cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Severity of Venous Thromboembolism in a General Population During the COVID-19 Pandemic

The purpose of this study is to investigate the prevalence of venous thromboembolism in a regional health care system (Region Östergötland, Sweden) before and during the SARS-COV-2 pandemic. In a retrospective observational study, we will review patient data, diagnostic data and treatment data over a three-month period since the onset of the SARS-COV-2 pandemic. This data will be compared with data from the corresponding time frame during the years 2015 to 2019.

In the current SARS-COV-2 pandemic there is a concern about an increased risk of venous thromboembolism (VTE) concurrent with the infection, including both pulmonary embolism (PE) and deep venous thrombosis (DVT) (Klok et al. 2020; Cui et al. 2020; Helms et al. 2020; Leonard-Lorant et al. 2020; Poissy et al. 2020). International guidelines now recommend prophylactic anticoagulation for all hospitalized patients with a SARS-COV-2 infection in the absence of any contraindication (Thachil et al. 2020). The majority of the studies on VTE in SARS-COV-2 infections have been carried out in the ICU and show prevalence of VTE of between 20 and 30%.(Klok et al. 2020; Cui et al. 2020; Helms et al. 2020). This is a clear increase compared to the less than 10 % prevalence seen in other ICU patients (Muscedere, Heyland, and Cook 2007; Deborah Cook et al. 2005; D. Cook et al. 2000). However, a single center study on consecutive ICU patients with severe sepsis showed a prevalence of VTE of 37% (Kaplan et al. 2015) and another recent publication of patients with severe influenza A/H1N1 infection had a prevalence of VTE of 44% (Obi et al. 2019).

This raises the question whether the increase in VTE seen in recent publications of SARS-COV-2 infections is the result of the specific pathophysiology of the virus itself or the subsequent sepsis with multiorgan failure seen in most complicated and severe cases. The former would have large implications for patients treated outside the ICU and possibly outside hospitals (Thachil et al. 2020).

The aim of this study will be to investigate the prevalence of VTE in a regional healthcare system prior to, and during the SARS-COV-2 pandemic and the differences between ICU, hospitalized and outpatient cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Any patient that has done a Computer Tomography Angiography of the lungs between 1:st of March and 31:st of May each year from 2015 to 2020
* Any patient that has done a Ultrasound of the legs between 1:st of March and 31:st of May each year from 2015 to 2020
* Any patient with a new diagnosis of pulmonary embolism or deep venous thrombosis between 1:st of March and 31:st of May each year from 2015 to 2020

Exclusion Criteria:

* Incomplete diagnostic examination
* Follow-up examination of know acute VTE
* Primary investigation done outside the healthcare system
* Patient \<18 years of age
Perceived Impact of Art Therapy in Patients With Cystic Fibrosis and in Professional Interdisciplinary Teams Taking Care of Them.

Cystic fibrosis is so far a disease whose treatment remains essentially symptomatic care teams perceive the boundaries of a support mainly focused on drug treatments. The patient had no other choice but to learn to live with their disease, the goal is to make every effort so that tames the disease while maintaining high self-esteem that gives meaning to his life, allowing, among other things, a good grip of treatment.

Through this research we hope to encourage the integration of art therapy in the course of care of cystic fibrosis patients, from children to adults before and after transplantation, in connection with the patient education and counseling


Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis aged adolescents 13 to 18 years, as part of their monitoring at cystic fibrosis center of Nantes
* Adults over 18 years nontransplanted in their follow at cystic fibrosis center/transplantation center of Foch
* More than 18 adult transplant as part of their monitoring at cystic fibrosis center/transplantation center Foch
* Professional interdisciplinary teams taking care of the cystic fibrosis children center of Nantes, cystic fibrosis center/transplantation center of Foch
* Agreeing to participate in research

Non Inclusion Criteria:

* Patient refusal of adolescent parents to participate in the study
* Professional refusal of teams to participate in the study
Cesarean Niche Examination by Transvaginal us

The developed uterine scar developing due to cesarean section is usually clinically evaluated and visualized by transvaginal sonography (TVS) and saline infusion sonography (SIS) or Gel installation sonography (GIS)

In 2015, WHO displayed and reveled a systematic review of the research studies in the scientific literature to evaluate and asses the linkage and connection between cesarean section rates and maternal

Eligibility Criteria:
Inclusion Criteria:

- women with secondary infertility

Exclusion Criteria:

* obstructed labor, pregnant women having chronic diseases;
Individualized Anterior Cruciate Ligament Versus Conventional Reconstruction

A randomised prospective control trial comparing the efficiency of a more individualized approach in ACL reconstruction with the help of neuromuscular computer models with traditional ACL reconstruction practices.

Until now the ACL reconstruction was based on the surgeon's experience. An individualised ACL reconstruction is customized based on each patient's special characteristics. Preoperative and intraoperative evaluation of the native ACL (both anteromedial and posterolateral bundles), knee anatomy and function, level of activity and generalised ligamentous laxity are assessed. Femoral and tibial tunnels should be placed in their anatomical location accounting for both the native ACL insertion site and bony landmarks. Two groups will be created, one with patients undergoing ACL reconstruction based on a surgeon's experience and one based on a more individualised approach according to the particular characteristics of each patient separately. In addition, patients in the second group will undergo ACL reconstruction with the use of Computer Assisted System (Navigation).

Preoperatively and postoperatively, the patients will be assessed with the KT2000 system, the KOOS (Knee injury and Osteoarthritis Outcome), the Tegner- Lysholm Knee scoring system and the IKDC (International Knee Documentation Committee). Additionally, all patient will be examined for their knee function with the use of a 3D gait analysis system.

The follow-up examination will take place 6 and 12 months after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ACL rupture undergoing ACL reconstruction surgery with closed epiphyses, younger than 45 years old

Exclusion Criteria:

* No previous surgery in the knee (except partial meniscectomy), no major systematic pathology
Support for the Resumption of Training of High-level Athletes Post-epidemic COVID-19

As of March 2020, COVID-19 has become a global pandemic, halting athletic competition worldwide.

Reports from China show a high prevalence of cardiac involvement in patients with severe SARS-CoV-2 infection. These cardiac forms were found to be closely associated with adverse outcomes. The use of Magnetic resonance Imaging (MRI) had allowed to show that cardiac dysfunction could be mediated by myocardial inflammation (i.e. myocarditis). The direct implication of the virus was demonstrated with Severe Acute Respiratory Syndrome (SARS)-CoV-2 being detected on myocardial biopsies in a patient with severe heart failure.

The experience with other viruses causing acute myocarditis shows that there is a high rate of undetected injuries. Indeed, although severe heart failure can be present at the acute stage, acute viral myocarditis is most commonly pauci or asymptomatic, but still leaving occult myocardial scars visible on MRI, and exposing to higher risks of ventricular arrhythmia and sudden cardiac death over the long term.

Although athletes are younger and have fewer comorbidities than the general population and therefore are at lower risk for severe disease or death, there is a critical and urgent need to assess the prevalence of occult scars in the population of high-level athletes returning to training after the SARS-CoV-2 pandemia.


Eligibility Criteria:
Inclusion Criteria:

* High level athlete,
* Of both sexes and age ≥ 18 years,
* Affiliated to or beneficiary of a social security system,
* Free, informed, written consent signed by the participant and the investigating physician (no later than the day of inclusion and before any examination required by the research),
* Effective method of contraception for women with childbearing capacity.

Exclusion Criteria:

* Minor,
* History of ventricular arrhythmia, myocarditis, identified coronary artery disease or documented myocardial fibrosis,
* Pregnant or breastfeeding women,
* Person unable to give informed consent,
* Person deprived of liberty by judicial or administrative decision,
* Adults subject to a legal protection measure (guardianship, curator, safeguard of justice).

Specific exclusion criteria for the MRI component (Contraindications):

* Subject with an implantable pacemaker or defibrillator, intraocular metallic foreign body, intracranial metallic clip, pre 6000 Starr-Edwards type cardiac valve prosthesis, or biomedical device such as insulin pump or neurostimulator,
* Hypersensitivity to gadolinium or to one of the excipients of the contrast product used,
* Claustrophobic subjects or those unable to remain in an immobile lying position for 30 minutes,
* Renal insufficiency with creatinine clearance of less than 30 ml/min,
* A patient whose shoulder width does not allow installation in the MRI machine.
Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

This is a randomized clinical trial in U.S. Veterans to evaluate the impact of treatment for obstructive sleep apnea (OSA) on the effectiveness of cardiac rehabilitation, including impact on exercise capacity, disability, and quality of life.

Obstructive sleep apnea (OSA) is a highly prevalent condition in patients with coronary heart disease and is associated with impaired exercise performance, functional limitation and reduced health-related quality of life. The investigators hypothesize that identification and treatment of OSA in patients undergoing cardiac rehabilitation will improve the response to rehabilitation. The proposed study will test this hypothesis using a parallel group, randomized, clinical trial comparing OSA treatment with continuous positive airway pressure (CPAP) to an educational control group in patients undergoing cardiac rehabilitation who screen positive for previously undiagnosed OSA.

Eligibility Criteria:
Inclusion Criteria:

* Veterans referred for cardiac rehabilitation at the VA Boston Healthcare System.
* Moderate to severe OSA (AHI \>15) on home sleep testing.

Exclusion Criteria:

* Dangerous levels of sleepiness (Epworth Sleepiness Scale score \>16 or a report of falling asleep at the wheel of a car within the past 2 years).
* Physical limitation precluding exercise testing.
GMP Powdered Substitutes in PKU and TYR

Four new GMP-based protein substitutes have been developed to support the dietary management of PKU and TYR. These products are powdered protein substitutes, low in phenylalanine and low in phenylalanine and tyrosine respectively, with a mix of glycomacropeptide (GMP), essential and non-essential amino acids, carbohydrates, fibres, fats (including DHA) and micronutrients. The proteins in these new protein substitutes are based on GMP, a peptide isolated from milk during cheese manufacturing and the only known naturally derived protein source low in phenylalanine and tyrosine. The GMP is supplemented with other amino acids which are naturally low or not present in GMP, as well as carbohydrates, fats, fibre and micronutrients. Studies to date have illustrated that PKU patients who replace their regular phenylalanine-free amino acid-based formula with GMP-based foods may have better diet compliance and prefer the taste whilst maintaining metabolic control.

This series of case-studies aims to evaluate the gastrointestinal tolerance, acceptability, compliance, and safety of these four GMP based protein substitutes in both adults and children over 3 years. These case studies will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple specialist metabolic centres in the UK. A series of case studies is undertaken due to the rarity of these conditions, the diversity of patient types and the difficulty in recruiting these patients to trials.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Over 3 years of age
* Patients diagnosed with any phenotype of PKU characterised by hyperphenylalaninaemia or patients diagnosed with tyrosinaemia
* Have been compliant in taking at least one protein substitute, providing at least 15g protein equivalents, for at least 1 month prior to trial commencement
* Have a prescribed daily phenylalanine or phenylalanine and tyrosine allowance for PKU or TYR respectively
* Written or electronic informed consent from patient, and/or from parent/caregiver if applicable
* Participants who are anticipated to be able to take at least one sachet of GMP Product per day

Exclusion Criteria:

* Pregnant or lactating
* Requiring parenteral nutrition
* Major hepatic or renal dysfunction
* Participation in other studies within 1 month prior to entry of this study
* Allergy to any of the study product ingredients
* Investigator concern around willingness/ability of patient or parent/caregiver to comply with protocol requirement
Magnetic Resonance Myocardial Stress Perfusion in Pediatric Patients with Cardiovascular Disease

the goal of this observational study is to evaluate myocardial ischemia and myocardial microcirculation dysfunction in children with cardiovascular disease by myocardial stress perfusion imaging.

During their disease progress, participants will undergo myocardial stress perfusion, laboratory tests when hospitalization and follow-up, and the baseline data will be collected in the admission. all the above examination data will be analysed to identify early subclinical myocardial changes and evaluate the value of magnetic resonance myocardial stress perfusion in predicting prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with cardiovascular disease, including Kawasaki disease, anomalous origin of coronary artery, postoperative congenital heart disease.

Exclusion Criteria:

* Mental abnormalities or poor compliance ; heart, kidney and other important organs were seriously incomplete.
* MRI examination contraindications ; gadolinium contrast agent contraindications ; claustrophobia.
Stockholm Acute Kidney Injury Cohort

Since 2009, adult patients with acute kindney injury (AKI) at the department of Nephrology, Danderyd University Hospital and Karolinska Institutet, have been included in a prospective cohort. All patients were treated and evaluated according to a detailed clinical memorandum, and data collected prospectively.

By 2020, 1861 patiens have been included of which 1519 fulfill current AKI criteria (as defined by KDIGO AKI guidelines) and will be evaluated regarding the following main research questions:

1. Descriptive study on patient characteristics, changes in biomarkers and in-hospital outcome.
2. One year outcome with focus on renal and cardiovascular outcomes.
3. Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes.

Acure kidney injury (AKI) remains a complex clinical challenge associated with high risk for short-term and long-term adverse events. Since 2009 patients with AKI at the department of Nephrology, Danderyd University Hospital and Karolinska Institutet, have been included in a prospective cohort. Adult patients with either s-creatinine \>130 micromol/L and previously unknown level, or 30% increase from previous known level were included; patients on dialysis were not included. All patients were treated and evaluated according to a detailed clinical memorandum, and data collected prospectively.

By 2020, 1861 patiens have been included of which 1519 fulfill current AKI criteria and will be evaluated regarding the following main research questions:

1. Descriptive study on in-hospital outcome (death, renal recovery), patient characteristics, hyperkalemia and changes in biomarkers reflecting inflammation, acidosis and malnutrition.
2. One year outcome with focus on renal and cardiovascular outcomes (death, new dialysis, worsened renal function, myocardial infarction, stroke, or heart failure; MARCE).
3. Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes (MARCE).

Eligibility Criteria:
Inclusion Criteria (one of the following):

* Serum creatinine (sCr) \>130 µmol/l (1.47 mg/dl) at admission with previously unknown baseline,
* Increase in sCr by 30% from previous stable out-patient value.

Exclusion Criteria:

Ongoing dialysis treatment.
Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients

This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.


Eligibility Criteria:
Inclusion criteria:

* Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
* Female subjects only using acceptable birth control method
* Non-smokers
* FEV1 between 60 and 90% predicted
* Increase in FEV1 12% or greater and 300mL and greater after salbutamol use

Exclusion criteria:

* Past or present disease conditions
* Normal screening Holter ECG
* Respiratory tract infection within 4 weeks of screening
* History of life threatening asthma
* Previous use of COA
Effect of Arterial Cannulation on the Continuous and Non-invasive Hemoglobin Monitoring

The primary purpose of this study is to investigate the effect of arterial cannulation on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic gastrectomy under general anesthesia

Exclusion Criteria:

* atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease
Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain

This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 diabetes with painful neuropathy
* Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
* Meet pre-defined level of pain severity at entrance

Exclusion Criteria:

* History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
* Participated in a previous or ongoing pregabalin clinical trial
* Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain
Role of Oxytocin in Post-menopausal Osteoporosis: Evaluation on the Population of the OPUS Cohort

Oxytocin is a neurohypophysial hormone involved in several central and peripheral functions including parturition, milk let-down reflex and social behaviour. In vitro and animals studies have shown growing evidence that oxytocin plays a role in bone remodeling and osteoporosis. The investigators have previously show in a small sample of post-menopausal women with severe osteoporosis (n=20) compare to healthy control (n=16) that oxytocin serum level is significantly decreased, independently of leptin and estradiol, that are known to modulate oxytocin secretion. Thus, oxytocin appears as a new interesting factor in the osteoporosis pathophysiology. The aim of the present study is to confirm the relationships between bone status, evaluated by bone mineral density and prevalent fragility fractures, body composition and oxytocin serum levels on a large population. The investigators will also determine if the relationship between bone mineral density and oxytocin is independent of estradiol and leptin in this population and evaluate the relationships between oxytocin serum level and co-morbidities such as cardiovascular diseases, depression and dementia. Theses analysis will be done on the serum already available of 1000 women of the international OPUS cohort. Bone mineral density, body composition analysis by Dual energy X-ray Absorptiometry (DXA), estradiol and clinical data are already available. The investigators will select women, aged from 55 to 79 y at the time of inclusion.


Eligibility Criteria:
Inclusion Criteria:

* post-menopausal women,
* able to undergo bone density,
* without cognitive limitation,
* Age at the time of inclusion: 55 -79y,
* Written consent.

Exclusion Criteria:

* Individuals were excluded because of inability to undergo bone densitometry or perform specified investigations or because of cognitive limitations
Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency

A randomized placebo controlled trial to determine if increased dietary fiber will prevent weight gain, inhibit adiposity and reduce perceived stress levels in residents at the Waco Family Health Center as the result of changes in distal gut microbiota composition and function.

This study will utilize a single blind, placebo controlled, parallel design to assess the effect of dietary fiber \[Prebiotin\] on the gut microbiome, perceived stress, anthropometric variables, and clinical biomarkers of metabolism. All participants in this study will be resident physicians at the Family Health Center in Waco, TX. This population was selected based on pilot data indicating they are at a greater risk for weight gain and have higher levels of stress than the average population. The goal is to recruit 40 participants for a 12 week intervention trial.

Eligibility Criteria:
Inclusion Criteria:

* Currently a resident in training at the Family Health Center in their first year.

Exclusion Criteria:

* Pregnancy
* Currently on prescribed metformin or NSAIDS
* A diagnosed gastro-intestinal disease (i.e. irritable bowel syndrome or Crohn's disease)
* Known allergy to the supplement, placebo, or provided meal replacements
* Antibiotic use within the last 3 months.
Partner Assistance in Learning and Performing Skin Self-Examination

This study is a behavioral science study designed to identify aspects of the dyadic relationship that promote Skin Self-Examination (SSE) in patients at high risk of developing melanoma. The patient is randomized to receive the educational intervention either as a solo learner or with the partner.


Eligibility Criteria:
Inclusion Criteria:

* Personal or family history of melanoma. If a personal history of melanoma, the patient was treated at least 1 month ago
* Evidence of dysplastic nevus syndrome or a large number of moles (Greater than 50)
* Able to see to read a newspaper, can read at an eighth grade level
* Speaks English
* 18 to 70 years old with a spouse or cohabitating partner

Exclusion Criteria:

* Under 18 years of age
* Patient overburden by other co-morbid diseases such as chronic immunosuppression from organ transplantation
* Have insufficient vision to to read a newspaper
* Unable to read English
* Have insufficient cognitive skills to follow instructions provided at an eighth grade language level