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NCT ID: NCT05230771 Not yet recruiting - Surgery Clinical Trials

Clinical Outcome of Palliative Surgery After Translational Therapy for Metastatic Gastric Cancer Versus Maintenance Chemotherapy for Metastatic Gastric Cancer

Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

This single-center, prospective study was conducted to investigate the efficacy and safety of palliative surgery after translational therapy in the treatment of metastatic gastric cancer. The primary endpoint was 2-year overall survival (OS) rate. Secondary endpoints were median OS, progression-free survival (PFS), 1-year OS, adverse events (AE), severe AE, the quality of life (QOL) and treatment cost.

NCT ID: NCT05231733 Not yet recruiting - Solid Tumors Clinical Trials

Study of SPX-101 in Subjects With Advanced or Refractory Solid Tumors

Start date: April 1, 2022
Phase: Phase 1
Study type: Interventional

A Phase 1, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of an anti-Claudin 18.2 Antibody SPX-101 in Patients with Advanced or Refractory Solid Tumors

NCT ID: NCT05239806 Not yet recruiting - COVID-19 Clinical Trials

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine

Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

The objective of study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E as booster compared with Sinopharm inactivated COVID-19 vaccine as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations.

NCT ID: NCT05240443 Not yet recruiting - Obesity Clinical Trials

Bariatric Surgery and Chronic Renal Disease

BARICADE
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Obesity can be a major driver for the development of chronic kidney disease (CKD), which is a leading cause of death and significant loss in quality of life. A growing body of evidence has shown bariatric (metabolic) surgery as a novel approach to reduce the progression of CKD and reduce morbidity with sustained weight loss. This pilot trial will inform the design and execution of a large RCT that could determine the efficacy of bariatric surgery in the treatment of patients with CKD in the context of obesity. Ultimately, the results have the potential to influence guidelines that may deem bariatric surgery as a viable treatment option for CKD and reduce the morbidity from this chronic condition and inform clinical practice.

NCT ID: NCT05245344 Not yet recruiting - Healthy Clinical Trials

Effects of Ozanimod on Immune-mediated Mechanisms of Neurodegeneration in Multiple Sclerosis - a Preclinical Study

Start date: April 1, 2022
Phase:
Study type: Observational

This is a prospective non interventional study including patients with Relapsing-Remitting Multiple Sclerosis (RRMS) or with Neuromyelitis Optica Spectrum Disorders (NMOSD) and healthy subjects, who are enrolled within the routinely programmed clinical examinations at the IRCCS Neuromed (Pozzilli, Italy), IRCCS Polyclinic Hospital San Martino (Genoa, Italy) and Sant'Andrea Hospital - University of Rome La Sapienza (Rome, Italy). Specifically, the study investigates how ozanimod may contrast neurodegenerative mechanisms triggered by both arms of the adaptive immune response (T and B cells) and by their suboptimal regulation in MS. Overall, the project aims at assessing by in vitro experiments (there will be no patients on treatment with ozanimod and the drug will be only used in vitro): AIM1: ozanimod ability to modulate the synaptotoxic effect of T-cells derived from patients with MS relapse in a MS-chimeric ex-vivo model and to identify possible mediators (IRCCS Neuromed-Pozzilli, in collaboration with Synaptic Immunopathology Laboratory Dep. Systems Medicine, Tor Vergata University of Rome); AIM2: ozanimod ability to reduce the cytokine-mediated breakdown of the BBB and the migration of the here studied immune cells through ex vivo models of BBB (IRCCS Polyclinic Hospital San Martino); AIM3: ozanimod ability to affect the migration properties of Epstein Barr virus (EBV) infected B cells in MS (Sant'Andrea Hospital); AIM4: ozanimod ability to modulate the number and/or function of regulatory T cells (Treg), a lymphocyte population playing a key role in the control of pathogenic adaptive immune responses (Treg Cell Laboratory, Università degli Studi di Napoli "Federico II", Naples, Italy, receiving blood samples from Neuromed Hospital and Sant'Andrea Hospital; not recruiting unit). The work of the four labs is conceptually and operationally integrated: the labs at IRCCS Neuromed-Pozzilli/Tor Vergata University (Aim1) and at Polyclinic Hospital San Martino (Aim2) will investigate the effects of ozanimod on well-known mechanisms of damage in MS, inflammatory synaptopathy and BBB damage and immune cell migration. The lab at Sant'Andrea Hospital (Aim3), will verify whether B cells infected by different EBV genotypes are involved in BBB migration, and how ozanimod may interfere with this mechanism. The Treg Cell Laboratory (Aim4) will investigate whether ozanimod can also act "upstream" of these mechanisms by regulating the adaptive immune response.

NCT ID: NCT05249179 Not yet recruiting - Nutrition Disorders Clinical Trials

Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

This study, it was aimed to compare the effects of oral stimulation and non-nutritive sucking practices on the transition to full oral feeding in babies with a gestational age of 26-32 weeks. Non-oral feeding methods are frequently used in babies born prematurely since sucking and sucking-swallowing coordination have not yet developed. While some premature babies gain the sucking and swallowing reflexes faster, some of them cannot develop this reflex for a long time, so the length of hospital stay is prolonged. All infants who can be fed completely enterally (PMA >29 weeks) will be randomized into 4 groups as oral stimulation (group 1), pacifier (group 2), oral stimulation + pacifier (group 3), and control group by using a stratified blocked randomization method with a block size of 4. Stratification on GA (26-27, 28-29, 30-32 weeks GA) was used to ensure that the groups had similar gestational age distribution. The time of the patients to start breastfeeding and the length of hospital stay (days) will be compared.

NCT ID: NCT05249504 Not yet recruiting - Depressive Symptoms Clinical Trials

Effectiveness of AMICOPE Intervention to Maintain Self-Perceived Health and Intrinsic Capacity in Older People

EFICIS
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

In their day to day, persons do from simple to more or less complicated tasks and activities (ie: stand from a chair, open a door, shopping, read, drive, play chess, remind an appointment...). Such ability to do things is called capacity. Intrinsic capacity is the combination of all the physical and mental capacities that a person has, and reach its maximum in the early adulthood and then declines as the person ages. Each kind of capacity declines at her own speed (which may be faster or slower according to each person lifestyle), and once drops below a threshold may lead to a reduction in quality of life and loss of autonomy. Nevertheless there are some actions that may be effective to prevent or slow such decline. To do so the investigators have design an intervention that combines several things of different nature (what is know as a complex intervention) called AMICOPE. The AMICOPE intervention is performed in the community or in primary care centers through 12 weekly group sessions of 2 h 30 min which combine structured and adapted physical activity, group dynamics to promote social support and address loneliness, social isolation and depressive symptoms, and dietary advice. Our study is addressed to persons over 70 with light problems in mobility, nutrition or mood state. The purpose of this study is to assess if the AMICOPE intervention is better than the standard advice to follow healthy lifestyles to improve or maintain self-perceived health, mobility, nutritional status an psychological wellbeing.

NCT ID: NCT05249699 Not yet recruiting - Tuberculosis Clinical Trials

The Prophylaxis of Tuberculosis According to TSPOT Results After Kidney Transplantation

PTTKT
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Organ transplant recipients are a high incidence group of tuberculosis infection, and the incidence rate is 7-27 times that of the general population. The prevention of postoperative tuberculosis infection is an important part of kidney transplant recipients postoperative follow-up. Taking reasonable tuberculosis prevention strategies for organ transplant recipients can better prevent the occurrence of postoperative tuberculosis and reduce the unreasonable use of anti-tuberculosis drugs. The previous screening methods for active tuberculosis mainly include sputum smear culture, tissue biopsy, tuberculin skin test, tuberculosis antibody, tuberculosis DNA, and chest imaging. However, there is still a lack of accurate and effective means for screening for latent tuberculosis infection. The tuberculosis interferon-γ release test has recently received more and more attention as a means of screening for potential tuberculosis infection. However, how to apply tuberculosis interferon-γ release test in clinical practice is still controversial. The investigators hope to explore the clinical application prospects and practical value of tuberculosis interferon-γ release test through this research. According to the conclusion of the retrospective study, the investigators found that the recipients with negative TSPOT result maybe don't need follow the isoniazid treatment to prevent the development of tuberculosis even though participants have clinical risk factor of tuberculosis(include past tuberculosis history, the close contact with active tuberculosis patients, an area with a high incidence of tuberculosis, abnormal chest x ray performance ). The investigators will divided the recipients with tuberculosis risk factors into three groups randomly. Of course, the invention require written informed consent. The first group with positive tuberculosis interferon gamma release assay (TSPOT) result will follow through with the treatment ,which is a daily dose of isoniazid for six months(300mg daily) after kidney transplant surgery. The second group with negative TSPOT result will not follow through the isoniazid treatment. The third group will follow through with the isoniazid treatment no matter their TSPOT results. The investigators will conduct a prospective clinical trial with the first aim of exploring the effectiveness of TSPOT results in kidney transplant recipients with clinical tuberculosis risk factors, and the second aim of exploring the benefit of the isoniazid treatment follow the TSPOT results rather than clinical risk factors.

NCT ID: NCT05251961 Not yet recruiting - Deformity of Limb Clinical Trials

The Use Of Growing Rods In Pediatric Long Bones Deformity Correction

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the value of growing rods for the correction of long bone deformities in pediatric cases attending Sohag University Hospital and follow up aiming at determining benefits and obstacles to this technique

NCT ID: NCT05252104 Not yet recruiting - Clinical trials for Thoracic Outlet Syndrome

Inter-rater Reliability of Diagnosing Thoracic Outlet Syndrome by Physiotherapists

Start date: April 1, 2022
Phase:
Study type: Observational

Thoracic outlet syndrome (TOS) denotes the collection of symptoms which may arise from compression of the neurovascular structures in the region of the brachial plexus. TOS has historically been a clinical enigma, with lack of consensus regarding its diagnosis limiting the validity of any research into it. Literature and local audit both note significant patient morbidity and redundant use of secondary care clinics and investigations in sufferers. The last decade has seen the creation of a consortium of leaders in the field and development of the CORE-TOS diagnostic tool. This tool has 5 subsets of clinical diagnostic criteria (CDC). Positivity in 4 or more suggests a diagnosis of TOS. The current study seeks to specifically examine whether physiotherapy clinicians - both in primary and secondary care - can consistently identify cases of TOS using the CORE-TOS tool and refer them appropriately to an extended scope physiotherapist (ESP) specialising in the condition. Specific education will be provided to relevant physiotherapists who will be asked to note all relevant CDC in any suspected cases thereafter referred to the ESP in an out-patient physiotherapy department setting. These referrals will follow the standard local pathway to physiotherapy and no clinical testing manoeuvres out with the current scope of physiotherapy will be applied. The patients' case notes will thereafter be retrospectively examined, and the inter-rater reliability of the CDC recorded by the both the referring physiotherapist on their referral and the researcher at initial review. This will analysed using intraclass correlation coefficient, SEM and Bland and Altman's agreement tests, coupled with descriptive analysis.