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NCT ID: NCT05669521 Active, not recruiting - Mucositis Clinical Trials

Phase 2a Study to Evaluate Suppression of 5-Fluorouracil -Induced Mucositis by TK112690

Start date: June 15, 2022
Phase: Phase 2
Study type: Interventional

Patients expected to receive a 500 mg/m2 of Leucovorin by iv & 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours & 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 weeks. The TK112690 dose will be 45 mg/kg.

NCT ID: NCT05665595 Active, not recruiting - Melanoma Clinical Trials

A Study of Adjuvant Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab for Resected High-Risk Melanoma in Participants With High-Risk Stage II-IV Melanoma (MK-7684A-010/KEYVIBE-010)

Start date: January 19, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to compare pembrolizumab/vibostolimab to pembrolizumab with respect to recurrence-free survival (RFS). The primary hypothesis is that pembrolizumab/vibostolimab is superior to pembrolizumab with respect to RFS as assessed by the investigator in participants with high-risk resected Stage IIB, IIC, III and IV melanoma.

NCT ID: NCT05658016 Active, not recruiting - Mucositis Clinical Trials

Phase 2a Study to Evaluate Suppression of Radiotherapy-induced Mucositis by TK112690

Start date: June 17, 2022
Phase: Phase 2
Study type: Interventional

Patients expected to receive a continuous course of radiation as single daily fractions of 2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT, 3DRT,IMRT etc. Prior to each radiation treatment the patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization. 6 Hours after the completion of TK-90 infusion or TK-90 placebo dose, the patients will receive another identical TK-90 or TK-90 placebo treatment depending on randomization. This treatment cycle will continue for 7 weeks. The TK112690 dose will be 45 mg/kg.

NCT ID: NCT05656521 Active, not recruiting - COVID-19 Clinical Trials

101-PGC-005 for the Treatment of COVID-19

Start date: January 31, 2023
Phase: Phase 2
Study type: Interventional

This is a prospective, randomized, comparative, multi-centric, adaptive design clinical study to evaluate efficacy, safety, and tolerability of 101-PGC-005 ('005) when used alongside standard of care (SOC) for the treatment of hospitalized patients with coronavirus disease (COVID-19).

NCT ID: NCT05648045 Active, not recruiting - Quality of Life Clinical Trials

Resilience and Obesity Prevention in Adolescents

Start date: February 20, 2023
Phase:
Study type: Observational [Patient Registry]

This is a cross-sectional observational study where investigators are trying to see the associations between factors contributing to obesity (dietary behavior and physical activity), resilience (self-efficacy, self-esteem, and optimism), and HRQoL in Indian adolescents. The key research question and sub-questions are as follows: Main research question: Is there a relationship between resilience (measured as self-efficacy) and obesity in children? 1. What is the level of other resilience factors (measured as self-esteem and optimism) among overweight, obese, and normal-weight adolescents? Are there differences between the groups? Are there differences between ages? Are there differences between genders? 2. Is there a relationship between resilience factors (measured as self-esteem and optimism) and HRQoL among overweight, obese, and normal-weight adolescents? Are there differences between the groups? Are there differences between ages? Are there differences between genders? 3. Is low resilience (measured as self-esteem, self-efficacy, and optimism) associated with overweight or obesity among adolescents and a lower HRQoL? Are there differences between ages? Are there differences between genders? 4. What is the level of association between resilience (identified as self-esteem, self-efficacy, and optimism) and factors contributing to obesity (dietary habits - measured in terms of more frequent unhealthy eating, such as eating fast food, sugary beverages, more calories, and less frequent healthy habits, such as more junk foods for meals, less physical activity, higher BMI, or higher weight-for-age Z scores, more body fat percentage and psychosocial factors related to obesity: socio-economic status

NCT ID: NCT05629962 Active, not recruiting - COVID-19 Clinical Trials

SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19

Start date: November 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate whether bemnifosbuvir (BEM) is effective and safe in adults with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible subjects will be randomly assigned (by chance) to receive BEM or matching placebo orally for 5 days. Co-administration of locally available standard of care (SOC) is allowed. The total duration of the study is 60 days.

NCT ID: NCT05619770 Active, not recruiting - COVID-19 Clinical Trials

Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects

Start date: October 29, 2022
Phase: Phase 1
Study type: Interventional

The goal of this interventional study is to evaluate the pharmacokinetics, safety, and tolerability of 101-PGC-005 in healthy, adult, human subjects. The main question it aims to answer is what are the single and multi-dose PK properties of 101-PGC-005 in the systemic circulation Participants will receive a bolus injection of 101-PGC-005 administered intravenously once daily for 3 consecutive days. Blood and urine samples will be collected at predetermined timepoints for analysis.

NCT ID: NCT05609747 Active, not recruiting - PERIAPICAL LESIONS Clinical Trials

Effect of NSRCT on HbA1c and Inflammatory Markers in Healthy and Type 2 Diabetes Patients With Apical Periodontitis

Start date: December 27, 2021
Phase: N/A
Study type: Interventional

To the best of knowledge, only 2 prospective studies, and 1 cross-sectional study have been reported which have seen the periapical healing after non surgical endodontic treatment in diabetic patients and their effect on HbA1c. Because of the inconsistencies in data available from the literature and considering the limitations of cross-sectional studies, further studies, especially using a prospective design, are required. So, aim is to investigate the effects of non surgical endodontic treatment on healing and systemic inflammation in individuals with and without diabetes.

NCT ID: NCT05603845 Active, not recruiting - Severe Asthma Clinical Trials

Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients

iOUTRUN
Start date: February 20, 2023
Phase:
Study type: Observational

This study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia, Kuwait, United Arab Emirates, Oman, and Qatar), Latin America (Brazil, Argentina, and Colombia), and India. It is anticipated that the data generated will provide practical, patient-focused real-world evidence and enhance communications between patients and physicians in an objective and structured manner to ensure better disease control in patients under benralizumab treatment.

NCT ID: NCT05567796 Active, not recruiting - Obesity Clinical Trials

A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

REDEFINE 1
Start date: November 1, 2022
Phase: Phase 3
Study type: Interventional

This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.