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NCT ID: NCT04893291 Recruiting - Clinical trials for Coronary Artery Disease

Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels

TRANSFORM II
Start date: November 16, 2021
Phase: N/A
Study type: Interventional

International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).

NCT ID: NCT04851808 Recruiting - COPD Clinical Trials

Chronic Respiratory Disease Burden in Bangladesh

Start date: February 1, 2021
Phase:
Study type: Observational

Chronic Respiratory Disease (CRD), particularly asthma and chronic obstructive pulmonary disorders (COPD) are leading causes of mortality and reduced quality of life due to its wide-reported association with other multi-morbidities.There is limited knowledge on the burden of CRD in the rural communities in Bangladesh due to poor awareness on the impact of CRD on quality of life and unavailability of diagnostic facilities due to weaker primary healthcare settings. The study aims to estimate the CRD burden in Bangladesh in a large representative population to draw the attention of policy makers to the creation of social awareness and improvement of primary healthcare infrastructure for respiratory disease in Bangladesh. The study is a prospective observational one in nature. The study will be implemented in Mirzapur, a rural sub-district of Tangail district in Bangladesh within the period of February to May 2021. A total of 981 participants will be enrolled from the study. Verbal consent will be taken initially. Participants who are assessed to be COVID-19 negative will be invited for a visit to the mobile clinic following national health guidelines to perform the spirometry. The study team will provide an information sheet (written in local language) that describes the study aim and objectives with potential risk benefits to the participants. All participants will be enrolled through written consent and satisfactory response to the patient information sheet. The Research Assistant (RA) will collect the relevant metadata such as demographics, information on risk factors, screening questionnaires relevant to asthma and COPD, reported health status and symptoms related to CRD etc. from the participant after obtaining the written consent. Data quality will be ensured by the Field Research Supervisor through checking all the collected information. The enrolled participants will undergo spirometry for the evaluation of their lung function. Spirometry will be collected by trained personnel and will be quality checked by an expert panel at CHRF. Repeated collection will take place in the event if the test results do not pass quality checking. Participant will also be invited to the study clinic within the next 10 days after assessment for any further clinical assessment that is deemed necessary by the study physician. The collected data and spirometry reports will be reviewed to evaluate the CRD patient in terms of their disease. The study will analyse the rate of CRD burden stratified by age, sex, and income group. The productivity loss will be measured in terms of work hours lost due to CRDs.

NCT ID: NCT04757493 Recruiting - Clinical trials for Irritable Bowel Syndrome

The Effects of Prucalopride in Patients With Constipation Predominant Irritable Bowel Syndrome

Start date: March 10, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Irritable bowel syndrome (IBS) is very common functional gastrointestinal disorder in daily gastrointestinal practice. Its etiology is multifactorial and incompletely understood. Different types of treatment have been trying but no single drug is effective for every patients. After the discovery of 5HT4(5 hydroxytryptamine-4) receptor and its effect on gastrointestinal motility, 5HT4 receptor agonist becoming a good therapeutic tool in different functional gastrointestinal disorder. Prucalopride is a selective 5HT4 agonist and it has proven benefit in chronic idiopathic constipation but there is not enough evidence that it is effective in constipation predominant IBS. Objective: To assess the efficacy of Prucalopride in constipation predominant IBS patients. Material & method: Consecutive patients of both sexes, age more than 18 years attended the outpatient department of Gastroenterology meeting the inclusion Criteria of IBS-C will be initially enrolled for the study. Their clinical history, examination & initial investigations report will be noted on the standard data sheet. Any alternative diagnosis if proven by clinical examination or laboratory investigation will be excluded from the study. Randomization into two groups (Prucalopride and placebo) will be performed by lottery. Patients will be randomly assigned to receive either Prucalopride 2 mg or placebo for 6 weeks. IBS symptoms will be assessed by IBS-SSS (symptom severity score) and IBS-QOL(quality of life) at the baseline, 2nd week and 6th week of treatment (end of treatment). Any adverse effect due to drugs will also be monitored by base line ECG, calculation of corrected QT interval and ECG monitoring (2 weeks and 6 weeks) during the course of treatment. Data analysis By SPSS. IBS-SSS and IBS-QOL instrument scores will be expressed as mean ± standard deviation. Statistical analysis will be done by paired and unpaired 't' test. P value <0.05 will be considered statistically significant. Ethical Consideration: Every ethical issue will be discussed with the patient regarding the study and informed written consent will be obtained. There will be no chance of disclosure of information that will have been harmful to the patients or others. Permission have been taken from the concerned departmental ethical committee as well as ethical review committee of BSMMU in order to carry out the study.

NCT ID: NCT04750070 Recruiting - Blood Transfusion Clinical Trials

Management of Shock in Children With SAM or Severe Underweight and Diarrhea

Start date: August 17, 2021
Phase: Phase 3
Study type: Interventional

Diarrhea is one of the leading causes of under-five childhood mortality and accounts for 8% of 5.4 million global under-5 deaths. The coexistence of sepsis and hypovolemic shock in children with severe acute malnutrition (SAM) having diarrhea is common. At Dhaka hospital of icddr,b, the death rate is as high as 40% and 69% in children with severe sepsis and septic shock respectively with co-morbidities such as severe malnutrition. The conventional management of SAM children with features of severe sepsis recommended by WHO includes administration of boluses of isotonic saline followed by blood transfusion in unresponsive cases with septic shock; whereas the Surviving Sepsis Campaign (SSC) guideline recommends vasoactive support. To date, no study has evaluated systematically the effects of inotrope(s) and vasopressor or blood transfusion in children with dehydrating diarrhea (for example, in cholera) and SAM having shock and unresponsive to WHO standard fluid therapy. This randomized trial will generate evidence whether inotrope and vasopressor or blood transfusion should be selected for severely malnourished children having hypotensive shock and who failed to respond to WHO standard fluid bolus.

NCT ID: NCT04715867 Recruiting - Clinical trials for Non Inferiority Trial

Non Inferiority Trial of Locally Manufactured Rabies Vaccine 'Rabix-VC' in Bangladesh

Start date: January 1, 2021
Phase: Phase 1
Study type: Interventional

Rabies is a viral infectious disease of mammals including humans. Early symptoms of rabies include fever and tingling at the site of exposure, followed by one or more symptoms such as fear of water, violent movements, confusion, uncontrolled excitement, inability to move parts of the body, and loss of consciousness. Once symptoms of the disease develop, rabies is invariably fatal. It is one of the oldest human diseases. It continues to be a major public health problem in developing countries. Rabies is the 10th biggest cause of death due to infectious diseases worldwide. Rabies is endemic in Bangladesh with high public health significance and ranked third highest among rabies-endemic countries for human rabies deaths. In Bangladesh, an estimated 200 000 animal bite cases with more than 2000 human rabies deaths are reported annually. Most importantly, most of the victims are children below 15 years old coming from poor rural communities. Rabies is a vaccine-preventable viral disease and is highly effective when given pre- or post-exposure to a bite from a potentially rabid animal. Currently there is no locally manufactured Rabies vaccine available in Bangladesh. The results of this study will provide information regarding the immunogenicity and safety of the locally manufactured Rabies vaccine 'Rabix VC' as a test vaccine using 'Rabipur' as a comparator vaccine in a non inferiority study design.

NCT ID: NCT04701164 Recruiting - Clinical trials for Guillain-Barre Syndrome

Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome

Start date: December 17, 2020
Phase: Phase 3
Study type: Interventional

This study is intended to evaluate the efficacy and safety of ANX005 administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS). The total duration of study participation is approximately 6 months.

NCT ID: NCT04693026 Recruiting - Covid19 Clinical Trials

Efficacy of Ramdicivir and Baricitinib for the Treatment of Severe COVID 19 Patients

Start date: September 10, 2020
Phase: Phase 3
Study type: Interventional

This study was designed to evaluate the efficacy of Remdesivir and Baricitinib combination therapy for the treatment of severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to compare the outcome of the "Remdesivir + Baricitinib" combination against "Remdesivir + Tocilizumab" therapy and find the best option for the management of ARDS in COVID-19 patients.

NCT ID: NCT04686474 Recruiting - Clinical trials for Keratotic Nodular Size

Effect of the Compound Extracted From Azadirachta Indica Leaves in the Treatment of Arsenical Keratosis

Start date: October 20, 2019
Phase: N/A
Study type: Interventional

Prepare an ointment from Azadirachta indica leaves extract and its apply on palmer arsenical keratosis patient, for 12 weeks. After intervention, effect of the ointment will be observed by measuring the nodule (before and after apply the ointment)

NCT ID: NCT04686461 Recruiting - Clinical trials for Keratotic Nodular Size

Effect of Thymoquinone Extracted From Nigella Sativa in the Treatment of Arsenical Keratosis

Start date: October 20, 2019
Phase: N/A
Study type: Interventional

Prepare an ointment from Nigella sativa seeds extract and apply it over palmer arsenical keratosis patient for 12 weeks. After than the effect of the ointment will be observed by measuring the keratotic nodular size before and after the intervention.

NCT ID: NCT04633655 Recruiting - Quality of Life Clinical Trials

International CIPN Assessment and Validation Study

ICAVS
Start date: June 8, 2020
Phase:
Study type: Observational

This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.