cyrilzakka/clinical-trials huggingface dataset:
Effects on Cognitive Functions and Mood of Food Products Rich in Polyphenols

The purpose of this study is to investigate effects of a selected food product rich in polyphenol on cognitive performance and mood.

The metabolic syndrome (MetS) includes a cluster of dysfunctions that identifies subjects at risk of developing type-2 diabetes and cardiovascular disease (CVD). A key feature appears to be chronic increased inflammation and activation of the innate system. Consequently, increased low-grade inflammation has been connected to adverse effects on insulin sensitivity, glucose- and lipid metabolism, and blood pressure, and circulating markers of inflammation such as IL-6. A growing body of evidence also link low-grade inflammation to poorer cognitive functioning. Type 2 diabetes, MetS, and glucose intolerance are increasingly being associated with impaired cognition.

Dietary patterns which promote sub-clinical inflammation are increasingly being considered predictive of future risk of CVD and type-2 diabetes. Epidemiological data shows that a high consumption of vegetables and fruits is associated with a lowered risk of cancer and cardiovascular disease, which may be due to the high concentrations of polyphenols or other anti-oxidants that are found in such foods.

In the presently described project it is hypothesized that four weeks daily consumption of a product specific high in flavanols can improve metabolic risk variables and cognitive functions in healthy subjects.

The purpose is therefore to investigate effects of flavanols on cognitive functions and cardiometabolic risk, and to investigate relations between cardiometabolic risk markers and cognitive performance. The test product is a commonly used food product, known to be specifically rich in flavanols. The effects of the test product is compared with effects of a control product that is based on a similar food product but is lacking flavanols.

Test parameters:

Cognitive tests: Working memory tests (an oral test), selection attention test (measure also reaction time, a computerized test ), and stroop test (a computerized test.

Mood is determined for 6 different mood sensations using VAS scales.

Bio markers in blood: glucose regulation (glucose, insulin), markers of inflammation and oxidative stress (IL-6, MDA, oxLDL), blood lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides), vascular function (P-Selectin, PAI-1, NO), gut hormones involved in metabolism and satiety (PYY, GLP-1) gut hormon involved in mucosa integrity (GLP-2), markers of brain function (BDNF, neurotensin).

Blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women and men
* Between 50-70 years
* BMI 19-25

Exclusion Criteria:

* Metabolic diseases
* Food allergies
* Smoker
Prevention of Capecitabine Induced Hand and Foot Syndrome

Capecitabine is a common anti cancer drug. One of the most common side effects is a syndrome called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness and painful sores. Quite often the drug dose is reduced to suboptimal level due to this side effect. There is no way to prevent or an effective way to treat this side effect. The investigators aim is to investigate whether wearing socks which contain copper fibers may prevent or alleviate the patient symptoms.

Capecitabine is a common anti cancer drug. One of the most common side effects is a syndrome called hand and foot syndrome which comprises of hands and feet redness, swelling, dryness and painful sores. Quite often the drug dose is reduced to suboptimal level due to this side effect. There is no way to prevent or an effective way to treat this side effect. Our aim is to investigate whether wearing socks which contain copper fibers may prevent or alleviate the patient symptoms.

The patients will use socks containing copper-oxide impregnated fibers which are sold in the Pharma stores without physician's prescription.(EPA numbers 8454-2, 8454-3 from April 30 2009).

Drug Toxicity and skin reaction will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stage IV cancer - treated with Capecitabine

Exclusion Criteria:

* Any patient who can not sign an informed consent
* Pregnant women
Cystatin c: a Biomarker of AKI in Aneurysmal Subarachnoid Haemorrhage Patients

The goal of this observational study is to assess cystatin c as a predictive biomarker of early acute kidney injury in aneurysmal subarachnoid hemorrhage patients. The main question it aims to answer is:

- Does cystatin c biomarker can predict early acute kidney injury in aneurysmal subarachnoid hemorrhage patients?

Participants will be grouped into Aki and Non-Aki groups based on RIFLE criteria and Cystatin c biomarker will be tested to answer the study question.


Eligibility Criteria:
Inclusion Criteria:

* Patient admission to hospital within 48 hours of subarachnoid haemorrhage onset.
* Subarachnoid haemorrhage caused by intracranial aneurysm rupture and is confirmed via computed tomography angiography (CTA).
* Medical treatment, microsurgical clipping, or interventional endovascular treatment of aneurysm is performed within 48 hours of subarachnoid haemorrhage onset.

Exclusion Criteria:

* Prior onset of subarachnoid haemorrhage or other neurological diseases such as ischemic stroke, hemorrhagic stroke, or severe head trauma.
* Systemic diseases, such as chronic liver diseases, chronic lung diseases, chronic heart failure, thyroid diseases and cancer.
* Renal impairment at time of admission (creatinine-based eGFR less than 60 ml/min per 1.73 m2 body surface area).
* Patients who are hemodynamically unstable at time of admission.
* Mortality within 10 days after admission (duration of study).
Dexanabinol in Severe Traumatic Brain Injury

Each year a large number of patients are hospitalized at Shock Trauma Centers with severe head injuries. Bleeding into and swelling of these patients' brains may cause compression of vital structures, disability and death. Sometimes surgery is needed. Unfortunately, the investigators have no medication to treat the bad effects of head trauma. Part of the brain damage is due to toxic chemicals (including one called glutamate) that are released by the damaged nerves. Dexanabinol may prevent some of the bad effects of glutamate on the brain and may protect the brain against uncontrollable swelling and death.

Dexanabinol is a synthetic, non-psychotropic cannabinoid derivative that because of its dextro-configuration is compatible with activation of cannabinoid receptors in the brain. It combines the ability to block NMDA receptors and neuroinflammatory cascades in the same molecule. Dexanabinol scavenges free radicals, protects neurons from toxicity of free radical generators and inhibits lipopolysaccharide-induced production of prostaglandin E2, NO and TNF-a by macrophages in culture.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic head injury within the last 6 hours
* Glasgow Coma Motor score of 2 to 5; severity requires intracranial pressure (ICP) monitoring
* Brain computed tomography (CT) showing intracranial parenchymal abnormality and hemodynamically stable
* An informed consent

Exclusion Criteria:

* Penetrating head injury
* Spinal cord injury
* Coma due to pure epidural hematoma with initial Glasgow Coma Scale (GCS) of =\> 12
* Previous major cerebral damage
* Concomitant severe conditions
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes

The purpose of this investigation is to examine the mechanisms mediating vascular dysfunction in women who have had gestational diabetes and how metformin may be a valuable treatment tool to improve microvascular function in these women before the onset of disease.

Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.

The purpose of this investigation is to examine the mechanisms mediating vascular dysfunction in women who have had gestational diabetes and how metformin may be a valuable treatment tool to improve microvascular function in these women before the onset of disease. This study will give rise to a new line of research that will center around the goal of improving lifetime cardiovascular outcomes in women with a history of GDM.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had GDM. Local heating of the skin at the microdialysis sites is used to explore differences in mechanisms governing microvascular control. As a compliment to these measurements, the investigators also draw blood from the subjects and isolate the inflammatory cells.

Eligibility Criteria:
Inclusion Criteria:

* ≥12 weeks and ≤5 years postpartum
* history of GDM or healthy pregnancy

Exclusion Criteria:

* prediabetes or diabetes (HbA1c ≥5.7%)
* current tobacco use
* cardiovascular or metabolic disease
* cardiovascular or metabolic medication
* history of hypertension during pregnancy
* current pregnancy
Metabolic Syndrome and Inflammatory Markers

The metabolic syndrome has been recognized as a proinflammatory state. It has been shown that many different diets such as Mediterranean diet, DASH diet, Foods with low glycemic index and low saturated fat diet, independent of weight loss, may be effective in improving the metabolic syndrome. Our objective was to evaluate the effect of Ramadan fasting on High-sensitive C-reactive protein (hs-CRP) and fibrinogen levels in metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Males with metabolic syndrome

Exclusion Criteria:

* Conditions with insulin resistance including;
* Type 2 diabetes mellitus,
* Infections,
* Stresses,
* Uremia,
* Acromegaly,
* Glucocorticoid excess,
* Hypertension ,
* Cirrhosis and
* Any addiction or drug therapy and conditions witch cause changes in hs-CRP and fibrinogen levels including infection, trauma, infarction, inflammatory arthritis, various neoplasm and liver diseases.
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy

The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation.

The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).

The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis. Power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn System Driver.

The Destination Therapy trial is a prospective, randomized, unblinded, non-inferiority evaluation of the HeartMate II LVAS, compared to the HeartMate XVE.

Eligibility Criteria:
Inclusion Criteria:

The following are general criteria; more specific conditions are included in the study protocol:

* Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:

  * On optimal medical management and are failing to respond; or
  * In Class III or Class IV heart failure and dependent on IABP and/or inotropes; or
  * Treated with ACE inhibitors or beta-blockers and found to be intolerant.
* Ineligible for cardiac transplant
* VO2max \<=14 ml/kg/min
* LVEF \<=25%

Exclusion Criteria:

The following are general criteria; more specific conditions are included in the study protocol:

* Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
* Existence of factors that would adversely affect patient survival or function of the LVAS
* Intolerance to anticoagulant or antiplatelet therapies.
* Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
* Participation in any other clinical investigation that is likely to confound study results or affect study outcome
Prognosis and Virulence Determination of Capsule and Endotoxin During Klebsiella Spp. Ventilator-associated Pneumonias

Ventilator-associated pneumonia is the leading cause of nosocomial infection in the ICU. The pathogens responsible are multiple, but enterobacteria constitute a major source of pathogens involved. Within this family, Klebsiella spp. and Escherichia coli are the two most frequent genera, with Klebsiella spp. often present in severe forms. The factors associated with the occurrence of Ventilator-associated pneumonia and its adverse course depend on host defenses and the virulence of the pathogen. The virulence of Klebsiella spp. depends on several structures, notably the presence of a capsule, the particularities of its lipopolysaccharide, its adhesins (type 3 fimbriae), its capacity to capture iron (siderophores). The objective of this work is to evaluate the role of these different virulence mechanisms in the evolution of Ventilator-associated pneumonia and the hospital prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient whose age is ≥ 18 years
* Patient hospitalized in an intensive care unit
* Patient with ventilator-associated Klebsiella spp. pneumonia
* French-speaking patient

Exclusion Criteria:

* Patient with a severe psychiatric disorder
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient who objects to the use of his or her data for this research
Targeted Reversal of Inflammation in Pediatric Sepsis-induced MODS

The TRIPS study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS).

The TRIPS study is a prospective, multi-center, double-blind, adaptively randomized, placebo-controlled clinical trial of the drug anakinra for reversal of moderate to severe hyperinflammation in children with sepsis-induced multiple organ dysfunction syndrome (MODS). Eligible subjects will undergo centralized immunophenotyping on day 2 of MODS. Subjects without immunoparalysis (a whole blood ex vivo LPS-induced TNF-alpha production capacity \< 200 pg/ml) and a serum ferritin level of 500 - 2,000 ng/ml or a serum C-reactive protein (CRP) ≥ 4 mg/dl will be eligible for randomization, along with subjects with a serum ferritin level of 2,000 - 10,000 ng/ml regardless of their TNF-alpha response. Eligible subjects will receive intravenous (IV) anakinra at a dose of 4, 8, 12, or 16 mg/kg/day or placebo for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 40 weeks corrected gestational age to \< 18 years; AND
* Admission to the PICU or CICU; AND
* Onset of ≥ 2 new organ dysfunctions within the last 3 calendar days (compared to pre-sepsis baseline) as measured by the modified Proulx criteria; AND
* Documented or suspected infection as the MODS inciting event.

Exclusion Criteria:

* Weight \<3kg; OR
* Limitation of care order at the time of screening; OR
* Patients at high likelihood of progression to brain death in opinion of the clinical team; OR
* Moribund condition in which the patient is unlikely to survive the next 48 hours in opinion of the clinical team; OR
* History of myeloid leukemia, myelodysplasia, or autoimmune thrombocytopenia; OR
* Current or prior diagnosis of hemophagocytic lymphohistiocytosis or macrophage activation syndrome; OR
* Peripheral white blood cell count \< 1,000 cells/mm3 as the result of myeloablative therapyOR receipt of myeloablative therapy within the previous 14 days; OR
* Known allergy to anakinra, or E. coli-derived products; OR
* Known pregnancy; OR
* Lactating females; OR
* Receipt of anakinra or GM-CSF within the previous 28 days; OR
* Resolution of MODS by MODS Day 2; OR
* Previous enrollment in the TRIPS study.
Comparison of Dexmedetomidine and Meperidine for the Prevention of Shivering Following Coronary Artery Bypass Graft

This study aims to compare the effects of dexmedetomidine and meperidine on the incidence of shivering in patients undergoing CABG.

Shivering is a common complication in the postoperative period. The incidence of shivering has been reported to range from 5% to 65% under general anesthesia and as 33% during epidural anesthesia. Shivering can increase perioperative risk in patients. Both dexmedetomidine and meperidine are effective agents for the prevention of postanesthetic shivering. However, few studies have compared the anti-shivering effects of different agents following coronary artery bypass graft (CABG). This study aims to compare the effects of dexmedetomidine and meperidine on the incidence of shivering in patients undergoing CABG.

Eligibility Criteria:
Inclusion Criteria:

(1) aged between 18 and 75 years, (2) undergoing elective CABG, (3) ASA grade of II-IV, and (4) in accordance with ethical guidelines, patients must voluntarily participate in the trial and sign the informed consent for the clinical study.

Exclusion Criteria:

(1) patients with neurological or psychiatric disorders, (2) hepatic and renal dysfunction, (3) severe hyperthyroidism or hypothyroidism, (4) a body temperature greater than 38 °C or less than 36 °C, (5) postoperative hemodynamic instability, (6) preoperative use of a left ventricular assistance device, (7) pa severe diabetic complications (diabetic ketoacidosis, hyperosmolar coma, various infections, diabetic nephropathy), (8) participation in other clinical studies within the past 3 months, (9) acute or chronic pain, (10) addiction to opioids, (11) drug abuse, (12) pain management, and (13) neuromuscular disease, (14) on-pump CABG.
Evaluation of a Training Model for the Proficient Use of the Belmont Rapid Infuser

The Belmont Rapid Infuser is a device currently approved to replace larger volumes of necessary fluids such as blood in a fast and safe manner. The purpose of the study is to evaluate proficiency and the retention of knowledge of how to use the device based on current methods of training compared to revised training methods.

Hypotheses:

1. The use of the traditional method of training is not effective, predicting less then half of staff will pass on the first attempt.
2. Restructured test with hands-on training as opposed to oral presentation only with a written test will result in a pass rate of \> 80%.
3. Staff members who work in pairs will perform better than working alone when setting up the Belmont Rapid Infuser (BRI).
4. Retention at 3 months will be higher with the restructured training method than with the traditional training method.

Participants will be recruited to complete a test after undergoing either the traditional or the restructured training method. This training will be completed on one day and takes about 1 hour.

All participants who pass via either method of training are evaluated again to test retention 3-4 months later .

Eligibility Criteria:
Inclusion Criteria:

* Participants will be recruited from the faculty, Certified Registered Nurse Anesthetists, and fellows from the Department of Anesthesia at Cincinnati Children's Hospital Medical Center.
* They may have had educational exposure or use of the Belmont Rapid Infuser without independent assembly.

Exclusion Criteria:

* None
CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program

The purpose of the study is to compare assessments of arm function following a standard exercise program in chronic stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Single qualifying stroke event as confirmed by CT or MRI
* At least 1 month post stroke
* Score of at least 2-/5 on Manual Muscle Test for wrist flexors or extensors, indicating adequate movement to complete robotic device use
* Able to follow written instructions

Exclusion Criteria:

* Prior arm injury impacting available passive or active range of motion or significant arm pain with movement
* Underlying brain pathologies such as metastatic or primary brain malignancies, comorbid multiple sclerosis, etc.
* Prior significant drug or alcohol abuse
* Diagnosed with dementia
* Pre-stroke baseline modified Rankin Scale (mRS) \>3
* History of seizure/epilepsy
* History of clinically significant ischemic or hemorrhagic stroke prior to index stroke resulting in prior arm injury or weakness.
* Pregnancy
* Contraindication to MRI or Transcranial Magnetic Stimulation (TMS).
* Medical instability assessed by the treating stroke physician to participate to the study.
CaMaPi for Adolescents/Young People With a History of Self-harm and Suicidal Ideation in Jos, Nigeria

Suicide and self-harm are global disease burden that contributes significantly to years of lost life and mortality.

Self-harm and suicidal ideation represent a significant global public health concern (Knipe et al., 2022), affecting about 14.6 million people yearly (Nichols et al., 2021). Globally, over 700 000 people die by suicide annually (World Health Organization -- WHO, 2023).

Suicide is the fourth leading cause of death among 15-29-year-olds, and 77% of global suicides occur in low- and middle-income countries, including Nigeria (WHO, 2023). The psychological impact of suicidal ideation includes continuing high tendencies of self-harm (Jidong et al., 2024).

Despite the increasing rates of suicide and self-harm in Nigeria, this topic is understudied, with no culturally appropriate or sustainable psychological interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 16-24 years presenting to the participating services, and emergency departments or admitted after an episode of self-harm to the participating hospitals or self-referrals.
* Participants will have to be living within the catchment area of the participating practices, services and hospitals.
* Not needing inpatient psychiatric treatment.

Exclusion Criteria:

* Severe mental illness (such as Psychotic disorder).
* Conditions limiting engagement with assessment/intervention.
* Temporary resident unlikely to be available for follow up.