There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The primary purpose of this study is to evaluate the efficacy of the study drug known as LY2875358, administered alone or in combination with a second drug named Erlotinib, in participants affected by a defined type of lung cancer (MET biomarker diagnostic positive Non-Small-Cell Lung Cancer) that experienced a disease progression during the most recent treatment with Erlotinib.
Primary Objective: To evaluate the efficacy of sarilumab at week 16 in patients with non-infectious uveitis (NIU). Secondary Objectives: To evaluate the change in best corrected visual acuity (BCVA). To evaluate the safety of subcutaneous sarilumab in patients with NIU. To evaluate the change in macular edema. To evaluate the change in other signs of ocular inflammation. To evaluate the effect on retinal vessel leakage. To evaluate the effect of sarilumab on reducing concomitant immunosuppressant therapy. To evaluate the change in ocular inflammation in the anterior chamber. To evaluate the pharmacokinetics of sarilumab in NIU patients. To evaluate the immunogenicity with anti-drug antibodies (ADA).
The aim of this randomized, single-blind, split-mouth design, clinical trial was to evaluate the effectiveness in plaque removal of the vertical and the horizontal brushing methods. Trauma on soft tissues were also registered. Sixty-one (61) young adults were enrolled for this trial and forty-three (43) completed the brushing session. All subject were asked to abstain from oral hygiene procedures for 48 hours before the brushing session to allow adequate plaque accumulation. They were firstly instructed to use a dental disclosing tablet in order to easily permit to detect dental plaque on teeth and to highlight soft tissue abrasions. Plaque and the abrasion indexes were recorded according to the Rustogi Modified Navy Plaque Index (RMNPI) and the Danser Index (DI) by the same examiner. The brushing session was always performed by the same dental hygienist who brush with a randomized split-mouth design. After the brushing session, the blinded examiner recorded the indexes again.
1. PROTOCOL SUMMARY This is a prospective, randomized open-label, 2 arm, 3-phase trial to compare the 48-weeks virological response of two different regimens containing abacavir/lamivudine (abacavir/lamivudine +darunavir/ritonavir (DRV/r) vs abacavir/lamivudine + raltegravir (RAL) in antiretroviral therapy naive, HIV+ individuals presenting for care with CD4+ counts < 200/mm3. 1.1 Clinical Objectives: Primary Objective: To compare the 48-week virological response to two different regimens containing abacavir/lamivudine (abacavir/lamivudine +darunavir/ritonavir (DRV/r) vs abacavir/lamivudine + raltegravir (RAL) in antiretroviral therapy naive, HIV+ individuals presenting for care with CD4+ counts < 200/mm3. Secondary Objective: a) To compare immunological response at 48 weeks; b) To determine the safety and tolerability of the 2 regimens. 1.2 Study population: 350 in/out patients 1.3 Outcome Primary Endpoint - Proportion of patients with HIV RNA<50 copies/mL after 48 weeks Secondary Endpoints(s) - Change in CD4+ cell count from baseline through week 48 - Time to virological rebound 1.4 Study design: Multicentre, parallel group, randomised, open label, non-inferiority study 1.5 Treatment regimens: Arm A: abacavir/lamivudine 1 tablet once a day + raltegravir 400 mg (1 tablet twice a day) Arm B: abacavir/lamivudine 1 tablet once a day + ritonavir 100 mg + darunavir 800 mg once a day. All drugs have been approved for the treatment of HIV infection. The study population will consist of 350 HIV-positive, HLA B5701-negative patients. At baseline, patients will be randomized 1:1 to start abacavir/lamivudine plus either raltegravir or darunavir/ritonavir. Randomization will be stratified on the basis of the screening CD4+ cell count (≤100 vs ≥100 cells/µL), to ensure balance across treatments groups 1.7 Criteria for Safety: Adverse events and laboratory assessments. 1.8 Statistical analysis: As this is a non-inferiority trial, we will calculate the difference in the proportions of patients experiencing the primary outcome in the two treatment arms and will calculate a 95% confidence interval for this. Non-inferiority of the raltegravir arm will be demonstrated if the lower limit of the 95% confidence interval is greater than -12%. In case non-inferiority will be met, analyses for superiority will be performed.
Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced ovarian, fallopian tube or primary peritoneal cancer.
The effectiveness of surgical fundoplication in treating classical reflux symptoms is well documented, but the role of surgery in alleviating extra-esophageal symptoms allegedly secondary to gastro-esophageal reflux disease (GORD) is far to be assessed. The effectiveness of anti-reflux surgery on extra-esophageal reflux symptoms varies from 15% to 95%; the spread of these data is largely attributable to disparate study design and methodology, patient selection, and outcome metrics. In order to assess whether anti-reflux surgery may have beneficial effects on chronic cough allegedly secondary to GERD and to eventually identify the preoperative clinical profile which could predict those positive effects, we considered two groups of patients presenting with 1) GERD associated to chronic cough, 2), typical GERD who underwent anti-reflux surgery.
The purpose of this study is to assess the safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an extended dosing regimen of ITF2984: part A, designed as double-blind, placebo-controlled, randomized, tested an extended dosing regimen, i.e. 14 consecutive dosing days and higher doses, i.e. up to 6000 mcg/day and in part B, open label, continuous subcutaneous infusion for 7 days were tested as ascending doses of ITF2984 up to 9000 mcg/day of ITF2984.
This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).
Type 2 diabetes mellitus is becoming an increasingly problem for public health and it is related with various complications such as sexual problems. The prevalence of erectile dysfunction has been widely studied in men as a complication of diabetes; the prevalence of sexual dysfunction in women, instead, has not been well investigated. The aim of this study is to evaluate the prevalence of sexual dysfunction in type 2 diabetic women using international validated questionnaires.
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy of ipatasertib in combination with oxaliplatin, 5-fluorouracil, and leucovorin (modified FOLFOX6 [mFOLFOX6]) chemotherapy in participants with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. Participants will be randomized to receive either ipatasertib or placebo orally daily on Days 1 to 7 of each 14-day cycle in combination with mFOLFOX6 on Day 1 of each cycle.