Clinical Research Directory

Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure

The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.

Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes

The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.

Physiological and Psychological Profiles

The participation of women in high-impact sports such as rugby and basketball has been steadily increasing in Saudi Arabia. These sports are known for their physical demands and competitive nature, which have heightened the incidence of sports-related injuries. Understanding the predictive factors for these injuries is critical for developing preventive strategies, reducing long-term health consequences, and reducing healthcare burdens. Therefore, this study aims to identify the predictive effect of physiological factors (e.g., muscle strength, anaerobic power, oxygen consumption) and psychological factors (e.g., self-efficacy, resilience) on sports injuries among female athletes in Saudi Arabia, particularly focusing on those involved in rugby and basketball. A prospective cross-sectional design will be employed, involving a total of 30 female athletes aged 18-35 years actively participating in rugby and basketball. Data will be collected at the lifestyle research center through a series of physiological assessments, including maximal oxygen consumption, anaerobic power testing, isokinetic muscle strength testing, and psychological evaluations using validated questionnaires. The findings are expected to provide insights into the specific factors that increase injury risk among Saudi female athletes, offering targeted strategies for injury prevention. These strategies aim not only to minimize injuries but also to reduce associated healthcare costs, thereby supporting the sustainable growth of women's sports in Saudi Arabia. Ultimately, this study seeks to contribute to the broader objectives of Vision 2030 by promoting a vibrant sports culture and enhancing public health.

A Quantitative, Cross-Sectional and Observational Study to Characterize Age-Related Structural Changes in Facial Skin of Chinese Women Using Line-Field Confocal Optical Coherence Tomography (LC-OCT)

This is a single-center, non-interventional, observational, cross-sectional clinical study designed to quantitatively and qualitatively characterize skin properties in a cohort of 100 Chinese female Subjects aged 20 to 70 years. The study involves no product application and poses minimal risk to participants. The primary objectives are to establish a comprehensive skin aging profile database, characterize skin color, aging signs, and biomechanical properties, and create a histomorphometric database for the development and validation of ordinal photographic scales for aging research. Data will be collected through questionnaires, clinical assessments (including LC-OCT imaging), standardized photography, and non-invasive biophysical measurements. All procedures will be conducted in accordance with the ethical principles originating from the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, and the relevant laws and regulations of China (including the \*Measures for the Ethical Review of Biomedical Research Involving Human Subjects\*). All data will be anonymized and stored securely.

Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma

Add-on dostarlimab to chemoradiation with etoposide and cisplatin and radiotherapy can improve progression-free survival (PFS) compared with historical controls who were treated with chemoradiation alone in SCNECC

Pain Neuroscience Education and Basic Body Awareness Therapy in Women With Chronic Pelvic Pain

This randomized controlled trial aims to investigate the effects of Pain Neuroscience Education and Basic Body Awareness Therapy, when added to standard physiotherapy and rehabilitation, on pain, autonomic nervous system responses, and pelvic floor muscle activity in women with chronic pelvic pain. A total of 45 women diagnosed with chronic pelvic pain will be randomly allocated into three groups: (1) standard physiotherapy and rehabilitation, (2) standard physiotherapy plus Pain Neuroscience Education, and (3) standard physiotherapy plus Basic Body Awareness Therapy. The study will assess pain intensity (algometry, NRS, SF-MPQ), pain catastrophizing, autonomic responses (electrodermal activity), pelvic floor muscle activation (EMG), and related psychological, cognitive, and body awareness parameters. Secondary outcomes will include sexual function, quality of life, and patient satisfaction. The aim is to compare two awareness-based interventions-one primarily mind-to-body (Pain Neuroscience Education) and the other body-to-mind (Basic Body Awareness Therapy)-to determine their relative and complementary effects on pain perception and physiological regulation in women with chronic pelvic pain.

Progesterone and Muscle Protein Synthesis in Premenopausal Women (MP4-MPS)

The goal of this clinical trial is to learn if micronized progesterone (PROMETRIUM®) influences the muscle-building response to resistance exercise in healthy premenopausal women aged 18-30 years. The main questions it aims to answer are: 1. Does progesterone change the rate of muscle protein synthesis after exercise? 2. Does progesterone alter the difference in synthesis between an exercised leg and a rested leg? Researchers will compare micronized progesterone to a placebo to see if progesterone changes the way skeletal muscle adapts to resistance exercise. Participants will: * Take two oral doses of progesterone (400 mg total, 34 and 10 hours before testing) or placebo * Complete a unilateral leg extension exercise session in the lab * Receive an infusion of a stable isotope tracer and provide blood samples * Undergo muscle biopsies from the exercised and rested legs

Oral Mucosal Graft Versus Labial Graft in Female Urethroplasty

This study aims to compare the oral versus labial graft in female urethroplasty in female urethral stricture.

Pain Science Education for Labour and Postpartum Pain

This Delphi study aims to establish expert consensus on the role, content, and delivery of pain science education (PSE) for labour and postpartum pain management. Despite the growing application of PSE in other populations, its use in maternity care remains underexplored. Through a three-round electronic Delphi survey, multidisciplinary experts-including physiotherapists, midwives, gynaecologists, pain specialists, nurses, and psychologists-will contribute their perspectives to guide the development of a structured PSE intervention for future clinical testing.

Emulsion 8-Week Anti-acne Efficacy Clinical Study

65 male and female adult subjects will be enrolled in the study, recruited according to inclusion and non-inclusion criteria listed below, at least 60 subjects should complete questionnaire, at least 40 of them should complete clinical assessment, instrumental measurement and image capture. 20 of them should complete lipid sample collection, and at least 30 of them should complete the RCM captured.

Atraumatic Zirconia Abutment Versus Customized Composite Healing Abutment in Maxilla or Mandible.

40 patients are included in the study, 20 patients in group 1 (=closure with composite material shaper; test group) and 20 patients in group 2 (=closure with custom-made zirconia oxide abutment; control group). Randomisation envelopes will be used for randomisation. Device under study: Straumann BLX, Roxolid® , SLActive® dental implants with a diameter of 3.5, 3.75, 4, 4.5 mm are used. Allogenic bone botiss maxgraft® cortical granules are used as graft material. Inclusion criteria: 1. Males and females at least 18 years of age or older. 2. One implant per patient. 3. Prior to any study-related activity, the subject must voluntarily sign informed consent, be willing and able to attend scheduled follow-up visits, and agree to the collection and analysis of pseudonymised data. 4. Lateral individual teeth (premolars and molars). 5. Class I extraction socket (intact buccal wall) or class II (1/3 of buccal wall). 6. The gingival contour of the tooth to be extracted - without recession. 7. Adjacent anterior teeth have no periodontal loss. 8. There are no implants in the adjacent teeth. 9. Non-traumatic tooth extraction, which results in intact walls of the socket. Exclusion criteria: 1. Deep occlusion (severe, class II). 2. The patient smokes a lot (more than 10 cigarettes per day). 3. Systemic disease (osteoporosis). 4. No initial stability has been achieved after the implant insertion procedure.

Effect of Education With Mobile App on Metabolic Control in Patients With Type 2 Diabetes

The objective of this study is to compare the effect of education through a mobile application with medical and nutritional reinforcement on the metabolic control of Mexican patients with type 2 diabetes attending primary care clinics in Mexico. The research question is: What is the effect of education through a mobile application with medical and nutritional reinforcement vs. nutritional and medical reinforcement, versus an educational platform to influence the metabolic control of patients with type 2 diabetes? Multicenter clinical trial in six family medicine units of the Mexican Institute of Social Security. These selected units are: UMF 9, UMF 28, UMF 7, UMF 1, UMF 9 and UMF 10. Patients with type 2 diabetes will be randomly assigned to the educational intervention through the educational site, (n=160 patients), two clinics will be assigned for the use of the mobile App and the educational site (n=160 patients), and two clinics will be part of the control group (n=160 patients).

Exploring Pelvic Floor Dysfunction Among Egyptian Female Athletes

This Study is aiming to identify the prevalence of pelvic floor dysfunction in female athletes in Egypt and which sports contribute more in increasing their number. helping in gathering information about the risk factors and raising awarness about Pelvic floor dysfunction

Identification With the Aggressor (IWA)

This is a randomized control study, comprising of 2 assessments :before (T1) and after (T2) the identification with the aggressor (IWA) lab task.

Gender-specific Evaluation of Symptom Awareness in Female Versus Male Patients with Severe Aortic Stenosis

The objectives of this single center cross-sectional cohort study are to compare symptoms and disease perception of male and female patients with severe aortic stenosis.

Fertility and Ovarian Reserve in Female Childhood Cancer Survivors

Ovarian function impairment affects the quality of life of the survivors of paediatric cancer by impacting fertility, bone quality and mental and cognitive health. The objective of this project is to evaluate the impact of low-intermediate dose alkylating agents associated or not with ovarian cryopreservation technique on ovarian function in female survivors of paediatric cancer. We propose to identify new epigenetic markers in order to predict the risk of premature ovarian insufficiency. The project will be led by a national multi-disciplinary team (paediatric oncologists, gynaecologists, endocrinologists). Paediatric cancer clinical data (therapy, fertility preservation, ...) will be extracted from the Paediatrics Late Effects database and additional data will be collected during PRINCESS fertility evaluation. Through translational and multi-disciplinary approaches, results should improve quality of life and fertility preservation in female survivors of paediatric cancer by developing new personalised screening tools for premature ovarian insufficiency.

KNUCH CadAI-B-1(KCB-1)

The CadAI-B (Computer Aided Design Artificial Intelligence-Breast) system is a real-time AI diagnostic tool for breast ultrasound. It integrates with ultrasound devices to detect suspicious lesions, providing size, BI-RADS, and malignancy probability. After installation and user training, the system displays real-time breast conditions and automatically analyzes lesions when a freeze frame is set, showing results in seconds. This study will assess CadAI-B\'s accuracy and reliability by comparing its findings with biopsy results.

SEx-specific Differences in Cardiac Surgery Patients (SECS).

The aim of this study is to evaluate the differences between females and males undergoing cardiac surgery. The investigators will look at perioperative factors such as adaption of body weight, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at sort-term (within 30 days) and long-term (90 days and 1 year).

Epidemiology of Injuries in the Professional Women's Swedish National IceHockey League Permitted to Body-Checking

This research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. An understanding of common injury types and mechanisms aids the clinician in diagnosis and management. This information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. Today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. Reducing the number and severity of sport-related injuries is therefore of importance. Knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. Currently, only a minority of all sports medicine research is made on female study participants (26). This research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. Knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions.

Towards a Sex-specific "Female Enhanced Recovery After Cardiac Surgery'' (F-ERAS) Pathway:

The aim of this study is to evaluate the differences between men and women undergoing cardiac surgery. We will look at perioperative factors such as body weight, body surface area, previous medical history, pharmacokinetics, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, cardiac function, inotropic requirements, risk, and outcome scores as well as morbidity and mortality at 30 and 90 days, 1, 5, and 10 years.

Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus

This clinical study is a prospective, multicenter, randomized, controlled, double-blind clinical study. Sun Yat Sen Memorial Hospital of Sun Yat sen University was the central unit, and Nanjing First Hospital, Sun Yat Sen people's Hospital, Guanfzhou Panyu central Hospital and Zhuhai integrated traditional Chinese and Western medicine hospital were the cooperative units. In this study, 388 patients with chronic subjective tinnitus were recruited. In view of chronic subjective tinnitus, a common ear disease, the study gave the patients three months of treatment with transcutaneous vagus nerve stimulation paired with tailor-made notched music therapy or tailor-made notched music training alone. By comparing the changes of subjective scale scores related to tinnitus before and after treatment in patients receiving two different therapies, such as THI, VAS, BAI, BDI, PSQI, to evaluate the efficacy of the two therapies, so as to judge whether transcutaneous vagus nerve stimulation paired with tailor-made notched music therapy is better than tailor-made notched music training alone. In addition, the study will continue to follow up the patients after the treatment for one year to observe the difference in the long-term sustained efficacy of the two therapies. This clinical study will also evaluate the two therapies from the perspective of compliance and safety, and explore the factors that affect the efficacy of the two therapies.