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Filter by:This is a single arm and open-label phase I trial to evaluate the safety, tolerability and efficacy of the oncolytic virus M1 （M1-c6v1）(iv 1×109 CCIC50, 1 dose per day, on day 1-5 each 28 day cycle) combined with anti-PD-1 antibody SHR-1201 (iv, 200 mg, once every two weeks) and Apatinib (po. 250 mg qd ) in the patients with advanced/metastatic hepatocellular carcinoma. 10 participants will be sequentially enrolled. The treatment duration is 12 months. All patients continue combination treatment until disease progression, unacceptable toxicity, death, or discontinuation for any reason.
The investigators conduct this study to clarify the clinical features and to evaluate the prevalence of anti-nodal/paranodal antibodies of patients with combined central and peripheral demyelination (CCPD) .
Children aged 6 months to 12 years of age will be randomised to receive vitamin D 60,000IU once a month for 3 months or a placebo. The vitamin D will be in form of granules supplied in sachets. The primary study outcomes will be incidence of hospitalisation and change in vitamin D levels following supplementation. Secondary outcomes will include incidence of vaso-occlusive crisis (VOC), acute severe respiratory illness, Vitamin D related Severe adverse events and requirements for blood transfusion
To investigate the impact of cTBS on the incidence of postoperative delirium and changes of cognitive function in elderly patients after surgery. To explore whether short-term cTBS can reduce the risk of postoperative delirium as a preventive strategy.
The overall objective of this study is to determine if there are pyloric sphincter abnormalities in patients with gastroparesis symptoms and determine how prevalent these abnormalities are using tests to assess the pyloric sphincter - endoluminal functional luminal imaging probe (Endoflip™), water load satiety testing (WLST), and high-resolution cutaneous electrogastrography (HR-EGG) using Gastric Alimetry™ System.
The Early Start Denver Model (ESDM) has shown its efficiency in the early management of ASD. The study aims to evaluate the efficiency of a new type of management based on a semi-intensive center-based intervention (8h per week) coupled with a MOOC (Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations) for remote parental training/supervision. The goal is to determine if compared to the ESDM reference intervention (15h per week), this type of care can bring, a sufficient improvement in child development course and decreased symptoms of autism in young children, and if it could be, therefore, better suited to the needs of children and their family, bypassing the previously stated obstacles.
The purpose of the study: Validation of the use of intentional ultrasound examination, which includes Doppler and elastography for the diagnosis of obstructive venous disease of the liver within 21 days after bone marrow transplantation. Protocol: Patients who are planned for a bone marrow transplantaion will be recruited for the study by the staff of the Transplant Department. Inclusion criteria: Patients over the age of 18 before a bone marrow transplantation. Eligibility criteria: Transplanted under 18 years of age Research protocol: After informed consent, patients will undergo an ultrasound examination before the transplant. After 14 days and again after 21 days patients will undergo two more US exams, If there is a change in their clinical condition the patients will undergo additional examination accordingly. At the same time on the 14th and 21st day a clinical evaluation will be performed by the clinical physician in the transplant department based on clinical criteria of European Blood and Brain Transplant Association (EBMT). The results of the clinical evaluation and blood test results will be collected. Patients will be divided into two groups: - Control group: Patients who did not develop VOD( veno occlusive disease ) during 21 days. - Study group: Patients who developed VOD during 21 days. All ultrasound examination data will be compared between the two groups in In addition will be collected: - Demographics - age, sex. - Background diseases including heart and liver diseases. - Basic disease as a transplantation cause. All data will be collected anonymously and coded separately.
This research aims to assess the use of an experimental and non-invasive procedure, Remote Ischemic Conditioning (RIC), as an adjunct therapy in attenuating severe COVID-19 disease. An excessive and counterproductive systemic inflammatory response is thought to be a major cause of severe disease and death in patients with COVID-19. Severe ICU cases frequently have markedly higher levels of inflammatory markers such as CRP, IL-6, IL and TNF-a; which is thought to be correlated with increasing disease severity. The relationship between dysregulated inflammatory processes and disease states such as acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are well understood. ALI is characterized by an acute exaggerated mononuclear/neutrophilic inflammatory response followed by progressive collagen deposition in the lung, and if severe enough, may progress to ARDS requiring ventilation.
This study evaluates the addition of Sintilimab to current 2nd line salvage therapy of Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). All patients will receive four cycles of sintilimab plus R-GemOx. Afterwards, 1) patients who achieve CR assessed by PET-CT and are eligible for autologous stem cell transplantation (ASCT) will undergo ASCT. After transplantation, patients will receive sintilimab monotherapy up to 8 cycles or until disease recurrence and progression, death, intolerance and toxicity, withdrawal of informed consent, or other reasons specified in the protocol. 2) Patients who achieve CR assessed by PET-CT and are not eligible for ASCT will directly receive sintilimab monotherapy as maintenance treatment for a maximum of 8 cycles as described above. 3) Patients achieved PR, SD or PD assessed by PET/CT will withdraw from this study and receive proper treatment based on investigator's decision.
Diabetes is a chronic disorder of metabolism characterized by hyperglycemia, defect in Insulin secretion, defection in Insulin action or both, which has a high potential for serious complications with high mortality and morbidity, if poorly treated. Outcome improves with better control. It is a very common disorder with current global prevalence of 425 million and the latest diabetes survey of Pakistan in 2017-18 shows a prevalence of 26 % in adults. Lifestyle intervention especially nutritional modification was the earliest intervention tried and still relevant. Strict Diet plans are difficult to follow; hence a functional Food based intervention is more likely to be acceptable. Various functional foods have been tried in diabetes but beta glucan , a soluble fiber found in barley has been widely tested and found to be effective not only in controlling glycemia, but also in improvement of dyslipidemia, blood pressure and weight. This study has been planned with the objectives of formulating a composite flour based on wheat and barley, which is palatable, economical and can be used instead of wheat flour in the routine diet of people with diabetes.Xanthan Gum shall be added to compensate for the gluten loss. Various ratios of the flour shall be tested for sensory qualities, rheology, and glycemic index, and beta glucan content, and an acceptable flour with best attributes shall be further evaluated through proximate analysis and finally tested in a randomized in an open label randomized controlled clinical trial in real patients at Akhuwat Medical Center which is a charity facility.The sample size for a power of 90 has been calculated to be 31 and adding for dropouts , rounded up to 35 for each group. 70 Adult non pregnant Type 2 Diabetics above the age of 25, with no serious comorbidity shall be recruited and randomized through computer generated random number table. One group shall receive the 2 kg of composite flour every week for 3 months in addition to usual treatment while the con troll group shall receive only the usual treatment. BMI, HbA1C, Creatinine, fasting lipid profile and ALT shall be measured at the start and end of the study, while ,Fasting and post meal sugars, BP, appetite, satiety, and compliance shall be measured every week. The data shall be processed in SPSS 23 This study is expected to show a significant improvement in glycemic control with a possible benefit in BP, weigh and lipid profile as well