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NCT ID: NCT04711525 Recruiting - Clinical trials for Childhood Obesity Prevention

i-MaCHeL Study is a Two-group, Cluster-RCT, Involves 460 Preschool's Child-parent Dyads, to Prevent Childhood Obesity

i-MaCHeL
Start date: March 16, 2022
Phase: N/A
Study type: Interventional

Background: Strategies to treat and prevent obesity are urgently required in Malaysia, and it is now considered a public health priority. Aims: The present study aims to evaluate the effectiveness of the i-MaCHeL intervention for preschool's child-parent dyads. The primary objective of the present study is to compare the changes in the child BMI-for-age z-score at 3- and 9-month after baseline measurement. The secondary objectives of the present study are to compare the changes in child dietary intake, child physical activity, child health-related quality of life, parental self-efficacy, parental role modeling, and parental policies at 3- and 9-month after baseline measurement. Study design: The i-MaCHeL intervention is a single-blind, two-group cluster-randomized controlled trial that evaluates the effectiveness of a 3-month obesity prevention intervention on preschool's child-parent dyads at 3- and 9-month after baseline. The participating preschools (n=12) will be randomized to either the intervention or control group in a 1:1 ratio. The present study will involve 460 child-parent dyads of preschool children aged 5 and 6 years old and their parents in Terengganu, Malaysia. Briefly, the preschool children in the experimental group will be received the i-MaCHeL program delivered through interactive classroom instruction, and their parents will have access to the i-MaCHeL Web-based program. In the control group, the preschool children will be received a standard preschool health education curriculum, and their parents will have access to the general Web-based health newsletters. Instruments: Anthropometric measurements (body weight and height) will be assessed according to the WHO standard procedures. Dietary intake of children will be measured using dietary records for three days. Child physical activity, child health-related quality of life, parental role modeling, parental policies, and parental self-efficacy will be assessed using previously validated parent-proxy questionnaires. Conclusion: The strategies to promote healthy eating in reducing the prevalence of obesity among Malaysian preschool children may have long-term benefits to children's health. The combinations of the two modes of delivery (interactive classroom instruction for preschool children and a Web-based program for parents) will have a strong potential to be effective strategies to sustain child-parent engagement and participation in the health-related behavior change program.

NCT ID: NCT04686305 Recruiting - Clinical trials for Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

DL03
Start date: March 9, 2021
Phase: Phase 1
Study type: Interventional

DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

NCT ID: NCT04686201 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

Development of Diabetes Mobile Application

Start date: August 1, 2019
Phase: Phase 3
Study type: Interventional

this study is to measure the effectiveness of a diabetes mobile application for improving patient's knowledge, compliance and diabetes control among uncontrolled Type 2 Diabetes Mellitus mellitus patients in Kedah

NCT ID: NCT04678609 Recruiting - Clinical trials for Osteoarthritis, Knee

OKV Versus CKC for Biomechanics and Function in Mild Knee OA Patients

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Background: Clinical recommendations suggest exercises as the core treatment for knee osteoarthritis (OA) patients. However, the biomechanical modification following exercise therapy and its influence on pain remains unclear. The purpose of the study to compare the effectiveness of two different exercise programs, open kinetic chain (CKC) and closed kinetic chain (CKC) strengthening exercises, on pain and lower limb biomechanics for people more than 50 years old with painful mild grade knee OA. Method: 66 individuals with mild knee OA, with knee pain in the previous one week, aged 50 years and above, and who have body mass index (BMI) between 18.9kg/m2 - 29.9 kg/m2 in Kelantan, Malaysia will be recruited in this study. Participants will be randomly allocated into three different groups, either OKC, CKC, or control groups. Participants in OKC and CKC groups will perform the exercises at their home three times per week for eight weeks. The control group will receive only the patient's clinical education about clinical manifestations, risk factors, diagnosis, treatment, and nursing care for knee OA and printed materials will be given. The outcome will be measured before and after the intervention. Primary outcomes are self-reported pain, disability, and quality of life scores. Secondary outcomes include lower limb biomechanics during gait and sit-to-stand, and knee isokinetic strength. Discussion: This study will compare the efficacy of two different home-based exercise intervention programs for people with mild grade knee OA. Findings will provide valuable information for creating an effective exercise program that could slow down the progression of OA.

NCT ID: NCT04669015 Recruiting - Covid19 Clinical Trials

Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19

NOVATION-1
Start date: June 10, 2021
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blind, multicenter, placebo-controlled trial to evaluate the safety and efficacy of a novel therapeutic agent, Novaferon, in hospitalized adult patients diagnosed with COVID-19. The study is comprised of two cohorts: - Cohort A: This is a blinded safety lead-in comprising two arms. 40 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus Standard of Care (SOC) - Cohort B: This is the main portion of the study, which comprises two arms. Up to 874 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC

NCT ID: NCT04654429 Recruiting - Tremor Clinical Trials

Does Higher OT Temperature and IV Ondansetron Reduce Incidence of PSS in Parturients?

HOTON
Start date: October 13, 2020
Phase: Phase 4
Study type: Interventional

This study will look at the incidence of post-spinal shivering (PSS) among the obstetrics population and will investigate whether higher operation theater (OT) temperature range or/and IV Ondansetron are able to reduce the incidence of PSS. This is a double-blind, randomized, factorial study, patients will be grouped into 4 groups - LP, HP, LO, HO (L= low-temperature range, H= high-temperature range, P= placebo, O=Ondansetron). All patients undergoing cesarean section under spinal anesthesia will be recruited, and it will be conducted in obstetrics OT.

NCT ID: NCT04650685 Recruiting - Gingivitis Clinical Trials

Effectiveness of Salvadora Persica Miswak in Improving Plaque Control and Gingival Health

Start date: December 22, 2020
Phase: N/A
Study type: Interventional

Dental plaque is a main etiologic agent in periodontal disease. Global of Burden Disease Study 2016 ranked periodontal disease as the 11th most prevalent disease affecting 10.5% population worldwide. Tooth brushing is a reliable mechanical means to control dental plaque accumulation in order to maintain oral health. For decades, studies have demonstrated the efficiency of unprocessed Salvadora persica (miswak) chewing stick practice as an alternative to a standard toothbrush. Recently, a local Malaysian company has invented and successfully mass manufactured a world-first Salvadora persica toothbrush where its nylon bristles are primarily mixed with miswak powder and natural silica. With the benefits of Salvadora persica properties intact, it is also claimed to be effective without the application of toothpaste. However, the claim remains to be fully elucidated. There is also no randomized controlled trial available evaluating the efficacy of Salvadora persica toothbrush to date. Therefore, the aim of this study is to evaluate the effectiveness of the newly invented Salvadora persica toothbrush on oral health, particularly on anti-plaque and anti-gingivitis effects. The patient related-outcomes of Salvadora persica on a short-term use will also be assessed. The hypotheses of this study are that Salvadora persica toothbrush does not contribute to the significant effects on oral health and there is no difference in the use of Salvadora persica chewing stick, Salvadora persica toothbrush as well as the standard toothbrush on anti-plaque and anti-gingivitis in a standardized manner. Additionally, a hypothesis that there is no patient-related outcome of Salvadora persica on a short-term use has also been devised. A randomized, single blind, and parallel clinical study will be conducted over a five-week period involving the healthy non-dental students of the National University of Malaysia. This study consists of three groups of different oral hygiene tools: (i) Salvadora persica toothbrush; (ii) Salvadora persica chewing stick; and (iii) Standard toothbrush and toothpaste as control. The primary outcomes of this study are the clinical parameters that will be recorded at four different appointments. Salvadora persica toothbrush is expected to show positive effects to that of standard toothbrush with respect to plaque and gingivitis control. This study is thus designed to provide an insight on Salvadora persica toothbrush as a good preventive home care therapy.

NCT ID: NCT04638647 Recruiting - Clinical trials for Autoimmunity, Inflammation

Secukinumab Open Label Roll-over Extension Protocol

Start date: December 22, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.

NCT ID: NCT04623060 Recruiting - Stroke Clinical Trials

Low-Volume Interval Training and Resistance Exercise in Individual With Stroke

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

To examine the feasibility of Low-Volume Interval Training (LV-ITT) and Resistance Exercise (RE) on walking performance (walking endurance, gait speed, functional balance), lower limb muscle strength and quality of life among individuals with post-stroke.

NCT ID: NCT04618055 Recruiting - Partial-edentulism Clinical Trials

Clinical Evaluation of NiTiDent Tuah Porous NiTi Dental Implants

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

The purpose of this prospective, open-label, randomized, double arm multicenter study is to evaluate the safety and clinical performance of a newly developed NiTiDent Tuah porous NiTi dental implant (from Nitium Technology Sdn Bhd) in singletooth gap in the posterior mandible 1 year after implant placement and 8 months after implant loading. Second, To investigate the clinical outcome of the interventional dental implant (NiTiDent Tuah Porous NiTi dental implant) compared to control dental implant. The hypothesis is set to no difference in the clinical outcome for the two types of implants based on the outcomes of the primary and secondary endpoints.