cyrilzakka/clinical-trials huggingface dataset:
Effect of an Enhanced Recovery After Surgery Program on Outcomes After Pancreatoduodenectomy

This study assesses whether patients with pancreatic cancer who undergo surgery experience improved outcomes following the implementation of a multidisciplinary care pathway, specifically an enhanced recovery after surgery (ERAS) program.

This pathway includes various interventions in the preoperative, intraoperative, and postoperative care of these patients, all aimed at enhancing their health status and postoperative results.

This prospective observational study is conducted by the same surgical team at two high-volume pancreatic cancer referral centers in Greece.

Patients undergoing elective pancreatic surgery are prospectively enrolled and managed according to a standardized ERAS protocol (ERAS group).

A control group, which received standard perioperative care before the implementation of ERAS, was retrospectively selected and matched based on demographic and clinical parameters.

The primary study endpoint is the length of hospital stay (LOS), while secondary endpoints include 30-day mortality and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* adult patients
* diagnosis of pancreatic cancer
* elective open pancreatic surgery

Exclusion Criteria:

* age \<18 years
* emergency pancreatic surgery
* other surgical procedures
* missing data
* lost to follow-up
The Development of a COVID19 Oral Vaccine Consisting of Bacillus Subtilis Spores

This is a study trial to assess the effectiveness of the immune response stimulated by the genetically engineered Bacillus subtilis which express and display Spike protein of the SARS-COV2 on the spore coat.

Bacillus subtilis is regarded as safe organism by The Food and Drug Administration and it is presented in most food sources. Preliminary experiments have shown that the genetically engineered Bacillus subtilis can express and display receptor binding domain of spike protein of the SARS-COV2 on its spore coat, thus successfully induce the secretion of cytokines of human cells in vitro. Previous experiments also successfully demonstrated that a increased detection of neutralizing IgG and igM levels in mice after oral administrated with the Bacillus subtilis. This suggests that the transgenic spores of Bacillus subtilis have successfully activated the immune system, producing high-affinity neutralizing antibodies and memory B cells. Furthermore, no adverse effects were shown in all the mices. The engineered Bacillus subtilis will be further studied in a human trials through oral administration to test its safety and the immune effect resulted in human bodys.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* age over 25 years
* the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial);
* participant vaccinated with Sinovac over 4 months
* anti-SARS CoV 2 neutralizing antibody is negative in serum.

Exclusion Criteria:

* pregnant women
* history of COVID-19 infection or showing COVID-19 infection symptoms
* having had contact to people with known COVID-19 infection in the last 14 days
* having fever (\> 37.4oC in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea.
* positive real time RT-PCR COVID-19 test.
* persons with autoimmune diseases
* allergic diathesis or any clinically significant allergic disease (i.e. asthma)
* any condition that might impair the immune response
* recent or current immunosuppressive medication
* any other vaccine application 30 days before the first dose
Functional Characteristic Properties of Skeletal Muscle Tissue Assessed by P31 Spectroscopy in Young and Older Adults

P31 nuclear magnetic resonance (RMN) Spectroscopy (SRM P31) has currently being poorly used in the field of sarcopenia.

The aim of the CAMUS study is to investigate the feasibility a protocol of SRM P31 at rest, during and after a standardized physical task. The secondary objective is to compare the metabolism of tyhe skeletal muscle tissue assessed by SRM P31 in young and older individuals. A pilot study, cross-sectional study will be conducted. Ten healthy sedentary 70+ years males and 10 sedentary 25 to 30 years old male will be included.

Level of physical activity, physical performances, will be assessed at baseline. RMN (T1; tractography and SRM P31) will be performed. SRM P31 will be performed at rest, during and after an exhausting muscle task at 70% 1-RM. Feasibility will be judged on the rate of valuable variables recorded (\>90%) inorganic phosphate (iP), phosphocreatine (PCr) and isoform of adenosine triphosphate (ATP : alfa, beta, gamma).


Eligibility Criteria:
Inclusion Criteria:

* Old group : 70+ years males
* Young group : 25 to 30 years males
* Sedentary males in the 2 groups
* Informed consent

Exclusion Criteria:

* Contraindication to perform a RMN
Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.

Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ one day of life and ≤ 18 years
* Purulent bacterial conjunctivitis
London Underground Study - Health Effects of Particulate Matter

An average of 4.8 million journeys are made on the London Underground every day and as the 'Tube' has elevated airborne particulate matter concentrations compared to ambient air, this raises concern about the potential health impact of this environment. This study explores the health effects of particulate matter from the London Underground on patients with COPD and healthy volunteers.

Patients with COPD and healthy participants will be invited to undertake a set 90 min journey on the London Underground, and on a separate occasion (3-8 weeks apart), a 90 min journey on the London Overground (as a proxy for a clean air London area while maintaining other aspects of a train journey). A series of clinical, physiological and inflammatory data will be collected before, during and after (at different time points) each of the sessions in order to compare their response in relation to exposure and/or to disease status.


Eligibility Criteria:
Inclusion Criteria for both groups:

* Give informed consent
* London resident

For participants with COPD:

* GOLD stage 2 COPD (FEV1/FVC\<70%; 50%\>FEV1\<80% predicted), GOLD stage 3 COPD (FEV1/FVC\<70%; 30%\>FEV1\<50%) and GOLD stage 4 (FEV1/FVC\<70%;FEV1\<30%)
* No history of ischaemic heart disease

For healthy volunteers:

* No history of ischaemic heart disease.
* Normal lung function with no evidence of airflow obstruction.

Exclusion Criteria for both participants with COPD and healthy volunteers:

* Those with unstable ischaemic heart disease or COPD.
* Current smokers and those who are ex-smokers of \<12 months duration.
* Those who work in the London Underground or are occupationally exposed to - - high levels of vehicle traffic exposure on a frequent basis.
* Those who cannot walk for 30 mins.
* Involvement in another research study
* Those unable to give consent.
Towards Personalized Dosing of Natalizumab in Multiple Sclerosis

A prospective clinical trial with the aim of maintaining drug efficacy of natalizumab while extending dose intervals guided by drug concentrations in patients with relapsing remitting multiple sclerosis.

Our main objective is to prove that extending dose intervals guided by natalizumab serum concentrations, will not result in radiological or clinical disease activity in completely stable RRMS patients treated with natalizumab. Adult patients with RRMS with no evident disease activity during the last 12 months of natalizumab infusions with a minimum treatment of 12 months wil be included. Before subsequent natalizumab infusions, serum concentrations will be evaluated. If the concentration exceeds 15μg/ml the dose interval will be extended with a week to a maximum of eight weeks. Patients will get regular brain MRI scans and clinical follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting multiple sclerosis (RRMS) according to the McDonald criteria, revised by Polman 2010
* Natalizumab treatment for 12 months or longer at inclusion.
* An expanded disability status scale (EDSS) score of 0.0-6.0 at baseline.
* Natalizumab level of ≥15 μg/ml
* Written informed consent.

Exclusion Criteria:

* Any MS disease activity (radiologically or clinically) during the last 12 months of natalizumab treatment.
* Unable to undergo frequent MRI.
* The use of other immunomodulatory medication other than natalizumab.
A Resilience Promotion Program for Parents of Children With Cancer

Cancer is a leading cause of death for children. With the increasing incidence of childhood cancer, the mental health problems emerge in those parents struggle with their children's life-threatened disease. Caring for children with cancer is described as life-changing experience and overwhelming stress for parents. Many studies have been conducted to screen the psychological distress for these parents and found a considerable percentage of them suffering from depressive symptoms. Poorer quality of life was also found in parents of children with cancer when compared to parents of children without cancer. Additionally, parental distress interacted with children's emotions and could have detrimental effects on children's both physical and mental health. Therefore, it is important to take measures improving the mental health for parents of children with cancer.

Although current various psychological interventions illustrated small to moderate improvements of mental health for parents of children with cancer, the total effect base on a systematic review was not statistically significant. The purpose of these interventions was predominantly to treat negative mental health problems such as depression and no recognized effective psychological interventions were available for parents of children with cancer until now. Along with the paradigm shift from problem-oriented approach to nurturing strengths in the post-modern period, instead of exclusively treating mental health problems, researchers payed more attention to positive therapy such as resilience promotion program. Resilience usually refers to the ability to adapt adverse conditions and maintain positive status. Resilience studies are mounting since the flourishing of positive psychology movement and meaningful results were gained from corresponding intervention program concentrating on resilience promotion in adolescent education, handling chronic disease and recovery of breast cancer. However, there is a lack of targeted resilience promotion program for parents of children with cancer. The results of our pilot study showed low levels of resilience in parents of children with cancer and strong associations among parental resilience, quality of life and depression. It indicates that the increase in resilience can benefit for the mental health of parents. Therefore, a resilience promotion program will be conducted to examine efficacy for parents of children with cancer.


Eligibility Criteria:
Inclusion Criteria:

* having a child (0-19 years old) with cancer diagnosis.
* Chinese resident and able to read Chinese and speak Mandarin.

Exclusion Criteria:

* having physical impairment or cognitive and learning problems identified from family history of medical records.
* attending other researches.
Injecting Lateral Pterygoid Muscle by Botulinum Toxin Type A With 2 Different Methods : 3D Guided Appliance and Electromyography (EMG) .

The goal of this study is to evaluate intra-oral botulinum toxin type A injection into lateral pterygoid muscle using a surgical guide synthesized by virtual planning based on CT with soft tissue window.

* To evaluate improvement of maximum interincisal opening (MIO) before and after injection.
* To assess change in disc position before and after injection.
* To evaluate recovery of symptoms as clicking, tenderness of TMJ and tenderness of lateral pterygoid muscle after injection.

Researchers will compare intra-oral botulinum toxin type A injection using a surgical guide synthesized by virtual planning based on CT with soft tissue window to conventional EMG guided botulinum toxin injection into lateral pterygoid muscle in patient with anterior disc displacement with reduction.

Participants will be injected with botulinum toxin type A by intraoral approach.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes that are diagnosed with ADDWR according to DC/TMD.
2. Their age range between 20 and 45 years.
3. Angle class I maxilla-mandibular relation.

Exclusion Criteria:

1. Patients with degenerative joint disease, musculoskeletal, neuromuscular disorders, cardiovascular, bleeding disorders, breathing difficulties, neurological disorders.
2. Pregnancy and lactating women.
3. History of surgical TMJ intervention.
4. Botox hypersensitivity
5. History of tumors or maxillofacial trauma.
6. Posteriorly edentulous saddles or anterior open bite.
7. Patient contraindicated to MRI examination
Effect of Prolonged Military Exercises With High Load Carriage, on Neuromuscular Fatigue and Physiological/Biomechanical Responses

Land military missions generally combine prolonged walking/moderate-pace-running and other physical actions such as creeping, jumping, shooting,... which are associated with the direct carrying of high to severe loads of equipment and supplies (20-30 to 50 kg) by soldiers. For an infantry section, "typical" intervention phases last about 20-24 h and combine variable intensity grades. Consequently, military mission characteristics are an interesting investigation field of human fatigue. Previous studies have investigated human neuromuscular alterations after prolonged "normal" locomotion exercises \[Millet et al., 2004, 2009\], thus the aim of this study is to characterize the neuromuscular determinants of fatigue induced by a 24-h Simulated Military Effort (SME) and a 4-h Military Road March (MM), both performed with high load carriage. Additionally, the consequences of fatigue on physiological and biomechanical parameters of locomotion will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* to be a male
* to have a VO2max \> 45ml/min/kg (mean observed value in military subjects)
* to be aged from 30 to 45
* to be recently retreated from National Army
* to be highly experienced in military efforts
* to be trained in exercises involving load carrying
* to benefit from a social security insurance

Exclusion Criteria:

* All subjects with recent (\< 3 month) bone, articular or muscle diseases.
* All subjects presenting a clinic sign of intolerance to testing procedures, especially subjects with knee, ankle, hip or back diseases.
* All subjects intolerant to muddy or wooded environment.
* All subjects presenting a clinic sign of intolerance to exercise, and particularly to running or walking while carrying a load
* All subjects involved at the same time in another medical research
* All subjects militarily active
* All subjects with cardiac or pulmonary identified and known diseases
Development of Predictive Biomarkers

Investigators aim to further the understanding of the various factors that govern the progression of beta-cell death in individuals recently diagnosed with Type 1 diabetes (T1D). Specifically, the investigators wish to examine the utility of plasma-induced signatures and other measures as predictive biomarkers for the rate of C-peptide decline in individuals with recent onset T1D. Persistent C-peptide in individuals with T1D reflects some degree of β-cell function and is clinically associated with a reduction in both severe hypoglycemic events and microvascular complications such as diabetic nephropathy and retinopathy. There is significant heterogeneity in the rate of C-peptide decline in individuals with T1D, reflective of the complex disease process. For example, \~10% of individuals have no discernable fall in stimulated C-peptide after two years from clinical diagnosis as compared to other individuals with very rapid C-peptide decline. It is currently impossible to predict how long, and to what extent, someone will have residual C-peptide production. This complicates clinical management but also the design and interpretation of T1D β-cell preservation trials. The "gold standard" outcome measure of any T1D β-cell preservation trial is the stimulated C-peptide to a mixed meal tolerance test (MMTT). Given the variability in this measure, intervention studies must include more subjects over a longer period of time. This slows the rate of scientific discovery and increases cost. This study aims to define the governing mechanisms of post-onset T1D disease trajectory. Understanding the trajectory of the disease may lead to the development of biomarkers to predict disease progression and therapies that could reverse or prevent the development of Type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 5-17 years of age with a clinical diagnosis of T1D
2. T1D diagnosis date between 1-3 months at the time of study visit 2 (baseline visit)
3. Treatment naïve of any immunomodulatory agent
4. Receiving routine out-patient diabetes care at the CHW Diabetes Clinic

Exclusion Criteria:

1. Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism or celiac disease that is well-controlled on a gluten free diet.
2. Diabetes other than T1D
3. Chronic illness known to affect glucose metabolism
4. Psychiatric impairment, with the exception of well-controlled depression or anxiety, that will affect the ability to participate in the study
5. Female participants of child-bearing age with reproductive potential must not be knowingly pregnant
6. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
V-A ECMO AUTO Mode Registry

Abiomed Impella V-A ECMO AUTO Mode - Observational Study

The overall objective of this study is to collect data during routine Impella usage in an ECpella setting to analyze and assess potential clinical effects, usability, and ease of use of an automated Impella mode to run in conjunction with a VA ECMO system for continued assessment and development of the underlying algorithms in different clinical settings.

The primary objective is thus the collection of clinical events to serve as a database for an in-silico post-hoc analysis of the V-A ECMO AUTO Mode algorithm for the Impella pump. This is accompanied by a secondary objective assessing usability, confirming the user friendliness and ease of use by collection of user experience and insights through a questionnaire and data on alarms and manual user interaction with the AIC out of the operational console data.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ongoing or planned ECpella therapy

Exclusion Criteria:

* Age \< 18 years
* Treatment with other than VA ECMO setup
* Treatment with Impella CP® heart pump only
Non-Contact Measurement of Aortic Compliance

Reduced aortic stiffness is a powerful way to predict the outcome of cardiovascular (CV) disease. There are several non invasive methods for its estimation, most of which are based on the measurement of speed of the arterial pulse wave. (The stiffer the artery, the faster the pulse wave travels.) They rely on detecting the arterial pulse with 2 sensors placed on the skin a known distance apart and measuring the time for the pulse to travel between them. However all current methods require skilled operators and are of limited accuracy. Thus, there is a need for an easy to use and reliable device to measure pulse speed. The aim of this project is to develop a non contact device to detect the aortic pulse as it moves into the small arteries following the ribs, using the principle of thermal imaging, by means of a high sensitivity infra red camera, directed towards the subjects back. The investigators plan to validate the device and conduct a small feasibility study in patients undergoing elective angiography, by simultaneously measuring pulse speed using established methods. These are Doppler ultrasound (non-invasive) and direct intra-arterial measurement (the gold standard).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and above
* Patients eligible for coronary angiography
* Informed consent obtained
* Able to complete experimental protocol

Exclusion Criteria:

* Refusal of consent
* Age below 18 years
* Breast feeding
* Known or suspected pregnancy
* Patient participating in another study at time of study entry or previous participation in this registry
* diagnosed but untreated hypertension
Training Workshop for Promoting Family Well-being Through a Community-based "Learning Families" Campaign

To strengthen family well-being and neighborhood cohesion in Kwun Tong community, a community -based "Learning families" campaign was conducted. As an initial step of this project, the investigators conducted a need assessments before designing and conducting a train-the-trainer workshop.The train-the-trainer workshop aimed to prepare the members of Estate Management Advisory Committees (EMAC) and Mutual Aid Committees (MACs) to implement and assist in conducting a series of community-based family well-being activities for residents in a public housing estate. Focus group interviews (before and one year after training workshop) were conducted to obtain opinion from the members of EMAC and MACs of the public housing estate. Questionnaire assessments were conducted before, immediately after finishing the training workshop, one year after training workshop.

According to the Social Welfare Department statistics, Kwun Tong has been ranked as the highest for the reported cases of elderly abuse (12.3%), the second and fourth highest for the reported cases of battered spouse (9.2%) and child abuse (7.9%) respectively . To strengthen family well-being in the Kwun Tong community, the investigators adopt a community-based participatory (CBP) approach and implement a community-based "Learning Families" campaign in Kwun Tong district with our collaborator, the Christian Family Service Centre (CFSC). The campaign aims to promote family health, happiness, and harmony (3Hs) through cultivating cooperative and self-regulated family learning culture in the public housing estate

Given that CFSC is the leading non-government organization based in Kwun Tong district, the investigators believe that the proposed campaign will deliver the family well-being messages effectively in the community via engaging major stakeholders such as the Estate Management Advisory Committees (EMACs) and the Mutual Aid Committees (MACs).

The investigators implemented a brief training sessions to the resident leaders of EMAC \& MACs to engage and equip them with the general concept of "Family well-being", " Learning family", "Neighbourhood cohesion" and activities organizing skills. The train-the-trainer workshop aimed to prepare the members of Estate Management Advisory Committees (EMAC) and Mutual Aid Committees (MACs) to implement and assist in conducting a series of community-based family well-being activities for residents in a public housing estate.

Focus group interviews (before and one year after training workshop) were conducted to obtain opinion from the members of EMAC and MACs of the public housing estate. Questionnaire assessments were conducted before, immediately after finishing the training workshop, one year after training workshop.

Eligibility Criteria:
Inclusion Criteria:

* Ethnic Chinese older 18 years of age,
* able to read Chinese and speak Cantonese,
* willing to carry out the duties of peer health promoters in the project.

Exclusion Criteria:

- not fit the inclusion criteria