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NCT ID: NCT03315325 Completed - Clinical trials for Sterility, Reproductive

Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men

Start date: August 8, 2014
Phase: Phase 3
Study type: Interventional

The present study was designed to assess the responsiveness of the hypothalamic pituitary gonadal axis to kisspeptin administration with increasing age in men.

NCT ID: NCT03312478 Recruiting - Type 1 Diabetes Clinical Trials

Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes

Start date: October 13, 2017
Phase: Phase 4
Study type: Interventional

Primary Objective: To measure the association between a parental history of diabetes and the odds of an offspring being Type 1 diabetics. Secondary Objectives: - To document the profile of Type 1 diabetes patients. - To document the glycemic parameters (Fasting blood glucose [FBG] and glycosylated hemoglobin [HbA1c]) of Type 1 diabetes. - To capture the current therapeutic management.

NCT ID: NCT03310762 Recruiting - Clinical trials for Immunization; Infection

Immunization Reminder Bracelets Study

Start date: July 19, 2017
Phase: N/A
Study type: Interventional

Pakistan has one of the highest infant mortality rates in the world in part, due to the low coverage (54%) for all basic vaccinations. Low uptake, lack of awareness among parents to complete the recommended immunization schedule and inability to remember vaccine appointments are some of the key factors hindering improvement in uptake of immunization services. On the supply side, ineffective methods to track children's' vaccine doses means that there is no reliable mechanism to verify vaccine administration and estimate accurate immunization coverage. This study proposes to develop and test two types of silicon bracelets for children to stimulate immunization demand and simultaneously address supply side verification issues. These bracelets use a combination of numbers and symbols to denote the age of the child and due vaccines and are designed for illiterate or uneducated mothers; are low-cost and adaptable to most local settings. At the time of vaccine administration, the appropriate symbol denoting the vaccine on the bracelets is punched and therefore the bracelets can serve as effective reminders for mothers for timely immunization of their child and as a tool for vaccinators to verify vaccine administration and coverage. An individually randomized, three-arm parallel group design randomized control trial will be conducted with equal allocation in the two treatment groups and control group. Children in intervention group A will receive the simple silicon bracelets, children in intervention group B will receive the bracelets developed by Alma Sana Inc. and children in the Control group will not receive any intervention. The impact of these immunization reminder bracelets on immunization coverage and timeliness will be evaluated through a randomized control trial (RCT) across 4 immunization centers in Karachi. To evaluate the bracelets' impact, variables of interest-coverage and timeliness rates of pentavalent-3/PCV-3/polio-3 and Measles 1 vaccine will be compared between Group A and the Control Group and Group B and the Control Group. Proposed results include increase in immunization coverage and timeliness of Pentavalent-3/Pneumococcal Conjugate Vaccine (PCV-3)/Polio-3 and Measles-1 in the intervention versus control group. The study will provide evidence of the bracelet's effectiveness for the global health community and provide a simple tool for strengthening routine immunization efforts in Pakistan.

NCT ID: NCT03303287 Recruiting - Health Education Clinical Trials

School Health Education Program in Pakistan(SHEPP)

Start date: September 15, 2017
Phase: N/A
Study type: Interventional

Pakistan is a developing country and there have been a considerable rise in obesity and hypertension in children in recent years. In this setting a focus on primary prevention of cardiovascular diseases is more cost effective than spending resources on secondary or tertiary prevention,. Primary prevention includes interventions to promote physical activity (> 30 minutes/day in school), healthy dietary habits (decreased consumption of sweetened beverages and snacks, and increased consumption of fruit and vegetables) and health education focusing on cardiovascular risk factors in school children. This would translate into healthier cardiovascular outcomes (eg. less hypertension, dyslipidemia and diabetes) in adult life. The investigators propose a school health education program for Pakistan (SHEPP) for children aged 9-11 years in 3 schools in Karachi for a period of one year. This program will comprise of 140 minutes physical activity/week (including aerobics):30 minutes aerobic PA(30*2=60) + 10 minutes (10*5=50)physical activity in assembly daily+ 1 minute between periods(1*6*5=30) and healthy diet and healthy heart teaching. Additionally teaching will also be given to teachers and parents, who will further reinforce these habits in children. We hypothesise that SHEPP will improve physical activity levels, dietary habits and knowledge about healthy heart in children, will decrease blood pressure, body mass index, waist circumference, at the end of the year. If this healthy behavior is carried on to adult life it will serve as an excellent primary prevention measure. The investigators , later on plan to study long term outcomes after implementation of this intervention.

NCT ID: NCT03299218 Recruiting - Stunting Clinical Trials

Effectiveness of SNF, Cash and BCC to Prevent Stunting Among Children 6-24 Months in Rahim Yar Khan, Pakistan

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

Malnutrition is a public health problem, with long-lasting physiological consequences and increased risk of morbidity and mortality. It can be recognized as one of the key obstacles in national development, due to its influence on individual productivity, school performance and physical work capacity. Malnutrition is a hidden crisis in Pakistan, with rates increasing during the last decade. High prevalence of food insecurity, illiteracy, lack of nutritional knowledge, poor hygiene status, and under recognized role of nutrition are some of the possible causes. The situation of malnutrition in Pakistan necessitates an urgent need for addressing its causes through various nutrition interventions, in order to ensure a bright future for the coming generations. Although, malnutrition is a major problem across Pakistan, its burden and implications in the remote districts of Punjab are quite evident. The levels of undernutrition in district Rahim Yar Khan are high, with 47% of children being underweight. These numbers also highlight the presence of long-term undernutrition in the district, as evidenced by 45% of the children being stunted in 2014. Given the alarming situation of child malnutrition in district Rahim Yar Khan, the World Food Program (WFP) Pakistan is proposing an intervention program comprised of cash-based transfers, specialized nutritious foods and behaviours change communication to prevent stunting in district Rahim Yar Khan, province Punjab. The interventions will be delivered through the existing health system and Benazir Income Support Programme (BISP). It is anticipated that the intervention will reduce the widespread macro and micro nutrient malnutrition and food insecurity in the targeted areas. Furthermore, to ensure the presence of adequate evidence to persuade policymakers for further scaling up, it is essential that an impact evaluation be conducted. Therefore, the Department of Paediatrics and Child Health, Aga Khan University (AKU) using robust methodologies on a representative sample size in the district of Rahim Yar Khan to assess the effectiveness of the WFP interventions on process and outcome indicators.

NCT ID: NCT03298126 Completed - Clinical trials for Radial Artery Occlusion

Is Conventional TR Band Deflation Protocol Inferior to Internationally Developed TR Band Removal Protocol in Reducing Occurrence of Radial Artery Occlusion

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

Coronary artery disease (CAD) is one of the major health concerns among other non-communicable diseases globally. Cardiac catheterization is a diagnostic gold standard to determine the extent of disease in coronary arteries due to atherosclerosis. Among the two approaches for cardiac catheterization, trans-radial approach has gained more popularity than conventional trans-femoral approach over the past decade with availability of compression devices for radial artery that assures lesser risk of bleeding and hematoma and has translated into increased patient comfort and early mobility post procedure. Radial artery occlusion is a common complication of trans-radial procedures often ignored by the operator after procedure due to dual blood supply by ulnar artery. Although clinically silent usually, it necessitate the need of monitoring radial artery for patency because of risk of limited trans-radial access later.Reportedly, RAO occurs in about 10% of cardiac catheterizations. , compression devices applied after sheath removal may be a contributing factor to radial artery occlusion because of selective pressure for extended time duration (3-4 hours). Various protocols have been developed to remove TR band by different institutions across the globe and have been tested to assess post procedure complications. To the best of what we know, there exists no standard protocol to deflate TR band. Also, the current protocol in practice at our institution has not been evaluated against other protocols that are followed in other institution across the globe claiming lesser post procedure complications. Hence, our aim was to test through a randomized trial whether our hospital standard protocol is non-inferior to the existing international protocol of Cohen & Alfonso that promises lesser complication rate

NCT ID: NCT03297671 Not yet recruiting - Rhesus Disease Clinical Trials

The Prevention of Rh Disease of Newborns in Pakistan

Start date: October 2017
Phase: N/A
Study type: Observational

The investigators aim to demonstrate the feasibility of point-of-care identification of Rh-negative women in a poor, rural setting in Pakistan. Feasibility will be assessed across 2 major domains: 1) acceptance by pregnant women to receive the point-of-care test; and, 2) ability of health workers to administer the point of care test and interpret results. The investigators will also measure whether RhIg prophylaxis can be successfully delivered and is accepted by pregnant women in this setting. The socio-demographic correlates of the acceptance of point-of-care testing and where applicable, the acceptance of RhIg prophylaxis will also be assessed. In addition, the investigators will also explore the baseline knowledge of Rh disease among pregnant women and lady health visitors in this study population and will investigate socio-demographic correlates of baseline knowledge and the uptake of knowledge among pregnant women. Finally, the prevalence of Rh negativity will be calculated and stillbirth and neonatal mortality will be tracked among all participants. All stillbirths and neonatal deaths in this population will be characterized with respect to cause and Rh-negativity.

NCT ID: NCT03287882 Recruiting - Pregnancy Clinical Trials

Effect of Micronutrients and Life Skills Education on the Health and Nutrition of Adolescent and Young Women in Pakistan

Start date: June 30, 2017
Phase: Phase 3
Study type: Interventional

The primary aims of this study are: 1) To evaluate the impact of supplementation with multiple micronutrients (MMN) from preconception and life skills education among women 15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2) To evaluate the impact of supplementation with MMN from preconception and life skills education among young women 15-24 years of age on the rate of low birth weight (LBW) in a population setting. Infants born to mothers enrolled in the study will be followed for 1 year. This study aims to enrol 25,400 non-pregnant young women in Matiari district. This sample size is anticipated to equate to 1456 births. Participants will be randomized by cluster to receive either MMN supplements and life skills education or the standard of care at enrolment. Clusters have been defined based on health facility catchment areas. MMN supplements will be provided twice weekly during the preconception period, once daily during the pregnancy period, and once daily until 6 months after giving birth during the postpartum period; and a package of life skills education materials will be provided bi-monthly during the preconception period. In addition to the primary outcomes, measurements will include micronutrient status, anthropometrics, birth outcomes, dietary intake and feeding practices, adherence, and indices of empowerment.

NCT ID: NCT03286803 Recruiting - Poliomyelitis Clinical Trials

Comparison of Immunity Following IPV Versus fIPV: a Community Based Randomized Controlled Trial in Pakistan

Start date: August 1, 2017
Phase: Phase 4
Study type: Interventional

This study will be conducted in four low-income areas of Bin Qasim Town Karachi. This will be a community based randomized control trial of 21 months duration. The trial will include four arms; arm A and B will enroll children age 14-18 weeks and randomize them to either full dose IPV (0.5ml) or fractional IPV (0.1ml). Arms C and D will enroll children at 9 months of age and randomize them to either fractional or full dose IPV. Children aged 14 weeks for arms A and B and 9 months for arms C and D living in the selected communities of Bin qasim Town Karachi who have not received IPV vaccine during routine immunization for arms A and B and who have documentary evidence of receiving IPV vaccine at 14 weeks of age for arms C and D will be eligible for enrollment. The investigators will exclude children who are found acutely ill or those requiring emergent medical care/hospitalization at the time of enrollment. The investigators will use the Demographic Surveillance System (DSS) in the four study areas to identify the households with eligible children. The children of the parents who agree to participate in the study will be screened for eligibility by the trained research associates. After randomization into four different arms, the study trained research vaccinators will administer the IPV or fIPV as per randomization. Children will be observed in the center for 30 minutes after vaccination before leaving for home. Parents/guardians of all the participants will also be requested to immediately report any adverse effect occurring later. This study will be conducted in compliance with this protocol, GCP guidelines and all applicable international and local regulatory requirements. The study has approval by the Ethical Review Committee of the Aga Khan University (AKU), the National Bioethics Committee of Pakistan, and ethical approval at WHO/Headquarters in Geneva. All study procedures will be conducted in AKU's field research sites from where subjects will be recruited. The Clinical Trials Unit (CTU) of AKU will be engaged in providing support for specific study procedures conducted at CTU such as randomization, management of vaccines (storage, dispensing and incineration), and other responsibilities agreed in writing. Adverse events following vaccine administration will be monitored and all serius adverse events will be reported within 24 hours to WHO, DSMB and AKU IRB. All the vaccines used are licensed in Pakistan and in routine use.

NCT ID: NCT03286517 Completed - Clinical trials for Reproductive Physiological Phenomena

Link Between the Sensitivity of Kisspeptin Signalling and Pubertal Onset in Boys.

Start date: June 26, 2014
Phase: Phase 3
Study type: Interventional

The specific objective of this study was to investigate the sensitivity of Kisspeptin receptor 1 (KISS1R) by determining the responsiveness of GnRH neuron to kisspeptin administration across the pubertal stages and adult group through measuring plasma LH (luteinizing hormone) and testosterone concentrations.