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NCT ID: NCT05528809 Recruiting - Clinical trials for Systemic Sclerosis, Diffuse

Quantification and Characterization of Circulating Epithelial and Endothelial Cells in Gougerot-Sjögren Syndrome, Compared to Systemic Sclerosis

CIRCEE
Start date: October 12, 2022
Phase: N/A
Study type: Interventional

Primary Gougerot-Sjögren's syndrome is a systemic autoimmune disease belonging to the group of connectivities, whose physiopathology remains largely unknown. Quantification and characterization of epithelial and endothelial circulants in Gougerot-Sjögren's syndrome could reflect the intensity of the epithelial aggression, and thus possibly constitute a biomarker.

NCT ID: NCT05528731 Completed - Clinical trials for Female Hormonal Contraception

Perception of Female Hormonal Contraception by the Main Prescribers

CHF
Start date: May 31, 2022
Phase:
Study type: Observational

The recommendations for contraception, after researching contraindications to certain methods, are to offer clear and honest information to allow the patient to make an informed choice, adapted to her lifestyle. The best contraception is the one chosen by the patient. The choice of contraception illustrates the difficulty of assessing the benefit-risk balance in the context of functional and preventive treatment. Taking into account this imbalance between patient beliefs and medical advice is an essential step in improving the provision of gynecological care.

NCT ID: NCT05528614 Completed - Tumor of Pancreas Clinical Trials

Evaluation of the Results of Simultaneous Pancreatic and Hepatic Resections for Metastatic Neuroendocrine Tumors.

ReSiPaTNE
Start date: January 13, 2022
Phase:
Study type: Observational

The indications for synchronous liver resection for metastatic neuroendocrine tumors of pancreatic origin remain debated and poorly described in the literature. The reported mortality of this type of simultaneous resection remains very high, especially when a cephalic duodenopancreatectomy is associated with a hepatic resection (up to 40%). The benefit in terms of survival remains to be evaluated. The ReSiPaTNE study proposes to create a retrospective cohort of simultaneous pancreatic and hepatic resections for metastatic neuroendocrine tumors in order to evaluate the short and long term results of this type of resection. The evaluation of the results of this type of resection may be useful for the selection of patients for treatment.

NCT ID: NCT05528510 Active, not recruiting - Colitis, Ulcerative Clinical Trials

A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

ASTRO
Start date: September 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT05528497 Recruiting - Virtual Reality Clinical Trials

Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia

OVOREV
Start date: September 26, 2022
Phase: N/A
Study type: Interventional

Medically Assisted Reproduction provides help to infertile couples, single women and couples of women with a pregnancy project, and to women who wish to preserve their gametes. In the context of In Vitro Fertilization (IVF), oocyte donation or oocyte preservation, it is necessary to perform an oocyte stimulation, followed by an ovarian puncture in order to retrieve mature oocytes. Several types of anesthesia can be used for this procedure: general anesthesia, local anesthesia and spinal anesthesia. The puncture can also be performed under hypnosis, but this practice is difficult to generalize, as it requires specific training. None of these different types of anesthesia has proven to be superior in terms of number and quality of oocytes collected, so the choice is left to the patient. General anesthesia is mostly chosen at Rennes, although it exposes to more risks and represents a higher socio-economic cost. Improving the comfort of these patients during oocyte retrieval is a priority, especially since they may have to undergo several successive retrievals during their treatment. What if virtual reality could be a way to improve the comfort of these patients? Indeed, this technology, which allows activity in an artificial 3-dimensional world, is considered as a non-pharmacological tool for pain management and its use during surgery would also reduce the level of anxiety. In our study, during the oocyte retrieval under local anesthesia, the patients randomized in the experimental group will wear a virtual reality headset diffusing an atmosphere considered as relaxing. The expected results of this work would be a significant decrease in pain during oocyte retrieval under local anesthesia in patients wearing the virtual reality headset, associated with a decrease of anxiety and a significantly higher satisfaction score. The final objective would be to consider this tool as a non-invasive means that could be used in routine in the department of Medically Assisted Reproduction of Rennes, but also in other cities. In the longer term, the reduction of pain and anxiety could encourage patients to choose local anesthesia and therefore increase its use. Observational, prospective, randomized, open-label, monocentric study.

NCT ID: NCT05528328 Recruiting - Scars Clinical Trials

Post-surgical Scars After the Use of CACIPLIQ20

MATRISCAR
Start date: March 21, 2023
Phase: Phase 3
Study type: Interventional

Following surgical procedures or injury, cutaneous scars can develop due to production of collagen-rich connective tissue. These scars may be accompanied by redness, itching, pain, and restricted mobility of the skin. Typically, after a few weeks, the scar matures, becoming lighter and narrower, although full maturation of a scar may take up to 2 years. In some cases, however, cutaneous scars can be unsightly or can even become hyper- trophic or result in keloids. Preventing pathological scarring is much easier than treating scars later and should be started as early as possible after the injury or surgery. CACIPLIQ20® is a medical device used for the treatment of chronic skin ulcers, and contains a molecule belonging to the family of ReGeneraTing Agents (RGTA®). RGTA®s are biodegradable polymers that mimic the action of heparan sulfates found in the extracellular matrix of injured tissues. RGTA® accelerates tissue healing in various animal models, by stabilizing and protecting heparin-binding growth factors (HBGFs) and matrix proteins. In addition to its effects on hard-to-heal chronic wounds, CACIPLIQ20® was found to improve acute wound healing in pre-clinical models and in several case reports and controlled clinical studies. A first open label-controlled study showed that the topical application of RGTA® improved skin healing in mammoplasty patients and notably reduced oedema and pain in patients who had undergone centrofacial lift surgery compared to untreated patients. Results from this first study were confirmed in a double-blind placebo self-controlled trial conducted in two medical institutions in China involving 71 patients. The Chinese study showed that a single application of CACIPLIQ20® significantly improved scar healing quality at 14 days as well as scar symptoms including pain, swelling and exudate. The aim of the MATRISCAR study is to confirm the previous results in a double-blind, placebo-controlled randomized clinical trial.

NCT ID: NCT05527873 Completed - Esophageal Atresia Clinical Trials

Respiratory Complications of Operated Esophageal Atresia in Children

ATRESIA
Start date: March 16, 2022
Phase:
Study type: Observational

The respiratory complications of esophageal atresia have already been identified. They are mainly related to tracheomalacia linked to the esophageal malformation, and are aggravated by frequently associated gastroesophageal reflux. In this context, symptoms of asthma (or bronchial hyperreactivity) occur more frequently than in the general population and persist into adulthood. Their pathogenesis is still poorly understood and is the subject of much discussion. The therapeutic management of these respiratory complications, poorly codified, remains very heterogeneous from one center to another. In France, the summary of knowledge is updated by the Reference Center for chronic and malformative diseases of the esophagus.

NCT ID: NCT05527860 Recruiting - Osteoarthritis Clinical Trials

Evolution of the State of Health of Patients Undergoing Surgery for Osteoarticular Surgery

EPOPEE
Start date: August 8, 2022
Phase:
Study type: Observational

Osteoarticular surgery is frequently associated with the occurrence of moderate to severe postoperative pain. This pain can persist and become chronic post-surgical pain that is often debilitating. The transition between early postoperative pain and chronic pain is poorly understood, which complicates treatment.

NCT ID: NCT05527795 Recruiting - Melanoma Clinical Trials

Predictive Clinical Features for Response to Adjuvant Immunotherapy in Stage II,III and IV Resected Melanoma

Mel-ImmAdj
Start date: January 1, 2019
Phase:
Study type: Observational

Surgical excision is the treatment of choice for stage II, III and resectable stage IV melanoma and is curative in most cases. Given the recent success of immunotherapy for the treatment of patients with advanced metastatic melanoma, the use of immunotherapy has been evaluated in the adjuvant setting for patients at high risk of recurrence. In this context, Nivolumab prolonged Recurrence-Free Survival (RFS) while reducing toxicity compared with Ipilimumab in a phase III clinical trial, and was subsequently FDA-approved in December 2017 for adjuvant treatment of locally advanced melanoma with metastatic lymph node involvement after resection of cutaneous lesions. While a fraction of patients benefit from adjuvant PD-1 immunotherapy, approximately 40% of patients are still relapsing despite this adjuvant treatment, without being able to identify them early and with poor understanding of resistance mechanisms. Additionally, about 15% of the patients will develop serious adverse effects driven by immunotherapy and often discontinuing or even contraindicating the onset of subsequent treatments, hence affecting global patients care. It is therefore of prime importance to identify clinical features able to predict response and toxicities to adjuvant immunotherapy in melanoma.

NCT ID: NCT05527769 Completed - Clinical trials for Breast Cancer Female

Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique

DREAM-RMI
Start date: September 7, 2022
Phase:
Study type: Observational

This is a prospective, single-center, non-randomized study of immediate breast reconstruction (IBR) using a pre- or retro-pectoral technique in patients with breast cancer who have undergone total mastectomy. The technique used is chosen according to the characteristics of the breast, the morphology of the patient and her wishes after informed information on the different techniques. The aim is not to compare the two techniques but rather to evaluate the early functional results of these two methods in order to better understand them and to propose a management adapted to each. The main objective will be to evaluate the postoperative pain by BPI questionnaire. The investigators also wish to observe the functional results of the homolateral upper limb by DASH questionnaire, the quality of life by BREAST Q questionnaire and the occurrence of complications.