cyrilzakka/clinical-trials huggingface dataset:
PET Study of Cerebral Metabolism of 11C-acetoacetate and 18F-FDG in Patients Under Moderate Ketosis

Regional brain glucose hypometabolism occurs during aging and may contribute to the onset of aging-related cognitive impairment in humans. Ketones are the main alternative energy substrate to glucose for the brain. Several studies show that brain ketone uptake and metabolism are unaltered in cognitively-normal older persons and in Alzheimer's disease (AD). Nutritional ketosis is reported to have a positive impact on cognitive performances in mild cognitive impairment and AD. Nevertheless, changes in regional brain glucose and ketone uptake in adults are poorly understood during diet-induced experimental ketosis. The investigators hypothesis was that during diet-induced ketosis, brain ketone uptake would be directly correlated with the elevation of blood ketone levels and inversely correlated to brain glucose uptake.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* No signs of cognitive impairment

Exclusion Criteria:

* Not within the age limits
* Pregnancy or breast feeding
* Incapacity to withstand a supine position for 40 min
* Non lacunar infarction
* Known psychiatric history of schizophrenia, psychotic disorders, major affective disorders (bipolar disorder and major depression \<5 years), panic disorder, obsessive compulsive disorders and other conditions that may affect memory
* Epilepsy, brain trauma with loss of consciousness, subarachnoid hemorrhage
* History of alcool and/or substances abuse (excessive alcool consumption ≥10 drinks/weeks)
* Parkinson disease
* Down syndrome
* Inflammatory disease
* Abnormal blood pressure, liver or kidney function, blood count
* Dyslipidemia, hypothyroidism, osteoporosis
* Presence of a metal object in the body
Effect of Cilostazol on Endothelial Progenitor Cells and Endothelial Function in Coronary Artery Disease

1. The number and function of circulating endothelial progenitor cells (EPCs) are inversely associated with coronary risk factors and atherosclerotic diseases such as coronary artery disease (CAD) and cardiovascular high risk.
2. This double-blind, randomized, placebo-controlled trial to evaluate the effects of cilostazol on human early EPCs and endothelial function as well as the potential mechanisms of action in patients with CAD and cardiovascular high risk.

1. titration of drugs

   1. run-in period: eligible subjects are screened and baseline blood samples are obtained
   2. study period: 12 weeks

      * subjects with cilostazol and subjects with dummy placebo
      * On the first day after the end of the study period, the follow-up data are obtained by the same procedure
   3. blood sampling and measurement of serum biomarkers

      * obtained from peripheral veins in all study subjects at the run-in period and the end of the treatment period of the study
      * sent for isolation, cell culture, and assays of human EPCs
      * also stored for enzyme-linked immunosorbent assay (Stromal cell derived factor-alfa1, adiponectin, soluble thrombomodulin, vascular endothelial growth factor)
2. assays of human EPCs

   1. colony formation by EPCs
   2. quantification of EPCs and apoptotic endothelial cells
   3. chemotactic motility, proliferation/viability and apoptosis assays
3. measurement of flow-mediated dilatation (FMD) of left brachial artery by sonography
4. assessment of long-term cardiovascular outcomes

Eligibility Criteria:
Inclusion Criteria:

* stable CAD documented by stress test, computed tomography angiography or coronary angiography or
* old myocardial infarction (\>6 months)
* history and evidence of CAD
* history and evidence of cerebrovascular accident
* history and evidence of peripheral artery disease
* diabetes mellitus
* metabolic syndrome
* stage 3 to 5 chronic kidney disease
* at least 2 of the followings: male ≥45 years old or female ≥55 years old; hypertension; current or past 3-year tobacco smoking; hyperlipidemia; family history of premature CAD (male \<55 years old or female \<65 years old)

Exclusion Criteria:

* unstable CAD
* have plan to do percutaneous intervention or bypass surgery for CAD or peripheral artery disease within recent 3 months
* severe liver dysfunction (transaminases \>10 times of upper normal limit, history of liver cirrhosis, or hepatoma)
* left ventricular ejection fraction (\<50% by echocardiography)
* documented active malignancy
* chronic inflammatory disease
* known drug allergy history for cilostazol
* current use of cilostazol or any other cAMP-elevator
* premenopausal women
A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

The purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).

Bronchiolitis is a common admitting diagnosis for children less than 1 year of age. Although bronchiolitis has a high prevalence, there is a lack of a unified inpatient treatment plan beyond supportive care of supplemental oxygen and intravenous hydration. There have been many different approaches to the treatment of bronchiolitis, but none have conclusively proven to be beneficial. Several early studies show promise for the use of nebulized hypertonic saline, however the majority of these studies are done outside the United States and with adjunctive therapy. To date, the data suggesting that nebulized hypertonic saline is safe and effective for reducing length of stay in bronchiolitis is strong but not generalizable for the United States. The objective of this study is to conduct the first double-blind, randomized controlled trial in the United States of nebulized hypertonic saline without adjunctive therapy, including infants with bronchiolitis, including those with prior history of wheeze, to assess the effect on length of stay and therefore resource utilization.

Eligibility Criteria:
Inclusion Criteria:

* Patients 0-12 months of age admitted to the hospital with a diagnosis of bronchiolitis.

Exclusion Criteria:

* status asthmaticus
* chronic cardiopulmonary disease
* Trisomy 21
* immunodeficiency or transplant recipient
* neuromuscular disease
* admission directly to the intensive care unit
* previous use of nebulized hypertonic saline less than 12 hours prior to presentation
* previous enrollment in the study in the 72 hours prior to presentation
Efficiency and Usability of the Iontophoretic Patch Feeligreen Diclofenac in Treating Acute Osteoarthritic Knee Pain

The aim of the study is to evaluate the antalgic efficacity of Feeligreen® patch on osteoarthritic knee pain acute. This patch work by diffusion controlled by iontophoresis allowing an improvement of transdermal diffusion of active (Diclofenac).


Eligibility Criteria:
Inclusion Criteria:

* Patients with age above 70 years,
* Having a knee Arthritis (unilateral or bilateral) for at least 6 months,
* Pain intensity ≥ 40 mm on a visual analog scale (VAS)
* Lack of analgesic treatment or analgesic,

Exclusion Criteria:

* Cognitive disorders : moderate to severe stage or not allowing an understanding of the VAS (as determined by the clinician)
* A history of chronic inflammatory rheumatic disease,
* Diagnosis of osteoarthritis of secondary origin,
* Non-steroidal anti-inflammatory medication within 7 days prior to inclusion,
* Diagnosis of severe hepatic and renal insufficiency, gastrointestinal bleeding, severe heart failure,
* Allergy to diclofenac or similar activity substances such as other NSAIDs, aspirin, excipients,
* Damaged skin
A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of parsaclisib in the treatment of Japanese participants diagnosed with previously-treated B-cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* First generation Japanese; subject was born in Japan and has not lived outside of Japan for \> 10 years, and subject can trace maternal and paternal Japanese ancestry.
* Histologically confirmed aggressive/indolent DLBCL, FL, MZL, or MCL.
* Previously received at least 1 prior line of systemic therapy with documented progression, and there is no further effective standard anticancer therapy available.
* Willing to undergo an incisional or excisional lymph node or tissue biopsy or to provide a lymph node or tissue biopsy from the most recent available archival tissue.
* Life expectancy \> 3 months.
* Eastern Cooperative Oncology Group performance status of 0 to 2.
* Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

* Evidence of transformed non-Hodgkin's lymphoma histologies.
* Histologically confirmed, rare non-Hodgkin's B-cell subtypes.
* History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
* Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-phosphatidylinositol 3 kinase (PI3K) inhibitor.
* Allogeneic stem cell transplant within the last 6 months or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug.
* Active graft-versus-host disease.
* History of stroke or intracranial hemorrhage within 6 months of study drug administration.
* Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of the date of the first dose of study drug.
* Known human immunodeficiency virus infection.
* Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
A Multiple Baseline Design Study to Investigate the Effectiveness of OT-SI Using an Intensive Intervention Model

The investigators hypothesize that children completing 30 sessions of occupational therapy using a sensory integration approach (OT-SI) will demonstrate positive changes in outcome measures related to motor coordination, functional performance and sensory processing (changes pre-post test).


Eligibility Criteria:
Inclusion Criteria:

* Have a medical diagnosis of "lack of coordination" or "other coordination impairment"
* Children and caregivers able to communicate verbally in English
* Sensory processing impairments as determined by scores in the SPM-H form (screening). Scores must fall in the "definite dysfunction" range in one of three categories (Body Awareness, Balance \& Motion, or Planning \& Ideas), OR fall in the "some problems" range in 2/3 areas.

Exclusion Criteria:

* Diagnosed with autism spectrum disorder or other significant psychological impairment (e.g. bipolar disorder)
* Receiving occupational therapy services at CHoR or another therapy site for more than 3 months
* Significant motor impairment (e.g., cerebral palsy)
* Significant language impairment (e.g., non-verbal, or aphasia)
The Short-Term Effect of a Technology Driven Weight Control (SMART) Program for Obese Adults

The purpose of this study is to evaluate the short-term effect of a technology based weight reduction program for obese (BMI \> 30 kg/m2) adults in a primary care office.


Eligibility Criteria:
Inclusion Criteria:

1. Participant between the ages of 18-65 years.
2. Participant with a BMI (Body Mass Index \> 30.0 kg/m2)
3. Have access and use email a minimum of 2-days per week.

Exclusion Criteria:

1. Participant is not pregnant or lactating: Weight loss is not recommended for pregnant women and extra energy requirements are essential for fetal development (Butte, Wong, Treuth, Ellis, \& O'Brian Smith, 2004; Durnin, 1991).
2. Participant is not currently participating in any structured/self-help weight loss program. The elimination of individuals actively participating in a current weight loss program will reduce the potential of a carry-over effect from these weight loss modalities (Fife-Shaw, 2006).
3. Participant has not attempted weight loss in the past 3 months. Same as number two.
The Safety of Intravenous Tranexamic Acid in Patients Undergoing Supratentorial Meningiomas Resection

Growing evidence of Tranexamic Acid (TXA) being used to reduce blood loss and blood transfusions in various guidelines. However, the adverse effects of TXA especially seizure has always been a problem of concern, especially in neurosurgery. Therefore, this study aims to provide a scientific evidence for the safety of TXA in supratentorial meningiomas resection patients.


Eligibility Criteria:
Inclusion Criteria:

* 1) age 18-80 years
* 2) American Society of Anesthesiologist (ASA) classification score I\~III

Exclusion Criteria:

* 1) allergic to tranexamic acid
* 2) preoperative seizures
* 3) history of thrombotic disease
* 4) chronic kidney disease
* 5) breastfeeding or pregnancy
* 6) refuse to participate in the study
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

The objective of this investigation is to compare the cardioprotective effects and safety of two cardioplegic solutions, HTK Cardioplegic Solution (Custodiol) and Custodiol-N in patients undergoing aortic valve surgery. The study design is a prospective, double blind, multicenter, randomized, Phase III comparison study intended to demonstrate superiority in surgical outcome between Custodiol and Custodiol-N as determined by CK-MB peak value 4-24 hours after opening of the aortic cross-clamp (primary endpoint), catecholamine requirement (cumulative dose) and cardiac Troponin T, occurrence of comorbid events postoperatively (e.g., myocardial infarction).


Eligibility Criteria:
Inclusion Criteria:

* Patients \>/= 30 and \</= 85 years of age
* Male or female with aortic valve disease
* Able to understand character and individual consequences of the clinical trial and to provide written informed consent to participate in the study
* Women of childbearing potential (ie, those who have not undergone a hysterectomy or who have not been post-menopausal for at least 12 consecutive months) must test negative for pregnancy prior to bypass surgery.

Exclusion Criteria:

* History of recent (\< 6 weeks) Q-wave myocardial infarction
* Left ventricular ejection fraction \< 25% (as assessed by any one of the following: contrast ventriculography, multigated acquisition scanning \[MUGA\], or 2-D ECHO)
* Patients on intra-aortic balloon devices or with history of previous coronary artery bypass surgery
* Pregnant or lactating patients
* Patients who have participated in any other investigational studies within 30 days previous to enrollment
* Patients in cardiogenic shock (defined as a systolic BP \< 90 mmHg for over one hour despite inotropic and chronotropic support)
* Patients with severe chronic obstructive lung disease (FEV1 \< 50%)
* Previous cardiac valvular disease (clinical relevant)
* GFR \<60 ml/min
* Planned Ross-procedure, Mitral valve surgery, Aortic valve reconstruction, double valve surgery, other concomitant operations excluding coronary artery bypass surgery or closing a patent foramen ovale
* Evidence of severe organic (e.g. cirrhosis of the liver) or psychiatric disease by history or physical examination
* History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrollment.
Validation of the Spanish Version of the Clinically Useful Depression Outcome Scale (CUDOS) Scale

The Clinically Useful Depression Outcome Scale (CUDOS) is a brief, self-administered instrument that not only evaluates depressive symptoms but also both functioning and quality of life. The assessment of patients´ perspective may provide valuable information that could be lost if relaying only on clinician evaluation. The purpose of this study is to achieve a psychometric validation into Spanish of the CUDOS scale in patients with major depression disorder in a primary care setting.


Eligibility Criteria:
Inclusion Criteria:

* Major depression disorder diagnosis according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria in the last 3 months
* Major depression disorder diagnosis according to Prime-MD criteria in the last 3 months

Exclusion Criteria:

* Be unable to understand and comply with the study requirements as judged by the investigator
* Participation in another trial prior to enrolment into this study
The Burnout Syndrome in Emergency Department Triage Nurses

Assessment of burnout syndrome of triage nurses from Emergency Departments from Cluj-Napoca, Romania.

This study is aiming at assessing the burnout syndrome amongst triage nurses working in the Emergency Departments in Cluj-Napoca. The study design is observational, prospective and multicentric.

At this moment, there are 43 nurses covering triage shifts in the Emergency Clincial County Hospital Cluj and 18 more within Emergency Clinical Hospital for Children Cluj-Napoca. On average, these ED roughly attend 90.000 patients yearly.

Questionnaires are based on Copenhagen Burnout Inventory, with additional clinical cases that require triage coding according to The Romanian National Triage Protocol of 2016. Each triage nurse will complete the questionnaire when beginning the triage shift and after a period of 2, 4 or 6 hours.

Eligibility Criteria:
Inclusion Criteria:

* ED nurse within Emergency Clinical County Hospital Cluj and Emergency Clinic Hospital for Children Cluj-Napoca.

Exclusion Criteria:

* triage experience of at least 1 year
Evaluation of HQ® Matrix Medical Wound Dressing for Healing of Donor Site Wounds

The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Medical Wound Dressing for repair of donor site wounds. Half of participants will receive HQ® Matrix Medical Wound Dressing, while the other half will receive Sidaiyi® wound dressing.

HQ® Matrix Medical Wound Dressing is a transparent, non-porous, pliable, gas-permeable, and waterproof film dressing which is comprised of silk fibroin protein of the Bombyx mori (B. mori) silkworm. It is intended to provide a moist, gas-permeable and sterile environment to facilitate the normal wound healing process. It is used in the management of non-infected skin defects and various dermal wounds.

Sidaiyi® wound dressing (Suzhou Soho Biomaterial Science and Technology Co., Ltd, Suzhou, China) is a CFDA approved (Su2012-2640182), silk fibroin-based, two-layered spongy dressing. Upon the silk fibroin spongy dressing layer is a membrane made of medical silicone. It is used in the management of partial- and full-thickness wounds, donor site wounds and burns. Currently, it is the sole silk fibroin biomaterial for wound healing that has received regulatory approval worldwide.

Eligibility Criteria:
Inclusion Criteria:

1. Patients, aged from 18 - 60, male or female, with wet wounds or burns, ulcerative skin and soft tissue wound surfaces;
2. The wound surface area ranged from 20cm\^2 to 600cm\^2;
3. The patients had a clear mind and there was no misunderstanding;
4. The patients voluntarily signed the subjects' informed consent form and received timely follow-ups.

Exclusion Criteria:

1. Patients with active bleeding in wound surfaces;
2. Vasogenic diseases: patients with no blood supply or phlebothrombosis in local wound tissues;
3. Those allergic to silk materials;
4. Those with serious infection;
5. Those with coagulation disorders;
6. Those with tumors or diabetes;
7. Patients who, according to other doctors' opinion, are unsuitable to use this material for wound treatment.
Pharmacokinetics of Talsaclidine After Administration to Healthy Subjects

Study to investigate metabolism, pharmacokinetic, safety and tolerability of talsaclidine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Age range from 50 to 65 years
* Participants should be within 20% of their normal weight (Broca-Index)
* Written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria:

* Results of the medical examination or laboratory tests (especially those which indicate liver malfunction) are judged by the clinical investigator to differ significantly from normal clinical values
* Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Disease of the central nervous system (such as epilepsy) or with psychiatric disorders
* Known history of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (≥ 24 hours) within one month before enrolment in the study
* Intake of any other drugs which might influence the results of the trial during the week previous the start of the study
* Participation in another study with an investigational drug within the last 2 months preceding this study
* Unability to refrain from smoking on study days
* Volunteers who smoke more than 10 cigarettes (or 3 cigars or pipes) per day
* Volunteers who drink more than 40 g of alcohol per day
* Volunteers who are dependent on drugs
* Blood donation ((≥ 100 ml) within the last 4 weeks
* Excessive physical activities (e.g. competitive sports) within the last week before the study