cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Multiscore Feedback in Professionalism for Anesthesia

Professionalism is one of the six competences required by The Accreditation for Graduate Medical Education Outcome Project to be taught and evaluated during residency. Anesthesia residents are faced with unique communication challenges in their practice including brief contact time with their patients, operating room efficiency pressure, etc. To assess professionalism in Anesthesiology residents is important to obtain evaluations from people with whom they interact including patients, surgeons, colleagues and members of the support team. The Multisource feedback (MSF) approach has been used to evaluate communication skills and professionalism among practicing physicians and residents in a variety of settings. This evaluation model has never been used previously to evaluate anesthesia residents. The investigators propose a randomized controlled trial to validate and evaluate a MSF in professionalism for anesthesia residents. Participants include eighty residents doing two months rotation in Pediatric Anesthesia Department at The Cleveland Clinic Anesthesia Institute from July 1, 2011 and June 30, 2013. MSF questionnaires will be validated using face and content validity methods and comparing them with the current system of evaluation. Residents will be randomly assigned to a feedback group or to the control group. Both groups will receive MSF evaluation from the faculty, patients' parent and coworker. Only the group assigned to feedback is going to have a 'coaching meeting' every month to identify strengths and weaknesses and create strategies for improvement. The investigators are planning to compare the mean values of the baseline evaluations with the mean values obtained after the first and second months from the MSF.


Eligibility Criteria:
Inclusion Criteria:

* CA2 and CA3 residents doing a two month rotation in Pediatric Anesthesia Department

Exclusion Criteria:

* N/A
A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin")

The purpose of this research study is to find out more about an investigational drug, 10XB-101, for people with fat under their chin which they would like to remove. The Sponsor of this study thinks there may be a chance this drug could be used to dissolve, or "melt" this fat away.

About 15 subjects with excessive submental fat (SMF) will be enrolled across 2 sites in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a male or non-pregnant female 18-65 years of age
* Signed informed consent
* Subject has a score of 2 or 3 on the Clinician Submental Fat Scale (CSFS) at Visit 2/Baseline
* Subject is in good general health

Exclusion Criteria:

* Loose skin or prominent platysmal bands in the neck or chin area
* Recent treatment with anticoagulants
* Presence of clinically significant health problems
Axillary Plexus Block in a High Resolution MRI

Background and aims:

Magnetic resonance imaging (MRI) has proved beneficial for presenting anatomy for regional anaesthesia and to demonstrate spread of local anaesthetic.

A new axillary plexus block with a triple injection (1), combining a short axillary catheter method with a transarterial axillary block, is now being evaluated with a 3 Tesla MRI. In this study, the investigators are investigating MR visualisation of three different block techniques and compare the clinical efficacy of the techniques, with the MR findings.

Patients \& Methods:

After obtaining approval of the protocol from the regional ethical committee, 3 x 15 adult patients, scheduled for hand surgery, were included in a randomised, blinded prospective study.

After obtaining approval of the protocol from the regional ethical committee, 3 x 15 adult patients, scheduled for hand surgery, were included in a randomised, blinded prospective study.

In all patients a short axillary plexus catheter is positioned close to the median nerve using nerve stimulator.

Technique 1 = 40 ml in catheter Technique 2 = 30 ml behind and 10 ml in front of the brachial artery (BA) Technique 3 = 20 ml behind, 10ml in front of the BA and 10 ml in catheter

Clinical High Field MRI (3T) scanner has simplified the recognition of brachial plexus nerves in the axilla. After injection of local anaesthetic (LA), the identification of the nerve structures is nevertheless difficult. When all nerves are surrounded of LA in the axilla (MRI), it seems to be associated with a clinical complete brachial plexus block

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for hand surgery
* ASA 1 - 2
* Weight from 50 - 95 kg
* MR compatible, suitable

Exclusion Criteria:

* Neurologic deficit
* Reaction to LA
A Study Comparing a Plant-Based Diet With Supplements and Placebo in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)

The researchers are doing this study to look at how butyrate levels change in participants' stool after they are on a- plant-based diet for at least 12 weeks. All participants will have monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). We will compare how the plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo (an inactive substance that looks like the study supplements) affect butyrate levels in participants' stool.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of MGUS or SMM
* If non light chain MGUS/SMM then M spike must be either ≥ 0.2 g/dL or BM PC ≥10% (both not required)
* If light chain MGUS/SMM then involved must be ≥10 mg/dL or BM PC ≥10% (both not required)
* If IgA MGUS/SMM then an IgA level \>350 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
* If IgD MGUS/SMM then an IgD level \>50 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
* Age ≥18 years
* Willingness to comply with all study-related procedures
* ECOG performance status of 0-3
* Interested in learning to cook plant based recipes

Exclusion Criteria:

* Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded)
* Legume allergy
* Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals.
* Concurrent participation in weight loss/dietary/exercise programs
* Mental impairment leading to inability to cooperate
* Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date
* Concurrent pregnancy
* Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll
* ≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study)
* If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications
* Heavy drinker (defined as \>2 drinks per day or \>14 drinks per week)
* Current self-reported illicit drug use (eg heroin, cocaine not marijuana)
Remote Delivery of Weight Management for Adults With IDD

The purpose of this study is to compare different weight loss programs in people with IDD to see which program works better.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate IDD as determined by a Community Service Provider operating in Kansas under the auspices of a Community Developmental Disability Organization (CDDO). Participants will be judged competent to provide informed consent by their CDDO, or will have a guardian with power of attorney.
* Ability to provide assent, regardless of guardian consent.
* BMI of 25 to 45 kg/m2
* Sufficient functional ability to understand directions, communicate preferences (e.g. foods), wants (e.g. more to eat/drink), and needs (e.g. assistance with food preparation) through spoken language
* Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner
* No plans to relocate outside the study area over the next 24 months
* Internet access in the home

Exclusion Criteria:

* Unable to participate in moderate-to-vigorous physical activity (MVPA)
* Insulin dependent diabetes
* Participation in a weight management program involving diet and physical activity in the past 6 months
* Serious food allergies, consuming special diets (vegetarian, Atkins etc.), aversion to common foods (e.g., unwilling to consume dairy products, vegetables), diagnosis of Prader-Willi Syndrome
* Pregnancy during the previous 6 months, currently lactating or planned pregnancy in the following 24 months.
* Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty
* Unwilling to be randomized.
To Evaluate the Visual Performance After Bilateral Implantation of Multifocal Intraocular Lenses

To evaluate the visual performance after bilateral implantation of multifocal intraocular lenses.

This study evaluates the visual performance after bilateral implantation of multifocal intraocular lenses (IOL). This prospective study is performed at the department of Ophthalmology, Goethe University, Frankfurt, Germany.

Patients who received bilateral implantation of a multifocal intraocular lens pre-enrollment were included consecutively. Exclusion criteria were previous ocular surgeries excluding cataract surgery and refractive lens exchange, regular corneal astigmatism of \>1.5 diopter, and ocular pathologies or corneal abnormalities. At 3 months postoperative examination included manifest refraction; monocular and binocular uncorrected (UCVA) and distance-corrected (DCVA) visual acuity in at far, intermediate at near distance (logMAR); slit-lamp examination. 3 months postoperatively defocus testing, binocular contrast sensitivity (CS) under photopic and mesopic conditions, and a questionnaire on subjective quality of vision, optical phenomena, and spectacle independence were performed.

Eligibility Criteria:
Inclusion Criteria:

* bilateral cataract surgery or refractive lens exchange with the implantation a multifocal intraocular lens
* a regular corneal astigmatism \< 1.5 D measured with Pentacam (Oculus, Wetzlar, Germany)

Exclusion Criteria:

* other previous ocular surgeries
* ocular pathologies
* corneal abnormalities
* endothelial cell count below 2000/mm²
Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)

This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.


Eligibility Criteria:
Inclusion Criteria:

* Has met all the entry criteria for either CYB003-002 APPROACH, or CYB003-003 EMBRACE.
* Has successfully completed either CYB003-002 APPROACH or CYB003-003 EMBRACE and received both dose administrations of trial medication.
* Has continued the same antidepressant medication at the stable dose/day throughout CYB003-002 APPROACH or CYB003-003 EMBRACE.
* Has provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.

Exclusion Criteria:

* Meets any of the exclusion criteria for CYB003-002 APPROACH.
* Significant suicide risk as defined by suicidal ideation as endorsed on items 4 or 5 on the C-SSRS at Baseline OR has experienced an adverse event (AE) of suicide ideation/attempt or self-harm in CYB003-002 APPROACH OR has had a \>1 point change in item 1 or 2 of the C-SSRS from Screening in CYB003-002 APPROACH.
* Positive urine test for drugs of abuse, cannabis, or alcohol breath test prior to dosing.
* Unwilling to consent to audio and video recording of psychological support and dosing sessions
Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris

This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.

Same as above.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with a minimum of 20 inflammatory lesions on the face;
2. Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
3. Subject has a Global Severity Assessment

Exclusion Criteria:

1. Subjects with more than three nodulo-cystic lesions
Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

This is a safety and tolerability study of GW572016 given with docetaxel (TAXOTERE).


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumors.
* Able to swallow oral medication.
Exercise Training Intervention in Children With Type 1 Diabetes

Type 1 diabetes mellitus (T1DM) is associated with multiple co-morbidities, such as hypertension, dyslipidemia, coronary heart disease and osteoporosis. The foundation of these conditions lays in childhood. Exercise is known to have a positive influence on bone mineral density (BMD) and some impact on cardiovascular disease risk factors in healthy children, but little is known about these associations in children with T1DM.

The main purpose of this study is to assess the effects of a 9-month weight-bearing exercise training program on skeletal development in children with T1DM, compared to healthy subjects. The second aim is to evaluate whether the program influences also cardiovascular diseases risk factors.

This is a randomized controlled study incorporating 30 children with T1DM and 30 healthy children. Both groups are randomly divided (1:1) in an exercise or a control group: 1) exercise diabetic, 2) controls diabetic, 3) exercise healthy, 4) controls healthy.

Exercise groups participate to an identical weight-bearing exercise training program 2 x 90 minutes per week and controls are relatively inactive.

Main measures include: total body, lumbar spine and hip BMD by DXA, body fat and fat-free mass, bone biomarkers levels, resting and ambulatory blood pressure and fasting blood lipids.


Eligibility Criteria:
List of inclusion criteria for Type 1 diabetes patients:

1) disease for at least 1 year.

List of inclusion criteria for healthy subjects:

1) good general health and normal growth.

List of exclusion Criteria for all subjects:

1. presence of other chronic disease, including thyroid disease;
2. medications, hormones other than insulin, or calcium preparations taken in the preceding 6 months;
3. presence of nephropathy;
4. systemic disease or hospitalization for more than 2 weeks in the preceding year;
5. less than 6 menstrual cycles in the past year for post-menarche girls;
6. participation in competitive sport.
Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV

The purpose of this study is to characterise the pharmacokinetic profiles of non-nucleoside analog reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs), and the influence of the individual characteristics on the pharmacokinetic parameters in the Spanish population of HIV-infected subjects.

The antiretrovirals were administered conventionally according to fixed dosage systems, or depending on the weight of the individual in the case of certain agents. However, the plasma levels of antiretrovirals following the administration of a fixed dose present a marked interindividual variability. Moreover, a significant proportion of the patients on treatment with PIs presented plasma levels regarded as suboptimal in previous studies.

Moreover, for the correct modification of the dosage of a drug, populational data on its pharmacokinetic behaviour during the dosing interval is required. Only by integrating this information with the specific characteristics of each individual is it possible, using mathematical models, to estimate the effect that a modification of the dosage of the drug would have on its plasma concentration. However, populational data on the pharmacokinetic behaviour of antiretroviral agents are still very limited at this moment, and have not always been obtained in populations similar to the one to which they are to be applied.

Thus, knowing the pharmacokinetic behaviour of the antiretroviral agents in our population and the influence of certain individual characteristics on this behaviour may be of great interest, since only in this way will we be able to tailor the dosage of antiretrovirals reliably in our patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age higher than 18 years.
2. Documented HIV infection (at least one positive Western-blot)
3. Stable antiretroviral treatment with PI or NNRTI, no changes over the last 4 weeks.
4. Women may not be of fertile age (defined as at least one year from menopause or undergoing any surgical sterilisation technique), or negative pregnancy test.

Exclusion Criteria:

1. Subjects on treatment with more than one PI or with combinations of PI and NNRTI (the use of ritonavir in doses below 400 mg BID will not be regarded as a second PI).
2. Treatment with other drugs with known significant pharmacological interactions with the investigational drug over the previous two weeks.
3. Unsuitable adherence to treatment (one or more doses omitted in the last week, or two or more doses omitted in the last two weeks).
4. Presence of clinical findings or a background of gastrointestinal disease or digestive surgery that may interfere in the pharmacokinetics of the medication.
5. Active consumption of alcohol (\>50 grams/day) or illegal drugs (except cannabis).
6. In the case of women, pregnancy or breastfeeding.
7. Record or suspicion of inability to cooperate properly
The Value of Measuring Retinal Vascular Density by Optical Coherence Tomography-Angiography (OCT-A) in Patients with Microvascular Angina Confirmed by Myocardial Microcirculatory Resistance Index (MRI).

Microvascular angina is thought to affect around 112 million patients worldwide. However, this figure is underestimated due to the difficulty of making the diagnosis. It is a pathology caused by an alteration in the microcirculation of the heart muscle, which is not detectable on a standard coronary angiogram.

In view of its prognostic, therapeutic and medico-economic value, scientific societies currently recommend invasive measurement of the microcirculatory resistance index (MRI) to diagnose microvascular angina, in the absence of significant lesions on coronary angiography.

Several research teams, including our own, have shown that cardiovascular risk is associated with alterations in the vascularization of the small vessels (microcirculation) of the retina. Unlike the study of cardiac vessels, the study of retinal microcirculation using fundus photography (OCT-A) is simple, rapid, non-invasive and inexpensive. It appears to be an interesting alternative to the measurement of IMR for the diagnosis of microvascular angina.

This hypothesis has never yet been tested. The demonstration of an association between a decrease in retinal vascular density measured by OCT-A and an alteration in coronary microvascular function measured by IMR would pave the way for a completely non-invasive diagnosis of patients.

This is an observational, cohort, prospective, single-center pilot study comparing people who have received an IMR measurement as part of INOCA.

It is planned to include 158 participants. The overall follow-up period for each patient in the research is 12 months.

In routine care, IMR is measured during coronary angiography in patients presenting with ischemia on a non-invasive test and/or stress symptoms such as angina or dyspnea, for whom coronary angiography does not reveal any significant epicardial lesion.

Following this examination, two groups will be formed: a group with an IMR\<25 and a group with an IMR≥25. Clinically, the study aims to determine the potential role of retinal OCT-A as a non-invasive examination for the diagnosis and/or follow-up of INOCA.


Eligibility Criteria:
Inclusion Criteria:

* Patients managed at Dijon University Hospital, having had an IMR measurement as part of INOCA during a coronary angiographic examination, consecutively includible, without angiographically or functionally significant coronary epicardial lesion (FFR \< 0.80) explaining the clinical picture (= INOCA)
* Person having given oral consent
* Adult

Exclusion Criteria:

* Person not affiliated or not benefiting from a social security scheme
* Person subject to a legal protection measure (curatorship, guardianship) or a safeguard of justice measure
* Pregnant or breast-feeding women
* An adult incapable or unable to give consent
* Person with macular or retinal pathology, or severe bilateral myopia
* Person with genetic or idiopathic cardiomyopathy (dilated, hypertrophic or restrictive cardiomyopathy)
Study on AI Recognition System Of Heart Sound In Congenital Heart Disease Screening

The objective of this study is to establish AI algorithm based on the deep learning to strengthen the ability to classify the heart murmurs of healthy people and different major or other subdivided congenital heart diseases(CHDs) and to evaluate the effectiveness of artificial intelligence technology-assisted heart sound recognition system (referred to as: Heart sound AI recognition system) for multi-center CHD screening.

This is a multi-center cluster cross-sectional study in CHINA. Heart sounds will be collected by auscultation using an electronic stethoscope in children (0 \~ 18 years old) confirmed with or without CHDs by echocardiography during outpatient or hospitalization in 10 pediatric medical centers. Heart sounds will be visualized as phonocardiogram, and feature extraction will be done after classification of normal and abnormal heart sounds and labeling the characteristics of heart murmurs by pediatric cardiovascular specialists. Artificial intelligence algorithm (machine learning, deep learning, etc.) will be trained to build a heart sounds recognition system with the data mentioned above.We will use the receiver operating characteristic (ROC) curve to compare the ability of recognition and classification of abnormal heart sounds between different artificial intelligence algorithm. Taken the results of echocardiography as the gold standard, we will use the evaluation indexes,such as sensitivity, specificity, accuracy, positive predictive value, negative predictive value, etc, to compare the diagnostic capacity of CHD screening between the AI recognition system and human cardiovascular pediatricians. Our target is to use artificial intelligence technology to assist heart auscultation for CHD screening.

Eligibility Criteria:
Inclusion Criteria:

1. 0 \~ 18 years of age, regardless of gender ；
2. Children with or without congenital heart disease confirmed by echocardiography；
3. On the basis of informed consent，willing to cooperate with our group.

Exclusion Criteria:

1. ≥ 18 years of age;
2. Children who can not undergo echocardiography or other related tests;
3. Subjects who refuse to join in, or who are unwilling to cooperate with the provision of diagnostic and therapeutic data for further analysis and research.