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NCT ID: NCT04797728 Completed - Breast Cancer Clinical Trials

Elacestrant in Preoperative Setting, a Window of Opportunity Study

ELIPSE
Start date: February 9, 2021
Phase: Early Phase 1
Study type: Interventional

ELIPSE is a window of opportunity, prospective, multicenter, phase 0 trial which evaluates the effect of Elacestrant on proliferation after 4 weeks of treatment in postmenopausal women with Estrogen Receptor-positive (ER+) and Human Epidermal Growth Factor Receptor 2-negative (HER2-negative) early breast cancer (BC) amenable to surgery.

NCT ID: NCT04797650 Completed - Alopecia Areata Clinical Trials

Study to Evaluate the Efficacy and Safety of CTP-543 in Adults With Moderate to Severe Alopecia Areata (THRIVE-AA2)

THRIVE-AA2
Start date: June 10, 2021
Phase: Phase 3
Study type: Interventional

This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.

NCT ID: NCT04796883 Completed - Glaucoma Clinical Trials

A Study for Assessing the Safety of Hanita Glaucoma Shunt in Glaucoma Patients

Start date: June 30, 2015
Phase: N/A
Study type: Interventional

The HANITA Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed.

NCT ID: NCT04796753 Completed - Clinical trials for Musculoskeletal Injury

Detection of Neuromuscular Deficits in Uninjured Youth Basketball Players

DPL
Start date: October 1, 2018
Phase:
Study type: Observational

Basketball is an impact, coordination-opposition sport with continuous contact among players and it is considered a sport of medium-high injury incidence. Players are force to have a physical condition appropriate to their practice and the demand to which they must respond due to the intensity of the efforts this sport requires. In order to achieve this, it is necessary to establish an evaluation protocol that allows the detection of functional deficiencies, to guide and conduct in a specific and early way every moment of players' health and growth. The purpose of this study is to evaluate and detect federated youth basketball players' (U12 - U17) neuromuscular deficiencies in mobility, stability and landing technique in static and dynamic situations to simulate all the most important actions of basketball demands.

NCT ID: NCT04795544 Completed - Clinical trials for Laryngeal Mask Airway

Three Inflation Methods of Ambú Auragain™ and Its Adverse Effects

Start date: January 18, 2021
Phase: N/A
Study type: Interventional

Laryngeal mask is a common supraglottic device (SGD) used in the daily practice for airway management. Consecutive generations have permitted an expansion of its use. At the moment, the SGD is being used in several situations, which include general anesthesia, cardiopulmonary resuscitation, and difficult airway management. To insert the SGD safely in these situations, the Fourth National Audit Project has encouraged the use of second-generation SGD equipped with the passage of a nasogastric tube. Ambu Auragain™ is a recent second-generation SGD with an incorporated gastric drainage channel and the capability of working as a conduit for tracheal intubation. It has higher leak pressure than the ones of first generation, which is a key marker of efficacy and safety of its use; a higher leak pressure suggests a better seal between the artificial airway and patient's airway. However, there are still few reports of which volume of cuff is the most appropriate for it use. The cuff inflating volume is not standardized and it is common practice to inflate the SGD cuff according to the manufacturer's recommendations, without using a manometer. A hyperinflation of the laryngeal mask cuff was associated with complications ranging from sore throat, or dysphagia and dysphonia, to more serious complications such as paralysis of the vocal cord, arytenoid cartilages dislocation, recurrent laryngeal nerve injury and hypoglossal nerve injury. Also, the excess of volume or pressure is related to poor ventilation and increase the risk of gastric insufflation. The aim of this study is to evaluate the best cuff inflation method, in order to limit the intracuff pressure beyond the recommended maximum pressure (PM < 60 cmH2O) and to allows decrease the pharyngo-laryngeal complications. The Primary outcome is to compare three different cuff inflating methods using Auragain™ laryngeal mask during fibro bronchoscopy and endobronchial ultrasound (EBUS) procedures, and to control the intracuff pressure, and the effect on pharyngo-laryngeal complications. The three different cuff inflating methods are: 1) residual volume group (RV group ) 2) half of the maximum volume group (MV group) 3) unchanged volume group (NV group)

NCT ID: NCT04795180 Completed - Rectal Cancer Clinical Trials

Pilot Randomized Evaluation of Butyrate Irrigation Before Ileostomy Closure on the Colonic Mucosa in Rectal Cancer Patients (BUTYCLO)

BUTYCLO
Start date: December 10, 2013
Phase: Phase 2
Study type: Interventional

Low Anterior resection with total mesorectal excision and diversion loop ileostomy is a gold standard surgical treatment in rectal cancer. Ileostomy reversal performed in a second stage carries a high burden of postoperative complications. Terminal ileum and colon dysfunction during bowel disconnection could negatively influence postoperative morbimortality after loop ileostomy reversal in Rectal Cancer patients. Colonic microflora performs anaerobic breakdown of dietary fibre that reaches the gut in regular patients without ileostomy. One of the short-chain fatty acids (SCFAs) produced by bacteria is butyrate, the preferred substrate to be oxidized by colonocytes. The effects of butyrate irrigations before ileostomy closure on colonic mucosa will be studied in 45 rectal cancer patients. The effects of butyrate irrigation trough the efferent limb of loop ileostomy before its closure will be compared to the saline and non-irrigations group. Short term outcomes, colonic microbiota composition and functional outcomes will be evaluated after ileostomy reversal.

NCT ID: NCT04794036 Completed - Fatigue Clinical Trials

Efficacy of an Asynchronous Telerehabilitation Programme in Post-COVID-19 Patient

Start date: April 5, 2021
Phase: N/A
Study type: Interventional

SARS-CoV-2 is the coronavirus responsible for developing the disease known as COVID-19. Its evolution can range from an asymptomatic course, to rapidly evolve and cause an acute respiratory syndrome. In addition to respiratory symptoms, is also has an impact on the neuromuscular systems. Therefore, the additional inactivity for hospitalization, negatively influences the loss of muscular, cardiovascular and metabolic fitness. In view of this, it is recommended that early post-acute rehabilitation be continued after the hospital phase to increase levels of physical activity, which can also be continued with long-term telerehabilitation. This project would offer a free service of asynchronous physical telerehabilitation for the patient that is easy to implement and follow up. For this purpose, patients will be recruited at the time of discharge from the Hospital Provincial Nuestra Señora de Gracia (HPNSG) and the Hospital Royo Villanova (HRV) in Zaragoza and two intervention groups with the same physical therapy and educational programme will be carried out. The experimental group will be carried out by means of home telerehabilitation, while the control group will receive the programme in an explanatory booklet. The main objective is to analyse the preliminary efficacy on physical fitness of a 12-week physical therapy and therapeutic education programme using asynchronous telerehabilitation in post-COVID-19 patients, and to compare its effects with patients who have undergone the same programme, but in a non-telematic format. The secondary objective is to analyze the feasibility of a physical home-based asynchronous telerehabilitation programme in post-COVID-19 patients. Hypothesis: the implementation of a 12-week programme of physical therapy and therapeutic education using asynchronous telerehabilitation software is feasible and preliminarily effective in increasing physical fitness as well as adherence to treatment, and in the improvement of psychosocial factors.

NCT ID: NCT04792944 Completed - Hydrocephalus Clinical Trials

Brain Aneurysms: Utility of Cisternal Urokinase Irrigation

BA&UK
Start date: January 1, 2007
Phase:
Study type: Observational

Despite the efforts made in its treatment, aneurysmal subarachnoid haemorrhage continues to induce high mortality and morbidity rates. Today there are treatment protocols in all hospitals. The vast majority prefer, whenever possible, the endovascular route, given its lesser aggressiveness and morbidity. Although embolization prevents aneurysm' rebleeding, it does remove the subarachnoid blood clot. Therefore, it does not modify the evolution, incidence and severity of vasospasm. The idea is to carry out a 10-year retrospective study classifying patients into five groups based on the type of treatment received, analyzing the results' differences. The aim is to improve what is done as much as possible and to be able to propose potential areas for improvement. Besides, this study will be the basis of a future prospective study, prepared without the current one's biases and errors.

NCT ID: NCT04791852 Completed - Clinical trials for Cardiac Allograft Vasculopathy

Potential Role of Donor-derived Cell-Free DNA as a Biomarker in Cardiac Allograft Vasculopathy

FreeDNA-CAV
Start date: January 10, 2019
Phase:
Study type: Observational

Cross-sectional study. We will prospectively obtain ddcf-DNA levels in all patients who undergo routine coronary angiography > 1 year after HT. Our main goal is to evaluate the performance of Donor-derived Cell Free DNA (ddcf-DNA) as a biomarker of CAV.

NCT ID: NCT04790903 Completed - Clinical trials for Lymphoma, Large B-Cell, Diffuse

A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)

Start date: July 2, 2021
Phase: Phase 1
Study type: Interventional

This Phase Ib, open-label, multicenter study evaluates the safety, efficacy, and pharmacokinetics of venetoclax in combination with Pola + R-CHP in previously untreated participants with BCL-2 IHC-positive DLBCL. Approximately 50 participants will be enrolled in this study in five consecutive cohorts each consisting of approximately 10 participants.