cyrilzakka/clinical-trials huggingface dataset:
Resveratrol in Type2 Diabetes and Obesity

The main objective of this study is to investigate the effect of resveratrol (plant derived food supplement) on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo.

The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo. This research will investigate the hypothesis that resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in reactive oxygen species (ROS) generation and the pro-inflammatory transcription factor nuclear factor-kB (NF-kB) and the inflammatory mediators regulated by it. The hypothesis that resveratrol suppresses the high fat, high carbohydrate (HFHC) meal induced inflammatory and oxidative response, will also be investigated. This research will also investigate the hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the Homeostasis model assessment of insulin resistance (HOMA-IR), an index of insulin resistance and, that resveratrol intake will cause an increase in incretins.

Eligibility Criteria:
Inclusion Criteria:

1. 20 years of age and older
2. Healthy Obese subjects with BMI \> 30
3. Type 2 Diabetics with BMI \> 30
4. Subjects with good peripheral vein.
5. Subjects on statins, ACE inhibitors and thiazolidenediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study.

Exclusion Criteria:

1. Subjects on any antioxidant medication
2. Patient on non-steroidal anti-inflammatory drug
3. On any agent with significant antioxidant properties.
4. History of drug or alcohol abuse
5. Any life threatening disease
6. Allergy to peanuts, grapes, wine, mulberries.
7. Pregnant women.
8. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks.
9. Subjects on anticoagulants.
Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage

This randomized clinical trial aims to compare the analgesic efficacy of intranasal fentanyl to placebo as analgesic adjunct to conventional local anesthesia for the treatment of pain of the overall procedure in adult patients undergoing lidocaine infiltration and subsequent abscess incision and drainage in the Emergency Department (ED).


Eligibility Criteria:
Inclusion Criteria:

* Presenting to the ED for an abscess requiring incision and drainage
* ED attending physician's judgment that the patient has capacity to provide informed consent.
* Patients must be able to understand English or Spanish.

Exclusion Criteria:

* Use of opioids or tramadol within past 7 days.
* Prior adverse reaction or allergy to opioids.
* Patients who are pregnant
* Patients weight \> 100kg
* Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
* Medical condition that might affect metabolism or opioid analgesics such as cirrhosis (Child Pugh A or worse) or kidney impairment (CKD 3 or worse)
* Chronic malnutrition, severe hypovolemia (dehydration of blood loss) or hepatic disease
* Alcohol intoxication: history of alcoholism or the presence of alcohol intoxication as judged by the treating physician may alter pain perception and has previously increased adverse events.
* SBP \<100 mmHg: Opioids can produce peripheral vasodilation causing orthostasis.
* HR \< 60/min: Opioids can cause bradycardia.
* Oxygen saturation \< 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
* Use of MAO inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
* Patients using transdermal pain patches or oral opioid use \> 10 days in the prior month: frequent opioid use may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments.
* Patients with a history of traumatic brain injury, seizures or hallucinations
* Patients with anatomical anomalies or medical conditions precluding intranasal administration
RPE Characterisation With Transscleral Optical Phase Imaging in Retinal Disorders

Accumulating evidence suggest that the functional unit of photoreceptor/ retinal pigment epithelium (RPE)/Bruch's membrane/choriocapillaris plays a key role in pathophysiologic processes of a wide range of medical retinal disorders of the eye. Little is known about in vivo morphometric characteristics of human RPE cells as in vivo observation of these cells was so far technically challenging and hence nearly impossible to implement in a clinical setting. Transscleral optical phase imaging is a novel in-vivo microscopy technique allowing human RPE imaging on a cellular level with the potential of clinical application in a multimodal retinal imaging approach for diagnostic purpose in medical retina patients.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature (Appendix Informed Consent Form)
* Patients with a medical retinal disease involving the retinal pigment epithelium (age related macular degeneration, diabetic retinopathy, retinal vascular occlusive disease, central serous chorioretinopathy, tapetoretinal degeneration)
* Participants with healthy eyes for the control group

Exclusion Criteria:

* Inability to follow the procedures of the study due to language problems, psychological disorders, dementia etc. of the participant
* Aged \< 18 years.
* Pregnancy
* Epilepsy
An Open-Label Trial of Memantine in the Treatment of Binge Eating Disorder

We hypothesize that memantine may be a safe and effective treatment for moderate to severe binge eating disorder associated with obesity.

During this 12-week, open-label, outpatient study, male and female subjects between the ages of 18 and 65 years who have moderate to severe binge eating disorder and are obese will be treated with open-label memantine. Following this 12-week treatment phase, subjects may be eligible to continue into an extension phase which will last an additional 12 weeks. During the extension phase subjects will continue open-label memantine treatment.

Binge eating disorder is a newly recognized disorder characterized by recurrent episodes of binge eating without extreme behaviors to lose weight characteristic of bulimia nervosa or anorexia nervosa and it is associated with overweight and obesity in both clinical and community populations. Preliminary clinical data from a recent, small, 5-week, open-label therapeutic trial in obese patients with binge eating disorder in Germany found memantine to be effective in weight reduction and reduction of binge episodes.

We plan to study 15 male and female subjects between the ages of 18 and 65 years who have binge eating disorder (with 3 or more binge days per week in the 2 weeks prior to baseline) and have a body mass index (BMI) between 30 and 50 kg/m2. During the 12-week treatment phase subjects will receive open-label memantine titrated up to 20mg/day, or the subjects maximum tolerated dose. Upon completion of the treatment phase, subjects will either taper their study medication and return for a final post-taper visit or continue on their current dose of study medication in the 12-week extension phase.

Eligibility Criteria:
Inclusion Criteria:

* Subjects may be male or female, 18-65 years old
* Diagnosis of binge eating disorder
* Subjects must have 3 or more binge days per week for the two weeks prior to the start of the study
* Subjects must have a BMI between 30 and 50 kg/m2

Exclusion Criteria:

* Current or lifetime history of schizophrenia, other psychotic disorder, or bipolar disorder
* Subjects with a history of a personality disorder
* Subjects with clinically significant depression
* Subjects with substance use of dependence
* Subjects who are pregnant or lactating
* Subjects with a serious medical condition
Effect of Intranasal Insulin on Postoperative Cognitive Dysfunction

Our study is designed to evaluate the effect of intranasal insulin on postoperative cognitive dysfunction.

Primary outcome:

1. The occurrence of cognitive dysfunction at approximately 7 days after surgery.

Secondary outcome:

1. Incidence of any side effect.


Eligibility Criteria:
Inclusion Criteria:

1. Age 40 - 60 years.
2. Both gender.
3. Patients will be scheduled for elective major abdominal, thoracic, orthopedic, open gynecological, open urological, spine, otolaryngological surgeries under general anesthesia with expected hospital stay \>4 days.

Exclusion Criteria:

* 1. Drug allergy. 2. Patients with major psychiatric disease. 3. Patients receive major tranquillizers and antidepressant. 4. Those undergoing neurosurgery or cardiac surgery. 5. Those unable or unwilling to abide by the study procedure 6. Those who could not follow procedure or who had poor comprehension of dutch language. 7. Those with sever visual and auditory disorder / handicaps.
Epidemiology of Neonatal Sepsis in Neonatal Intensive Care Unit in Assiut University Children Hospital

Neonatal sepsis is an important cause of morbidity and mortality in the pediatric age group . It is one of the leading causes of death in the first 28 days of life both in the developed and developing countries.

More than 40% of under-five deaths globally occur in the neonatal period, resulting in 3.1 million newborn death each year.

The majority of these deaths usually occur in low income countries . On the other hand, the survivors of neonatal sepsis are vulnerable to short- and long term neurodevelopmental morbidity .

Neonatal sepsis is a clinical syndrome characterized by signs and symptoms of infection with or without accompanying bacteremia in the first month of life. It includes various systemic infections of the newborn such as septicemia, meningitis, pneumonia, arthritis, osteomyelitis, and urinary tract infections. Superficial infections like conjunctivitis and oral thrush are usually not included under neonatal sepsis.

Diagnosis of sepsis in neonates is challenging due to nonspecific signs and symptoms. The salient clinical features include systemic signs of infection such as fever, hypothermia, tachycardia, failure to thrive, lethargy, irritability, restlessness In addition, laboratory diagnosis until recently was time-consuming. This, therefore, necessitates the initiation of empirical antibiotic therapy pending a definitive diagnosis .

Neonatal sepsis is caused by Gram-positive and Gram-negative bacteria and Candida. The diversity of organisms causing sepsis varies from region to another and changes over time even in the same place .

Eligibility Criteria:
Inclusion Criteria:

• All admitted inborn and out born neonates during this study period will be screened for sepsis

Exclusion Criteria:

• All cases that mimic neonatal sepsis such as;

* Inborn errors of metabolism
* Congestive heart failure
* Hemolytic Disease of Newborn
* Hypoxic ischemic encephalopathy
* Congenital Diaphragmatic Hernia
* Intra cranial hemorrhage
* Respiratory Distress Syndrome
Preoperative Levosimendan in CABG Patients With Poor LV Function

The investigators want to test the hypothesis that an infusion of levosimendan started prior to CABG surgery can reduce incidence and severity of low cardiac output syndrome in patients with poor LV function (EF 40% or less).

Background: Patients with an ejection fraction of less than 40% are at high risk of developing postoperative low cardiac output syndrome (LCOS). Despite the use of potent inotropic agents or even ventricular mechanical assist devices, the mortality rate of such patients remains very high (from 17 to 38%). Their hospital stay is also prolonged and the cost of care for this population is increased. Two studies have suggested that post-operative administration of levosimendan could reduce hospital length of stay and long term (Day180) mortality in patients with LCOS. In addition a few studies have also suggested that pre-operative infusion of levosimendan (pre-conditioning) could reduce the use of other inotropes and mechanical assist devices in patients at high risk of developing LCOS. Unfortunately, the data supporting the beneficial effects of levosimendan in high risk cardiac surgery patients is very limited. Main goal: To evaluate the efficacy of a pre-operative infusion of levosimendan in high risk patients (EF less than 40%) undergoing cardiac surgery (CABG or combined surgery: CABG and valve replacement) to improve outcome. Secondary goals: To evaluate: 1) the clinical safety of a pre-operative infusion of levosimendan, 2) the costs of care in the levosimendan and control groups. Experimental setup: Prospective, multicenter, randomized versus placebo, double-blind trial. Treatment modalities: levosimendan will be administered by the intravenous route, according to a continuous infusion of 0.1mcg/kg/min over 24 hours. Levosimendan infusion (0.1mcg/kg/min) will be started immediately after induction of anaesthesia. The delay between infusion start and skin incision can be estimated between 30 to 60 min. The investigators decided to skip the bolus infusion that is frequently associated with systemic hypotension, which may result in serious adverse events and protocol exclusion. Study duration and patient follow-up: Patients will be recruited over 23 months. Individual follow-up will last 6 months. Overall duration of study will be 29 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* scheduled for CABG with CPB
* with or without asociated cardiac repair
* ejection fraction less than 40%
* signed informed consent

Exclusion Criteria:

* preoperative renal failure (creatinine clearance less than 30 ml/min)
* liver failure (prothrombine time less than 50% in the absence of vitamin K antagonist)
* cardiac surgery without CABG
* pregnancy
* emergency surgery
* known allergy to levosimendan
* severe hypotension prior to surgery
* severe tachycardia
* prior history of torsade de pointe
* dynamic obstruction od left ventricular outflow tract
* lack of signed informed consent.
Age-Specific Strategies for Immunization Reminders and Recalls

The objective of this study was to assess the relative effectiveness of reminder/recall strategies among children who live in an urban area targeting alternative age-specific milestones.


Eligibility Criteria:
Inclusion Criteria:

* 7 and 19 month recall groups: children not up to date for at least one vaccination at the time of notification
* 12 month reminder group: 12 months of age at time of notification
* Hib vaccination series was not assessed due to a vaccine shortage

Exclusion Criteria:

* Children were ineligible for notifications if they were designated in the Michigan Care Improvement Registry (MCIR)as having died, documented previously as having moved out of the jurisdiction ("Moved or Gone Elsewhere" (MOGE)), opted out of MCIR by their parent, or if they had been previously mailed for MCIR reminder/recall activity in the prior 60 days.
Maintaining Optimal Trauma Outcomes: Resilience in the Midst of a Ransomware Attack

Retrospective review of de-identified hospital emergency room and trauma registry data and operating room case logs from April 9th through June 9th, 2016, 2017 examining outcomes as affected by a ransomware attack in a level I trauma center

On April 9, 2017, Erie County Medical Center, Western New York's sole level I trauma center was under cyberattack. The perpetrators utilized ransomware that gained access to the hospital's web server and encrypted hospital data, forcing a system-wide downtime for nearly 2 months. Electronic medical records, imaging, and interdepartmental communication were severely affected, forcing the hospital to temporarily return to pre-EMR era operations. We examined the impact of this cyber disaster on the outcomes of trauma care.

Retrospective review of de-identified hospital emergency room and trauma registry data and operating room case logs from April 9th through June 9th, 2016, 2017, and 2018. Baseline characteristics of study cohort for each period will be examined using the chi-square test for categorical variables and the Student's t-test for continuous variables that are normally distributed.

This was an exempt study in our institution.

Eligibility Criteria:
Inclusion Criteria:

* All trauma patient admissions that were seen through the ECMC Trauma Center from April to June 2016 and April to June 2017
* Adult patients \>13 years old

Exclusion Criteria:

-Patients who came through the emergency department that were not categorized as trauma patients
A Multiple Ascending Dose Study of ETC-1002 in Healthy Subjects

This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy subjects.


Eligibility Criteria:
Major Inclusion Criteria:

* Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements
* Body Mass Index of 18-32 kg/m2 inclusive with body weight \>50 kg

Major Exclusion Criteria:

* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.2 x Upper Limit of Normal(ULN), serum creatinine \>ULN, Hemoglobin \<12.0 g/dL
* Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
* History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization
* Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization
* Other exclusion criteria apply
Topical Calcipotriol /Betamethasone Ointment in the Treatment of Plaque Psoriasis

comparing the clinical efficacy of topical ointment containing calcipotriol and betamethasone dipropionate used alone with the simultaneous use of fractional carbon dioxide laser and the same topical ointment containing these two ingredients as treatment modalities for plaque psoriasis. Additionally, looking into how both therapy modalities affect individuals with psoriasis in terms of how their quality of life is improved.

Psoriasis is a widespread, persistent papulosquamous skin condition that can affect anyone at any age and places a heavy strain on both the individual and society. It is linked to a number of serious medical disorders, such as cardiometabolic syndrome, depression, and psoriatic arthritis (1).

Patients with psoriasis indicate that the condition interferes with their ability to sleep and rest, limits their everyday activities, particularly their mobility, and stigmatises them and causes problems in their social lives. Additionally, psoriasis can negatively impact mental health. Many psoriasis sufferers struggle with addiction, anxiety, and depression (2, 3).

Topical medicines continue to be the basis of treatment for those with mild psoriasis, and they include topical corticosteroids, vitamin D analogues, calcineurin inhibitors, and keratolytics (4).

For the topical management of mild psoriasis, preparations containing calcipotriol in combination with betamethasone (in the form of betamethasone dipropionate) are available (5). In comparison to the effects of these active substances when given separately, pharmacodynamic investigations demonstrated the synergy between the anti-inflammatory and immunoregulatory actions of calcipotriol and betamethasone dipropionate (6). The synergistic activity of the two drugs is what makes calcipotriol/betamethasone dipropionate combinations successful. Betamethasone impacts inflammatory processes and lessens skin irritation and pruritus following calcipotriol administration, while calcipotriol alters keratinocyte differentiation (7).

Fractional lasers were used in the treatment of dermatological diseases. They create tiny ablation channels in the skin that act as shunts for topically applied medications, particularly those with high molecular weights (8), by ablation of the skin in the form of fractions and splitting laser beams into microbeams (9).

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic plaque psoriasis of either sex.
* Aged more than 18 years of age.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients with severe skin infection.
* Patients who are under systemic ttt or phototherapy in the last 3 months.
* Immunosuppression or being under any kind of treatment causingabsolute or relative immunosuppression
* History of any bleeding, clotting disorder or using anticoagulants.
* Chronic systemic diseases such as chronic renal failure, hepatic insufficiency, and cardiovascular disorders.
Preoperative Hepatic Arterial Infusion Chemotherapy

To assess the feasibility and results of liver resection after preoperative hepatic artery infusion (HAI) chemotherapy with FUDR.

Between 1995 and 2004, 239 patients with isolated colorectal liver metastases received HAI chemotherapy with neoadjuvant intent. Fifty of these patients underwent subsequent curative liver resection (HAI group).

Postoperative morbidity, liver function tests, and long term outcomes were evaluated. Adverse events related to HAI chemotherapy were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable liver metastases
* Potentially resectable liver metastases

Exclusion Criteria:

* Extrahepatic disease
Respiratory Decompensation and Model for the Triage of COVID-19 Patients

The purpose of this study is to prospectively evaluate a machine learning algorithm for the prediction of outcomes in COVID-19 patients.

In a multi-center prospective clinical trial, a machine learning algorithm was deployed at five partner hospitals to analyze live patient data, including blood pressure and Creatinine levels, to determine the algorithm's ability to predict COVID-19 patient prognosis. The primary endpoint was mechanical ventilation of study subjects within 24 hours after hospital admission separate from a decompensation alert related to oxygen levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older
* Confirmed COVID-19 infection through RT-PCR test

Exclusion Criteria:

* Patients aged less than 18 years
Expanded Access to Provide GL-ONC1 for the Treatment of Advanced Cancers With No Standard of Care

GL-ONC1 expanded access is for patients who are ineligible for an ongoing GL-ONC1 clinical trial. Expanded access is intended to treat individual patients with advanced stage cancers, including blood cancer, with no standard of care options for treatment. Potential patients will be evaluated individually depending on GL-ONC1 product supply.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced cancers with no standard of care option for treatment.
* Willing and able to provide written, signed informed consent.
* Use of adequate contraception.
* Negative pregnancy test.

Exclusion Criteria:

* Have not recovered from severe adverse events from prior therapy.
* Major surgery occurred within 28 days prior to treatment.
* Known immune system disorders such as HIV, or active hepatitis B or C infection.
* Clinically significant cardiac disease (New York Heart Association Class III or IV).
* Have received prior therapy with an oncolytic virus of any type.
* Be receiving antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, ST-246).
* Have known allergy to ovalbumin or other egg products.
* Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any unhealed skin wounds or ulcers) as assessed by the treating physician.