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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: NCT06009016 Recruiting - Inflammation Clinical Trials

Inflammation and Coagulation Factors for Predicting Cerebral Edema After SAH

Start date: August 1, 2022
Phase:
Study type: Observational

Explore the role of Inflammation and coagulation factors in cerebrospinal fluid for predicting persistent cerebral edema after subarachnoid hemorrhage

NCT ID: NCT05622461 Recruiting - Clinical trials for Traumatic Brain Injury

Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery

Start date: February 13, 2023
Phase: N/A
Study type: Interventional

This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up. The two conditions will be: a) usual medical care plus access to internet resources regarding pediatric brain injury (Internet Resources Comparison group, IRC), and b) usual medical care plus the R2R-TBI intervention (Road-to-Recovery group, R2R-TBI).

NCT ID: NCT05585255 Recruiting - Clinical trials for Ischemic Stroke, Acute

Clinical Significance of DKK2 Protein in Cerebral Ischemia-reperfusion Injury

Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

The study is a two-center prospective cohort clinical trial. The primary purpose of this trial is to identify the pattern of DKK2 serum levels in ischemic stroke patients after revascularization therapy and determine the correlation between serum DKK2 levels and prognosis.

NCT ID: NCT04950972 Recruiting - Clinical trials for Large Hemispheric Infarction (LHI)

Intravenous Administration of BIIB093 (Glibenclamide) in the Treatment of Severe Cerebral Edema After Massive Cerebral Infarction

Start date: September 1, 2020
Phase: Phase 3
Study type: Interventional

The current study is to assess efficacy and safety of intravenous (IV) BIIB093 to improve functional outcomes in subjects with LHI.

NCT ID: NCT04414020 Recruiting - Clinical trials for Diffuse Traumatic Cerebral Edema

Cytoprotective Effect and Clinical Outcome of Perioperative Proesterone in Brain Tumors

Start date: June 1, 2020
Phase: Phase 1
Study type: Interventional

Neuronal injury is evident in elective craniotomy for space occupying lesions. Surgical trauma and mechanichal impact of the tumor causes neuronal injury. Neurosreroid progesterone is a neurotransmittern , trail to use in abolishing neurotoxcicty

NCT ID: NCT04303065 Recruiting - Clinical trials for Traumatic Brain Injury

Dexamethasone for the Treatment of Vasogenic Pericontusional Edema.

DEXCON-TBI
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

The DEXCON-TBI trial is a multicenter, pragmatic, randomized, triple-blind, placebo controlled trial to quantify the effects of the administration of dexamethasone on the prognosis of TBI patients with brain contusions and pericontusional edema. Adult patients who fulfil the elegibility criteria will be randomized to receive dexamethasone or placebo. Patients who have suffered a head injury and have one or more cerebral contusions with visible pericontusional edema in the CT scan can be included in the study. The doses of dexamethasone will be a short and descending course: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days). The primary outcome is the Glasgow Scale Outcome Extended (GOSE) performed one month and 6 months after trauma. Other secondary outcomes are: compare the number of episodes of neurological deterioration; compare the symptoms associated with TBI; compare the presence of adverse events during treatment; compare the volume of pericontusional edema before and after 12 days of treatment in both groups of patients; and compare the results of the neuropsychological tests between the two groups of patients one month and 6 months after the TBI. The main analysis will be on an ''intention-to-treat´´ basis. A descriptive analysis of the baseline variables will be made for each treatment group. Logistic regression will be used to estimate the effect of dexamethasone and placebo on GOSE at one month and at 6 months, dichotomized in unfavorable outcome (GOSE 1-6) and favorable outcome (GOSE 7-8). Since the severity of the initial injury will determine significantly the final outcome of the patient, to assess the effect of dexamethasone, efficacy will also be analyzed using the 'sliding dichotomy'. A subgroup analysis will be carried out by stratifying the patients as they present more or less than 10mL of pericontusional edema in the preinclusion CT. We will perform an interim analysis with the patients included during the first year to calculate the conditional power. An independent statistician will blindly perform this analysis. At the same time a safety analysis will be also perfomed. A study with 600 patients would have about 80% power (two sided alpha=5%) to detect a 12% absolute increased (from 50% to 62%) in good outcome.

NCT ID: NCT04247659 Recruiting - Cerebral Infarction Clinical Trials

Study on the Relationship Between Asymmetric Vascular Sign of Cortex and Prognosis in Massive Cerebral Infarction

Start date: January 9, 2020
Phase: Phase 4
Study type: Interventional

Susceptibility weighted imaging (SWI) technology has developed in the decade which is being a kind of cerebrovascular disease diagnostic tools in the clinical application, especially for paramagnetic material (such as DNA hemoglobin and hemosiderin) has a high sensitivity. The change of the signal on SWI bases on the change of local oxygenated hemoglobin content in the blood and deaeration hemoglobin content ratio, which can be used to indirectly reflect the hypoxia group oxygen intake fraction (OEF) and cerebral metabolic rate. When the intracranial vascular occlusion, corresponding responsibility vascular blood flow area of brain tissue will occur hypoperfusion, brain tissue will improve the compensation in accordance with its own OEF, causing ischemia area inside the venous drainage of deaeration hemoglobin content ratio increases and the hypointensity on SWI ,which display the asymmetric cortical vessel sign (ACVS). Studies have suggested that ACVS is more prone to early neurological deterioration and has a poor long-term outcome. After recanalization of ischemic stroke, the presence of equal CVS(return to normal) on SWI is associated with a good clinical outcome. In addition, the relationship between ACVS grade and collateral circulation in patients with acute ischemic stroke has been studied. For patients with massive cerebral infarction, the relationship between ACVS on SWI and the clinical prognosis of cerebral edema and cerebral hemodynamics is not completely clear. In this study, the clinical data of patients with massive cerebral infarction will be analyzed to explore the relationship between ACVS, cerebral edema , cerebral hemodynamic and clinical prognosis. Sodium aescinate is widely used in cerebral edema caused by cerebral hemorrhage or cerebral infarction.The main mechanism of sodium aescinate is anti - inflammatory, anti - exudate, anti - oxygen free radical, anti - edema, increase vein tension, improve blood circulation and nerve protection. In this study, investigators will investigate whether the application of sodium aescinate had an effect on ACVS on SWI in patients with massive cerebral infarction. Plasma s100-β, procalcitonin, neutrophil count, serum fibronectin, and endothelin-1 could predict cerebral edema in patients with cerebral infarction, this study will analyze the relationship between these markers and ACVS on SWI in patients with massive cerebral infarction.

NCT ID: NCT04114799 Recruiting - Brain Edema Clinical Trials

Haemodynamical Optimization During Brain Surgery

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

The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using invasive measurement SPV/PPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).

NCT ID: NCT04057690 Recruiting - Stroke, Acute Clinical Trials

Automatic PredICtion of Edema After Stroke

APICES
Start date: April 1, 2019
Phase:
Study type: Observational

To use machine learning for early detection of malignant brain edema in patients with MCA ischemia