cyrilzakka/clinical-trials huggingface dataset:
Hypothermia and Hemostasis After Cardiac Arrest

This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48, ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac arrest.

The overall aim of this sub-study is to examine the hemostasis in patients resuscitated after cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia

Our specific aims are:

* To investigate the whole blood coagulation using the rotational thromboelastometry.
* To investigate the function of platelets


Eligibility Criteria:
Inclusion Criteria:

* Out of hospital cardiac arrest of presumed cardiac cause
* Return of spontaneous circulation (ROSC)
* Glasgow Coma Score \< 8
* Age \> 18 years and \< 80 years

Exclusion Criteria:

* \> 60 minutes from the circulatory collapse to ROSC
* Time interval \> 4 hours from cardiac arrest to initiation of therapeutic hypothermia
* Terminal illness
* Coagulation disorder
* Unwitnessed asystolia
* Cerebral performance category 3-4 before the cardiac arrest
* Severe persistent cardiogenic shock
* Pregnancy
* Persistent cardiogenic shock (systolic blood pressure \< 80 despite inotropic treatment)
* New apoplexy or intracerebral hemorrhage
* Lack of consent from the relatives
* Lack of consent from the GP
* Lack of consent from the patient if he/she wakes up and is relevant
Level of Burn Out of Surgical Residents Working in Government Hospitals of Lahore

The term burnout was coined by psychologist Herbert Freudenberger in 1974 in an article entitled "Staff Burnout" in which he discussed job dissatisfaction precipitated by work-related stress. A broadly applicable description defines burnout as a state of mental and physical exhaustion related to work or care giving activities. A long-standing conceptual and operational definition characterized burnout as a triad of emotional exhaustion (emotional over extension and exhaustion), depersonalization (negative, callous, and detached responses to others), and reduced personal accomplishment (feelings of competence and achievement in one's work) In the World Health Organization International Classification of Diseases, 10th revision, burnout is defined as a "state of vital exhaustion." Although no specific diagnosis of burnout is mentioned in the Diagnostic and Statistical Manual of Mental Disorders, burnout is a clear syndrome with significant consequences.

Burnout in health care professionals has gained significant attention over the last several years. Given the intense emotional demands of the work environment, clinicians are particularly susceptible to developing burnout above and beyond usual workplace stress. Residency training, in particular, can cause a significant degree of burnout, leading to interference with individuals' ability to establish rapport, sort through diagnostic dilemmas, and work though complex treatment decision making. Overall, burnout is associated with a variety of negative consequences including depression, risk of medical errors, and negative effects on patient safety. The goal of this review is to provide medical educators and leaders with an overview of the existing factors that contribute to burnout, the impact of burnout, inter specialty variation, and suggestions for interventions to decrease burnout.


Eligibility Criteria:
Inclusion Criteria:

* General Surgical resident

Exclusion Criteria:

* Residents of all other specialties
* All the General surgical consultants
Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology

Prospective, non-comparative, multi-centre, multi-country, observational post-authorization study, to correlate predictive factors with number of oocytes in relation to the gonadotropin dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation and GnRH-antagonists for pituitary suppression

This will be a prospective, non-comparative, multi-centre, multi-country, observational post-authorization study in Germany and Austria. The study will evaluate the use of follitropin alfa (Bemfola®) in controlled ovarian stimulation for IVF/ICSI.

About 30 ART centres will be involved in the study. Upon site initiation, each investigator site will enrol the subjects who meet the inclusion criteria.

As this is an observational study, there will be no additional treatment or diagnostic procedures performed on subjects other than those of the investigators' local routine clinical practice. The decision to start ART treatment and to use Bemfola® in controlled ovarian hyperstimulation (COH) following a GnRH antagonist protocol will be made independently by the investigators as per the ART centre's protocol, preceding patient enrollment for this study.

Eligibility Criteria:
Inclusion Criteria:

* Female subject justifying an IVF/ICSI treatment
* Age over 18 years (inclusive) at the time of the screening visit
* Signed informed patient consent
* Received only Bemfola® for ovarian stimulation
* Pituitary suppression with GnRH-antagonists

Exclusion Criteria:

* Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients
* Tumours of the hypothalamus or pituitary gland
* Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
* Gynaecological haemorrhages of unknown aetiology
* Ovarian, uterine or mammary carcinoma
Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform

The primary study objective is to generate evidence as to the feasibility, usability, perceived value, and potential benefits of implementing the AMAZE™ platform into clinical practice.

AstraZeneca has developed the AMAZE™ disease management platform to be used across multiple disease indications to provide a unified experience for the management of participants throughout their participant care journey. AMAZE™ integrates multiple systems, including a patient mobile application where patients can enter daily symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials. Implementation of AMAZE™ within clinical practice has not yet been evaluated. The results from this study will be used to inform any changes or modifications that need to be made to the technology platform, its implementation process, and explore impact on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age at the time of enrollment
* Clinically confirmed diagnosis of asthma
* Access to a smartphone with internet access with the following requirements: iOS (Operating System iOS 13 or newer and Devices iPhone 8 or newer) or Android (Operating System 8.0 or newer)
* Able to understand and speak English sufficiently to be able to use the AMAZE™ patient app
* Willingness to participate in a telephone interview and be audio-recorded
* Consenting to participate in the study

Exclusion Criteria:

* Current diagnosis of active chronic obstructive pulmonary disease (COPD) or any pulmonary diagnosis other than asthma
* Has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, or insufficient knowledge of the English language that, in the opinion of the investigator, would interfere with his or her ability to agree to participate and/or complete the ACT™.
Impact of Congenital Heart Disease on Neurodevelopmental Outcome

The project aims toward clarifying the underlying mechanism and the long-term impact of congenital heart disease on neurodevelopment.

The project provides detailed information on the impact of congenital heart disease on neurodevelopmental outcome in adulthood. The study investigates if brain maturation and development, and the neurocognitive outcome is compromised in patients with atrial or ventricular septal defects more than 20 years after diagnosis and treatment. Data on brain morphology, brain tissue architecture, and resting-state function will be obtained by 3.0 Tesla MRI. Data on neurocognitive outcome will be obtained by a customized wide neuropsychological test battery. This study will clarify the extent of these patients' neurodevelopmental challenges and guide evaluate targeted interventions to alleviate potentially long-term effects.

Eligibility Criteria:
Inclusion Criteria:

* ICD codes DX Q21.0 (VSD) or DX Q21.1 (ASD), surgically repaired VSD or open ASD

Exclusion Criteria:

* lack of medical record, suffering from coronary artery disease or other congenital cardiac abnormalities, diagnosed syndromes, spontaneous closure of the atrial septum defect before inclusion-date, magnetic implants or non-MRI compatible foreign objects, pregnancy, lack of Danish language skills or suffering from severe lung disease
Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults

The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 6-week acute treatment in study NCT00839423 / 11492A.


Eligibility Criteria:
Inclusion Criteria:

- Patients who completed 6-week short-term treatment study for Major Depressive Episode (MDE), NCT00839423 / 11492A, followed by a 2-week taper period

Exclusion Criteria:

* Any current psychiatric disorder other than MDD as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV TR)
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication

Other protocol-defined inclusion and exclusion criteria may apply.
Immunomodulation Analysis of Radiation Therapy in Pediatric Malignant Brain Tumors

To investigate the effect of radiotherapy on peripheral blood immune cell composition and function in pediatric malignant brain tumor patients.


Eligibility Criteria:
Inclusion Criteria:

* Age from 3 to 18
* To be diagnosed with malignant brain tumors
* To eligible for radiation therapy
* Karnofsky performance status ≥ 70
* No prior radiation exposure
* Informed consent signed for blood sample collection and used for research purpose

Exclusion Criteria:

* Patients had received radiotherapy previously.
* Patients who had no histological diagnosis
* Patients who do not wish to participate
* Patients with infections
A Prospective Observational Study to Evaluate Long-term Changes in Cartilage Morphology in Subjects Who Previously Received TPX-100 or Placebo in Study TPX-100-1 for Patellar Osteoarthritis Involving Both Knees

To evaluate the long-term changes in patellar cartilage thickness in TPX-100 versus placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2.

No drug intervention. Study to collect 1 additional MRI of each knee treated in either TPX-100-1 or TPX-100-2.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who participated in TPX-100-1 and received 4 injections of 200 mg/injection TPX-100 in one knee, or subjects who participated in TPX-100
* Cruciate and collateral ligament stability as assessed by screening history and clinical examination
* Stable medial and lateral menisci as assessed by screening history and clinical examination
* Able to read, understand, sign and date the subject informed consent

Exclusion Criteria:

* Contraindication to MRI, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight \> 300 lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure
* Prior surgery in the knees, excluding procedures for debridement only (no previous microfracture procedure)
* History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis
* Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee \< 3 months before enrollment
* Last intra-articular knee injection of corticosteroids \< 3 months before enrollment
* Use of any steroids (except inhaled corticosteroids for allergy or respiratory problems) during the previous month before enrollment
* History of arthroscopy in either knee in the 3 months before enrollment
* History of septic arthritis, gout or pseudo-gout in either knee in the 12 months before enrollment
* Clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear)
* Active systemic infection
* Participation in other clinical osteoarthritis drug studies, except for studies TPX-100-1 and TPX-100-2, within two years prior to enrollment in TPX-100-4.
Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1

The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.

Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular condition that contraindicates contact lens wear.
* Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.
* Other protocol-specified exclusion criteria may apply.
CBT-I for Cannabis Use

The purpose of this study is to investigate the efficacy of a group-based behavioral sleep intervention, and the incremental benefit provided by an adjunct sleep mobile app, on cannabis and sleep outcomes among cannabis dependent Veterans.

The Prevalence of cannabis use disorder (CUD) has been steadily increasing within the Veteran Health Administration (VHA), along with the related significant physical, cognitive, and psychological sequelae. Even in patients with a strong motivation to quit and the presence of empirically-supported interventions, Veterans who receive treatment for CUD have high rates of lapse (63% by 6-months post-treatment) and relapse (71% within 6-months post-treatment). Thus, identifying strategies to improve response to CUD treatment is in the interest of all VHA stakeholders.

Disturbed sleep is common among individuals with CUD and has been shown to result in increased rates of lapse/relapse to cannabis. Providing a behavioral sleep intervention within the context of CUD treatment, and prior to a cessation attempt, has the potential to improve these cessation outcomes.

Cognitive behavioral therapy for insomnia (CBT-I) is a well-established first-line treatment for insomnia. While CBT-I is being disseminated throughout VHA, it is rarely received by Veterans with substance use disorders (SUDs) and, among those that do receive it, it is almost always delivered following a cessation attempt. While CBT-I has been shown to be an effective treatment for improving sleep among individuals with insomnia and co-occurring conditions, including SUDs, there has yet to be an investigation of the impact of providing CBT-I prior to CUD treatment with the goal of improving cessation outcomes. In addition, the development of an adjunct behavioral intervention delivered via mobile app technology within VA holds great promise to bolster outcomes.

The current study seeks to fill this gap by conducting a randomized prospective study designed to evaluate the efficacy of CBT-I, as well as the incremental benefit of including an adjunct sleep mobile app (CBT-I-MA), on both cannabis and sleep outcomes among Veterans with CUD.

Eligibility Criteria:
Inclusion Criteria:

To be included in the current study individuals must

* be a Veteran 18 years or older
* meet Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria for cannabis use disorder;
* meet Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for insomnia;

Exclusion Criteria:

Individuals will be excluded based on evidence of the following:

* inability to provide fully-informed written consent to participate;
* history of, or current, psychotic symptoms;
* current pregnancy;
* Sleep apnea (\>5 on the STOP-Bang assessment);
* active suicidal/homicidal intent.
Carotid Arteries Stenting Complications: Transradial Approach Versus Transfemoral

The aim is to compare the safety of using transfemoral and transradial approach in patient undergoing carotid arteries stenting.

The use of transradial approach in carotid arteries stenting can significantly decrease the amount of adverse events associated with transfemoral approach such as bleeding or hematoma. Otherwise providing transradial approach is fraught with technical difficulties of common carotid artery canulation that can result in embolic complications. Taking into account the absence of studies in this area of medicine, providing investigation evaluating parameters of safety for both methodics is very actual.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic patients with internal carotid artery stenosis(\>50%)
* Asymptomatic patients with internal carotid artery stenosis(\>60%)
* Anatomy of internal carotid artery applicable for stent implantation and use of embolic protection device

Exclusion Criteria:

* Stroke, myocardial infarction or underwent operative treatment within 1 month
* Prior carotid artery stenting
* Cerebral vessels aneurisms/ malformations
* Subclavian artery/ brachiocephalic trunk stenosis
* Contraindications for antiplatelet or/and anticoagulation therapy
Hypertonic Saline Solution in Heart Failure

Patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. Some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. The infusion of hypertonic saline solution has been tested in different conditions of cardiovascular collapse. Current evidence indicates that the infusion of hypertonic solution in heart failure patients can provide clinical and haemodynamic improvement. The investigators are testing the hypothesis that the infusion of hypertonic solution in association with diuretics may prevent the occurrence of renal dysfunction in patients with decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Heart failure according to Framingham criteria
* Episode of acute decompensation,with need of in-hospital treatment
* Presence of congestive phenomena

Exclusion Criteria:

* Patient denial
* Left-ventricle ejection fraction over 0,4, as measure by transthoracic echocardiography
* Rheumatic disease
* Restrictive cardiomyopathy
* Alcohol abuse
* Chronic obstructive pulmonary disease
* Cancer
* Pulmonary embolism during the last 6 months
* Surgical procedures or acute illness during the last 30 days
* Chronic or acute infection
* Any other circumstance that may hamper patient prognosis for the next 6 months
* Serum creatine over 3.0mg/dL
* Serum potassium over 5.5 mEqs/L
* Any specific condition associated to the acute episode of decompensation, such as new onset cardiac arrhythmias, heart ischemia, infection, etc.
Efficacy of New Post Kasai ILBS Protocol in Biliary Atresia.

Biliary atresia (BA) is a neonatal progressive fibrosing cholan- giopathy and the most frequent indication for pediatric liver trans- plantation \[1\]. Surgical removal of biliary remnants and Roux-en-Y hepatoportoenterostomy (HPE) aims to restore biliary drainage and suppress progression to cirrhosis. Successful HPE, defined as a serum total bilirubin level \<2 mg/dL at three months after surgery, occurs in ∼50% of patients in the United States \[2\]. Young age seems to be the best predictor of response to HPE, with limited data on the efficacy of adjuvant therapies such as corticosteroids, antibiotics, and choleretic agents \[3,4\]. Potential modes of action of these therapies are to increase bile flow as well as exert an anti- inflammatory effect \[5\].

In 2007, a double-blind randomized trial in the United Kingdom identified a beneficial effect on corticosteroid therapy on reduction of bilirubin level at one month post HPE without sig- nificant change in the need for liver transplantation \[6\]. Since then there have been multiple trial most prominent being, Kings hospital trial \[7\] and START trial \[8\] which demonstrated reduction in bilirubin levels; however both failed to demonstrate any effect on native liver survival.

However one study done by Bezerra et al \[9\] where they employed steroid in customised manner showed significant improvement in bile drainage in their subjects versus their historical cohort. Hence we propose to perform a prospective cohort study to assess the Efficacy of new post Kasai (steroid) ILBS protocol in Biliary Atresia.

Study population : Subject undergoing Kasai Sx at Institute of Liver and Biliary Sciences would be enrolled and will include retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).

Study design: Cohort study with historical control ( Jan 2015- Dec 2017) Sample size: Time bound. All cases presenting during the study period will be included in the study.

Monitoring and assessment: Liver function test, Hemogram and International Normalised Ratio (INR) would be done weekly for one month, twice weekly for 2nd month and monthly thereafter till 1 year.

Statistical Analysis: Appropriate statistical test for correlation analysis will be applied.

Adverse effects: As per previous studies done , no serious adverse effect has been noted in treatment group vs control group.

Eligibility Criteria:
Inclusion Criteria:

1. Post Kasai Biliary atresia operated at ILBS with retrospective historical cohort (Jan 2015 to Dec 2017) and retrospective + prospective cohort with new protocol (Jan 2018 till June 2024).

Exclusion Criteria:

1. Subjects having major surgical complications
2. Defaulters or Patient not following protocol/not giving consent
3. Biliary atresia splenic malformation
Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure

In the scoliosis screening program of the Student Health Service (SHS), Department of Health (DH), in Hong Kong, more than 50% of screened school children prescribed with x-ray examination basing on the screening protocol did not have Cobb angle greater than the referral threshold of 20°; ie they did not need specialist referral and thus were subjected to unnecessary x-ray exposure. Our primary objective is to determine whether a new radiation-free ultrasound system could identify subjects with Cobb angle greater than the referral threshold of 20° thus avoiding unnecessary x-rays in the referral workflow. The secondary objective is to evaluate if Angle of Trunk Rotation (ATR) can further increase the accuracy of ultrasound assessment.


Eligibility Criteria:
Inclusion Criteria:

i. Schoolchildren in Hong Kong attending School Screening Program provided by Student Health Service ii. Recommended for radiographic assessment in the scoliosis screening program

Exclusion Criteria:

* i. Patients with standing height \<1 m, or \>2 m ii. Patients with body mass index (BMI) ≥25 kg/m2 iii. Subjects with skin diseases iv. Subjects with fracture or wound that affect ultrasound scanning v. Subjects with ferromagnetic implants vi. Subjects with surgery done for the spine vii. Subjects with winged scapula or other irregularity of back contour that affect ultrasound scanning viii. Subjects who cannot stand steadily during scanning ix. Subjects with allergy to ultrasound gel