cyrilzakka/clinical-trials huggingface dataset:
Retinal Therapy Guided by 3D OCT Image Analysis

The main purpose is to find a better way to predict the timing of treatments given to patients with Wet Age-related macular degeneration using image analysis.

The study focuses on making better use of advanced three-dimensional imaging and analysis to allow physicians to know when a treatment is being effective and thus not overuse it. The study will examine how 3-D optical coherence tomography and related image analysis can be used to assess changes in the macula and retina of patients' eyes. These changes can reveal how well a person is responding to anti-VEGF treatment and thus help doctors provide proper treatment timing and care.

Eligibility Criteria:
Inclusion Criteria:

* fundoscopically confirmed AMD and patient eligible for treatment with anti-VEGF

Exclusion Criteria:

* Patients with a CNV due to other causes (OHS, trauma)
* eyes that have been previously treated for CNV
A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts

This trial is performed to evaluate the safety and clinical efficacy of subcutaneous specific immunotherapy in patients suffering from seasonal allergic rhinitis/rhinoconjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Positive history of allergen specific allergic rhinitis/rhinoconjunctivitis
* Positive screening skin prick test (wheal diameter \> 3 mm)
* Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
* Signed and dated patient´s Informed Consent,

Exclusion Criteria:

* Previous immunotherapy within the last 3 years,
* Simultaneous participation in other clinical trials,
* Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
* Auto-immune disorders,
* Severe chronic inflammatory diseases,
* Malignancy,
* Alcohol abuse,
* Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
* Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Study of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)

This study will assess transcranial magnetic stimulation (TMS) as a biomarker and characterize TMS readouts of the activity of MK2637 and dextromethorphan. Resting quantitative electroencephalography(qEEG) readouts are also characterized with MK2637 and dextromethorphan.


Eligibility Criteria:
Inclusion Criteria:

* Subject is right-handed
* Subject is in good health
* Subject is a nonsmoker

Exclusion Criteria:

* Subject works a night shift
* Subject has a history of any illness that might make participation in the study unsafe or confound the study results
* Subject has a history of head injury
Total Knee Arthroplasty Analgesia: Single-shot Femoral Nerve Block or Epidural?

Single-shot femoral nerve block is similar to continuous epidural technique for postoperative analgesia in total knee arthroplasty


Eligibility Criteria:
Inclusion Criteria:

* Elective total knee arthroplasty

Exclusion Criteria:

* Coagulopathy
* Neuropathy
* Morbid obesity
* local anesthetics allergy
Study of Dalotuzumab (MK-0646) in Adults With Solid Tumors (MK-0646-009)

This clinical study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity of dalotuzumab (MK-0646) in participants with relapsed or refractory locally advanced or metastatic solid tumors using once weekly and once every other week dose infusion regimens.

The primary study hypothesis is that administration of dalotuzumab as a once weekly and an every other week infusion will be generally safe and well tolerated


Eligibility Criteria:
Inclusion Criteria:

* Has histologically- or cytologically-confirmed metastatic or locally advanced solid tumor(s) that has (have) failed to respond to standard therapy, or for which adequate standard therapy does not exist
* Has tumor(s) associated with insulin-like growth factor 1 receptor (IGF-1R) expression in the literature (e.g. prostate, pancreatic, colon, lung and breast)
* Has Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Demonstrates adequate organ function

Exclusion Criteria:

* Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
* Is concurrently using growth hormone (GH), or growth hormone inhibitor
* Has any active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has any primary CNS tumor - any symptomatic ascites or plural effusion
* Has a history or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the participant's participation, or pose an additional risk to the participant
* Is pregnant or breast-feeding
Intra-Operative Evaluation of the Glenoid Implant Position With Structured Light

Positioning of the glenoid component is one of the most challenging steps in shoulder replacement surgery. Prosthesis longevity and functional outcomes are considered highly dependent on accurate positioning. Currently, there are no adequate means to verify the position of the glenoid component during surgery which is a significant impediment to accurate positioning. We propose a non-interventional study to validate a novel technology for verifying the position of the glenoid component during shoulder replacement surgery.

Positioning of the glenoid component is one of the most challenging steps in shoulder replacement surgery. In this study, we are testing a new method of checking the glenoid component position using an optical light 3D scanner for both total and reverse total shoulder replacements. Currently, the position of the glenoid component is verified by the operating surgeon visually and there is no routine imaging to verify the position of the glenoid component during surgery.

Participants in this study will have a 3D optical image of their glenoid bone taken during the surgical procedure. Taking this image will require less than 3 minutes and the image will only include their surgical wound (no facial features or other identifying features will be taken in the images). Two to six weeks after the surgery, the study participants will have CT scan of their replaced shoulder. This will allow the researchers to measure the accuracy of the new imaging system.

It is anticipated that about 14 people will participate in this study at Sunnybrook. The length of this study for participants is 6 weeks. The entire study is expected to take about 1 year to complete and the results should be known 6 months after study completion.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age.
* Scheduled to undergo total shoulder arthroplasty surgery.
* Scheduled pre-operative CT imaging of the shoulder and the surgical plan includes open exposure of the glenoid.

Exclusion Criteria:

* Previous shoulder surgery involving the glenoid.
* No clinically indicated pre-operative CT imaging.
* Pregnancy (current or planned).
* Current or planned participation in other research, or having a clinical condition that would result in cumulative annual radiation exposure exceeding the regulatory limit (30 mSv) from all sources.
Virtual Chromoendoscopy for Distal Polyps

To assess the accuracy of predicting histology with virtual chromoendoscopy for distal colorectal polyps according to the ASGE PIVI statement.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Screening or surveillance colonoscopy

Exclusion Criteria:

* history of inflammatory bowel disease
* poor bowel preparation
* colectomy
* anticoagulation
* polyposis syndrome
MRSA in a Trauma Population: Does Decolonization Prevent Infection?

All trauma patients admitted to certain Intensive Care Units (ICU) will have Methicillin-resistant Staphylococcus aureus (MRSA) nasal swabs performed to determine MRSA colonization status. Only those patients who are determined to be colonized with MRSA at admission will be included in the study. All patients must be age 18 and older, admitted directly to the ICU from either the Emergency Department or the operating room with trauma-related injuries, and must not have active or recent known history of MRSA infections. Once patients have been determined to be colonized with MRSA, they will be randomized to receive "decolonization" treatment or placebo. "Decolonization" treatment will include Chlorhexidine baths and Mupirocin ointment to both nares for 5 days and placebo will entail "routine" soap baths and Lubricating Jelly. Both groups will be kept on standard contact precautions throughout the course of the study. Repeat nasal swabs will be performed at the completion of the treatment regimen to determine the efficacy. Patients will be screened for invasive MRSA infections as dictated by their clinical course. The primary outcome measure will be invasive MRSA infection rate (pneumonia, urinary tract infection, bacteremia and soft tissue infection). Secondary endpoints include hospital lengths of stay, ICU lengths of stay, mechanical ventilatory support requirements, colonization status at the end of treatment, and death rates. As determined by our power analysis, we aim to enroll 75 patients in each arm over the course of 12-24 months.

Partway through the enrollment period, it was determined that in the best interests of the patients, the protocol would be altered to eliminate the randomization process and treat all patients with the decolonization treatment regimen.

Eligibility Criteria:
Inclusion Criteria:

* colonized with MRSA at admission
* age of 18 years or older
* admitted directly to the ICU from either the ED or the OR with trauma-related injuries

Exclusion Criteria:

* active or recent known history of MRSA infection
* previous institutionalization
Evaluation of Mobiderm Intimate Bra in the Management of Breast Edema Related to Breast Cancer Treatment

The aim of this exploratory study is to assess the performance and tolerability of the MOBIDERM Intimate Bra in the management of breast edema related to breast cancer treatment.

Breast cancer is the most common malignancy in women in the Western World. BCS followed by radiotherapy is a safe and effective procedure to treat patients with early-stage \[Verbelen H., 2021\]. But some patients are troubled by breast edema in the operated and irradiated breast. The consequences of breast edema can be : an increase in breast volume, orange peel skin, heaviness of the breast, redness of the skin, breast pain, thickening of the skin, hyperpigmented skin pores \[Verbelen H., 2014\]. Breast edema can also imply deterioration in patients' quality of life, physical functioning, and body image \[Young-Afat D. A., 2019\].

According to the literature, only a few clinical studies evaluated the value of compression medical devices in the management of breast edema.

The aim of the study is to perform a prospective, exploratory, monocentric, uncontrolled clinical study to look at the performance and safety of Mobiderm Intimate Bra in the management of breast edema related to breast cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 18 years and older.
* Patients who have undergone conserving surgery for breast cancer.
* Patients scheduled to undergo radiation treatment of the breast/chest wall within the next 12 weeks after surgery.
* Patients with a morphology compatible with the proposed sizes of the devices, including bust girth and cup size.
* Patients who have signed an informed consent form prior to any study intervention.
* Patients with full legal capacity and enrolled in a social security system or covered by a similar health insurance.

Exclusion Criteria:

* Patients with an A cup bra size.
* Patients with infected or acutely inflammatory skin on the chest.
* Patients who require chemotherapy during the follow-up period.
* Pregnant women or women of childbearing age without adequate contraception or in the lactation period.
* Participation in other clinical trials that impact the primary endpoint.
* Patients with a known allergy to the investigational device components.
* Patients with psychiatric, psychological, or neurological disorders that are incompatible with the conduct of a clinical trial.
* Patients unable to be followed for 12 months.
* Vulnerable patients, or those subject to a judicial protection measure or unable to provide informed consent freely.
VIrtual REality Glasses for the Enhancement of Acute BRACHYtherapy Tolerance for Endometrial Cancer Patients.

This randomized phase III multicenter trial aims to evaluate the impact of virtual reality helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of pain and anxiety.

Endometrial cancer is one of the most common gynaecological cancers among women in the developed countries. After a curative surgical treatment, many relapses occur in the vaginal cuff. The PORTEC-2 trial has demonstrated a similar reduction in local relapses of intermediate- to high-risk endometrial cancer with vaginal cuff brachytherapy (VCB) than with external beam radiotherapy (EBRT). However, VCB induced less late toxicities. VCB is therefore indicated after surgery for intermediate- to high-risk endometrial cancer. VCB is also recommended after radiation therapy, for patients with stage II or III type 1 endometrial cancers according to the International Federation of Gynaecology and Obstetrics classification (FIGO), and for all patients with histological type 2 endometrial cancers.

If the late tolerance of VCB is correct, the acute tolerance remains limited, and is mainly characterized by local pain and anxiety) Virtual reality appears to be a promising tool to enhance treatment cancer tolerance, offering a safe and entertaining environment. By the way, the use of virtual reality could limit physical and psychical discomfort induced by VCB.

This randomized phase III multicenter trial aims to assess the impact of virtual reality helmets (visual and audio) during VCB in patients treated for endometrial cancer, in terms of pain (primary endpoint), and in terms of anxiety (secondary endpoint). Randomization will define which patient will wear a virtual reality helmet. Stratification will be performed according to the following criteria: vaginal molded applicator versus cylinder, two applications versus four; \<70 years versus\> 70 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old.
* Patients with endometrial cancer, with histological type I and II, regardless of the degree of differentiation.
* Patients with stage I, II or III endometrial cancer according to the FIGO classification.
* Patients treated with high-dose-rate vaginal cuff brachytherapy, with curative intent.
* Patients affiliated or entitled to a social security scheme.
* Patients who received information about the study and co-signed with the investigator the consent to participate at the study.

Exclusion Criteria:

* Patients with stage IV endometrial cancer according to FIGO classification.
* Patients presenting recurrence of endometrial cancer.
* Pregnant or nursing women.
* Patients under protection of justice or unable to give consent.
A Study of the Efficacy and Safety of a 3-month Treatment Course of Ulipristal Acetate for the Treatment of Abnormal Uterine Bleeding Associated With Leiomyomas

This study will evaluate the superiority of ulipristal acetate versus placebo for the treatment of abnormal uterine bleeding associated with uterine fibroids


Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal women, 18-50 years, inclusive.
* Cyclic abnormal uterine bleeding (heavy or prolonged).
* Menstrual blood loss (MBL) of ≥ 80 mL as measured by the alkaline hematin method in the first 8 days of menses.
* Minimum of one discrete leiomyoma observable by transvaginal ultrasound.
* Endometrial biopsy without evidence of malignancy or atypical or non-atypical hyperplasia

Exclusion Criteria:

* History of uterine surgery that would interfere with the study endpoints.
* Known coagulation disorder including bleeding disorder or clotting disorder.
* History of, or current uterine, cervix, ovarian, or breast cancer.
* Alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), or total bilirubin two times or greater than the upper limit of normal rang
Pilot Trial of KB001 in Mechanically-Ventilated Patients Colonized With Pseudomonas Aeruginosa

Pseudomonas aeruginosa is an opportunistic pathogen that rarely causes disease in healthy people, but is a significant problem for critically ill or immunocompromised individuals. Experts estimate that there are greater than 100,000 patients in the United States, Europe and Japan where Pseudomonas pneumonia occurs. Patients with Pseudomonas pneumonia currently represent only about 20% of the patients in the hospital who get Pseudomonas infections.

This trial will evaluate KB001 in patients in the intensive care setting who are receiving ventilator therapy and who have Pseudomonas infections. They will receive either placebo, or one of two dose levels of KB001, a Humaneered™, high-affinity antibody fragment that KaloBios is developing for the treatment of Pseudomonas aeruginosa (Pa) infections. This trial will evaluate the ability of KB001 to protect host epithelium and immune cells, and evaluate reduction of pulmonary Pa burden.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent obtained from patient or patient's surrogate if unconscious or altered sensorium
* Age \>18 years
* On mechanical ventilation and expected to remain mechanically ventilated for at least 3 days
* Documented pulmonary Pa colonization

Exclusion Criteria:

* Patients with known chronic pulmonary infection with Pa (i.e., patients with cystic fibrosis)
* Patient currently diagnosed with Pa VAP
* Change in systemic antibiotic therapy active against Gram negative bacteria within 72 hours
* Use of an investigational medication within 4 weeks prior to randomization
Analgesic Effect of Bilateral Quadratus Lumborum Block in the End of Colorectal Laparosopic Surgery.

The primary purpose of COLOQUAL study is to demonstrate the superiority of analgesic effect of a bilateral quadratus lumborum block (QLB), performed at the end of laparoscopic colorectal surgery, compared to standard of care.

The investigators hypothesized that a bilateral quadratus lumborum block performed at the end of laparoscopic colorectal surgery would reduce the incidence of post operative pain, time spent in recovery room, improve patient's satisfaction, and reduce hospitalisation time

Visits:

* The patient will arrive in the department the day before the surgical intervention (Day-1). During this preoperative visit (Day-1), the investigator

  * will preselect potentially eligible patients
  * will offer to participate to this study
  * will give the notice form to the patients
  * will present the research: objectives, benefits and constraints for the patients
* The intervention day (Day 0):

The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria.

The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF.

Surgical Intervention (Day 1):

All patients will receive standard anaesthesia using sufentanyl, propopol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score. Anti microbial prophylaxis is performed according recommendations.

All patients will receive post operative multimodal analgesia using intravenous lidocaine, acetaminophene, ketaminophene, and morphine if NRS (numerating rating scale) \> 3 At the end of the surgery, patients in the experimental group will receive a bilateral ultrasound guided quadratus lumborum block with 15 ml of 3,75 mg/mg of ropivacaine. Patients in the control group will not receive the block

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patients operated of a scheduled laparoscopic colorectal surgery
* Patients having given consent in the mannen described in Article L1122-1-1 of the Public Health Code
* Patients affiliated with asocial security regimen or beneficiary of such a regimen

Exclusion Criteria:

* Renal insufficiency (ie glomerular filtration output \< 35 ml/min)
* Patients with chronic inflammatory bowel disease
* Body mass index \> 35 kg/m2
* Chronic pain with opiates
* Patients with cognitive troubles
* Coagulation disorders (platelets count \< 80G/L, PT\< 50%, V factor \< 50%)
* Pregnancy
* Breastfeeding
* Local anesthesics (amide class) allergy
* Laparotomy conversion
Assessment of the Quality and Sexual Health Needs of Patients with Advanced-stage Cancer

Sexual health is an important determinant of the overall health of a population, as addressed in the French National Strategy 2017-2030. For a long time neglected in oncology, sexual health is now part of clinical assessments in cancer support care and is fully integrated into practice recommendations. However, existing evidences, though limited, are still suggesting unmet needs during the palliative phase of the disease.

Current literature focuses on the assessment and management of potential issues related to genital cancers - primarily gynecological, breast, and prostate cancers - but also on post-cancer experiences. The sexual health needs of patients in palliative care are understudied, except one study that reports how patients are considering sexuality as an important aspect of their lives, even during the last weeks to days of life.

In the aim of developing an efficient complex intervention for the population of patients with cancer in palliative situations, it is necessary to identify the needs, facilitators, and modalities required for promoting sexual health in this population (beyond the extensively studied cases of genital cancers). A solely patient-centred approach would be limiting, and this objective requires an approach dedicated to the life partners as well.

To assess satisfaction related to sexual health and gain insights regarding the expectations of patients and their partners towards the healthcare system, the study INTIMI-K will utilize a mixed methodology involving the use of a questionnaire, including validated scales, and semi-structured interviews. Patients aged 18 and older, diagnosed with advanced solid or hematological cancers, along with their life partner will be included.


Eligibility Criteria:
Inclusion Criteria:

For patients:

* Individuals aged 18 and older,
* Patients diagnosed with advanced solid or hematological cancers,
* Whether or not undergoing specific treatment for the ongoing oncological condition,
* Having a cancer diagnosis for more than 3 months (baseline diagnosis consultation),
* Capable of understanding study-related documents,
* Capable of completing questionnaires,
* Fluent in French,
* Individuals who have not objected to participating in the study.

For partners:

* Individuals aged 18 and older,
* Individuals whose life partner has been diagnosed with advanced solid or hematological cancer for more than 3 months, whether or not they have received treatment,
* Capable of understanding study-related documents,
* Capable of completing questionnaires,
* Fluent in French,
* Individuals who have not objected to participating in the study.

Exclusion Criteria:

* Individuals unable to complete the entire questionnaire due to their clinical condition.
* Individuals under guardians, curators, or legal protection.