cyrilzakka/clinical-trials huggingface dataset:
Flow Controlled Ventilation in Thoracic Surgery

This trial investigates effects of individualized (by compliance guided pressure settings) flow-controlled ventilation compared to best clinical practice pressure-controlled ventilation in thoracic surgery requiring one lung ventilation.

Flow-controlled ventilation (FCV) is a novel ventilation method with promising first results in porcine studies as well as clinical cross-over trials. A more efficient and maybe lung protective ventilation strategy would be crucial in the challenging situation of one lung ventilation during thoracic surgery, when the whole gas exchange has to be provided by just one half of the lungs.

Thus, individualized FCV, based on compliance guided pressure settings, will be compared to standard of pressure-controlled ventilation in thoracic surgery requiring one lung ventilation in a randomized controlled trial. Based on previous preclinical trials an improvement of oxygenation by 15% will be expected and in order to transfer the preclinical results to humans oxygenation assessed by paO2 / FiO2 ratio after 30 minutes of one lung ventilation is the main primary outcome parameter of this study. Furthermore, improved recruitment of lung tissue due to controlled expiratory flow in FCV will be anticipated without the need of recruitment maneuvers, which may cause deleterious effects on lung tissue. Accordingly any recruitment maneuvers will be omitted in the FCV group.

The investigators hypothesize that improved gas exchange in terms of improved oxygenation and reduced respiratory minute volume required for CO2-removal will be achieved with FCV compared to PCV. Secondary outcome parameters such as the incidence of postoperative pulmonary complications will be additionally assessed in order to plan future studies with clinically relevant outcome.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects ≥ 18 years
* Body weight ≥ 40 kg
* Elective thoracic surgery requiring OLV
* ASA I-III
* Written informed consent

Exclusion Criteria:

* Emergency surgery
* Female subjects known to be pregnant
* Known participation in another interventional clinical trial
* high pulmonary risk (ppo FEV1\<20ml/kg in male or ppo FEV1\<18ml/kg in female)
* Empyema evacuation or signs of pulmonary infection
* High grade CMP (EF\<30%)
Drug-drug Interaction Study of SPH3127

A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent;
2. Chinese Male ≥18 and ≤45 years；
3. BMI≥18.5 and ≤26.0 kg/m2 and a weight ≥50.0 kg;
4. Normal or no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the vital signs, physical examination, clinical laboratory tests, and 12-lead ECG.
5. Subjects agreed to have no family planning during the study period and within 6 months after the last study drug administration, voluntarily take effective contraceptive measures and have no sperm donation plan. Non-drug contraceptive measures will be used voluntarily during the trial.
6. Subjects can communicate well with investigators, understand and comply with the requirements of this trial.

Exclusion Criteria:

1. Patients with diseases that need to be excluded, not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism, bone, and other systems;
2. History of allergic diseases;
3. History of dysphagia or any gastrointestinal illness that affects drug absorption;
4. Participated in clinical trials of other investigational drugs within 3 months prior to initial administration of the investigational drug;
5. People who drink excessive tea, coffee and/or caffeinated beverages every day within 3 months before screening;
6. Prescribed medications, over-the-counter medications, dietary supplements, or Chinese herbal medicines were taken within 14 days prior to initial administration of the study drug;
7. Unwilling to avoid vigorous exercise from 48 hours before the first administration of the study drug to the end of the study;
8. Used of any drug that inhibits or induces hepatic metabolism of the drug in the 28 days prior to taking the study drug.
9. Those who have special dietary requirements and cannot follow a uniform diet;
10. Assessed by the investigators as unsuitable for participating in the study.
The Effects of Observer Presence and Type on Patients' Perception of Exercise in Patients With Soft Tissue Sarcoma

The primary aim of the study is to investigate the effects of supervised exercise, telerehabilitation and home-based exercise on patient perception in patients with soft tissue sarcoma. The secondary aim of the study is to identify the barriers to starting exercise in these patients.

An exploratory-descriptive qualitative study will be conducted. There will be three groups in the study with each of them will consist of ten participants. Within the scope of the study, each group will perform a similar exercise program, 2 sessions a week, for 6 weeks, in one of the 3 groups below; Group 1: Exercising under the supervision of a face-to-face physiotherapist, Group 2: Exercise under the observation of the physiotherapist via video-conference (telerehabilitation), Group 3: Exercising in the absence of the observer (home based exercise program). The exercises to be applied to the groups will include breathing exercises, passive range of motion exercises and strengthening exercises. Semi-structured focus group interviews will be held with the participants twice, before and after the 6-week exercise program. In the semi-structured focus group interviews, the same questions will be asked to all participants and the verbal answers to these questions will be recorded with voice recorders. Compared to taking notes by hand; It will be preferable to record the conversation with a voice recorder because it has advantages such as recording all the interviews and allowing the interviewer to focus on the interview. In the pre-exercise interview, questions will be asked to determine the patient's views about exercises and the barriers to starting the exercise. In the interview held at the end of the exercise program, questions will be asked to learn the views/perceptions of the patients about the results of the exercise program. Thematic analysis method will be used in the evaluation of the data.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged between 18 and 65,
* Individuals without communication problems,
* Individuals who have been diagnosed with soft tissue sarcoma
* ECOG score ≤2

Exclusion Criteria:

* Uncontrollable arrhythmia and/or hypertension
* Presence of advanced sensory deficit
* Visual and hearing problems
* Not having sufficient communication skills (Mini Mental Test score below 24 points)
* ECOG score\>2
Assessing the Impact of the Early and Systematic Hormonal Replacement After Radio-isotopic Ablation of Graves'hyperthyroïdism on Quality of Life, Efficiency and Tolerance

The aim of our study is to compare in a randomized multicentric study the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation (experimental arm) compared to a conventional approach based on the initiation of LT4 as soon as the first biological signs of hypothyroidism. Two hundred patients with Graves' disease with no or minimal (eyelid retraction or oculopalpebral asynergy) and non inflammatory ophthalmopathy (clinical activity score to 0) will be included in this study. The administrated iodine-131 activity will be adjusted to the weight of the thyroid gland (20 MBq/g thyroid tissue). Patients will be evaluated at 6 weeks, 3 months, 6 months and 12 months post-ablation. The primary objective will assess differences in terms of quality of life at 3 months using a specific questionnaire (ThyPRO). Secondary objectives will compare quality of life outcomes at different study visits (using ThyPRO and SF36), fatigue (MFIS) and depression (Beck), autoimmune parameters (signs of ophthalmopathy, TSH receptor antibodies assessment), efficacy and medico-economic data.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting a hyperthyroïdie Basedowienne proving a treatment by iodine 131.

  * Patient without or with ophtalmopathie junior defined by a score of ophtalmopathie in 0 or in 1 and a score of clinical activity in 0 (see secondary).
  * Patient whose rate of fT4 and\\or of fT3 is lower than 1,5 times the superior limit of the standards of the laboratory during the balance sheet(assessment) which precedes the treatment by iodine 131 (15j.
  * Patient whose thyroïdien volume estimated by echography is lower than 60 mL.
  * Patient whose treatment by anti-thyroïdiens of synthesis was interrupted at least 5 days before the administration of iodine 131.
  * 18 years old male or feminine Patient or more.

Exclusion Criteria:

* Patient presenting a thyroïdien nodule suspect of wickedness.

  * Patient presenting disorders not thyroïdiens known to distort the fixation of I131 (congestive heart failure of class III or IV, renal insufficiency).
  * Patient having received by intravenous way a product of hydrosoluble contrast for radiography in 4 weeks preceding the randomization, or by way intra-thécale or for cholécystographie by a product of contrast iodized in three months preceding the randomization.
  * Patient taking medicines susceptible to disrupt the function thyroïdienne or renal (renal medicines, lithium, amiodarone, in particular).
  * Patient presenting a contraindication to Levothyroxine with high dose: décompensée heart disorder, coronaropathie, shady of the unchecked rhythm.
  * pregnant or breast-feeding Women, or patient being able to have children and refusing to follow a reliable contraceptive method during the duration of the study.
Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease

In this research study the investigators want to learn more about how well the investigators can visualize scar tissue in the heart by MRI. In patients with congenital heart disease who need a procedure in the electrophysiology laboratory, how the MRI findings match the findings in the electrophysiology laboratory is not known. This study works to answer these questions. Participants will undergo a cardiac MRI as part of the routine clinical care that was ordered by their doctors and additional imaging by cardiac MRI will be performed.

Atrial arrhythmias including intra-atrial reentrant tachycardia (IART) and atrial fibrillation (AF) routinely develop after surgical repair of congenital heart disease (CHD), contributing to heart failure exacerbation, increased hospital resource use, and reduced health-related quality of life. The combination of atriotomy scars, intra-cardiac suture lines, and chronic pressure or volume overload from residual lesions creates the necessary milieu of heterogeneous atrial fibrosis capable of supporting wavefront reentry. While catheter ablation has become a primary tool in the management of IART and AF, long-term ablation outcomes have stagnated over the preceding decade despite advances in mapping and ablative technologies. Left atrial (LA) fibrosis analysis using 3-dimensional (3D) late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMR) has shown utility in the management of adults with structurally normal hearts and atrial fibrillation (AF), having associations with endocardial bipolar voltage amplitude, likelihood of maintenance of sinus rhythm after ablation, and thromboembolic risk. Excellent reproducibility of LA fibrosis quantification has been demonstrated in adults with structurally normal hearts and AF. To date, the use of 3D LGE in CHD has been limited to the ventricles. Prior studies have described altered LA function in adolescent and young adult patients with rTOF. Additionally, right atrial (RA) functional abnormalities have also been described in patients with rTOF. No prior studies have attempted to validate this technology in the atrium of patients with congenital heart disease. Our studies aims to investigate the reproducibility of atrial fibrosis quantification by cardiac MRI and may provide insights to correlations with voltage mapping in the electrophysiology laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>13 years old with congenital heart disease referred for cardiac MRI and receiving gadolinium as part of routine clinical care or for pre-ablation planning will be included.

Exclusion Criteria:

* Those with self-reported anxiety or claustrophobia and/or the presence of a permanent pacemaker or implantable cardioverter defibrillator will be excluded.
Study Electromyographic Activity of the Muscles of the Pelvic Floor Runners With Conventional Shoes and Minimalist.

JUSTIFICATION:

Urinary incontinence is highly prevalent among women who play high impact sports such as running. that observed one of the possible reasons for this high prevalence is delayed activation of the pelvic floor in relation to the abdominal muscles.

The use of minimalist shoes during the race produces changes in muscle and joint biomechanics and efficiency in the race. However, to date no studies evaluating the influence of footwear in the musculature of the pelvic floor during the race.

OBJECTIVE: Describe and compare the electromyographic activity of the muscles of the pelvic floor and abdominal during the race with conventional shoes and minimalist.

DESIGN: cross-over study experimental, analytical and prospective. METHODOLOGY: conventional and minimalist: 50 healthy young women, 6- randomly distributed in two groups will be included to characterise the electromyographic activity of the pelvic floor muscles before and during running at 6-9-11 km/h with the two types of running shoes.

A baseline assessment will be performed to confirm that the women meet the inclusion and exclusion criteria. The ability to run a 10-minute treadmill at a speed of 6-9-11 km/h will be assessed, as well as the ability to adequately contract the pelvic floor muscles.

The group of 50 women will initially run randomly with conventional running shoes or with minimalist running shoes, and then, after a 10-minute washout period, will run with the other type of running shoe, i.e. if a participant in the first phase used conventional running shoes, she will run with a minimalist running shoe in the second phase.

The cadence of step, the range of movement of the femur and the EMG recording with electromyographic sensors of the pelvic floor musculature (using an intravaginal probe of the germproof brand), abdominal (internal and external oblique), spinal erectors and gluteus (using a surface sensor) in relation to the cycling gait will be collected and recorded with barographic sensors. The variables to be included in the electromyography for each muscle in relation to the gait cycle will be: onset of activation, duration, intensity and synergy with their corresponding standard deviation.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 38 years.
* Nulliparous.
* Clinically healthy at the time of the study.
* Physically able for the requirement of the race on tape.
* Body Mass Index (BMI) 20-25 kg / m2
* Having signed the informed consent.

Exclusion Criteria:

* Pregnant women.
* urogynecological dysfunction.
* Lower limb surgeries performed in the last six months.
* Not be able to make voluntary contractions of the pelvic floor standardized according to the Modified Oxford Scale
Informative of Surface Electromyography and Prognostic Factors in Assessing the Recovery of Balance and Gait After Stroke

The aim of the biomedical research is to determine the informativeness and prognostic factors of surface electromyography by assessing the probability of recovery of balance and gait parameters in the second stage of rehabilitation of persons with cerebral infarction.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral infarction for the first time;
* Age from 18 to 89 years old;
* Muscle strength according to the Oxford scale is 3-5 points;
* Able to walk without the help of others;
* Is able to communicate and understand instructions properly;
* Agrees to participate in the study (voluntary, explicit, informed written consent to participate).

Exclusion Criteria:

* Muscle strength according to the Oxford scale is 0-2 points;
* Unable to walk without the help of others;
* Sensorimotor aphasia or other perceptual disorders;
* Do not sign the informed consent.
National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies

Sudden unexpected death in epilepsy (SUDEP) is the main concern of professionals and patient associations involved in epilepsy. These represent a priority for the Ligue Française Contre l'Epilepsie (LFCE). The SUDEP affect primarily young adults, between 18 and 40 years, suffering from epilepsy uncontrolled by medication. In this population of close to 100,000 people in France, the incidence of SUDEP is estimated at 0.5%, or nearly 500 deaths per year. It is clear that the majority of these deaths occur in the immediate consequences of a crisis..

Investigators suppose that a causal link exists between the occurrence of a SUDEP and a per / post-critic decline of SpO2 below 80 % (75 % of cases, 20 % of controls).The constitution of a cohort of 1500 patients clinically well described and a national database will allow other ambitious projects in a speciality where French centres benefit from a unique knowledge, recognized by their foreign colleagues, but underexploited to date. The LFCE (Ligue Française Contre l'Epilepsie) is developing structuring actions to facilitate such exploratory studies for the next two years.

The high death rate which characterizes the drug-resistant partial epilepsies and, in particular, Sudden Unexpected Deaths in Epilepsy (SUDEP) represents the main axis of research for the Ligue Française Contre l'Epilepsie (LFCE) as well as for associations of epileptic patients and the European representatives of the international league against epilepsy ( ILAE). Today, SUDEP occurrences cannot be anticipated. Patients can't be warned against SUDEP.

Although the SUDEP physiopathology remains uncertain, many elements plead for the essential role of a per-and post-critic apnea (central or obstructive). Investigators observe that about 20 % of the patients admitted in a EEG-video monitoring - EEG unit for recording their crisis are going to present experience an per / post-critic severe apnea, severe per / post-critic enough to have induce a SpO2 \< 80 % decrease.

However, today, no study has estimated the link relation between the arisen occurrence of such apneas and the later risk of SUDEP.


Eligibility Criteria:
Inclusion Criteria:

* patients suffering from drud-resistant partial epilepsy ;
* Patients who are at least 15 years ;
* Patients for whom a video-EEG monitoring of their seizures was scheduled as part of a pre-surgical assessment ;
* Patients having a registration number in the RNIP (Répertoire National d'Identification des Personnes Physiques) or a Social Security number
* Patients who have given their written consent ;
* Patients with a social security

Exclusion Criteria:

* Patients under 15 years
* Patients without drug-resistant partial epilepsy
* Patients without a registration number in the RNIP (Répertoire National d'Identification des Personnes Physiques) or a Social Security number)
* Patient without a consent signed
Vascular Endothelial Growth Factor Levels in Patients Undergoing Embryo Transfer

Assessing the relationship between the VEGF levels in blood and the IVF protocol

The investigators are assessing the VEGF levels in the blood in IVF patients undergoing different protocols

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing IVF -

Exclusion Criteria:

* Women with any malignancy
* Patients request to be withdrawn
Anterior and Posterior Decompression Surgery in Individuals with Cervical Radiculopathy and Headache

This is a prospective observational register-based cohort study with 2 years follow-up with data from the national Swedish Spine Register (Swespine). The aim is to study the differences between anterior and posterior decompression surgery on neck-related disability, headache, and neck- and arm pain in individuals with cervical radiculopathy and headache. Secondary, to study predictive factors for an improvement in neck-related disability, headache and neck- and arm pain after decompression srurgery. All individuals underwent either anterior or posterior decompression surgery and were operated between 2014-2021. Patient-reported data was collected preoperatively (baseline), and at 1- and 2-year follow-ups and surgeon-reported data regarding the operation were collected directly after the operation. Primary outcome is self-reported neck-related disability measured with Neck Disability Index and secondary outcomes are headache, measured with an item about headache of Neck Disability Index, and neck- and arm pain, measured with a 0 to 10-point numeric rating scale.


Eligibility Criteria:
Inclusion Criteria:

* Underwent anterior cervical decompression surgery or posterior cervical foraminotomy with or without laminectomy for cervical radiculopathy 2014 - 2021
* Age ≥ 18 years
* Preoperatively rated 1 (I have slight headaches, which come infrequently) - 5 (I have headaches almost all the time) on an item about headache of Neck Disability Index (27)

Exclusion Criteria:

* Myelopathy
* Previous neck surgery
Functional Outcome After Anastomotic Leak After Oesophagectomies

The main surgical treatment for oesophageal cancer is a curative resection, mostly performed according to Ivor Lewis. However, despite careful work and refined surgical techniques, anastomotic leakage (AL) occurs in more than 1/10 of the patients. This severe complication normally requires immediate intervention, while over the last 10 years, endoscopic vacuum therapy (EVT) has become the crucial therapy for broken-down anastomosis. The hypothesis is that despite suffering a severe complication, the subjective swallow function is not impaired in patients treated by EVT after an anastomotic leak, compared to patients without AL.

The investigators will select patients after oesophagectomy and perform a structured interview regarding their quality of life and subjective swallow function. Results will be compared according to defined subgroups, especially patients with and without anastomotic leak.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received an Ivor Lewis Oesophagectomy with reconstruction due to any reason
* Patients older than 18 years

Exclusion Criteria:

* Patients with achalasia
* inability to understand study procedure or to provide informed consent