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Morbidity clinical trials

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NCT ID: NCT06132633 Not yet recruiting - Morbidity Clinical Trials

A Pilot Study for Adaptation of Neospot Device for Health Care at Primary Health Facilities in Kenya

Start date: December 2023
Phase: N/A
Study type: Interventional

Neospot device is a 5-in-1 wearable vital signs monitor designed to measure temperature, blood pressure, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SPO2). We propose to study the experiences of patients and nurses regarding spot measurement of vital signs at the outpatient department in primary care facilities in Kenya. The study aims to investigate the capability, opportunity, and motivation of nurses to use the Neospot device for vital signs measurement in level 3 facilities in Kenya by validating the accuracy of the Neospot and assessing the experience of patients while using the Neospot, the study also aims to assess the experiences of nurses as they use the Neospot and determine how the Neospot affects their workflow.

NCT ID: NCT06107725 Recruiting - Ischemic Stroke Clinical Trials

Maimonides Minocycline in Stroke Study

Start date: November 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this study is to determine if oral Minocycline's proposed neuroprotective effects further improve the clinical outcomes, including mortality, of acute stroke patients beyond the current standard stroke care in a large scale randomized prospective open label (outcome assessor blinded) clinical trial. Participants will be randomly assigned (1:1) to take Minocycline 200mg orally every 24 hours for five days, starting within 24 hours from stroke symptoms onset, in addition to standard care or standard care alone. NIHSS (The National Institutes of Health Stroke Scale) and mRS (Modified Rankin Scale) will be collected at the time of presentation, discharge and again at 30- and 90-days post-discharge. All-cause mortality will also be obtained at 30 days and 90 days.

NCT ID: NCT05696301 Recruiting - Cesarean Section Clinical Trials

Interest of Tecartherapy on a Painful Caesarean Section Scar: a Randomized Clinical Trial.

NOCEPAIN
Start date: July 4, 2023
Phase: N/A
Study type: Interventional

Cesareans are a frequent procedure in obstetrics and 15.4% (95% CI, 9.9-20.9%) of women with cesareans still have pain at 3 months after delivery. Currently, self-massage of the scar is recommended to them. Post-cesarean pain is associated with psychological disorders (including, e.g., anxiety, depression). Tecar therapy could improve the healing and pain associated with cesareans and therefore improve women's quality of life and their satisfaction. Objectives: The principal objective is to study the analgesic efficacy of tecar therapy for postoperative scar pain and/or discomfort at 3 month after cesarean delivery, by comparing it with sham tecar therapy. A randomized clinical trial with 2 parallel arms and single blinding, to study the efficacy of this medical device for therapeutic purposes. In both groups (randomization stratified as a first cesarean or repeat cesarean), the women will have the standard recommended treatment - manual self-massage of the scar. Women's instruction in this self-massage will be structured and identical for both groups, including the provision of an informational document describing how to perform this massage. The training will be provided immediately after randomization. - Description of the experimental group These women will receive Tecar through Winback® technology [CE medical 1984, Norma 60601-2, ISO9001, ISO13485. Class IIa medical device, CET (capacitative mode) 400 VA and RET (resistant mode) 100 Watts, weight 4 Kg)]. Each session will last for 20 minutes, and each individual will have 3 sessions over a period of 3 weeks. - Description of the control group ("sham treatment") The women will follow the same study design as the experimental group with activation of the portable placebo device identical to the active medical. Each session will last for 20 minutes, and each individual will have 3 sessions over a 3-week period. Principal endpoint: Visual analogic scale (VAS) for pain and/or discomfort at 3 months after delivery partum (with a ruler scored from 0 for no pain to 10 for the worst pain imaginable). Succinct description of the products: "Tecar" is an acronym for a type of therapy (transfer electrical capacitive and resistive). The Winback® is a portable, easy-to-handle noninvasive regenerator. This study will use only the instrumental mode and 4-cm electrodes. During each session, this electrode will be moved over the entire scar. We will use the following 3 modes: capacitive (CET), CET Dynamic, and resistant (RET). These allow us to standardize the treatment without taking into account either the thickness of the abdominal wall or the woman's morphology. Each session will take 20 minutes (CET for 4 min, CET Dynamic 6 min, RET 6 min and CET 4 min). The intensity of CET and RET will be adapted to each woman and the diathermy chosen according to the woman's threshold of comfort, to be determined by her at each session, in the experimental group. There will be 1 session a week for 3 weeks. Study plan and procedures: The eligible women will be identified by the physicians in both of the obstetrics departments participating in this study. The women will receive oral information as well as written information. If they are interested, they will be offered an inclusion visit, normally scheduled for one week later. After a second verification of the eligibility criteria at this inclusion meeting, reading the information form and signing the consent, they will be randomized into one of the two groups by random drawing. Each woman will have 3 sessions (1 session a week for 20 min for 3 consecutive weeks): active treatment by tecar therapy or sham/placebo tecar therapy. They will receive self-administered questionnaires at 3 and 6 months after delivery to be completed and returned.

NCT ID: NCT05506748 Completed - Mortality Clinical Trials

Association Between Preoperative HALP and Immediate Postoperative Outcomes

Start date: April 20, 2021
Phase:
Study type: Observational

Multiple inflammation-based prognostic scores have been developed for the prediction of perioperative morbidity and mortality following pancreaticoduodenectomy (PD). Preoperative "Hemoglobin, Albumin, Lymphocytes and Platelets index (HALP)" is one of the promising inflammatory markers that has emerged as a predictor of postoperative survival. To date, no study has been done with preoperative HALP to predict 30days morbidity and mortality. Is there any association between Preoperative HALP (hemoglobin, albumin, lymphocyte, and platelet) and 30 days post operative morbidity and mortality in patients undergoing Pancreaticoduodenectomy?

NCT ID: NCT05447611 Not yet recruiting - Quality of Life Clinical Trials

Role of Empathy in Curative Treatment Outcomes of Non-metastatic Colorectal Cancer.

EMPACOL
Start date: September 2022
Phase:
Study type: Observational

The aim of project EMPACOL will be to investigate, while taking into consideration the clinical factors known and well described in the literature, among the non-clinical factors, in particular, patient-healthcare personnel (HCP) relationship, a link between HCP's empathy perceived by the patient, and the results of the curative treatment of non-metastatic colorectal cancer, throughout the patient's care.

NCT ID: NCT05367115 Completed - Clinical trials for Health Care Utilization

Verification of the Epidemiology and Mortality of Rare Diseases in Taiwan With Real-world Evidence

Start date: December 9, 2020
Phase:
Study type: Observational

This study aims to explore the longitudinal incidence and prevalence trends of selected muscular and bone-related rare diseases, i.e., Familial Amyloidotic Polyneuropathy (FAP), Primary hyperoxaluria, Wilson's disease, Cystic fibrosis, Osteogenesis imperfecta, Porphyria, and Primary Paget disease, and analyze healthcare utilization.

NCT ID: NCT04740619 Completed - Mortality Clinical Trials

Natural Orifice Specimen Extraction in Sigmoid Volvulus

Start date: January 1, 2018
Phase:
Study type: Observational

Sigmoid resection can be performed using conventional and laparoscopic methods. There are few publications in the literature reporting specimen removal from the natural hole in patients with a diagnosis of sigmoid volvulus. Here, the investigators aimed to present the literature that transanal specimen removal is a technically feasible method after laparoscopic surgery in patients with sigmoid volvulus.

NCT ID: NCT04694469 Completed - Morbidity Clinical Trials

Comparison of Day-time and Night-time Operations of Supracondylar Humeral Fractures

Start date: June 26, 2019
Phase:
Study type: Observational

This study aims to investigate that performing supracondylar humerus fracture operations during daylight hours may have better results than performing them at night.

NCT ID: NCT04641858 Completed - Covid19 Clinical Trials

BCG to Reduce Absenteeism Among Health Care Workers During the COVID-19 Pandemic

EDCTP
Start date: December 3, 2020
Phase: Phase 4
Study type: Interventional

The COVID-19 pandemic challenges available hospital capacity. Strategies to protect health care workers (HCW) are desperately needed. Bacille Calmette- Guérin (BCG) has protective non-specific effects against other infections; a plausible immunological mechanism has been identified in terms of "trained innate immunity". The primary objective of the study is to evaluate whether BCG can reduce unplanned absenteeism due to illness among HCW during the COVID-19 pandemic. Secondary objectives are to reduce the number of HCW that are infected with COVID-19, reduce hospital admissions for HCW and to improve the capacity for clinical research. Design: Single-blind, parallel-group placebo-controlled multi-centre block randomized trial including a total of 1050 HCW. The study sites will be the Manhiça hospital in Mozambique, Central Hospital Dr. Agostinho Neto and Central Hospital Dr. Baptista de Sousa in Cape Verde and Hospital Nacional Simão Mendes and other hospitals in the capital Bissau in Guinea-Bissau. Population: HCW (nurses/physicians/others) ≥18 years. Intervention: Block randomization 1:1 to intradermal standard dose (0.1 ml) of BCG vaccine or placebo (saline). Endpoints: Primary: Days of unplanned absenteeism due to illness. Secondary: Days of absenteeism because of documented COVID-19; cumulative incidence of infectious disease hospitalizations. Follow-up: mobile phone interviews every second week, regarding symptoms, absenteeism and causes, COVID-19 testing (if done) and their results. Perspectives: If BCG can reduce HCW absenteeism it has global implications. The intervention can quickly be scaled up all over the world.

NCT ID: NCT04542330 Completed - Covid19 Clinical Trials

Using BCG to Protect Senior Citizens During the COVID-19 Pandemic

Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

Background: The virus SARS-CoV-2 has spread rapidly throughout the world. Seniors are at high risk of severe COVID-19 when infected. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other infections; significant reductions in morbidity and mortality have been reported, and a plausible immunological mechanism has been identified: "trained innate immunity". The investigators hypothesize that BCG vaccination can reduce the risk of COVID-19 and other infections among senior citizens during the COVID-19 pandemic. Objectives: Primary objective: To reduce senior citizens' risk of acute infection during the COVID-19 pandemic. Secondary objectives: To reduce senior citizens' risk of SARS-CoV-2 infection during the COVID-19 pandemic. To reduce senior citizens' risk of self-reported respiratory illness during the COVID-19 pandemic. Study design: A placebo-controlled randomized trial. Study population: 1900 seniors 65 years of age or above. Intervention: Participants will be randomized 1:1 to intradermal administration of a standard dose of BCG vaccine or placebo (saline). Outcomes: Primary outcome: "Acute infection" identified either by a doctor, antibiotics use, hospitalization, or death due to infection. Secondary outcomes: Verified SARS-CoV-2 infection and self-reported respiratory illness. With an expected incidence of "acute infection" of 20%, the trial can show a 25% risk reduction in the the intervention group versus the placebo group by including a total of 1900 individuals, 950 individuals in each group. Risk for participants and impact: Based on previous experience and randomized controlled trials in adult and elderly individuals, the risks of BCG vaccination are considered low. If BCG can reduce the risk of acute infection in seniors by 25% it has tremendous public health importance, both during the COVID-19 pandemic and overall.