cyrilzakka/clinical-trials huggingface dataset:
Microbiota-anastomotic Leak Among Colorectal Surgery Patients : Pilot Study

The study is based on the hypothesis that patients with postoperative anastomotic leakage have a different bacterial profile contributing to poor tissue healing, and that patients operated for colon cancer presumably have a different preoperative microbiota than healthy patients. This different composition is probably induced by the high heme level in the light intestinal tract that tumor spoliation generates.

The objective of the study is to evaluate the feasibility of a larger study to evaluate the difference between microbiota composition of patients with and without colorectal cancer, with inflammatory bowel disease and those with and without anastomotic leakage postoperatively of a colonic resection.

Stool samples will be taken from 20 patients, including 5 without intestinal pathology, 5 with colorectal cancer undergoing colorectal surgery, 5 with inflammatory bowel disease and 5 with anastomotic leakage after colectomy for colorectal cancer or inflammatory bowel disease.

The stool samples will be analyzed at CRCHUM to draw up a profile of the bacteria that make up the microbiota of each patient.

No more details required.

Eligibility Criteria:
Inclusion Criteria:

ALL

* Informed consent obtained.
* Between 18 to 90 years old inclusive.
* Group 1 (colorectal cancer patients)

  * Patients with colorectal cancer confirmed with pathology results.
  * Oncological colon and / or rectal resection planned and performed by a surgeon from the digestive surgery department of the CHUM.
* Group 2 (anastomotic leak patients)

  * Patients with colorectal cancer confirmed with pathology and / or patients with inflammatory bowel disease.
  * Patients who underwent colonic and / or rectal surgical resection, complicated by an anastomotic leak in the postoperative period.
* Group 3 ("healthy" patients)

  * Patients with uncomplicated hernia pathology assessed externally in anticipation or after hernia repair surgery that does not involve gastrointestinal resection.
  * Patients with no history of colorectal neoplasia or surgical resection of the gastrointestinal tract.
* Group 4 (inflammatory bowel disease patients)

  * Patients with inflammatory bowel disease (IBD), waiting for elective surgery involving gastrointestinal resection.

Exclusion Criteria:

* Pregnancy.
* Class of the American Society of Anesthesiologists (ASA)\> 3.
* Chemotherapy and / or pelvic and / or abdominal radiotherapy within 6 months prior to collection of the stool sample prior to surgery (group 3 with healthy patients only).
* Colonoscopy within 3 months prior to collection of the stool sample prior to surgery (group 3 with healthy patients only).
ET-blockade and Exercise Induced Blood Flow in T2DM

The purpose of this study is to establish the effect of ET blockade on the acute exercise induced blood flow and endothelial function in subjects with T2DM. We hypothesize that combining ET - blockade with exercise training leads to an acute increase of exercise induced blood flow when compared with exercise alone. We expect that this will lead to an optimization of vascular training effect in T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus (\>2 years since diagnosis) OR controls

Exclusion Criteria:

* \<40 years of age
* \>65 years of age
* smoking
* cardiovascular disease
* diabetes related manifest vascular complications
* Type 1 Diabetes Mellitus
* use of Glibenclamide
* use of HIV drugs
* use of calcineurin inhibitors
* use of drugs that interfere with CYP3A4 and CYP2C19
Role of Sphingolipids in Pulmonary Edema

In this mono-center prospective study, the impact of changes in the sphingolipid metabolism in patients with pulmonary edema will be investigated.

There will be three groups of patients:

1. hydrostatic pulmonary edema
2. toxic pulmonary edema
3. not ventilated patients without any pulmonary edema

Samples of a routine bronchoalveolar lavage and EDTA-blood will be analysed in respect of sphingolipids, ceramide, sphingomyelin-phosphodiesterase and several cytokines.

Eligibility Criteria:
Inclusion Criteria:

* above the age of 18

Exclusion Criteria:

* taking steroids
A Study to Investigate the Plasma Concentration of YM150 After Repeated Administration to Elderly Subjects

The purpose of this study is to evaluate the safety and plasma concentration change of YM150 after repeated administration to healthy elderly male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations and all tests
* Body weight: male: ≥45.0 kg, \<85.0 kg; female: ≥40.0 kg, \<75.0 kg
* BMI (at screening): ≥17.6, \<30.0

Exclusion Criteria:

* Use of any other investigational drug in another clinical study or a post-marketing clinical study within 120 days before the administration of the study drug
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment.
* Any surgical intervention (including tooth extraction) or trauma within 90 days before hospitalization until the administration, or plan of any surgical intervention within 10 week after the final administration
* A deviation from the normal reference range of blood pressure, pulse rate, body temperature, or 12-lead ECG
* PT or aPTT on blood coagulation tests outside the upper or lower reference limits (PT: 9.9 to 15.4 sec.; aPTT: 22.5 to 49.5 sec.)
* Upper gastrointestinal disease (e.g. nausea, vomiting, stomachache) within 7 days before the study
* Concurrent or previous hepatic disease (e.g. viral hepatitis, drug-induced liver injury)
* Concurrent or previous heart disease (e.g. congestive heart failure, angina pectoris, arrhythmia requiring treatment)
* Concurrent or previous respiratory disease (e.g. serious bronchial asthma, chronic bronchitis; except for a history of childhood asthma)
* Concurrent or previous renal disease (e.g. acute renal failure, glomerulonephritis, interstitial nephritis; except for a history of calculus)
* Concurrent or previous malignant tumor
* Excessive smoking or drinking habit \[measure of "excessive": alcohol: average 45 g/day (a 633 mL bottle of beer contains 25 g of alcohol, and 180 mL of Japanese sake contains 22 g of alcohol), smoking: average 20 cigarettes/day\]
* Previous treatment with YM150
A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers

This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound healing process.


Eligibility Criteria:
Inclusion Criteria:

1. Venous Leg Ulcer
2. Exuding wound
3. Wound surface covered with sloughy tissue\* (before debridement)
4. Wound size ≥ 6 cm2
5. In case of multiple wounds, target wound must be ≥ 3cm distant from other wounds.
6. Wound suitable for treatment with the relevant primary dressing\*\*
7. Male or female, 18 years of age and above
8. Signed Informed Consent

   * Sloughy tissue defined as wet, yellow-brown fibrinous tissue present in the wound bed \*\* Mepilex XT in the intervention group. Standard care in the observation group

Exclusion Criteria:

1. More than two products of 15 cm x15 cm needed to cover the whole wound and affected peri-wound area
2. Wound cavity and/or fistula
3. Full thickness burns
4. Exposed tendons and/or fascia
5. Bleeding wounds
6. Malignant or fungating wounds
7. Wound age \> 12 months
8. Use of antimicrobial dressings or topical agents such as antiseptics, local antibiotics and steroids within 7 days from inclusion on the wound intended to be included
9. Untreated limb ischemia (according to investigator's judgement) at the time of inclusion
10. Subject not suitable for the investigation according to the investigator's judgement
11. Subject included in other ongoing clinical investigation which could interfere with this investigation, as judged by the investigator
12. Known allergy/hypersensitivity to any of the components of the primary dressing
Clinical Study to Evaluate Effectiveness of Digital Refraction

Prospective, comparative, randomized, non-masked clinical study to compare the a digital refraction with LogMAR VA testing utilizing trial lenses, to standard manual refraction using a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement.

A digital refraction tool is a device meant to measure visual acuity and to subjectively measure refractive value for a patient's eye for the conditions of myopia and astigmatism. It is intended for adults aged 22 to 55 years that have no prior correction with up to 3.00 diopters (D) of myopia and up to 2.00 D of astigmatism, or those with prior correction up to 10.00 D of myopia and require an over-refraction of no more than 2.75 D.

LogMAR (ETDRS) chart to measure visual acuity.

The manual manifest refraction is performed by an eyecare specialist using a phoropter.

The LogMAR Visual Acuity chart is used to measure visual acuity. The manual refraction will be used in this study for obtaining the refractive error of each eye.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be between 22 and 55 years of age at the time of consent.
2. Subject must have a refractive error

   1. With no greater than -3.00 D myopia and -2.00 D astigmatism in either eye.
   2. With prior correction of no greater than -10.00 D myopia and requiring over-refraction of no more than 2.75 D in either eye.

5. Subjects with Best Corrected Visual Acuity (BCVA) of 20/32 or better.

Exclusion Criteria:

1. Subjects with diabetes mellitus.
2. Subjects using ophthalmic or systemic corticosteroids.
3. Subjects with autoimmune conditions.
4. Subjects with active corneal or conjunctival infection.
5. Subjects with active corneal, conjunctival, or intraocular inflammation (ie, uveitis).
6. Subjects with diabetic retinopathy.
7. Subjects with glaucoma or ocular hypertension.
8. Subjects with macular degeneration.
9. Subjects with previous ocular surgery.
10. Subjects on antihyperglycemic agents; corticosteroids; hydroxychloroquine (Plaquenil) and chloroquine (Aralen); tamoxifen (Nolvadex).
11. Pregnancy
12. Subjects who, in the judgment of the Investigator, may be inappropriate for the intended study procedures.
Co-inhibitory Molecules on Treg and miR-155-5p in Patients With Sepsis

there is high mortality rate of sepsis, 36% in 90-days of sepsis in China, and there is no effective treatment. Immunosuppression mediated by sepsis is an important cause of death in patients. Treg cells are important immunomodulatory cell. Treg's over-differentiation is involved in the development of sepsis induced immunosuppression. In sepsis patients, the expression of PD-1、CTLA-4 and TIGIT on Treg cell surface increased, and Treg cells with high expression of co-inhibitory molecules showed stronger immunosuppressive characteristics. MiR-155-5p is an unencoded RNA transcript from a proto-oncogene B cell integration cluster. In sepsis, the expression of miR-155 increased in peripheral blood and correlated with the patient's prognosis. Recent studies have shown that miR-155-5p promotes co-inhibitory molecules expressed on T cells in LCMV infected animal models. However, the relationship between the expression of peripheral blood miR-155-5p in sepsis patients and the expression of co-inhibitory molecules on Treg cell surface is not clear.

1. peripheral blood Treg cells and their surface PD-1、CTLA-4 and TIGIT levels in sepsis patients were measured by flowcytometry. SOFA score、APACHE II score were recorded
2. the level of miR-155-5p were measured by RT-qPCR in patients with sepsis on day 0-1 and day 3-5, and the correlation between the expression of the co-inhibitory molecules and miR-155-5p were evaluated

Eligibility Criteria:
Inclusion Criteria:

* sepsis 3.0 diagnositic criteria are met. older than 18 years old. total course is less than 7 days. Informed consent is obatained.

Exclusion Criteria:

* pregnancy. patients with active malignant tumors. chronic hepatitis or HIV. patients under treatment with immunosuppressive drugs (except patients with glucocorticosteroid prednisone or equivalent dose\<10 mg/d per day)
The Safety and Efficacy of Fecal Microbiota Transplantation in the Treatment of Digestive Diseases and Non-digestive System Diseases Associated With Gastrointestinal Symptoms in the Gastrointestinal Tract.

The exploration of the safety and efficacy of fecal microbiota transplantation in the treatment of non-digestive system diseases associated with gastrointestinal symptoms in the gastrointestinal tract, while also investigating the impact of fecal microbiota transplantation on the intestinal system, and assessing the improvement of symptoms in other systems.Simultaneously optimizing the conditions during the FMT process, identifying the most effective treatment methods to enhance the therapeutic outcomes of FMT.


Eligibility Criteria:
Inclusion Criteria:

* Being able to tolerate a nasoenteric tube or swallow a capsule.

Exclusion Criteria:

* Intestinal barrier dysfunction. Inability to tolerate enteral nutrition.
Smart Technology Facilitated Patient-centered Care for Patients With Pulmonary Thromboembolism

Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.

The objective of this study is to evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of pulmonary thromboembolism (PTE) on the long-term outcome of PTE patients, in order to enhance clinical practice and establish a foundation of evidence for managing patients with PTE.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients aged ≥18 years;
* （2）PTE confirmed through imaging examinations, meeting at least one of the following criteria: a.Newly diagnosed PTE during the current hospitalization; b. Prior PTE with imaging evidence of residual thrombus.
* Signed informed consent.

Exclusion Criteria:

* Previous PTE combined with CTEPH;
* Mental retardation or a combination of other serious illnesses that make them incapable of living on their own;
* Inability to use smartphones, computer tablets and other smart devices;
* Being pregnant or breastfeeding;
* Have participated in similar trials or are undergoing other clinical trials.
Protective Effects of Edaravone Dexborneol

The patients of acute ischemic stroke were divided into two groups, edaravone dexborneol treatment group and edaravone treatment group. The purpose of this study was to observe the changes of imaging and the improvement of NIHSS and mRS in different groups.

A total of 80 patients with acute ischemic stroke of middle cerebral artery were randomly divided into two groups, edaravone dexborneol treatment group and edaravone treatment group. The mismatch area between the low perfusion area of MRI 3D-ASL and the infarct area of DWI was defined as the ischemic penumbra, and the CBF perfusion pseudo color images with PLD of 1.5s and 2.5s were recorded. The above two CBF perfusion images were subtracted, and the residual area was quantitatively analyzed to reflect the establishment of collateral circulation. We aimed to observe whether there were differences in the improvement of ischemic penumbra and the establishment of collateral circulation between two groups after treatment. Besides, the improvment of NIHSS and mRS was also observed in different periods.

Eligibility Criteria:
Inclusion Criteria:

1. Aged from 50 to 80 years old;
2. Patients diagnosed as acute ischemic stroke according to Chinese guidelines for the diagnosis and treatment of acute ischemic stroke 2018 and who met the requirements of middle cerebral artery blood supply area infarction (except deep perforator disease) without treatment;
3. Brain MR showed that the low perfusion area of ASL was at least 20% larger than that of DWI core infarct area, and the contralateral mirror brain tissue was basically normal;
4. NIHSS score was between 4 to 24;
5. Patient or their legal representatives were willing to sign the informed consent form.

Exclusion Criteria:

1. Serious mental abnormality, complicated with heart, lung, liver, renal insufficiency or malignant tumor and other serious diseases;
2. Combined with cerebral vascular malformation or cerebral hemorrhage;
3. Pregnant or lactating women;
4. Allergic to edaravone or dexborneol;
5. There are interactions between the drugs being taken by patients and the study drug or affect the clinical trial parameters.
HEalthCAre Workers' Health: a Transversal Evaluation

The research focuses on assessing the overall health of residents at the Cochin Port Royal hospital Group.

* physical health
* Mental health: detection of signs of anxiety, depression, eating disorders, substance abuse, etc.
* Sexual health
* Quality of medical care (dental, gynecological)
* Knowledge of risk prevention, particularly infectious risks, in the workplace.

In the societal and medical crisis the investigators are currently facing, healthcare workers are a key element in maintaining public health institutions.

Nevertheless, their health has only been analyzed and managed from a fragmented or piecemeal perspective, despite the multiple dimensions of their health vulnerabilities: physical health, mental health, eating disorders, sedentary lifestyles, risk behaviours and so on.

In 2022, the occupational medicine department at Hôpital Cochin-Port-Royal will be systematically evaluating all residents during their 6-month internship at the hospital (not just new residents, during their first internship at AP-HP). To the knowledge of the investigators, this initiative is unique among AP-HP hospitals.

The investigators hope to take advantage of this unique procedure to gain a more precise knowledge of the health of residents at AP-HP in 2023-5.

The primary objective is to evaluate the health status of residents in a tertiary teaching hospital.

Secondary objectives:

* Determine the relevance and performance of a systematic occupational health consultation offered to every resident at the center.
* Identify levers for improvement to meet the unmet health needs of this specific population.

Eligibility Criteria:
Inclusion Criteria:

- Residents at Cochin Port Royal hospital between November 2023 and October 2025

Exclusion Criteria:

* Opposition to anonymous data collection
* Residents who benefited from the evaluation outside the analysis period: November 2023-October 2025.
Bilateral Benefit in Adult Users of the HiRes 90K Bionic Ear System

Normal hearing listeners gain important everyday benefits from listening with two ears (bilateral hearing) compared to their baseline performance with hearing aids. Advantages of bilateral hearing include the ability to determine where sounds are coming from and the ability to hear sounds and understand speech in noisy environments. Based upon these advantages, this study will (1) evaluate the benefit of hearing with two Bionic Ear implants (one in each ear) and (2) compare HiResolution sound processing with conventional sound processing.


Eligibility Criteria:
Inclusion Criteria:

1. No previous implant experience.
2. Age 18 years or older.
3. Postlingual onset of hearing loss.
4. Sensorineural hearing loss of a severe or greater degree in both ears.
5. Normal/patent cochlear anatomy in each ear.
6. English language proficiency.
7. Willingness and ability to participate in all scheduled procedures.

Exclusion Criteria:

No exclusion criteria specified, except for the opposite of inclusion criteria listed above.
Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon

The aim of the present study was to evaluate whether antibiotics is mandatory for the treatment of acute uncomplicated right-sided diverticulitis.

The hypothesis is that patients having acute uncomplicated diverticulitis at right-sided colon will be recovered without antibiotics.

All patients in the study were randomly allocated to one of the following two treatment groups; no-antibiotics group or antibiotics group.

Patients of no-antibiotics group were admitted to the ward and administered intravenous fluid and bowel rest at least up to 5 days until clinical symptom and sign were stabilized. And then the patient discharge until oral intake was tolerated.

In antibiotics group, the treatment was initiated with an intravenous combination of a third generation cephalosporin or quinolone and metronidazole until oral intake was tolerated. Oral antibiotics such as cefpodoxime together with metronidazole were initiated subsequently on the ward. The total duration of antibiotic treatment was an expected average 10days.

Patients in both group were re-visited outpatient clinic after an expected average 7 days for check-up of serology test (including complete blood count and C-reactive protein), and after an expected average 6 weeks for CT. If the patients did not re-visit outpatient clinic, we checked the call.

Eligibility Criteria:
Inclusion Criteria:

* Right-sided colonic diverticulitis
* Uncomplicated diverticulitis

Exclusion Criteria:

* Pregnancy
* Refuse to investigation
* Immunosuppressive therapy or immunologic incompetence
* Colonic diverticulitis except right-sided diverticulitis
* Complicated diverticulitis
* Disorder of psychology or cognition
* Allergic reaction to antibiotics being used in the study (3rd generation cephalosporin, quinolone, metronidazole)