nucleus pulposus and annulus fibrosus, so as to assist the early detection of the main reason in patients with neck and shoulder pain and the evaluation of the efficacy of treatment.

This is an observational, longitudinal, and single-center study. Confirmed patients with cervical and shoulder pain will complete several clinical and imaging programs before and after 3 and 12 months of non-surgical treatment for exploring the main reason of the symptom and the imaging predictors of treatment effect in the disease. The collected materials are listed below: (1) 3 times cervical MRI scans, including T2-mapping, T1ρ and DKI sequences, (2) visual analog scale (for pain assessment) and disease duration. Then the T2 value, T1ρ, and DKI derived parameters will be measured in the nucleus pulposus and annulus fibrosus.

Eligibility Criteria:
Inclusion Criteria:

1. Neck and shoulder pain, with or without upper limb pain and numbness;
2. Disease duration longer than 2 months
3. Visual analogue score (VAS) ≥ 3
4. Cervical MRI showing cervical disc degeneration, bulge, protrusion, etc.
5. Patients will undergo non-surgical treatment (maxillary occipital traction, massage, etc.)

Exclusion Criteria:

1. Severe trauma and surgery in neck and shoulder region.
2. X-ray or CT showing the severe cervical spine hyperplasia, infection (suppurative, tuberculous), neoplasm (various primary and secondary tumors), rheumatic (rheumatoid arthritis, ankylosing spondylitis), and nuclei pulposus calcification.
3. Cervical MRI revealed organic lesions such as inflammation of the spinal cord, tumors, syringomyelia, etc.
4. Chronic pain in other regions.
Science Engagement to Empower Disadvantaged adoleScents (SEEDS Project)

SEEDS is a multicenter 24-month citizen science (CS) cluster randomized controlled study, with interventions conducted in four European countries acting as pilot sites: 1) Greece, 2) The Netherlands, 3) Spain and 4) The United Kingdom. This project will merge CS and traditional approaches and will target high schools located in deprived neighborhoods.

The methodology, that combines CS and traditional science, could build effective cooperation between science and society to empower adolescents from low-income environments to adopt healthy lifestyles to prevent obesity, increase their interest in science and improve their critical thinking.

SEEDS is a multicenter 24-month citizen science (CS) cluster randomized controlled study, with interventions conducted in four European countries acting as pilot sites: 1) Greece, 2) The Netherlands, 3) Spain and 4) The United Kingdom. This project will merge CS and traditional approaches and will target high schools located in deprived neighborhoods.

The methodology, that combines CS and traditional science, could build effective cooperation between science and society to empower adolescents from low-income environments to adopt healthy lifestyles to prevent obesity, increase their interest in science and improve their critical thinking.

The aim is to engage teenagers on this citizen science project to collaborate in all phases of the study: problem definition, data collection, analyses and dissemination. This will empower them to change habits, thereby contributing to behavioural changes. This cluster-randomized control trial involves intervention and control high-schools from deprived areas in the Netherlands, England, Greece and Spain. Teenagers with leadership skills from intervention schools (called ambassadors) and stakeholders will participate in focus groups to gain insights on the barriers and facilitators for healthy lifestyles of teenagers, and how science could help address these. Building on the information of the focus groups, ambassadors, stakeholders and other peers will participate in a collaborative competition event where the SEEDS intervention(s) will be designed. The intervention(s) will be implemented at intervention high-schools. Outcomes in health behaviours and science literacy will be assessed by validated questionnaires at the start and end of the project.

Eligibility Criteria:
Inclusion Criteria per high schools:

* High schools located in deprived areas. Deprived areas will be selected according to what is considered an area with a low socioeconomic level according to each country.
* Informed consent must be signed by the responsible of each high-school.

Exclusion Criteria per high schools:

* The non-completion of one of the inclusion criteria.

Inclusion Criteria per participants:

* Adolescents aged 13- to 15-years at baseline who attended one of the participating high schools, previously randomized.
* Informed consent must be signed by their parents/legal guardians and by each adolescent.

Exclusion Criteria per participants:

* The non-completion of one of the inclusion criteria.
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Participants With Thyroid Eye Disease

The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of subcutaneous (SC) satralizumab, a recombinant, humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody, in participants with thyroid eye disease (TED).


Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of TED based on CAS

Exclusion Criteria:

* Decrease in CAS or proptosis of \>= 2 points or \>= 2 mm, respectively, in the study eye between Screening and Study Baseline (Day 1)
* Requiring immediate surgical ophthalmological intervention or planning corrective surgery or irradiation during the course of the study, in the judgment of the investigator
* Identified pre-existing ophthalmic disease that, in the judgment of the investigator, would preclude study participation or complicate interpretation of study results, including corneal decompensation unresponsive to medical management and including ophthalmic diseases that will likely require prohibited therapy during the study
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of satralizumab
Acute Effects of Two Different Trainings on Balance and Performance in Young Footballers

The aim of this study is to investigate the acute effect of two different training on the balance and performance of healthy young football players. Cognitive-Based Neuromuscular Education (CBNE) will be applied to one group and Game Based Education (GBE) will be applied to the other group. In addition to study groups, there will also be a control group. Individuals will be randomly placed in groups. Sociodemographic data will be recorded at the beginning for all athletes. Then the first measurements of dynamic balance and performance will be taken. Star Balance Excursion Test will be used to assess the dynamic balance. Measurements shall be taken in 8 directions including anterior (A), anterolateral (AL), lateral (L), posterolateral (PL), posterior (P), posteromedial (PM), medial (M) and anteromedial (AM) for the right and left sides. Performance will be evaluated by Speed Dribbling test. After the first measurements, two study groups will be trained. The control group will spend this time relaxing. After the trainings, the final measurements will be taken.

Purposes The primary purpose; The aim of this study was to investigate the acute effect of CBNE and GBE on dynamic balance and performance in healthy young football players.

Secondary objectives; The aim of this study is to investigate the relationship between dynamic balance and performance in healthy young football players.

hypotheses H0: In healthy young soccer players, CBNE and / or GBE has no acute effect on balance.

H0: In healthy young soccer players, CBNE and / or GBE has no acute effect on performance.

H1: CBNE and / or GBE have an acute effect on balance in healthy young football players.

H2: CBNE and / or GBE have an acute effect on performance in healthy young football players.


Eligibility Criteria:
Inclusion Criteria:

* To be playing active football for at least three years
* Males

Exclusion Criteria:

* Those with orthopedic, neurological or congenital problems
* Those who have experienced injuries that affect balance and performance in the last 6 months
* Individuals staying more than two weeks away from sport in the last three months