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NCT ID: NCT03794544 Completed - NSCLC Clinical Trials

Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

Start date: March 8, 2019
Phase: Phase 2
Study type: Interventional

Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).

NCT ID: NCT03793556 Completed - Clinical trials for Gastro-oesophageal Reflux Disease

Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor

Start date: May 5, 2017
Phase: N/A
Study type: Interventional

The aim of the present study was to evaluate the effect of a 6-weeks treatment of a CE-marked combination oral formulation of hyaluronic acid with chondroitin sulphate and aluminium hydroxide (GERDOFF®), in addition to proton pump inhibitors (PPI) at the standard dose, versus PPI only, in patients with first diagnosed clinical presentation of extra-esophageal GERD symptoms. The investigators verified the reduction of symptoms frequency, using a Likert questionnaire, and severity, using the Reflux Symptom Index (RSI) questionnaire, to evaluate the proportion of Responders and Non-Responder patients in these two groups after 6 weeks of treatment, compared to baseline. Moreover investigators evaluated the persistence of effects of GERDOFF® + PPI treatment on extraesophageal symptoms, after a 12-weeks follow up, only in responder patients.

NCT ID: NCT03792555 Completed - Acromegaly Clinical Trials

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)

Start date: December 18, 2018
Phase: Phase 2
Study type: Interventional

A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.

NCT ID: NCT03791775 Completed - Clinical trials for Second-degree Hemorrhoids

Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease

SCLEROFOAM
Start date: January 2, 2019
Phase: Phase 2
Study type: Interventional

Hemorrhoidal disease (HD) is one of the oldest and most common proctologic diseases that has been described with an estimated prevalence between 4.4% and 86%. Despite the proposal of three mechanisms that might underlie haemorrhoidal development - the varicose vein theory, the vascular hyperplasia theory and the sliding anal-lining theory, the exact pathophysiology of symptomatic hemorrhoid disease is poorly understood. HD seems to be the most common cause for rectal bleeding, or hematochezia, and the second most frequent cause for severe rectorrhagia after diverticulitis. The blood is bright red and coats the stool at the end of defection. Other symptoms include pain, mucous discharge, itching or the sensation of tissue prolapse. The most widely accepted classification is the Goligher classification: - Grade I: hemorrhoids bleed but do not prolapse out of the anal canal; - Grade II: hemorrhoidal cushions prolapse outside of the anal canal on straining or during bowel movements, but reduce spontaneously; - Grade III: hemorrhoidal cushions prolapse outside the anal canal on straining and require manual reduction; - Grade IV: hemorrhoidal prolapse is irreducible even with manipulation

NCT ID: NCT03791320 Completed - Clinical trials for Coronary Artery Disease

Fast Assessment of STenosis Severity- FASTII Study

FASTII
Start date: October 15, 2018
Phase:
Study type: Observational

The Multicenter FAST (Fast Assessment of STenosis severity) study is a prospective observational multicenter study designed to evaluate the diagnostic accuracy of offline 3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands) in identifying hemodynamically significant coronary artery disease with pressure wire-based FFR (≤0.80) as the reference standard.

NCT ID: NCT03791242 Completed - Clinical trials for Obstructed Sleep Apnea Syndrome in Patient Candidate to Baratric Surgery

Ketogenic Diet and CPAP Previous Bariatric Surgery

Start date: March 21, 2019
Phase: N/A
Study type: Interventional

Obstructive Sleep Apnea Syndrome (OSAS) and obesity tend to coexist and are often associated with arterial hypertension, dyslipidaemia, and insulin resistance [1]. Polysomnography (PSG) is the standard technique for diagnosing OSAS and determining its severity [2]. The results of the examination provide the Apnea-Hypopnea Index [AHI], or the Respiratory Disturbance Index [RDI]), which will be used to quantify apnea and classify its severity based on an international score. In general, an AHI scoring less than 5 is considered "normal" (5-15 mild sleep apnea; >15 moderate sleep apnea; ≥30 severe sleep apnea). In order to improve those parameters in obese patients who have been diagnosed with OSAS and are candidates for BS (BS), national and international guidelines recommend preoperative CPAP (Continuous Positive Airway Pressure) treatment in order to reduce anaesthesia risks [3-6]. Furthermore, several studies report that obese OSAS patients benefit from preoperative weight loss [1,7] (in terms of AHI index, night snoring and arterial hypertension). Obese patients who are candidates for BS often go on a preoperative diet in order to decrease weight and liver volume (especially of the left lobe) and correct any vitamin/mineral deficiency. The results of a recently published study show that 4 weeks of Ketogenic Micronutrient Enriched Diet (KMED) significantly reduce body weight, liver lobe volume and vitamin/mineral deficiencies in obese patients who prepare to undergo BS [8], with resulting foreseeable reduction of intraoperative complications and surgical time. To date, there are no prospective multicenter randomized trials demonstrating whether a preoperative ketogenic diet associated with CPAP use improves OSAS versus treatment with CPAP alone, with the possibility of reducing the preoperative treatment period. Aim of the study: To assess the clinical advantage in combining two preoperative strategies (CPAP + KMED) compared to preoperative treatment with CPAP alone, for the reduction of surgical risks in morbidly obese patients with severe OSAS who are scheduled for BS.

NCT ID: NCT03790267 Completed - Clinical trials for Arthroplasty, Replacement, Knee

Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty

PaRIS-IOR
Start date: January 1, 2019
Phase:
Study type: Observational

PaRIS-IOR is a prospective observational study that aims to collect and analyze functional outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR).

NCT ID: NCT03790254 Completed - Clinical trials for Antibiotic Prophylaxis

D Mannose for Prevention and Treatment of RUTIs

mannoseRUTIs
Start date: January 1, 2010
Phase:
Study type: Observational

The aim of this review is to address clinical reliability, efficacy and safety of long-term treatment with oral D Mannose for the prevention of recurrent urinary tract infections (RUTIs) in females.

NCT ID: NCT03789656 Completed - Acromegaly Clinical Trials

An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

Start date: January 15, 2019
Phase: Phase 2
Study type: Interventional

An open label exploratory study designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly that are treated with somatostatin analogue (SSA) based treatment regimens.

NCT ID: NCT03789435 Completed - Clinical trials for Lower Limb Amputation Below Knee

Pain in Trans Femoral and Trans Tibial Amputees

AMPUPHANTOM
Start date: March 7, 2019
Phase:
Study type: Observational [Patient Registry]

Phantom limb is difficult to manage and has a significant impact on the patient's quality of life. At present, the scientific evidence shows that the infusion of local anesthetics with epidural and perineural catheters in the perioperative phase correlates with good pain control in the immediate post-operative, expressed in terms of reduced demand for opiates by the patient undergoing amputation. of lower limb. Few are studies that highlight the effectiveness of such treatments in the medium and long-term prevention of phantom limb syndrome. The study aims to evaluate the incidence in the medium term of the phantom limb in trans femoral and trans tibial amputees and the possible relationship with the use of adequate pre and perioperative analgesia using peridural and peripheral nerve catheters. The results of the study could provide indications about the need to modify both the perioperative analgesic therapy protocol and also rehabilitation for lower limb amputation surgery in order to reduce the prevalence of phantom limb syndrome with consequent improvement in quality of life.