cyrilzakka/clinical-trials huggingface dataset:
"VARIABLE-PSV" Study

Variable PSV is a new ventilatory mode which delivered a pressure support "variable" from 0 to 100% variation of the set PSV level.This study aimed to compare the ventilatory behavior, sleep quality and gas exchange between VARIABLE (or Noisy)-PSV and "standard" (or fixed)-PSV during the weaning phase of critically ill patients who required mechanical ventilation.

Twenty patients will be enrolled. They will be ventilated withVARIABLE-PSV and STANDARD-PSV: for 24 h each in a randomized crossover order. The ventilatory parameters, ventilator/patient asynchrony, gas exchange effects, sleep quality and ventilatory comfort produced by the two ventilation modes will be compared. Before randomisation, a sequence of VARIABLE-PSV will be performed with different level of variation setting to better define the future behavior of the patient under this mode during the 24 h of Variable-PSV.

Eligibility Criteria:
Inclusion Criteria:

* ventilation planned for more than 48 h
* patient alert and calm corresponding to a Richmond Agitation-Sedation Scale (RASS) between -2 and 0
* Age \> or equal 18
* Surrogate decision maker's consent

Exclusion Criteria:

* Clinical instability for any reason.
* Life support withdrawal code
* Patient under tutelage
* Pregnancy
* No French health insurance
Cardiac Strains for Optimization of CRT in Non-Responders

The aim of this study is to investigate the possibility of optimizing the performance of CRT-D in non-responding patients through utilization of cardiac strain speckle tracking

In approximately 30% of patients, cardiac resynchronization therapy (CRT) fails to lead to any improvement of the patients' status.

In this study, an investigation of a possible method of optimization through speckle tracking of cardiac strains is attempted.

Patients not responding to Cardiac Resynchronization Therapy-Defibrillators (CRT-D) after 3 months are randomly divided into control and intervention groups. Atrioventricular interval is adjusted so that E and A waves do not overlap and the interventricular interval subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains. The left ventricular ejection fraction (LVEF) and NYHA (New York Heart Association Classification improvement 3 months after optimization are evaluated and use of other strain combinations assessed.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic heart failure with NYHA III/IV, pharmacological treatment options exhausted, LVEF below 30%, and QRS duration over 130ms who did not respond to the implantation of CRT-D

Exclusion Criteria:

* Age below 18
* response to the original CRT implantation
Treatment of Mild Enteropathy Celiac Disease

The main purpose of this study is to evaluate the natural history of gluten sensitivity in endomysial antibody positive adults with celiac disease suspicion, who were found to have a only mild enteropathy (Marsh I-II) in the small-bowel mucosa. The investigators hypothesize that these subject are indeed gluten-sensitive, as measured by clinical, serological and histological indicators. If this would be the case, the current diagnostic criteria for celiac disease might need re-evaluation.

The current diagnostic criteria of celiac disease require small-bowel mucosal villous atrophy with crypt hyperplasia (Marsh III). However, the mucosal damage develops gradually and the patients may have clinical symptoms and endomysial antibodies before the development of villous atrophy.

The main purpose of this study is to evaluate the natural history of gluten sensitivity in endomysial antibody positive adults with celiac disease suspicion, who were found to have a only mild enteropathy (Marsh I-II) in the small-bowel mucosa. We hypothesize that these subject are indeed gluten-sensitive, as measured by clinical, serological and histological indicators. If this would be the case, the current diagnostic criteria for celiac disease might need re-evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Celiac disease suspicion
* Positive endomysial antibodies
* At least Marsh I -type small-bowel mucosal lesion

Exclusion Criteria:

* Earlier celiac disease diagnosis
* Consuming oral corticosteroids or immune suppressants
Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer:

Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population.

Study design:Randomised-controlled study

Place and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023.

Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature.

Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization.

The curative treatment of gastrointestinal tumors is surgery referring to an en block resection of the primary tumor along with its lymphovascular drainage.Unfortunately, despite of these radical resections, published literature shows that recurrences occur in up to 38% of patients in 5 years. Morover, these rates may reach to 60% in patients with locally advanced tumor following radical surgery. However, this mesentery-based surgery is harder to apply in gastric cancer due to differences in embriyological development. In our prospective study and a review of the literature, following the descripiton of mesogastrium concept, we aimed to search and analyse former techniques and viewpoints about mesogastric excision by different surgical approaches from various countries. Later, we aimed to show our technique of mesogastrectomy, compared our short term results with limited publications from the literature.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histopathologically confirmed gastric adenocancer without evidence of distal metastasis and resectable tumors which have been treated with open total gastrectomy.

Exclusion Criteria:

* Patients with prior upper gastrointestinal system surgery
* Patients with neoadjuvant therapy
* Patients with peripheral organ involvement and/or distant metastasis
* Patients who underwent subtotal gastrectomy
* Patients who underwent laparoscopic and robotic operations
Carbetocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy.

Poor uterine tone after the birth of a baby can cause excess bleeding (called postpartum hemorrhage or PPH). This is a major cause of maternal death worldwide. Uterotonic drugs are used to improve the muscle tone of the uterus after birth, and these are effective at reducing the incidence of PPH. The Society of Obstetricians and Gynecologists of Canada (SOGC) has recommended a single dose of 100 mcg of carbetocin at elective cesarean delivery to promote uterine contraction. In a study performed at Mount Sinai Hospital, the investigators have shown that smaller doses of carbetocin (14.8 mcg) are effective in achieving adequate uterine tone at elective cesarean section.

In these dose-finding studies, women with multiple pregnancies have been excluded. Because women with multiple pregnancy have a higher risk of severe PPH, uterine atony, hysterectomy, prolonged hospital stay and death, it is plausible that a higher dose of carbetocin is required. This question remains unanswered.

The hypothesis is that the ED90 of carbetocin in women with twin pregnancy undergoing elective cesarean delivery under regional anesthesia is greater than 20 mcg but less than 100 mcg.

There is a lack of consensus as to what the optimal uterotonic regime is globally. Furthermore, variability in the international guidelines regarding the choice of first line uterotonic in prevention of PPH adds to the confusion. With the widespread availability of carbetocin in some developed countries, including Canada, the question of which uterotonic to adopt and at which dose becomes even more difficult to ascertain. Studies that have currently been published suggest the ED90 doses of carbetocin and oxytocin provide adequate uterine contraction with possibly fewer side effects associated with the lower dose regimens. There is evidence to suggest that lower doses of both carbetocin provide equivalent uterine contractions with a better side effect profile in patients with a singleton pregnancy. However, there is no clinical dosing data specifically for patients with twin pregnancy. The results of our study will provide guidance to obstetric and anesthetic providers worldwide when deciding what dose of carbetocin to use in women with twin pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Twin Pregnancy
* Elective cesarean delivery under regional anesthesia
* Gestational age ≥ 36 weeks
* No known additional risk factors for postpartum hemorrhage
* Written informed consent to participate in this study

Exclusion Criteria:

* Refusal to give written informed consent
* Allergy or hypersensitivity to oxytocin
* Conditions that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, severe preeclampsia (as defined by SOGC guidelines (25)), polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis and obesity, defined as pre-pregnancy BMI \>40
* Hepatic, renal, and vascular disease
* Use of general anesthesia prior to the administration of the study drug
Hip-spine Intervention for Older Adults With Chronic Low Back Pain

Low back pain (LBP) is extremely common in older adults and is associated with a host of negative consequences, including decreased physical function and increased healthcare utilization. Among older adults with LBP, hip impairments indicative of hip joint disease are more prevalent and associated with greater disability than among older adults without LBP. This study will investigate a novel intervention designed to improve LBP-related disability by combining a typical spine-focused exercise program with a hip-focused intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age 60-85
2. Low Back Pain for ≥ 3 months with pain of at least moderate intensity every day or almost every day that requires activity modification.
3. Presence of at least 1 hip impairment denoted by the American College of Rheumatology as potential indicators of hip osteoarthritis: hip pain, pain on hip internal rotation or morning stiffness of the hip of \<60 minutes.

Exclusion Criteria:

1. Previous hip fracture repair or total hip replacement
2. Prominent component of radicular pain: CLBP with distal radiation below the knee
3. Known spinal pathology other than osteoarthritis: (e.g., a history of back surgery or recent trauma, spinal stenosis, vertebral compression fractures, ankylosing spondylitis, carcinoma metastatic to the spine)
4. Non-ambulatory, or severely impaired mobility (i.e., require the use of a wheelchair)
5. Folstein Mini-Mental State Examination score of \<24
6. Severe visual or hearing impairment.
7. Red flags indicative of a serious disorder underlying the LBP: Red flags that would require specialized medical attention include fever, significant unintentional weight loss, a sudden recent change in the character or intensity of pain, trauma that preceded the onset of pain, or signs and symptoms of caudae equinae (i.e. loss of sensation over saddle region, significant disturbances in bowel and bladder function).
8. Significant pain in parts of the body other than the back or acute LBP.
9. Acute, ongoing illness.
10. Inability to participate in the study for the full six months for any known reason.(i.e. moving away, extended vacation)
11. Received physical therapy for their LBP within in the last 3 months.
Impact of 5% Lidocaine Medicated Plaster on Allodynic Symptoms of Localized Neuropathic Pain After Knee Surgery

The aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on allodynic symptoms of localized neuropathic pain after knee surgery.

This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing 5% lidocaine medicated plaster (5LP) and placebo whether neuropathic pain symptoms (dynamic mechanical allodynia, pressure, hot and cold) have a different chronological improvement with 5LP compared to placebo. Pain intensity and pain relief, sleep and quality of life and osteoarthritis severity are also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 80 years
* Male or female, for women of childbearing potential, a negative pregnancy test
* Patients with PONP following knee surgery
* Patients with neuropathic pain DN4 ≥ 4
* Patients at least 3 months post-surgery
* Patients suffering from at least the allodynic brush-induced mechanical allodynia symptom (DMA) rated as ≥ 5/10 on the numerical scale
* Patient with no localized neuropathic pain symptoms (DN4\<4) on the contralateral knee
* Intact skin besides the scar of surgery (absence of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, wounds) in the area where the medicated plasters will be applied
* Naive from Versatis® treatment
* Treated with stable systemic analgesic and planned to remain stable all over the duration of the study
* Insured by French social security
* Included or agreement to be included in the national register of participants in biomedical research

Exclusion Criteria:

-
Application of the Health Action Process Approach Model Program to Patients With Heart Attacks

This research is conducted to determine whether the nurse-led Health Action Process Approach Model-based Cardiac Rehabilitation Program is effective in patients with myocardial infarction. The population of the study will consist of coronary angiography patients with myocardial infarction in the cardiology service of a state hospital. In this study, which is planned as a randomized controlled experimental model, 35 intervention and 35 control groups will be studied. As data collection tools; patient identification form, Laboratory Investigations Monitoring Form, Perceived Stress Scale, Health Action Process Approach Based Participant Assessment Form, Health Action Process Approach Based Myocardial Infarction Risk Factors Participant Assessment Form Functional Capacity Assessment Form, Myocardial Infarction Dimensional Assessment Scale and Turkish Modified Morisky Scale will be used. Health Action Process Approach Modeled Cardiac Rehabilitation Program will be applied to the intervention group and no intervention will be applied to the control group. Data will be collected with data collection tools at 6, 12, 24 weeks. SPSS 25.0 (Stastical Package for Social Science) package program will be used for statistical analysis of the data. Descriptive statistics will be given as number, percentage, mean, standard deviation and median values. The normal distribution of the data of numerical variables will be evaluated by Shapiro Wilk test. Two group comparisons will be made with independent two sample t-test for normally distributed variables and with Mann-Whitney U test for variables that do not show normal distribution. Comparisons of the groups' pre-test, week 6, week 18 and week 24 scale scores will be made with two-way analysis of variance in repeated measures from general linear models.


Eligibility Criteria:
Inclusion Criteria:

* To be between 18-70 years old,
* Becoming literate,
* Living in the city center
* Having had a heart attack within the last month,
* Not having had a heart attack before,
* Dyspnea less than 4-5 degrees according to the modified Borg Scale
* No deformity or diagnosis related to the musculoskeletal system that may prevent physical activity, no orthopedic limitation
* Stable New York Heart Association (NHYA) functional class I or II coronary artery disease with myocardial infarction

Exclusion Criteria:

Those with communication disabilities such as speech, vision, hearing

* Dyspnea score of more than 4-5 degrees according to the modified Borg Scale
* Those who stayed in intensive care for a long time after MI
* Complications related to treatment and interventions after MI
* Those who underwent surgical treatment after MI,
* Those with chronic diseases (chronic obstructive pulmonary disease, chronic renal failure, hypertension, diabetes, pulmonary emphysema, rheumatic valve disease, cancer diagnosis, etc.)
* Those who indicated that they would not participate in intervention programs due to time constraints.
* Failure of the six-minute walk test
RETRIEVE-AMI Study

Heart attacks are caused by the sudden formation of a clot inside a diseased coronary artery which reduces blood flow beyond the blockage site. During conventional treatment of the blockage with what is known as a stent; a stainless steel tub that keeps the artery open, the clot that has formed is disrupted and is pushed further down leading to damage in smaller blood vessels supplying the heart muscle. This additional damage can lead to long-term heart muscle damage influencing recovery and wellbeing. The original concept that was tested to prevent this 'clot shower' was that of a suction device to withdraw the clot before stenting. However, this approach has not translated to patient benefit. Amongst the reasons put forward for the inefficacy of the suction device was that it does not remove the entire clot as it does not interact with it. A new device that physically interacts with the clot and traps it before pulling it out - the stent retriever - is now routinely used in stroke therapy to remove clots in the arteries supplying the brain. This device has been successfully used as a last resort to remove clots in a small number of heart attacks. The investigators hypothesize that stent retriever therapy will be more effective in clot removal than the current standard of care; suction or stenting. To study this, the investigators propose the RETRIEVE-AMI randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Primary PCI patient with ST elevation myocardial infarction (STEMI)
* TIMI 0/1 flow at presentation
* Angiographic thrombus score ≥ 4
* Vessel diameter at site of occlusion ≥ 3.0 mm (measured by quantitative coronary angiography)

Exclusion Criteria:

* Female participant who is pregnant or lactating
* Participant with known hypersensitivity to nickel-titanium
* Unconscious at presentation
* Late presenter (pain to wire time \> 12 h)
* Class Killip III/IV and/or profound bradycardia (Heart rate \< 40 bpm)
* Known history of kidney failure
* Ostial occlusion
* Highly tortuous vessel
* Highly calcified vessel
* Suspected (angiographically) spontaneous coronary artery dissection
* Stent thrombosis
* Previous stent implanted proximal to the occlusion site
* Previous coronary artery bypass graft surgery (CABG)
* Previous STEMI/Transient Ischemic Attack/Stroke
* Known anaemia (Hemoglobin \<9)
Risk Factors for Human Corneal Graft Failure : a Monocentric Retrospective Observational Cohort

Keratoplasty is one of the most common grafts and penetrating keratoplasty is still the technique most used in the world, ahead of lamellar grafts, and is estimated to represent 70% of the total.

Graft rejection is still the main cause of failure of this type of surgery, to the extent that nearly a third of all patients will in some way be affected by rejection in due course.

Numerous risk factors for rejection have been identified, whether related to the donor, the recipient, or the surgical procedure itself.

In addition, many of the studies performed have used univariate analysis only, and yet there is a strong case for multivariate analysis, given the wide range of factors that need to be examined.

This study seeks to analyze the rejection rates and the survival of penetrating keratoplasty for a group of patients from Montpellier Hospital (France).


Eligibility Criteria:
Inclusion criteria:

-keratoplasty performed in the ophthalmology department of the CHRU of Montpellier between 15/06/2005 and 18/09/2018

Exclusion criteria:

* a non-optical graft (tectonic and analgesic graft)
* lamellar graft (DALK (Deep Anterior Lamellar Keratoplasty) and DSAEK (Descemet Stripping Automated Endothelial Keratoplasty))
* Silica gel re-dried cornea, duplicates (we included each patient only once per eye)
* medical record missing from the archives.
Angiography Versus (vs) IVUS Optimisation

The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions


Eligibility Criteria:
Inclusion Criteria:

* A complex lesion is regarded as a lesion where the operator would expect a lower immediate and long term success rate compared to non-complex lesions (according to the results of Randomized Controlled Trials and from large Registries). The operator must consider the implantation of a drug-eluting stent, feasible and appropriate for this particular complex lesion

Exclusion Criteria:

* Contra-indication to dual anti-platelet therapy.
* Ejection fraction \<30%.
* Renal failure (creatinine \>2 mg/dL).
* Significant co-morbidity precluding clinical follow-up.
* Acute myocardial infarction in the 48 hours prior to the procedure.
* In-stent restenosis
* Prior brachytherapy
* Thrombocytopenia \<100,000
* Unprotected left main stem stenosis
* Venous or arterial grafts
* Recipient of heart transplant
* A positive pregnancy test in women with child bearing potential
* Acute infections
* Major surgery planned which will lead to discontinuation of antiplatelet therapy
* Patients with prior BMS or DES implanted in the target vessel less than one year prior to the enrollment, including one year from any intercurrent restenotic or thrombotic event
* Age under 18 years old.
* There is no maximum number of lesions which can be treated
Isolation and Authentication of Mesenchymal Stem Cell-like Progenitor Cells From the Degenerated Intervertebral Disc of Lumbar Spine

The study is designed for evaluating the presence of mesenchymal stem cells of vertebral disc. Isolation and authentication of these cells may be applied for the vertebral disc regeneration and the research tissue engineering.

We will collect the degenerative disc from adults and isolate the mesenchymal stem cell-like precursors cells. The function of osteogenic, chondrogenic, and lipogenic differentiation will be authenticated. The results will offer the information for cell source of tissue engineering in the future.

Eligibility Criteria:
Inclusion Criteria:

* The adults with disc degeneration（age \>= 20 years old） A. Herniated intervertebral disc. B. Spondylolisthesis. C. Spondylolysis. D. Other causes of disc degeneration.

Exclusion Criteria:

* Age \< 20 years old.
* Pregnancy.
* Spinal tumors.
* Spinal infections.