There are about 3133 clinical studies being (or have been) conducted in Romania. 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 purpose of this study is to evaluate the effect of TAK-875 compared to placebo on glycemic control over a 24-week Treatment Period when used as an add-on to glimepiride in addition to diet and exercise.
The primary purpose of this study is to evaluate the efficacy of lurasidone 20 mg/day in subjects with an acute exacerbation of schizophrenia.
The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).
This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 250/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.
Patients will be selected from the Dialisys Centers in Iasi, Romania. Patients will be randomized 1:1 to have a dry-weight assessment based on clinical (control) or lung US and bioimpedance (active) guided protocol. In the control group post-dialysis dry weight will be adjusted based on clinical criteria only (blood pressure, presence of edema, intradialytic hypotension, cramps etc.) and in the active group the target weight will be prescribed using lung US and bioimpedance evaluation. In patients randomized to the active arm of the study, the US B-line score (BLS) will be measured before dialysis and these measurements will be used to titrate ultrafiltration prescription. In patients presenting moderate to severe lung congestion (≥15 BLS pre-dialysis) LUS measurements will be repeated once a week until the treatment goal was achieved (<15 BLS pre-dialysis) and once a month thereafter. The same (monthly) monitoring frequency will be adopted also in patients without pulmonary congestion at pre-dialysis baseline (<15 BLS). Furthermore, the use of the technique is allowed whenever its application is deemed useful to assume clinical decisions by attending physicians. Patients in the active arm of the study without evidence of lung congestion at baseline who developed pulmonary congestion (≥ 15 BLS) during the trial will received the same treatment contemplated for those with lung congestion at baseline during the trial. The treatment goal will be pursued by ultrafiltration intensification realized within the same HD schedule (3 sessions x 4 hours/week) or, if not tolerated, by extra-dialyses, according to individual tolerance and feasibility. In case of clinical hypovolemia (persistent cramps, hypotension etc) additional dry-weight adjustments will be performed according to the bioimpedance measurement, provided that the patients are below 15 BLS. This addition will be necessary in order to be able to increase the dry-weight in patients with a persistent BLS < 15 and avoid under perfusion. Patients in the control arm of the study will be followed up and managed strictly with standard criteria according to current recommendations (implying optimization of fluids volume control on the basis of clinical criteria and the use of carvedilol, ACE inhibitors/sartans whenever deemed necessary); the use of lung US / bioimpedanc assistance will not be messured in these patients. The main exclusion criteria will be the presence of severe cardiac failure (NYHA class III-IV), past myocardial infarction, stable or unstable angina and acute coronary syndrome. Due to bioimpedance assessment limitation patients with metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations will be excluded, as BIS cannot be accurately performed in such cases. Due to lung US measurement limitation we will exclude patients with known persistent pleurisy, pulmonary fibrosis or pneumectomy. Other exclusion criteria will be malignancy, active infections, temporary or permanent catheter as a vascular access, mental incompetence and unwillingness to participate in the study.
This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy. Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest. Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited. This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.
The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. The safety and tolerability of canagliflozin will also be assessed.
The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia
This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. Participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.
The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.