cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Apixaban in Patients With Short Bowel Syndrome Requiring Long Term Parenteral Nutrition

Short bowel syndrome (SBS) is defined as a loss of function of the small intestine resulting in a malabsorptive disorder. In SBS, oral drug absorption may be altered due to extensive intestinal resection. It remains unclear to what extent apixaban exposure is impacted in SBS.Therefore this study tries to investigate the pharmacokinetics (PK) of apixaban in adult patients with SBS requiring long-term parenteral nutrition (PN).


Eligibility Criteria:
Inclusion criteria SBS single dose:

- patients with SBS (small bowel length of \<2m after Treitz ligament) on long term (\>3 months) PN or fluids who are apixaban-, vitamin K antagonist- and teduglutide naive

Inclusion criteria SBS steady-state:

- patients with SBS (small bowel length of \<2m after Treitz ligament) on long term (\>3 months) PN or fluids who are teduglutide naive and who are already taking apixaban 2,5 mg or 5 mg twice daily for ≥ 4 days

Inclusion criteria non-SBS single dose:

- healthy individuals without history of GI resections or other conditions associated with impaired absorption, who are apixaban- and vitamin K antagonist naive

Inclusion criteria non-SBS steady-state:

- patients without history of gastrointestinal resections or other conditions associated with impaired absorption (= controls), who are already taking apixaban 2,5 mg or 5 mg twice daily for ≥ 4 days

Exclusion criteria SBS (single dose+ steady-state):

* \<18 years
* non-Dutch speaking
* recent (\<6 months) major bleeds according with the International Society on Thrombosis and Haemostasis definition of major bleeding in non-surgical patients (20)
* creatinine clearance of \< 15 mL/min or dialysis dependent
* liver failure classified as Child Pugh C
* total bilirubin ≥ 1.77 mg/dL (= 1,5 x upper limit of normal)
* presence of coagulopathy and a clinically relevant bleeding risk
* pregnancy or lactation
* concomitant intake of strong combined inhibitors of CYP3A4 and P-gp
* participation in a recent (\<1 month) trial with an investigational product
* recent (\<6 months) gastrointestinal surgery
* gastrointestinal mucosal disease interfering with absorption (e.g. radio-enteritis, inflammatory bowel disease, celiac disease, ...)
* gastrointestinal fistulae
* SBS with intestinal failure resulting from gastric bypass surgery

Exclusion criteria non-SBS (single dose+ steady-state):

* \<18 years
* non-Dutch speaking
* recent (\<6 months) major bleeds according with the International Society on Thrombosis and Haemostasis definition of major bleeding in non-surgical patients (20)
* creatinine clearance of \< 15 mL/min or dialysis dependent
* liver failure classified as Child Pugh C
* total bilirubin ≥ 1.77 mg/dL (= 1,5 x upper limit of normal)
* presence of coagulopathy and a clinically relevant bleeding risk
* pregnancy or lactation
* concomitant intake of strong combined inhibitors of CYP3A4 and P-gp
* use of prokinetics, antimotility drugs or opioids
* participation in a recent (\<1 month) trial with an investigational product
Healthcare Worker Resilience as Measured by Physiologic Feedback

Reliably achieving peak performance requires balancing the strain of the prior day with sufficient recovery to be ready for the next day. Surgery has a long standing tradition long hours of hard work often at the expense of adequate sleep. Decreased sleep and recovery has physiologic consequences which can be measured using biometric data. The goal of this study is to quantify surgeon performance and biometric data to understand how modifiable behaviors including mindfulness training and diet can maximize recovery and performance. The goal of this study is to quantify the impact if modifiable daily behaviors including sleep, nutrition, in order to understand the factors that contribute to high level performance, burnout, and physician wellbeing in surgical trainees and attendings.

Informed consent will be obtained prior to participation in the research study. A member of the research team will provide the participant with the consent form and allow them adequate time to read and ask questions prior to giving consent. If consent is not obtained, the participant will not be allowed to participate in the research study.

Participants will be asked to wear a biometric sensor for six months. The biometric sensor (The WHOOP strap) collects heart rate, heart rate variability, activity, and sleep metrics. Half of the participants will complete coaching to improve resilience with Arena Strive and half will be a control group instructed that sleep is important. In the latter 3 months of the study, the control group will have the opportunity to wear a continuous glucose monitor. At the completion of the study period all participants will have access to Arena strive coaching.

Other data gathered will be in the form of surveys and comments from subjects on wellness, burnout, modifiable activities including sleep, nutrition, glucose levels using continuous glucose monitoring, exercise and mindfulness.

Eligibility Criteria:
Inclusion Criteria:

* Study participants will include full time clinically active healthcare workers

Exclusion Criteria:

* Exclusion criteria will be anyone who is not a full-time clinical healthcare worker
ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)

Acute GVHD following allogeneic HCT is an immune-triggered process, leading to profound immune dysregulation and organ dysfunction. Despite pivotal advances, aGVHD is one of the leading causes of non-relapse mortality in patients undergoing HCT.

Placenta-derived DSCs, isolated from the fetal membrane of maternal origin, are a type of stromal cells with well-characterized immunosuppressive properties. The current study is designed to assess the safety and efficacy of 4 intravenous (IV) doses of ASC930 DSC cells in aGVHD patients.


Eligibility Criteria:
Inclusion Criteria:

* Participants ≥ 2 months of age
* Diagnosis of aGVHD grade II-IV following allogeneic HSCT according to standard criteria (Harris, 2016).
* Diagnosis of SR-aGVHD according to Mohty (2020)
* Meet one of the following criteria:

  * Participants who are Ruxolitinib-refractory, according to Mohty (2020)
  * Participants who are not eligible for SOC therapy
  * Participants who agree to receive ASC930 as a second-line therapy
* Karnofsky/Lansky Performance Status of at least 30 at the time of study entry
* Minor participants must be capable of giving written assent as appropriate per the applicable age (per local regulatory requirements).

Exclusion Criteria:

* Diagnosis of active Hepatic Sinusoidal Obstruction Syndrome (SOS)
* Presence of an active uncontrolled infection
* Active treatment for a hyprecoagulation disorder
* Evidence of diffuse alveolar hemorrhage or other active pulmonary disease
* Evidence of encephalopathy as defined by a change in mental status since the onset of aGVHD
* Evidence of relapse of malignancy
* Receival of agents other than steroids for primary treatment of aGVHD
* Severe allergic history to cell-based products
Emotion Regulation Training for Adolescents With ADHD

The goal of this single-case study is to pilot and evaluate a new psychological intervention (SKILLS-ER) targeting emotion regulation in adolescents with ADHD. Participants (n=9; 13-18 years of age) and their parents will partake in the intervention consisting of a total of eight sessions.

Attention-Deficit/Hyperactivity Disorder (ADHD) results in functional impairment across several life domains and is associated with high comorbidity rates and negative long-term outcomes. For adolescents with ADHD, emotional dysregulation constitute an increasing health problem. The ability to regulate one's emotions has been suggested as a major candidate for transdiagnostic sources of risk and/or resilience. A sample of adolescents (n=9; 13-18 years of age) with ADHD and emotion dysregulation will participate in an emotion regulation intervention (SKILLS-ER) in order to evaluate feasibility, potential effectiveness and to detect mechanisms that could strengthen adaptive regulation skills. The emotion regulation programme will include eight weekly sessions, and although primarily directed towards the adolescent, parents will be invited and participate in some sessions. The researchers will apply a single-case multiple baseline design across participants with repeated measurements and pre-intervention baselines at different lengths (5, 6 and 7 weeks) to which participants are randomized. The researchers will analyze the data with a combination of visual and quantitative analyses, see study protocol and statistical analysis plan.

Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosis
* Self- and/or parent-rated emotion regulation difficulties, as indicated via the Emotion Questionnaire (EQ).

Exclusion Criteria:

* Intellectual disability
* Autism
* Psychosis
* Bipolar disorder
* Severe depression
* Non-stabilized medication for ADHD at intake (if on medication for ADHD)
* Other ongoing psychological treatment
Stroke Prognosis in Intensive CarE

The S.P.I.C.E registry is an investigator-initiated prospective multicenter cohort study which will be conducted in 35 ICUS in the Paris area.The aim of the study is to determine the trajectory of acute stroke patients requiring invasive mechanical ventilation, focusing on functional outcomes at 3 months and 1 year following ICU admission. This project is funded by the French Agence Régionale de Santé (ARS).


Eligibility Criteria:
Inclusion criteria:

* Age\>18 years
* Acute stroke (acute ischaemic stroke, brain hemorrhage, subarachnoid hemorrhage). The stroke diagnosis date is defined by the date of the initial brain imaging (TDM or MRI).
* Admitted to ICU within 7 days before or after the diagnosis of stroke.
* Requiring invasive mechanical ventilation in ICU for more than 24 hours.

Exclusion criteria:

* Traumatic causes of stroke
* Refusal of the patient, or his reliable person, to participate in the study.
* Privation of liberty by administrative or judicial decision
Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer

The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

This study was terminated on April 22th, 2010, based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that sunitinib did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer. Patients on sunitinib who are judged by the investigator as receiving clinical benefit may chose to remain on study and continue treatment with sunitinib until clinical benefit as per the investigator's judgment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed diagnosis of hepatocellular carcinoma
* presence of measurable disease by radiographic imaging
* Child-Pugh class A
* ECOG PS 0 or 1
* adequate organ function.

Exclusion Criteria:

* Prior treatment with any systemic treatment for hepatocellular carcinoma
* prior local treatment within 4 weeks from entry
* presence of clinically relevant ascites
* severe hemorrhage \<4 weeks of starting study treatment
* known HIV or serious acute or chronic illness
* current treatment on another clinical trial
* pregnancy or breastfeeding
Better Sleep in Psychiatric Care - ADHD Pilot Study

Comorbidities, including sleep problems, are common in adult Attention Deficit Hyperactivity Disorder (ADHD). Treatment of choice for insomnia is cognitive behavioral therapy (CBT-i), but evidence is lacking for CBT-i in patients with ADHD and sleep problems.

The purpose of this study was to investigate if patients at a specialist clinic for ADHD benefit from a group delivered CBT-i treatment; whether insomnia severity improves following this treatment.

This pragmatic within-group pilot study with a pre to post and three-month follow-up design was set at a specialist psychiatric out-patient clinic for adult ADHD.

As an adjunct to care-as-usual at the clinic, a CBT-i-based group treatment targeting sleep problems prevalent in the ADHD-population, designed for patients with executive difficulties, was offered as 10 weekly 90-minute group sessions and scheduled telephone support.

All outcome measures were subjectively reported by participants. Data analyzed with dependent t-tests according to intent-to-treat.


Eligibility Criteria:
Inclusion Criteria:

* being a patient at the clinic (i.e. having a diagnosis of AD(H)D)
* self-reported sleep problems
* returning pre-treatment questionnaires and signed consent form

Exclusion Criteria:

* none
Can a Pulmonologist Reliably Assess the Tumor Burden on ROSE Slides Obtained From Pulmonary Nodules and Lymphadenopathy

The study is aimed at verifying if a pulmonologist can reliably assess the tumor burden for the extractive molecular analysis in ROSE samples obtained with endoscopic sampling procedures from intrathoracic lymphadenopathy and pulmonary nodules.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Indication for endoscopic sampling of suspected malignant lymphadenopathy or pulmonary lesion
* Written informed consent

Exclusion Criteria:

* High risk conditions for the performance of bronchoscopy and/or EBUS-TBNA
* High risk condition for deep sedation (ASA 4)
* Pregnancy
Creation of an Image Database for the Development of a Computer Aided Diagnostic (CAD) System in Patients With Prostate Cancer

Prostate cancer is currently detected by ultrasound-guided biopsy. Computer-aided diagnostic (CAD) systems based on multiparametric MRI are now capable of detecting most aggressive cancer foci non-invasively, but additional progress is needed for the technique to be accepted in clinical practice. We hypothesize that combining MRI and ultrasound imaging can improve the detection of cancerous tumors. As a first step in this direction, we need to create a database with MR images, 3D ultrasound images, and corresponding histopathology results, in patients treated by radical prostatectomy for prostate cancer. This is the purpose of the present study.

In a later stage (outside the scope of this study), we will be learning how to combine these images to best recognize cancerous tumors, we will use that knowledge to develop a new CAD system, and we will assess the performance of the new CAD. We expect this future system to improve the detection of prostate cancer and to reduce the number of patients requiring biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Patient referred for radical prostatectomy
* Patient with multiparametric prostate MRI (3T) performed in our institution (Edouard Herriot Hospital) in the year preceding the surgery
* Informed consent signed
* Patient affiliated to the French Health Insurance system

Exclusion Criteria:

* History of prostatic surgery or radiation therapy (prostatic or pelvic)
* History of hormone therapy for prostate cancer
* Previous surgery of the abdomino-perineal region, or other contraindication for transrectal ultrasound
* Patient on protection of the court, under supervision or under trusteeship
* Inability to express a consent
Evaluation of Culture-specific Popular Music as a Mental Metronome for Cardiopulmonary Resuscitation

Abstract

Introduction

Bystander cardiopulmonary resuscitation (CPR) can more than double the patient's chance of survival in Out-of-hospital cardiac arrest (OHCA). In Singapore, bystander CPR rate was low. Recent studies have proposed and validated the use of popular songs as aids in performing CPR. These songs may not be widely known when applied to a different population, and further, may lose popularity over time. "Count on me Singapore" (COMS) is believed to be known to over 90% of the Singapore population. Pilot data indicated that CPR performed using COMS as a mental metronome (COMSCPR) can achieve guideline-compliant rate of chest compression with lower fatigue level than CPR guided by the conventional "one-and-two-three-and" (Standard CPR). The investigators hypothesize that COMSCPR is non-inferior to Standard CPR in achieving guideline-compliant rate of chest compression.

Methodology

The investigators planned a prospective, randomized, crossover non-inferiority trial comparing COMS CPR and Standard CPR. 80 eligible volunteers will be recruited from a convenience sample of camp personnel from a military training camp. After a 15 minutes familiarization session, they will be randomized into two groups (A and B). Group A will proceed to perform one cycle (two minutes) of Standard CPR, while group B will proceed to perform one cycle of COMS CPR. participants will cross over to perform one cycle of the other method of CPR. After completing this second cycle, a survey form will be administered. The Laerdal SkillReporter will be used to measure the CPR performed. After a 7-14 days interval, participants will be recalled to attend a test scenario. Statistical analysis will be used to compare the two arms.


Eligibility Criteria:
Inclusion Criteria:

* All volunteers are eligible. This mimics a real world situation where any trained member of the public can provide bystander CPR.

Exclusion Criteria:

* Lack of informed consent
* Existing medical conditions that may cause danger to the participant (e.g. cardiac conditions or musculoskeletal injuries)
* Recent CPR course attended (within past one month)
Fish Oil (Omega 3 ) in Sjogren's Syndrome

Sjögren's syndrome (pSS) is an autoimmune disorder affecting mainly the exocrine glands.this lead to dryness of the main mucosal surface ,such as the mouth ,eye,skin nose,pharynx,larynx and vagina . The history of the disease is characterized by a slowly progression of sicca symptoms and fatigue; however, a subset of patients would experience extra glandular activity. Lipid mediators derived from polyunsaturated fatty acids, related to inflammation and immune response regulation. In this sense, the polyunsaturated fatty acids omega-3 (ω-3 FA) have been associated with several illnesses such as cancer, cardiovascular disease and autoimmune diseases and their balance at the cellular membranes can result in an anti-inflammatory .

this is a randomized double -blind placebo -controlled clinical trial .the participants will be randomize into two groups .Group 1 receive dietary omega-3 supplementation (omega-3 group) whereas Group 2(placebo group) receive a placebo . The two types are similar to each other in the form of soft gel ,both are given two times daily for two months with follow-up of patients whom they full fill the inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Age≥ 18 and ≤ 70 years old .
* Able to provide inform consent
* Patients diagnosed as syndrome according to 2016 ACR(American college of Rheumatology)/ EULAR(European league Against Rheumatism classification criteria for Sjögren's syndrome

Exclusion Criteria:

* any preexisting ocular disease or on eye drops lubricants.
* patients on (Beta blockers, Diuretics , anticholinergic, α 1antagonist and α 2 agonist ,anticoagulant, antidepressant, antihistamine ,pilocarpine, cevimeline ) .
* past history of diabetes, psychiatric disorder.
* pregnancy, lactating mother
* malignancy
Dexmedetomidine and Ketamine in MRI

The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults.

The results of this study will help in making the best decisions regarding the anesthesia medications used for sedation outside of the operating room.

Upper airway obstruction is a common problem in spontaneously breathing patients under anesthesia. This study is examining the effects of combining dexmedetomidine and ketamine on the muscle tone and airway configuration in children under anesthesia. The hypothesis is adding ketamine to dexmedetomidine will not significantly reduce airway caliber or morphology when compared to previously collected data using dexmedetomidine alone.

Eligibility Criteria:
Inclusion Criteria:

* Patient requires anesthesia for a MRI scan of the brain or MRI brain/spine
* Patient must be 1 to 18 years of age
* Patients legally authorized representative has given written informed consent to participate in the study

Exclusion Criteria:

* Allergy to dexmedetomidine or ketamine
* History or obstructive sleep apnea
* The patient has a life-threatening medical condition (ASA status 4, 5, or 6)
* The patient is not scheduled to receive anesthesia sedation for the MRI
* Patient has a history or a family history of malignant hyperthermia
Development of Personalized Balanced Nutrition Concept Through an IT Platform

By achieving effective cooperation between the Children's Hospital Srebrnjak (CHS), the Reference center for clinical allergology in children of the ministry of health, and IN2 Ltd., part of Constellation Software Inc., it is planned to develop an IT platform for the introduction of personalized balanced nutrition in kindergartens. The collected data which include the screening of the population, anthropometrical measurements, physical activity status, and medical examination, will be used to create a Registry of Allergies. Through the implementation of research activities, it is expected to develop an IT platform for personalized balanced nutrition of preschool children, which consists of a developed information system for continuous monitoring using a website and/or a mobile application.

This study will involve kindergarten children (aged 1-6 years). The research takes place in six different phases: 1) development of the information system and data integration, 2) classification of target groups of kindergarten children according to nutritional status, 3) anthropometric monitoring of the development of kindergarten children, 4) establishment of an electronic register of allergies, 5) implementation of an information platform in kindergartens, and 6) assessment of the validity of platform. The research will include a minimum of 450 participants from Split, Osijek and Zagreb County. Based on the completed standardized questionnaires the target groups of kindergarten children will be classified according to their nutritional status:

1. children who have a developed food allergy
2. children at risk of developing mild, moderate or severe allergic reaction to food
3. children with an allergological indication

The children with allergological indication (c) will be sent for further specialist evaluation, diagonstics and nutritionist advice at CHS.

The investigators will monitor how many kindergarten children have developed food allergy, food intolerance and another allergy (eg. inhalation allergy). Children with another type of allergy will be the refference control.

Eligibility Criteria:
Inclusion Criteria:

* Parental approval
* Children from 1 to 6 years old

Exclusion Criteria:

* Chromosomal abberations
* Neurological disorders that affect oral motorics
* Chronic gastrointestinal disorders
* Severe metabolic disorders