cyrilzakka/clinical-trials huggingface dataset:
Salicylic Augmentation in Depression

The investigators are doing this research study to find out if using aspirin along with antidepressant treatment can lessen symptoms of depression. This study also aims to find out if some people improve more from taking aspirin than others. The investigators also want to see if it is possible to predict which participants will do better based on a blood test.

Aspirin is approved by the U.S. Food and Drug Administration (FDA) as an over-the-counter pain medication. But, aspirin is not approved by the FDA to make antidepressant treatment better.

This research study will compare aspirin to placebo.

This study is a randomized, double-blind, placebo-control trial. The primary aims of this study are:

Aim 1: To evaluate the clinical effect of aspirin augmentation on depression.

Aim 2: To assess the inflammatory profile of the blood of the aspirin augmentation responders compared with the non-responders.

Aim 3: To evaluate whether immune gene expression patterns are associated with antidepressant response to aspirin.

Aim 4: To collect samples for later, more detailed immunologic characterization.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of major depressive disorder
* Hamilton Depression Rating Scale (HDRS) score of \>19
* Stable treatment regimen (no medication changes or changes in psychotherapy treatment in past 8 weeks, and no participation in stepped treatments, such as completion of a course of cognitive behavioral therapy, during the trial)
* Failed to remit with at least 1 antidepressant trial, or combination of 1 antidepressant and 1 augmentation agent
* Women of childbearing age must agree to use an approved method of contraception for the duration of the study

Exclusion Criteria:

* Active suicidal ideation
* History of manic episodes or psychosis
* Alcohol or substance use disorder up to one month prior to first testing session
* Comorbid neurologic condition affecting the central nervous system
* Comorbid autoimmune condition
* Uncorrected thyroid disease or a current abnormal thyroid-stimulating hormone (TSH)
* Active or recent (within the past month) infection (such as otitis, pneumonia, urinary tract infection); temperature \> 100.3 or white blood cell (WBC) count \> 11 K/microL will be considered evidence of active infection even in the absence of other symptoms
* History of GI bleed
* History of stroke
* History of a bleeding disorder
* Platelet count \< 150,000/mm3 on initial screening
* On a blood-thinning agent or taking NSAIDs daily
* Current use of oral steroids or other immunomodulating medications
* Salicylate sensitivity
* Pregnancy or breastfeeding
Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)

The objective is to compare the efficacy and safety of masitinib in combination with riluzole in the treatment of patients suffering from Amyotrophic Lateral Sclerosis (ALS).

Masitinib is novel tyrosine kinase inhibitor that targets microglia and mast cells through inhibiting a limited number of kinases. Masitinib blocks microglia proliferation and activation, and mast cell-mediated degranulation, the release of cytotoxic substances that might further damage the motor nerves.

There are two distinct populations of ALS patients: population of "Normal progressors" and population of "Faster progressors". Targeted population for primary analysis is population of "Normal progressors".

"Normal progressors" are ALS patients whose progression of ALSFRS-R score before randomization is less than 1.1 point per month.

Eligibility Criteria:
Inclusion Criteria:

Main inclusion criteria:

1. Familial or sporadic ALS
2. Patient diagnosed with probable of definite ALS
3. Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening

Exclusion Criteria:

1. Patient who underwent tracheostomy and/or gastrostomy
Dietary Oxalate and Immune Cell Function

The purpose of this study is to evaluate mitochondrial function in white blood cells and platelets from healthy individuals following dietary oxalate intake.

Inflammation and dietary oxalate have been shown to play an important role in the development of kidney stones. Oxalate is a small molecule found in plants and plant-derived food. Individuals that have high oxalate intake have an increased risk of developing kidney stones. The co-investigators have previously shown that healthy subjects that consume dietary oxalate have increased plasma and urine oxalate.

White blood cells are essential for the immune response and rely on the mitochondria to carry out important cell functions. The Principal Investigator's current research shows that patients with calcium oxalate kidney stones have decreased mitochondrial function in their immune cells. Using the expertise of the investigators, this study will test whether oxalate has a direct effect on mitochondrial function in immune cells from healthy subjects. This information could help us understand the role of oxalate on the immune system during kidney stone pathogenesis.

Eligibility Criteria:
Inclusion Criteria:

* Mentally competent adults who are able to read and comprehend the consent form, written in English
* Male or Female
* Age 18 to 70 years
* Non-tobacco users
* BMI between 19 and 27
* Willingness to abstain from vigorous exercise during study period
* Normal blood comprehensive metabolic panel

Exclusion Criteria:

* Mentally incompetent adults who are unable to read or comprehend the consent form, written in English
* Pregnant females
* Active medical problems
* History of kidney stones
* Any medical disorder that could influence absorption or excretion of oxalate
* BMI less than 19 or greater than 27
* Tobacco users
* Current use of medications or dietary supplements
Challenges in Management of Abdominal Trauma in Sohag University Hospital A Prospective Study

The present study will be conducted to evaluate the different patterns of abdominal trauma patients and their management in the Emergency Department of Sohag University Hospital

The present study will be conducted to evaluate the different patterns of abdominal trauma patients and their management in the Emergency Department of Sohag University Hospital This study will be a prospective study which will be conducted at the Emergency Department of Sohag University Hospital the study population include all patients with abdominal trauma

Eligibility Criteria:
Inclusion Criteria:

* any patient presented with abdominal trauma

Exclusion Criteria:

* Patients with extra abdominal injuries
Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children

AIM: To determine the efficacy of Lactobacillus reuteri DSM 17938 at a dose of 10(9) CFU for the prevention of nosocomial diarrhea.

TRIAL DESIGN: Double-blind, placebo controlled RCT. INTERVENTION: L reuteri DSM 17938 in a daily dose of 10(9) CFU. PRIMARY OUTCOME: Nosocomial diarrhoea (3 or more loose or watery stools in a 24 h that will occur more than 72 h after admission).

Nosocomial diarrhea is a common problem in hospitalized children. Previously, it has been documented that the administration of L reuteri DSM 17938 at a dose of 10(8) colony forming units (CFU) compared with placebo had no effect on the overall incidence of nosocomial diarrhea (Wanke \& Szajewska, J Pediatr 2012). Whether higher doses of L reuteri DSM 17938 have such effects needs to be substantiated in further randomized trials.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1-48 mo admitted to the hospital for reasons other than diarrhea
* Signed informed consent.

Exclusion Criteria:

* Acute gastroenteritis within 3 days before admission
* Symptoms other than diarrhea suggesting gastroenteritis
* Use of probiotics within 7 days before admission
* Immunodeficiency disorders
* Breastfeeding \>50%
* Underlying gastrointestinal tract disorder
* Malnutrition (weight/high \<3pc)
Fluid Lavage of Open Wounds

Open fracture wounds are a constant challenge to orthopaedic surgeons, with infections a common complication. There is currently little evidence as to which is the most effective way to wash out these wounds. This study is a multi-center, prospective, randomized study. The infection rates will be compared between irrigation using high pressure versus low pressure versus gravity flow, and also saline versus a soap solution as the irrigation solution. The results from this study will help to determine the best method of washing out open fractures wounds. In this study, all open wounds will be washed out using methods commonly used by orthopaedic surgeons


Eligibility Criteria:
Inclusion Criteria:

1. Men or women who are skeletally mature.
2. Fracture of any extremity with complete radiographs.
3. Open fractures (Gustilo-Anderson Types I-IIIB) (Table 2)\*.
4. Fracture requiring operative fixation.
5. Provision of informed consent.

Exclusion Criteria:

1. Open fractures with an associated vascular deficit (Gustilo-Anderson Type IIIC).
2. Known allergy to detergents or castile soap ingredients.
3. Previous wound infection or history of osteomyelitis in the injured extremity.
4. Previous fracture with retained hardware in injured extremity that will interfere with new implant fixation.
5. Surgical delay to operative wound management greater than 24 hours from hospital admission.
6. Use of immunosuppressive medication within 6 months.
7. Immunological deficient disease conditions (e.g. HIV).
8. Fracture of the hand (metacarpals and phalanges).
9. Fracture of the toes (phalanges).
10. Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
11. Previous randomization in this study or a competing study.
Surgical Stress and Colorectal Surgery

The purpose of this study is to evaluate surgical stress and immune function after robotic versus laparoscopic colectomy.

The short-term advantages of minimally invasive colon resection have been well established in several randomized trials. A major factor in the development of morbidity is the surgical stress response with subsequent increased demand on the patient's reserves and immune competence. Although the advantage in term of stress response of laparoscopic surgery over open surgery has been widely reported, little is known about the role of robotic surgery.

Robotic approaches have seen significant growth in the last 5 years. Taking advantage of three-dimensional visualization, improved articulation, and multiple operating arms provides theoretical advantages in colorectal cancer surgery. In an attempt to evaluate the surgical stress response and immune function after robotic colorectal surgery a comparative study has been designed. Two surgical procedures were evaluated: Robotic colorectal resection (Experimental group) and Laparoscopic colorectal resection (Control group).

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will be those with a histologically confirmed malignancy planned for an elective, segmental, curative colectomy

Exclusion Criteria:

* Patients with a previous midline laparotomy, emergency surgery, or immune depressant disease or medication will be excluded from this study. Peri-operative or post-operative complications will be considered exclusion criteria.
Effect of Eplerenone on Novel Biomarkers of Mineralocorticoid Receptor Activation (ENOVA)

This blinded cross-over clinical trial will enroll participants with mild stage 1 hypertension to evaluate whether urinary extracellular transcript abundance predicts response to an mineralocorticoid receptor (MR) antagonist, eplerenone.

Eligible participants will have a 2 week wash-in period followed by 4 weeks of treatment with placebo or eplerenone. There will be a 2 week wash out period from study medications and then participants will take the other drug (placebo or eplerenone) for 4 weeks. In addition, participants will also provide urine and blood samples during the trial, have physical assessments, and be monitored for safety.


Eligibility Criteria:
Inclusion Criteria:

* History of mild stage 1 systemic hypertension as defined by:

  1. Systolic blood pressure (SBP) ≥ 140 millimeters of Mercury (mmHg) or diastolic blood pressure (DBP) ≥ 90 mmHg on 2 occasions and
  2. Treatment with 1-2 antihypertensive medications (stable dose for 6 weeks)

     Exclusion Criteria:
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Stage 2 hypertension (history of blood pressure ≥ 160/100 mmHg)
* History of hypertensive urgency, hypertensive crisis, or hospitalizations for hypertension
* Current mineralocorticoid antagonist use
* Type II Diabetes with microalbuminuria
* Primary adrenal insufficiency
* Current glucocorticoid use
* Electrolyte abnormality on baseline laboratory assessment
* Current potassium supplementation
* Positive test for leukocyte esterase on urinalysis
* Creatinine clearance \< 50 mL/min on baseline laboratory assessment
* Hyperkalemia
* Potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene)
* Serum potassium \>5.0 milliequivalents per liter (mEq/L) on baseline laboratory assessment
* Current use of strong CYP3A4 inhibitors (some include: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir).
* Serum creatinine \> 1.5 mg/dL in males on baseline laboratory assessment
* Serum creatinine \> 1.3 mg/dL in females
* Current beta blocker use
* Any other condition thought by the Principal Investigator to place the participant at increased risk of injury during the clinical trial or compromise the scientific integrity of the study
Evaluation of Novel Cone-Beam CT for Guidance and Adaptation of Precision Radiotherapy

This is a feasibility study investigating the image quality of a new, high-performance cone beam CT (CBCT) used for on-couch imaging during radiotherapy treatments.

This study focuses on potential benefits of a high performance cone beam CT (CBCT) image guidance system for improved precision in the delivery of radiotherapy. CBCT is currently used during radiation therapy to align the patient to their original treatment plan to increase the precision of radiation delivery. Current CBCT imaging technology requires approximately a minute to acquire an image. In order to acquire images with sufficient quality to allow accurate targeting, the patient may need to perform multiple breath hold maneuvers to "freeze" the motion of tumors that move with the breathing cycle (e.g. lung, liver, and breast tumors). The new high-performance CBCT can acquire an image in approximately 6 seconds, potentially enabling acquisition of images with a single breath hold. Improved motion compensation algorithms used in image reconstruction may allow acquisition of good quality images even while a patient is not holding their breath.

The methodology for the subject's treatment setup, CT simulation, treatment planning, image guidance and treatment delivery will be determined by the subject's treatment team and is not specified by this study. Enrollment in the study may occur after treatment delivery has started but must be prior to the fifth fraction.

Following completion of informed consent to participate in this study, high-performance CBCT imaging will be scheduled immediately before or after one of the subject's first five scheduled radiation treatment fractions. Two research CBCT images will be acquired, one with breath hold, the other with free breathing.

With minimal disruption for participating patients, this study will enable a comparison of (i) the subject's treatment planning fan-beam CT and (ii) the conventional CBCT acquired on an existing treatment unit with (iii) the high-performance CBCT. Image quality of the high performance CBCT image data will thereby be compared to both a best-case standard (fan-beam) and the status-quo for on-couch imaging to isolate and identify improvements.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for treatment on one of the five TrueBeam platforms at the NS Health QE2 site.
* Subject is receiving radiation therapy using a breath-hold technique (for example, lung, liver and left breast cancers).

Exclusion Criteria:

* Patient is pregnant or has plans for pregnancy during the period of treatment.
* Patient is unwilling to consent to participating to the study, or for whom informed consent is not possible.
Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus

The primary objective of this study is to quantify the clinical burden of Japanese Encephalitis (JE) and the asymptomatic circulation of JEV among Cambodian children, through two pediatric cohorts: non-febrile children at recruitment and children hospitalized with febrile neurological syndrome (FNS). Secondary objectives include estimating anti-JEV seropositivity rates, identifying individual risk factors and living conditions associated with JEV infection, characterizing clinical and biological profiles related to disease severity, and evaluating the role of deficiencies in interferon (IFN) response in severe JEV infections.

This is an observational prospective study (with cross-sectional and longitudinal designs) involving two pediatric cohorts recruited from Kantha Bopha hospitals in Phnom Penh and Siem Reap. Group 1 will consist of 2000 non-febrile children aged 2-14 years, recruited from trauma units and followed up for two years to monitor JEV seroconversion. Group 2 will include 2000 children hospitalized with FNS, confirmed JE participants will be followed up for one year to assess the severity of JEV infection. Diagnostic tools such as the QIAstat molecular diagnostic platform and ELISA will be used to detect multiple pathogens, including JEV and dengue virus (DENV). Data collection will involve clinical assessments, etiological testing, and environmental surveys. All collected information will be integrated into a centralized database for analysis.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1

* All children aged between 2 and 14 years.
* No fever or history of fever in the past 14 days.
* Consenting to return to the hospital for follow-up visits.
* Consenting to blood sampling.
* Written informed assent/consent to participate in the study.

Cohort 2

* Hospitalized patients aged between 2 and 14 years.
* Any neurological disorder.
* Any fever within the past 72 hours.
* Written informed assent/consent to participate in the study.
* No contraindication for lumbar puncture (LP).
Racial Variation in ACE--Genetic and Physiologic Bases

To determine whether differences in the activity of the renin-angiotensin and bradykinin systems are involved in the pathogenesis of blood pressure variation in African Americans.

BACKGROUND:

Each year, more than 40,000 new patients require treatment for end stage renal disease, a condition which is 4-fold higher among African Americans than Caucasians. Trials of angiotensin converting enzyme inhibitors (ACEIs) in Caucasians support a role of the renin-angiotensin system in the pathogenesis of glomerulosclerosis. Yet, despite the high prevalence of nephropathy among African Americans, Blacks have been under-represented in studies in ACEIs. Data from our laboratory suggest that the renal effects of ACEI may differ in African Americans. African Americans are resistant to the anti-hypertensive effects of ACEI and, thus, may be resistant to the renoprotective effects as well. The ACE deletion allele, a variant associated with increased ACE activity and progression of renal diseases, is increased in frequency in African Americans, while the frequency of the Ang AT1 receptor C allele, a variant associated with antihypertensive responsiveness to ACEI is decreased. Moreover, African Americans exhibit decreased sensitivity to Ang I and increased sensitivity to bradykinin. Taken together, these data suggest the hypothesis that ACE activity is increased in African Americans, leading to decreased bradykinin levels ( and receptor sensitization) and increased tissue Ang II (and receptor desensitization).

DESIGN NARRATIVE:

The study tests the hypothesis that ACE activity is increased in African Americans, leading to decreased bradykinin levels (and receptor sensitization) and increased tissue Ang II (and receptor desensitization). The effects of race, hypertension and ACE insertion/deletion genotype on ACE activity will be determined, as measured by the pressor and renal vasoconstrictor responses to Ang I and Ang II and the vasodilator response to bradykinin. Specific bradykinin and angiotensin receptor antagonists will be used to determine the relative contribution of increased bradykinin and decreased angiotensin II to the renal hemodynamic effects of ACEIs in African Americans and Caucasians.

Eligibility Criteria:
No eligibility criteria
Apoptotic Signaling Pathways in Rats With Endometrial Hyperplasia

The purpose of the study is to determine apoptotic signaling pathways such as Survivin, Bcl-2, Bax, c-Myc and caspase-9 expression levels in rats model with iatrogenic endometrial hyperplasia after metformin and medroxyprogesterone acetate administration.


Eligibility Criteria:
Inclusion criteria:

Forty-eight weeks old female Wistar-Albino rats, weighting between 180 and 260 g

Exclusion criteria.

We have no exclusion criteria because we examine drugs effects in the experimental rats