cyrilzakka/clinical-trials huggingface dataset:
Smart Eyewear to Automatically Detect Drug Delivery Events

This project is designed as a prospective observational study of medication preparation and delivery using a novel wearable data input device to automate detection of drug delivery events in the anesthesia workspace at University of Washington Medical Center.

Detailed Summary: The goal of this study is to devise a high-fidelity system that automatically collects data about anesthesia care, specifically drug preparation and delivery to the patient. We use a novel wearable data input device that collects computer processed images (video only, no audio) to determine details of the preparation and delivery of medications in the operating room. The wearable data input device is used by an anesthesia provider. The device collects computer processed images and in the anesthesia workspace, which will be used to develop machine learning algorithms that can automatically recognize drug administration events in order to automate medical record keeping in this environment.

Procedure: The principle investigator or a study coordinator will review the electronic operating room schedule to screen for potential data collection. The operating room team will be notified of the study the day prior to and day of data collection. The consented anesthesia provider will wear a point of view device to record drug preparation and drug delivery events in the operating room. Video recordings will be edited to remove Protected Health Information (PHI). Edited footage will then be annotated by volunteers on a computer vision learning tool website. The computer processed images will be then used to develop machine learning algorithms that can automatically recognize drug administration events.

Participants: The initial recruitment goal for the study is 10 nurse anesthetists recording 5 days each in the operating room. Nurse anesthetists are recruited as participants through word of mouth. If determined after data analysis that additional data needs to collected, additional anesthesia providers will be consented.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesia providers (attending anesthesiologist or certified registered nurse anesthetist) who work in an operating room at University of Washington Montlake Medical Center

Exclusion Criteria:

* Medical students and anesthesiology residents
MRI Radiomics Combined With Pathomics on the Prediction of Molecular Classification and Prognosis of Endometrial Cancer

Molecular typing provides accurate information for the diagnosis, treatment and prognosis prediction of endometrial cancer, which has important clinical significance. However, due to its high cost and complicated process, it is difficult to be widely used in clinical practice. Based on the artificial intelligence method, this study fused the characteristics of MRI radiomics and pathomics, combined with the clinical pathological information, built a model to predict the molecular typing and prognosis, analyzed the biological characteristics of endometrial cancer from the multi-scale level, guided the personalized and precise diagnosis and treatment, in order to improve the prognosis of patients.

In this project, 150 cases of endometrial cancer were retrospectively collected, and 200 cases of endometrial cancer will be prospectively collected. All patients were pathologically confirmed and underwent Promise molecular typing. Before treatment, all patients completed abdominal MRI. Based on artificial intelligence technology, image features were extracted from magnetic resonance imaging, pathological features were extracted from pathological data, and clinical pathological data were collected at the same time. The treatment effect, recurrence and metastasis of patients were followed up, and the five-year survival rate and five-year progression free survival rate were calculated. It is proposed to focus on the following research:

1. Construction of molecular typing and prognosis prediction model of endometrial cancer based on magnetic resonance imaging Radiomics
2. Construction of molecular typing and prognosis prediction model of endometrial cancer based on pathomics.
3. Construction of a prediction model for molecular typing of endometrial cancer by integrating pathomics and radiomics.

Eligibility Criteria:
Inclusion Criteria:

* •Pathologically confirmed as endometrial malignant tumor with complete pathological H＆E stained sections;

  * Age ≥ 18 years and ≤ 80 years;
  * No other malignant cancers was found;
  * The complete immunohistochemical and second-generation sequencing results can be used for the molecular typing of ProMisE;
  * Magnetic resonance examination was performed within 2 weeks before treatment, and there was at least one measurable lesion according to RECIST 1.1 Criteria.

Exclusion Criteria:

* • The image quality is poor or the tumor is too small due to serious graphic artifact and degeneration, and the ROI cannot be accurately delineated;

  * Patients who received any antitumor therapy before surgery;
  * Diagnostic endometrial biopsy before MRI
Energy-efficient and Health Promoting Light for Elderly People

to investigate the effect of two lightning conditions on sleep hypothesizing that sleep length is influenced by the color of light during daytime

Lightning conditions seems to be important for the length and quality of sleep, as light have an influence on the production of the sleep hormone (melatonin) and the the circadian rhythm. Entrainment of the circadian rhythm to the surroundings is accomplished by light-sensitive retinal ganglion cells and these cells are sensitive to blue light.

Based on previous research, blue light early in the day and abscence of blue light during evening is important for the entrainment.

In this study, lightning conditions in the home of healthy subjects are set to either blue enriched or red enriched from 8 a.m to 1. p.m. The lightning condition is based on a randomization protocol in a cross-over study for 3 weeks in each condition, separated by a one week pause.

Eligibility Criteria:
Inclusion Criteria:

* age 65 to 85 years

Exclusion Criteria:

* Conditions which will interfere by the primary endpoint as evaluated by the medical doctor
Advance Care Planning in Cognitive Disorders Clinic

Advance care planning among patients with cognitive disorders poses unique challenges to clinicians. To improve planning in patients with Alzheimer's disease and other dementias, the researchers suggest a routine, standardized approach to these conversations. The main outcome measure is the rate of entry of Advance Directive completion in the patient's Electronic Health Record (EHR). A control group of similar patients from another provider specializing in cognitive disorders will be used to tease out confounding variable effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients having mild cognitive impairment (MCI) or very mild to mild dementia (CDR 0.5-1).

Exclusion Criteria:

* Patients with moderate to severe dementia (CDR 2-3).
Effect of Daily Consumption of Orange Maize on Breast Milk Retinol in Lactating Zambian Women

The purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating Zambian women.

Lactating women were randomly assigned to one of three intervention groups to receive 6d/wk for 3 wk either 1) provitamin A biofortified orange maize and a corn oil capsule, 2) white maize and a vitamin A capsule, or 3) white maize and a corn oil capsule. The 'orange maize' and 'vitamin A' groups received \~600 ug RAE/d as provitamin A biofortified maize or retinyl palmitate, respectively. The 'white maize' group was a negative control group that did not receive any supplemental vitamin A.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy lactating women 18-35 years of age
* who are breastfeeding a single infant, 4-12 mo of age.

Exclusion Criteria:

* Pregnancy,
* Chronic disease,
* Hb concentration \<90 g/L,
* Signs or symptoms of vitamin A deficiency
Video-Based Cognitive Behavioral Therapy for Insomnia in Adults Cancer Patients and Survivors

SLEEP-4-ALL-1 is a pilot and ecological study corresponding to the developpement phase of a randomized controlled multicentric trial SLEEP-4-ALL-2. The main objective of this second study will be the validation of a stepped-care model in the treatment of persistant insomnia in cancer patients.

The primary objective of SLEEP-4-ALL-1 is to determine the acceptability of a self-screening for insomnia in cancer outpatients at Gustave Roussy.


Eligibility Criteria:
Inclusion Criteria:

1. Adults outpatients at Gustave Roussy,
2. with a breast, colorectal, pulmonary or urological,
3. localized or metastatic cancer,
4. during or after their treatment,
5. able to readily read and understand French,
6. able to use informatic tools confidently and with Internet access at home,
7. who have signed a written informed consent form prior to any study specific procedures,
8. affiliated to a social security system or beneficiary of the same.

Exclusion Criteria:

1. Age \> 85 years old,
2. patient receiving a cancer diagnostic during a consultation of announcement
3. with a WHO index of 3 or 4
4. severe cognitive impairements or psychiatric disorders which are incompatible with the conditions and the conduct of the study (understanding of the objectives, completion of the questionnaires)
5. simultaneous participation in another study of the same type
6. patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
Dynamic Response to Probiotics in Context of Alzheimer Disease: a Proof-of-concept Study

proof-of-concept study to adequately design a larger trial to investigate the effect of supplementation of a probiotic (SLAB51) on AD biomarker.

BACKGROUND: A growing body of evidence suggests an effect of gut bacteria and their metabolites on brain health, including the development of neurodegenerative conditions and Alzheimer's disease (AD). Probiotic supplementation is commonplace in medicine but targeting the gut microbiome to prevent AD is poorly understood and little is known on the dynamic effects of probiotics on physiology.

AIM: This is a proof-of-concept study to adequately design a larger trial to investigate the effect of supplementation of a probiotic (SLAB51) on AD biomarker. The study will use a high frequency sampling to closely monitor the physiological dynamics as the result of low and high dose consumption of the probiotic.

METHODS: Study subjects will be three patients with prodromal AD between 60 and 80 years old and carrying the apolipoprotein E (APOE) e4 allele. Participants will sequentially receive no supplement (run-in), low and high doses of probiotics for five consecutive days with a washout period in-between. Blood and stools will be collected every day or every second days. The main readout will be the established plasma markers of AD, and more exploratory analysis will be performed on putative mediators of the gut-brain axis.

EXPECTED OUTCOME: Curves of dynamic change of the readouts will be built for each subject, and a model of the response will be estimated. The results of this project will help design a larger trial to identify the most promising analytes showing a dynamic response to probiotic consumption and better understand the link to the pathology.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild cognitive impairment (MCI) due to AD, obtained from the clinical path of the participant in the memory clinic according to the criteria of Petersen et al. 1999 (46)
* Previous evidence of brain amyloidosis (assessed by positron emission tomographie (PET) or cerebrospinal fluid (CSF))
* Carrier of APOEe4 gene allele
* Defecates at least once a day

Exclusion Criteria:

* Antibiotic consumption 1 month prior the intervention
* Prebiotic consumption 1 month prior the intervention
* Recent change in diet habit (eg: vegetarian, vegan, high protein diet)
* Current alcohol addiction
* Current smoking habit
* Clinical diagnosis of dementia.
* Contraindications to probiotic consumption
* Inability to undergo the procedures of the study, e.g., severe behavioural disturbances.
* severe diseases:

  1. Life threatening diseases,
  2. Severe systemic diseases (e.g., kidney insufficiency, cardiac insufficiency, decompensated diabetes, decompensated metabolic diseases, decompensated hypothyroidism, uncontrolled autoimmune diseases);
  3. Chronic digestive diseases (e.g.: Crohn's disease, Ulcerative colitis, C. difficile infection)
  4. Chronic immune diseases
* The participation to a clinical trial involving potential Alzheimer's disease modifying therapies.
Outcome of COVID-19 Patients After Extracorporeal Membrane Oxygenation for Acute Respiratory Distress Syndrome

This study aims to investigate outcomes and predictors of outcome after extracorporeal membrane oxygenation (ECMO) therapy for severe acute respiratory syndrome (ARDS) in COVID-19 patients.

We evaluated the outcome of adult patients with coronavirus disease 2019 (COVID-19)-related acute respiratory distress syndrome (ARDS) requiring the use of extracorporeal membrane oxygenation (ECMO).

Eligibility Criteria:
Inclusion Criteria:

* PCR-confirmed or suspected COVID-19 infection with ARDS who require any ECMO therapy

Exclusion Criteria:

* None
Measuring Various Variables in Obstructive Sleep Apnea

This study included 90 volunteer Obstructive Sleep Apnea Syndrome patients. Only 7 mL blood samples collected from patients. Some biochemicals parameters analyzed in blood serum/plasma.

This study included 90 volunteer patients diagnosed with OSAS, and they were divided into three groups according to the apnea-hypopnea index (AHI) score: mild OSAS (n=30;5≤ AHI ≤13.70), moderate (n=30;15.80≤AHI≤26.60) and severe (n=30;34.10≤AHI≤86.30). Demographic data, as well as biochemical parameters, nocturnal oxygen saturation percentage (SpO2), and body mass index (BMI) were measured. Plasma agmatine levels were measured by ultra-high-pressure liquid chromatography (UHPLC), plasma trace elements (Cu, Co, Mg, Mo, Zn, Se) levels were determind by inductively coupled plasma mass spectrometer (ICP-MS) and serum telomerase levels were measured by enzyme-linked immunosorbent assay (ELISA) method. Analyzes were carried out at the Cumhuriyet University advanced technology research and application center.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of obstructive sleep apnea disease
* Apnea-hypopnea index (AHI) score between 5-87

Exclusion Criteria:

* asthma
* chronic obstructive pulmonary disease
* pneumonia
* psychiatric
* diabetes
* heart failure
* who work at night work
Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders

This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.

One of the areas receiving very little attention in Pervasive Developmental Disorders (PDDs) is that of anxiety. Anxiety is common in PDD, but has not yet been fully characterized. The primary objective of this study is to conduct a preliminary placebo-controlled trial of mirtazapine for the treatment of anxiety associated with PDDs. We hypothesize that mirtazapine will be safe and well tolerated.

Eligibility Criteria:
Inclusion Criteria:

* Ages 5-17 years
* Diagnosis of autistic disorder, Asperger's disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS)
* Clinically significant anxiety as evidenced by a Pediatric Anxiety Rating Scale (PARS) score of 10 or greater
* Abbreviated intelligence quotient (IQ) greater than 50 on the Stanford Binet 5th Ed.

Exclusion Criteria:

* Diagnosis of Rett's disorder or childhood integrative disorder
* Diagnosis of obsessive-compulsive disorder (OCD), post-traumatic stress disorder, major mood disorder, psychotic disorder, or substance use disorder
* Presence of any past or present medical conditions that would make treatment with mirtazapine unsafe
* Use of other antidepressants or benzodiazepines
* Use of other psychotropic medications which are ineffective, poorly tolerated, or sub-optimal in terms of dose
* Previous adequate trial of mirtazapine
Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B

The primary objectives of the study were: to evaluate the safety and tolerability of rFIXFc; to evaluate the efficacy of rFIXFc in all treatment arms; to evaluate the effectiveness of prophylaxis over on-demand (episodic) therapy by comparing the annualized number of bleeding episodes between participants receiving rFIXFc on each prevention (prophylaxis) regimen and participants receiving rFIXFc on an episodic regimen. The secondary objectives of the study were: to evaluate and assess the pharmacokinetic (PK) parameter estimates of rFIXFc and rFIX (BeneFIX®) at baseline in the Sequential PK subgroup as well as rFIXFc at Week 26 (±1 week); to evaluate participants' response to treatment; to evaluate rFIXFc consumption.


Eligibility Criteria:
Inclusion Criteria:

* Male and 12 years of age and older and weigh at least 40 kg
* Diagnosed with hemophilia B (baseline Factor IX level less than or equal to 2%)
* History of at least 100 exposure days to any Factor IX product
* Platelet count ≥100,000 cells/μL

Exclusion Criteria:

* History of Factor IX inhibitors
* Kidney or liver dysfunction
* Diagnosed with another coagulation defect other than hemophilia B
* Prior history of anaphylaxis associated with any Factor IX or intravenous (IV) immunoglobulin administration
Evaluation of Performance of Automatic Fusion for Radiofrequency Ablation of Hepatocellular Carcinoma

Fusion imaging of US and MRI is very helpful for interventional procedure such as radiofrequency ablation in liver. However, manual registration of US and magnetic resonance (MR) imaging is somewhat time-consuming and difficult for less-experienced physicians. Recently, automatic registration function was developed to help the fusion of US and CT/MRI imaging. The purpose of this trial is to compare the registration time and accuracy of manual registration system and automatic registration system.

1. Patients will be randomized and assigned.
2. For automatic registration group, automatic image fusion will be done by RS80A US unit and RF ablation will be performed. Image fusion time will be measured.
3. For manual registration group, manual image fusion will be done by LOGIQ-E9 US unit and RF ablation will be performed. Image fusion time will be measured.

3) After radiofrequency (RF) ablation, immediate, contrast enhanced CT will be performed to evaluate technical success and complications 4) Accuracy of registration will be measured by home-made software using 3D techniques.

5) After one month, technical effectiveness will be evaluated by contrast enhanced CT 6) F/U of CT images will be obtained until one year after RF ablation with a interval of 1-3 months.

Eligibility Criteria:
Inclusion Criteria:

* More than 40-years old
* Patients with hepatic malignancy who will underwent radiofrequency ablation

Exclusion Criteria:

* Not using fusion imaging (CT guidance or fluoroscopic guidance)
Additive Intra-ocular Pressure Reduction Effect of Fixed Combination of Maleate Timolol 0.5%/Dorzolamide 2% on Monotherapy With Latanoprost in Patients With Elevated Intra-ocular Pressure

The purpose of this study is to evaluate the additive effect of dorzolamide/timolol fixed combination in patients undergoing monotherapy with latanoprost.


Eligibility Criteria:
Inclusion Criteria:

All patients were at least 18 years old, with unilateral or bilateral open-angle glaucoma (defined as IOP \> 21 mmHg, mean of three consecutive measurements, at any time during the day, at the moment of glaucoma diagnosis) or ocular hypertension (IOP\> 25 mmHg, mean of three consecutive measurements, at anytime during the day, at the moment of diagnosis). Glaucoma was defined as a reproducible glaucomatous visual field defect based on GHT outside normal limits and/or PSD lower than 0,5% or glaucomatous changes of the optic disc associated to elevated IOP. A visual acuity (ETDRS) of 20/80 or better was required for randomization.

Exclusion Criteria:

Included woman of childbearing potential, pregnancy, systemic contra-indication to beta-blocker therapy, argon laser trabeculoplasty three months before screening visit, any history of filtering surgery, ocular surgery or uveitis three months before screening visit, hypersensitivity to any compound of the study drugs, concomitant use of any experimental drug, any condition in which treatment with beta-blocker is contraindicated or any other abnormal and/or ocular condition or symptom that would prevent study participation, according to the judgment of the investigator. The use of systemic beta-blocker, if needed, was allowed and not considered an exclusion criterion. Latanoprost non-responders defined as lower than 15% IOP reduction after run-in period with latanoprost monotherapy were excluded from the study.
Influence of Intestinal Microbiota Implantation in Preterm Infants on Microbiota and Immune Orientation at 3 Years

The main objective of this research is to study the links between changes in the intestinal microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and the presence / absence of a TH1 immune status at 36 months of age.

The secondary objectives are to study the links between changes of the intestinal microbiota premature infants in terms of:

* changing diversity of the microbiota in the first 6 weeks of life;
* changes in the bacterial community (UniFrac study) during the first 6 weeks of life;
* diversity of the microbiota up to 6 weeks;

-AND-

* diversity of the microbiota at 1, 2 \& 3 years;
* bacterial communities (UniFrac study) at 1, 2 \& 3 years;
* lymphocyte subpopulation profiles at 3 years;
* serum immunoglobulin A, G, M, E levels at 3 years;
* history of infectious episodes, allergic and inflammatory episodes during the first 3 years of life.

The links between certain variables known in the literature and neonatal microbiota will be confirmed / studied in our population:

* mode of delivery;
* length (and type) of antibiotic therapy in the neonatal period;
* duration of breastfeeding.

Eligibility Criteria:
Inclusion Criteria:

* The parents of the patient (or legal guardian if any) have been informed about the implementation of the study, its objectives, its constraints, and patient rights
* The parents of the patient (or legal guardian if any) must have given their free and informed consent and signed the consent form
* The patient must be affiliated with or beneficiary of a health insurance plan
* Premature infants born at less than 33 weeks of gestation

Exclusion Criteria:

* The patient is participating in another interventional study (Excepted " Recherche du Portage de Clostridium butyricum et de Toxines de Clostridium chez les Prématurés Hospitalisés en Néonatologie afin de prédire la survenue d'Entérocolites Nécrosantes", RCB 2016-A00-529-42 ; " BetaDose Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth ", RCB 2016-001486-90.
* It is not possible to correctly inform the parent (or legal guardian, if applicable)
* A serious deformity or digestive malformation was diagnosed at birth
* During the hospital stay in the neonatology department, the patient had a digestive disease requiring surgery (except necrotizing enterocolitis)
* A transfer to another hospital is foreseen/predictable (eg, due to geographical distance)