cyrilzakka/clinical-trials huggingface dataset:
Perioperative Multimodal General AnesTHesia Focusing on Specific CNS Targets in Patients Undergoing CarDiac SurgERies

In the PATHFINDER 2 trial, the study investigators will test the intraoperative EEG-guided multimodal general anesthesia (MMGA) management strategy in combination with a postoperative protocolized analgesic approach to:

1. reduce the incidence of perioperative neurocognitive dysfunction in cardiac surgical patients
2. ensure hemodynamic stability and decrease use of vasopressors in the operating rooms
3. reduce pain and opioid consumption postoperatively

The investigators propose to randomize (1:1) 70 patients undergoing cardiac surgery to the perioperative EEG-guided MMGA bundle (described in full below) or standard-of-care management based primarily on the use of sevoflurane for unconsciousness and intermittent doses of fentanyl and hydromorphone for antinociception.

The team will test the intraoperative EEG-guided MMGA management strategy in combination with a postoperative protocolized analgesic approach to reduce the postoperative increase of surgical and delirium markers, reduce intraoperative abnormalities in brain health monitoring, ensure hemodynamic stability and decreased use of vasopressors in the operating rooms and reduce pain and opioid consumption postoperatively. The team will also investigate whether EEG-guided MMGA strategy reduces the incidence of perioperative neurocognitive dysfunction in cardiac surgical patients. This approach will further individualize care and minimize the use of intraoperative vasopressor-inotropic dose, dose of anesthetic medications, and postoperative opioids given to each patient potentially preventing hemodynamic complications and post-operative cognitive dysfunction after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Undergoing any of the following types of surgery with cardiopulmonary bypass limited to coronary artery bypass surgery (CABG), CABG+valve surgeries and isolated valve surgeries.

Exclusion Criteria:

* Preoperative left ventricular ejection fraction (LVEF) \<30%
* Emergent surgery
* Non-English speaking
* Cognitive impairment as defined by total MoCA score \< 10
* Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
* Significant visual impairment
* Chronic opioid use for chronic pain conditions with tolerance (total dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
* Hypersensitivity to any of the study medications
* Known history of alcohol (\> 2 drinks per day) or drug abuse Active (in the past year) history of alcohol abuse (≥5 drinks/day for men or ≥4 drinks/day for women) as determined by reviewing medical record and history given by the patient
* Liver dysfunction (liver enzymes \> 4 times the baseline, all patients will have a baseline liver function test evaluation), history and examination suggestive of jaundice.
Micropulsed Laser Trabeculoplasty Using Different Parameters

This randomized, double blinded, clinical trial compares two different parameters setting of micropulsed laser trabeculoplasty for open angle glaucoma. Group one is treated with 1500 mW of Power, Group two with 1000 mW. The other settings (300 micron of diameter, 300 ms of duration, 15% duty cycle) are the same for both groups, and the laser is applied for 360°.

The main outcome is to evaluate the IOP (IntraOcular Pressure) lowering effects of both treatments and the safety on the corneal endothelium.

This study is a randomized, double blinded, clinical trial. Eligibility criteria are: primary open angle glaucoma, pigmentary glaucoma and pseudoexfoliation glaucoma.

Exclusion criteria are: secondary glaucoma, previous glaucoma surgery (not including cataract surgery as a glaucoma surgery), uncooperative patients, corneal endothelial diseases (such as Fuchs dystrophy or cornea guttata) and severely decompensated glaucoma.

Both eyes of the patient are treated: each eye is allocated in a group using the closed envelopes method. Both the patient and the surgeon who performs the post laser examinations are not aware of the group allocation.

The exams required before the trabeculoplasty are: best corrected visual acuity, IOP measurement, specular microscopy with corneal central thickness.

The IOP is measured an hour after MLT (micropulsed laser trabeculoplasty), then on day one, at one month, at three months and six months. Best corrected visual acuity and specular microscopy are repeated at three months.

Expected outcomes: to compare the IOP lowering effects between group one and two and to assess the safety of the procedure on the corneal endothelium.

Secondary outcomes: decrease the number of glaucoma medications applied by the patients.

Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma
* Pigmentary glaucoma
* Pseudoexfoliative glaucoma

Exclusion Criteria:

* Secondary glaucoma
* Previous glaucoma surgery
* Severely decompensated glaucoma
* Corneal endothelial disease
Prognostic Study of Via Dynamic Change of PCA3 mRNA in Drainage Fluid After Radical Prostatectomy

This study investigates the prognostic value of dynamic changes in PCA3 mRNA levels found in the abdominal cavity drainage fluid after radical prostatectomy. Prostate cancer is one of the most common cancers in men, and radical prostatectomy is a standard treatment. While PSA levels in the blood are commonly used as a marker for diagnosis, this study focuses on the significance of PCA3 mRNA levels in the prognosis of prostate cancer. The findings may provide insights into improved post-surgical monitoring and more tailored therapeutic strategies for prostate cancer patients.

This study examines the prognostic significance of PCA3 mRNA levels in the drainage fluid collected from the abdominal cavity following radical prostatectomy, a common surgical treatment for prostate cancer. PSA is widely used as a biomarker for prostate cancer diagnosis, treatment response, and recurrence monitoring in the blood. However, this research seeks to explore the prognostic value of PCA3 mRNA in the drainage fluid. The study involves continuous monitoring of PCA3 mRNA levels in the drainage fluid after radical prostatectomy, with the hypothesis that dynamic changes in these levels could serve as an early warning system for potential tumor recurrence, residual disease, or metastasis. The research will correlate these fluid PCA3 mRNA levels with patient outcomes, recurrence rates, and other clinical factors to determine their predictive value.

By investigating this novel source of PCA3 mRNA monitoring, the study aims to reduce invasive tests, enhance post-operative surveillance, and improve early detection of disease recurrence for prostate cancer patients. This research could contribute to refining post-surgical care protocols, offering a new tool for predict long-term outcomes for individuals undergoing radical prostatectomy.

Eligibility Criteria:
Inclusion Criteria:

•Prostate cancer patients treated with radical prostatectomy

Exclusion Criteria:

* 1. Received neoadjuvant endocrine/chemotherapy before surgery;
* 2. Urine leakage after surgery (positive creatinine test of drainage fluid).
Mirabegron And Ureteral Stent-related Pain (MAP) Trial

Ureteric stents are used often following ureteroscopy for prevention of obstruction from edema and/or stone fragments.

Up to 75% of patients experience pain following stenting, as well as lower urinary tract symptoms (LUTS) such as finding blood in the urine, voiding often, the need to urinate quickly resulting in a significant source of morbidity. The negative impact of stents results in a significant impact on health related quality of life.

There is no standard of care for managing ureteric stent pain and lower urinary tract symptoms following surgery. A combination of α-blockers, antimuscarinics, acetaminophen, nonsteroidal anti-inflammatory drugs and opioids are currently the mainstay for treatment of post-operative pain and LUTS following stenting.

Mirabegron is a beta-agonist that mediate relaxation of the detrusor muscle and has been useful in treating overactive bladder (OAB) which has similar symptoms to patients with an ureteric stent in place. Our goal is to assess if mirabegron can improve symptoms and decrease the need for additional pain medications.

The investigators hypothesize that Mirabegron is effective in decreasing ureteral stent related LUTS and pain.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. First ureteroscopic treatment for the ureteric or renal stone
3. Retrograde semi-rigid or flexible ureteroscopy
4. Placement of a 6Fr, 22-28cm hydrophilic coated ureteric stent
5. Follow-up 7 days post operatively at St. Michael's Hospital
6. Patient who can read and understand English

Exclusion Criteria:

1. Bilateral ureteral stents
2. Stent in situ prior to ureteroscopy
3. Pregnancy or breast feeding, or planning on becoming pregnant in the upcoming weeks
4. Patients with congenital renal abnormalities (eg: pelvic kidney, ureteric duplication) that may impair proper stent placement
5. Patients with urinary diversion or stone in a transplant kidney
6. Patients with a history of interstitial cystitis/painful bladder syndrome, prostatitis, pelvic pain due to other conditions (eg: endometriosis), or neurogenic bladder
7. Indwelling Foley catheter
8. Patients currently taking antimuscarinics, mirabegron, or α-blockers
9. Patients with contraindications to receiving mirabegron (ie: urinary retention, end-stage renal disease, uncontrolled hypertension, known QT prolongation)
10. Significant cognitive impairment
11. Patients with contraindications to opioid use (hypersensitivity, MAO inhibitor use within 14 days, severe respiratory depression, acute or severe asthma, GI obstruction, paralytic ileus, GI stricture)
12. Suspected or confirmed ureteral perforation
13. Stent placement without tether
14. Untreated urinary tract infection
15. Antegrade ureteroscopy
16. Opioid addiction
17. Plan for stent removal at another centre other than St. Michael's Hospital
18. Moderate to severe cardiovascular disease and cerebrovascular disease
19. Signs of hepatic dysfunction including significant liver function test elevation
20. Patients who cannot read and understand English
Effect of Anti-CD303 Antibodies in Autoimmune Diseases

The pathogenic role of type I interferons (IFNs) in the development of different autoimmune diseases has been extensively described in the literature. Since plasmacytoid dendritic cells (pDCs) are the main source of type I IFNs, there is evidence of the involvement of pDCs in autoimmune diseases. The CD303 surface protein (also called BDCA-2) is specifically expressed by the pDCs.

The hypothesis leading to the realization of this study is to observe, in vitro, an inhibition of the secretion of the type I IFNs by pDCs in the peripheral blood in patients with autoimmune disease, thanks to the action of the anti-CD303 antibody Developed by the LFB Group, which could reduce the inflammatory response and improve patients with autoimmune disease


Eligibility Criteria:
Inclusion Criteria:

* Have the ability to understand the requirements of the study, provide written informed consent, and comply with the study data collection procedures
* Patient followed in the department of internal medicine of CHU Lille
* Patient with one of the following autoimmune disease, defined according to international criteria: systemic lupus erythematosus, systemic sclerosis, Gougerot-Sjögren syndrome and idiopathic thrombocytopenic purpura
* Being socially insured

Exclusion Criteria:

* Overlapping syndrome with another autoimmune disease
* Age ≤18 years
* Pregnant or nursing women
* People in emergencies
* Person incapable of consent
* Persons deprived of liberty
* Persons without social security cover
Thermal Energy in the Treatment of Cervicogenic Dizziness

Cervical pain contributes to postural deviations and imbalance. Nanotechnology may be used for the treatment of neck pain by fixing to the skin small rounds silicone patches containing double spiral carbon nanotubes arranged in the form of a coil (Helical), which would then relieve dizziness caused by muscular contraction.

The selected patients should have neck pain arising from muscle contraction with loss of balance or instability lasting more than 90 days and normal electrooculography. Treatment consisted of placing 10 Helical patches, placebo or active, distributed as follows: two in the upper cervical area, two in the lower cervical area (near the 5th and 6th vertebrae), two in the upper trapezius muscle area (between neck and shoulder), and four in the tender point area (as reported by the patient). Using a Visual Analogue Scale (VAS) and specific questionnaires, the investigators will match pain, muscle tension and dizziness scores from Day 1 to those from Day 15 and Day 30.

Eligibility Criteria:
Inclusion Criteria:

* Cervicogenic Dizziness diagnosis
* Normal otoneurological examination
* Signed the informed consent form
* Neck without other radiological changes, which are not solely attributable to aging (osteophytosis, rectification, disc space reduction).

Exclusion Criteria:

* Active vestibular disease
* Traumatic neck injury
* Neurological
* Rheumatic or orthopedic diseases not attributable to aging (fractures, tumors) and/or that have surgical indication
* Somatoform diseases; cognitive limitations.
Transcutaneous PCO2 Assessment During Intubation in ICU

PtcCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods.

Transcutaneous PCO2 assessement during intubation in ICU. Comparison of three different preoxygenation methods and hemodynamic changes during this period.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient 18 years of age or older
* Requiring intubation in Resuscitation

Exclusion Criteria:

* Contraindication to orotracheal intubation
* Intubation in a respiratory or cardiocirculatory arrest situation
* Need for intubation in great urgency preventing the installation of the transcutaneous capnia sensor and its calibration
* Major Incapable
* Opposition of the patient or his relatives to the research
Effect of LL-BFRE Training on Volitional Muscle Activation in Subjects with Knee Joint Impairment

The aim of this study was to investigate whether 4 weeks of exercise training against low mechanical resistance in combination with partial blood flow restriction has an additional therapeutic effect on the patients\&#39; ability to activate the knee extensor muscle. Patients with chronic deficits in muscle strength due to knee injuries or surgery on one leg were invited to participate in this study on a completely voluntary basis.

The effects of low-load exercise with blood flow restriction (BFR) on the ability to voluntarily activate skeletal muscle in people with joint injuries are poorly understood. The aim of our study was to investigate the effects of low-load BFR training on the level of voluntary activation (AL) of the quadriceps femoris muscle assessed using the interpolated twitch technique in people with different knee joint injuries. Thirty-three orthopedic patients assigned to either the BFR group or the SHAM-BFR group participated in the study. Over a period of four weeks, the participants completed 12 training sessions of unilateral knee extension and leg press at 30 RM. The BFR group trained with a pneumatic cuff-induced blood flow restriction (pressure = 120-140 mmHg), while the SHAM-BFR group trained with a sham blood flow restriction (pressure = 20 mmHg) that did not interfere with normal muscle perfusion. The assessment of knee muscle capacity and function consisted of dynamometric measurements of maximal isometric strength and endurance of the knee extensor muscles, level of voluntary muscle activation, surface electromiography, pain intensity and assessment of perceived exertion. All tests and measurements were performed twice, once before the intervention (baseline) and once at the end of the 4-week training period (POST).

Eligibility Criteria:
Inclusion Criteria:

* no systemic illness,
* no history of injuries to the contralateral knee,
* pain intensity during exercise ≤ 2 on numeric pain rating scale (0-10).

Exclusion Criteria:

* neuromuscular impairments,
* spine or other lower limb injuries,
* presence or history of any vascular diseases or deep vein thrombosis
* pain intensity during exercise ≥ 3 on numeric pain rating scale (0-10).
Prospective Observational Study of Localized Angiosarcoma of Any Site: ProStars

This study will be a multi-institutional, prospective, observational study of patients with localized primary AS of any site within ISG and RTR centers. Patients will be treated according to clinical practice of the center and according to ISG clinical recommendations on localized AS.

The management of localized AS remains a clinical challenge and needs to be better defined and standardized, especially with regards to the role of radiation-therapy and systemic treatment. Several questions about the best treatment approach to some clinical presentations remain open and would need to be answered by clinical studies. Unfortunately, the rarity of this histology among sarcomas makes it challenging to carry out clinical studies in all such presentations. Moreover, prognostic factors are lacking and differences in epidemiological, pathological and clinical aspects between primary AS and secondary AS need to be better characterized.

These issues may be addressed with a prospective multi-institutional observational study, through the collection of clinical and pathological data of patients with localized AS.

Involving all reference centres for sarcoma in Italy, the Italian Sarcoma Group (ISG) will be the ideal network for this study, with the collaboration of the Italian Rare Cancer Network (RTR), a 7collaborative network among Italian centres focusing on improving the quality of care of patients with rare tumors.

Eligibility Criteria:
Inclusion Criteria:

* pathological diagnosis of AS;
* any site of origin;
* any age;
* primary, localized, resectable disease.

Exclusion Criteria: NA
Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes

This trial is conducted globally. The aim of the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age at least 18 years at the time of signing informed consent For Japan only: Male or female, age at least 20 years at the time of signing informed consent
* Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days prior to day of screening
* HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive).
* Stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose as documented in subject medical record) alone or in combination with SU (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) within 90 days prior to the day of screening

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). For certain specific countries: Additional specific requirements apply
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)
* History of pancreatitis (acute or chronic)
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
* Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
European SIR-Spheres Surgical Registry

Liver resection is the only curative treatment option for primary and secondary liver tumors. For some primary or secondary malignancies (HCC, NET) liver transplantation is a possible treatment option. Unfortunately, the majority of patients show a high hepatic tumor load or adverse intrahepatic distribution, that resection or transplantation at the time of initial diagnosis is not possible. In that case different treatment approaches are possible. For those patients that are very unlikely to ever become resectable, palliative systemic therapy is the preferred treatment option. For those patients that may become resectable after downsizing of the tumors or increase of volume of the future liver remnant secondary resection after induction therapy may be a possibility. Then, an induction treatment that has the most likelihood of causing physical shrinkage of the tumors is usually preferred. One of the approaches to create contralateral hypertrophy to increase future liver remnant is portal vein embolization. However, tumor growth might be stimulated during the phase of hypertrophy. Selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres is an endovascular interventional radio-oncologic procedure treating primary and secondary liver tumors1-3. It offers radiation therapy with yttrium-90, a high-energy beta-emitting isotope, directly in the vascular system of liver tumors. It treats the tumor locally, saves healthy liver tissue and could lead to hypertrophy of this residual healthy liver tissue due to the embolization effect. Therefore secondary liver resection after SIRT might become possible4,5. SIRT could also be an option as bridging-, downsizing- or downstaging-therapy before liver transplantation.

Liver resection with local tumor treatment and hypertrophy induction after SIRT seems to be a promising therapy option. Previous reports have shown the feasibility, safety and efficacy of this therapeutic strategy.

Aim of the European SIR-Spheres Surgical Registry - ESSURE - is now to further improve the understanding and optimize the process and patient selection of this therapy strategy in its true clinical setting. This registry enables data collection on the real-life clinical application of liver resection/liver transplantation after SIRT.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Primary or secondary liver tumors
* Treatment of liver tumors with SIR-Spheres Y-90 resin microspheres with the intention to make patient eligible for liver resection/liver transplantation
* Decision of a multidisciplinary tumor board on the patient's therapy regime
* Signed informed-consent form

Exclusion Criteria:

* under 18 years
* not able to sign informed consent
* no decision of a multidisciplinary tumorboard