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NCT ID: NCT03861299 Recruiting - Glioblastoma Clinical Trials

The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.

SAFE
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The trial is designed as a multicenter randomized controlled study. 246 patients with presumed Glioblastoma Multiforme in eloquent areas on diagnostic MRI will be selected by the neurosurgeons according the eligibility criteria (see under). After written informed consent is obtained, the patient will be randomized for an awake craniotomy (AC) (+/-123 patients) or craniotomy under general anesthesia (GA) (+/-123 patients), with 1:1 allocation ratio. Under GA the amount of resection of the tumour has to be performed within safe margins as judged by the surgeon during surgery. The second group will be operated with an awake craniotomy procedure where the resection boundaries for motor or language functions will be identified by direct cortical and subcortical stimulation. After surgery, the diagnosis of GBM will have to be histologically confirmed. If GBM is not histologically confirmed, patients will be considered off-study and withdrawn from the study. These patients will be followed-up according to standard practice. Thereafter, patients will receive the standard treatment with concomitant Temozolomide and radiation therapy and standard follow up. Total duration of the study is 5 years. Patient inclusion is expected to take 4 years. Follow-up is 1 year after surgery. Statistical analysis, cost benefit analysis and article writing will take 3 months.

NCT ID: NCT03863236 Recruiting - Colon Cancer Clinical Trials

A Study of Perioperative Oral Nutritional Support for Patients Having Surgery for Colon Cancer, Peri-Nutri

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

This is a multicenter, unblinded, randomized study. The aim of this study is to research whether preoperative and postoperative oral nutritional supplement (ONS) (Resource 2.5 Compact/fibre compact) used at least 2 weeks prior the surgery and 10 days after surgery can improve the nutritional status of a colon cancer patient and reduce number of complications. The aim is also to investigate whether the oral nutritional support can shorten the hospital stay and improve the patients´ quality of life. The aim is also to find out whether the oral nutritional support can reduce 90-day mortality and improve disease free and overall survival. Consecutive patients diagnosed with primary adenocarcinoma of the colon who are considered for radical surgical procedure are enrolled in this study provided that the inclusion criteria are filled. Patients in the intervention group start oral nutritional support (ONS)2 portions a day for about 2 weeks prior to the operation starting at the time of randomization and continue ONS 10 days after the operation. Control group will continue with their regular diet without ONS until the operation. Both groups keep a food diary for 4 days right after the randomization and both one month and three months after the operation to assess the energy and nutrient intakes. Laboratory markers, NRS 2002, quality of life questionnaire, exercise questionnaire, bioelectrical impedance analysis (BIA) and handgrip strength as well as body composition on computer tomography scan are assessed prior to any treatment or supplement in order to estimate the patients' well-being and nutritional status prior to surgical operation. Laboratory parameters and QoL questionnaire are repeated right before the operation on admission to hospital as well as about 30 and 90 days after the operation in addition to BIA, handgrip strength to assess the effect of nutritional support. Data on complications, infections, length of stay in the hospital and mortality are collected. Another arm in this research is to discover more information on biological markers in colon cancer and cancer related malnutrition thus providing targets for future treatment and prognostic predictors. Tissue samples are collected during this research at the surgery.

NCT ID: NCT03865589 Recruiting - Clinical trials for Stem Cell Transplant Complications

Using Ultrasound Elastography to Predict Development of Hepatic Sinusoidal Obstruction Syndrome

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

To perform an receiver operating characteristic (ROC) analysis, define a threshold and quantify the sensitivity and specificity of US SWE for risk stratification of patients into three categories as defined by the European Bone Marrow Transplant (EBMT) adult and pediatric criteria: no sinusoidal obstruction syndrome (SOS), mild to moderate SOS, and severe to very severe SOS. Secondarily, the investigators would also like to quantify the temporal relationship between US SWE changes and SOS diagnosis according to various clinical criteria (Modified Seattle, Baltimore, EBMT consortium).

NCT ID: NCT03869528 Recruiting - Anesthesia, Local Clinical Trials

5 Versus 10 Sprays of Lignocaine for Pharyngeal Anaesthesia During Bronchoscopy

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Flexible bronchoscopy is one of the most widely performed procedures for diagnosis of various bronchopulmonary diseases. Most patients tolerate the procedure well although cough is often reported as a distressing symptom. It is likely that the acceptance of bronchoscopy would be significantly improved with control of cough. Topical lignocaine is administered during bronchoscopy for local anaesthesia. There is uncertainty regarding the adequate dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy. This study would help to determine the optimal dose of lignocaine sprays for pharyngeal anaesthesia during flexible bronchoscopy.

NCT ID: NCT03872323 Recruiting - Artery Injury Clinical Trials

Open and Endovascular Surgical Treatment for Artery Injuries

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Traumatic injuries of peripheral arteries are often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply, as well as with high mortality. Traditionally, an open surgical approach is suggested for the management of artery injury. With the advancement of endovascular techniques, the traditional open vascular exposure and vessel repair are no longer the only option available. The purpose of this study is to compare the effectiveness, long-term safety and explore the safety and efficacy factors between open and endovascular surgical techniques.

NCT ID: NCT03875326 Recruiting - Clinical trials for Mild Cognitive Impairment

Stimulation to Improve Memory

STIM
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

This study will test the effects of different doses of a form of non-invasive brain stimulation for the treatment of individuals with mild cognitive impairment (MCI) and dementia of the Alzheimer's Type (DAT).

NCT ID: NCT03875625 Recruiting - Diabetes Mellitus Clinical Trials

Change of Adipose Tissues and Triglyceride After Bariatric Surgery or Life-style Intervention

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The study is aimed - To quantify the change of adipose tissues, triglyceride in liver and pancreas and cholesterol after lifestyle intervention or bariatric surgery. - To test the hypothesis that Brown fat is an independent biomarker for the development of Non Alcoholic Fat Liver Disease (NAFLD) - To study the association among Brown fat, NAFLD and obesity.

NCT ID: NCT03876444 Recruiting - Infantile Spasm Clinical Trials

Intravenous Methylprednisolone Versus Oral Prednisolone for Infantile Spasms

MPIV
Start date: April 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Infantile Spasms (IS) are classically refractory to the usual antiepileptic drugs and often pose a therapeutic challenge. Since, there is associated significant morbidity, much effort has been directed over the past years to evaluate the role of various anticonvulsants in the management of IS. High dose oral prednisolone has been shown to cause early cessation of spasms and resolution of hypsarrythmia on Electroencephalogram. Recently, role of intravenous methylprednislone pulse therapy has been explored as one of the therapeutic modality in IS, in order to avoid the development of side-effects associated with prolonged oral steroid therapy and maintain long-term efficacy.However, there are no studies comparing iv methylprednisolone pulse therapy with high dose oral prednisolone..

NCT ID: NCT03877354 Recruiting - Clinical trials for Protective Ventilation

Comparison of Tidal Volume Between Pediatric Anaesthesia and Paediatric Intensive Care Patients

TIVAC
Start date: April 1, 2019
Phase:
Study type: Observational

Paediatric anaesthesiology and paediatric intensive care unit data will be retrospectively screened for the data regarding mechanical ventilation. The primary aim will be the tidal volume setting and the secondary the level of positive end-expiration pressure (PEEP) according to the inspired oxygen fraction (FIO2), and the level of driving pressure.

NCT ID: NCT03878472 Recruiting - Gastric Cancer Clinical Trials

Neoadjuvant Immunotherapy for Resectable Gastric Cancer

Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

1. Target population: patients with resectable locally advanced gastric cancer (cT3-4bN+M0). 2. Primary objective: (1) To evaluate the pathological remission rate (PRR) of PD-1 antibody monotherapy or in combination with anti-angiogenesis VEGFR2-TKI apatinib ± S1 ± Oxaliplatin in neoadjuvant (preoperative) treatment of resectable locally advanced gastric cancer. (2) To evaluate the relationship between tumor pathological remission and biomarkers related to immunotherapy. 3. Secondary objectives: 1. To evaluate the imaging objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) of PD-1 antibody alone or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant therapy for locally advanced gastric cancer. 2. To evaluate the safety of PD-1 antibody or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant (preoperative) treatment of resectable locally advanced gastric cancer. Trial design: This is a monocenter, open, single arm, phase II study to evaluate the efficacy and safety of PD-1 antibody or in combination with apatinib ± S1 ± Oxaliplatin in neoadjuvant treatment of resectable locally advanced gastric cancer.