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NCT ID: NCT06304844 Not yet recruiting - Type 2 Diabetes Clinical Trials

Risk of CKD in Diabetic Patients With MAFLD

Start date: April 20, 2024
Phase:
Study type: Observational

This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. By evaluating hepatic measurements and metabolic markers, the study aims to identify key risk factors for CKD in this population, contributing valuable insights to inform targeted interventions.

NCT ID: NCT06307405 Not yet recruiting - Pulmonary Infection Clinical Trials

The Value of mNGS in Diagnosis of Pulmonary Infection

Start date: April 20, 2024
Phase:
Study type: Observational

Retrospective analysis of clinical data from 50 hospital-admitted patients with suspected pulmonary infection (as judged by clinical manifestations and imaging findings) was performed on study participants who had collected two different samples of alveolar lavage fluid (BALF) and sputum and underwent metagenomic next generation sequencing (mNGS) and routine pathogen detection, respectively. The positive rate of pathogen detection and the consistency of pathogen detection results of the two detection methods were compared to evaluate the clinical manifestation and role of mNGS in pathogen diagnosis.

NCT ID: NCT06309849 Not yet recruiting - Clinical trials for Cervical Radiculopathy

Efficacy of Physical Therapy Intervention in Cervical Angina Patients at Jerash University Office Employees, "Randomized Clinical Trail".

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

Cervicogenic angina (CA) is defined as paroxysmal angina- like pain that originates from the disorders of the cervical spine or other neck structures. Because CA mimics typical cardiac angina, symptoms in the elderly with cervical spondylosis are more frequently misdiagnosed Nakajima H, 2006. Patients with CA may have suffered symptoms for longer periods of time and seen several clinicians due to conflicting cardiac exams. Clinicians and patients are unaware that CA symptoms are stemming from cervical spine disorders. However, the mechanism of pain occurrence in patients with CA remains unclear.

NCT ID: NCT06316856 Not yet recruiting - Clinical trials for Refractory Acute Lymphoblastic Leukemia

CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia

Start date: April 20, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a single-center, open-label, non-randomized, phase 1/2 study of anti-CD5 CAR-T cell therapy in patients with CD5+ relapsed or refractory T-cell malignancies. A bayesian optimal interval (BOIN) 12 design will be used to explore the optimal biological dose (OBD) from starting dose level 1: 1×10^6 (±20%) to dose level 2: 2×10^6 (±20%) in three cohorts (autologous, previous-transplant-donor or newly matched donor-derived CD5 CAR T cells). If the manufactured cells are not sufficient to meet the preassigned standard dose criteria, patients will be given infusion at a low dose level of 5×10^5 (±20%) /kg. The primary objective is to evaluate the safety and tolerability of CD5 CAR T cell therapy in subjects, determine the OBD and recommend phase 2 dose (RP2D) in phase 1, and evaluate the efficacy of CD5 CAR T cell therapy in phase 2. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days, and the incidence and severity of adverse events (AEs) within 30 days after CD5 CAR T-cell infusion in phase 1, the best overall response (BOR) at 3 months (± 1 week) after CD5 CAR T-cell infusion in phase 2. A total number of 54 subjects will be enrolled.

NCT ID: NCT06327646 Not yet recruiting - Pregnancy Related Clinical Trials

Maternal Adherence to MMS in Nepal

NAMASTE MMS
Start date: April 20, 2024
Phase: N/A
Study type: Interventional

Although clinical studies highlight the value of MMS for pregnant and lactating women, implementation research studies are necessary to understand adherence and acceptability to the product and to uncover potential obstacles to implementation in specific contexts. For Nepal, it is crucial to establish whether adherence to MMS supplementation is non-inferior to the existing IFA supplementation for 180 tablets, which has a high (65%) adherence rate. It is also important to investigate how whether providing MMS in bottles (containing a substantial quantity, such as 90 count bottles twice during pregnancy) might impact ANC utilization, particularly in terms of ensuring that pregnant women attend at least eight ANC visits. Furthermore, assessment of MMS acceptability, including pill taste, smell, size, swallowability, side effects, benefits as well as aspects such as product labeling and packaging, among end users in Nepal, is needed to understand acceptability of MMS vs. IFA. Finally, implementation issues within the health system, including the need of trainings for healthcare workers' and, female community health volunteers (FCHVs)' training needs; and government stakeholders' interest and barriers;; community s Social and behavioral change communication needs, and issues around supply chain issues should be well-understood and documented to inform prior to scale-up to support a smooth transition of MMS. Thus, Helen Keller International, in collaboration with Nepal's Ministry of Health and Population (MoHP) and the Eleanor Crook Foundation (ECF), will conduct a set of four mixed-methods studies to generate evidence and insights that inform the development of an MMS supplementation strategy. This trial in one province of Nepal is the first study that will be complemented by one additional quantitative study and two qualitative studies to generate evidence on the topics mentioned.

NCT ID: NCT06340828 Not yet recruiting - Clinical trials for Diabetic Gastroparesis

Washed Microbiota Transplantation Alleviates Diabetic Gastrointestinal Motility Disorders: an Efficacy and Safety Study

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about effectiveness and safety of washing microbiota transplantation in diabetic gastrointestinal motility disorders participant population. The main questions it aims to answer are: - The risk factors of diabetic gastrointestinal motility disorders in routine clinical data or biochemical tests. - The composition of gut microbiota in diabetic gastrointestinal motility disorders patients and potential pathogenic bacteria. - The efficacy of washing microbiota transplantation in the clinical treatment of diabetic gastrointestinal motility disorders patients and potential factors that may influence treatment outcomes. - The potential mechanisms of washing microbiota transplantation in treating diabetic gastrointestinal motility disorders patients. Participants will be collected fasting venous blood and random stool samples before treatment and at week 12 post-treatment, conducting scale assessments before treatment and at weeks 1, 4, and 12 post-treatment.

NCT ID: NCT06341270 Not yet recruiting - Liver Cancer Clinical Trials

Efficacy of TEAS on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to access the effect of transcutaneous electrical acupoint stimulation on postoperative pain in patients undergoing hepatectomy

NCT ID: NCT06348641 Not yet recruiting - Pain Clinical Trials

Reducing Pain and Increasing Comfort During a Retinopathy of Prematurity Examination

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the effect of baby massage applied to babies with retinopathy of prematurity on the pain and comfort of the newborn. This was randomised-controlled study in the NICU at the Health Sciences University Bursa High Specialization Training and Research Hospital, Bursa, Turkey. The population of the study will consist of preterms hospitalized in the neonatal intensive care unit during the time period of the study. In the calculation of the sample size, the power level was 80% and the significance level was 5%. When the effect size was determined as 0.8 in the examination of the difference between the experimental and control groups in terms of the premature infant pain profile (PIPP) variable, it was determined by the statistical expert that the number of babies to be included in each group was 26 and 52 babies in total should be included in the study. Based on this, the study sample was determined as 60 preterm infants in 30 experimental and 30 control groups. Block randomization method will be applied in the randomization of the groups. Case report form, PIPP=Premature Infant Pain Scale and Premature Infant Comfort Scale (PBIQ) will be used to collect the study data. Patients included in the study will be examined by the same ophthalmologist. The infant massage to be applied before the examination will be applied by a single nurse=researcher. Video recordings will be taken before and during the ROP examination and evaluations will be made by two neonatal nurses other than the researcher. Infants will be massaged by the researcher in accordance with IAIM guidelines and massage techniques. Total massage time will be equal for each infant. The researcher has an IAIM infant massage certificate. Before starting the infant massage, jewelry will be removed and hands will be washed. In the study, leg and face massage will be applied among the massage techniques in the IAIM guidelines.

NCT ID: NCT06351956 Not yet recruiting - Cardiac Arrhythmia Clinical Trials

New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes.

Start date: April 20, 2024
Phase:
Study type: Observational

New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes

NCT ID: NCT06353022 Not yet recruiting - Multiple Myeloma Clinical Trials

Minimal Residual Disease-based Strategy With T-Cell Redirector After Treatment With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma

IFm2022-01
Start date: April 20, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study, open-label, 2-cohort, multicenter, national, interventional in patients with newly diagnosed multiple myeloma. The study will investigate teclistamab (Tec) in combination with lenalidomide (Len) (Tec-Len; Cohort A) or in combination with talquetamab (Tal) (Tec-Tal; Cohort B), allocated based on minimal residual disease (MRD) status (MRD [-] [standard-risk] vs MRD [+] [high-risk] respectively). The patient population will consist of adults men and women at least 18 years to younger than 66 years of age, who meet eligibility criteria.