cyrilzakka/clinical-trials huggingface dataset:
Normal Values of Facial Thermography

An objective of this study is to standardize temperature values derived from thermograms of the facial region. It is anticipated that the mean temperature of a defined region of interest, such as the eyes, nose, or sinuses, might be useful for future applications.

The investigators will attempt to determine normal temperature ranges based on participants' age and gender.

Medical thermography is a noninvasive technique that allows an examiner to visualize and estimate the temperature of the skin surface. An infrared scanning device is used to convert infrared radiation emitted from the skin surface into electrical impulses that can be captured as an image called a thermogram. During the past 20 years medical thermography has been used to study the pathology in the vascular, muscular, neural and skeletal systems.

An objective of this study is to standardize temperature values derived from thermograms of the facial region. It is anticipated that the mean temperature of a defined region of interest, such as the eyes, nose, or sinuses, might be useful for future applications. This protocol addresses the definition of overall health, symptomology, and anthropometrical features (age, weight, height, body mass index and gender), and what effect, if any, each has on mean temperature. Environmental conditions, mapping procedures, and image evaluations will also be standardized. We will attempt to determine normal temperature ranges based on participants' age and gender. Future use of standardized values will be to assess the severity of rhinoconjunctivitis symptoms being experienced by a subject.

Subjects will make one visit to our clinic. They will be asked to acclimate to room temperature for at least 30 minutes. Subjects are requested not to consume hot drinks or food for at least an hour before imaging and not to use any skin preparations such as creams or talcum powder. A picture of the participant's face will be taken using the thermal camera which will demonstrate the temperature of each facial area of interest.

Please note that participants in this study will take part on a completely voluntary basis. No payment will be provided.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 7 and 70
* No mobility problems
* No restrictions in performing normal activities
* No regular pain or discomfort
* No anxiety or depression

Exclusion Criteria:

* Restrictions in performing normal activities
* Regular pain
* Anxiety or Depression
* Mobility problems
Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

The primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the management of intractable chronic migraine, when used in conjunction with anti-migraine medications.

Initial reports of managing migraine headache with ONS described a technique in which electrical leads were implanted in the subcutaneous space transverse to the occipital nerve, in the back of the head, under x-ray guidance. The leads were tunneled under the skin to an implantable pulse generator (IPG) implanted in the chest wall or abdomen. The OPTIMISE Trial is designed to be a pivotal study of the Boston Scientific PRECISION neurostimulation system, when the system is used for ONS. The PRECISION System has been previously been approved for Spinal Cord Stimulation (SCS).

Eligibility Criteria:
Key Inclusion Criteria:

* Onset of chronic migraine at least 6 months prior to start of Screening determined by a well-documented history
* Evidence of intractability
* Posterior-dominant head pain
* Stable pattern of headache symptoms for at least 6 months prior to the beginning of Screening
* Onset of migraine before the age of 50
* If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test

Key Exclusion Criteria:

* Diagnosed with any major psychiatric disorder not specifically listed in Key Exclusion Criteria 2-4 (e.g. multiple personality disorder, schizophrenia)
* Untreated panic disorder
* Untreated major depression evidenced by a PHQ-9 score \>20
* Untreated generalized anxiety disorder evidenced by a GAD-7 score ≥15
* Currently diagnosed with severe personality disorder
* A female of childbearing potential planning to get pregnant during the course of the study or not using adequate contraception
* Participating in another drug, device, or biologics trial within 3 months prior to Screening
* A terminal illness associated with survival \<24 months
Comparison of PEEP Effect on Perioperative Oxygenation and Postoperative Pulmonary Complications in Lithotomy Position

The main purpose of the study is to compare the effectiveness of PEEP application in terms of perioperative oxygenation level in the use of classical LMA and i-gel, which is often preferred. The secondary aim is to compare parameters such as gastric insufflation and the rate of postoperative pulmonary complication development in the case of PEEP with two supraglottic airway devices.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Patients who will undergo transurethral resection of the bladder and prostate taken in the lithotomy position, ureter and kidney stone operations with ureteroscopy

Exclusion Criteria:

* Heart failure (ejection fraction \< 40%),
* unstable hemodynamic conditions
* Having neck or upper respiratory tract pathology,
* have an increased risk of aspiration (gastroesophageal reflux disease, full stomach, acidity),
* obesity (body mass index≥30 kg m-2)
* Patients with poor tooth structure will also be excluded.
Telemedicine for PrEP Throughout Mississippi

This study will develop and test a program to deliver PrEP care in underserved communities in Mississippi (MS) through telemedicine, distance-based, clinical care delivered in local community based organizations (CBOs). The intervention will be developed in collaboration with medical specialists at the University of Mississippi Medical Center (UMMC) and local CBO stakeholders (providers, administrators and patients). Approximately 75 individuals will be recruited from CBOs in MS. Participants will be able to receive PrEP counseling in the CBO and PrEP care via telemedicine from a PrEP specialist at UMMC. Participants will complete three assessments in the six months after enrolling. Our study will provide a wealth of information about PrEP-related outcomes and HIV testing among MS residents living in underserved communities. If successful, this program will be able to be disseminated to other CBOs in the South.

Uptake of PrEP in the southern United States has been slow, especially in areas distant from academic medical centers that provide PrEP care. Despite underserved populations in the South having alarmingly high rates of HIV, a large percentage of at-risk individuals are not engaged in PrEP care due to limited access to academic medical centers. Mississippi (MS), the site of this proposed project, has the seventh highest incidence of HIV of any state and CBOs that provide HIV/STI testing outside of urban areas report that very few of their at-risk individuals use PrEP. Unfortunately, physicians outside of academic centers are often reluctant to prescribe PrEP because they lack the expertise, training, and the support necessary to provide comprehensive HIV prevention care. Those are at-risk do not seek PrEP from academic centers because of stigma, travel burdens, and financial concerns. To overcome these barriers, this project will develop and pilot test a program to deliver PrEP care in underserved remote communities in MS through telemedicine clinical care delivered in local CBOs. Telemedicine will allow specialists to provide care at a distance and while simultaneously enhancing the capacity of local CBOs to provide quality HIV testing and counseling, PrEP treatment, and linkage to HIV care if needed. It will allow patients to receive the highest level of medical care from trusted CBOs within their local communities. It will also enhance the CBO's mission by allowing it to provide a new, high-quality medical service.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Presented at a collaborating CBO for HIV testing during trial months
* PrEP eligible based on HIV Risk Checklist
* Able to read and speak English
* Able to give meaningful consent as determined by research staff
* No known HIV infection

Exclusion Criteria:

* None
Evaluation of Modified Treatment Regimens for Treatment of Heavy Menstrual Bleeding Using the HerOption® System

The Her Option® Cryoablation Therapy System is a closed-loop cryosurgical device that is used to ablate the endometrial lining in pre-menopausal women with menorrhagia (excessive menstrual bleeding) due to benign causes. This is a non-incisional procedure, which can be performed in a physicians office with minimal sedation.

Initial FDA clinical studies were conducted with a two-freeze treatment pattern consisting of a 4 minute freeze with the Cryoprobe positioned in one cornu followed by a second freeze of 6 minutes with the Cryoprobe repositioned in the contralateral cornu.

Since completion of the early studies, many physicians have experimented with varying freeze patterns using longer freeze durations and/or additional freezes at the fundus and the lower uterine segment. The results, as reported in the literature, indicate that these extended freeze patterns produce significantly better results than the original regimen.

American Medical Systems, Inc. (AMS) hypothesized that the original treatment pattern used to support a previous FDA approval for the Her Option® Cryoablation Therapy System for Treatment of abnormal uterine bleeding was not optimal and that extended freeze regimens will result in improved outcomes for patients.

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal adult women 30 years of age or older who have completed childbearing
* Heavy or prolonged menstrual bleeding
* Willing and able to complete all follow-up exams as required by protocol

Exclusion Criteria:

* Known or suspected endometrial cancer or pre-malignant change of the endometrium
* Untreated cervical dysplasia
* Hereditary malformations of the uterine cavity that would prevent insertion and/or placement of the cryoprobe
* Uterine myomas \> or = to 3 cm in diameter
* Past history of invasive treatment for abnormal uterine bleeding or uterine myomas
* History of classical (not low transverse incision) cesarean section
* Active genital or urinary tract infection or acute pelvic inflammatory disease (PID)
* Intrauterine device (IUD) in place
* Other medical conditions could be exclusionary upon evaluation for study treatment
Value of 6-minute Walk Test in Grown Ups With Congenital Heart Defects (GUCH)

The six-minute walk test is an established submaximal exercise test. Its role in examination of grown-up patients with congenital heart disease (GUCH) is not studied so far. Objective of this study was a comparison of the 6MWT with other established parameters of functional capacity, in grown-up patients with GUCH.


Eligibility Criteria:
Inclusion Criteria:

* congenital heart defect
* \> 18 years

Exclusion Criteria:

* mental or physical incapability of exercise testing
* non-cardiac limitations of physical capacity, as e.g. orthopedic diseases or febrile infections
* severe psychiatric diseases
Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females

Patients with psychiatric disorders, including depression, anxiety, and schizophrenia, often require antipsychotic medications for symptom management. However, metabolic changes, especially weight gain, are a common and challenging side effect of many antipsychotics. Aripiprazole, an atypical antipsychotic, has shown promise in mitigating this adverse effect when used in combination with other antipsychotic medications.

This study aims to investigate the effectiveness of different combinations of aripiprazole with atypical antipsychotics in preventing or minimizing weight gain in patients with various psychiatric conditions. While weight gain affects both genders, females may be particularly vulnerable due to physiological differences and societal pressures related to body image.

Collectively, while individual studies have specific nuances, the general trend suggests that combining Aripiprazole with dietary modifications and potentially lifestyle changes shows promise in managing weight gain associated with antipsychotic medications in females.

Eligibility Criteria:
Inclusion Criteria:

* Females aged 18-65 years diagnosed with a mental health condition necessitating antipsychotic treatment.
* Diagnosis of Schizophrenia or Schizoaffective Disorder
* On stable doses of atypical antipsychotics, either Olanzapine, Clozapine, or Risperidone for at least 1 month
* Willingness to comply with the study protocol.

Exclusion Criteria:

* Pregnancy or lactation.
* Severe medical conditions impacting weight or metabolism.
* Previous intolerance or contraindications to Aripiprazole.
* Non-compliant with prescribed medications
* Mental Retardation
* Participant with an eating disorder
* Participants with serious suicidal thoughts, or who pose a serious risk of harm to self or to others.
* Diagnosis of Hyper or Hypothyroidism; Evidence of thyroid dysfunction as evidenced by serum thyroid function tests (i.e Thyroid Stimulating Hormone and -Free Thyroxine (fT4) levels \&gt; 10 % above or below the limits of the normal range Use of any medication for weight loss within the past one month to the study entry
* Clinically significant abnormalities in physical examinations, ECG or lab assessments
Active and Healthy Ageing for All: a Multi-component Healthy Lifestyle Program

AHAA is a healthy lifestyle program offered to older adults aged 60+ years. The program is developed based upon co-creation with the target group and implemented and evaluated in several locations.

1. co-creation : all participants will be questioned and included in the co-creation session
2. implementation : the developed multicomponent healthy lifestyle program will be enrolled and implemented in 6 locations (community services for older adults in Flanders and Brussels)
3. evaluation : the program will be evaluated (effects and process)

Eligibility Criteria:
Inclusion Criteria:

* age 60+ years

Exclusion Criteria:

* not being able to attend the weekly meetings
Resilience and Acute Stress in Simulation

The objective is to study an association between the resilience developed by anesthesia professionals and the level of acute stress during a simulation session.

This trial will take place at the Grenoble Alpes University Hospital. Volunteer anaesthetists, nurse anaesthetists, professionals or students will perform a simulation scenario. This scenario generates a high level of stress and focuses on medication errors, which is a good educational tool for the participants.

The simulation is performed in an available operating room with a dedicated anesthesia cart. In this environment, 17 error opportunities were created, i.e., factors that could contribute to the occurrence of a medication error. A person playing the role of the anesthesiologist will give instructions, leave the room, and return to interrupt the participant several times, which will contribute to the intensity of the stressor. The simulation will proceed as follows:

Briefing:

Welcome and explanation of the session. Collection of age, gender, number of years in anesthesia, number of previous simulation sessions, participation or not in stress management training. Presentation of the context and the anesthesiologist, then the participants evaluate their stress using the VAS (visual analog scale) Stress, which triggers the beginning of the scenario. Introduction of the setting and the anesthesiologist, then participants rate their stress using the VAS Stress scale, triggering the start of the scenario.

Scenario:

10 minutes in length. After the briefing, the anesthesiologist announces the imminent arrival of a patient with a suspected abdominal aortic aneurysm. The participant must quickly prepare a tray of medications. The scenario ends just prior to the patient's arrival, with the anesthesiologist presenting the stress VAS again for further evaluation.

Debriefing:

The participant completes a questionnaire about opportunities for detected errors, followed by a 15-minute debriefing after the simulation session.

For each participant, data regarding stress VAS, CD-RISC, PSS-10 and number of errors detected will be compared.

The primary objective is to analyze an association between resilience developed by anesthesia professionals and acute stress level.

The secondary objectives are to study the association between the resilience developed by the anesthesia professionals and the level of acute stress present immediately at the end of the simulation.

immediately at the end of the simulation. Measure the association between resilience (CDRISC 10) and performance (number of potential errors detected). Compare resilience and acute stress between different statuses (anesthesiologist, intern, nurse anesthetist, student nurse anesthetist).

Eligibility Criteria:
Inclusion Criteria:

* Accepts Healthy Volunteers

Exclusion Criteria:

* Participants who object to the use of their data for research purposes.
Epigenetics in Lupus Nephritis

This is a translational study for the identification of epigenetic changes detectable in sera of patients suffering from Systemic Lupus erythematosus. The aim of the study is to analyze whether circulating DNA fragments are 1) different in patients with or without Lupus nephritis and 2) present and detectable in the circulation before the development of Lupus nephritis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus according to the current classification criteria
* a subgroup requires the presence of Lupus nephritis (no restriction to specific LN histologic subtypes)

Exclusion Criteria:

* patients not able or unwilling to provide written informed consent
A Comparison Between Two Strategies for Postpartum Anemia Diagnosis and Follow up After Vaginal Deliveries

Anemia diagnosis by hemoglobin level monitoring in women after vaginal delivery by symptoms versus screening of women at increased risk for post-partum anemia.

Anemia is common following delivery. It is associated with some serious complications including increased risk for syncope and in severe cases even cardiogenic shock. Yet, anemia-associated symptoms might manifest relatively late after the patient have lost a fair amount of blood, which was not diagnosed early enough. To date, there are not acceptable guidelines for monitoring hemoglobin levels after delivery. Theoretically, there are 2 approaches for hemoglobin monitoring - one by taking hemoglobin levels in order to diagnose anemia in patients reporting anemia-associated symptoms. The other approach is by screening of women at increased risk for post-partum anemia. In the present study we aimed to compare those 2 approaches.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women after vaginal delivery

Exclusion Criteria:

* pregnant women with known sensitivity to the product iron sucrose
* pregnant women after cesarean section
A Retrospective, Observational Chart Review of Biologics in Monotherapy Versus the Combination Biologic Plus Methotrexate in Patients With Rheumatoid Arthritis

This cross-sectional, non-interventional, retrospective chart review will compare the efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy in patients with rheumatoid arthritis who have had an inadequate response to prior treatment with disease-modifying anti-rheumatic drugs including methotrexate. Data will be collected from patients who have been on first-line biologic treatment for at least 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of rheumatoid arthritis by a rheumatologist
* Patients who have responded inadequately to methotrexate or disease-modifying anti-rheumatic drugs (DMARDs) and are being prescribed a biologic in monotherapy or in combination with methotrexate and other classical DMARDs as per NICE guidelines

Exclusion Criteria:

* Primary diagnosis of a condition other than rheumatoid arthritis
* Current treatment with a biologic in combination without methotrexate
* Prior treatment with an experimental agent for rheumatoid arthritis
Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

The purpose of this study is to evaluate neurotomy as an alternative treatment to Botox injections for severe synkinesis following peripheral facial palsy

Patients with severe synkinesis treated at Karolinska University Hospital with Botox injections with unsatisfying results are invited to participate in this study aiming to evaluate surgical neurotomy to synkinesis causing branches of the facial nerve.

Surgical procedure:

Small branches of the facial nerve are identified under microscopic magnification. Using a precise nerve stimulator the movement each nerve branch elicits is evaluated as normal or synkinetic. Pathological branches are then parted while normal functioning nerve branches are left intact.

Evaluation procedure:

Study participants are measured in a multimodal manner at 5 different time points during the study period; at study start, with and without Botox effect before surgery, and at 6 and 12 months after surgery. Evaluation methods:

* Clinical evaluation with Sunnybrook facial grading scale, blinded to observer from video recordings at the end of the study
* Neurophysiological measurements,
* Quality of life, measured with validated questionnaires FaCE, FDI, SAQ
* Reports of potential side effects, using Clavien-Dindo classification as well as free text

Eligibility Criteria:
Inclusion Criteria:

* Synkinesis following peripheral facial palsy
* Sunnybrook score \<61
* Botox injections at least 3 times a year
* Have received at least 3 Botox injections
* Botox injections not satisfying treatment
* Read and signed written consent

Exclusion Criteria:

* Synkinesis since less than 2 years
* Contractures in facial muscles
* Other planned surgery in the face during study period
* Smoking
* Uncontrolled hypertension
* Diabetes mellitus
* Pregnancy or breast feeding
* Severe systemic disease (ASA 3-4)