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NCT ID: NCT04849429 Recruiting - Clinical trials for Chronic Low Back Pain

Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain

Start date: April 15, 2021
Phase: Phase 1
Study type: Interventional

Management of chronic low back pain (LBP) has contributed to its high socioeconomic burden. The intervertebral disc accounts for 40% or more cases of chronic LBP. Available treatment options do not improve the underlying degenerative condition, although they do resolve its symptoms. This indicates the need for new therapies and/or interventions that actually treat the underlying causes of discogenic pain. Biological therapies by direct injection of PRP into the annulus fibrosus and nucleus pulposus seems an effective and feasible option. Exosomes derived from blood may potentially transmit some of the unique stem cell properties to other stem cells, facilitating stemness maintenance, differentiation, self-renewal, and repair. We propose to have a controlled, randomized, double-blind clinical trial to compare the safety and efficacy of exosomes in LBP. Informed consent will be obtained from all subjects prior to study participation. Patients will be randomized into 2 arms with either to receive PRP with exosomes at the centre of the nucleus pulposus or equal amount of placebo and will be evaluated by 2 interventional spine and medicine physicians. Outcome measures Primary Visual analog scale (VAS), Roland Morris Disability Questionnaire (RDQ), SF 36 health questionnaire, Functional rating index Secondary: MRI - disc degeneration grading, T2 quantification, Adverse events any evidence of discitis or discontinuation , worsening of pain will be deeply analyzed. Monitoring visits will be conducted according to standard monitoring procedures. Differences in paired samples will be compared using the two-tailed Student's t-test. All routine monitoring functions will be performed prior to the study termination visit.

NCT ID: NCT04847557 Not yet recruiting - Obesity Clinical Trials

A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT)

Start date: April 20, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

NCT ID: NCT04847388 Not yet recruiting - HIV Infections Clinical Trials

Prevalence of Substance Abuse Among Anti-retroviral Treatment Naive Patients Positive for HIV Antibodies

Start date: April 2021
Study type: Observational

Individuals use substance for mood-alerting purposes. Substance can be alcohol, cannabis, nicotine, cocaine and methamphetamine. Substance addiction/abuse is excessive use of a drug that is detrimental to self and society . These drugs are linked to risky sex behavior and they are related to unsafe sex and thereby chances are more to contracting HIV infection in two ways. Firstly, people inject drugs and shares needle; secondly, drugs impair judgment that leads to unprotected sex with infected partner. The relationship between drug use and HIV disease progression may be mediated by several factors, including immunologic and virologic conditions affecting host susceptibility, underlying comorbidities among drug users, use of antiretroviral therapy, and viral strain, as well as pharmacodynamic aspects of drug use, such as the pattern and type of drug administration and the route of administration. Laboratory based studies show exacerbation of HIV progression among patient with drug addiction.

NCT ID: NCT04845022 Recruiting - Clinical trials for THROMBOTIC MICROANGIOPATHY

Incidence of Snakebite Associated Thrombotic Microangiopathy & Role of Peripheral Blood Smear as a Predictor of Clinical Outcome

Start date: April 12, 2021
Study type: Observational

The aim of this study is to find the overall incidence of thrombotic microangiopathy in snakebite victims. As we know snakebite is a common in tropical regions. Many a times the early diagnosis of TMA is missed and precious time which could have helped in improving the patient prognosis is lost. Also via this study we wish to learn the role of cost effective test like peripheral smear which could help learn morphological picture of red blood cells and thus help in early prediction of patients clinical prognosis.

NCT ID: NCT04844242 Recruiting - SARS-CoV2 Infection Clinical Trials

Pediatric COVID Study

Start date: December 23, 2020
Study type: Observational

Rationale: Severe Acute Respiratory Syndrome - Coronavirus - 2 (SARS-CoV2) and its related Coronavirus Disease - 19 (COVID-19) has become a health emergency worldwide. The medical community has been concerned since the beginning of the outbreak about the potential impact of COVID-19 in children, especially in those with underlying chronic diseases. Fortunately, COVID-19 has been reported to be less severe in children than in adults. Unfortunately, a new multisystem inflammatory syndrome apparently related to infection with SARS-CoV-2 has recently been reported in older children (known as MIS-C), manifested by severe abdominal pain, cardiac dysfunction and shock. However, the SARS-CoV2 infection and the underlying immunology of COVID-19, its correlation with disease severity and MIS-C in children is not fully explored. Objectives: To perform systems immunology and strain diversity among SARS-CoV2 and MIS-C infected children. Study design: Cross sectional study. Study population: Children attending outpatients units and admitted in wards in pediatric hospitals in Chennai. Main study parameters/endpoints: Immune responses in children with SARS-CoV2 infection and multisystem inflammatory syndrome in children (MIS-C) infection and its association of SARS-CoV2 viral diversity.

NCT ID: NCT04843839 Recruiting - Clinical trials for Congenital Hereditary Endothelial Dystrophy of Cornea

CHED - Congenital Hereditary Endothelial Dystrophy: New Paradigm Shift in Therapy Using Topical Eye Drops

Start date: December 15, 2020
Phase: Phase 2
Study type: Interventional

CHED- Congenital Endothelial Endothelial Dystrophy is a condition that causes corneal cloudiness. Since, currently only surgery is being done to cure this condition, we are taking up the research of using topical eye drops for this condition which is a very simple and easy method. Also, there are no significant side effects to this treatment.

NCT ID: NCT04842994 Recruiting - Clinical trials for Malignant Neoplasm of Thyroid Gland

Trial on Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery.

Start date: August 16, 2019
Phase: N/A
Study type: Interventional

Scientific objectives: Primary objective: • To assess if the use of IONM can decrease the rates of temporary RLN palsy after thyroid cancer surgery Secondary objectives: - To assess if the use of IONM can decrease permanent RLN palsy rates in patients with thyroid cancers - To assess voice parameters in patients with RLN palsy Methodology: All patients undergoing total thyroidectomy with or without central compartment neck dissection, for thyroid cancers, will be eligible for participation. After confirmation of eligibility and obtaining informed consent, all patients will undergo preoperative screening procedures. Fibreoptic laryngoscopy (FOL) examination will be done to document function of the vocal cords. Preoperative voiceevaluation, GRBAS voice scale assessment and Voice Related Quality of Life (VR-QOL) assessment will be performed for all patients. Patients will then be randomized in a 1:1 ratio to receive IONM or not during surgery. Patients will be stratified as per predefined stratification factors. After surgery, endpoint assessment of vocal cord mobility will be done with a FOL study, by an assessor blinded to the randomization arm. Voice evaluation, GRBAS scale assessment and VR QOL assessment will also be done. An event will be defined as any vocal fold paresis/palsy. Patients without the event will be followed up for 6 months while patients with the event will be followed up for 2 years to assess recovery of vocal cord function and changes in speech parameters. All patients with vocal cord paresis/palsy will be given speech and swallowing rehabilitation

NCT ID: NCT04842786 Not yet recruiting - Clinical trials for Late-Onset Neonatal Sepsis

Topical Coconut Oil Application and Incidence of Sepsis in Neonates

Start date: April 15, 2021
Phase: N/A
Study type: Interventional

The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no treatment control.

NCT ID: NCT04842539 Completed - Liver Cirrhosis Clinical Trials

Fecal Microbiota Transplantation in Decompensated Cirrhosis

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Cirrhosis of the liver is the culmination point of long-standing chronic liver disease hallmarked by the cardinal features of liver fibrosis and portal hypertension. The prognosis of patients with cirrhosis is punctuated by the onset of complications which denote the stage of decompensation characterized by ascites, hepatic encephalopathy (HE), and variceal bleeding. Patients with cirrhosis have been demonstrated to have significant changes in their gut microbiota characterized by alteration in the intestinal microbiome (gut dysbiosis) as well as small intestinal bacterial overgrowth (SIBO). Gut dysbiosis has been closely linked to the complications associated with decompensated cirrhosis. Several studies have documented the alteration of gut microbiota in patients with hepatic encephalopathy. Therapeutic modalities that restore normal gut flora and stabilize the gut liver axis are being extensively studied in the management of cirrhosis and its complications. Antibiotics, probiotics, and long-chain fatty acid supplementation are being evaluated as methods to restore the gut dysbiosis and consequently limit progressive liver damage. Fecal Microbiota Transplantation (FMT) involves the infusion of intestinal microorganisms by the transfer of stool from a healthy individual into a diseased individual for restoration of normal intestinal flora.The ultimate goal of FMT is to replace aberrant native microbiota with a stable community of donor microorganisms. The treatment is based on the premise that an imbalance in the community of microorganisms residing in the gastrointestinal tract (i.e., dysbiosis) is associated with specific disease states. FMT has been well-established as a treatment modality to stably modify the gut microbiome and has been shown to be safe and efficacious in several disease states resulting from gut dysbiosis. With this background, a trial is proposed to determine whether an FMT from a healthy donor to a patient with advanced cirrhosis improves overall survival and prognosis.

NCT ID: NCT04834960 Recruiting - Under-vaccinated Clinical Trials

Missed Opportunities for Vaccine Equity

Start date: September 24, 2020
Phase: N/A
Study type: Interventional

Despite the overwhelming impact of vaccines on child health and the tremendous progress in vaccine coverage globally, challenges of vaccine inequities persist. Missed opportunities for vaccination (MOV) is defined as any contact with health services by an individual who is eligible for vaccination which does not result in the recommended vaccines being given. This is common in several countries, and it presents a window of opportunity to provide vaccine services to those vulnerable children accessing healthcare facilities. The overall purpose of this project is to reduce missed opportunities for vaccinations by targeting hospitalized children who are vulnerable to poor health outcomes, but who are also within easy access of the healthcare system. The research team proposes implementing the Missed Opportunities for Vaccination Equity (MOVE), an intervention to improve timeliness and coverage of vaccination, and increase demand for vaccination services, through a combination of sensitization of children's caregivers and health workers, manual vaccination data capture in the ward, and re-purposed vaccination resources. The strategy engages key stakeholders in the design of the intervention through a co-creation workshop; their involvement in the design and execution of the intervention will improve sustainability in the long-term. This intervention builds on existing healthcare systems, and, when scaled up, can target inequities in vaccination coverage in the general population, without placing additional strain on the healthcare system in terms of workforce or financial resources.