cyrilzakka/clinical-trials huggingface dataset:
POSSUM, P-POSSUM and Charlson's Comorbidity Index in Abdominal Surgery.

Abdominal surgery represents the most frequent activity in the surgical block. Advances in surgical techniques and improvements in postoperative care imply the need for greater control of the surgical outcomes obtained and the comparison of results between services with the same characteristics with the help of assessment scales.

A prospective observational study will be carried out during 2021. All patients undergoing abdominal surgery will be included. Demographic variables, personal and surgical history, preoperative and intraoperative data, and variables related to surgery will be collected. At 30 days postoperatively, the clinical history of the patients will be reviewed and postoperative complications will be collected as well as the mortality that occurred. With these data, the POSSUM, the P-POSSUM and the Charlson comorbidity index will be calculated.

Abdominal surgery represents the most frequent activity in the surgical block. Advances in surgical techniques and improvements in postoperative care imply the need for greater control of the surgical outcomes obtained and the comparison of results between services with the same characteristics with the help of assessment scales.

A prospective observational study will be carried out during 2021. All patients undergoing abdominal surgery will be included. Demographic variables, personal and surgical history, preoperative and intraoperative data, and variables related to surgery will be collected. At 30 days postoperatively, the clinical history of the patients will be reviewed and postoperative complications will be collected as well as the mortality that occurred. With these data, the POSSUM, the P-POSSUM and the Charlson comorbidity index will be calculated.

Once this data are collected, the following objectives will be met:

* Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery in our hospital, comparing the estimated morbidity and mortality with that observed 30 days after surgery.
* Analyze the correlation of estimated morbidity and mortality of the POSSUM and P-POSSUM with respect to that observed in scheduled surgery vs. emergencies.
* Analyze the correlation of estimated morbidity and mortality of POSSUM and P-POSSUM with respect to that observed in laparoscopic surgery vs. laparotomy
* Establish the relationship and predictive ability of CHF with respect to morbidity and mortality at 30

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing scheduled or urgent intervention for gastrointestinal surgery will be included in the study.

Exclusion Criteria:

* Patients operated under locoregional anesthesia.
* Patients undergoing Major Ambulatory Surgery (CMA) regardless of postoperative destination (home or hospitalization floor).
* Patients intervened on a scheduled basis in the afternoon shift
* Patients who require surgery after the first 24 hours of hospital admission
LIP-01 in Hypercholesterolemia

The purpose of this study is to determine a safe and tolerable dose of LIP-01


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-75 years
* Plasma total-cholesterol \>5.2 mmol/L (\> 200 mg/dL)
* Willingness to adhere to the requirements of the protocol, including availability for follow-up visits and donation of blood samples
* Willingness and ability to sign written informed consent
* Women of child bearing capacity who agree to use an acceptable form of birth control during the trial \[i.e., oral contraception, reliable use of a double-barrier method (e.g., condom and diaphragm, condom and foam, condom and sponge), IUD or tubal ligation\]

Exclusion Criteria:

* Plasma triglycerides \> 4.0 mmol/L (\> 354 mg/dL)
* Plasma LDL ≥ 5.0 mmol/L (≥ 195 mg/dL)
* Current coronary artery/ cardiovascular disease or history of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, angioplasty or coronary artery bypass grafting, angina pectoris)
* Moderate/high risk of coronary artery/ cardiovascular disease
* Diabetes mellitus
* Uncorrected hypothyroidism
* Other significant metabolic endocrine disease
* Uncontrolled hypertension (\>160 systolic or \>100 diastolic)
* Active liver disease (ALT \>2x normal)
* Significant gastrointestinal disease
* Acute inflammatory disease
* Significant kidney disease (calculated by eGFR \<60 mL/min)
* Any other significant medical condition which, in the opinion of the investigator, could compromise patient safety or confound trial results
* Any significant/relevant surgery within the last year
* Use of lipid-lowering drugs
* Treatment within the previous 6 months with any medication that is known to affect lipid or lipoprotein levels (such as statins, fibric acid derivatives, bile acid sequestrants, ezetimibe, nicotinic acid)
* Regular use of natural health products or dietary supplements known to affect lipid or lipoprotein levels (omega-3 fatty acids, green tea extracts, guggulipid, psyllium, plant sterols, policosanols). If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.
* Pregnant or lactating women
* Known allergy to any ingredient in the study product, including: Coptis chinensis, Ilex kudingcha, microcrystalline cellulose and magnesium stearate
Pilot RCT Feasibility Study: Cancer and T2D

The purpose of this study is to test a nurse-led intervention for adults with newly diagnosed cancer and undiagnosed/newly diagnosed Type-2 diabetes

Specific Aim 1: To examine study feasibility of a nurse-led intervention for adults with newly diagnosed cancer and T2D. We define feasibility indicators as: (a) efficient study recruitment is possible given prevalence of T2D (diagnosed and undiagnosed) in UF patients with newly diagnosed cancer; (b) retention rates in both groups ≥80% to indicate that the study design and methods are adequately patient-centered; (c) identified barriers to and facilitators of a nurse-led intervention are respectively modifiable or optimizable; and (d) patient acceptability scores \>8 for the study procedures. We hypothesize that we will recruit up to 40 patients within 18 months and retain ≥ 80% of patients in all groups; minor but important revisions will be required to resolve issues identified with using the nurse-led intervention; and 80% of patients from both groups who complete the study will report that the burden of the study is acceptable through their retention in the study.

Specific Aim 2: To determine the variation in HbA1c at baseline and at the end of the three-month intervention period in each of the two study groups.

Eligibility Criteria:
Inclusion Criteria:

* a) 18 years and older
* b) Using pathology reports, a new diagnosis of a solid tumor cancer or lymphoma within the past 3 months
* c) Patients being treated with curative intent or those with a prognosis estimated to be \>2 years, as best assessed by the oncologist.
* d) First medical oncology outpatient visit at UF within the past 3 months
* e) Plans to continue cancer care at UF
* f) Speaks and reads English
* g) Can comply with study related procedures, per the treating oncologist or advanced practice provider

Exclusion Criteria:

* a) Diagnosis of leukemia or pancreatic cancer as the new cancer diagnosis
* b) Being treated for T2D for \> than 3 months
* c) eGFR \<45mL/minute/1.73m2
* d) Liver insufficiency (defined as liver enzymes over 5 times the upper limit of normal or clinical sequelae of advanced cirrhosis as documented by the treating oncologist or Advanced Practice Providers.
* e) Active infection requiring systemic antibiotics
* f) Taking systemic steroids of more than 1-week duration. Must have stopped \>3 days prior to study enrollment. Note, inhaled or topical steroids are not exclusion criteria.
* g) Planning to receive cancer care at a location outside of UF
* h) Enrolled in another study with similar outcomes.
* i) Currently taking metformin or known inability to tolerate it
AS-OCT Study of Cornea and Tear Film Parameters in Juvenile SLE Patients

The aim of thie study to assess tear film parameters such as tear meniscus height (TMH), tear meniscus area (TMA), and tear meniscus depth (TMD). In addition, corneal pachymetry and epithelial thickness maps in juvenile SLE patients and compared to healthy subjects of similar age and gender.

Juvenile systemic lupus erythematous (SLE) is a relapsing and remitting autoimmune connective tissue disorder that can affect many organs such as skin, joints, kidneys, eye, and brain (1) . SLE has a global prevalence of 0.3 to 23.2 cases per 100,000. Women are more likely than men to develop the disease. Four out of the following 11 diagnostic criteria are sufficient for the diagnosis of SLE, malar rash, discoid rash, oral ulcers, non-erosive arthritis, serositis, photosensitivity, renal disorder, neurological disorder, hematological disorder, immunological disorder, and presence of antinuclear antibodies. (2,3)

Ocular manifestations occur in about one third of juvenile SLE patients with keratoconjunctivitis sicca being the most common manifestation which is characterized by decreased tear film aqueous layer. Scleritis, retinal vasculitis (which is often associated with CNS lupus), and papillitis are considered as the most serious ocular manifestations. (4)

Corneal involvement in juvenile SLE affects the superficial epithelium, resulting in superficial punctate keratitis, which is believed to be caused by Sjögren\&#39;s syndrome (SS). However, some cases of non-infiltrative and infiltrative peripheral ulcerative keratitis have been identified (5) .

Schirmer\&#39;s test and fluorescein breakup time test (FBUT) are two common clinical tests used to analyze tear film. (6,7) Using an in vivo, non- contact technique, anterior segment optical coherence tomography (AS- OCT) is now used to image the tear film, measure the lower tear film height and area, measure corneal thickness (pachymetry), and measure surface epithelial thickness. (8,9)

Eligibility Criteria:
Inclusion Criteria:

- Age ≤18 years old. Patients with juvenile SLE diagnosed by a rheumatologist with no ocular involvement upon clinical examination

Exclusion Criteria:

* 1- Patients with history of intraocular surgery as cataract surgery ,retinal detachment surgery, anti-glucoma surgery.

  2. Patients with history of any corneal refractive surgery as LASIK, PRK. 3. Patients with significant media opacity as corneal opacity, cataract. 4. Patients with ocular diseases as glaucoma, uveitis. 5. Patients with any retinal affection as pathological myopia, macular hole, age related macular degeneration and retinal vascular occlusion.

  6. Patients with systemic diseases as diabetes mellitus, hypertension, abnormal kidney function.
OptiMuscle - Improving Respiration by Optimising Muscle Function

The primary aim will be to understand whether a digital breathing biofeedback system can improve the outcomes of physiotherapist guided breathing retraining.

Approximately 10% of people in the United Kindom exhibit some form of dysfunctional breathing. This term describes a range of conditions which are characterised by an impairment in the muscular control of breathing and which can result in breathlessness, hyperventilation and, in some cases, dizziness. Current clinical assessment techniques and treatments for dysfunctional breathing are low-tech. The investigators propose that patients would get more benefit from a system which uses biofeedback on muscle patterns to guide breathing re-education. The investigators have developed a new digital health system for the clinical management of dysfunctional breathing. The system uses an avatar to provide biofeedback to communicate abnormal muscle function in real-time, guiding patients through a process in which they gradually learn the correct muscular control of breathing. The proposed intervention seeks to understand if the addition of a digital breathing biofeedback system improves the outcomes of physiotherapy guided breathing retraining. Patients awaiting respiratory physiotherapy for dysfunctional breathing will be recruited to receive 4 sessions of breathing retraining with the assistance of the digital breathing biofeedback system. All patients will complete lung function tests and Quality of Life questionnaires pre- and post- treatment. Patients will also be offered an interview to understand their experiences of using the system.

Eligibility Criteria:
Inclusion Criteria:

* Ability to stand and walk independently
* History of breathing difficulties, such as breathlessness and difficult or laboured breathing for at least previous 6 months.
* Clinical diagnosis of dysfunctional breathing, sometimes referred to as breathing pattern disorder.
* If participants have co-existing respiratory problems, e.g. asthma, these should not be felt (in the opinion of the referring clinician) to be the cause of the current symptoms of breathlessness.

Exclusion Criteria:

* Inability to speak and understand English sufficient to read and understand the information sheet and sign the consent form.
* BMI \>34
* Currently receiving active treatment for dysfunctional breathing
* Received treatment for acute lower respiratory tract infection or asthma exacerbation with last 4 weeks
* Significant respiratory co-morbidity (i.e. where the major respiratory diagnosis is not asthma)
Safety and Effectiveness of Autologous Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With CP

Safety and Effectiveness of Autologous Adipose Tissue Derived mesenchymal Stem Cell Implantation in Patients with CP

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Cerebral Palsy(CP)

Eligibility Criteria:
Inclusion Criteria:

* Children with spastic cerebral palsy of spastic paraplegia or quadriplegia involving the two side occurred at birth or before birth
* Age : 36 months - 12 year, males and females
* Subjects who understand and sign the consent form for this study
* Kaufman Assessment Battery for Children 50\<K-ABC\<100

Exclusion Criteria:

* The last three months had seizures or epilepsy patients taking the durg
* Genetic Diseases
* Recent cancer patients within 1 year
* patients witn a psychiatric disorder that may interfere in the clinical trial
* participating another clinical trials within 3 months
* Recently there is a change of the abrupt symptoms within three months of the patient
* Subjects with a infectious disease include HIV and VDRL
* Patients who penicillin hypersensitivity reactions
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Ketamine Treatment Plans for Chronic Conditions

A study aimed to assess the efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the study plan of those with chronic conditions who are receiving ketamine.

Ketamine can be administered in multiple ways (IV, IM, SubQ, and Sublingual, among others), and there have been few if any, studies that have compared the impact of Ketamine at home without any thearpy.

The study will identify other treatment modalities used in concurrence with Ketamine. Psychotherapy, music therapy, and acutherapy are some of the most popular. How do these adjunct therapies affect the outcomes of Ketamine treatments?

Secondarily, the study will focus on these significant issues to observe the impact of Ketamine treatments and suicidal ideation. Suicidal ideation is multifaceted and is one reason for prescribing off-label Ketamine. Chronic issues such as depression, pain, and anxiety have been identified as underlying causes and may be improvable with Ketamine.

Eligibility Criteria:
Inclusion Criteria:

Must have an identifiable chronic condition.

Exclusion Criteria:

Healthy population
An Analysis of Blood Management in Patients Having Hip or Knee Arthroplasty

The main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospital

The main objective of this study is to examine the transfusion rate and appropriateness in patients undergoing elective knee and hip replacement surgery at Siriraj Hospita by reviewing data from previous medical records (retrospective chart review).

Eligibility Criteria:
Inclusion Criteria:

* Patients Having elective Hip or Knee Arthroplasty in Siriraj Hospital

Exclusion Criteria:

* none
Case Notes Review on Patients With Hereditary Haemorrhagic Telangiectasia

This observational study is for individuals with Hereditary haemorrhagic telangiectasia and pulmonary arteriovenous malformations that are reviewed at the Hammersmith Hospital, London.

The Hammersmith Hospital provides a clinical service for patients with Hereditary haemorrhagic telangiectasia and pulmonary arteriovenous malformations that is unique in the United Kingdom. Measurements obtained as part of standard clinical practice that has evolved since 1985 allow us to assess whether particular groups of individuals that we see are more prone to recognised complications such as strokes, brain abscesses, pregnancy related complications or pulmonary hypertension. We hypothesise that certain clinical characteristics will predict the susceptibility of individuals to particular complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending Hammersmith Hospital

Exclusion Criteria:

* None
Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).


Eligibility Criteria:
Key inclusion criteria:

* A diagnosis of recurrent symptomatic paroxysmal or persistent AF
* Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Key exclusion criteria:

* Long-standing persistent AF (sustained \>12 months)
* Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
* History of thromboembolic events within the past six months
* Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
* Any cardiac surgery within the previous six months
* Prior left atrial ablation or surgical procedure
* Presence of an implanted cardiac device
* Body mass index (BMI) \>40 kg/m\^2
* Left ventricular ejection fraction (LVEF) \<35%
* Anterior-posterior left atrial (LA) diameter \>55mm
The Role and Dynamics of Liver Dysfunction in Patients Undergoing Cardiac Surgery

The aim of the present study is the evaluation of the occurrence and effect of hepatic dysfunction on outcome following cardiac surgery, as well as the monitoring of changes in liver haemodynamics in the early postoperative period.

Prospective, consecutive study of patients undergoing cardiac surgery in Heart and Vascular Center, Semmelweis University, Budapest.

Registered data:

* Anamnestic and demographic data
* Liver dysfunction prior surgery, etiology of liver dysfunction
* Perioperative clinical data: laboratory tests, imaging, haemodynamic measures
* risk prediction score of the American Society of Anesthesiologists(ASA), EUROpean System for Cardiac Operative Risk Evaluation (EuroScore), Acute Physiology and Chronic Health Evaluation II (APACHE II), Simplified Acute Physiology Score (SAPS II), Canadian Cardiovascular Society grading of angina pectoris (CCS)
* Model for End-Stage Liver Disease (MELD), MELD excluding International Normalised Ratio (INR) (MELD-XI), modified MELD score (modMELD), Child-Pugh

The occurrence and etiology pattern of hepatic impairment are going to be evaluated according to age and type of cardiac illness. Correlations between perioperative haemodynamical alterations and structural, functional changes in hepatic status will be investigated.

The impact of hepatic impairment on surgical outcome is going to be examined by multivariate regression models.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age admitted for elective cardiac surgical procedures

Exclusion Criteria:

* Not willing to participate.
* Pregnant women.
* During active psychiatric hospital care.
* Patients with defined legal incapability or limited capability.
* Non-evaluable patient due to insufficient clinical information
* Patients with a transplanted heart.
Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes

Heat Intolerance (HI) is a life threatening deficiency that can lead to heat exhaustion, heat stroke (and possibly death) in a large number of military and civilian occupational groups. We have demonstrated malfunction of transcriptional pathways in the heat stressed HI phenotype and an altered gene expression profile compared to Heat Tolerant (HT) individuals. Such differences are evident even under normothermic basal/comfort conditions. Heat and exercise challenges during the heat tolerance test (HTT) further emphasize the differences between the groups, particularly during recovery at comfort temperatures. Our results indicate that it may be possible to identify markers of heat intolerance. To achieve this goal, we plan to design a cellular (lymphocyte) HTT experimental model and detect gene expression profiles using customized DNA microarrays and bioinformatic tools (the genes selected will be based on our previous DNA microarray studies). Lymphocyte samples collected from HT and HI individuals under resting/comfort conditions will be examined. Treatments and analyses are designed to reveal HI-associated gene-expression profiles (constitutive or inducible), and thereby find lymphocyte markers to identify individuals predisposed to heat injury. The identification of such subjects could prevent unnecessary loss of life. Notably, the rapidly changing climate in our era increases the number of occupation/age groups in which manifestations of HI will appear.


Eligibility Criteria:
Inclusion Criteria:

* Experienced heat exhaustion or heat stroke in their past
* Participating in heat tolerance tests (HTT)

Exclusion Criteria:

* Unambiguous result of the HTT
* HTT stop by the subject decision
Family-centered Round in Neonatology

The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. In France, parents are rarely actively involved in the medical round. The aim of this study is to plan the implantation of the Family-centered round in a neonatal department using the 6 steps of the "Intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; Curriculum development; 5- adoption and implementation; 6- evaluation and dissemination


Eligibility Criteria:
Parents Group:

Inclusion Criteria:

* French speaking
* voluntary to participate
* parents of an hospitalized newborn

Exclusion Criteria:

* not fluent in French speaking
* mental health problems

Professional group:

* any staff member
* voluntary to participate