cyrilzakka/clinical-trials huggingface dataset:
Cost-Minimization Analysis After a Targeted Intervention for EGD and Colonoscopy

This study performs a single intervention of informing endoscopists how much the disposable accessories cost following each procedure. Following this single and simple intervention, prospective analysis of EGD and colonoscopy accessory use and pathology specimen costs will be compared to the same resource costs during a control period where endoscopists are blinded to their observation.

This study is a prospective cost-identification and cost-minimization analysis of accessories used during the EGD and colonoscopy procedures. The endoscopists will be the participants under study and not the patients. The study will be conducted in two phases - pre and post-intervention phases. Each phase will include a minimum of 337 combined EGD and colonoscopy procedures and a total of upto a minimum 674 and a maximum of 1200 procedures for both phases. All consecutive patients undergoing EGD and colonoscopy will be included. For the first phase of the study, the endoscopist will not be made aware of the study and also will not be briefed at the end of the procedure with the number of accessories used during the procedure and the dollar value of the accessories. For the second phase of the study, endoscopist will be briefed by the endoscopy nursing staff after completion of each procedure about the total number of accessories used and the dollar value of the accessories used during the procedure. Once the study is completed, endoscopists will be debriefed about the study and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults with age of 18 or greater
* All races
* Indication for therapeutic EGD or colonoscopy
* Outpatient procedures done at OU Physicians Building endoscopy unit
* Procedure is performed by one of the observed endoscopists

Exclusion Criteria:

* Pediatric population
* Diagnostic EGD and colonoscopy procedures
Microbiome Benchmarking to Identify Perturbations in Multiple Sclerosis II

The goal of this longitudinal study is to (1) explore the association between the gut microbiota and inflammatory disease activity in early onset multiple sclerosis, (2) investigate whether/how gut microbial composition vary when patients experience a relapse, and (3) to assess whether the gut microbiota shows increased similarities between affected pairs of first-degree relatives within the same family when compared with discordant pairs of first-degree relatives.

Using metagenomics, as well as clinical, immunological, and radiological observations, the investigators will investigate if active relapsing-remitting multiple sclerosis patients have a more pro-inflammatory gut microbiota signature than multiple sclerosis patients with less active disease and matched healthy controls.

More specifically, the investigators will investigate whether temporal variability of the gut microbiota is related to inflammatory disease activity in multiple sclerosis, whether changes in the gut microbiota are predictive of future inflammatory disease activity in multiple sclerosis, and whether gut microbiota characteristics are predictive of the disease course after 2 years.

Eligibility Criteria:
Inclusion Criteria patients:

* Diagnosis of MS (as defined by the 2010 McDonald criteria).
* Occurrence of symptoms no longer than 5 years before baseline.
* Aged 18-65.
* Willingness to participate in the study and to sign the informed consent.

Exclusion Criteria patients:

* Treatment with high doses of systemic steroids 2 months before baseline.
* Use of antibiotics 3 months before baseline.
* Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer).
* Other immune-mediated or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1 and 2, psoriasis).

Additional inclusion criteria for MS patients undergoing a relapse:

• Ability to provide a faecal sample within 4 weeks from onset of the first symptoms suggestive of a relapse, before cortisone treatment. A relapse is defined by a new clinical sign or clinical worsening of a previous sign/symptom persisting for \>=24 hours in the absence of fever.

Additional exclusion criteria for MS patients undergoing a relapse:

* Treatment with cortisone before collection of baseline faecal sample.
* Evidence of a relapse less than 2 months before baseline.
* Switching disease modifying treatment less than 2 months before baseline.

Inclusion criteria healthy controls:

* Willingness to participate to the study and to sign the informed consent.
* Aged \>=18.

Exclusion criteria healthy controls:

* Neurodegenerative disorders.
* Chronic gastrointestinal disease (e.g. inflammatory bowel disease, colon cancer) or autoimmune diseases (e.g. rheumatoid arthritis, diabetes type 1, psoriasis).
* Use of antibiotics 3 months before baseline.
* Treatment with high doses of systemic steroids 2 months before baseline.
Study of the Effect of SR57667B in Patients With Alzheimer's Disease

The primary objective is to demonstrate that SR57667B at the dose of 4 mg/day, in comparison to placebo, decreases the decline in cognitive performance and the global clinical decline over 1 year in patients with mild to moderate AD.

Secondary objectives are to assess the effect of SR57667B on functional decline and its safety/tolerability in patients with mild to moderate AD, and to document plasma concentrations of SR57667 in patients with mild to moderate AD.

Multinational, multicenter, randomized, parallel-group, double-blind, phase II study

Eligibility Criteria:
Inclusion Criteria:

* Male / female outpatients.
* Age \> 50 years at screening.
* Dementia of Alzheimer's Type (DSM-IV 290.0) according to DSM-IV criteria, Probable AD according to NINCDS-ADRDA criteria, Mini-Mental State Examination score \> 12 and \< 26.
* Untreated or treated for a minimum of 6 months before randomization with a stable dose of the cholinesterase inhibitors
* Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
* Presence of a reliable caregiver.
* Patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures

Exclusion Criteria:

* Any cause of dementia not due to Alzheimer's disease, Delusions, delirium, psychosis, depression, or other significant psychiatric disorder.
* Treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, rivastigmine or galantamine.
* Females who are pregnant or breast-feeding. Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit, and must use an acceptable method of birth control.
* Severe or unstable cardiovascular, respiratory, renal, hematological, endocrinological, neurological or other somatic disease.
* Use of CYP3A4 strong inhibitors
* Evidence (detected by history, physical examination and / or laboratory / ECG tests) of any clinically significant or unstable medical disorder that could interfere with the subject's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. Alterations of laboratory tests or ECG findings of potential clinical significance.
Pharmacokinetic of Sevoflurane During a 48h Sedation in Intensive Care Unit With AnaConDa®

This is a prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sevoflurane.

Prospective clinical monocentric study in ICU with sedated ventilated patients with sevoflurane during 48 h with the AnaConda® system, establishing pharmacokinetic model of sévoflurane and its metabolites (hydroxyfluroisopropanol, fluoride)

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ventilated more than 48 h
* Stable respiratory and hemodynamic conditions
* Consent of patients or family
* Arterial line

Exclusion Criteria:

* Acute kidney injury
* Obesity
* Sevoflurane anaphylaxia
Evolution of DMDD Children and Adolescent

Little is known about the natural course and prognosis factors of inpatients and outpatients with Disruptive Mood Dysregulation Disorder (DMDD). The investigators conducted a cross-sectional study to determine the evolution of a sample of DMDD patients referred to the hospital for suicidal behaviors between 2013 and 2018 in terms of diagnostic stability, psychiatric comorbidity, and psychosocial factors. A group of patients with various episodic mood disturbances was used as a clinical case control group.

In addition to change in DMDD symptoms across time, the investigators examined the onset and persistence of psychiatric comorbidity using the KIDDIE-SADS PL and suicidal behaviors using the Colombia Suicidality Severity Rating Scale. The investigators also examined the persistence of depressive symptoms using the Beck Depression Inventory (BDI-II), the persistence of emotional lability (Affective Lability Scale-18), borderline traits (Abbreviated Diagnostic of Inventory Borderline). Socio-demographic, clinical features and actigraphy-measured sleep characteristics determined between 2013 and 2018 were used to predict the evolution of the DMDD patients and the clinical control group.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls between 10 and 25-year-old
* patients who had been referred to the university hospital of Amiens for suicidal behaviors between 2013 and 2018
* patients who participated to the study "Clinical and actigraphy-measured profiles of inpatient youths with suicidal behavior: exploration of the severe mood dysregulation"

Exclusion Criteria:

* No affiliation to a social security service
* Persons deprived of their liberty as stipulated in article L.1121-6 of the Public Health Code
Spectacles for Patients With Down Syndrome

This study tests the hypothesis that objectively derived spectacle prescriptions based on wavefront aberration measurements of the eyes of individuals with Down syndrome can provide an improvement in visual acuity over that obtained with spectacle prescriptions based on standard clinical prescribing techniques. The objectively derived prescriptions are derived using strategies to optimize retinal image quality as measured by image quality metrics, and thus these prescriptions will be referred to as metric-derived.

Individuals with Down syndrome suffer from significant ocular complications including high levels of lower-order refractive error (sphere and cylinder) and elevated levels of higher-order aberrations. These optical factors likely contribute to the poor acuity observed in this population. Current clinical prescribing practices may under-serve this community, as the cognitive demands of the subjective refraction sequence are difficult for this population and often leave clinicians to prescribe from objective clinical findings that target full correction of sphero-cylindrical refractive error. This prescribing practice can lead to sub-par outcomes given the fact that full lower-order corrections can exacerbate the effects of higher-order aberrations in more aberrated eyes.

For this study, individuals with Down syndrome will be dispensed three pairs of spectacles for 2 months each, in random order: one clinically-derived, and two objectively-derived refractions based upon methods designed to optimize a given metric of retinal image quality which takes into consideration the wavefront aberration measurements of the eye. Both initial and adapted visual acuity in the presence of each correction will be evaluated to determine whether the objectively-derived refractions outperform clinically-derived refractions.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Down syndrome

Exclusion Criteria:

* Nystagmus (Involuntary beating movement of the eyes)
* Visually significant media opacities (e.g. cataracts or corneal scars)
* Strabismic amblyopia (reduced vision in one eye related to a constant eye-turn)
* Anisometropic amblyopia (reduced vision in one eye related to a long-standing uncompensated difference in prescription between the two eyes)
Smartphone Application for Breastfeeding Education in Medical Students

The purpose of this study was to compare the efficacy of two educational interventions to enhance breastfeeding knowledge among senior medical students. One intervention consisted of a traditional face-to-face teaching lecture and the other consisted of the use of a smartphone application containing information about breastfeeding.

A quasi-experimental study was performed. Students were allocated to two groups; the first group underwent a 6-hour face-to-face breastfeeding course which was divided in four 1.5-hour sessions during a time span of two weeks. The second intervention consisted of downloading a digital smartphone application designed by the research team to teach proper breastfeeding concepts which participants freely navigated during the same time span of two weeks. Before and after each intervention, students answered a general breastfeeding knowledge test consisting of twenty multiple choice answers with a score range of 0 to 20. Statistical comparisons between pre- and post-test scores were performed in each group and mean change in scores was compared between them to establish which method was the most efficient. Moreover, amount of time spent on the application was descriptively measured.

Eligibility Criteria:
Inclusion Criteria:

* Senior adult medical students of any gender who at the time were enrolled on the Pediatrics biannual course during the July 2018 th -July 2019 th academic period.
* Provide verbal informed consent
* At least 18 years old

Exclusion Criteria:

* Students who did not possess an electronic device (smartphone or tablet) or decided not to participate in the study.
* Rate of non-attendance to the general pediatric course greater than 50%
Metformin in Children With Motor Deficit

Obesity with insulin resistance in the paediatric population provides an increasing challenge. Children with neurological or neuromuscular diseases are even more prone to obesity: their locomotor impairment leads to an increasingly sedentary lifestyle, a decrease in physical fitness and an increase in body fat (1-3). Obesity, in turn, can be associated with a decrease in physical fitness and a further increase in body fat. In this study we want to evaluate the effect of an insulin-sensitizer, metformin, in a group of overweight/obese patients with neurological or neuromuscular diseases. Metformin is a well-established insulin sensitizer.

Obesity with insulin resistance in the paediatric population provides an increasing challenge. Children with neurological or neuromuscular diseases are even more prone to obesity: their locomotor impairment leads to an increasingly sedentary lifestyle, a decrease in physical fitness and an increase in body fat (1-3). Obesity, in turn, can be associated with a decrease in physical fitness and a further increase in body fat. In this study we want to evaluate the effect of an insulin-sensitizer, metformin, in a group of overweight/obese patients with neurological or neuromuscular diseases. Metformin is a well-established insulin sensitizer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with neurogenic or myogenic motor deficit, clinically obese or who had excessively gained weight over the last year.

Exclusion Criteria:

* Exclusion criteria were known type 1 or type 2 diabetes mellitus and contraindications to metformin therapy.
Detection of Micrometastases in Lymph Nodes of Patients With Prostate Cancer

The purpose of this study is to set up a model for detecting micrometastases in Lymph nodes of patients with prostate cancer by quantitative polymerase chain reaction and its impact on progression-free survival.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate cancer
* Locally operable tumor
* Negative bone scan (obligatory if Gleason Score \> 7 or PSA \> 20ng/ml
* Karnofsky ≥ 80%
* Age 18 - 75 years
* Informed consent in written form
* Sufficient hematologic, coagulatory and renal function
* Compliant patient and geographic precondition for adequate follow-up given

Exclusion Criteria:

* Manifest secondary tumor
* Organ metastases on CT-scan /MRI or in Histology
* Myocardial infarction or stroke within the last 6 months
* Severe cardiovascular (Grade III - IV according to NYHA), pulmonary (pO2 \< 60 mmHg), renal, hepatic oder hematopoetic impairment
* Severe active or chronic infection (z.B. pos. HIV-Antibody-Test, HBs-Ag-detected in Serum and/ or chronic Hepatitis)
* Severe psychiatric disease
* Previous chemotherapy
* Previous pelvine radiotherapy
Study on Cemented Versus Non-cemented Hemiarthroplasty in Elderly With Hip Fractures

The objective is to study the overall frequency and cumulative rate (during one year) of clinical morbidity (defined as any hospitalization without fatal outcome) and mortality in all consecutive patients undergoing HF surgery (pins and prosthetic implants) and compare this to the group of patients receiving prosthetic implants and further find out if there is a difference between the non-cemented and cemented groups.

Between the same prosthetic groups, the investigators want to study the overall frequency of in-hospital subclinical organ damage and dysfunction of myocardium, liver and lungs, using biochemical plasma markers. Finally, the investigators want to perform perioperative cost benefit calculations and out of hospital quality of life analysis between the surgical groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient with Garden 3 or 4 fracture in acute hip fractures.
* Age over 75 years.

Exclusion Criteria:

* Patient or relative refuse enrollment
Does Oral Lactate Affect Gut Hormone Secretion in a Dose-response Relationship?

To investigate whether there is a linear dose-response relationship between oral lactate and its effects on gut hormone secretion, motility, and appetite.

Hypothesis Oral lactate administration affects gut hormone secretion, insulin levels, motility, appetite sensation and the amount of food intake in a linear dose-response relationship.

The participants will meet up fasting at the Steno Diabetes Centre Aarhus Research Lab. Immediately after arrival, they will be placed in a bed. The four trial days will be completely alike, besides the interventions.

The participants will have one intravenous (iv.) access placed in the elbow on the four trial days for a continuous drawing of blood samples throughout the trial day.

Before drinking the intervention, baseline blood samples will be drawn. Immediately after drinking the intervention, the participants will take 1500 mg paracetamol to determine ventricular emptying rate through the acetaminophen test.

After this, the participants can lay in their bed and watch TV, Ipad or work on their computer. Blood samples will be collected at 0, 10, 20, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes after the intervention. Appetite sensations will be measured by a visual analog scales (VAS). After 3 hours the trial day is finished, and the participants can go home.

Before and after each trial day the participants will collect a fecal sample.

We will use ANOVA and mixed model regression analyses for comparing the four groups.

Based on a previous study we will need 11 individuals to detect a difference of 17,3 pmol/L in mean insulin concentrations at time 60 minutes, with a SD of 18,3 (α=0.05, β=0.80). To account for potential missing values, we will include a total of 12 participants

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years
* Written and oral consent
* Healthy

Exclusion Criteria:

* HbA1c \> 39
* Taking medicine
* Any diseases
* Allergy to paracetamol
* Doesn't speak or understand Danish.
* Special diets
Effects of Coffee on Hepatic Steatosis Induced by a High Fructose Diet

This study will assess

* whether coffee consumption protects against fructose-induced hepatic steatosis in healthy humans
* whether the protective effect of coffee is dependent on it's antioxidant composition

Epidemiological studies suggest that coffee consumption improves glucose homeostasis in insulin resistant subjects. An increase in intrahepatic lipids (hepatic steatosis) is highly prevalent in patients with the metabolic syndrome and may be used as a marker of altered hepatic lipid metabolism. Such an increased hepatic lipids content can be experimentally produced in healthy humans by a 6-day high fructose diet.

The purpose of this study is to evaluate whether coffee prevents hepatic lipid deposition in healthy male subjects fed a fructose-rich hypercaloric diet. Both caffeine and antioxidants (yet unspecified) may be involved.. To sort out the role of caffeine and antioxidants, we will test 3 different soluble coffee, ie fully torrefied decaffeinated coffee , partially torrefied decaffeinated coffee, and partially torrefied caffeinated coffee.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 19 and 15 kg/m2
* less than 30 min physical activity /day
* habitual coffee consumption less than three cupy /day
* consumption of caffeine-containing sodas less than 2 servings/day
* non-smoker

Exclusion Criteria:

* consumption of alcohol more than 40g/day
* presence of metallic foreign bodies
* history of eye surgery
* family history of diabetes mellitus
* history of food intolerance
* vegetarians
An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 (Vesleteplirsen)

The purpose of this extension study is to evaluate the safety, tolerability, and pharmacokinetics of repeat administrations of SRP-5051 (vesleteplirsen) in participants with Duchenne muscular dystrophy (DMD) who participated in studies of SRP-5051.


Eligibility Criteria:
Inclusion Criteria:

• Has completed a study of SRP-5051 and continues to meet the Eligibility Criteria of Study 5051-102.

Exclusion Criteria:

* Initiation or change of dosing (except for modifications to accommodate changes in weight or changes in standard of care) since completing a study administering SRP-5051 and while participating in this study for any of the following: angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blocking agents (ARBs), beta-blockers, potassium and steroids\*.
* Requires antiarrhythmic and/or diuretic therapy for heart failure.
* Use of any herbal medication/supplement containing aristolochic acid.
* Treatment with any experimental therapy since entering original study or any experimental gene therapy for the treatment of DMD at any time.
* Participation in an interventional clinical trial since completing original study.

Other inclusion/exclusion criteria apply.

\* The dose of steroids must remain constant except for modifications to accommodate changes in weight.