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NCT ID: NCT01604096 Completed - Clinical trials for Upper Respiratory Tract Infections

Controlled Trial to Evaluate a Local Information Campaign on Antibiotic Prescribing in Italy

LOCAAL
Start date: November 2011
Phase: Phase 2
Study type: Interventional

Use of information campaigns and educational interventions directed to citizens and supported by physicians, aimed at promoting the appropriate use of medicines, have been evaluated by several studies with conflicting results. These interventions are potentially relevant, favouring the reduction of unnecessary use of medicines and related risks. Several studies have specifically evaluated the promotion of the appropriate use of antibiotics in adults and children, with variable results. A controlled study has been proposed to evaluate the feasibility and effectiveness of a multifaceted intervention aimed at reducing antibiotic prescription by increasing awareness on risks of their unnecessary use. Information has been provided to citizens through several media (posters, local TV, radio and newspapers, video terminals, websites of Local Health Authorities). Brochures with information on expected benefits and risks of antibiotics has also been available, either with direct access in waiting rooms and pharmacies or handed out and mediated by doctors. Physicians and pharmacists received specific data on local antibiotic resistance. A small group of representative doctors have also actively participated in defining the campaign key messages. A sample of general practitioners and paediatricians have been trained in patient counselling strategies. The information campaign has been implemented in two Provinces of Emilia-Romagna during the fall-winter season (November 2011-February 2012). Change in the overall prescribing rate of antibiotics (expressed as DDD per 1000 inhabitants/day) in the intervention area will be compared versus other areas in the same Region. Knowledge and attitudes of the general population will be evaluated through a phone and internet survey on a representative sample. This study could observe a reduction lower than 5% in the prescribing rate of antibiotics.

NCT ID: NCT01604044 Completed - Female Infertility Clinical Trials

Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.

Start date: May 2012
Phase: Phase 1
Study type: Interventional

This study evaluates the effects of different therapies in ovulation induction in Intrauterine Insemination Cycles.

NCT ID: NCT01603654 Completed - Clinical trials for Colon Cleansing for Colonoscopy

Sodium Picosulphate/Magnesium Citrate and Low-volume PEG -Ascorbic Acid as Preparation for Colonoscopy

Start date: January 2011
Phase: Phase 4
Study type: Interventional

Adequate bowel cleansing is essential for effective colonoscopy. Acceptance of colon preparation affects the quality of colon cleansing. The study is aimed at comparing the efficacy, safety and acceptability of sodium picosulphate/magnesium citrate (PMC) and low-volume PEG -ascorbic acid (PEG+ASC)in colon cleansing, and to identify predictors of poor bowel preparation.

NCT ID: NCT01603641 Completed - Cerebral Palsy Clinical Trials

BOTOX® Open-Label Treatment in Pediatric Lower Limb Spasticity

Start date: November 5, 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.

NCT ID: NCT01603628 Completed - Cerebral Palsy Clinical Trials

BOTOX® Treatment in Pediatric Lower Limb Spasticity

Start date: September 11, 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.

NCT ID: NCT01603459 Completed - Clinical trials for Spasticity of the Upper and Lower Limb Due to Cerebral Causes

Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm

Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.

NCT ID: NCT01603407 Completed - Clinical trials for Duchenne Muscular Dystrophy

Finding the Optimum Regimen for Duchenne Muscular Dystrophy

FOR-DMD
Start date: January 2013
Phase: Phase 3
Study type: Interventional

The Finding the Optimum Regimen for Duchenne Muscular Dystrophy (FOR DMD) study will compare three ways of giving corticosteroids to boys with Duchenne muscular dystrophy (DMD) to determine which of the three ways increases muscle strength the most, and which causes the fewest side effects. Using the results of this study, the investigators aim to provide patients and families with clearer information about the best way to take these drugs.

NCT ID: NCT01602965 Completed - Obesity Clinical Trials

Effectiveness Between Nutritional Counseling Monthly Phone Call Versus Self Help Informative Booklet

Start date: September 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the most effectiveness between a personalized nutritional program with a counseling monthly phone call Versus personalized nutritional program with self help Informative Booklet in a group of obesity or overweight patients without counseling phone call.

NCT ID: NCT01602406 Completed - Clinical trials for Advanced HER2-positive Breast Cancer or Gastric Cancer

Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer

Start date: September 21, 2012
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination with trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2) overexpressing Metastatic Breast Cancer (MBC) or gastric cancer (MGC). The study consists of a dose escalation part and a dose expansion part. LJM716 will be administered intravenously once weekly unless a less frequent dosing regimen such as every 2 weeks or once every 4 weeks is introduced. Patients will continue on their trastuzumab dosing, administered intravenously once weekly at 2mg/kg. During dose escalation, a minimum of 15 patients are anticipated to be treated in successive cohorts. The dose escalation will continue until the MTD/RDE is declared. The RDE dose selected will either be the MTD or a dose below the MTD based on safety and Pharmacokinetic/Pharmacodynamic (PK/PD) considerations. Following the MTD/RDE declaration, approximately 20 MBC and 20 MGC patients will be enrolled in separate arms in the dose expansion part and treated at the MTD/RDE to further assess the safety, tolerability, and anti-tumor activity of the combination.

NCT ID: NCT01602393 Completed - Alzheimer's Disease Clinical Trials

Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Prolonged Open Label Extension Phase

CT04 POLEP
Start date: May 2012
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.