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 phaseSerum β2-Microglobulin Predicts Time to Recovery of Delayed Graft Function in Kidney Transplant Recipients
Serum β2-Microglobulin Predicts Time to Recovery of Delayed Graft Function in Kidney Transplant Recipients Background Delayed graft function (DGF) after kidney transplantation can lead to negative patient and allograft outcomes. Prolonged DGF is linked to worse graft outcomes. The relationship between posttransplant serum β2-microglobulin (B2M) and DGF recovery is not well understood. Methods All kidney-only […] ➡️➡️➡️
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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 phaseEffect of Messaging on Support for Breast Cancer Screening Cessation Among Older US Women: A Randomized Clinical Trial
Effect of Messaging on Support for Breast Cancer Screening Cessation Among Older US Women: A Randomized Clinical Trial Abstract Many older women are screened for breast cancer beyond recommended guidelines. This study aimed to investigate the impact of a message on older women’s support for and intentions of stopping breast cancer screening. Intervention A pilot-tested […] ➡️➡️➡️
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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 phaseVital parameter monitoring in harsh environment by the MedSENS in-ear multisensor device
Vital parameter monitoring in harsh environment by the MedSENS in-ear multisensor device ABSTRACT Accurate assessment of vital parameters is crucial for diagnosing and prioritizing critically ill patients, especially in out-of-hospital settings where suitable devices may be lacking. We conducted a pilot study to extensively validate a novel in-ear device designed for non-invasive measurement of core […] ➡️➡️➡️
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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 phaseAdverse event assessment in a parenting programme: experiences from a multisite randomised controlled trial
Adverse Event Assessment in Parenting Program: Multisite Trial Results Key Findings Clinical trial results from the RISE project revealed that adverse event (AE) assessment in parenting programs significantly improved over three phases of study, with 100% response rate achieved in the final phase. During the intervention, no serious adverse events (SAE) were registered, and 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 phaseMultiplex real-time PCR in non-invasive respiratory samples to reduce antibiotic use in community-acquired pneumonia: a randomised trial
Multiplex real-time PCR in non-invasive respiratory samples to reduce antibiotic use in community-acquired pneumonia: a randomised trial Abstract We evaluated whether using multiplex real-time PCR in addition to standard microbiological testing is safer and more effective than standard testing alone in reducing antibiotic use for community-acquired pneumonia (CAP). In this randomised trial, adults hospitalized 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 phaseNutritional support in hospitalised patients with diabetes and risk for malnutrition: a secondary analysis of an investigator-initiated, Swiss, randomised controlled multicentre trial
Nutritional Support in Hospitalised Patients with Diabetes and Risk for Malnutrition Secondary Analysis of an Investigator-Initiated, Swiss, Randomised Controlled Multicentre Trial Objective: Investigating the effects of nutritional support on mortality in hospitalised patients with diabetes and nutritional risk. Design: Secondary analysis of a Swiss-wide multicentre, randomised controlled trial. Participants: Patients with diabetes and risk for […] ➡️➡️➡️
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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 phaseSweat lactate sensor for detecting anaerobic threshold in heart failure: a prospective clinical trial (LacS-001)
Sweat Lactate Sensor for Detecting Anaerobic Threshold in Heart Failure: LacS-001 Clinical Trial Abstract A prospective clinical trial (LacS-001) aimed to investigate the safety and correlation between sweat lactate threshold (sLT) and ventilatory threshold (VT) in patients with heart failure (HF). 50 HF patients participated in incremental exercise tests while using a sweat lactate-monitoring sensor. […] ➡️➡️➡️
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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 phaseNontargeted metabolomic profiling analysis of patients with type 2 diabetes mellitus undergoing corn silk treatment
Nontargeted Metabolomic Profiling Analysis of Corn Silk Treatment for Type 2 Diabetes Mellitus Medicine (Baltimore). 2024 Aug 16;103(33):e39396 Patients with newly diagnosed type 2 diabetes mellitus (T2DM) were studied to understand the effects of corn silk treatment. The study found that patients receiving corn silk experienced a significant decrease in glycosylated hemoglobin and fasting blood […] ➡️➡️➡️
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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 phasePelvic floor muscle training in women with urinary incontinence and pelvic organ prolapse: A protocol study
Pelvic Floor Muscle Training in Women with Urinary Incontinence and Pelvic Organ Prolapse: A Protocol Study Objective To assess the impact of pelvic floor muscle training (PFMT) on pelvic floor muscle (PFM) function and quality of life (QoL) in women with stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Methods This study will involve […] ➡️➡️➡️
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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 phaseSelf-reported menses physiology is positively modulated by a well-formulated, energy-controlled ketogenic diet vs. low fat diet in women of reproductive age with overweight/obesity
Study Title Self-reported menstrual cycle is positively influenced by a well-designed, energy-controlled ketogenic diet compared to a low-fat diet in overweight/obese women of reproductive age Study Information Published in PLoS One on August 16, 2024, this study aimed to compare the effects of a ketogenic diet (KD) and a low-fat diet (LFD) on menstrual patterns […] ➡️➡️➡️
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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
Suvorexant for Reduction of Delirium in Older Adults After Hospitalization: A Randomized Clinical Trial
Suvorexant for Reduction of Delirium in Older Adults After Hospitalization: A Randomized Clinical Trial Objective To evaluate the orexin receptor antagonist suvorexant for reducing delirium in older adults at high risk for delirium after hospitalization. Design and Participants Double-blind, placebo-controlled, phase 3 randomized clinical trial conducted at 50 hospitals in Japan. Study population included Japanese […] ➡️➡️➡️
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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 effect of promoting factors on learning by four different delivery modes
The Effect of Promoting Factors on Learning by Four Different Delivery Modes BMC Med Educ. 2024 Aug 15;24(1):880. doi: 10.1186/s12909-024-05864-7. Background: Developing effective teaching methods in the digital era is crucial due to challenges in maintaining students’ concentration. This study assessed the effects of learning-promoting factors across group boundaries and within RCT learning groups, comparing […] ➡️➡️➡️
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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 phaseExpanding Xpert MTB/RIF Ultra and LF-LAM testing for diagnosis of tuberculosis among HIV-positive adults admitted to hospitals in Tanzania and Mozambique: a randomized controlled trial (the EXULTANT trial)
EXULTANT Trial: Improving Tuberculosis Diagnosis in HIV-Positive Hospitalized Patients Overview The EXULTANT trial aims to evaluate a new screening strategy for diagnosing tuberculosis (TB) in hospitalized people living with HIV (PLHIV) in Tanzania and Mozambique. The trial focuses on the impact of using multiple specimens (sputum, stool, and urine) for TB diagnosis, along with urine […] ➡️➡️➡️
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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
Impact of Vojta therapy combined with standard care on psychometric and functional parameters in patients with chronic lower back pain: a randomized controlled trial
Impact of Vojta Therapy on Chronic Lower Back Pain Key Findings: Combining Vojta therapy (VT) with standard care and electrotherapy significantly improved posture, reduced depression, and enhanced self-esteem in patients with chronic lower back pain (LBP). Study Details: A randomized controlled trial involving 148 patients diagnosed with chronic LBP. Patients were split into LBP-VT (n […] ➡️➡️➡️
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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 phaseBenefits of home-based foot neuromuscular electrical stimulation on self-reported function, leg pain and other leg symptoms among community-dwelling older adults: a sham-controlled randomised clinical trial
Benefits of Home-Based Foot Neuromuscular Electrical Stimulation for Older Adults Introduction Many older adults experience lower leg pain and circulation issues, impacting their daily function and quality of life. This study examined the effects of home-based foot neuromuscular electrical stimulation (NMES) using Revitive® on self-reported function, leg pain, and other leg symptoms. Methods A randomized […] ➡️➡️➡️
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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 phaseInsomnia prehabilitation in newly diagnosed breast cancer patients: Protocol for a pilot, multicentre, randomised controlled trial comparing nurse delivered sleep restriction therapy to sleep hygiene education (INVEST trial)
Insomnia prehabilitation in newly diagnosed breast cancer patients: Protocol for a pilot, multicentre, randomised controlled trial comparing nurse delivered sleep restriction therapy to sleep hygiene education (INVEST trial) ABSTRACT Insomnia is a common sleep disorder that affects breast cancer patients, impacting their quality of life. This trial aims to test the feasibility and effectiveness of […] ➡️➡️➡️
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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 phaseEfficacy and Safety of Shi Cervical Rotational Manipulation in Patients With Atlantoaxial Joint Subluxation: Protocol for a Randomized Controlled Trial
Efficacy and Safety of Shi Cervical Rotational Manipulation in Patients With Atlantoaxial Joint Subluxation: Protocol for a Randomized Controlled Trial ABSTRACT In this study, we aim to evaluate the effectiveness and safety of Shi cervical rotational manipulation (SCRM) in patients diagnosed with atlantoaxial joint subluxation (AJS). SCRM is a traditional Chinese medicine (TCM) manual therapy […] ➡️➡️➡️
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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 phaseRelative motion splints versus metacarpophalangeal joint blocking splints in the management of trigger finger: Study protocol for a randomized comparative trial
Relative motion splints versus metacarpophalangeal joint blocking splints in the management of trigger finger: Study protocol for a randomized comparative trial ABSTRACT Hand-based metacarpophalangeal joint (MCPJ) blocking splints are commonly used for trigger finger (TF), but finger-based relative motion (RM) splints are also used without evidence. This trial aims to compare the effectiveness, function, occupational […] ➡️➡️➡️
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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
Exploring the impact of the environment on physical activity in patients with chronic obstructive pulmonary disease (EPCOT)-A comparative analysis between suggested and free walking: Protocol study
Exploring the Impact of Environment on Physical Activity in Patients with COPD Practical Solutions and Value Individuals with chronic obstructive pulmonary disease (COPD) often have reduced physical activity levels, which can lead to poorer outcomes. Traditional trials aimed at increasing physical activity have not been very successful. To address this, an ecological model incorporating individual, […] ➡️➡️➡️
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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
Increasing coverage in cervical and colorectal cancer screening by leveraging attendance at breast cancer screening: A cluster-randomised, crossover trial
Increasing Cancer Screening Participation Study Overview: A clinical trial investigated the effectiveness of increasing cervical and colorectal cancer screening participation by leveraging attendance at breast cancer screenings. The trial was conducted in the Central Denmark Region from September 2021 to May 2022. Intervention: At selected breast cancer screening units, women attending were offered self-sampling kits […] ➡️➡️➡️