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NCT ID: NCT03834402 Completed - Alzheimer Disease Clinical Trials

INTERCEPTOR Project: From MCI to Dementia

INTERCEPTOR
Start date: May 1, 2019
Phase:
Study type: Observational

In the next years a number of phase 2-3 trials which utilize experimental drugs possibly disease modifying for Alzheimer Dementia will reach their conclusion. This dense clinical trials activity has triggered a fundamental question both from Patients and Scientific Communities and Health Authorities/Insurances: on which basis will the new drugs -if effective-be distributed to patients or at-risk population? This question mainly deals with the "MCI prodromal to AD"condition since the MCI population actually includes about 50% of those who will progress to AD (the real "prodromic to AD" MCI form) while the remaining 50% will never convert to AD. The INTERCEPTOR project is focused on the prodromic AD condition (IWG2) or the MCI condition (NIA-AA) which form the neuropsychological point of view and is characterized by means of: cognitive questionnaires, screening test (MMSE), extended neuropsychological evaluation. The study is an observational, longitudinal cohort one, in which the baseline clinical and biomarkers characteristics of the enrolled MCI subjects at baseline will be compared for those classified as "AD converters" after 3.0 years of follow-up with respect to those "non-converters". MCI subjects who will convert to other forms of dementia will be examined separately. It will be considered the conversion to Alzheimer's disease within 3.0 years after diagnosis of MCI, together with the assessment of those who remain in a stable condition and those who have a reversion to normal cognitive profile. People with MCI who convert to other forms of dementia will be considered separately. The biomarker or a set of biomarkers that can predict the conversion to Alzheimer's disease with higher accuracy will be evaluated.

NCT ID: NCT03833908 Completed - Dry Eye Clinical Trials

Evaluation of the Performance of MAF-1217 on Cataract Surgery

Start date: November 20, 2018
Phase: N/A
Study type: Interventional

MAF-1217 is meant as the medical device which is to be effective in most forms of DED; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symptoms of surgery induced DED in patients undergoing cataract surgery, in a TID application pre-surgery.

NCT ID: NCT03833882 Completed - Clinical trials for Evaporative Dry Eye Disease

Evaluation of MAF-1217 in Patients With DED

Start date: November 27, 2018
Phase: N/A
Study type: Interventional

This is a pre-market, multicentre, double-blind, randomized, crossover, non-inferiority study comparing the efficacy of MAF-1217 and Cationorm® in adult patients with evaporative DED. The study population will be divided in 4 different subgroups, according to the different types of evaporative DED: 1. Group A: high evaporative levels 2. Group B: females in menopause, whether using hormonal integration or not 3. Group C: presence of active obstructive Meibomian gland disease 4. Group D: glaucomatous patients

NCT ID: NCT03833687 Completed - Clinical trials for Skin Flaccidity and Roughness of the Abdomen and Inner Arms

Aesthetic Performance of an Injective Treatment for the Skin Roughness and Laxity of Inner Arm and Abdomen

Start date: September 11, 2018
Phase: N/A
Study type: Interventional

The objective of this study was to investigate the aesthetic performance of the Hyaluronic acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique ("BAP" technique) in woman aged 40-65 years with mild-moderate skin flaccidity and roughness of the abdomen and inner arms.

NCT ID: NCT03833661 Completed - Cholangiocarcinoma Clinical Trials

M7824 Monotherapy in Locally Advanced or Metastatic Second Line (2L) Biliary Tract Cancer (Cholangiocarcinoma and Gallbladder Cancer)

Start date: March 26, 2019
Phase: Phase 2
Study type: Interventional

The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.

NCT ID: NCT03833635 Recruiting - Premature Infant Clinical Trials

Effects of OMT on Premature Physiological Parameters

Start date: March 22, 2019
Phase: N/A
Study type: Interventional

Osteopathic manipulative treatment has been showed to reduce LOS in premature infants. Despite the clinical effectiveness, lack of data and information on the physiological underpinning effects during the treatment has been revealed. The aim of the study is to explore the immediate physiological effects of osteopathic treatment on premature infants

NCT ID: NCT03833167 Active, not recruiting - Clinical trials for Carcinoma, Squamous Cell

Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).

NCT ID: NCT03833154 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Durvalumab vs Placebo With Stereotactic Body Radiation Therapy in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients / Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation

PACIFIC-4
Start date: March 6, 2019
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC. An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

NCT ID: NCT03833076 Completed - Clinical trials for Proctological Disorders

A New Class IIb MD in Proctological Disorders

Start date: August 22, 2019
Phase: N/A
Study type: Interventional

The aim of this study is primarily to investigate the performance of a new medical device not yet CE marked in comparison with placebo, in relieving proctological symptomatology in adult patients reporting symptoms of hemorrhoids (grade 1-3), anal fissures and proctitides.

NCT ID: NCT03832998 Recruiting - Migraine Clinical Trials

Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine

OASIS(CM)
Start date: September 5, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The study hypothesis is that in pediatric participants with chronic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).