Clinical Research Directory

Tumour Cell Response to Acute Aerobic Exercise in Breast Cancer Survivors: Modulatory Effects of Exercise Type and Intensity

Cancer has emerged as a prominent cause of mortality in the 21st century, with breast cancer (BC) being the most diagnosed malignancy. Multidisciplinary cancer management has improved survival chances, but side effects and long-term consequences of treatments have significant implications for cancer survivors' health-related quality of life. Exercise is increasingly considered and used in cancer treatment and follow-up. However, studies demonstrating the biological mechanisms underlying the anticarcinogenic effects (ACE) of exercise are insufficient to justify the most appropriate physical activity for different clinical scenarios. Achieving scientific excellence in understanding the ACE of exercise in cancer management is critical to optimize treatment and enhance patients' quality of life.

The Impact of Trunk and Lower Extremity Electrical Stimulation on Pelvic Floor Muscle Strength in Females

This study aims to investigate the effects of whole-body electrical muscle stimulation (EMS) applied to the trunk and lower extremity muscles on pelvic floor muscle strength in healthy women. Since pelvic floor muscles are deep-seated and can be difficult to activate voluntarily, this research explores whether stimulating related muscle groups (core and legs) can provide an indirect benefit to pelvic floor strength. Participants will be divided into three groups (EMS + exercise, Sham-EMS + exercise, and exercise only) and will undergo a 6-week intervention program. Changes in pelvic floor muscle strength will be evaluated using a perineometer to determine the effectiveness of this non-invasive approach.

TMS-Induced LH Response in Healthy Women in Luteal Phase

The purpose of this research is to establish whether non-invasive Transcranial Magnetic Stimulation (TMS), can affect modulation of hormones such: Luteinizing Hormone (LH) and Follicle-stimulating hormone (FSH). The hypothesis is that applying TMS to the Dorsolateral Prefrontal Cortex with specific pulse patterns, mimicking endogenous Gonodotropin-Releasing Hormone (GnRH) pulses that are known to stimulate LH secretion may modulate hormonal levels.

The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries Among Mothers of Infants in Terengganu.

This study will be conducted in Ministry of Health (MOH) Maternal and Child Health Clinics (MCHCs) and MOH dental clinics in Setiu and Hulu Terengganu, selected for their similar sociodemographic characteristics. A two-arm, parallel cluster-randomized controlled trial (1:1 allocation) will be implemented, where the study group receives Anticipatory Guidance (AG) through Motivational Interviewing (MI), and the control group receives conventional MOH AG. Mothers aged ≥18 years who can understand Bahasa Malaysia and their healthy 6-month-old infants (full-term, without congenital conditions) are eligible. Mothers with postpartum depression and infants requiring special oral healthcare are excluded. A total of 228 mother-infant pairs will be recruited using multistage sampling. Three MCHCs from Setiu and three randomly selected MCHCs from Hulu Terengganu will participate. Systematic sampling will be applied within each clinic. Data collection occurs at infant ages 6, 9, and 12 months during routine immunization visits. At each visit, infants undergo oral examination using ICDAS and a caries risk assessment. Mothers complete age-specific validated questionnaires on knowledge and practices. The study group receives two MI sessions (at 6 and 9 months) with follow-up phone calls, while the control group receives routine AG by MOH staff. The MI protocol will be developed based on established MI frameworks and be validated through expert review, will be pretested among mothers and dental officers/therapists in MOH MCHC and MOH dental clinic in Besut district. While fidelity assessment of MI sessions conducted will be done using MITI 4.2.1 guidelines. All MI sessions will be delivered by the trained principal investigator. Approximately 8 minutes are required for infant oral examination, 7 minutes for questionnaire completion, and 30 minutes for MI. Data will be analysed using descriptive statistics, paired t-tests, independent t-tests, McNemar's test, and Chi-Square test with significance set at p \< 0.05. Ethical approval was obtained from Jawatankuasa Etika Penyelidikan Manusia USM (JEPeM)/ Human Research Ethics Committee USM (HREC) and Medical Research and Ethics Committee (MREC) MOH. Participation is voluntary, with confidentiality ensured. No major risks are expected.

Effect of Magnesium Supplementation on Sleep Quality and Cognitive Function in Saudi Adults

The goal of this clinical trial was to evaluate whether magnesium citrate supplementation improved sleep quality and cognitive function in healthy Saudi adults. It also assessed the effects of magnesium on selected blood markers. The main questions it aimed to answer were: Did magnesium supplementation improve sleep quality? Did magnesium supplementation improve cognitive function? Researchers compared participants who received magnesium citrate to a control group that did not receive any intervention to evaluate its effects. Participants: Took magnesium citrate (400 mg daily) for 90 days (two capsules: one in the afternoon and one 1-2 hours before bedtime) Visited Umm Al-Qura University twice (before and after the intervention) for: Sleep quality assessment Cognitive function assessment Blood sample collection to measure serum magnesium and HbA1c The control group did not receive any supplementation during the study period.

Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women

This is a prospective, comparative, double-blind, randomized, monocentric study. The objective of this project is to evaluate the effects on health of probiotic supplementation (PS) with or without physical activity (PA). Participants who meet the study criteria will be randomized into 4 groups: probiotic and physical activity group (A+), probiotic and non-physical activity group (A-), placebo and physical activity group (T+), placebo and non-physical activity group (T-). The probiotics used are Lactibiane® Reference provided by Pileje Laboratory. The study population are healthy women (university students) who do not practice sports. A total of 120 participants will participate. At inclusion, each participant will undergo a medical examination, collect microbiota and salivary samples and perform different tests (questionnaires, assessments of strength and endurance). Then, a follow up phase will last 6 weeks. Each participant will receive a pillbox containing capsules (probiotic or placebo in a double-blind manner). Participants which randomized in the PA groups (A+ and A-) will perform 2 physical activity sessions per week for 6 weeks. At the end of this follow up phase, tests conducting during inclusion will be performed again.

A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception

This is a multicenter, open-label, Phase 2b study to evaluate the efficacy and safety of 2 LB SQ injections administered at a 4-month (approximately 17 weeks) interval for female contraception.

A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception

This is a Phase I multicenter, open-label, dose-ranging, three-dose PK and PD study of injectable LB administered as an IM or SQ injection at 40 mg, and subsequently at 50mg SQ and then 60 mg SQ depending on the preliminary pharmacokinetic and pharmacodynamic results obtained with 40 mg dosing.

The Effect of Web-based Education on Gynecological Cancer Awareness and Healthy Life Behaviors

There are cross-sectional or quasi-experimental studies in the literature on gynecological cancer awareness, but there are no fully experimental studies. The study we will conduct will use a control group and will be a fully experimental study. Thus, it is thought to contribute more to the field. The purpose of the study is to determine the effect of gynecological cancer education given to married women on their gynecological cancer awareness and healthy living behaviors.

The Effect of the Menstrual Cycle on Immune Cell Activity and Recovery After Resistance Exercise

The goal of this observational study is to learn how the menstrual cycle affects immune cell activation, recruitment, and recovery responses after resistance exercise in healthy, resistance-trained women aged 18-40. The main questions it aims to answer are: Does the menstrual cycle influence neutrophil recruitment and adhesion after resistance exercise? Does the menstrual cycle affect markers of muscle damage and functional recovery? Researchers will compare three menstrual phases (early follicular, late follicular, and mid-luteal) to see if immune responses and recovery outcomes differ across these phases. Participants will: Complete resistance exercise protocols across three different menstrual cycle phases. Provide blood samples to assess immune cell activation and muscle damage markers. Track sleep, mood, and recovery with questionnaires and wear an accelerometer.

The Effect of Dimenhydrinate on Postoperative Nausea and Vomiting After Abdominal Hysterectomy: Randomized-controlled Trial

The aim of this clinical trial is to learn if Dimenhydrinate works to prevent postoperative nausea-vomiting in adult women who undergoing abdominal hysterectomy. The primary question is: Does Dimenhydrinate lower the proportion of postoperative nauseavomiting during the day 1 after surgery. Researcher will compare Dimenhydrinate to a placebo (a-look-alike substance that contains no drug) which will give intravenously when the patient come back to the ward, to see if Dimenhydrinate work to prevent nauseavomiting during the postoperative day1. All participants will receive standard treatment during pre-operative, intra-operative and the immediate post-operative periods. Participants will receive Dimenhydrinate or placebo only one dose after discharge from the recovery room. During the day 1 postoperative, participants will report their symptoms and keep a diary of the number of tmes they use additional anti-emetic drugs.