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NCT ID: NCT04449848 Not yet recruiting - Sudden Hearing Loss Clinical Trials

The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

During the regular protocol of Intra-tympanic injections of Dexamethasone to the middle ear due to Sudden Sensorineural Hearing Loss, the patients will be sitted once after the injection instead of lying down. They will be then asked to rate their taste as a reference to the amount of fluid leaking to the throat through the eustachian tube.

NCT ID: NCT04454151 Not yet recruiting - Clinical trials for Familial Adenomatous Polyposis

Azithromycin Treatment for Readthrough of APC Gene Stop Codon Mutations in Familial Adenomatous Polyposis

FAP
Start date: August 1, 2020
Phase: Phase 4
Study type: Interventional

Colorectal cancer (CRC) is a leading cause for cancer related mortality in the western world with a lifetime risk of 6%. Etiology is complex, while genetic background significantly affects the risk. Around one third of all genetic disorders as well as most cases of Familial Adenomatous Polyposis (FAP) and a large proportion of all sporadic CRC cases occur as a result of premature nonsense mutations (creating a stop codon) in an individual's adenomatous polyposis coli (APC) gene. Nonsense mutations are single-point alterations in the DNA that prematurely halt the protein translation process, producing a shortened, nonfunctional protein. In many of these cases, if the cell can be 'persuaded' to ignore the premature stop codon signal, the resulting protein may be able to ameliorate or stop the disease. Recently, members of the aminoglycoside family of antibiotics have been found to induce ribosomal read-through of nonsense mutations, leading to expression of a full length, functional protein. Investigators have recently shown that members of the aminoglycoside and macrolide antibiotic families can induce read-through of the nonsense mutations in the APC gene and lead to reduced oncogenic phenotypes in CRC cells and in different mice models. The aim of this project is to determine the ability of the macrolide antibiotic-Azithromycin to induce read-through of the nonsense mutations in the APC gene and to induce expression of a full length, functional APC protein in patients suffering from FAP and to tests its effect on adenoma number and size and on desmoid tumors in these patients. The future goal is to maximize the effect of stop-codon suppressors on APC while minimizing side effects. In this study the investigators will select FAP patients which carry APC nonsense mutations, treat them with Azithromycin PO for 4-6 months and examine colonic and duodenal adenomas as well as abdominal desmoid tumors, that will be documented before during and after treatment. In parallel, investigators will test polyp, adenoma and desmoid tissue samples as well as blood samples from these patients for changes in expression levels of the APC protein and related oncogenic markers. Suppression of nonsense mutations within the APC gene should be of benefit for patients suffering from FAP, attenuated FAP or multiple adenomas and for patients with advanced or diffuse CRC. Furthermore, given the rapid progress being made in the identification of different nonsense mutations in human genes that lead to mostly non-curable disease, the identification of clinically approved compounds that suppress nonsense mutations and that can be administered long-term without significant side effects would open new venues in the treatment of genetic human diseases that arise from pre-mature stop codons in important coding sequences. Immediate goal: establish the ability of Azithromycin to read-through APC nonsense mutation in FAP patients. The read-through effect of Azithromycin will be clinically tested by counting and measuring the number and size of both colonic and duodenal adenomas before and over treatment and by measuring the size of known desmoid tumors. Samples of the adenomas and desmoid tumors will be tested by western blot, immunofluorescence and immunohistochemistry for restoration of APC expression and changes in oncogenic markers. These experiments should be conducted within 6 month. Long term objective: 1. Determine the lowest dose of Azithromycin that can inhibit growth of colonic neoplasia and CRC in patients expressing a truncated APC protein due to nonsense mutations. 2. Examine the ability of a panel of additional macrolide antibiotics to induce APC nonsense mutation suppression using in-vitro methods. Investigators will focus on macrolide antibiotics that are currently in clinical use and are administrated for long terms. These objectives should take around 4 month and will be conducted in parallel.

NCT ID: NCT04454502 Not yet recruiting - Clinical trials for Oral Colostrum Administration in Very Low Birth Weight Premature Infants

Analysis of the Effects of Oral Colostrum Administration in Premature Infants on the Breastfeeding

Oral colostrum
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

In the literature, it is emphasized that oral colostrum administration in very low birth weight infants supported the immune development of the premature newborn, contributed to the development of oral microbiota and reduced the length of hospital stay (Manzoni 2011; Pammi 2011; Zhang 2017; Moreno‐Fernandez 2018; Rodriguez 2009). However, there was no source answering the question of how both the mother and the infant are affected by oral colostrum administration in very low birth weight infants. Based on the studies indicating that premature infants distinguished their mother's milk smell and taste (Lecanuet and Schoal, 1996; Aoyama et al. 2010), it was aimed to find answers to the questions of whether this administration in infants without oral intake had positive effect on the success of breastfeeding. Research Hypotheses: H0: Oral colostrum administration in very low birth weight premature infants who cannot be fed orally has no effect on breastfeeding. H1: Oral colostrum administration in very low birth weight premature infants who cannot be fed orally affects the success of breastfeeding

NCT ID: NCT04455243 Not yet recruiting - COVID-19 Clinical Trials

Inflammatory Regulation Effect of NAC on COVID-19 Treatment

INFECT-19
Start date: August 1, 2020
Phase: Phase 3
Study type: Interventional

Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.

NCT ID: NCT04458493 Not yet recruiting - Weight Loss Clinical Trials

Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Participants will be randomized into two groups, one group will be the control (no intervention at all) and the other will be CHO-PRO (meal replacement, Generation UCAN supplement, 400ml, 20% solution). Prior to the start of the experiment, all participants will be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after their regular dinner for 3 days. On the first day of the experiment, all participants will be asked to measure their waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast. Instructions on how to do the measurements properly will be recorded in a video and distributed to the participants. Participants in the control group will not receive any intervention. Participants in the CHO-PRO group will be provided with the supplement and they will be asked to consume the CHO - protein supplement (Generation UCAN supplement, 250ml, 10% solution) 6 to 7 hours after lunch, in place of their dinner for 6 weeks. They will also be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after each meal replacement drink. All participants will be required to complete a dietary record, prior to, and during (at weeks 2 and 4) intervention. To track adherence of the CHO-PRO group, participants will be asked to check off the calendar that they did not consume the meal replacement due to various reasons. On day 43, all participants will be asked measure again waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast again.

NCT ID: NCT04463134 Not yet recruiting - Clinical Outcomes Clinical Trials

An Observational Study on Patients With NTM Pulmonary Disease

Start date: August 1, 2020
Phase:
Study type: Observational

Non-tuberculous mycobacterial (NTM) infection is becoming more and more common, especially causing pulmonary diseases in those elderly or the immunocompromised. The diagnosis, treatment and monitoring of NTM pulmonary disease(NTMPD) are not updated and real life management if also challenging.

NCT ID: NCT04464031 Not yet recruiting - Acute Kidney Injury Clinical Trials

Electronic Alert for Acute Kidney Injury in Geriatric Wards

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Operating acute kidney injury electronic alert in geriatric wards; Acute authenticity evaluation of acute kidney injury electronic alert; To explore the clinical value of electronic alert for acute kidney injury prevention and treatment in geriatric wards.

NCT ID: NCT04468438 Not yet recruiting - Clinical trials for Activity of Lupus Nepheritis

Role of Estrogen in the Flarring up of Lupus Nepheritis

Start date: August 1, 2020
Phase:
Study type: Observational

Role of estrogen in the flarring up of lupus nepheritis

NCT ID: NCT04469829 Not yet recruiting - Metabolic Syndrome Clinical Trials

Methotrexate Versus Secukinumab Safety in Psoriasis Patients With Metabolic Syndrome

Start date: August 1, 2020
Phase: Phase 4
Study type: Interventional

A prospective, controlled, open trial in psoriasis patients with metabolic syndrome, candidate to methotrexate or secukinumab was conducted between January 2019 and May 2020. The primary end point of the study was investigating any variations in waist circumference, body mass index (BMI), blood pressure, fasting glucose, total cholesterol, low density lipoprotein (LDL)-cholesterol, high density lipoprotein (HDL)-cholesterol, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine levels between baseline and month-6 and 12 of follow-up.

NCT ID: NCT04470414 Not yet recruiting - Covid19 Clinical Trials

COVID-19 IgG Antibodies in the Serum of Recovered Patients

Start date: August 1, 2020
Phase:
Study type: Observational

Coronavirus disease 2019 (COVID‐19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2), which first appeared in China, in December 2019 and is now spreading worldwide and poses a great threat to public health. In 12th July 2020, the total number of cases worldwide was about 13 million cases with case fatality rate of 4.4% and in Egypt the total cases was 81158 and case fatality rate was 4.6%. (1,2). In recent years, novel coronaviruses emerge periodically in different areas around the world. Severe acute respiratory syndrome coronavirus (SARS‐CoV) occurred in 2002, which reportedly infected 8422 people with about 10% case fatality rate (3). Middle East respiratory syndrome coronavirus (MERS‐CoV) was first identified in 2012 in Saudi Arabia, bringing a total of 1401 MERS‐CoV infections, and about 35% case fatality rate (1). All the infection cases and recent epidemics show that coronaviruses impose a continuous threat to human beings and the economy as they emerge unexpectedly, spread easily, and lead to catastrophic consequences. As the number of recovered patients with COVID-19 continues to be increasing, the strength and duration of immunity after infection is an important point to be studied. Moreover, understanding this issue is a critical point for controlling this epidemic as they are the key for herd immunity and for informing decisions on how and when to ease physical distancing restrictions and to be ready for other waves of the infection. There is currently no evidence if the people who have recovered from COVID-19 have antibodies and protected from a second attack of infection or future wave of this pandemic or not. Therefore, we will carry out a longitudinal study of immunity in recovered patients to assess SARS-Cov2 patients' risk for future reinfection.