cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Hypothyroidism Incidence After Breast Cancer Supraclavicular Irradiation

Prospective, multicentric, comparative, non randomised, in current care.

Primary objective:

* To evaluate the incidence of hypothyroidism in breast cancer patients treated by radiotherapy including the supra-clavicular area over a period of 5 years (60 months).

Secondary objectives :

* To calculate the dose of irradiation received by thyroid gland during the treatment.
* To compare the rate of incidence of hypothyroidism in women who received a supra-clavicular irradiation (group 1)and in those who did not (group 2).
* To estimate and compare the rate of incidence of chronic thyroid lesions in the 2 groups.
* To look for predictive factors of hypothyroidism de novo in group 1 women particularly regarding the dose-volume parameters.
* To propose recommendations for the thyroid follow-up after supra-clavicular irradiation.

Prospective, multicentric, comparative, non randomised, in current care study

2 patient groups, non randomised, according to the necessity or not to perform a supra-clavicular irradiation:

* Group 1 : patients receiving a supra-clavicular irradiation
* Group 2 : patients not receiving a supra-clavicular irradiation.

Schedule

Projected inclusion duration of 18 months (duration to possibly adapt in order to obtain the number of required patients)

Intermediate study of the results in 30 months

Duration of follow-up of 60 months

Eligibility Criteria:
Inclusion Criteria:

* Women older than 18
* Non metastatic breast cancer, histologically proved, whatever T and N stages and receptors status.
* Breast cancer treated by surgery (either initial treatment then biotherapies and/or neoadjuvant chemotherapy, either secondarily after biotherapies and/or neoadjuvant chemotherapy, either without chemotherapy and/or biotherapies)
* Breast cancer requiring an adjuvant radiotherapy
* Treatment by radiotherapy made in participating centers
* Information of patient and signature of the informed consent.

Exclusion Criteria:

* Pre-existent dysthyroidism revealed before radiotherapy or at inclusion checkup (THS lower or superior to the standard of the laboratory, whatever the rate of free T4)
* History of thyroid surgery
* Bilateral breast cancer
* History of cervical and/or supra-clavicular radiotherapy
* Lack of social security insurance
* Subjects deprived of free behavior or under administrative control
The Effect of Virtual Reality Application on Anxiety and Fear Levels of Children Planned for Daily Surgery

Objective: This study was conducted to determine the effect of the animation video to be watched by child patients aged 5-10 before day surgery on their anxiety and fear levels in the preoperative period. Method: This research, which was conducted as a randomized controlled experimental study, was conducted with 80 children. Participants sociodemographic data, blood pressure, heart rate, Child Fear Scale and Yale Modified Preoperative Anxiety Scale Child Form were used to collect data. Comparisons in independent pair groups with Kolmogorov Smirnow Test whether the data received comply with normal distribution; Since the assumption of normality is met, comparisons in dependent pair groups are made with the significance test (t test) of the difference between two means; Since the assumption of normality was met, the significance test of the difference between two spouses was performed (two paired samples t test).

Objective: This study was conducted to determine the effect of the animation video to be watched by child patients aged 5-10 before day surgery on their anxiety and fear levels in the preoperative period. Method: This research, which was conducted as a randomized controlled experimental study, was conducted with 80 children. Participants sociodemographic data, blood pressure, heart rate, Child Fear Scale and Yale Modified Preoperative Anxiety Scale Child Form were used to collect data. Comparisons in independent pair groups with Kolmogorov Smirnow Test whether the data received comply with normal distribution; Since the assumption of normality is met, comparisons in dependent pair groups are made with the significance test (t test) of the difference between two means; Since the assumption of normality was met, the significance test of the difference between two spouses was performed (two paired samples t test).

Eligibility Criteria:
Inclusion Criteria:

Not having an audiovisual disease

Exclusion Criteria:

Having an audiovisual disease
A New Method of Muscle Strength Testing Using a Quantitative Ultrasonic Technique and a Convolutional Neural Network

In addition to muscle thickness and average echo intensity, this study aimed to use quantitative ultrasonic technology to increase the number of related parameters of power Doppler ultrasonography measured to describe the number, quality, and recruitment level of muscles. In addition, this method was compared with the existing muscle strength testing methods. Image recognition was performed using the traditional multivariate linear regression statistical method and the AI convolutional neural network algorithm to investigate the application of quantitative ultrasonic technology for direct evaluation of muscle strength in clinical practice.

Collection of all quantitative ultrasonic data was performed by one ultrasound physician. The Aixplorer® series color ultrasonic diagnostic instrument of Supersonic Imagine (France) and an L15-4 linear array probe were used. The medial head of the quadriceps muscle was measured. The subjects wore short pants that settled above the knees. Tight pants were avoided to prevent impaired venous return, which can affect the power Doppler ultrasonography result. The subjects did not exercise within half an hour before testing. Two-dimensional images of the subjects' muscles were collected in a quiet resting state and used to measure muscle thickness and the average echo intensity. The power Doppler images were used to measure the level of muscle hyperemia. The measurements were performed in the 0° knee extension position and the most prominent part of the medial head of the quadriceps muscle was measured by the ultrasound physician using visualization. The probe angle was perpendicular to the trajectory of the muscle bundle, and the measurement was performed with the muscle in a relaxed state. After the measurements, the knee was restrained to complete the isokinetic muscle strength test. When testing of the last group was completed, the knee was released immediately. The two-dimensional image and the power Doppler image at the same location were captured and the image acquisition time was no more than 3 s.

Eligibility Criteria:
Inclusion Criteria:

* no major complaints of muscle numbness, spasm, or atrophy, muscle-related physical activity impairment or joint swelling and pain
* no obvious malformation in the lower limbs
* no disease history in the musculoskeletal system, nervous system, and peripheral blood,
* no history of severe trauma in the lower limbs
* joint mobility and muscle tension met the thresholds of muscle strength assessments
* no severe osteoporosis
* no acute inflammation or acute bone fracture repair
* between 18-55 years of age

Exclusion Criteria:

-
Brijjit® for Wound Closure in Gender Affirming Mastectomies

This study will evaluate the use of Brijjit® for wound closure in individuals undergoing bilateral double incision gender affirming mastectomies with a single surgeon (Rachel Bluebond-Langner, MD). The study will be a randomized prospective interventional study utilizing internal controls (one side of chest receives intervention, other serves as control). Primary endpoints will include scar appearance/quality and wound complications

The hypothesis of this study is that the use of Brijjit® FMTB will result in improved scar outcomes as measured by both patient and treating physician as compared to traditional suture based wound closure methods. As mentioned, at present there is no standard of care for wound closure following double incision GAM, therefore an internal control approach will be taken with patients serving as their own controls. This will be achieved by having one side of the chest receive the of Brijjit® FMTB (intervention) in addition to suture closure of the skin, while the other side will be closed with traditional methods, a combination of sutures and steri-stripsTM (control).

Eligibility Criteria:
Inclusion Criteria:

* Patient self-identifies as Transgender or Gender Expansive
* Patient will undergo primary bilateral double incision mastectomy at NYULH
* All clinical criteria to be eligible for primary mastectomy must be met
* Ability to care for donor site and adhere to wound therapy (either solo or with care-giver assistance)
* Willingness to return for scheduled follow-up visits through 1 year post-operatively
* 18 years of age or older
* English Speaking

Exclusion Criteria:

* Individuals with previously diagnosed allergies or a history of adverse effects related to adhesives / adhesive tapes
* Individuals with a history of the following prescription medication use in the last year: Accutane, Systemic glucocorticoids and/or Local glucocorticoids or immunosuppressants (i.e. topical tacrolimus, topical clindamycin etc.) at the intervention site
* Individuals with a history of significant scarring or adverse scarring (hypertrophic scars or keloid scars)
* Individuals with pre-existing scars at the GAM wound closure site
* Individuals with a disorder known to negatively affect wound healing (i.e. autoimmune disease, connective tissue disease)
* Individuals with malnutrition
* Individuals with a BMI \>30 kg/m2
* Individuals with a history of radiation therapy
* Active smokers or smokeless nicotine use
* History of Previous Mastectomy
* Patient is actively immunosuppressed i.e. AIDS (HIV+ acceptable), or Systemic immunosuppressants
* Patients unable to attend post-operative follow-ups in person
* Patients with a considerable history of medical non-compliance
* Patient will receive GAM not including double incisions (i.e. periareolar)
Learning Management of Open Fractures on Virtual Patient

* A novel virtual world programme with over 240 multiple choice questions was developed to assess the competencies in managing an open fracture of the lower limb according to the British Orthopaedic Association Standards for Trauma (BOAST) and Advanced Trauma Life support (ATLS) guidelines.
* A longitudinal, observational, multi-centre prospective cohort study was conducted at Imperial College London.
* Primary objective consisted of objective scores calculated in real-time from the 240 multiple choice questions between Novices, Intermediates and Experts.
* Participants who had either completed ATLS training, or had familiarised themselves with BOAST guidelines were also identified and correlated with objective scores.

This is a multi-centre prospective randomised controlled educational trial observing for validity and training effect of managing an orthopaedic emergency using a virtual patient within an online world. Cohorts consist of junior, intermediate and expert surgeons being tested on 240 multiple choice questions to assess for competency as well as face, content and construct validity.

Eligibility Criteria:
Inclusion Criteria:

* Postgraduate orthopaedic trainees and naïve to surgical simulation

Exclusion Criteria:

* undergraduates and previous exposure to surgical simulation involving cognitive task analysis
The Ajyal Salima Longitudinal Study to Prevent Childhood Obesity

The study was carried out to determine the long-term effectiveness of a school-based intervention programme when implemented over 2 years and its sustained effect one year later.


Eligibility Criteria:
Inclusion Criteria:

Schoolchildren Aged 8-12 years

Exclusion Criteria:

* no exclusion criteria
Better tArgetting, Better Outcomes for Frail ELderly Patients

The acronym for this proposal, BABEL, refers to the fact that a common "language" - the interRAI risk-stratification and decision-making tool - will be used in this project, allowing several measures of care quality in long-term care facilities to be compared with those in other provinces for the first time. The impact of the use of this assessment system and associated care planning protocols will also be investigated using usual practice as the point of reference.


Eligibility Criteria:
Inclusion Criteria:

* All nursing home residents in a particular unit where standardized evaluations are being introduced (for example, all residents in a particular floor or wing of the longterm care facility)

Exclusion Criteria:

* Residents who are admitted to a nursing home unit for less than 1 week.
Use of an Educational Multimedia Tool Versus Routine Care for the Uptake of Postpartum LARC in High-Risk Pregnancies

The purpose of the study is to evaluate if the implementation of a multimedia based educational tool and regular reminders with shared decision-making will increase the rate of LARC uptake and retention in high risk pregnancy patients within 12 weeks of delivery and to study the rates of retention of LARC at 12 and 24 months and short-interval pregnancy rates.

This study will include 380 women aged 18-50 enrolled between 28 weeks gestation and postpartum day #1 who have a pregnancy that is considered high-risk. After consent, participants will be randomized to either routine care or multimedia based intervention. The intervention will include an investigator created decision aid presented at the time of randomization and reminder texts until 12 weeks postpartum.

The primary objective is to evaluate the rate of LARC uptake and retention within 12 weeks of delivery. Secondary objectives include i) the retention of LARC at 12 and 24 months and ii) short-interval pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* Aged 13-50 years old
* High risk pregnancy due to either maternal medical conditions or obstetric/neonatal complications

Exclusion Criteria:

* Planned cesarean hysterectomy
* Unable to provide informed consent in either English or Spanish
* Unable to provide reliable cell phone access for the study duration
* Not willing to provide follow-up for two years
Assessment of Efficacy & Safety for a New Wound Dressing Urgo 310 3166 in the Local Treatment of VLU or Mixed Leg Ulcers

Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old who has provided his/her written informed consent,
* Patient who can be monitored by the same investigation team throughout the whole duration of the study,
* Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing,
* Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3,
* Ulcer area \> or equal to 5cm2,
* Ulcer duration \> or equal to 6 months,
* Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,
* Moderately or heavily exudative ulcers.

Exclusion Criteria:

* Clinical infection on the wound bed.
Observational Study to Determine the Effectiveness and Safety of Vismodegib (Erivedge®) in Participants With Locally Advanced Basal Cell Carcinoma (laBCC)

The primary purpose for this multi-center, non-interventional study is to evaluate the duration of response defined as duration from first documented response of complete response (CR) or partial response (PR) until disease progression (as determined by the treating physician) for participants with laBCC.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed IaBCC (inappropriate for surgery or radiotherapy)
* Participant is not included in any other trial
* Male or female participants are included in the pregnancy prevention program

Exclusion Criteria:

Participants for whom treatment with Vismodegib is contraindicated according to the SmPC, which has been in effect at the time of treatment with Vismodegib, including:

* Hypersensitivity to the active substance or to any of the excipients
* Women who are pregnant or breastfeeding
* Women of childbearing potential who do not comply with the Vismodegib Pregnancy Prevention Programme
* Coadministration of St John's wort (Hypericum perforatum)
Improvement of Lower Digestive Endoscopy Without Anesthesia : Evaluation of the Virtual Reality Mask

90% of colonoscopies are performed with general anesthesia (GA). GA carries risks and requires a prior anesthesia consultation, a dedicated team and technical platform on the day of the examination. These constraints increase the time it takes to organize examinations. This was particularly highlighted during the recent health crisis. The success of colonoscopy without GA varies depending on the patient's experience of the examination. Any measure allowing better tolerance of the exam is therefore likely to increase its success rate and avoid rescheduling the exam under GA. A 2017 meta-analysis showed that the use of virtual reality (VR) reduced pain and anxiety during care for burn victims, in trauma and oncology. In upper digestive endoscopy, retrospective studies have shown good tolerability of the examinations and a reduction in pain compared to patients with only local anesthesia. Thus, if the VR mask improves the success rate of total colonoscopy by improving tolerance and acceptability, more examinations without GA could be considered. It could also have an economic impact.


Eligibility Criteria:
Inclusion Criteria:

Patient over 18 years old with an indication for total colonoscopy and accepting without General Anesthesia

Exclusion Criteria:

* Hearing problems or low vision
* Psychiatric or cognitive disorders hindering communication
* History of epilepsy
* Claustrophobia which can lead to a rejection of the virtual reality mask
* History of cybercynetosis during previous use of VR
* Chronic abdominal pain with baseline Visual analogue scale (VAS) \> 5
* Emergency examination
* Patient participating in another interventional research on digestive endoscopy
* Patient not speaking French
* Patient under guardianship
Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve

The objective of this study is to evaluate the medium- to long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease in the Chinese population.

The study is designed as a post-market, retrospective, single arm and multicentric data collection

This study is conducted to evaluate the medium and long-term safety of the Carbomedics OptiForm Mitral Heart Valve after the implantation for mitral valve disease. The data will be used for regulatory purposes, to support the re-certification of the valve in the Chinese market.

Valve-related SAEs such as prosthetic valve dysfunction, death, valve-related bleeding events, valve thrombosis and thromboembolic events, endocarditis and reintervention will be studied to describe the safety profile of the valve. Data of approximately 400 subjects will be collected in two clinical sites in China.

Eligibility Criteria:
Inclusion Criteria:

* Subject who has been treated with the Carbomedics OptiForm Mitral Heart Valve.
* Subject (or representative or family member) who can understand the objective of the study and is willing to provide verbal informed consent and the available medical information.

Exclusion Criteria:

* Subject (or legal representative or family member) who do not provide their verbal consent to the data collection, or who are unable to provide follow-up information
Chronic Hepatitis C (CHC) - Genotype 3 Infection in Canada

Hepatitis C is a small RNA virus spread by blood to blood contamination. There are to date 6 known genotypes and within each there are several subtypes. Although all genotypes are distributed worldwide some are more common in certain countries and/or among certain populations.

Genotype 3(G3) infection is the predominant type in South East Asia (Bangladesh, Pakistan, India and Sri Lanka). In addition, because of the "promiscuous exposure" to hepatitis C amongst injection drug users, it is not unusual for the latter to be infected with G3 as well. There are several subtypes of G3. Viral genotype has long been recognized as a major factor influencing the response to interferon-based therapy. Patients infected with G2 and G3 respond much better to current therapy with peginterferon and ribavirin than those infected with G1 and G4. Most studies have grouped patients with G2 and G3 together, with few published comparisons of rates of viral clearance between these two favourable genotypes.

More recently it has become evident that in all individuals with chronic hepatitis C, the presence of insulin resistance, with or without the accompanying metabolic syndrome, is a major factor which influencing the response to antiviral therapy in CHC.

Very recently it has been reported and confirmed by several sites worldwide that specific polymorphisms of the IL28 gene are closely correlated with response to antiviral therapy in genotype 1 CHC. Interestingly, the polymorphisms were also shown to segregate according to ethnicity and may explain, at least in part, the marked differences in treatment response between different ethnic groups.

Eligibility Criteria:
Inclusion Criteria:

* Infected with only genotype 3, hepatitis C
* Treatment naïve before current course of therapy
* Age 18 or older

Exclusion Criteria:

* Under age 18
* Co-infection with HIV or Hepatitis B or any other HCV genotype in addition to genotype 3
* Prior treatment for Hepatitis C aside from herbal remedies
Cardiovascular Outcomes in Bariatric Surgery Patients With Type 2 Diabetes

The objective of the analysis was to evaluate the relationship between bariatric surgery and cardiovascular outcomes in obese patients with type 2 diabetes. This is a retrospective matched cohort study of patients with diabetes that underwent bariatric surgery at the Cleveland Clinic between 2004-2017. Each bariatric patient was matched to a non-surgical control with obesity and type 2 diabetes in a 1:5 ratio using data from the Electronic Medical Record (EMR). The maximum observation time was 10 years. Cumulative incidence rates for all-cause mortality and cardiovascular events were calculated at years 1, 3, 5, 7 and 10. Kaplan-Meier curves were created for all the outcomes with all-cause mortality considered as a completing risk.


Eligibility Criteria:
Inclusion Criteria:

* Type II diabetes
* 18-80 years old
* BMI\>=30
* HBA1c \>6.4 OR taking at lease one (1) diabetes medication (insulin or non-insulin)

Exclusion Criteria:

* History of liver, heart, or lung transplant
* Emergency department admission within 5 days prior
* Cancer diagnosis within 1 year prior
* Any prior ejection fraction \<20%
* Non-surgical controls were excluded if they died within 30 days after the index date (date of surgery for the bariatric patients)
* Last follow-up date on or before the index date