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NCT ID: NCT06239233 Recruiting - Gallstone Disease Clinical Trials

Gallbladder Infundibulum as a Guide for Ductal Identification.

Start date: December 25, 2023
Phase:
Study type: Observational [Patient Registry]

Introduction: Bile duct injury (BDI) is a catastrophic complication of cholecystectomy, and misidentification of the cystic anatomy is considered to be the main cause. Although several techniques have been developed to prevent BDI, such as the "critical view of safety", the infundibular technique, the rates remain higher during laparoscopic cholecystectomy (LC) than during open surgery. Strategy for ductal identification during laparoscopic cholecystectomy can help to prevent laparoscopic bile duct injury. Methods: A prospective study of 196 patients who will undergo LC during the study period of one year at Nepal Mediciti Hospital will be conducted. The gallbladder infundibulum will be classified by its position located on an imaginary clock with the gallbladder neck as the center point of the dial, 3 o'clock position as cranial, 6 o'clock as dorsal, 9 o'clock as caudal, and 12 o'clock as ventral, as well as the axial position. Patient demographics, pathologic variables and infundibulum classification will be evaluated. Detailed analysis of ductal identification based on gallbladder infundibulum position will be performed in this study. All infundibulum positions will be recorded during intraoperative laparoscopic procedure.

NCT ID: NCT06213207 Recruiting - Newborn Morbidity Clinical Trials

Cluster Randomized Controlled Trial Applying Helping Baby Breathe in Nepal

SaLiN
Start date: February 18, 2024
Phase: N/A
Study type: Interventional

The cluster randomized controlled trial will be conducted in the selected health facilities/birthing centers of Sarlahi district in Nepal. Further from the selected health facilities. The investigators will assess the newborn in terms of their health outcomes. Characteristics related to the performance of skilled birth attendants will be measured prior to the intervention. After six months of the intervention, endline assessment will be conducted. The intervention unit are the health facilities which provide the services as birthing centers. The effectiveness of the intervention will be examined using generalized estimating equation against baseline vs. endline on skills performance of the health workers and newborn health outcomes. The study will be implied in the similar settings to improve the skill performance and newborn health outcomes in order to reduce neonatal mortality.

NCT ID: NCT06163859 Recruiting - Hypertension Clinical Trials

Female Community Health Volunteers Led Hypertension Prevention and Control in Nepal

Start date: January 5, 2024
Phase: N/A
Study type: Interventional

Hypertension (HTN) poses a significant global public health challenge, contributing to approximately 13.5% of premature deaths, 54% of incident strokes, and 47% of incident coronary heart disease cases worldwide.(1) In Nepal, HTN prevalence among adults is 25% (2), similar to the global average, but a larger proportion (44%) remain unaware of their condition. (3) To address this issue, Nepal has implemented the Package of Essential Non-Communicable Diseases (PEN) Implementation Plan in line with the Multi-sectoral Action Plan for NCD prevention and control.(4) Studies on the implementation of PEN demonstrate barriers at multiple levels that can not be addressed in just health facility-based service system. In response to multi-level implementation barriers, this study will respond to an urgent need for cost-effective evidence-based HTN control strategies in low-resource settings, particularly reaching the marginalized and disadvantaged population. The study aims to conduct a type III hybrid implementation effectiveness study with two primary objectives. First, it will assess the implementation outcomes of the Female Community Health Volunteers (FCHVs) implementation strategy at various levels using the RE-AIM framework. Secondly, it will examine the effectiveness of the FCHVs strategy compared to facility-based PEN through a pre-post intervention trial, specifically focusing on systolic blood pressure. The study will support Nepal's national NCD priorities. The FCHVs will deliver health education and promotion activities, forming peer groups. Employing a mixed-method approach, the research will employ a cluster randomized controlled trial among 350 participants, collected quantitative data on various implementation dimensions in the intervention arm, supplemented with in-depth interviews and focus group discussions with patients and FCHVs to understand implementation outcomes. Qualitative tracking logs will be maintained to document interactions with FCHVs and healthcare workers. The intervention strategy involves training Female Community Health Volunteers (FCHVs) in health facilities to address hypertension (HTN) in Nepal. The implementation bundle consists of several components: FCHVs will undergo comprehensive training covering mass screening, counseling, medication compliance, self-care, and referrals to healthcare facilities. Mass screening events will be conducted by FCHVs in collaboration with healthcare facility in-charges to identify individuals with hypertension, forming the FCHV-HTN group. Monthly sessions will be held with the FCHV-HTN group, focusing on hypertension discussions, BP log reviews, addressing challenges, and encouraging family involvement. Spouses or adult caretakers will also be invited to promote a supportive environment. FCHVs will have monthly meetings to share experiences, challenges, and refer non-adherent or uncontrolled HTN patients to healthcare facilities with monthly reports and BP logs. This intervention aims to enhance hypertension prevention and management, fostering active community engagement and effective healthcare coordination. The findings of the study will be shared in a comprehensive and inclusive approach, empowering the community with valuable knowledge, fostering evidence-based healthcare practices, and contributing to the advancement of hypertension management strategies in our community and beyond.

NCT ID: NCT06146491 Recruiting - Pain, Postoperative Clinical Trials

A COMPARISON OF TRANSDERMAL DICLOFENAC AND ORAL COMBINATION OF PARACETAMOL AND IBUPROFEN IN POSTOPERATIVE PAIN MANAGEMENT FOLLOWING SURGICAL EXTRACTION OF MANDIBULAR THIRD MOLAR- A RANDOMISD CONTROLLED TRIALS.

Start date: August 10, 2023
Phase: Phase 4
Study type: Interventional

This is comparative interventional study, will be conducted in patient indicated for surgical extraction of mandibular third molar at the Department of Oral and Maxillofacial surgery, College of Dental Surgery, BPKIHS, Nepal. Verbal and written will be taken . Participants meeting inclusion criteria will be included in the study and will be divided in to two groups, group A (Oral combination of paracetamol-500mg and ibuprofen -400mg) and group B ( Transdermal diclofenac patch-200mg) using computer generated randamization. Extraction will be carried out using standard protocol. Aformention drugs will given to participants accordingly for management of post operative pain.Tramadol will be given to each patient as rescue analgesics and allowed to have if pain score exceeds 7.post operative instruction will be given carefully. Rescue phone number will be provided in case of emergency. Telephonic interview will be performed at 12, 24 and 72 hours post operatively and pain score using numeric rating scale will be recorded.Any adverse effects of drugs will be recorded. The data collected will be entered in Microsoft excel sheet. It will then be transferred into SPSS (Statistical Package for Social Sciences) for statistical analysis.

NCT ID: NCT06094959 Recruiting - Suicide Prevention Clinical Trials

Integrating Suicide Prevention Packages Into Task-shifted Mental Health Interventions in Low-resourced Contexts

Start date: May 30, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to assess the feasibility and acceptability of implementing a co-designed suicide prevention package of implementation strategies (SuPP) in a pilot open, non-randomized, clinical trial. The main questions it aims to answer are: 1. What is the feasibility of implementing the SuPP open clinical trial? 2. What is the degree to which SuPP was implemented correctly 3. What is the perceived acceptability of SuPP among providers and patients? Participants will include healthcare providers and patients at risk for suicide. Providers will identify and provide culturally adapted safety planning and contact follow up to at-risk patients over a period of six months. Patients will receive an initial culturally adapted patient-centered safety plan and receive a tapered series of contacts (phone calls) over the course of six months from health providers.

NCT ID: NCT06090370 Recruiting - Silicosis Clinical Trials

Reducing Silica Exposure Among Brick Kiln Workers in Nepal

Start date: January 24, 2024
Phase: N/A
Study type: Interventional

Inhaling respirable silica increases the risk for silicosis, an incurable and debilitating lung disease. In South Asia, one high-risk industry is brick manufacturing, where more than 4 million manual laborers mold bricks by hand. In Nepal, brick manufacturing employs over 200,000 workers across 1,200 registered brick kilns. These workers are exposed to respirable silica concentrations 1.4 to 6.6 times higher than the limits set by the U.S. National Institute for Occupational Safety and Health. Preventing silicosis is paramount, as the average brick kiln worker cannot afford medical care and only 6.8% receive regular health checks. Few studies have evaluated interventions in brick kiln workers to reduce silica exposure and prevent silicosis. One promising intervention involves providing workers who are exposed to silica above the permissible exposure limit with personal protective equipment (PPE), specifically respirators. When properly used, respirators decrease silica inhalation and the risk of silicosis. Brick kiln workers in Nepal do not use any PPE. Several studies have explored PPE barriers and have evaluated the feasibility of implementing PPE but to date none have been conducted in Nepali brick kiln workers. To close this gap, the goal of this research is a human-centered design approach to develop and pilot a PPE training program in one brick kiln in Nepal guided by the Discover, Design, Build, and Test (DDBT) framework. This research is necessary to understand the Nepali context and to efficiently develop appropriate and feasible PPE intervention components that will be trialed in future research.

NCT ID: NCT06082154 Recruiting - Sepsis Clinical Trials

A Prognostic Model Based on POCUS at ICU Admission in Critically Ill Patients With Sepsis

Start date: April 26, 2023
Phase:
Study type: Observational

Sepsis is responsible for one in three patient deaths. Understanding the severity of the disease, directing medications, prognosticating, and communicating with family members depend on the ability to predict outcomes in a patient presenting with sepsis in the ICU. The outcome of mortality reflects the caliber of ICU treatment. This is a prospective observational study that will include all patients diagnosed with sepsis for point-of-care ultrasonography within 24 hours of admission to the ICU from April 26, 2023, to March 30, 2024, and create a model that will predict 28 day outcome in these patients.

NCT ID: NCT06039475 Recruiting - Clinical trials for Acute Mountain Sickness

RISK FACTORS ASSOCIATED WITH HIGH ALTITUDE SICKNESS: A CASE-CONTROL STUDY

Start date: July 1, 2023
Phase:
Study type: Observational

Research Title: RISK FACTORS ASSOCIATED WITH HIGH ALTITUDE SICKNESS: A CASE-CONTROL STUDY Rationale: The Study will help us to identify risk factors of high altitude sickness among Nepalese and International patients. Aims and Objectives: - To identify risk factors for high altitude sickness, including AMS, HACE, and HAPE. - To compare the prevalence of high altitude sickness between individuals who ascended rapidly versus those who ascended slowly. - To examine the association between high altitude sickness and various demographic and environmental factors, such as age, sex, altitude, and temperature. - To evaluate the effectiveness of preventative measures, such as gradual ascent and medication, in reducing the risk of high altitude sickness Research Hypothesis (if relevant): N/A 1. Material & Methods: 1. Whether study involves Human/animals or both : Human 2. Population/ participants: Patients presenting in Emergency Ward of District Hospital, Mustang with AMS (Acute Mountain Sickness), HAPE (High altitude Pulmonary Oedema) or HACE (High altitude Cerebral Oedema) as CASES Healthy volunteers who didn't develop any symptoms of AMS/HAPE/HACE after their trip to high altitude as CONTROLS 3. Type of study design: : Case Control Study 4. Human study : Inclusion Criteria: Cases: Individuals age 18 years or older who have been diagnosed with AMS based on a LLS score of ≥3 or HAPE or HACE. Controls: Individuals age 18 years or older who did not develop AMS during their trip to high altitude as the cases, and who are matched to cases on age and sex. Exclusion Criteria: - Those who deny consent for participation. - Age<18 years - Pregnant Women 5. Expected sample size : Sample size calculation: Mentioned in methodology 6. Control groups : N/A 7. Probable duration of study: 180 days 8. Setting: Emergency Ward 9. Parameter/Variables to be applied/measured Independent Variables i. Socio-demographic characteristics such as age, sex, address, nationality. Dependent Variables: i. Symptoms of Presentation ii. Ascent Rate iii. Co-morbidities iv. Past History including previous history of altitude sickness v. Personal History such as smoking, alcohol intake, recreational drugs vi. Awareness on High Altitude Sickness vii. Intake of Prophylactic medicine (Acetazolamide) viii. Past history of Covid-19 , TB Outcome measures: Primary (main outcome): All dependent variables (i) Rational for statistical methods to be employed : Data will be entered in Microsoft Excel and converted it into SPSS for statistical analysis . Descriptive statistics will be used to summarize the characteristics of cases and controls. Univariate and multivariate logistic regression analyses will be performed to assess the association between risk factors and high altitude sickness. The results will be reported as odds ratios with corresponding 95% confidence intervals. A p-value of less than 0.05 will be considered statistically significant. (ii) Ethical clearance : Ethical clearance will be obtained from National Health Research Council of Nepal (iii) Permission to use copyright questionnaire/Pro forma: Not applicable (j) Maintain the confidentiality of subject Confidentiality of the participants will be maintained. Whether available resources are adequate: Yes 1. Other resources needed: No 2. For Intervention trial: Not applicable

NCT ID: NCT06004726 Recruiting - Substance Abuse Clinical Trials

"Effectiveness of School-based Substance Abuse Prevention Programme Among Adolescents .

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The objectives of the study is to 1. "to explore the perception of teachers, parents & students in the prevention of substance abuse among adolescents". 2. "to develop and determine the effectiveness of a School-based substance abuse Prevention Programme (SSPP) on awareness, attitude, peer pressure, and life skills towards prevention of substance abuse". In this study, SSPP refers to a Bilingual Multicomponent Training Programme which includes psychoeducation and video-assisted teaching to enhance awareness of substance abuse, role-play to develop a positive attitude towards prevention of substance abuse, Case based scenario to increase resistance to peer pressure and storytelling and demonstration to increase life skills towards prevention of substance abuse among adolescents of selected schools of Pokhara, Nepal.

NCT ID: NCT05990569 Recruiting - Hemorrhoids Clinical Trials

Pudendal Nerve Block With Bupivacaine Alone and Bupivacaine With Methylene Blue for Postoperative Analgesia

Start date: August 12, 2023
Phase: N/A
Study type: Interventional

Study Description: The goal of this clinical trial is to compare the duration of postoperative pain relief achieved with two different approaches to pudendal nerve block in patients undergoing elective perianal surgery. The main question this study aims to answer is whether adding Methylene Blue to Bupivacaine pudendal nerve block can prolong postoperative analgesia compared to using Bupivacaine alone. Participants in this study will be individuals with ASA I and II physical status undergoing elective perianal surgery under spinal anesthesia. They will be randomly assigned to one of two groups: 1. Group A (Case Group): Participants will receive a pudendal nerve block with Bupivacaine combined with Methylene Blue. 2. Group B (Control Group): Participants will receive a pudendal nerve block with Bupivacaine alone. The pudendal nerve block will be performed using ultrasound guidance at the level of the ischial spine. The needle tip will be positioned between the Sacro tuberous and sacrospinous ligaments to inject the local anesthetic or the local anesthetic combined with Methylene Blue. Throughout the study, the researchers will monitor the time to the first rescue analgesic, assess pain levels using the Numeric Rating Scale at various time intervals (2, 6, 24, 48 hours, and 7 days), and observe for any side effects or complications related to the intervention. Participants will be closely observed after surgery to assess their pain levels and analgesic requirements. The researchers will also evaluate patient satisfaction using the Likert scale. By comparing the outcomes between the two groups, the study aims to determine if the addition of Methylene Blue to Bupivacaine pudendal nerve block provides superior postoperative analgesia in perianal surgery patients. This information will contribute to the understanding of effective pain management strategies for individuals undergoing perianal surgical procedures and potentially reduce the need for opioids and improve patient outcomes.