Regulatory approval
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseProbing Dermal Immunity to Mycobacteria through a Controlled Human Infection Model
Probing Dermal Immunity to Mycobacteria through a Controlled Human Infection Model Immunohorizons. 2024 Sep 1;8(9):695-711. doi: 10.4049/immunohorizons.2400053. ABSTRACT Cutaneous mycobacterial infections are difficult to diagnose and treat. We conducted a study with 10 participants to understand the dermal immune response to mycobacteria. Participants received 2 × 106 CFUs of Mycobacterium bovis bacillus Calmette-Guérin (Tice strain) […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseMycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus: A Randomized Clinical Trial
Mycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus: A Randomized Clinical Trial Key Findings The study found that early use of mycophenolate mofetil (MMF) alongside prednisone and hydroxychloroquine sulfate reduced the risk of severe flare and incidence of lupus nephritis in patients with new-onset systemic lupus erythematosus (SLE) and a high titer of anti-double-stranded DNA (dsDNA) […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseSelective ultrasound-guided nerve root block improves outcomes for discectomy in patients with cervical disc disease: a randomized, controlled, single-blinded study
Study Results: Ultrasound-Guided Nerve Root Block for Cervical Disc Disease Key Findings: Ultrasound-guided selective nerve root block significantly improved pain intensity and neck disability index scores in patients with multilevel cervical disease. Patients in the study group showed a ≥50% reduction in pain scores and a VAS rating of ≤2 at weeks four, eight, and […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseThe Impact of Diabetes Education by Clinical Pharmacist on Quality of Life and Treatment Satisfaction of Sudanese Individuals With Type II Diabetes Mellitus: Randomized, Double-Blind, Controlled Trial
The Impact of Diabetes Education on Quality of Life and Treatment Satisfaction Study Details Published in J Prim Care Community Health in 2024, this study aimed to assess the impact of diabetes education on the quality of life and treatment satisfaction of individuals with type 2 diabetes mellitus in Sudan. Methodology The study involved 364 […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseQuality of life, pain and use of analgesic, anxiolytic and antidepressant medication, in people living in care homes
Quality of Life and Medication Use in Care Home Residents Study Overview People living in care homes often experience pain, anxiety, and depression. This study aimed to investigate the relationship between medication use and the severity of pain, anxiety, and depression, as well as the impact on the quality of life in care home residents. […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseImpact of a multimodal effort re-education programme on functionality, physical performance, and functional capacity in cancer patients with dyspnoea: a randomised experimental study
Impact of a Multimodal Effort Re-education Programme for Cancer Patients with Dyspnoea Study Overview A study was conducted to test the effectiveness of a re-education programme in improving respiratory symptoms and functionality in cancer patients with dyspnoea. Methodology The study was a randomised experimental trial involving cancer patients from a specific hospital in Spain. Two […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseClinical breakage, slippage and acceptability of two commercial ultra-thin polyurethane male condoms compared to a commercial thin latex condom: a randomised, masked, 3 way crossover, multi centre controlled study (SAGCS 2)
Study Title: Clinical Trial on Ultra-Thin Polyurethane Condoms Published in Reprod Health, 2024 Sep 4;21(1):128 Objective: Evaluate breakage, slippage, and acceptability of two ultra-thin polyurethane condoms against a thin latex condom in a randomized, crossover, non-inferiority study. Design: The study followed ISO 29943-1: 2017 and FDA guidelines, conducted at two Essential Access Health centers in […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseRandomized study for a novel elbow joint fixation device on postoperative complications in patients undergoing percutaneous coronary diagnostic or therapeutic procedures through the brachial artery
Study Results: Novel Elbow Joint Fixation Device Reducing Complications in Brachial Artery Procedures Patients undergoing percutaneous coronary diagnostic or therapeutic procedures through the brachial artery face a higher risk of vascular complications. A randomized study investigated the use of a 3D-printed elbow joint fixation device to reduce postoperative complications in these patients. Results showed that […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseComparison of established and preliminarily proposed ASAS MRI working group cut-offs for inflammatory MRI lesions in the sacroiliac joints in radiographic and non-radiographic axial spondyloarthritis
Comparison of MRI Cut-offs for Inflammatory Lesions in Axial Spondyloarthritis Background A study compared the established and newly proposed MRI cut-offs for inflammatory lesions in the sacroiliac joints in patients with axial spondyloarthritis. The new cut-offs were preliminarily proposed in 2021. Methods The study used MRI scans from 657 patients to categorize them as MRI-positive […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseA 2.6% Benzoyl Peroxide AV Cleanser Specifically Designed for Sensitive Skin Offers Good Efficacy and Tolerability
Study Highlights: 2.6% Benzoyl Peroxide AV Cleanser for Sensitive Skin Effective and Well-Tolerated Treatment for Acne Vulgaris A clinical study evaluated the efficacy and safety of a 2.6% Benzoyl Peroxide (BPO) cleanser designed for sensitive skin in treating mild-to-moderate acne vulgaris (AV). The results showed a significant reduction in AV lesions as early as one […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseEvaluation of dentoalveolar changes following maxillary incisor intrusion with one vs two anterior miniscrews in subjects with gummy smile: a randomized clinical trial
Evaluation of Dentoalveolar Changes in Gummy Smile Subjects Comparison of One vs Two Anterior Miniscrews for Maxillary Incisor Intrusion Objective: To assess dentoalveolar changes after maxillary incisor intrusion with one or two anterior miniscrews in subjects with gummy smile and deep bite. Materials and Methods: Forty-three subjects were divided into two groups: group I with […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseA Randomized Controlled Trial to Determine the Impact of Resistance Training versus Aerobic Training on the Management of FGF-21 and Related Physiological Variables in Obese Men with Type 2 Diabetes Mellitus
A Randomized Controlled Trial to Determine the Impact of Resistance Training versus Aerobic Training on the Management of FGF-21 and Related Physiological Variables in Obese Men with Type 2 Diabetes Mellitus Key Findings: Fibroblast growth factor 21 (FGF-21) is a potential therapeutic target for insulin resistance in type 2 diabetes. This study compared the effects […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseTime-restricted eating with or without a low-carbohydrate diet improved myocardial status and thyroid function in individuals with metabolic syndrome: secondary analysis of a randomized clinical trial
Time-restricted eating and low-carbohydrate diet improve heart and thyroid health in metabolic syndrome Summary Researchers found that time-restricted eating (TRE) and low-carbohydrate diet (LCD) can significantly improve heart and thyroid function in people with metabolic syndrome (MetS). The study involved 169 MetS patients, who were randomly assigned to the LCD group, the 8-hour TRE group, […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phase
Effects of fructan and gluten on gut microbiota in individuals with self-reported non-celiac gluten/wheat sensitivity-a randomised controlled crossover trial
Effects of Fructan and Gluten on Gut Microbiota in Non-Celiac Gluten/Wheat Sensitivity Practical Solutions and Value Highlights Individuals with non-celiac gluten/wheat sensitivity (NCGWS) often experience improvement in gastrointestinal symptoms with a gluten-free diet. This study aimed to investigate the effects of fructo-oligosaccharides (FOS) and gluten on gut microbiota and related factors in NCGWS patients. The […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phasePlace of telemedicine in the organization of emergency care: feasibility and benefits
Feasibility and Benefits of Telemedicine in Emergency Care Introduction Telemedicine involves remote patient care using new information and communication technologies. This study evaluates the remote management of patients in emergency services during pre-pandemic and pandemic periods of COVID-19. Methods A prospective, randomized, controlled study was conducted at FarhatHached Hospital in Sousse. The telemedicine group received […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseRandomized crossover trial of a demand oxygen delivery system in nocturnal hypoxemia
Study Highlights The study compared a newly developed portable oxygen concentrator with an auto-demand oxygen delivery system (auto-DODS) to a continuous flow oxygen concentrator for Home Oxygen Therapy patients with nocturnal hypoxemic symptoms. Primary Endpoint: The auto-DODS did not reduce oxygen saturation (SpO2) by at least 2.8% on average compared to continuous flow. Safety: No […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phase
Sintilimab (anti-PD-1 antibody) combined with high-dose methotrexate, temozolomide, and rituximab (anti-CD20 antibody) in primary central nervous system lymphoma: a phase 2 study
Sintilimab Combined with Immunochemotherapy in Primary CNS Lymphoma: Phase 2 Study Key Findings: – Sintilimab combined with high-dose methotrexate, temozolomide, and rituximab showed a 96.3% overall response rate in newly diagnosed primary central nervous system lymphoma (PCNSL) patients. – The treatment regimen demonstrated high efficacy and tolerability, with 25 complete responses out of 27 evaluable […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phase
Low dose TamOxifen and LifestylE changes for bReast cANcer prevention (TOLERANT study): Study protocol of a randomized phase II biomarker trial in women at increased risk for breast cancer
Low Dose Tamoxifen and Lifestyle Changes for Breast Cancer Prevention (TOLERANT Study) Study Overview The TOLERANT study aims to evaluate the impact of different interventions, including low-dose tamoxifen (LDT), intermittent caloric restriction (ICR), lifestyle intervention (LI), and their combinations on biomarkers associated with breast cancer risk in high-risk women. Study Design Unaffected women aged 18-70 […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phaseAssessment of photodynamic therapy with annatto and led for the treatment of halitosis in mouth-breathing children: Randomized controlled clinical trial
Assessment of Photodynamic Therapy for Halitosis Treatment in Children Published in PLoS One, September 2024 Objective: The study aimed to evaluate the effectiveness of antimicrobial photodynamic therapy (aPDT) using annatto-based dye combined with blue LED for treating halitosis in mouth-breathing children. Materials and Methods: 52 children aged six to twelve with mouth breathing and halitosis […] ➡️➡️➡️
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Adverse effects, Clinical outcomes, Clinical research, Clinical study, Control arm, Data collection, Double-blind, Drug trial, Efficacy, Patient consent, Patient enrollment, Placebo, Randomization, Regulatory approval, Safety profile, Study design, Study protocol, Treatment group, Trial monitoring, Trial phase
MRI Predicts Residual Disease and Outcomes in Watch-and-Wait Patients with Rectal Cancer
MRI Predicts Residual Disease and Outcomes in Watch-and-Wait Patients with Rectal Cancer Radiology. 2024 Sep;312(3):e232748. doi: 10.1148/radiol.232748. Background: MRI plays a crucial role in restaging locally advanced rectal cancer treated with total neoadjuvant therapy (TNT). However, its ability to accurately select patients for nonoperative management has not been fully evaluated in prospective studies. Purpose: To […] ➡️➡️➡️