cyrilzakka/clinical-trials huggingface dataset:
Oral Refeeding IntOlerance After Nasogastric Tube Feeding (ORION)

Acute pancreatitis (AP) is one of the most common diseases in routine clinical practice of surgeons and gastroenterologists throughout the world. The high rate of pain relapse after oral refeeding contributes to high consumption of healthcare resources and prolonged hospital stay in AP patients. The data from the pilot MIMOSA trial suggest that early administration of nasogastric tube feeding may prevent pain relapse after oral refeeding in AP. The potential beneficial effects of enteral tube feeding include induction of postprandial gastrointestinal motility and improving the tolerance of oral refeeding. This may reduce the risk of pain relapse, thereby shortening length of hospital stay and reducing cost of treatment. The primary endpoint of the ORION trial will be the incidence of oral food intolerance. All eligible AP patients will be randomly allocated to either the Early Nasogastric Tube (ENT) group or Conventional Nutritional Management group (CNM) at 24h of hospital admission.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AP
* Age 18 years or older
* Written informed consent
* Ongoing need for opiates

Exclusion Criteria:

* 96 hours after onset of symptoms
* Chronic pancreatitis
* Post-ERCP pancreatitis
* Intraoperative diagnosis
* Pregnancy
* Malignancy
* Received nutrition before randomisation
The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients

To assess the effect of addition of probiotic Lactobacilli to standard enteral feeding on infection rates and feeding efficacy in critically ill patients.

The study hypothesis is that critically ill patients who receive the addition of probiotic lactobacilli to the enteral feed will lead to a reduced rate of hospital acquired infections.

The null hypothesis is that there will be no significant difference in the rate of hospital acquired infection in critically ill patients who receive enteral feeding with or without the addition of probiotic Lactobacilli.

The patients are randomised to one of three treatment groups. Each comprising of 100 patients.

1. Standard therapy group. Patients will receive enteral feeding (with fibre) aiming at the target feeding rate that is determined by the treating physician and the ICU dietician, as is standard current practice. Two capsule containing placebo will be given 12 hourly via the feeding tube.
2. The first active treatment group, will receive enteral feeding (with fibre) plus probiotic Lactobacillus fermentum included in the feeding regime. Two capsules containing Lactobacillus fermentum (10 11 organisms per capsule) will be delivered via the feeding tube 12 hourly.
3. The second active treatment group will receive enteral feeding (with fibre) plus the probiotic Lactobacillus acidophilus included in the feeding regime. Two capsules containing Lactobacillus acidophilus (2x10 9 organisms per capsule) will be delivered via the feeding tube 12 hourly.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (18 years or over)admitted to ICU with an expected stay of more than 48 hours.
2. Patients who are commenced on enteral feeding via gastric or post pyloric routes.
3. Patients who consent or if the patients is incompetent, their next of kin who consent, to inclusion in the study

Exclusion Criteria:

1. Patients less than 18 years old.
2. Patients who are already receiving probiotic treatment.
3. The lactobacillus acidophilus preparation to be used in the study, contains a very small amount of MSG (total dose of 20mg/day, equivalent to 10% of the initial dose used to test MSG sensitivity) and as a precaution, patients with asthma or recurrent urticaria will be excluded.
4. Patients with HIV infection, pre-existing immunosuppression, or who are pregnant. As the Lactobacillus is a live micro-organism, immunosuppressed and pregnant pateints will be excluded.
5. Patients with a contra-indication to enteral feeding.
6. Patients with contra-indication to placement of enteral feeding tube.
7. Patients or next-of-kin who do not consent to inclusion in the study.
8. Patients who are already enrolled in another study that may influence the outcome of the probiotic study.
A Comparison of Intellivent-ASV Mode With Conventional Modes in Patients With BMI >35

compare effects of intellectual mode (in our case it will be Intellivent - ASV -) with conventional ventilation modes after uncomplicated cardiac surgery in patients with body mass index \>35

The study includes the comparison of two methods of invasive respiratory support ventilation( conventional ventilation modes and automatic IntelliventASV mode (a fully automated, or closed-loop, ventilation mode that consists of pressure-controlled ventilation or pressure support ventilation depending on a patient's respiratory activity. In fully automated ventilation mode, tidal volume, pressure levels (including PEEP), minute ventilation, and the oxygen fraction in inspired air are controlled solely by the ventilator) after uncomplicated cardiac surgery). It assumes 30 randomized patients:15 patients in two study groups male and female aged 30 to 70 years of age inclusive, with BMI \> 35 kg/m2. The study will be randomized, single-center, prospective.

Eligibility Criteria:
Inclusion Criteria:

* • Age from 30 years to 70 years inclusive

  * elective cardiac surgery which included bypass, valve and ascending aortic surgery,
  * a body mass index of \> 35 kg/m2,
  * postoperative treatment with mechanical ventilation,
  * informed consent

Exclusion Criteria:

* • GFI \<30 ml/min before surgery, serum aspartate and alanine transaminase concentration greater than 80 U/l before surgery, left ventricular ejection fraction less than 30% before surgery.

Postoperative exclusion criteria:

* chest tube drainage greater than 3 ml/kg/h,
* reoperation,
* myocardial infarction,
* need for high-dose inotropes or vasopressors or intraaortic balloon pump,
* presence of a bronchopleural fistula and refractory hypoxemia with an arterial oxygen tension to fractional inspired oxygen concentration ratio less than 150 mmHg,
* perioperative anaphylactic reaction,
* seizures,
* stroke,
* agitation
EPO906 Therapy in Patients With Advanced Colorectal Cancer

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause colorectal cancer.


Eligibility Criteria:
Inclusion Criteria

Patients must meet the following criteria to be eligible for the study:

* Histologically or cytologically documented evidence of colorectal cancer with at least one measurable lesion (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
* The patient should have failed or progressed on no more than two prior chemotherapies for metastatic disease (the prior chemotherapy must have included a fluoropyrimidine and either Irinotecan or oxaliplatin, or any combination of these agents, with the last chemotherapy having contained Irinotecan or oxaliplatin)
* Patients who have received only adjuvant therapy for their disease are eligible, as long as they have relapsed within six months of completing such therapy and that therapy contained 5-FU and Irinotecan or oxaliplatin administered in combination as part of an investigational protocol
* Must have a life expectancy of greater than three (3) months.

Exclusion Criteria

The following patients are not eligible for the study:

* Patients with symptomatic CNS metastases or leptomeningeal involvement
* Patients with unresolved bowel obstruction
* Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
* Patients with severe cardiac insufficiency
* Patients who have undergone major surgery for any cause less than 4 weeks prior to study entry
* Patients with radiation therapy or chemotherapy within the last four weeks
* Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
* History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
* Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
* HIV+ patients
* Pregnant or lactating females
Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation

The demographic shift and the increasing prevalence of chronic wounds represent major challenges for modern health care systems. Classic chronic wounds (venous ulcer, arterial ulcer, mixed ulcer) persist for months or years with a very slow or even no healing progress. Patients suffer from pain and immobility, which dramatically reduces their quality of life. Complications such as infections or tissue necrosis can lead to a bad outcome and amputation of extremities.

The Pio device offers a non-invasive and non-toxic therapeutic approach. The system combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area. The investigational medical device represents a promising combinational therapeutic approach to synergistically increase the tissues regenerative potential. By stimulating electrophysiological processes at the site of injury, the cells regain its capacity to efficiently regenerate the injured or diseased tissue. It is expected that the patient benefits from a faster healing process, reduced inflammation as well as an improved overall treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Male and female patients
* Age: 18 - 90
* Chronic wound (venous ulcer, arterial ulcer, mixed ulcer) since at least 4 weeks
* Wound area minimal 1 cm2, maximal 50 cm2
* No adaptions for treatment of causal therapy of disease

Exclusion Criteria:

* Women who are pregnant
* Known or suspected non-compliance, drug or alcohol abuse,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Patients with active devices (e.g. Pacemakers and defibrillators, infusion devices, insulin pumps)
* Metallic implants and endoprosthesis at extremities lower than hip
* Life threatening condition
* Immunosuppressive after foreign organ transplant or chemotherapeutic treatment within 30 days before study begin
Neutrophil to Lymphocyte Ratio in Inflammatory Bowel Disease

Detection of Inflammatory Bowel Disease activity by Using new measure : Neutrophil to lymphocyte ratio

Inflammatory bowel disease (IBD) has been a global healthcare problem with a sustained increasing incidence. It includes two major forms, Crohn's disease (CD) and ulcerative colitis (UC), which are distinct chronic bowel-relapsing inflammatory disorders (Gharagozloo et al., 2015). Ulcerative colitis (UC) is limitd to Mucosa and cause continuous bowel inflammation (Celikbilek et al., 2013) While Crohn disease is more complex because of its transmural inflammation and it is characterized by skip lesions, which are diseased sections of bowel next to uninvolved areas(Nishijima David L; Wisner, David H; Holmes, James F, 2016). The prevalence of IBD is highest in the second to third decade of life with another peak in the 60-70- year-old group.(Silva et al., 2016) Non-invasive tests, such as C reactive protein (CRP), erythrocyte sedimentation rate (ESR) and white blood cells (WBC) are therefore being increasingly recognized as important markers for initial diagnosis and disease activity detection.(Gao et al., 2015) In recent years, the neutrophil-to-lymphocyte ratio (NLR), calculated as total neutrophil count divided by total lymphocyte count, NLR represents two different immune pathways and can be easily derived directly from a standard blood test..(Argeny et al., 2018)

Eligibility Criteria:
Inclusion Criteria:

* patients with inflammatory bowel disease, diagnosed by endoscopy, clinical , biochemical correlation and histopathological biopsy

Exclusion Criteria:

* patients have :
* Appendicitis
* sigmoid diverticular disease
* Infectious colitis
* patients known to have cancer colon
Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery

Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular events (for example, heart attack) and the risk is related to one's overall control of blood glucose levels. In this study the investigators will measure the effects of saxagliptin, compared to placebo, before, during, and after coronary artery bypass graft (CABG) surgery. The investigators will use samples of the patients' blood and tissue to measure and evaluate indicators of the body's response to the treatment. This study is being done to evaluate the effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or controlling a person's blood glucose levels during and after CABG surgery will produce better clinical outcomes (for example, better heart health).

This study is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of saxagliptin on cardiac biomarkers of myocardial necrosis, cardiac function, inflammation, and apoptosis in subjects with Type 2 diabetes mellitus (T2DM) undergoing CABG surgery (on pump, via a median sternotomy approach) as an integrated measure of the potential mechanistic effects of saxagliptin on prevention of cardiovascular (CV) outcomes. Approximately 74 subjects will be randomized and complete the study.

Eligibility Criteria:
Inclusion Criteria:

* Known diagnosis of type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin (HbA1c) between 6.5% and 10%, inclusive.

  * Stable doses of oral antihyperglycemic agents for at least 2 months
  * Stable dose of chronic insulin therapy for at least 2 months
  * HbA1c documented within 3 months before study enrollment
* Planned first elective coronary artery bypass graft (CABG) surgery

Exclusion Criteria:

* Elevated Creatine Kinase-Myocardial Bands (CK-MB) or troponin level above the 99th percentile at screening
* Receiving incretin therapy or having received incretin therapy within the previous 2 months
* Type 1 DM or a history of ketoacidosis
* Women who are pregnant or breastfeeding
* Known end-stage Kidney disease
* Known sensitivity or intolerance to saxagliptin or dipeptidyl peptidase-4 (DPP-4) inhibitor
* Clinically apparent liver disease
* History of pancreatitis
Milk-only Lactation Study for Patients on Eltrombopag

This is a Phase IV study to evaluate eltrombopag concentrations in breast milk of nursing mothers taking marketed eltrombopag (PROMACTA®). Up to 10 subjects (mother-infant pairs) at as many as 10 study centers in the US will be enrolled. Nursing mothers who are registered with the PROMACTA Pregnancy Registry will be offered the option to participate in this trial if they continue to take commercial eltrombopag post-delivery and decide to breastfeed their infant. Information will be collected in a diary. Breast milk samples will be collected before and after infant feedings for a 24 hour period after eltrombopag dosing to evaluate the eltrombopag concentrations in the breast milk. Mothers will also be given the option to have a pharmacokinetic (PK) blood sample collected from the infant.


Eligibility Criteria:
Inclusion Criteria:

* Mother is registered with the PROMACTA Pregnancy Registry and meets all the enrollment criteria defined in the PROMACTA Pregnancy Registry study (113327).
* Mother is continuing to take eltrombopag.
* Mother has received 7 consecutive eltrombopag doses prior to the milk sample collection.
* Infant is 4 weeks to 26 weeks of age at the time of milk sampling.
* Exclusively breastfeeding mother-infant pair; either via breast or with expressed milk from the mother.
* Mother is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

* Infant was born with complications that could impact ability to participate in this study.
* Breastfeeding is not well established in the mother-infant pair (e.g., poor latching of the infant or low milk supply).
* Infants who are supplemented with formula or are consuming solid foods.
* Unwillingness or inability of mother to follow the procedures outlined in the protocol.
* Mother is mentally or legally incapacitated
Robustness Predictive Factors in People Aged Over 75 Years After Going to the Emergency Room (ROB-U)

After emergency room visits, the elderly patients can increase their dependence and functional decline. In this context the goal of this study is to demonstrate that there are robustness predictive factors after visit to the emergency room.

The emergency department is one of the main access routes to the hospital for elderly patients.

Older age is often associated with an increase risk of longer stay in the emergency room with a high subsequent risk of hospital re-admission. One of the essential care objectives when treating these patients is to maintain the autonomy to avoid any dependence in order to keep the quality of life, and limit the time of hospitalization.

Emergency room visits and hospitalizations are too often considered as a source of autonomy loss aggravation in the elderly. Many studies have demonstrated the mortality predictive factors existence, functional decline, or re-hospitalization of the elderly after an emergency room visit or after hospitalization.

No study until now has investigated the existence of factors directly predictive of robustness. Then the goal of this study is to demonstrate that there are robustness predictive factors after going to the emergency room.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the emergency room
* Patients aged ≥ 75 years old
* Patients without cognitive disorders or vigilance disorders
* Patients living at home
* Patients able to give its non-opposition

Non inclusion Criteria:

* Patients admitted to the hospital in the last 3 months
* Patients refusing to participate in the study

Exclusion Criteria:

* Patients whose stay is \< 14h or \> 48h
* Patients who die during hospitalization
* Patient not hospitalized
* Patient not returning home after discharge from hospital
Improving Characterization of Calcifications With Contrast-Enhanced Mammography

The purpose of this study protocol is to assess whether contrast-enhanced mammography (CEM) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant.


Eligibility Criteria:
Inclusion Criteria:

* Women with calcifications detected on screening mammogram for which biopsy is recommended following characterization on diagnostic mammography.
* At least 30 years of age.
* Able to understand and willing to sign an IRB-approved written informed consent document
* GFR ≥ 30 mL/min/1.73 m2

Exclusion Criteria:

* Pregnant
* Prior history of allergy or hypersensitivity reaction to iodinated contrast
* History of chronic renal disease (including dialysis, kidney transplant, single kidney, renal cancer, or renal surgery)
* Patients with known thyroid disorders, pheochromocytoma or sickle cell anemia
Mindbeacon Therapist Assisted Internet Delivered CBT for Depression

Utilization of therapist Assisted internet-delivered cognitive behavioural therapy (TAiCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT) and the Ontario Structured Psychotherapy Program (SPP), is a potential solution for addressing the treatment gap in mental health. Investigators propose to investigate the effectiveness of Beacon TAiCBT for Depression to demonstrate the potential value of TAiCBT in a stepped care model. Investigators propose to conduct a 12-week pragmatic randomized controlled trial with a 1:1 (iCBT intervention: waiting-list) allocation, for participants referred to the Anxiety and Mood, Prompt Anxiety and Mood, and Trauma Programs at Ontario Shores Centre for Mental Health Sciences and on a waiting-list to receive clinical service.

The primary outcome measures will be the Improving Access to Psychological Therapies (IAPT) definitions of Recovery, Reliable Improvement, and Reliable Recovery which are derived using the PHQ-9 and GAD-7 . The PHQ-9 (Depression), GAD-7 (anxiety) and WSAS (functional impairment) will be used as secondary outcome measures for all participants.

Over the course of the study, 200 participants will be randomized (iCBT, 100; waiting-list, 100). Statistical analyses will include intention-to-treat analyses to test the interaction effects for the primary outcome measures at discharge/12-weeks and 3, and 12 months post-treatment.

It is predicted that participants in the treatment condition will show significantly reduced symptoms of depression related to the waitlist control. It is predicted that this will be maintained through follow up.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Meets Diagnostic Assessment Research Tool (DART) screening criteria for a primary diagnosis of depression and reports being at least moderately depressed according to the PHQ-9
* Sufficient language proficiency to understand the treatment materials written at grade 10 reading level
* Understands what TAiCBT and is open and interested to participating in a study using this treatment modality
* Is able to reliably access the internet, and has basic computer skills to navigate the internet using a web browser
* Willing to participate in a waitlist-control study and be followed for 12 months

Exclusion Criteria:

* Suicidal intent or clinically significant suicidal ideation
* Clinically significant self-harm
* Active psychotic illness
* Currently participating in psychological treatment for depression and/or receiving evidence-based treatment (other than medication) for depression
* Clinically significant alcohol and/or other substance use including prescription and over the counter medication that would likely interfere with treatment
* Current or previous diagnosis of Borderline Personality Disorder
* Does not meet DART criteria for a primary diagnosis of depression
* Change in psychotropic medication within 3 weeks of treatment baseline