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NCT ID: NCT04125498 Suspended - Clinical trials for Cesarean Section Complications

The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study.

S-CARE
Start date: December 1, 2019
Phase: N/A
Study type: Interventional

This study aims to examine the effects of an osteopathic treatment on adhesions related to c-sections scars.

NCT ID: NCT04124016 Suspended - Diet Modification Clinical Trials

Metabotypes in the Urinary Excretion of Flavan-3-ol Metabolites: "Metanols"

Metanols
Start date: September 2, 2019
Phase: N/A
Study type: Interventional

Flavan-3-ols are the main source of flavonoids in Western diets. They are characteristic compounds of tea, cocoa, wine, apple, pears, etc. In plant-based foods, they occur as simple monomers or as oligomers and polymers of up to 50 units (also known as proanthocyanidins or condensed tannins). When ingested, both monomeric and high molecular weight flavan-3-ols are poorly absorbed and metabolized in the first gastrointestinal tract, reaching the colon and becoming a suitable substrate for the local microbiota. These compounds undergo an extensive microbial metabolism leading to the formation of hydroxyphenyl-γ- valerolactones (PVLs), which are then absorbed by colonocytes before reaching the liver and being converted into phase II conjugated metabolites. Since the microbiota composition varies among individuals, it results in differences in the production of PVLs and, consequently, the health effects of flavan-3-ols might change at an individual level. Another factor of variability might be due to a different asset in the fermentation of indigestible dietary carbohydrates, which are known to modify colonic pH through the production of short-chain fatty acids and may result in different profiles of gas production (i.e. hydrogen and methane), possibly affecting the bioconversion of flavan-3-ols as well. Nevertheless, these multiple variabilities are poorly understood to date.

NCT ID: NCT04090463 Suspended - Clinical trials for Borderline Resectable Pancreatic Cancer

IORT on Borderline Resectable Pancreatic Cancer

PancFORT
Start date: October 1, 2019
Phase: Phase 2
Study type: Interventional

This phase II study investigates the efficacy of IORT for patients with borderline resectable pancreatic cancer. The purpose of the study is to investigate whether the addition of IORT, after FOLOFIRINOX-base chemotherapy, and SBRT, increases the 3-year survival rate. A total of 101 patients will be enrolled, and these patients will receive IORT of 10 to 20 Gy, according to the resection status (to the tumor bed after resection, or to the tumor in situ in case of non-resection).

NCT ID: NCT04042116 Suspended - Clinical trials for Advanced Solid Tumor

A Study to Evaluate Lucitanib in Combination With Nivolumab in Patients With a Solid Tumor

Start date: July 29, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, Phase 1b/2 study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (Phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (Phase 2) and evaluate the effects of dosing under fasting or fed state (Food Effect)

NCT ID: NCT04026217 Suspended - Respiratory Failure Clinical Trials

Diaphragm Ultrasound as a Powerful Tool in Managing Acute Hypoxemic Respiratory Failure in Hematological Patients

Start date: May 27, 2019
Phase:
Study type: Observational

Acute hypoxemic respiratory failure due to parenchymal disfunction is one of the main complications of immunocompromised hematological patients. Mechanical ventilation is frequently needed and diaphragm activity has to be assessed not to worsen ventilator-induced lung injury.

NCT ID: NCT03869710 Suspended - Neck Pain Clinical Trials

Analgesic Effects of Ultrasound-guided Dry-Needling Therapy for Neck and Head Pain

Start date: March 8, 2019
Phase: N/A
Study type: Interventional

The analgesic effects of ultrasound-guided dry-needling therapy will be evaluated in the management of head and neck pain.

NCT ID: NCT03843320 Suspended - Clinical trials for Aortic Valve Stenosis

Impact of SAVR and TAVR on Patient's Activity and Mobility

CAPABILITY
Start date: December 2021
Phase:
Study type: Observational

This is an independent, investigator-initiated, prospective multicenter observational study with restricted grant provided by Edwards Lifesciences that aims to describe baseline (preoperative) physical function and to assess and compare 6-month postoperative changes in the physical function of patients undergoing aortic stenosis (AS) treatment with either transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) implanted with Edwards valve type ("SAPIEN 3" and "SAPIEN XT" for TAVR; "INSPIRIS RESILIA", "EDWARDS INTUITY" and "Carpentier-Edwards PERIMOUNT Magna-Ease" for SAVR). Secondary objectives of this study are: to evaluate the validity of wearable devices in assessing physical function in such patients and subjects' compliance in wearing the device also after a very long follow-up time up to 12 months; to assess and compare 6-month postoperative changes in Health-Related Quality of Life (HRQoL), sleep quality, cognitive function of patients undergoing AS treatment with either TAVR or SAVR. Smart watch activity tracker "Vívoactive® HR" devices by "Garmin©" will be used in the study. Devices will be distributed to the patients at time of baseline assessment, along with a Bluetooth-paired smartphone provided with a prepaid data-only SIM-card and study-customised interface. Patients will be asked to wear the device 24 hours a day, 7 days a week, from the baseline assessment to the last follow-up, 12 months after baseline.

NCT ID: NCT03719937 Suspended - Clinical trials for Acute Respiratory Distress Syndrome

Artificial Increase in Chest Wall Elastance as an Alternative to Prone Positioning in Moderate-to-severe ARDS.

ALTERPRONE
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

During moderate to severe ARDS, sessions of prone positioning lead to lung and chest wall mechanics changes that modify regional ventilation, with a final redistribution of tidal volume and PEEP towards dependent lung regions: this limits ventilator-induced lung injury, increases oxygenation and convincingly improves clinical outcome. Physiological data indicate that the increase in chest wall elastance is crucial in determining the benefit by prone positioning on oxygenation. In some patients, however, prone positioning may not be feasible or safe due to particular comorbidities and/or technical issues. In the present pilot-feasibility study enrolling 15 subjects with moderate to severe ARDS in whom prone positioning is contraindicated or unfeasible, we aim at assessing whether and to what extent an artificial increase in chest wall elastance while the patient is in the supine position may yield a significant benefit to oxygenation. The increase in chest wall elastance will be achieved placing 100g/kg weight on the anterior chest wall of the patient while he/she is in the supine position: this approach previoulsy appeared safe and effective in case reports and small case series. Patient's position will be standardized (30 degrees head-up, semi seated position). This one-arm sequential study will evaluate the effects of the procedure on gas exchange, haemodynamics, lung and chest wall mechanics, alveolar recruitment (measured with the nitrogen washout-technique and multiple PV curves) and tidal volume and PEEP distribution (assessed with electrical impedance tomography).

NCT ID: NCT03316833 Suspended - Clinical trials for Coronary Artery Disease

The Rolex Registry (Revascularization Of LEft Main With Resolute onyX)

Rolex
Start date: November 1, 2017
Phase:
Study type: Observational

The primary objective of this study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of unprotected left main coronary artery disease (ULMCAD), both isolated or in association with two- or three-vessel coronary artery disease.

NCT ID: NCT02749058 Suspended - Hip Arthrosis Clinical Trials

Capsulectomy vs Capsulotomy in Total Hip Arthroplasty. Clinical Outcomes and Proprioception Evaluation

Start date: April 2016
Phase: N/A
Study type: Interventional

The purpose of our study is to evaluate the differences in functional activities and proprioception after surgery in subjects who underwent hip prosthesis implant with capsulotomy or capsulectomy.