cyrilzakka/clinical-trials huggingface dataset:
Precision Medicine for Prediction & Prevention of Early Pre-eclampsia

This study aims to evaluate the feasibility of implementing a clinical model for precision screening of early pre-eclampsia into the current prenatal screening service at Sunnybrook Health Sciences Center (SHSC).

Pre-eclampsia (PE) represents a pregnancy-specific systemic disorder that affects 3-8% of all pregnancies. In developed countries PE is considered a major public health problem responsible for severe maternal complications such as coagulopathy, renal and liver failure, stroke, and maternal death (\>76,000 maternal death annually).

The traditional approach to screening for preeclampsia endorsed by national guidelines is based on a combination of maternal characteristics along with medical, obstetric and family history.

However, although these methods are simple and easy to perform, maternal factors can only identify less than 35% of all preeclampsia and approximately 40% of preterm-preeclampsia at a false- positive rate of 10%.

More recently, multivariate analysis has been used to develop predictive models for preeclampsia that can be applied as early as 11-13+6 weeks gestation. One such algorithm, developed by the Fetal Medicine Foundation UK(MFM UK), incorporates maternal risk factors, uterine artery doppler, mean arterial pressure, and serum markers of placental function and placental growth factor. The FMFUK algorithm has been shown to predict approximately 75-90% of those women destined to develop preeclampsia prior to 37 and 34 weeks respectively, at a false positive rate of 10%. This algorithm has been validated prospectively in several studies, including the prediction of other placental mediated complications of pregnancy, such as fetal growth restriction and perinatal death.

The new clinical model will include the following additions to the existing first trimester screening for aneuploidy:

* Additional Clinical History
* Blood pressure measurements
* Ultrasound for uterine artery Doppler measurements
* Expanded prenatal screening requisition
* Quality assurance training of ultrasound technicians for the uterine artery doppler measurements
* Fetal Medicine Foundation validated risk calculation algorithm
* Communicate results of the risk calculation algorithm from NYGH to SHSC and participant health care providers.

While the ultimate goal will be to scale up and adapt this new clinical model, this protocol focuses on the feasibility of implementing the new clinical model at a single centre, Sunnybrook Health Sciences Centre.

Eligibility Criteria:
Inclusion Criteria:

1. Women with a singleton pregnancy \> 18 years old
2. Not on low dose aspirin
3. Carrying a live fetus with crown rump length (CRL) between 41 and 84mm
4. Able to provide informed consent
5. Having a nuchal translucency ultrasound

Exclusion Criteria:

1. Women with a singleton pregnancy \< 18 years old
2. Women currently taking low dose aspirin
3. Women declining a nuchal translucency ultrasound
4. Women unable to provide informed consent
5. Women with a multiple pregnancy
6. Women with a demised fetus or a CRL \<41mm and \>84mm
Evaluating of the Hospital Universitario de Canarias Massive Transfusion Protocol

Massive haemorrhage is defined as the necessity of 3 or more packed red blood cells in one hour, the transfusion of 10 packed blood cells, the loss of the half of the blood volume, the loss of 4-5 cc/kg/h or more, and haemorrhage shock.

Haemorrhage shock provokes changes in the bloodstream with celular and organic disfunction. In many cases massive transfusion is needed to stabilize the vital function. This massive transfusion can have serious side effects (infectious and immunologic and no immunologic reactions) and increase the morbidity and mortality.

Massive transfusion protocols improve the survival in severe trauma injury patients. The transfusion of fixed rate of packed red blood cells, fresh frozen plasma and platelet concentrates have decreased the severity of trauma induced coagulopathy.

Recently several studies have shown the benefit of massive transfusion protocols with high transfusion ratios (1:1:1 RBC:FFP:PLT) in mortality after severe trauma. So early and aggressive transfusion improve the outcomes and the resources.

Massive Transfusion Protocol have been elaborated in the Hospital Universitario de Canarias with high transfusion ratios (1:1:1 RBC:FFP:PLT) . The goals of this protocol is to reduce the variability in the clinic experience, to reduce the transfusion necessities and to assure an safe treatment with blood products.

So with this study the investigators will evaluate if the goals of this Protocol are followed and if the use of this Protocol is really safe and efficient.


Eligibility Criteria:
Inclusion Criteria:

* Patients with massive haemorrhage and surgery
* Informed consent

Exclusion Criteria:

* \<18 years old patients
* Patients didn´t want to participate in this study
* Patients were participated in other studies
Study of the Carpal Tunnel Syndrome in Relation to Stress and Depression Among Medical Students

Participants will undertake validation of the median nerve and their anxiety and depression levels. Possible correlation will be searched.

Medical students of the University of Ioannina will be submitted to ultrasound of the medial nerve as to assess its surface. Those with pathological findings will undertake a non-interventional electromyography test. Afterwards they will complete anonymously two validated tests regarding depression and anxiety (Yung ans STAI scales). Statistical analysis will be conducted with the question of correlation between median nerve dysfunction and psychiatric disorders.

Eligibility Criteria:
Inclusion Criteria:

* medical students

Exclusion Criteria:

* known pathology of the carpal joint
An Investigational Study to Assess the Effect of a Light Meal and a High-Fat Meal on the Absorption of BMS-986205 in Healthy Participants

The purpose of this study is to investigate the effect of a light meal and a high-fat meal on the bioavailability (absorption) of of BMS-986205 commercial tablet in healthy participants. Eligible participants will receive a single dose of BMS-986205 under fasted or fed (high-fat meal or light meal) conditions on Day 1 and Day 15. The safety, tolerability and movement of the BMS-986205 into, through and out of the body (pharmacokinetics/PK) under these conditions will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Signed written consent form.
* Healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ECGs (electrocardiograms), and clinical laboratory determinations.
* Women participants must have documented proof they are not of childbearing potential.
* Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with BMS-986205, and for a total of 110 days after the last dose of BMS-986205; and must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements.
* Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2.
* Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.

Exclusion Criteria:

* Women who are of childbearing potential or breastfeeding.
* Any significant acute or chronic illness.
* Active tuberculosis (TB) requiring treatment, documented latent TB within the previous 3 years, or evidence of a past TB infection without documented adequate therapy. All participants will be required to have a QuantiFERON-TB Gold test performed at screening.
* History of Glucose-6-Phosphate Dehydrogenase deficiency (G6PD) or any other congenital hemolytic anemias.
* History of cardiac arrhythmias and/or autonomic instability.
* History of pulmonary, renal or liver disease.
* History of Gilbert's Syndrome.
* Recent (within 6 months of study drug administration) history of smoking or current smokers, including use of electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
* Participants with active, known or suspected autoimmune disease. Participants with vitiligo or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger may enroll.
* Major surgery within 4 weeks of study drug administration.

Other protocol defined inclusion/exclusion criteria could apply.
Evaluation of Losartan on Cardiovascular Disease in Patients With Mucopolysaccharidoses IV A and VI

Mucopolysaccharidoses (MPS) are multisystemic diseases with significant clinical overlap between their types, with cardiac problems being among the most commonly observed manifestations and are also among the main causes of mortality in these patients. For some of the cardiovascular manifestations, such as aortic root dilation and valve diseases, there is no effective treatment currently available. Losartan, on the other hand, has been shown to be an effective drug for dilation of the aortic root, at least in animal models. This study aims to evaluate the safety and efficacy of losartan in patients with MPS VI and other mucopolysaccharidoses.

Mucopolysaccharidoses (MPS) are a group of lysosomal diseases characterized by deficiency of enzymes responsible for the degradation of glycosaminoglycans. MPS are multisystemic diseases with significant clinical overlap between their types, with cardiac problems being among the most commonly observed manifestations and are also among the main causes of mortality in these patients. Enzyme replacement therapy and bone marrow transplantation, despite being well established treatments, are not yet capable of reversing or preventing the progression of some of the cardiological manifestations of MPS. On the other hand, these patients may benefit from other conventional drug or surgical treatment, which can be instituted at an appropriate time if there is a better understanding of how these manifestations progress. In particular, the occurrence of aortic root dilation, although described in animal models, has only recently been evaluated in the studies on mucopolysaccharidoses.

In addition, verifying the effectiveness of losartan in controlling these manifestations in the animal model opens the perspective of clinical use of this drug. Losartan is a low-cost drug and, if its efficacy is demonstrated, may represent an accessible therapy directed at the unmet needs of these patients.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed biochemical or molecular diagnosis of MPS VI or MPS IVA.
* Age between 10 and 40 years.
* Presence of aortic root diameter greater than 1.0 standard deviation, as determined by local measurement.
* Be in a stable treatment regime in the last 3 months (without performing Enzyme replacement therapy (ERT), or performing ERT on a regular basis).
* Patient who agree to participate in the study protocol by signing a free informed consent form.

Exclusion Criteria:

* Patient who underwent previous aortic surgery.
* Patient with aortic root diameter greater than 5 cm.
* Patient on angiotensin-converting-enzyme (ACE) inhibitor. In case of use of beta-blocker, or calcium channel blocker, patient without adequate control of blood pressure in the last 3 months.
* Patients with previous adverse events related to treatment with losartan or contraindication to this treatment.
* Inability, in the opinion of the investigator, to complete the study procedures.
The Use of Perfusion CT Derived Parameters as Early Acute Pancreatitis Severity Biomarker Compared to Clinico Biological Score

The investigators to establish whether early microvascular permeability parameter evaluated by perfusion-CT could be good biomarkers for severity in acute pancreatitis.

Therefore the investigators want to compare 48 hours-clinico-biological systemic inflammatory response syndrome score to initial microvascular permeability parameters ( ktrans - capillary membrane permeability factor- and pancreatic blood flow ) calculated by OLEA software using inclusion perfusion CT.


Eligibility Criteria:
Inclusion Criteria:

* Patient with acute pancreatitis (based on the Atlanta definition).

Exclusion Criteria:

* Patient under 18 yearras old
* Contraindication of injection of iodinated contrast medium
* Pregnancy
Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J)

This research is being done to study the safety of an investigational percutaneous endoscopic gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube prevents it from slipping back into the stomach.

The word "investigational" means the PEGJ feeding tube used in this study is not approved by the U. S. Food and Drug Administration (FDA) and is still being tested in research studies. Currently commercially available PEGJ tubes are long tubes which are placed into the part of the small intestine that connects to the stomach (duodenum) under endoscopic guidance. The tip of these PEGJ tubes usually have some built-in extra weight (several grams), which theoretically should prevent slippage of the tube back into the stomach. However, these tubes usually cannot be placed very far into the duodenum and the build-in weight is usually not sufficient to keep the tube in place.

The tip of the currently commercially available PEGJ tubes often (usually within 1-2 weeks) migrates back into the stomach and at that point the tube needs to be replaced. The investigational PEGJ feeding tube used in this study is self-propelled and has a balloon on its tip. The tip of this tube is directed endoscopically through the part of the stomach that connects to the duodenum (pylorus), then the balloon is filled with 5 cc of water and the endoscope is removed. The water filled balloon then is carried by the movement of the intestinal muscles through the duodenum into the middle section of the small intestine (jejunum). It is hoped that such a deep position of the tip of the self-propelled PEGJ tube and presence of the water-filled balloon on its tip will prevent migration of the tube back into the stomach and therefore eliminates the need for tube replacement.

The only difference between the currently approved PEGJ feeding tube and the investigational one being used in this study is the addition of the balloon to the tip of the J port. People who come to Johns Hopkins Hospital for PEGJ placement as part of standard clinical care and who are not pregnant may join the study.

Eligibility Criteria:
Inclusion Criteria:

* age 18-90 years
* need for post-pyloric feeding (patients unable to eat due to stroke, intubated patients with respiratory failure, patients with acute pancreatitis, etc)
* ability to give informed consent for the study

Exclusion Criteria:

* patients with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000)
* inability to get informed consent for the study from patients or their families
* pregnancy (all women of child-bearing age will undergo urine pregnancy testing)
Effects of Citalopram on Hostility and CHD Risk

To evaluate the therapeutic effects of the serotonergic agent, citalopram, on hostility and other behavioral risk factors, and biological markers of disease risk (serum lipids, insulin and glucose; autonomic balance and stress-related cardiovascular reactivity; platelet activation).

BACKGROUND:

Hostility, a broad personality dimension comprised of behavioral tendencies, cognitive biases and emotional or motivational characteristics appears to play an important role in the development of coronary heart disease (CHD). Furthermore, hostility apparently is important, not only as a function of its direct relationship to disease development, by virtue of its well documented link to a wide range of other risk factors, including life style factors (e.g., tobacco and alcohol use, imprudent diet), cardiovascular reactivity to stressful circumstances, and physiological indices (e.g., reactivity to acute stress, lipid levels, platelet activity, glucose regulation). It has been hypothesized that a common pathway underlying each of these factors is described by the serotonin system and by (dys) regulation of central serotonin pathways. Indeed, studies 1 and 2 of this program project application are devoted to an elaboration of this pathway as underlying behavioral, psychological, physiological and metabolic contributors to the development of CHD. The focus of this project is on the impact of short treatment with a selective serotonin reuptake inhibitor (SSRI) on hostility and the wide range of associated risk factors for CHD. Should this study prove successful, it will have the potential of significantly impacting treatment approaches that are aimed at reducing risk for the development and progression of CHD.

The study is one of four subprojects within a Program Project Grant entitled "Biobehavioral Studies of Cardiovascular Disease".

DESIGN NARRATIVE:

This is randomized placebo-controlled clinical trial of a select population, with the core questions revolving around the impact of brief (11 week) treatment with citalopram, a selective serotonin reuptake inhibitor (SSRI) on hostility as measured a number of ways. Healthy individuals who score above the median on standard measures of hostility will be identified. While questionnaire measures will be used to screen and select individuals, a host of measures of hostility will be employed to more fully capture the wide ranging aspects of this "personality" dimension, and thereby better ascertain the impact of the active agent. In addition to the measurement of the central personality dimension of interest, a wide range of other factors are to be measured. Life style risk factors measured include (e.g., the use of salivary cotinine to assess the validity of participants' self-report regarding tobacco use, the use of unannounced 24 hour dietary recalls, the use of pedometer to assess physical activity), autonomic activity (e.g., the wide range of indices available through the use of impedance cardiography, the use of heart rate variability, baroreceptor sensitivity), and platelet activity.

Eligibility Criteria:
No eligibility criteria
Safety & Efficacy of ICL670 vs. Deferoxamine in Beta-thalassemia Patients With Iron Overload Due to Blood Transfusions

The purpose of this study is to deterimine if the new orally active iron chelator, ICL670, is as effective and as safe as deferoxamine in preventing accumulation of iron in the body while a patient is undergoing repeated blood transfusions.

Patients who require repeated blood transfusions to live accumulate iron in the body as blood cells contain iron and there is no natural body mechanism to eliminate it. After a while the iron levels get high enough to be toxic to the body. The current therapy of choice is deferoxamine, which does a good job of removing excess iron, but is difficult to administer. Deferoxamine requires subcutaneous (under the skin) infusions over 4 to 8 hours nightly 3 to 7 nights per week. In addition to the need to wear an infusion pump nightly, adverse reactions around the site of the injection are frequent.

Eligibility Criteria:
Inclusion Criteria:

* Beta-thalassemia patients already treated with or suitable for treatment with deferoxamine 20 to 40 mg/kg/day
* Liver iron content greater than 2 mg iron/g dw as measured by liver biopsy
* Need for regular transfusions 8 or more times per year

Exclusion Criteria:

* Non-transfusional iron overload or transfusion-dependent anemias other than beta-thalassemia.
* Documented toxicity to deferoxamine
* Elevated liver enzymes in the year preceeding enrollment
* Active hepatitis B or hepatitis C
* HIV seropositivity
* Elevated serum creatinine or significant proteinuria
* History of nephrotic syndrome
* Uncontrolled systemic hypertension
* Fever and other signs/symptoms of infection within 10 days prior to start of the study
* Presence of clinically relevant cataract or previous history of clinically relevant ocular toxicity related to iron chelation
* Second or third degree AV block, clinically relevant Q-T interval prolongation, or patients requiring digoxin or other drugs that prolong the Q-T interval
* Diseases (cardiovascular, renal, hepatic, etc.)that would prevent the patient from undergoing any of the treatment options
* Psychiatric or additive disorders that would prevent the patient from giving informed consent
* History of drug or alcohol abuse within the 12 months prior to the study
* Pregnant or breast feeding patients
* Patients treated with systemic investigational drugs within 4 weeks or topical investigational drugs within 7 days before the start of the study
* Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug, such as gastrointestinal disease or major surgery, renal disease, difficulty voiding or urinary obstruction, or impaired pancreatic function.
* Non-compliant or unreliable patients.
* Patients unable to undergo any study procedures such as the hearing or eye tests, or the liver echocardiography.
* Inability to undergo a liver biopsy.
* Patients that would need a dose of ICL670 less than 125 mg per day.
Phase II Study of Maintenance Treatment of Nimotuzumab for Advanced Esophageal Carcinoma

There have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy. However, whether maintenance therapy of nimotuzumab provides benefit to advanced esophageal cancer patients is not known.

We design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient who was confirmed stage IV esophageal carcinoma by pathologic histology or cytology.
* The sample size estimate: 20 cases per arm.
* Males or females aged ≥18 years, \< 75 years.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy ≥12 weeks.
* Males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug.
* Adequate bone marrow, renal, and liver function are required.
* Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
* Institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment.

Exclusion Criteria:

* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
* Allergy to anti-EGFR antibody.
* Female subjects should not be pregnant or breast-feeding.
* Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥100 x 109/L. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, or ≥ 50 ml/min. Adequate liver function: total bilirubin \< 1.5 x upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases.
* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.