cyrilzakka/clinical-trials huggingface dataset:
Optimization of PK/PD Target Attainment for Meropenem in Critically Ill Patients With Sepsis

WP1.1. PK/PD target attainment: Plasma exposure, Excretion via urine \& ELF exposure; WP1.2. Predictive dosing algorithm; WP1.3. ECMO subset

First, the investigators will document exposure to meropenem in plasma and epithelial lining fluid. Moreover excretion in urine will be documented.

Second, the investigators will try to identify risk factors for not attaining PK/PD target. Based on significant predictors for target non attainment a predictive dosing algorithm will be constructed.

Finally in a small subset of ECMO patients PK exposure will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Severe sepsis or septic shock
* Admitted to an ICU ward
* Treated with meropenem

Exclusion Criteria:

* eGFR(CKD-EPI) \< 70ml/min/1.73m²
* Renal replacement therapy
* Pregnancy
* DNR code 1-3
The Effect of Different Food Products on Post Prandial Blood Glucose in Pregnant Woman With Diabetes

During pregnancy nutrition demands change and the pregnant woman needs to adjust her food intake and take into consideration the corrected daily recommendations for micro and macro nutrients. Pregnant woman tend to suffer from hyperemesis and this affects their food choice.

Amongst pregnant women with Diabetes the glucose balance is extremely important during pregnancy. Glucose balance is a result of correct nutrition and an exact amount of insulin. This delicate balance requires from the pregnant women an ability to perform correct carbohydrate count.

Hyperglycemia has already been proven to affect the fetus and the neonatal outcomes. Hypoglycemia may also have a negative effect but the main danger is immediate harm to the mother and therefore to the fetus. For those reasons glucose balance is crucial and demands delicate synchronization of nutrition and insulin therapy.


Eligibility Criteria:
Inclusion Criteria:

* age 18-45
* women who suffer from type 1 diabetes, type 2 diabetes or gestational diabetes
* Do not suffer from any intestinal disease
* Accept to sign a consent form

Exclusion Criteria:

* over age of 45
* under age of 18
* suffer from any intestinal disease
* do not accept to sign a consent form
Incisional Vacuum Assisted Closure (IVAC) Device and Its Effect on Implanted Bone Morphogenic Protein (BMP-2)

People who have been scheduled for surgery using Bone Morphogenic Protein (called BMP-2) and an incisional vacuum assisted closure device (called IVAC) will be asked to join this study.

The purpose of this study is to see if using the IVAC device removes BMP-2 from the wound. BMP-2 is a protein used by the body to increase bone healing, decrease the need for additional surgery, and reduce infection rates.

The IVAC is a device that involves a foam dressing secured with an adhesive drape to make an airtight seal over a surgical incision. Tubing runs from the foam dressing to a device that uses gentle suction to drain fluid out (like a vacuum). The IVAC stays on for 48-72 hours depending on amount of drainage. The IVAC by itself helps reduce wound swelling and complications (such as infection).

It is hypothesized that the negative pressure associated with an IVAC is not sufficient to remove BMP-2 from a surgical wound.

BMP-2 is commonly used in open tibia fractures at the time of definitive wound closure, and these wounds are prone to increased swelling and wound complications. The recent observation that IVAC decreases wound edema and increases oxygenation has led to their use in such cases. Used in conjunction, it is entirely possible that the negative pressure exerted by the IVAC can remove BMP-2 from surgical site and therefore decreases the effectiveness of BMP-2. We seek to determine if BMP-2 is present in effluent from the IVAC. If in this study the hypothesis is found to be wrong, and BMP-2 is found within the IVAC effluent, we are prepared to proceed with a follow-up study to quantify the BMP-2 removed by the IVAC.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older
* Subject has tibia fracture requiring treatment with BMP-2
* Subject to have an Incisional Vacuum Closure (IVAC) Device, placed on the skin directly over the BMP-2 implantation site
* Subject/guardian able to provide informed consent

Exclusion Criteria:

* Subject is less than 18 years old
* Subject has a wound at fracture/surgical site that cannot be closed
* Subject/guardian unable to provide informed consent
Effect of Russian Current Stimulation for Anterior Tibial Group on Postural Stability and Risk of Falling in Patients With Stroke

This study aimed to examine the effect of Russian current stimulation on Anterior tibial group on postural stability and risk of falling in patients with stroke.

Stroke is the second leading cause of death globally and the main cause of disability, with ischemic strokes accounting for about 87% of cases. In 2010, over 11 million ischemic strokes occurred, predominantly in low and middle-income countries, leading to approximately three million deaths. Hemorrhagic strokes account for 13% of cases.

Egypt, with an estimated population of 85.5 million, has a high stroke prevalence of 963 per 100,000 inhabitants. Postural imbalance is a common limitation, affecting 83% of acute stroke patients, and falls are frequent across all stages of recovery, with rates as high as 73% within six months post-discharge. Even in chronic stroke patients, the fall risk remains elevated compared to age-matched controls. Postural imbalance impacts quality of life, and rehabilitation is vital for regaining independence in daily activities.

Up to 30% of stroke survivors experience significant permanent disabilities, and 20% require rehabilitation. Motor impairments, particularly in the lower limbs, limit daily activities, community participation, and quality of life. Poor lower-limb muscle performance affects balance, gait, and functionality, but interventions like Russian current have shown effectiveness in improving walking performance and motor recovery in chronic stroke survivors.

Eligibility Criteria:
Inclusion Criteria:

* Forty patient with stroke manifest with weakness of anterior tibial group.
* Patients with moderate spasticity,
* Patient's ages ranged from 40-55 years.
* Patients BMI not exceed 30 kg/m².
* Medically and clinically stable patients.

Exclusion Criteria:

* Patients suffering from psychological, cognitive, or emotional disturbance.
* Patients with severe spasticity (3 or more by the modified Ashworth scale).
* Patients with atrial fibrillation.
* Patients with infectious processes.
* Patients with impaired pain sensitivity.
* Patients with epilepsy.
* Patients with lower limb joint endoprosthetics.
Treatment of Melasma With Stabilized Kligman Preparation Associated or Not With Pulsed Dye Laser

Melasma is an acquired disorder of pigmentation that leads to irregular pigmented patches on the face. Treatment is difficult and to date the best treatment option is the combination of hydroquinone, retinoic acid and steroids combined in topical daily application (called Kligman's trio). Q-switched pigmentary lasers are usually ineffective and can induce post inflammatory hyperpigmentation (PIH). Intense pulsed light can sometimes improve melasma but also induce PIH which limit their use. Recently, pulsed dye laser were demonstrated to be effective in treating some pigmentary defects. Associating blanching cream with hydroquinone to prevent PIH after laser or intense pulsed light has been already reported with success.

The objective of the study is to compare in a prospective intra individual comparative trial the association of pulsed dye laser plus stabilized Kligman's trio to Kligman's trio alone. The secondary objective was to study the frequency and the intensity of the potential side effects including PIH.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women or breastfeeding.
* Skin type 5 or 6.

Exclusion Criteria:

* Known allergy to the compounds of the Kligman preparation.
* Refusal to put very high protection sunscreen during the study.
* Concomitant use of topical products that might have an effect on melasma (topical steroids, retinoids, etc...)
Exercise and Muscle Stimulation in Patients With Knee Osteoarthritis

Objective: To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) combined with closed kinetic chain (CKC) exercises in patients with knee OA.

Abstract:

Introduction: Osteoarthritis (OA) is a degenerative and debilitating change that affects the synovial joints.

Objective: To evaluate the effectiveness of neuromuscular electrical stimulation (NMES) combined with closed kinetic chain (CKC) exercises in patients with knee OA.

Methods: Nineteen patients with knee OA were enrolled and randomized into two groups: group I was treated with CKC + NMES, and group II was treated with CKC + NMES placebo. Both groups underwent 20 sessions of mini-squat exercises at 30 degrees of knee flexion that were associated with and interspersed with NMES for 5 minutes at a frequency of 40 hertz (Hz), 10 minutes at 70 Hz and an addition 10 minutes at 150 Hz, for a total of 25 minutes. The data were analyzed using SPSS (Statistical Package for the Social Sciences) version 17.0. Data were expressed as a frequency, mean and standard deviation and were statistically analyzed using a one-way analysis of variance (ANOVA) for repeated measurements followed by Bonferroni's post-hoc test. The investigators also used an unpaired Student's t-test and Kruskal-Wallis and Wilcoxon tests with a level of significance of P \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* patients with grade I or grade II knee OA (based on the Kellgren-Lawrence classification;
* which was diagnosed by a medical traumatologist;
* radiographic changes that demonstrated a reduced joint space in at least one of the compartments of the knee;
* subchondral bone sclerosis;
* consent to participate in the study

Exclusion Criteria:

* patients who had grade III and grade IV knee OA (based on the Kellgren-Lawrence classification);
* who were involved in another rehabilitation program outside the center;
* who presented with clinical symptoms that would prevent them from participating in the exercises;
* who had heart disease;
* cardiac pacemakers;
* periarticular metal implants;
* who experienced changes in sensitivity;
* who had a previous history of knee injury (meniscus, ligaments, sprains);
* who had uncontrolled diabetes;
* neurological disorders with cognitive impairments;
* rheumatic diseases;
* history of knee trauma in the last six months;
* prior knee surgery;
* three consecutive unexcused absences.
Social Media Markers of Adolescents' Suicide Hazard

Suicide is the 2nd leading cause of death for teenage youth in Canada, and every year tens of thousands of young people engage in suicidal behaviors. Many young people manifest red-flag behaviors in the digital realm before these incidents occur. The faceless nature of online communication often emboldens youth to reveal details about their mental state: leaving tell-tale signs or "bread crumbs" of their suicidal intentions or behaviors.

This research will examine the content of adolescents social media entries to find red flags and detect patterns in social media interactions of adolescents that could be predictive of subsequent suicide risk. The study participants will be patients admitted to Child and Adolescent Psychiatry Emergency unit at BCCH, subdivided into two groups: those admitted due to suicidal behaviors, and those admitted for non-suicidal behaviors. The text of social media activity for the month prior to emergency admission of the two groups will be collected, anonymized, and analyzed using text-analytic algorithms. The objective of the study is to find patterns and indicators of social media entries, prior to admission, that would have been predictive of suicidality.

The implications of successful outcome of this project for mental health care of children and adolescents reaches well beyond the scope of this study. An objective method to predict risk of suicidal behaviors in youth has application in almost all pediatric clinical settings. The outcomes of this project will also serve as the foundation for further utilization of social sensing technology to identify, predict, and prevent many other mental health crises in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* use social media
* patient of BCCH

Exclusion Criteria:

* no use of social media
The Synchronized Trial on Expectant Mothers With Depressive Symptoms by Omega-3 PUFAs (SYNCHRO): Open Trial

The present study aims to examine the efficacy and safety of omega-3 polyunsaturated fatty acids for pregnant women with depressive symptoms.

Maternal depression can have a significant harmful influence on both mothers and children. Considering the possibility of adverse effects of antidepressants and previous meta-analyses showing the positive effects of omega-3 polyunsaturated fatty acids (PUFAs) supplementation in reducing depressive symptoms, omega-3 PUFAs may provide a safe strategy. The investigators evaluate efficacy and safety of omega-3 PUFAs for pregnant women with depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. pregnant women aged 20 years or older
2. between 12-24 weeks gestation
3. a Japanese conversational ability in Japan site or a Mandarin conversational ability in Taiwan site to understand the scope of the present trial and to provide written consent for study participation
4. planned to return to the hospital for checkup at 4-6 weeks after childbirth
5. an Edinburgh Postnatal Depression Scale (EPDS) score is 9 or more
6. to have good physical health judged by obstetricians.

Exclusion Criteria:

1. history and current suspicion of psychosis or bipolar I disorder or substance-related disorder or eating disorder or personality disorder
2. the item of EPDS concerning suicide ideation is 2 or more
3. other serious psychiatric symptoms such as self-harm behavior or in need of rapid psychiatric treatment
4. difficult to expect a normal birth (ex: fetal malformation etc.)
5. having a history of bleeding disorder such as von Willebrand's Disease
6. regular treatment with aspirin or warfarin within the last 3 months
7. a smoking habit of ≥40 cigarettes per day
8. regular treatment with ethyl icosapentate or regular consumption of omega-3 PUFA supplements within the last 3 months
9. a habit of eating fish ≥4 times per week.
Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease

This study evaluates the efficacy of the addition of prednisolone to conventional initial treatment (intravenous immunoglobulin \[IVIG\] plus aspirin) in reducing coronary artery lesion in children with Kawasaki disease (KD) .

This is a multicenter, open-label, blind-endpoints, randomized controlled trial at more than 10 hospitals in China. The investigators enrolled KD children diagnosed within 10 days of onset. Participants will be randomly assigned in a 1:1 ratio to the control group (receiving 2g/kg IVIG and 30 mg/kg aspirin) or the intervention group (receiving 2 g/kg IVIG, 30 mg/kg aspirin and additional 2 mg/kg prednisolone). Baseline characteristics of each participant will be collected, including sex, age of onset, height, body weight, subtype of KD, fever days before initial IVIG, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at admission, 2 weeks, 1 month, 3 months, 6 months，and 12 months after onset of KD to assess the coronary artery lesions.

Eligibility Criteria:
Inclusion Criteria:

* Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2017
* Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
* Not treated with IVIG yet
* Age ≥1 month

Exclusion Criteria:

* Z score of any coronary artery before initial treatment ≥10
* Receiving steroids or other immunosuppressive agents in the previous 30 days
* With a previous history of KD
* Afebrile before enrolment
* With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza
* With serious immune diseases such as immunodeficiency or chromosomal abnormalities
Changes in Renal Artery Movement Due to Respiration Before and After Fenestrated Endovascular Repair

Purpose: The purpose of this study is to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. Then, the renal artery segment with maximal angular displacement on each will be located and any changes described.

Participants: There will be 30 subjects recruited from UNC Hospitals.

Procedures (methods): For this study, patients will receive an additional CT sequence (end-expiration CT), which will be compared with the standard of care end-inspiration CT to calculate angular displacement and the distance from the aorta.

The investigators would like to evaluate the location within the renal artery of maximal angular displacement before and after fenestrated endovascular aortic repair (FEVAR) using CT with end-inspiration and end-expiration CT images before and after repair. The investigators would then locate the renal artery segment with maximal angular displacement on each and describe any changes. Because these patients would be getting pre and post-surgical CTs as part of standard of care, there would be no added charge to obtain the information for the study. There would be, however, minimal increased radiation exposure resulting from the extra scan being performed during end-expiration and the patients would have to consent to the slight added risk to participate.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing pre-procedural CT scan for FEVAR

Exclusion Criteria:

* Has aortic/renal stent already
* Cannot receive IV contrast due to renal insufficiency or allergy
* Renal arteries are not patent
Patient Compliance With the Spirometry Protocol

OBJECTIVE: In this study, the effect of brochure-based and video-assisted information given before spirometry on patient compliance will be evaluated.

PATIENTS AND METHODS: This is a randomized controlled clinical trial. Before the test, subjects in the intervention groups will be shown a brochure explaining the steps of the spirometry protocol and a video prepared for the same purpose. Standard routine information will be given to the control group by the technician before spirometry.

RESULTS: 450 patients will be included in the study. It will be investigated whether there is a difference in terms of test compliance between compliance status and age, gender, smoking status, presence of lung disease, spirometry indication, having spirometry for the first time and those receiving brochure, video and brochure-video information. Multivariate analyzes will be performed among the parameters found to be significant.


Eligibility Criteria:
Inclusion Criteria:

* Patients sent to the spirometry laboratory for forced vital capacity maneuver

Exclusion Criteria:

* illiterate and had communicational, hearing and visual impairment were excluded
Perioperative Monitoring to Assess Preoperative Anxiety in Inflammatory Bowel Disease Patients

Anxiety and depression are extremely common among Inflammatory Bowel Disease (IBD) patients undergoing surgery and may increase the risk of postoperative adverse outcomes. This study aims to objectively evaluate preoperative psychological distress by remotely measuring the patient's physiological parameters and Heart Rate Variability (HRV) with the Howdy Senior ® device (Comftech Srl). Additionally, the study will also investigate the feasibility and effectiveness of the Howdy Senior® device in improving the postoperative patient's monitoring.

Inflammatory Bowel Disease (IBD) patients are at high risk of postoperative complications and delayed recovery. Preoperative anxiety and low patient's awareness of the disease may increase the risk of postoperative complications inducing an autonomic impairment which may in turn determine an inflammatory unbalance. This correlation can be confirmed through the preoperative monitoring of the autonomic function- with wearable electrocardiogram (ECG) devices. The Howdy Senior® device (ComfTech Srl) allows the real-time remote ECG monitoring and the computation of stress and fatigue indexes.

The Howdy Senior® device may also provide a reliable tool for remotely monitoring the patient's clinical parameters after discharge.

This study aims to explore the pathophysiological mechanisms linking preoperative anxiety and autonomic response and assess the feasibility and effectiveness of the Howdy Senior® device for the postoperative patients' remote monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged more than 18 years old.
* Established Crohn's disease (CD) or Ulcerative Colitis (UC) at the time of surgery indication with a proven histological diagnosis.
* Patients scheduled for elective intestinal resection.

Exclusion Criteria:

* Diagnosis of Undetermined Colitis.
* Recurrent disease.
* Concomitant diagnosis of malignancy.
* Established diagnosis of major depressive disorder or anxiety disorder.
* Diagnosis of ventricular or supraventricular arrythmia.
* Active pharmacological treatment with β-blockers or other drugs affecting the heart rate.
* Known hypersensitivity to cotton or silver.
* Emergent surgery.
* Planned open surgery.
* Any concomitant surgery unrelated to the main surgical indication. Patients undergoing perianal surgery for related perianal disease can be included in the study.