cyrilzakka/clinical-trials huggingface dataset:
Global Hemostasis Monitoring by Using Sonoclot Signature in Traumatic Patients

1. Analyzing the effects of severe trauma using sonoclot analyzer (which depicts the entire hemostatic pathway) ,subsequently describing the convenient therapy .
2. Assessing the correlations between sonoclot variables and conventional coagulation and platelet function tests

Coagulopathy is a physiological response to massive bleeding that frequently occurs after severe trauma and is an independent predictive factor for mortality\[2\]. . There are two of the major causes of coagulopathy in trauma patients

1. coagulopathy secondary to hemorrhagic shock due to massive bleeding and
2. coagulopathy secondary to severe head injury\[3\] which results in release of tissue factor from damaged brain tissue.

Therefore, it is very important to grasp the coagulation status of patients with severe trauma quickly and accurately with objective indicator in order to establish the therapeutic strategy .

The importance of viscoelastic devices in understanding the disease condition of patients with traumatic coagulopathy has been widely recognized in Europe. Viscoelastic hemostatic assays devices have practical advantages as point-of-care devices for monitoring major hemorrhage including speed of results and a set of parameters that assesses a global coagulation profile .

Also In the USA, Massive Transfusion in Trauma Guidelines proposed by the American College of Surgeons in 2013 presented the test results obtained by the viscoelastic devices, as the standard for transfusion or injection of blood plasma, cryoprecipitate, platelet concentrate, or anti-fibrinolytic agents in the treatment strategy for traumatic coagulopathy and hemorrhagic shock .

However, some studies have reported limitations of these viscoelastic devices

Eligibility Criteria:
Inclusion Criteria:

* -Patients \>18 years.
* Both sexes will be included.
* Recent trauma

Exclusion Criteria:

* -patients \<18 years.
* Patients with documented evidence of coagulopathy or bleeding diocese .
* Patients with liver disease.
* Pregnant women
The Chloroquine for Influenza Prevention Trial

A randomised controlled trial to determine the efficacy of chloroquine for the prevention of influenza


Eligibility Criteria:
Inclusion Criteria:

* Age 18 -65
* Have the ability to provide informed consent
* If a woman of child-bearing potential, willing to use contraception for the period of the trial

Exclusion Criteria:

* Acute influenza-like illness at screening
* History of psoriasis, porphyria cutanea tarda, epilepsy, myasthenia gravis, myopathy of any cause, cardiac arrhythmias, or serious hepatic or renal disease
* Pregnancy or breast feeding
* Current use of medication with known serious hepatotoxic effects
* Current use of medication with known serious interaction with CQ: amiodarone, anticonvulsants, ciclosporin, digoxin, mefloquine, moxifloxacin
* Current severe depression (as indicated by current use of antidepressant medication)
* Known serious retinal disease
* Current or recent (within the past 30 days) participation in any other clinical intervention trial.
* Known G6PD deficiency
* Vaccination for influenza (seasonal or H1N1 strain) within the 3 months prior to screening
Perioperative Risk Factors of Outcomes for Cardiac Surgery: A Retrospective Study

Based on a review of about 10,000 patients undergoing cardiac surgery under CPB in West China Hospital of Sichuan University and the Second Affiliated Hospital of Zhejiang University, we try to evalute the effect of blood transfusion on outcomes in cardiac surgery.

Based on a review of about 10,000 patients undergoing cardiac surgery under CPB in West China Hospital of Sichuan University and the Second Affiliated Hospital of Zhejiang University, the following results were obtained:

1. Perioperative risk factors of death and complications of different organ systems after cardiac surgery, providing evidence for early prevention and intervention;
2. Risk factors of blood transfusion risk were analyzed to provide ideas for reducing intraoperative blood transfusion;
3. The relationship between hemoglobin and complications after heart surgery was explored to provide a factual basis for the development of blood transfusion indications for such patients

Eligibility Criteria:
Inclusion Criteria:

* The patients in the west China hospital of sichuan university (July 01, 2011, solstice during June 30, 2017) and the second affiliated hospital of zhejiang university (September 01, 2013, solstice, June 30, 2017) have cardiac surgery under Cardiopulmonary bypass (CPB)

Exclusion Criteria:

* No
Tissue Procurement Substudy for Participants in Study CP-MGA271-01

The purpose of this study is to gain a better understanding about how the study drug MGA271 works. No test drug will be given in this study. Patients with easily accessible tumors at the screening visit for participation in Study CP-MGA271-01 will be asked to participate in this substudy. Patients will undergo two excisional biopsies, punch biopsies, or core needle biopsies.

Patients with easily accessible tumors (generally, metastatic deposits involving skin, subcutaneous tissues, or peripheral lymph node whose excision would not require general anaesthesia or the invasion of a body cavity) at the screening visit for participation in Study CP-MGA271-01 (the main study) will be asked to participate in this substudy. After providing appropriate informed consent, patients will undergo excisional biopsy, punch biopsy, or core needle biopsy of the accessible tumor prior to receiving study drug in the main study and then again after the first cycle of study drug is completed.

Some of the biopsy tissue will be sent to a central laboratory for research purposes. The central lab will analyze the tissue to see what effects that the study drug might have on tumors.

Eligibility Criteria:
Inclusion Criteria:

* Qualified, by meeting all inclusion and exclusion criteria, for participation in Study CP-MGA271-01.
* Must have provided informed consent to participate in Study CP-MGA271-01.
* Must have accessible tumors (generally speaking, metastatic deposits involving skin, subcutaneous tissue, or peripheral lymph node whose excision, punch biopsy, or core needle biopsy would not require general anaesthesia or the invasion of a body cavity).
* Willing to undergo two minor surgical procedures with no expectation of personal benefit
* Have provided Informed Consent for this substudy as indicated by a signature on an approved consent document obtained from the patient or his/her legally authorized representative

Exclusion Criteria:

* Any medical condition that would contraindicate the use of local or locoregional anaesthesia, or conscious sedation for the intended minor surgical procedure.
* Any medical condition (eg. skin disease or bleeding diathesis) that would hinder wound healing following a minor surgical procedure.
* Dementia or altered mental status that would preclude understanding and rendering of informed consent.
Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy

This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.

Our first aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor push-off power and range of motion compared to standard (physician prescribed) AFOs during walking in CP.

Our second aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor muscle activity while maintaining improved posture compared to standard AFOs during walking in CP.

Our third aim is to validate the need and usability of real-time stiffness adjustment during play and school activities; obtain feedback from the children, their parents, and orthotists to design the MVP.

Eligibility Criteria:
Inclusion Criteria:

* Age between 8-35 years old, inclusive
* Diagnosis of cerebral palsy (CP)
* Gross motor functional classification score level I, II, or III
* Physician-prescribed AFOs of common design (i.e., rigid molded thermoplastic)
* Ability to walk for 6 minutes on a treadmill
* At least 20° of passive plantar-flexion range of motion
* No concurrent treatment other than those assigned during the study
* No condition other than CP that would affect safe participation
* No surgery within 6 months of participation.

Exclusion Criteria:

-Excessive knee flexion during walking caused by CP
Post Splenectomy Infections After Surgery for Peritoneal Malignancies (OPSI)

The spleen is involved in maintaining immunity and plays an important role in the elimination of encapsulated bacteria and parasites. Patients who undergo splenectomy in conjunction with complete CRS for peritoneal malignancy are at risk of overwhelming post-splenectomy infections post-operatively. These patients are therefore administered vaccinations to lower the risk of infections but as they do not completely eliminate the risk, patients are also prescribed prophylactic antibiotics without clear evidence that they are useful in preventing OPSI. The use of prophylactic antibiotics is not without risk with potential short and long-term risks including resistance, interaction with other medication, clostridium difficile infections, fungal infections, other changes to the microbiome and cost. This study will investigate the incidence of OPSI post splenectomy and assess compliance with prophylactic antibiotics. This is an observational study where consented patients will be telephoned at fixed time points which are 1,6,12 weekly and 6 monthly for a period of five years post-operatively. As part of routine care patients will be telephoned by the clinical nurse specialist at weeks 1,6 and 12. In addition to this the research nurse will telephone the patient 6 monthly for a period of 5 years and complete a questionnaire. The research nurse will complete the questionnaire during each telephone call and this should not take more than 20 minutes. At the start of the telephone call, consent will be confirmed each time and the research nurse will check that the patient is still happy to participate before going ahead.


Eligibility Criteria:
Inclusion Criteria:

- Patients aged \>18 and \<80 years Patients capable of providing informed consent Patients who have a splenectomy in conjunction with complete cytoreductive surgery (CRS) for any pathology

Exclusion Criteria:

- Patients who are \<18 and \>80 Patients who do not provide informed consent Patients on immunosuppression therapy
The Impact of COVID-19 Outbreak on Trans-population's Health in Italy

During the COVID-19 outbreak, it was necessary to remodel the healthcare offer for all categories of subjects in order to minimize unnecessary movements of people while maintaining an adequate level of assistance. This is also true for transgender people, who are periodically requested to come into the clinic for hormonal therapy monitoring and continuation. In our center telemedicine programs dedicated to users have been activated for the remote management of hormone therapy.

We use a web-based survey to assess the impact of COVID-19 outbreak on trans-population health and to assess the specific needs of this population in this particular moment.

Use of a dedicated web-based anonymous questionnaire to assess health needs of trans-population during COVID-19 outbreak and to assess specific risk factors for COVID-19 infection.

Evaluation of physical and psychological wellbeing of the trans-population during COIVD-19 outbreak in Italy using anonymous validated questionnaires (SF12, IES-R and BECK DEPRESSION INVENTORY)

Eligibility Criteria:
Inclusion Criteria:

* transgender subjects
* age \> 18 years

Exclusion Criteria:

- none
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.

Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF).

In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFpEF and T2D.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* LVEF \> 40 %
* a clinical diagnosis of HFpEF and/or left ventricular hypertrophy (posterior wall thickness \> 12 mm) and/or previous myocardial infarction
* age ≥ 18 years old,
* one of the following criteria (a-d) should be fulfilled:

  1. Echocardiographic signs of diastolic dysfunction E/e' \> 8
  2. Septal e ́\< 7 cm/s and/or lateral e ́ \< 10 cm/s
  3. Left atrium volume index ≥34 mL/m2 and/or left atrial diameter \> 4 cm
  4. NT-proBNP \> 125 pg/ml.

Exclusion Criteria:

* Insulin treatment, inability to give informed consent
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.

The purpose of this study is to evaluate the safety and performance of the ProstaCare System in relieving symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia.


Eligibility Criteria:
Key Inclusion Criteria:

* 45 years of age or older with a diagnosis of BPH,
* International Prostate Symptom Score (IPSS) of 12 or greater,
* Prostate volume between 25 cm3 and 55 cm3,
* Uroflow with peak flow rate (Qmax) no greater than 13 ml/sec with a corresponding voided volume of at least 100 ml and a post void residual (PVR) of 250 ml or less.
* Prostate length, width and height must be at least 3.2 cm, 3.5 cm and 2.5 cm, respectively

Key Exclusion Criteria:

* Obstruction due to an enlarged middle lobe, central gland or significant transverse asymmetry,
* Subjects on 5 alpha reductase inhibitors (5-ARI) (inclusion only if washed out prior to treatment),
* Subjects on alpha blockers (inclusion only if washed-out before treatment),
* Active urinary tract infection at time of treatment,
* Interest in maintaining fertility,
* Past history of urologic surgery or minimally invasive treatment for BPH,
* History of or current medical conditions contraindicating elective urological procedures.
Postoperative Systemic Corticosteroids When Utilizing a Steroid-Eluting Spacer Following Endoscopic Sinus Surgery

Chronic rhinosinusitis (CRS) is an inflammatory condition of the nose and sinuses. It affects about 5 to 10% of Canadians. Patients suffer from congestion in the nose and sinuses, nasal discharge, pressure in the face, and a reduced sense of smell. This affects people's enjoyment of life. Medical management uses sprays or pills to treat these symptoms but for some patients sinus surgery is needed. This type of surgery is called endoscopic sinus surgery (ESS).

There is no single correct approach to take care of patients after sinus surgery. Most experts would use a nasal spray and a short-course of oral steroid pills to reduce sinus swelling and minimize complications related to scarring.

"Steroid-eluting nasal spacers" are devices placed inside the sinus during surgery and slowly release topical steroids into the sinuses better than steroid sprays. These "spacers" have been shown to improve results following sinus surgery. When using these special "spacers", there may no longer be a need for oral steroid pills following surgery. This would help to avoid potential side effects associated with these medications.

The purpose of this study is to find out whether taking oral (systemic) steroid pills following sinus surgery is necessary to improve surgical results, now that steroid-eluting nasal spacers are commonly used during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult ( \> 18 years of age)
* CRS defined by 2007 Adult Sinusitis Guidelines19
* Electing endoscopic sinus surgery for the indication medically refractory CRS, as defined by having persistent symptoms despite the following "maximal medical therapy":

  1. Received 3 months of topical corticosteroid spray
  2. Received a 2 week course of a broad-spectrum antibiotic combined with a 2 week course of systemic corticosteroid
* Provide written informed consent
* Subject must be able to complete all study evaluations and HRQoL questionnaires written in English

Exclusion Criteria:

* Children (\< 18 years of age)
* Unable to complete questionnaires or clinical testing or cooperate with study evaluations in English.
* Unwilling to provide written, informed consent
* Patients who have not undergone previous "maximum" prescribed medical therapy
* Patients with suspected systemic inflammatory disease
Supplemental Oxygen and the Risk of Surgical Site Infection

This is a study to see whether increasing the oxygen concentration during and after a cesarean section decreases the infection rate.

This is a double-blinded prospective randomized,controlled trial to evaluate whether using a higher concentration of oxygen during and after surgery helps to decrease the wound infection rate in patients undergoing cesarean sections.

Eligibility Criteria:
Inclusion Criteria:

* mentally competent patients undergoing cesarean section under spinal or epidural anesthesia

Exclusion Criteria:

* fever/chorioamnionitis; GBS positive on antibiotics; immunocompromised / HIV patients; on antibiotics for any reason; general anesthesia; age less than 18 years custody patients stat cesarean section
Impact of a LCD on Metabolic Inflexibility and Cardiovascular Risk in Liver Transplant Patients

This study is looking to see how a 6-month low carbohydrate diet can affect the body's ability to use energy in addition to the affects it has on the heart and blood vessel health.

Weight gain often occurs following a liver transplant. This weight gain is problematic as it leads to many other health problems. The reasons of this weight gain are still poorly understood. To better understand weight gain, this study is looking to see how a 6-month low carbohydrate diet can affect the body's ability to use energy in addition to the affects it has on heart and blood vessel health.

This study will help researchers to better understand weight gain after a transplant. This knowledge will help doctors prevent weight gain after a liver transplant and therefore improve the health of liver transplant patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* At least 12 months after LT
* Obese (BMI \> 30kg/m2)

Exclusion Criteria:

* Acute cellular or chronic rejection within 3 months
* Post-LT liver or non-liver related malignancy
* Active viral hepatitis (B or C), autoimmune hepatitis
* Untreated biliary strictures or vascular complications (i.e. hepatic artery thrombosis)
* Poorly controlled Diabetes mellitus
* Relapse of alcohol abuse after LT
* Stage 5 Chronic Kidney Disease
* Current pregnancy
Impact of Nutrition Education on Knowledge and Beliefs About Dietary Supplements/Herbal Foods

A two session nutrition education intervention was administered to health professionals and non-health professionals in separate sessions. Nutrition knowledge status was evaluated with comparing the pre-test and post-test values.

The purpose of this study is to evaluate the efficacy of nutrition education intervention of health professionals and non-health professionals about the effectiveness of dietary supplements/herbal foods (DS/HF) in COVID-19. Study design is a cross-sectional study with an education intervention. This study was conducted through online video communication application. Overall, 106 health professionals and 110 non-health professionals completed the study. The education intervention was administered in two sessions, one week apart for both health professionals and non-health professionals separately. Knowledge level of nutrition and COVID-19 and beliefs about DS/HF in the prevention/treatment of COVID-19 were evaluated with a pre-test and post-test setting. Comparison of the groups before and after the intervention was implemented with the McNemar's test.

Eligibility Criteria:
Inclusion Criteria:

* being 18 to 65 years old
* using social media
* being able to understand Turkish

Exclusion Criteria:

* regular supplement use prior to COVID-19 pandemic
* having a chronic disease that requires dietary supplementation
Atrial Tachycardia as a Predictor of Atrial Fibrillation, Stroke and Mortality in Cryptogenic Stroke

There is few information about the association between supraventricular arrhythmia different from atrial fibrillation (AF) or atrial Flutter and the risk of stroke. In this study the investigators hypothesized that the presence of atrial tachycardia would lead to atrial fibrillation and recurrent stroke in patients hospitalized for cryptogenic stroke.

The investigators study the association of atrial tachycardia (AT), defined as four or more consecutive premature atrial beats, and AF, recurrent stroke and cardiovascular mortality in 192 consecutive patients hospitalized because of cryptogenic stroke. The follow-up was 12 months for all population

The investigators review all consecutive patients that were hospitalized from stroke in our hospital (Neurology department) between January 2010 and September 2013, and who had the diagnosis of cryptogenic stroke at discharge. All patients routinely underwent 24-hour ECG recording and an echocardiography during the hospitalization. The investigators have a global population of 210 patients who met these characteristics.

The investigators analyze the presence of atrial tachycardia in 24-hour ECG register in patients with cryptogenic stroke. The investigators consider atrial tachycardia as four or more consecutive atrial ectopic beats.

The investigators analyze baseline characteristics (cardiovascular risk factors, renal function, left atrial size _measured in M mode echocardiography in long paraesternal axis_ and total number of premature atrial complexes in the 24-hour ECG monitoring.

The patients are stratified according to the presence or absence of atrial tachycardia in 24-hour ECG data.

The investigators follow the clinical events (AF, recurrent stroke or death) of patients from the electronical medical data of general physician and the re-hospitalizations for recurrent ictus in our hospital (which is the reference hospital of the zone) and mortality during 12 months.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients that were hospitalized from stroke in our hospital (Neurology department) between January 2010 and September 2013, and who had the diagnosis of cryptogenic stroke at discharge

Exclusion Criteria:

* Patients with non-cryptogenic stroke
* Patients with haemorragic stroke
* Patients with terminal disease