cyrilzakka/clinical-trials huggingface dataset:
Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial

Wounds that are slow to heal (chronic) may be managed in different ways. In Ontario, care in the community for most of these is coordinated by the local Community Care Access Centre (CCAC). One or more health professionals might deliver treatment, individually or as part of a wound care team, with different members having different kinds of training (interdisciplinary team), which may or may not include wound care. Community treatment by interdisciplinary teams has been shown to be more effective and cost-effective for some long-standing health problems, but further scientific evidence is needed to determine if this is also true for chronic wounds.

This study compares the usual way chronic wounds are being managed in the community with a so-called "intermediate care" approach. In this study, intermediate care will involve health service providers following certain agreed-upon steps (evidence-based best practice) from first contact with the client through assessment, treatment, and on to referral to a hospital specialty wound care team, if needed.

For certain types of chronic illness, planning case management and providing care according to evidence-based guidelines (published methods that have been supported scientifically) results in better clinical outcomes and better cost-effectiveness. Wound management by interdisciplinary teams may have these advantages in both the community primary care setting and the hospital specialized care setting. Systematic review of the literature indicated that the evidence was incomplete to support implementation of an intermediate care model for community management of chronic wounds. Therefore, the Ontario Health Technology Advisory Committee recommended that a field evaluation be conducted to provide stronger evidence about the relative effectiveness, cost-effectiveness and feasibility of managing chronic wounds in the community using both standardized, comprehensive primary care and a systematic method of referral to a specialty, multidisciplinary team based in a hospital

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years of age) client with eligible wound type (not surgical, malignant or burns) referred to the Toronto Central CCAC for wound management.
* Client (or substitute decision maker) provides written, informed consent.
* Someone in client's home (or substitute decision maker) must be able to speak English.

Exclusion Criteria:

* Surgical wounds
* Burns
* Malignant wounds
* Clients who are designated palliative on CCAC referral form
TIMELY Prospective Study

Brief Summary:

Cardiac rehabilitation (CR) is a multi-factorial intervention, designed to limit the physiological and psychological effects of cardiovascular disease such as coronary artery disease (CAD), manage symptoms, and reduce the risk of future cardiovascular events. CR is a structured program not only addressing CAD but also comorbidities including hypertension, dyslipidemia, diabetes and obesity as well as other risk factors. CR aims at long-term lifestyle changes to reduce modifiable risk factors, and it's success depends on a large number of interacting variables including biological, psychological and social factors. Recently, the importance of patient-centered approaches to secondary prevention and CR success has been underlined but intra-individual factors and their interactions are not well understood. The TIMELY prospective study aims to collect high-resolution data for data mining and artificial intelligence machine learning models to identify dependencies between factors and predict favorable outcomes of CR. Data collection will include data documented during controlled center-based CR as well as remote-measurement of physical activity data, (central) blood pressure and pulse wave analysis as well as long-term ECG data during a 6-months period after discharge. Follow-up assessments will be performed at least at 6 months and at 12 months after discharge.

Main objectives of the study:

1. To examine uptake and adherence to a healthy lifestyle (i. e. adherence to CR guidelines in CAD) and the effects on long-term outcomes.
2. To identify potentially mediating mechanisms and predictive factors for long-term CR success in CAD.
3. To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR.


Eligibility Criteria:
Inclusion Criteria:

Coronary Artery Disease (CAD) patients after myocardial infarction (STEMI/NSTEMI) and/or angioplasty and/or Percutaneous Coronary Intervention (PCI) and/or coronary artery bypass graft surgery who participate in phase II Cardiac Rehabilitation (CR).

Exclusion Criteria:

* Incapability to give informed consent
* Conditions that prevent patients from participation in CR including unstable coronary or cerebrovascular conditions and acute infections
The Effect of Nefopam on Catheter-related Bladder Discomfort

In the present study, the investigators evaluated whether nefopam 20 mg reduce the catheter-related bladder discomfort in patients undergoing foley catheter insertion


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled to insert the catheter a new foley catheter more than 14 Fr in the operation site,
2. Adults 20 to 75years of age
3. American Society of Anesthesiologists Physical Classification 1,2 patients
4. Patients who pre-agreed to the study
5. Male patient

Exclusion Criteria:

1. Neurogenic bladder
2. Patients diagnosed with irritable bladder
3. study drug sensitive or contraindicated
4. Patients with central nervous system or neurological disorder (epilepsy, patients receiving MAO inhibitor)
5. Patients with urethral and prostate disorders
6. Patients with previous history of myocardial infarction
7. Patients with closed angle glaucoma
Bone Flap Osteomyelitis Following Craniectomy : Retrospective Evaluation of Clinical Presentation, Microbiological Diagnosis and Management

Osteitis of the cranial flap after craniectomy is an unknown complex osteoarticular infection and there are few data concerning its epidemiology, its risk factors, and its management.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cranial flap osteitis after craniectomy
* Patients who did not object to participating in the study
* Adult patients

Exclusion Criteria:

* NA
The Effects of Early-life Environmental and Behavioral Factors on Child Growth and Development

The Shanghai Sleep Birth Cohort Study (SSBC) is a prospective observational study investigating the sleep condition of women in their third trimester and children from the age of 42 days to 6 years. Both subjective and objective tools were used to assess different sleep characteristics, including sleep duration, sleep rhythm and sleep quality. From August 2012 to June 2013, total 277 pregnant women from the eastern division of Renji Hospital in Pudong New Area, Shanghai were included in the study. Demographic information, physical examination, developmental and psychiatric assessment, diet and physical activity, as well as biological samples were collected for further analysis. Main findings of the current study showed the effect of sleep disturbances during the third trimester on emotional regulation and the influence of different sleep characteristics on children's social-emotional development


Eligibility Criteria:
Inclusion Criteria:

* Long-term resident in Shanghai, and no relocation plan for 2 years
* Ultrasonography indicated singleton pregnancy at 34-36 weeks
* Willingness to participate in the study and engage in the follow-up at the specified time
* Neonates were included if they were partus maturus

Exclusion Criteria:

* Preterm labor symptoms during pregnancy
* Gestational hypertension or gestational diabetes mellitus
* Heart, liver, and kidney disease
* Apgar score was 7 or below at 1 minute or 5 minutes with history of asphyxia at birth
Human Amniotic Membrane to Decrease Post Operative Atrial Fibrillation

This study will evaluate the application of hAM at the time of cardiac surgery to decrease inflammation and the subsequent substrate to reduce incidence of post-operative atrial fibrillation. Patients will randomized 1:1 to receive either hAM application or standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary elective CABG at the University of Utah Hospital
* Ability to provided informed consent and follow-up with protocol procedures

Exclusion Criteria:

* Patients in AF at the time of surgery
* Prior history of sternotomy
* Prior history of pericarditis
* Currently on aggressive antiarrhythmic therapy (does not include beta blockers)
* Patients with an implantable cardiac device (pacemaker, ICD, CRT-D)
* Ejection fraction \<45%
Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction

This will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms and signs of congestive heart failure
* Recent Imaging Study (\<12 months) showing Left Ventricular Ejection Fraction (LVEF) \>50% and Left Ventricular End Diastolic Volume Index (LVEDVI) \<97ml/m2
* Evidence of abnormal Left Ventricular (LV) relaxation, filling, diastolic distensibility, and diastolic stiffness as shown by one of the following:

  1. Invasive Hemodynamic measurements

     * mean Pulmonary Capillary Wedge pressure (mPCW) \>12
     * Left Ventricular End Diastolic Pressure (LVEDP) \>16 mmHg
  2. Tissue Doppler Echocardiogram

     * E/E' \>15
     * E/E' 8-15 and one of the following

       * Left Ventricular Hypertrophy (LVH)
       * Atrial Fibrillation
       * Left Atrial Enlargement
       * E/A \<0.5 + Deceleration Time (DT) \>280 (if \>50yrs of age)
  3. Biomarkers
* Brain Natriuretic Peptide (BNP) \>200pg/mL

Exclusion Criteria:

* Age \<18
* Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme \[ACE\] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
* Hospitalization for worsening Heart Failure (HF) or acute decompensated HF within the previous 12months
* Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD)
* Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing
* Active infection including chronic infection
* Active cancer
* Recent (\<14 days) use of anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs \[NSAIDs\]), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study
* Pregnancy (determined by urine pregnancy test in women of childbearing potential)
* Inability to give informed consent
* Other conditions limiting completion of cardiopulmonary exercise test or completion of the study
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction

Ketamine is a commonly used anesthetic medication which is used for induction of anesthesia as well as as an analgesic. It has been shown to have anti-inflammatory properties which may decrease post-operative complications following cardiac surgery with cardiopulmonary bypass that are thought to associated with inflammation. Some studies have shown that ketamine does decrease these complications when compared with anesthetics that are not commonly used in our cardiac anesthesiology practice. Propofol is another commonly used anesthetic medication which is used for induction of anesthesia. Ketamine has not been compared with propofol for potential to reduce post-operative complications associated with the inflammatory process. This study aims to see if ketamine will reduce the incidence of cognitive dysfunction, delirium, and renal dysfunction in comparison with propofol. In addition, the hemodynamic impact of ketamine compared propofol will be investigated.


Eligibility Criteria:
Scheduled to undergo cardiac surgery.

Inclusion criteria:

* age greater than or equal to 75 years presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota;
* schedule to undergo complex cardiac surgery. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and CABG procedures.

Exclusion criteria will include:

* left or right ventricular assist device implantation or explantation,
* procedures not requiring cardiopulmonary bypass,
* active infection or sepsis, severe hepatic disease or ascites,
* pre-operative renal dysfunction including a baseline creatinine equal to or greater than 1.5 mg/dL or requiring dialysis,
* immunosuppressive medication use (including steroid use),
* immunodeficiency syndrome,
* known neurologic or psychiatric disorder, or
* use of drugs for psychosis.
Antiviral Activity of Oral Probiotics

The aim of this study is to test saliva samples obtained from healthy human participants for anti-viral activity after they have consumed S. salivarius probiotic in a powder format.

This is a randomized controlled open pilot study to evaluate saliva samples collected from participants following their consumption of powders containing the commercially marketed probiotic bacterium S. salivarius K12 or S. salivarius M18.

Participants will be randomly assigned to one of the 4 groups consuming probiotic powder containing Streptococcus salivarius K12 or S. salivarius M18 with or without prebiotics (e.g. sugars that may promote probiotic activity). Saliva samples will be collected at predetermined time points pre and post intervention. Antibacterial and Antiviral activity will be determined following established assays. Colonisation efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Eligibility Criteria:
Inclusion criteria:

1. In general good health 18 - 80 years of age.
2. Practice good oral hygiene.

Exclusion criteria:

1. Have a history of autoimmune disease or are immunocompromised.
2. Are on concurrent antibiotic therapy or regular antibiotic use within last 1 week
3. History of allergy (e.g. dairy).
Patients With Acute Renal Failure During Severe COVID-19

The occurrence of renal failure during severe forms of COVID-19 is common (20-35% of patients treated in intensive care) and associated with an unfavorable short-term prognosis, but the medium-term renal outcome is not is not known.

The aim of the study is to establish the frequency of chronic kidney failure after AKI KDIGO 2 and 3 occurring during severe COVID-19 in intensive care.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Subject hospitalized in an intensive care unit, Strasbourg, Nancy or Reims hospitals, for severe COVID-19 between February 1, 2020 and July 31, 2020.
* Having presented acute renal failure KDIGO 2 (assessed on a doubling of serum creatinine compared to the patient's reference values) or 3 (serum creatinine greater than 3 times the patient's reference, or anuria, or any recourse to extra-purification renal)
* Having left hospital alive after initial treatment for COVID-19
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice
A Study of Abatacept in Japanese Patients With Active Rheumatoid Arthritis While Receiving Methotrexate

The purpose of this study is to demonstrate that Abatacept combined with Methotrexate will demonstrate a dose response efficacy in Japanese subjects with active Rheumatoid Arthritis similar to the dose response efficacy previously observed in the International clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* patients with active Rheumatoid Arthritis while on methotrexate having 12 tender and 10 swollen joints at randomization

Exclusion Criteria:

* no current infection or other evolutive or uncontrolled disease
A Study to Compare the Efficacy of Alendronate With and Without Calcium or Calcium Alone In the Treatment of Osteoporosis in Postmenopausal Women (0217-088)(COMPLETED)

The purpose of this study is to see how well alendronate and calcium as compared to calcium alone increase bone density in postmenopausal women with osteoporosis


Eligibility Criteria:
Inclusion Criteria :

* Patient is postmenopausal (or surgically menopausal) for at least 5 years.
* Patient must be diagnosed with osteoporosis
* Patient has spinal anatomy suitable for DEXA of the lumbar spine

Exclusion Criteria :

* Patient is receiving or has received treatment prior to randomization which might influence bone turnover
* Patient has a history of or evidence for metabolic bone disease (other than postmenopausal bone loss)
* Patient is receiving or is expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism
Quality of Life in Colorectal (ex-)Cancer Patients, Based on the Belgian Cancer Registry.

This study is collecting data on quality of life, (care)needs and socio-economic factors in colorectal (ex-)cancer patients via a written questionnaire completed by the patient him/herself. The collected data will be linked with the patient- and tumour characteristics available in the database of the Belgian Cancer Registry and with the facturation data supplying information about diagnostic techniques and performed treatments (available via the insurance companies).

Based on the selection criteria, 1220 patients were finally selected from the database of the Belgian Cancer Registry. These patients received an invitation letter by regular mail, a detailed questionnaire and an informed consent.

The questionnaire contains topics as sociodemographic, life style, comorbidity, satisfaction with the provided information, care needs, quality of life, anxiety and depression, financial situation etc.

The patients were asked to complete the questionnaire and send it back, together with the signed informed consent, to the study-collaborators.

After 2-4 weeks, a reminder was sent. At that time, a reply card was added. If a patient doesn't want to participate in this study, a reason can be mentioned on the reply card.

The collected data are linked with the clinical data. The dataset will be coded before analyses will start.


Eligibility Criteria:
Inclusion Criteria:

* Invasive colorectal cancer (ICD-10: C18-C19-C20)
* Patient knows his/her diagnosis of cancer
* Incidence in 2008, 2009 or 2010
* The patient is at least 18 years at diagnosis
* The patient is maximal 90 years when completing the questionnaire
* The patient lives in Flanders and speaks Dutch
* The patient is treated/followed by 1 of the 7 participating hospitals
* The patient is able to complete the questionnaire him/herself (no cognitive problems)

Exclusion Criteria:

* More than 1 invasive tumour diagnosed
Evaluation of Microinvasive Glaucoma Surgery: MINIject® Versus Hydrus® Microstent in Combination With Cataract Surgery

The study aims to investigate postoperative outcomes after two different MIGS implants (MINIject or Hydrus) in combination with cataract surgery for patients with glaucoma.

The study aims to investigate postoperative outcomes in terms of intraocular pressure as well as safety measures after two different MIGS implants (MINIject® or Hydrus®) in conjunction with cataract surgery (CS) for patients with chronic glaucoma. The patients will be followed up for 5 years after the date of their implantation. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination and ocular imaging with OCT (Optical Coherence Tomography). Assessment of life quality as well as adverse events will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with glaucoma in which surgery is indicated to reach target intraocular pressure as well as lens opacities where CS is indicated
* Clinically eligible for both surgeries
* Subjects not anticipated to require any further surgery in the next 12 months
* Patients' age \> 18 years

Exclusion Criteria:

* Patients who do not want to make follow-ups at the department
* Angle closure, uveitic, neovascular, congenital glaucoma, iridocorneal endothelial syndrome, Axenfeld-Rieger syndrome
* Prior filtering glaucoma surgery, suprachoroidal stent, retinal surgery, corneal graft surgery or cyclophotocoagulation
* Allergy to any drugs or substances required for the protocol
* Pregnant women
Accuracy Assessment of a Novel Gas Detection Approach in Dyslipidemia Diagnosis

This study aims to validate the feasibility and accuracy of a novel gas detection method for dyslipidemia screening by analyzing the lipid profile of human breath metabolites. It explores a simple, rapid, and non-invasive method for screening dyslipidemia. The application prospects of this method are broad; it can be used not only for early screening and monitoring of dyslipidemia in hospitals and communities, providing strong support for the prevention of cardiovascular diseases, but also for the routine monitoring and treatment effectiveness evaluation of patients with hyperlipidemia, offering a scientific basis for personalized treatment plans. This study not only has profound scientific value but also provides a theoretical basis for the development of subsequent new clinical testing methods.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Voluntarily signed the informed consent form

Exclusion Criteria:

1. Patients with lung cancer, asthma, chronic obstructive pulmonary disease, pulmonary cystic fibrosis, or acute respiratory distress syndrome
2. Women who are pregnant or breastfeeding
3. Patients with chronic kidney disease (GFR \< 60 ml/min) or cirrhosis
4. Individuals unable to cooperate with the collection of exhaled gas samples
Anesthesia Management in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy

A combined approach of cytoreductive surgery (SRC) and hyperthermic intraperitoneal chemotherapy (HIPEC) represents a potential treatment option for patients diagnosed with primary or secondary gastrointestinal or gynaecological malignancies with peritoneal involvement. While the surgical phase of the operation macroscopically addresses the cancerous tissue, the HIPEC phase targets the microscopic tumour cells that remain after surgery (1). The surgical procedure known as SRC and HIPEC is one of the most complex surgical procedures, presenting numerous challenges for both the surgical and anaesthesia teams. The haemodynamic, haematological and metabolic changes that occur before, during and in the early postoperative period are associated with an increased risk of morbidity and mortality. It is therefore crucial for anaesthesia management to maintain normovolemia during surgery, compensate for hypothermia in the surgical phase and hyperthermia in the HIPEC phase, and maintain metabolic and haemodynamic balance throughout the entire procedure.

The objective of this study was to retrospectively examine the anaesthesia management and clinical outcomes in patients who underwent cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) in order to create literature information that can facilitate the early recognition and prevention of haemodynamic, haematological and metabolic problems that occur especially in the intraoperative and postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* patients with primary or secondary gastrointestinal or gynecologic malignancies with peritoneal involvement.
* Over 18 years of age

Exclusion Criteria:

* Over 80 years of age
* those with heart, lung and liver diseases