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NCT ID: NCT03862248 Not yet recruiting - Clinical trials for Tuberculosis, Pulmonary

Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More

TriDoRe
Start date: April 1, 2019
Phase: Phase 3
Study type: Interventional

Drug-resistance is a major challenge for tuberculosis (TB) care programs. The new WHO guideline recommends adding levofloxacin in previously treated patients with isoniazid-resistant rifampicin-susceptible TB. The investigators believe that such a retreatment regimen may result in acquired resistance to fluoroquinolone, the core drug of multidrug-resistant TB (MDR-TB) regimen, and thus threaten the effectiveness of the fluoroquinolone-based MDR-TB treatment regimen. Therefore the investigators propose to study if regimens strengthened by using high-dose first-line drugs, either a triple dose of isoniazid or a triple dose of rifampicin, are non-inferior to the WHO recommended levofloxacin-strengthened regimen. If one of both high-dose regimens would be non-inferior, it could replace the levofloxacin-strengthened regimen.

NCT ID: NCT03858595 Not yet recruiting - Clinical trials for Hypertension, Pregnancy-Induced

Optimizing Gestational Weight Gain, Birth Weight and Other Perinatal Outcomes Among Pregnant Women at Risk of Hypertension in Pregnancy

Start date: March 2019
Phase: N/A
Study type: Interventional

Background: 1. Burden: Hypertensive disorders of pregnancy, including preeclampsia, complicate up to 10% of pregnancies worldwide, constituting one of the greatest causes of fetal growth restriction, preterm birth, low birth weight, perinatal mortality, and maternal morbidity and mortality. In Bangladesh, 24% of all maternal deaths are directly attributed to hypertensive causes. Conventional antenatal care practice often delays in or misses diagnosing hypertension in pregnancy, which makes the women vulnerable to its adverse consequences. 2. Knowledge gap: Although there are randomised controlled trials (RCT) of efforts directed at preventing development of hypertension in pregnancy or reducing its complications, there have been no published RCTs of the intervention focusing on regular monitoring of weight gain and blood pressure among pregnant women who are at risk of developing hypertension in pregnancy or its complications to ensure early diagnosis, and thereby optimizing the perinatal outcomes through prompt referral and management. 3. Relevance: To undertake an RCT of intervention to optimize adverse consequences in hypertension in pregnancy raises important practical concerns including: commitment of the enrolled women, the need to make a decision regarding participation due to longer duration of intervention and adherence to protocol. Investigators aim to perform this study to address whether an RCT of the intervention in individual patients is an appropriate trial design, and is feasible. Objectives: 1. To evaluate the accuracy of Salu Health Gauge device in measuring blood pressure. 2. To test the design, feasibility, acceptability and fidelity of a future definitive randomized controlled trial focusing on regular monitoring of weight gain and continuous self-monitoring of blood pressure among pregnant women who are at risk of developing hypertension in pregnancy. Methods: The study will be completed in two steps: 1) the validation of Salu Health Gauge and 2) the pilot trial. The study will be conducted in Matlab, Bangladesh. Salu Health Gauge device will be validated according to the European Society of Hypertension International Protocol revision 2010 (ESH-IP revision 2010) in general adult population (including men and non-pregnant women) as well as in specific groups such as adolescents and pregnant women. The pilot trial is designed as a prospective, two-arm, parallel, and open-label randomized controlled external pilot trial. Eligible participants (pregnant women at risk of developing hypertension in pregnancy) will be individually randomized 1:1 to the intervention arm who will use a wearable device (Salu Health Gauge) from 20 weeks of gestation up to termination of pregnancy alongside conventional antenatal and postnatal care or the control arm who will receive conventional antenatal and postnatal care only. In Matlab, a woman is diagnosed as pregnant by HDSS field staff by 12-16 weeks of gestation and is enlisted. The investigators will obtain this list from HDSS and conduct baseline interviews to identify pregnant women at risk of developing hypertension in pregnancy. Outcome measures/variables: 1. Feasibility outcomes: Recruitment rate, Retention rate, compliance, Acceptability etc. 2. Clinical outcomes: gestational weight gain, birth weight, adverse consequence of hypertension in pregnancy (episodes or occurrence and when), blood pressure profile of high-risk pregnancies, prevalence of specific risk factors for hypertension in pregnancy 3. Serious adverse events

NCT ID: NCT03855150 Recruiting - Clinical trials for Human Papilloma Virus Vaccine

Trial of HPV Vaccine in Healthy Adult and Adolescent Female

HPV
Start date: December 22, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized, double-blind, active-controlled, phaseI/II clinical trial to enroll 200 healthy female including 80 healthy adult aged 19 to 26 years and 120 adolescents aged 9 to 13 years to assess the safety and immunogenicity of NBP615 in comparison with Gardasil. In order to confirm the safety, 80 healthy adult should be enrolled first, and the safety of the test product (NBP615) will be confirmed by 2nd vaccination in adults. After that, enrolled of 120 adolescents proceeds. participants who previously agreed to participate in the study will be screened and only those participants who met the inclusion/exclusion criteria will be randomized in to 1:1 to receive test product (NBP615) or reference product (Gardasil pre-filled syringe). Three/ Two doses of 0.5 ml IM injection will be given and two blood sample, pre vaccine and post vaccine 4 weeks after completion of vaccine will be collected to assess the immunogenicity of NBP615 and Gardasil, comparator HPV vaccine. Solicited adverse events occurring up to 7 days after each dose of the investigational product will be collected in the diary card. Unsolicited adverse events occurring up to 28 days after each dose of the investigational product will be collated in the diary card. Serious adverse events will be collected during the entire study period. In addition to this safety data will be collected through the study period by active contact with the study participants by doing home visit or by telephone contact.

NCT ID: NCT03836937 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Role of Obeticholic Acid in the Patients of NAFLD With Raised ALT

NAFLD
Start date: March 2019
Phase: N/A
Study type: Interventional

This study will be conducted upon the patients with fatty liver disease. Patients who will be diagnosed as a case of fatty liver disease by ultrasound with raised liver enzyme (ALT) will be primarily selected for the study. A total number of 150 patients will be randomly selected for the study that will also be divided into two groups for the study purpose. The patients will be informed about the details of the study. After getting the detail information those who will give informed written consent will be finally included in the study. One group of patients will be treated by both life style modification and Obeticholic acid. Another group of patients by only life style modification. After 3 months of treatment the two groups will be compared of improvement of fatty liver disease and liver enzyme by improvement of fibroscan with CAP value as well as improvement of ALT value.

NCT ID: NCT03818477 Not yet recruiting - Polio Clinical Trials

Environmental Surveillance (ES) for Polio and AMR Using the TaqMan Array Card

Start date: February 2019
Phase:
Study type: Observational

This study will be used to develop a tool to streamline poliovirus environmental surveillance for the polio endgame and to provide a tool for detecting polio in places where there is no capacity to carry out the gold standard culture-based detection.

NCT ID: NCT03801161 Recruiting - Healthy Infants Clinical Trials

Influence of Inflammation on Micronutrient Status Assessment

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Inflammation can influence several biochemical measurements those commonly used to interpret micronutrient status in children. Our primary objective is to investigate the effects of inflammation on several biochemical measurements used to interpret micronutrient status in children. A total of 40 infants (9-18 mo of age) will participate in this study. Investigators will use PENTA vaccines as a means to induce controlled inflammation (closely mimic to natural infection). PENTA is a combination of five different vaccine antigens (Hepatitis B (HBV)/ Haemophilus influenza type b (Hib) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)). The investigators will also use two different stable isotopic retinols for the assessment of total body vitamin A stores. Baseline blood samples (5 mL) will be obtained from all infants and then randomly selected 30 infants will receive PENTA vaccines, while the other 10 infants will receive no vaccines. 24 hours after vaccination a finger-prick blood sample will be obtained from the infants in the vaccinated group to measure CRP and on the same day, blood samples (5 mL) will be obtained from infants who develop inflammation (CRP> 5mg/L) in the vaccine group and also from infants in the control group. Thus estimated plasma micronutrients and vitamin A stores before and after inflammation will calculate the effects of inflammation on the interpretation of micronutrient deficiencies based on biochemical indicator assessment.

NCT ID: NCT03781895 Completed - Clinical trials for Stable COPD Patients

Effect of Vitamin D3 on Lung Function and Exercise Tolerance in COPD Patients

Start date: March 1, 2017
Phase: Phase 1
Study type: Interventional

Background: Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality throughout the world which is a preventable as well as treatable disease. It has some important extra pulmonary effects which may contribute to the magnitude of the severity of this disease. Standard therapeutic treatment alone does not optimize its remedy. Vitamin D3 has been found to improve the physical efficiency of patients with various morbid disorders, including respiratory ailments. Hypothesis:Vitamin D3 administration in stable patients with moderate COPD improves lung function variables along with exercise tolerance. Objectives: To evaluate the effects of Vitamin D3 on lung functions and exercise tolerance in patients with stable moderate COPD. Methods: For this, a prospective interventional randomized double blinded study will be carried out on 46 vitamin D3 deficient (serum 25 dihidroxycholecalceferol less than 30 ng/ml), male, stable (diagnosed patient, who has not experienced any acute exacerbation , hospitalizations , urgent care visits, or changes in routine medication within 4 weeks prior to study), moderate (post bronchodilator FEV1/FVC<0.70 of predicted value and FEV1=50 to 79% of predicted value) COPD patients (age ≥40 years), who will be selected from the Out Patient Department (OPD) of the National Institute of Diseases of Chest and Hospital (NIDCH) and will be grouped as A (control) and B (study) groups, respectively. All the patients will be again designated as A0, A90 (without D3) and B0, B90 (with D3) for before and after 90 days of follow up. All the participants will be matched in terms of duration of COPD, history of smoking, occupation and socioeconomic status. Along with the standard pharmacological treatment of COPD, the patients of the 'Study group' will be prescribed for 80000 IU of oral vitamin D3 pre week for consecutive 3 months. Along with this, all patients both the groups will be advised to continue ad lib (according to their own choice) diet. At the very 1st day of the study, the lung functions will be assessed by measuring Forced vital capacity (FVC), Forced expiratory volume in one second (FEV1), Forced expiratory ratio (FEV1/FVC%), Peak expiratory flow rate (PEFR) and Forced mid expiratory flow of FVC(FEF25-75%), with a portable digital spirometer. In addition, exercise tolerance will be assessed by change in 6 Minute Walk Distance (6MWD) in 6 Minute Walk Test (6MWT). Changes in peripheral capillary oxygen saturation (SpO2) by Pulse Oximeter and degree of dyspnoea by Modified Borg Scale (MBS) will also be measured both before and after 6MWT to evaluate their change in both the groups. All these variables will be measured again among same 46 patient after 90 days standard pharmacological treatment of COPD with D3 intervention (B group) and also without D3 intervention (A group). For statistical analysis, Chi-square test, independent sample 't' test between two groups, paired Student's 't' test within two specific measurements of different durations of each group ,will be done. In the interpretation of results, ≤0.05 level of probability (p) will be accepted as significant.

NCT ID: NCT03778125 Enrolling by invitation - Diarrhea Clinical Trials

Multidrug Resistant Shigella Infection in Bangladesh

Start date: December 13, 2018
Phase:
Study type: Observational

The purpose of this project is to systematically collect clinical and nutritional outcomes information on patients treated for Shigella infection so that physicians and clinical laboratories can better define which Shigella infections are "resistant" to antibiotics and which are "susceptible", focusing on azithromycin a last-line drug to treat drug resistant Shigella

NCT ID: NCT03775460 Not yet recruiting - Clinical trials for Erythema Nodosum Leprosum

Methotrexate and Prednisolone Study in Erythema Nodosum Leprosum

MaPs
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Erythema Nodosum Leprosum (ENL) is a painful, debilitating complication of leprosy. Patients often require high doses of corticosteroids for prolonged periods. Thalidomide is expensive and not available in most countries. The use of corticosteroids for long periods is associated with adverse effects and mortality. It is a priority to identify alternative agents to treat ENL. Methotrexate (MTX) is a cheap, widely used medication which has been reported to be effective in ENL resistant to steroids and thalidomide.

NCT ID: NCT03773809 Completed - Clinical trials for Vitamin D Deficiency

Impact of Vitamin D3 Administration on Cardiac Autonomic Tone in Asthma Chronic Obstructive Pulmonary Disease(COPD) Overlap Patients

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

Title:Impact of vitamin D administration on cardiac autonomic tone in Asthma Chronic Obstructive Pulmonary Disease (COPD) Overlap patients: A blinded randomized control trial. Background: Respiratory disease is closely associated with cardiovascular disease. Reduced Heart Rate Variability (HRV), reflecting impaired autonomic activity have been reported in both asthma and COPD. Vitamin D deficiency is a common feature in Asthma COPD Overlap (ACO) patient. Relationship between vitamin D deficiency and low HRV has been reported. Vitamin D administration has been reported to improve cardiac autonomic modulation in healthy subjects in response to external stressor. Objective: To assess the changes in cardiac autonomic tone after vitamin D administration for 90 days in vitamin D deficient ACO patients. Hypothesis:Null: Vitamin D administration does not have impact on cardiac autonomic tone in vitamin D3 deficient ACO patient. .Method: This randomized controlled trial will be conducted by Department of Physiology, Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbag, Dhaka from September' 2017 to August' 2018. For this study, a total number of 60 subjects (age > 40 years, both male and female) will be randomly selected. 30 diagnosed vitamin D deficient Asthma COPD Overlap (ACO) patients will form group A and another 30 diagnosed vitamin D3 deficient ACO patients with similar age, sex, (Body Mass Index) BMI will constitute control group B. Patients of study group B0 will take vitamin D3 with a prescribed schedule for 3 months and followed up after 3 months (group B90). On the other hand patients of group A1 will be given placebo and followed up after 3 months (group A90). All these patients will continue their medication prescribed by physician during these 3 months. On the basis of data recording - group B1 and group B90 will constitute pre and post vitamin D group whereas group A0 and group A90 will represent pre and post placebo follow up at day 0 and day 90. Cardiac autonomic nerve function will be assessed by recording ECG & Heart Rate Variability (HRV) analysis by a data acquisition device, powerlab 8/35, AD instruments, Australia. HRV measures of all patients will be recorded at baseline.Then after 3 months of follow up it will be recorded in both groups at day 90. Serum 25(OH)D level will be measured of all subject at day 0 and day 90. For statistical analysis unpaired and paired "t" test will be done by using Microsoft Office Excel Word version 2016