There are about 10004 clinical studies being (or have been) conducted in Brazil. 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.
Low-density lipoprotein (LDL) oxidation has a pivotal role in atherosclerosis development. There is a relationship between carotenoids serum concentration and cardiovascular (CV) benefits, mainly in oxidized LDL (oxLDL) reduction. Despite cardio protective effects of annatto carotenoids, bixin and norbixin, in vitro and in animal studies, its short or long-term supplementation effect on humans are not know. Objective: To analyse CV benefits of annatto carotenoids short-term supplementation in healthy individuals, comparing to lycopene effect. Methods: 16 healthy volunteers (8 men and 8 women) consumed 0.05 mg/kg b.w. of each treatment (bixin, norbixin, lycopene or placebo) through capsules, during 7 days. It was analysed the susceptibility of LDL to Cu2+-induced oxidation, biochemical parameters and oxidative stress biomarkers at the beginning and end of each treatment.
The purpose of this pharmacokinetic (PK) study was to evaluate if a double dose (3 mg) of levonorgestrel (LNG) overcomes known drug-drug interactions (DDIs) with efavirenz (EFV)-based antiretroviral therapy (ART) or rifampicin (RIF)-containing tuberculosis (TB) therapy. The safety of double-dose (3.0 mg) LNG versus standard-dose (1.5 mg) was also compared.
This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) on the reduction of swelling and postoperative pain in lower molar extraction procedures. This is a clinical study approved by the Research Ethics Committee, which will be performed in 40 patients between 20 and 60 years. Patients included in the study should have at least one lower molar (first or second molar) with indication of exodontia. Participants will follow the exclusion criteria: pregnant or breastfeeding women; patients with obesity (Body Mass Index - BMI); make use of any activity smokers and ex smoker to 6 months; diabetics; immunosuppressed; in osteoporosis; making use of antimicrobials in the last 3 months; making use of medications that interfere with bone remodeling; with cysts or tumors in place. Surgical procedures that exceeded the clinical time of 30 minutes and / or required opening of the flap or osteotomy were excluded from the study. After the sample calculation, forty patients will be involved in this project, where forty molars (first and second molars) will be extracted in the mandible, which will be randomly divided into 4 groups. The control group (C.G), will contain 10 patients, where 10 molars will be extracted in a conventional way, without any additional treatment to be done. Test group 1 (T.G1) will contain 10 patients where 10 molars will be extracted and immediately after extraction, the fresh sockets will receive in their inner portion a local application of aPDT. The test group 2 (T.G2) will present 10 patients, where 10 molars will be extracted that immediately after the exodontia, the fresh socket will receive local application of infrared in the outer vestibular portion. Finally, Test Group 3 (T.G3), will be composed of 10 patients, where 10 molars will be extracted, joining the approaches of the previous groups (aPDT + infrared). Pain intensity will be assessed through a visual analogue scale and swelling assessed by measuring a perimeter between the tragus, the base of the jaw and the commissure of the lips. The data will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days postoperatively.
This open-label, single arm study will evaluate the safety of obinutuzumab administered as a short duration infusion (SDI; target 90-minute infusion) during cycle 2 and from cycle 2 onwards in combination with chemotherapy in participants with previously untreated advanced follicular lymphoma (FL). The study has two phases: in the first phase, participants will receive the first cycle of obinutuzumab-based chemotherapy (G-chemo) induction therapy as usual with the first three infusions of obinutuzumab (1000 mg) administered at the regular infusion rate on Day 1, 8, and 15 of cycle 1. Phase 2 starts when participants who do not experience any Grade ≥ 3 infusion related reactions during the first cycle receive their first obintuzumab infusion given at the faster infusion rate in Cycle 2. For Cycle 2, Day 1 and all other following infusions (including maintenance), obinutuzumab will be administered at a faster infusion of 90-minute SDI, as long as the participant does not experience any Grade ≥ 3 infusion related reactions. The investigator is free to choose the chemotherapy for each participant (bendamustine, CHOP [cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone/methylprednisolone], or CVP [cyclophosphamide, vincristine, and prednisone/prednisolone/methylprednisolone]). The total number of cycles of G-chemo induction therapy and the cycles length depends on the chemotherapy chosen for each participant.
AR-301 is being evaluated as an adjunctive treatment of ventilator-associated pneumonia (VAP) due to Staphylococcus aureus (S. aureus) in combination with standard of care (SOC) antibiotic therapy in patients with confirmed S. aureus infection.
The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.
To compare the use of towels impregnated with 2% chlorhexidine gluconate in the traditional preoperative bath with 2% chlorhexidine gluconate in preventing the occurrence of surgical site infection among patients undergoing potentially contaminated elective surgery.
Colonoscopy is an important diagnostic and therapeutic tool in colon disorders. Different drugs and levels of sedation can be used in its accomplishment. There is no consensus on which is the ideal. The aim of this study was to compare the post anesthetic recovery time between patients deeply sedated with midazolam and propofol or fentanyl and propofol. 50 American Society of Anesthesiologist physical state (ASA) I and II candidates elective colonoscopy at Luxembourg Hospital were divided into two groups A) midazolam and propofol or B) fentanyl and propofol. Time of examination, post anesthetic recovery and discharge at home, intercurrence and propofol consumption were compared.
Objective: to evaluate the effect of two gingival smile treatment techniques using botulinum toxin. Materials and methods: The randomized, double-blind clinical trial (patient and examiner) will be conducted by two trained and calibrated dentists. Ten patients will be randomly assigned to each group, in a total of 20 patients with gingiva smile greater than or equal to 3mm. In group 1, 10 patients will receive 2 units/point of botulinum toxin Botulift® (botulinum toxin type A), in the muscles form the face: Levators labii superioris alaeque nasi muscle and Levators labii superioris muscle, totalizing 4 points. In group 2, 2 units/point was injected in the muscles: levators labii superioris alaeque nasi muscle, totalizing 2 points. The amount of exposed gingiva during smile will be measured using a pachymeter and the muscle activity of the region will be evaluated through electromyography, before and after treatment (2, 8, 12, 21 and 25 weeks). Patient satisfaction and discomfort due to treatment will be evaluated in the same periods through questionnaire. The impact of the treatment in life quality will be evaluated through OHIP-14 questionnaire.
Acqua GM (Grand Morse) Helix implants present an optimized implant design with adapted treatment protocol, allowing for treatment of patients with different bone qualities. The objective of the study is to prospectively collect clinical data to confirm the long-term safety and clinical performance of Acqua GM Helix implants and GM prosthetic abutments in daily dental practice setting, by means of success and survival rates of these devices. Devices will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (instructions for use). patients will be followed for 36 months after implant placement.