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.
Primary Objective: - Safety run-in part: to assess the tolerability and to determine the recommended doses of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy with or without pemetrexed to be tested in the expansion part of the study in the NSQ NSCLC population - Expansion part (including participants treated at the recommended dose for expansion [RDE] from the Safety Run-in part): to assess the antitumor activity of several dose levels (DLs; if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population Secondary Objectives: - To assess the safety and tolerability of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, and platinum-based chemotherapy with pemetrexed in the NSQ NSCLC population - To assess the antitumor activity of several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab, platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population - To assess the durability of the response to treatment with several DLs (if applicable) of tusamitamab ravtansine in combination with pembrolizumab and of 1 DL of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and of several DLs of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy, and pemetrexed in the NSQ NSCLC population - To assess the antitumor activity of tusamitamab ravtansine in combination with pembrolizumab and platinum-based chemotherapy in the NSQ NSCLC population - To assess the pharmacokinetics (PK) of tusamitamab ravtansine, pembrolizumab, pemetrexed, cisplatin, and carboplatin, each when given in combination as a doublet (tusamitamab ravtansine + pembrolizumab) or a triplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy) or a quadruplet (tusamitamab ravtansine + pembrolizumab + platinum-based chemotherapy + pemetrexed) - To assess the immunogenicity of tusamitamab ravtansine in combination with pembrolizumab and tusamitamab ravtansine in combination with pembrolizumab and platinum based chemotherapy with or without pemetrexed
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. This study will evaluate how well risankizumab works compared to ustekinumab. This study will assess change in Crohn's Disease Activity Index (CDAI). Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease (CD). Ustekinumab is an approved drug for the treatment of moderate and severe CD. Participants are randomly assigned to one of the three treatment groups. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to ustekinumab. Around 508 adult participants with moderate to severe CD will be enrolled in approximately 307 sites worldwide. In Part 1, participants assigned to risankizumab will receive intravenous (IV) doses of risankizumab at Week 0, 4,8 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. Participants assigned to ustekinumab will receive intravenous (IV) dose of ustekinumab at Week 0 and subcutaneous (SC) doses every 8 weeks thereafter through Week 48. In Part 2, participants who received risankizumab in Part 1 and completed the Week 48 visit will continue to receive SC risankizumab for up to an additional 220 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.
The clinical study aimed to study the effect of an intervention with foods containing folate and hazelnut oil to assess whether this diet could modulate the methylation levels of two obesity-related genes, LEP and POMC, in addition to impacting body weight and values of lipid profile of overweight women. The hypothesis of the clinical study is that the intervention diet could reduce the methylation levels of the genes mentioned and this would impact on the reduction of body weight and improvement of the lipid profile of the women studied.
Introduction: Diabetes Mellitus (DM) is a condition known to be associated with coronary artery disease (CAD) and its role as promoter of atherosclerosis is well stablished. The revascularization surgery is commonly indicated to patients with multivessel coronary disease and kidney injury is a prevalent complication in post operation. This work aims to evaluate the impact of a strategy to control Diabetes Mellitus using inhibitors of sodium-glucose cotransporters (ISGLT2) in diabetics patients with assigned myocardial revascularization with cardiopulmonary bypass
This study will evaluate the clinical response and safety of ultrasound guided percutaneous thermal ablation of lymph node metastases from thyroid carcinoma as an alternative to surgical treatment. The ablation of cervical lymph node metastases from differentiated thyroid carcinoma or medullary thyroid carcinoma will be directed to lesions larger than 0.8 cm, using ultrasound-guided radiofrequency ablation (RFA), laser ablation (LA) or cryoablation (Cryo) techniques, randomly assigned. Clinical and ultrasound monitoring will be carried out during 24 months, with examinations before the ablation procedure, immediately after including contrast-enhanced ultrasound (CEUS) when applicable, and B-mode, color Doppler and Shear-Wave elastography ultrasound follow up with 6, 12, and 24 months.
Skin Picking Disorder (SPD) affects up to 10% of the general population, causing significant socioeconomic damage in 75% of affected individuals. It is characterized by the repeated habit of touching the skin itself, causing or aggravating wounds, with difficulty in controlling the habit. It is associated with anxiety disorders in about 20% of cases and with depressive disorder in about 50%. Patients with SPD have difficulties in regulating emotions, being more vulnerable to having their mental symptoms aggravated in face of stressful situations, such as the current coronavirus-19 pandemia. Among the treatments available to SPD, cognitive behavioral therapy is the only intervention superior to placebo, and there is still no medication approved by the FDA indicated specifically to SPD. The effectiveness of cognitive behavioral therapy was assessed in a randomized clinical trial with Brazilian patients with SPD, but its long-term benefit has not yet been evaluated. Additionally, telemedicine interventions can be effective and used during pandemia, but the effectiveness of internet delivered cognitive behavioral therapy for SPD is not clear yet.
This was a 12-week study to evaluate the effectiveness and safety of Restylane Defyne when using two different injection approaches, stepwise down-up vs. top-down, when treating the lower face.
Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy (CFT) is a promising new intervention that deals with potentially modifiable multidimensional aspects of pain (eg, provocative cognitive, movement and lifestyle behaviors). In order to better understand the contextual effects, the aim of the current study is to investigate the efficacy of CFT compared with a sham-intervention for pain intensity and disability post-intervention in patients with non-specific chronic low back pain (CLBP). This study is a randomized clinical trial (RCT) in which 152 (18 - 60 years old) patients with CLBP will be enrolled. The patients will be randomly allocated to receive: (1) CFT intervention or (2) sham-intervention. The experimental group will receive individualized CFT in a pragmatic manner (5 to 7 sessions) based on the clinical progression of participants. The sham group will attend six sessions: consisted of 30 minutes of photobiomodulation using a detuned device and more 15 minutes of talking about neutral topics. Participants will be assessed pre and post-intervention, three months and six months after randomization. Patients from both groups also will receive an educational booklet. The primary outcomes will be pain intensity and disability post-intervention. The secondary outcomes will be: pain intensity and disability at 3- and 6-month follow-up, as well as self-efficacy, global perceived effect of improvement and functioning post-intervention, 3- and 6-month follow-up. The patients and the assessor will be blinded to treatment administered (active vs. sham). The between-group differences (effects of treatment) and their respective 95% confidence intervals will be calculated by constructing linear mixed models. Treatment effect for the primary and secondary outcomes will be estimated using mixed linear models. To the best of our knowledge, the current study will be the first to compare CFT vs. sham intervention. Sham-controlled RCTs may help to understand the influence of non-specific factors on treatment outcomes. Considering complex interventions as CFT, it is imperative to understand the impact of contextual factors on outcomes.
Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.