cyrilzakka/clinical-trials huggingface dataset:
Nutritional Supplement Compliance Study

Disease-related malnutrition is common across healthcare settings in the UK and if left untreated, may have severe consequences. One of the strategies commonly used to combat malnutrition is the use of oral nutritional supplements (ONS). However, there is uncertainty about the optimal way of delivering ONS to patients to maximize compliance and nutrient intake.

This randomised study will investigate the effect of different modes of delivery (ad libitum versus instructions on timing/serving volume) of ONS used in addition to the diet on total nutrient intake, compliance, nutritional status and outcome in participants at risk of malnutrition.

Participants will be randomised to receive one of two ONS (high energy or standard) for 4 weeks in addition to food, either taken 'Ad libitum', or according to instruction on what to take and when. The primary outcome measure is nutrient intake. Secondary outcome measures include compliance and acceptability of ONS, appetite, anthropometry, muscle strength, quality of life and gastro-intestinal tolerance.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age \> 18 years
* At risk of malnutrition (medium or high risk of malnutrition with 'Malnutrition Universal Screening Tool', 'MUST' score ≥ 1)
* Competent to provide written informed consent and able to answer questions
* No requirement for tube or parenteral feeding
* Willingness to take part in the study and to follow the study protocol

Exclusion Criteria:

* Requirement for tube or parenteral nutrition
* Participants receiving palliative care
* Participants with chronic renal disease requiring dialysis
* Participants with liver failure
* Participants that are pregnant or lactating
* Participation in other studies
A Trial of Cognitive Training in Euthymic Bipolar Disorder

Bipolar disorder (BD) is characterized by extreme changes in mood and emotion dysregulation. Mood changes are episodic in nature, with distinct periods of mania, depression, and asymptomatic periods of euthymia. In addition to impairments in mood, cognitive impairments are a common feature of the disorder. These cognitive impairments persist during periods of euthymia and are associated with negative clinical and psychosocial outcomes. Specifically, individuals with BD show impairments in executive functions. Recent studies show that emotion regulation can be down-regulated by taxing executive functions, and it can be improved with working memory training, a specific component of executive functions. These initial studies show that emotion regulation is under executive control in healthy individuals; however, the nature of this relationship is not well understood in populations that are affected by impairments in both executive control and emotion regulation. Previous work on cognitive training has not targeted specific cognitive domains with an emphasis on understanding the underlying mechanisms that promote change. Moreover, well-controlled randomized control trial (RCT) studies are needed in order to provide high quality evidence to inform the efficacy of cognitive training interventions for psychiatric populations. The aim of the proposed study is to use a commercially available cognitive training program to study the effects of working memory training on cognitive, clinical, and psychosocial outcomes in patients with BD. We hypothesize that training working memory will lead to improvements in cognitive and emotional functioning, leading to downstream changes that will positively impact untrained outcomes, such as mood and community functioning.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age between 18 and 65 years
* Clinically diagnosed with bipolar disorder I or bipolar disorder II and currently in a euthymic state
* Normal, or corrected to normal, vision and hearing
* Able to provide informed consent

Exclusion Criteria:

* Meeting Diagnostic and Statistical Manual 5th edition (DSM-5) diagnostic criteria for a current major depressive episode, manic episode, or hypomanic episode
* Past electroconvulsive therapy (ECT)
* Past Transcranial Magnetic Stimulation therapy (TMS)
* Past 3 month history of substance abuse
* Diagnosed with a medical condition known to affect cognition (e.g., endocrine disease)
* Score less than 70 on the Wechsler Abbreviated Scale of Intelligence (WASI)
Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study

1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound for pediatric appendicitis. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen.
2. Study activities and population group. The study population will be a convenience sample of patients 18 years and younger with suspected appendicitis, whose clinical care (unrelated to the study) includes ultrasound and/or CT of the abdomen. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. If not evident from the patient medical record, the final diagnosis will be confirmed by a telephone call to the subject 2 weeks after the initial visit.
3. Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images to determine the frequency of visualization of the appendix and whether the appendix was deemed normal or abnormal. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality.

This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. We are not measuring the effect of the ultrasound examination on the subjects' outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must be 0-18 years of age, presenting to the pediatric emergency department for evaluation of right lower abdominal pain and suspected appendicitis.
* The clinical diagnostic plan before subject enrollment must include abdominal ultrasound and/or abdominal CT.

Exclusion Criteria:

* Because ultrasound does not involve the use of ionizing radiation or contrast agents, it is not contraindicated in any patients, although image quality may be nondiagnostic in obese patients. The focus of this study is on acquisition of research 3D POC US images to determine feasibility of use in pediatric patients with suspected appendicitis.
* Patients with BMI \>30 or mass \>70kg, as these patients are anticipated to have nondiagnostic ultrasound images.
* Ultrasound also requires a gel material be applied to the skin surface as an acoustic transmission medium. Allergy to such gel will be an exclusion criterion.
Evolution of Menstruation

This study examines gene expression and gene regulation in the uterine lining during menses in women, for evolutionary comparison with other primates which do or do not menstruate. Samples will be obtained by non-invasive collection of menstrual fluid from healthy donors.

Menstruation corresponds to the shedding of the uterine lining when fecundation has not occurred. This is a recent evolutionary innovation in primates, and the cellular and genetic changes that led to the acquisition of menstruation are not well understood. Additionally, the uterine lining is poorly characterized in humans at the menstrual time point, which hinders both evolutionary and medically-relevant analyses.

In this study, the research team are collecting menstrual fluid samples from healthy female volunteers to profile gene expression and gene regulatory elements in the major cell types that compose the uterine lining during menstruation. The investigators will compare this data to similar samples collected from other primates at the same time point in the female hormonal cycle.

The objective is to identify genes that have acquired novel regulation and/or expression patterns and which may be involved in menstruation.

Eligibility Criteria:
Inclusion Criteria:

* having regular periods
* being comfortable using silicone menstrual hygiene devices ("cup")
* having giving consent in writing

Exclusion Criteria:

* use of an internal contraception method (hormone or non-hormone based) during or within three months before the study
* pregnancy during or within three months before the study
* amenorrhea (absent periods) during or within three months before the study
* gynaecological intervention or surgery within three months before the study
* hormonal treatment during or within three months before the study
* absence of written consent
* breastfeeding
* medical treatment during the study
* low (\< 18.5) or high (\> 30) body mass index (BMI)
Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation

The purpose of this study is to examine the neuropsychological effects of transvascular aortic valve implantation (TAVI). Patients undergoing TAVI usually suffer from congestive heart failure and low cardiac output which may limit their cognitive abilities. TAVI results in significant improvements in cardiac function and therefore may improve cognitive functions. However, TAVI may also be associated with stroke and may therefore have a negative impact on cognition. Therefore, in this study the investigators wish to perform a battery of standardized neuropsychological tests before and after TAVI to test the net effects of TAVI on cognitive performance over time.

The investigators plan to include all patients planned to have TAVI in the study and to test them before, 3,7, 30 and 360 days post TAVI with a standardized battery of test.


Eligibility Criteria:
Inclusion Criteria:

* All patients with severe aortic stenosis that are candidates for TAVI
* Able to perform the testing
* Able to sign informed consent

Exclusion Criteria:

* Language barriers precluding the administration of the testing
* Existing dementia
* Existing disease limiting life expectancy to less than 180 days
Post Market, Retrospective Study to Evaluate Patients Implanted With Medacta Versafit Cup DM ™️ 2 Years Post-op

This is a post-market, retrospective with one prospective visit, multi- center study, designed to assess the clinical outcomes, surgical details including Anterior or Posterior surgical approach, and collect all complication data of Medacta Versafit Cup DM used for primary or revision total hip arthroplasty at minimum two year post- operatively.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects age 18 years and above at the time of consent
2. Able to understand the requirements of the study, provide a written informed consent and comply with the study protocol. Written informed consent must be obtained prior to any study procedure. 3 Patients must be willing to comply with the prospective visit schedule.

4. Patient underwent a primary or revision total hip replacement for any etiology (osteoarthritis, avascular necrosis, inflammatory arthritis, post- traumatic arthritis, hip fracture, failed prior procedures, etc.). 5. Patients must have received a Medacta Versafit Cup DM component 6. Patient must have adequate pre-operative and post-operative radiographs 7. Patients must be at minimum 2 year (24 months) post-treatment 8. The operation was performed by the investigator.

Exclusion Criteria:

1. History of alcoholism
2. Currently on chemotherapy or radiation therapy
3. Habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than hip pain
4. History of a metabolic disorder such as Gout affecting the skeletal system other than osteoarthritis or osteoporosis
5. History of chronic pain issues for reasons other than hip pain
6. Women that are pregnant
7. Patients who underwent Total Hip Arthroplasty (THA) using standard polyethylene
Fertility Preservation in Breast Cancer Patients

The purpose of this study is to evaluate efficiency and safety of controlled ovarian stimulation (COS) associated with an aromatase inhibitor (letrozole) for fertility preservation in breast cancer patients.

Patients enrolled in this study undergo standard or "random start" ovarian stimulation with Gonadotropins using antagonist protocol before the beginning of chemotherapy. Ovulation is triggered in all patients with a GnRH agonist since amendment P2015/091 (Decapeptyl 0,2mg).

At oocyte retrieval, aspirated follicular fluid is separated from the flush medium for hormonal assays, and oocytes are denuded for ICSI(Intra Cytoplasmic Sperm Injection) or vitrification. Cumulus cells are collected for subsequent analysis of oocyte quality gene expression.

A. Primary objective of the study is to evaluate efficiency of letrozole associated ovarian stimulation for fertility preservation in breast cancer patients in terms of oocyte maturation rate.

Patients' results for primary endpoint are prospectively compared to infertile patients undergoing COS without letrozole.

B. Secondary objectives of the study aim to evaluate safety of the protocol:

1. Estradiol and progesterone levels at ovulation triggering, ovulation and during luteal phase after oocyte retrieval (days 3 and 8)
2. The risk of disease relapse will be assessed by long-term follow-up of these patients (up to 5 years) as well as an evaluation of circulating tumoral DNA before and after ovarian stimulation.
3. Finally obstetrical outcomes will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer female patients of less than 41 years old
* Addressed to fertility preservation Unit before starting chemotherapy

Exclusion Criteria:

* Metastatic breast cancer
* Known premature ovarian failure
* Basal FSH \> 20 IU(International Unit)
* Surgical contra-indications
Study for the Quantification in Ecological Conditions of Sensorimotor and Dysexecutive Disorders in Cerebral Palsy Patients

Executive functions are defined as the mental functions necessary for an individual to adapt to a complex or new environment that requires freedom from automatic and routine behavior. Deficits in executive functions are described under the term "dysexecutive syndrome", and call into question the quality of social and professional life as well as the autonomy of patients.

The usual methods of identifying dysexecutive syndrome are based essentially on batteries of neuropsychological tests known as "paper and pencil". However, these tests may lack sensitivity, in that they assess the patient in a very structured setting, very different from real life conditions, which are full of distractions and choices to be made.

Evaluations on real tasks are more rarely used but have the advantage of observing the difficulties encountered by a patient in everyday life.

Two tests of this type have been set up in the Neurology Department of the Hôpital d'Instruction des Armées Percy, and are integrated into the routine care of patients with a dysexecutive syndrome.

For this purpose, a room in the department has been set up as a studio in order to reproduce as much as possible an everyday life environment, in which executive functions, fine motor skills, neurovegetative functions, emotional state, posture, locomotor skills and visual information capture can be measured ecologically.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a dysexecutive syndrome OR healthy subjects
* Over 18 years-old

Exclusion Criteria:

* Patients

  * Psychiatric pathology (except for Post-Traumatic Stress Disorder)
  * Pregnant or breastfeeding woman
* Healthy subjects

  * Neurologic or psychiatric pathology
  * Pregnant or breastfeeding woman
Intellivent ASV in Chronic Obstructive Pulmonary Disease Patients in the ICU

This study will evaluate the effect of a fully closed loop ventilation mode (Intellivent ASV) on the duration of ventilation compared to conventional modes in COPD patients.

COPD patients often need invasive mechanical ventilation and due to the difficulties in the weaning of these patients, duration of mechanical ventilation can be relatively longer when compared with other ICU patients. Automated systems show promising results in shortening the weaning time in some patient groups. The aim of this study is to evaluate the effect of Intellivent-ASV with Quickwean function on the total duration of invasive mechanical ventilation as a primary outcome. Secondary outcomes are success rate and duration of weaning, ventilator free days at day 28 and intubation free days at day 28 (including NIV) when compared to conventional ventilation with t-piece weaning.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients intubated and mechanically ventilated for less than 24 hours (Including patients who received NIV before intubation)
* Age \> 18 years
* Written and/or informed consent

Exclusion Criteria:

* Septic shock
* Tracheostomy and/or home mechanical ventilation
* Expected poor short term prognosis
* Cardiac arrest with a poor neurological prognosis
* ARDS
* Broncho-pleural fistula
Virological and Immunological Monitoring in Patients (suspected Of/confirmed With) COVID-19

This study is a prospective, observational multicentric study. The study population entails adult patients hospitalized with a high clinical suspicion of COVID-19 and consists of two study arms (SARS-CoV2- vs. SARS-CoV2+).This combined fundamental research project has a dual goal: on the one hand assessing immunological predisposing factors for severe infection and investigating the immunological impact of SARS-CoV2 infection, on the other hand studying viral characteristics. Furthermore, a substudy will examine the pharmacokinetics and pharmacodynamics of hydroxychloroquine in patients receiving this antiviral treatment (REVIVE susbstudy). To answer these research questions, samples will be collected from patients with a high clinical suspicion of COVID-19, hospitalized at UZ Gent and 2 participating hospitals in Ghent (AZ Maria Middelares en AZ Jan Palfijn).


Eligibility Criteria:
Inclusion Criteria:

* Upper or lower respiratory symptoms and temperature ≥37.5°C, with high clinical suspicion of COVID-19
* Requiring hospitalization

Exclusion Criteria:

* Known pregnancy at the time of screening
* Inability to give informed consent or absence of legal representative who can give informed consent.
Montelukast and Nasal Epithelial Cell Inflammatory Responses in Asthma and Rhinitis

The airways of the lung are lined by specialised cells called airway epithelial cells. As well as being at the interface between the lungs and the air we breathe; airway epithelial cell (AEC) function is altered in people with respiratory diseases such as asthma. AEC secrete many mediators that contribute to asthma symptoms and these also contribute to asthmatic inflammation in the lungs. The study of such cells is difficult because of their location deep in the lungs. Nasal airway epithelial cells provide a useful and easily accessible model of model of lower airway cells. This study will examine whether the asthma medication Singulair (montelukast) can inhibit the inflammatory secretions of nasal AEC of asthmatic patents who also have allergic rhinitis compared with patients who have asthma alone. We will also examine if montelukast has differential modulating effects in these two patient groups.

Hypothesis

The inflammatory secretory profile of nasal airway epithelial cells (NEC) cultured from asthmatics with concomitant allergic rhinitis (AR) will differ from that of NEC from patients with asthma alone. Treatment (in vitro and in vivo) with montelukast may have differential modulating effects in these two patient groups.

For the primary objective of this proposal we will use nasal AEC from asthmatics with or without concomitant AR as to ascertain differences in pro-inflammatory cytokine and chemokine production between these two groups and determine whether in vitro treatment with montelukast has a differential modulating effect on NEC secretion. In the secondary pilot study any modulating effects by montelukast on AEC secretion in vitro will be correlated with any in vivo response to montelukast withdrawal. This sub study will provide pilot data indicating whether in vivo response to montelukast can be predicted from in vitro effects on NEC.

Eligibility Criteria:
Inclusion Criteria:

* stable physician confirmed mild/moderate asthma (Steps 1-4 of BTS/SIGN guidelines \<10 pack-year smoking histories Currently taking montelukast with a documented clinical history of benefit

Exclusion Criteria:

* Nasal corticosteroid therapy
Cerebrospinal Fluid IL-6, IL-8 and PCT as Early Marker of an Intrathecal Infection in Neurosurgical Patients

The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.

The value of CSF IL-6, IL-8 and Procalcitonin in detecting an early diagnosis of intrathecal infection in neurosurgical patients with an external ventricular drainage is evaluated.

Eligibility Criteria:
Inclusion Criteria:

* external ventricular drainage
* informed consent

Exclusion Criteria:

* no informed consent
* prior intrathecal infection
* prior systemic infection / sepsis
Safety Study of Colonoscopy Under Sedation

The aim of this study was to compare the analgesia provided by nitrous oxide/oxygen sedation or general anesthesia for colonoscopy

The purpose of this protocol is to compare two methods of analgesia/sedation for colonoscopy. Sedation and analgesia induced by a 50% nitrous oxide/oxygen mixture could sufficient to allow the practice of colonoscopy instead of general anesthesia which is accompanied with certain risks and post procedure drowsiness.

Eligibility Criteria:
Inclusion Criteria:

1. Patient referred for colonoscopy with general anesthesia
2. Age above 18 et below 75 year
3. Patient who gave an informed consent

Exclusion Criteria:

1. Age below 18 ou above 75
2. Need for gastroscopy in the same procedure than colonoscopy
3. History of surgery wih resection more extended than half of the colon
4. Dementia with autonomy loss or psychiatric disorder non controlled by therapeutic
5. Severe congestive heart failure or evolutive heart ischemia
6. Recent cerebral stroke
7. Hemodynamic instability
8. Respiratory failure, severe chronic obstructive pulmonary (including asthma) or progressive pneumothorax
9. Hepatic failure (Child-Pugh score\> 9)
10. Terminal renal failure 11 Hematopoietic disorders

12. Pathology with expected survival shorter than the duration of the study and cancer excepted basal cell carcinoma of the skin 13. Alcohol consumption higher than 100 gr per day 14. Pregnancy or breastfeeding at the inclusion period