cyrilzakka/clinical-trials huggingface dataset:
A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients

Enterome small molecule drug EB8018 is a first-in-class FimH blocker to be studied in Crohn's disease patients. The proposed indication for EB8018, as an add-on therapy, will be the treatment of adult patients suffering from Crohn's disease.

This open-label, multicenter study will enroll 8 evaluable patients with active Crohn's disease and will consist of 2 parts. Part 1 will include 2 sentinel patients with a single dosing period followed by a 13-day multiple dosing period. Part 2 will include the 6 remaining patients with multiple dosing only. This Phase 1b study will investigate the PK, safety, preliminary effects of the gut microbiome, and inflammatory biomarkers of EB8018 following 13 days of consecutive BID oral dosing in patients with Crohn's disease.

Part 1 of this study will demonstrate a single oral dose of EB8018 that is safe and tolerable in patients with Crohn's disease and Part 2 of this study will characterize the PK profile when administered as multiple oral doses.

Eligibility Criteria:
Selection Criteria:

* Male and female patients of nonchildbearing potential ≥18 years of age at screening and Day -1
* Active Crohn's disease based on an elevated calprotectin at baseline.
A Prospective Phase II Randomized Clinical Trial of Preoperative Chemotherapy Combined With Short-course Radiotherapy Versus Conventional Neo-adjuvant Therapy for Locally Advanced Rectal Cancer Implemented by MDT

The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy in a prospective cohort and to correlate this response with patient's outcome

This is a phase II , open label, randomized study in patients with confirmed diagnosis of locally advanced rectal cancer. The study is designed to analyze the pathological tumor response on locally advanced rectal cancer after preoperative treatment with neo-adjuvant therapy regimen or with chemotherapy combined with short-course radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 1. Consent to this study
* 2. Histological or cytological confirmed diagnostic of rectal carcinoma
* 3. Locally advanced rectal cancer without metastasis, confirmed by pelvic MRI (cT3CRM+、cT4NX or cTxN2M0)(cT3CRM+: margin between the deepest point of tumor and rectal adventitia/serosa surface is less than 1 mm measured in pelvic MRI)
* 4.With no presence of anemia (Hb≤60g/l) induced by tumor bleeding or bowel obstruction
* 5.With no presence of other organ metastasis or extra-regional lymph node involvement
* 6.With no history of chemotherapy
* 7.ECOG score is 0 or 1
* 8.Adequate ability of bone marrow, liver and kidney function
* 9.No pregnancy

Exclusion Criteria:

1. Unable to intake oral medicine
2. Arrhythmia need treatment(besides β-blocker or digoxin); Symptomatic coronary artery disease or history of myocardiac infarction within 6 months ；Congestive Heart Failure NYHA II grade or severe
3. HIV infection or Active chronic HBV or HCV
4. Severe clinical infection at active stage
5. Epileptic seizure need treatment
6. History of organ transplantation
7. Renal failure or intaking renal dialysis
8. Clinical hemorrhagic tendency or Disorders of blood coagulation or intaking anticoagulant or thrombolytics
9. Severe unhealed wound or skin ulcer or bone fraction
10. Measurable massive ascites 11 History of other malignant tumor(except cured cervical tumor in site and cured cutaneous basal cell carcinoma) in last 5 years

12.Chronic inflammatory bowel disease， bowel obstruction，hereditary fructose intolerance 13.Medicine abuse；medical，psychologic or social conditions might disturb patients or results 14.Known or suspected allergy to any drugs in this study 15.Any situation or status that might endanger patient's safety or compliance 16.Pregnant woman or suckling period woman; Fertility without taking sufficient contraception 17.History of pelvic radiotherapy
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin

An open-label, randomized, single-dose, 2X3X3 partial replicate, crossover study to compare the pharmacokinetics and safety between a fixed dose combination of Fimasartan/Amlodipine/Rosuvastatin and Co-administration of a fixed dose combination of Fimasartan/Amlodipine and Rosuvastatin in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subject, aged 19- 50 years

Exclusion Criteria:

* History of clinically significant hypersensitivity to study drug, any other drug
* Hypotension or hypertension
* Active liver disease
* History of gastrointestinal disease
* History of excessive alcohol abuse
* Participation in any other study within 3 months
Reduced-dose Alemtuzumab for Kidney Transplant Rejection

Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection.

Study design: Prospective observational cohort study. Study population: Adult patients who are treated with alemtuzumab for severe or glucocorticoid-resistant kidney transplant rejection.

Intervention (if applicable): Not applicable. Main study parameters/endpoints: Lymphocyte (subtype) repopulation, serious infections, one-year graft survival, alemtuzumab plasma levels, intra-cellular signalling of repopulated T and B cells, cytokine-levels, donor-specificity of repopulated T cells, differences pre- and post-treatment of donor-derived cell-free DNA, plasma nucleosomes, urinary chemokines, urinary extracellular vesicles, breath-pattern analysis.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Treatment for severe or glucocorticoid-resistant kidney transplant rejection with alemtuzumab.

Exclusion Criteria:

* Treatment with a different lymphocyte depleting agent (e.g. rATG) prior to treatment with alemtuzumab for the same rejection episode.
* Recipients who have T cell counts below 200 × 106/L before the start of therapy (for instance, because of lymphocyte depleting induction therapies).
* Inability to provide written informed consent
Paternal vs Maternal Holding-Cuddling for Procedural Pain in Healthy Term Neonates

This study investigated the effect of maternal holding-cuddling (MHC) and paternal holding-cuddling (PHC) on heel prick pain and crying duration in healthy term neonates

Newborns undergo many painful procedures. The heel prick, or heel lancing, is a painful procedure used for newborn screening tests. It is a more painful procedure than other venipuncture procedures. All pediatricians and healthcare professionals working with neonates should focus on pain management during heel pricks for two reasons. First, they are under an ethical obligation to help neonates experience as little pain as possible during medical procedures. Second, repeated painful exposure has harmful consequences. The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and Procedural Pain) also recommends pharmacological and non-pharmacological methods to prevent and effectively manage acute procedural pain in children. However, pharmacological methods for pain management in neonates may have some side effects. On the other hand, non-pharmacological methods are easy to use, affordable, and time-effective methods with no side effects. Healthcare professionals do not use non-pharmacological methods that are expensive, hard to apply, and time-consuming. Therefore, this study focused on maternal holding-cuddling and paternal holding-cuddling as alternative non-pharmacological methods to prevent procedural pain in neonates during heel pricks. Holding-cuddling is an effective non-pharmacological method for reducing procedural pain.

Eligibility Criteria:
Inclusion Criteria:

* healthy term neonates
* birth weight between 2500 and 4000 g
* 38-42 gestational week
* postnatal age of 48-72 hours
* a 5-minute APGAR score of ≥8,
* having had no experience of any painful interventions other than vitamin K and hepatitis B vaccine at birth
* fed between 30 and 60 min before the procedure
* undergoing heel prick only once
* blood collection for the Guthrie test
* willing to hold their babies during the procedure

Exclusion Criteria:

* sleeping during the procedure
* receiving analgesics up to 24 hours before the procedure
POLish Bifurcation Optimal Treatment Strategy Study for Left Main Bifurcation Percutaneous Coronary Intervention (PCI)

The primary objective of this study is to study the safety and efficacy of the BiOSS LIM C with respect to Patient oriented Composite Endpoint (PoCE) at 12 months in a "real world" left-main bifurcation population and as compared with a prespecified performance goal.


Eligibility Criteria:
Inclusion Criteria:

* Patient has distal unprotected Left-Main coronary artery (ULMCA) disease with angiographic diameter stenosis (DS) ≥50% requiring revascularization.
* Left-Main Medina classification 100, 110, 101, 011, 010, 111
* Clinical and anatomic eligibility for PCI as agreed by the local Heart Team including anatomic SYNTAX Score (\<33).
* Distal left main reference vessel diameter ≥3.0 mm and ≤5.5 mm. All target lesions must be located in a native coronary artery.
* Patient with silent ischemia, chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values
* Able to understand and provide informed consent and comply with all study procedures including follow-up

Exclusion Criteria:

* Prior PCI of the left main bifurcation at any time prior to enrollment
* Currently participating in another trial and not yet at its primary endpoint.
* Prior PCI of any other (non left main bifurcation) coronary artery lesion within 6 months (\<6 months) prior to enrollment.
* Left-Main Medina classification 001.
* Any segment of the left main bifurcation (distal left main, ostial Left Anterior Descending Artery (LAD) or ostial Left Circumflex Artery (LCX) presenting with a chronic total occlusion, or containing a visible thrombus.
* Excessive angulation of the left main bifurcation (i.e. an angulation \>90° between proximal LAD and proximal LCX)
* Direct stenting of the left main bifurcation
* Prior Coronary Artery Bypass Surgery (CABG) at any time prior to enrollment
* Patient requiring or may require additional surgery (cardiac or non-cardiac) within one year
* Ongoing myocardial infarction or recent myocardial infarction with cardiac biomarker levels still elevated.
* Known renal insufficiency (e.g. serum creatinine \>2.5mg/dL, or creatinine clearance ≤30mL/min, or patient on dialysis).
* Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor.
* Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 12 months.
* Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential).
* Concurrent medical condition with a life expectancy of less than 12 months.
* The patient is unwilling/not able to return for outpatient clinic at 12 month follow-up.
* Currently participating in another trial and not yet at its primary endpoint.
ERYthrocyte Morphology Using Flow Imaging on ImageSTREAM Cytometer

Erythrocyte morphology analysis is a key step in the diagnosis flowchart of anemia. It is performed on a peripheral blood smear after May Grümwald Giemsa staining. In the context of hemolytic anemias for example, it allows the recognition of therapeutic emergencies such as sickle cell disease crisis, malaria-induced hemolysis and thrombotic microangiopathy, the latter being characterized by the presence of schistocytes and justifying an immediate clinical care. However, cytological analysis of erythrocyte morphology requires pre-analytical interventions (smear spreading + staining), the quality of which determines the accuracy of the result. Moreover, it requires a good cytological expertise and may be sometimes subjective. For several years, alternative methods for erythrocyte morphology evaluation have been developed, based on automated hematology machines or automated microscopy. Nevertheless, none of them has yet proven itself in comparison with cytology, especially in the diagnosis of thrombotic microangiopathies. By combining the advantages of flow cytometry and microscopy, flow imaging appears to be a promising technology for the diagnosis of anemias: it does not require any pre-analytical intervention, does not require any spreading and analyzes a large number of events. Moreover, it can be coupled with artificial intelligence via the generation of an apprenticeship by the constitution of a large image data base, which then allows the recognition of the different red blood cells morphologies without human eyes. The objective of this study is to build a data base containing the main red blood cell morphologies relevant in anemia, and to validate it through a comparison in anemic patients of erythrocyte morphological assessment either directly on whole blood by flow imaging or routinely by cytological analysis of peripheral blood smear after by a trained operator.


Eligibility Criteria:
Inclusion Criteria:

* Any patient for whom a blood test including a cytological evaluation of RBC morphology is performed in the routine laboratory of CHU Amiens

Exclusion Criteria:

* patients who have opposed the use of their personal data for research work
Effect of Adjuvant Hyperbaric Oxygen Therapy on Bells Palsy Outcome

This is a randomized, single blinded, non-placebo controlled that will compare one group of Bells Palsy patients receiving the current standard of care including oral corticosteroids and oral antivirals against an experimental group receiving the current standard of care in addition to hyperbaric oxygen therapy. Outcome assessment will be based on both objective analyses of facial movements as well as subjective quality of life scales.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older exhibiting unilateral facial paralysis progressing to completion in 4 days or less.

Exclusion Criteria:

* No patients from vulnerable populations as listed above will be included.
* Subjects must be able to travel to NYULMC continually during the first 12 months following enrollment.
* During the initial visit candidates must have no associated clinical signs or symptoms consistent with other causes of facial palsy. This includes but is not limited to: auricular papules, skin rashes, parotid masses, craniofacial trauma, and the presence of other cranial or distal neuropathies excluding facial numbness, change in taste, and/or hyperacusis.
* Patients with atypical presentations will be referred for cross-sectional imaging and excluded.
* Patients with histories consistent with possible recent tick exposure, rashes, headaches, or excessive fatigue will be serologically tested for Lyme disease and excluded if it returns positive.
* Pneumothorax within the last two years is the only absolute medical exclusion criteria (FF).
* Patients who are epileptics, or are claustrophobic, will be carefully counseled on the risks of HBOT before being allowed to enroll.
* Patients with severe comorbidities will undergo evaluation by their primary care doctor and require physician approval prior to enrollment.
Teaching Obesity Treatment Options to Adult Learners Trial

Obesity is the second leading cause of death in the U.S. The treatment of obesity and its related health issues, including cardiovascular disease and diabetes, exceeds $150 billion annually. "Morbidly" or "severely" obese patients - defined by a body mass index \[BMI\] of \>35 kg/m2 or greater - are especially high risk for serious complications due to their weight. Within the Veterans Health Administration (VA) system, nearly 600,000 patients are severely obese. These Veterans create significant costs for the VA system, experience poorer quality of life, and have shortened lifespans. Bariatric surgery is the most effective treatment for severe obesity for weight loss, resolving weight-related health issues, and quality of life. Bariatric surgery is supported as a treatment option by many national societies, including those representing primary care and endocrinology. However, less than 1% of Veterans who qualify for bariatric surgery undergo it. Reasons for low utilization are unclear, although the investigators' preliminary research suggests that there are various patient, provider and system level barriers to severe obesity care. The goal of this study is to pilot-test an educational video that aligns patient preferences with treatment options to improve the care that severely obese Veterans receive.

Obesity is the second leading cause of death in the U.S. The treatment of obesity and its related comorbidities, including cardiovascular disease and diabetes, exceeds $150 billion annually. "Morbidly" or "severely" obese patients - defined by a body mass index \[BMI\] of \>35 kg/m2 or greater - are especially high risk for serious complications due to the metabolic and physiologic derangements that occur with severe obesity. Within the Veterans Health Administration (VA) system, nearly 600,000 patients are severely obese. These Veterans exert significant costs on the VA system, experience poorer quality of life, and have shortened lifespans. Bariatric surgery is the most effective treatment for severe obesity for weight loss, comorbidity resolution, and quality of life. Bariatric surgery is supported as a treatment option by many national societies, including those representing primary care and endocrinology. However, less than 1% of Veterans who qualify for bariatric surgery undergo it. Reasons for low utilization are unclear, although the investigators' preliminary research suggests that there are various patient, provider and system level barriers to severe obesity care. The goal of this study is to pilot-test an educational video that aligns patient preferences with treatment options to optimize the care that severely obese Veterans receive.

Eligibility Criteria:
Inclusion Criteria:

* Veterans scheduled to attend an in-person MOVE! visit led by a dietitian at the main VA hospital.

Exclusion Criteria:

* No access to telephone, doesn't speak English as their primary language, has undergone bariatric surgery
Cough Frequency in Chronic Obstructive Pulmonary Disease

Acute exacerbations of COPD remain a common cause of morbidity and are associated with a sustained increase in the normal respiratory symptoms of dyspnoea, cough, and sputum volume and purulence. It has previously been shown that a change in cough symptoms occurs in 51.7% of exacerbations in COPD. We wish to record cough during a COPD exacerbation to determine whether this can be a objective marker of exacerbation duration and severity.

Acute exacerbations of COPD remain a common cause of morbidity and are associated with a sustained increase in the respiratory symptoms of dyspnoea, cough, sputum volume and sputum purulence. Cough is one of the most commonly reported and key symptoms in COPD patients. Cough can also be a useful factor in finding patients at risk of progressive airflow obstruction and cough along with the breathlessness is the major cause of distress in patients with chronic obstructive airways disease (COPD). There is limited literature looking into cough and COPD especially objective assessments.

in clinical practice and in most clinical trials scoring systems ie quality of life questionnaires or visual analogue scores, have been used to measure COPD exacerbation severity, although these may give an indication of the perceived severity of the symptom, they are inherently subjective and may be influenced by other factors. Shortfalls have prompted the development of cough recorders as an objective measure of this symptom. With this in mind we propose recruit 30 subjects with non-infective exacerbations of COPD and monitor their cough frequency as an inpatient in acute exacerbation and for 45 days post hospital discharge in order to elucidate the natural history of cough during and after an exacerbation.

Eligibility Criteria:
Inclusion Criteria:

* Male/females aged between 40-80 years.
* Previous diagnosis of COPD.
* Acute exacerbation of COPD requiring treatment with antibiotics and/or corticosteroids.
* Symptoms of increased breathlessness, cough, sputum volume or sputum purulence.
* Acute exacerbation of COPD hospitalised within 48 hrs of study participation.
* On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion.
* Known history of cigarette smoking at least 10 pack yrs.
* Willing and able to comply with study procedures.
* Able to provide written informed consent to participate.

Exclusion Criteria:

* Acute exacerbation of COPD within 8 weeks prior to inclusion.
* Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus.
* On long-term oxygen therapy.
Preeclampsia-like Syndrome Induced by COVID-19: Is it a Real Public Health Issue in Pregnancy During the Pandemic?

By applying polymerase chain reaction (PCR) test for Covid-19 to preeclampsia patients who applied to our hospital during the Covid-19 pandemic period, we investigated the frequency of Covid-19 related preeclampsia-like syndrome in this patient group.

The investigators studied the frequency of Covid-19 related preeclampsia-like syndrome by PCR test and lung ultrasound for Covid-19 to preeclampsia patients presenting to the instutution during the Covid-19 pandemic period. The first consecutive 100 preeclampsia patients presented to our hospital during the pandemic will be involved in our study. The primary outcome measure is to detect Covid-19 positivity among the preeclamptic pregnant women..

Eligibility Criteria:
Inclusion Criteria:

* First consecutive 100 pregnant women presenting with preeclamptic symptoms and signs between March 15, 2020 and June 1, 2020.

Exclusion Criteria:

* The pregnancies with known diagnosis of preeclampsia before Covid-19 pandemic
* Preeclamptic patient without a Covid-19 PCR test result
* Pregnant women who does not want to participate in study or does not want their personal informations to be shared
* Pregnant women less than 18 years old and more than 40 years old are excluded
Transdiagnostic Treatment Personalization

The primary purpose of this study is to explore whether the efficiency of treatment for anxiety and depressive disorders can be increased using two discrete strategies: personalized skill ordering and 2) treatment discontinuation based on proximal indicators of improvements. The present study will specifically use treatment components drawn from an evidence-based psychological intervention, the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP). This intervention has strong empirical support for patients presenting with anxiety, depressive, and related disorders and contains therapeutic skills that are common in psychological interventions (e.g., psychoeducation, mindfulness training, cognitive restructuring, countering emotional avoidance, increasing interoceptive tolerance). This study will determine if prioritizing the order of treatment modules to capitalize on patient strengths or compensate for weakensses increases treatmen efficacy. Additionally, it will also identify under what conditions briefer treatment modules may be appropriate.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of at least one emotional disorder
* fluent in English
* medication stability

Exclusion Criteria:

* concurrent therapy
* psychological condition that would be better addressed by alternative treatments
* have received more than 5 sessions of cognitive behavioral therapy in the past 5 years