cyrilzakka/clinical-trials huggingface dataset:
Efficacy Trial for the Reduction of Glabellar Lines

The purpose of this study is to evaluate the ability of the Serene RF System to effectively improve the appearance of dynamic glabellar lines and sustain the effect for a minimum of 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Glabellar lines rating of at least two per the Merz Scale
2. Written informed consent
3. Understands and accepts the following obligations during the follow-up period (minimum of three months and up to one year)
4. available for the 3 day phone call and present for each follow-up visit;
5. receive NO other facial procedures in the upper face for a minimum of three months and up to one year after the RF procedure;
6. make NO changes to the eyebrows for a minimum of three months after the RF procedure.

Exclusion Criteria:

1. Injection of botulinum toxin to the upper face within the previous four months
2. Use of fillers in the upper face within the previous twelve months
3. Use of prescription treatments (e.g., Renova, Retin-A, micro-dermabrasion, chemical peels) on the upper face, in the area between the eyebrows where frown lines occur, within the previous four weeks or plans to use these treatments during the study
4. Facial or skin conditions that could interfere with treatment or confound results (e.g., signs or symptoms of eyebrow or eyelid ptosis, facial nerve palsy, scarring, infection)
5. Implanted pacemaker or automatic implantable cardioverter/defibrillator
6. History of keloid formation
7. Known bleeding disorder
8. Use of thrombolytics, anticoagulants, aspirin or non-steroidal anti-inflammatory drugs within seven days prior to study treatment Is receiving systemic corticosteroids or anabolic steroids (standard doses of inhaled or nasal corticosteroids are acceptable)
9. History of chronic or recurrent infection, or compromised immune system
10. Known lidocaine hypersensitivity
11. Enrollment in another research study
12. Pregnant, or plans to get pregnant during the follow-up period
13. Any other condition or circumstance that might either pose a risk, in the investigator's opinion, to the subject or interfere with the ability to acquire satisfactory clinical data throughout the follow-up period
Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis

The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The study will also provide some preliminary insights into whether the experimental treatment reduces pain in the knee.

Osteoarthritis is the most common joint disease, affecting over 20 million people in the US alone. Currently, pain treatments that are injected directly into the knee often work for only a short time and may also have side effects within the rest of the body. The experimental treatment is a steroid that is in the same family of drugs as the most common current injectable treatments for knee osteoarthritis. For this study, the drug is coated with a polymer intended to prolong the time it stays inside the knee and lessen potential side effects.


Eligibility Criteria:
Inclusion Criteria:

* OA of Index Knee
* Kellgren Lawrence Grade 2 or 3
* Patient-reported pain (PtPain) of Index Knee ≥4 but ≤9
* PtPain of non-Index Knee \<6
* BMI ≦ 40 kg/m2

Exclusion Criteria:

* Intra-articular joint injection in the Index Knee within the past 8 weeks for glucocorticoids and 6 months for hyaluronic acid
* Insulin-dependent diabetes
* Active infection
* Pregnant or breast feeding
Impact of Compression Garments on Pain in Patients With Complex Regional Pain Syndrome of the Upper Limbs.

The aim is to study another alternative for the treatment of pain in people with CRPS. Indeed, the TRAB / Medullary occupational therapy department of the CMRRF in Kerpape used compression garments to reduce edema when it was present.In the case of CRPS of the upper limbs, gloves or compression sleeves are used to decrease the edema which is sometimes associated, although they are not supported for this indication. In this context, our clinical experience leads us to believe that there would also be some efficacy in neuropathic pain, this improvement being regularly described by patients.This study is expected to show a notable reduction in neuropathic pain thanks to the wearing of a compression garment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CRPS of the upper limb with neuropathic pain

  * Diagnosis of CRPS according to the Budapest criteria
  * Diagnosis of neuropathic pain according to DN4
* CRPS evolving for more than 3 months
* No phlebitis or open sores on the upper limbs
* Patient consent to participate in the study
* No modification of his drug treatment for 1 month
* Affiliation to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* Patient under guardianship, curatorship or safeguard of justice
* Psychiatric pathology altering the ability to consent
* Severe cognitive disorders that do not allow the patient to assess his pain
* Skin pathology preventing the wearing of the compression garment
* Patient who has previously worn a compression garment
* History of vascular disorders of the upper limbs, lymph node dissection, or any other pathology that can lead to edema regardless of CRPS
* Known allergy to one of the components of the compression garments of the Cerecare brand
* Declared pregnancy, breastfeeding woman or woman of childbearing potential without contraception
* Inability to put on the compression garment alone
Noise-Enhanced Sensory Function in Elders at Risk for Falls

The long-term goal of this project is to develop a non-invasive, noise-based technique for enhancing somatosensation and thereby improving balance control in elderly fallers and older adults with somatosensory deficits.

Previous studies have shown that sub-sensory mechanical noise (i.e., random vibration with a small intensity) can enhance somatosensory function in healthy individuals and older adults with somatosensory deficits. Moreover, the postural sway of both healthy young and healthy elderly individuals during quiet standing can be significantly reduced by applying sub-sensory mechanical noise to the feet using vibrating shoe insoles.

The specific aims of this project are to determine the effects of noise-enhanced somatosensation at the feet on balance performance in elderly individuals with somatosensory deficits and/or recurrent falls, and to assess whether adaptation occurs in noise-enhanced balance control in these individuals. To accomplish these aims, quiet-standing and dynamic posture studies and clinical balance assessments will be conducted on elderly individuals with somatosensory deficits and elderly individuals with recurrent falls (two or more falls over a 12-month period).

This project could lead to the development of a novel bioengineering technique for improving balance control in older adults and patients with somatosensory deficits. The work could thus serve to reduce the frequency, morbidity and cost of falling, and assist aged individuals in achieving maximal independence in activities of daily living and mobility.

Two groups of participants will be recruited from the RNH Epidemiology Core: 85 elderly individuals with somatosensory deficits, and 85 elderly individuals with recurrent falls. The study consists of three visits--a one-hour neurological exam, and two 6-hour laboratory testing sessions scheduled one week apart.

Eligibility Criteria:
Inclusion Criteria:

* Participant must (1) have somatosensory deficit (mild to moderate sensory loss on the bottom of both feet) OR (2) be classified as a recurrent faller (two or more incident falls over a twelve-month period not related to syncope, major medical events, or overwhelming external hazards)
* Age 70 and older
* Able to stand unassisted for at least 60 seconds several times over a 30-minute period
* Able to walk without assistance from a walking aid

Exclusion Criteria:

* Known history of seizures or fainting
* Unstable medical condition
* Open lesions or poor skin condition on feet
* Unable to cooperate with or understand the protocol
* Foot size larger or smaller than the constructed vibrating insoles (men's sizes smaller than 3 or larger than 12; women's sizes smaller than 4.5 or larger than 13.5)
Remote Physician Care for Home Hospital Patients

This study examines the implications of providing remote physician care to home hospitalized patients compared to usual home hospital care with in-person/in-home physician visits.

Home hospital care is hospital-level care at home for acutely ill patients. In multiple publications, home hospital care delivered cost-effective, high-quality, excellent experience care with similar quality and safety as traditional hospital care. Most home hospital models require a licensed independent practitioner to see their patients physically in their home.

To further improve the efficiency and scalability of home hospital care, the investigators propose to test remote care, where the physician would provide care via a video interaction, instead of in-home/in-person care. The investigators propose a non-inferiority evaluation of this intervention.

Eligibility Criteria:
Inclusion Criteria:

* Resides within either a 5-mile or 20 minute driving radius of emergency department
* Has capacity to consent to study OR can assent to study and has proxy who can consent
* \>= 18 years-old
* Can identify a potential caregiver who agrees to stay with patient for first 24 hours of admission. Caregiver must be competent to call care team if a problem is evident to her/him. After 24 hours, this caregiver should be available for as-needed spot checks on the patient. This criterion may be waived for highly competent patients at the patient and clinician's discretion.
* Primary or possible diagnosis of cellulitis, heart failure, complicated urinary tract infection, pneumonia, COPD/asthma, other infection, chronic kidney disease, malignant pain, diabetes and its complications, gout flare, hypertensive urgency, previously diagnosed atrial fibrillation with rapid ventricular response, anticoagulation needs, or a patient who desires only medical management that requires inpatient admission, as determined by the emergency room team.

Exclusion Criteria:

* Undomiciled
* No working heat (October-April), no working air conditioning if forecast \> 80°F (June-September), or no running water
* On methadone requiring daily pickup of medication
* In police custody
* Resides in facility that provides on-site medical care (e.g., skilled nursing facility)
* Domestic violence screen positive
* Acute delirium, as determined by the Confusion Assessment Method2
* Cannot establish peripheral access in emergency department (or access requires ultrasound guidance, unless point-of-care ultrasound is available)
* Secondary condition: end-stage renal disease on hemodialysis, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage
* Primary diagnosis requires multiple or routine administrations of intravenous narcotics for pain control
* Cannot independently ambulate to bedside commode, unless home-based aides are available
* As deemed by on-call MD, patient likely to require any of the following procedures: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery
* High risk for clinical deterioration
* Home hospital census is full
Clinical Study Examining the Safety and Efficacy of Doxorubicin Drug Eluting Microspheres Transarterial Embolization in the Setting of Hepatocellular Carcinoma (HCC)

The study is designed to determine whether loading doxorubicin (a type of chemotherapy), when loaded onto a drug eluting microsphere will result in increased destruction of a tumor. The study will treat patients with surgically resectable liver cancers with varying doses of doxorubicin loaded into microspheres, with a close review of any side effects and chemotherapy concentrations in the bloodstream. The tumors will be surgically removed after at least 1 month, to determine how much the tumor has shrunk, and the amount of tumor destroyed. It is hoped that the study results will determine if this treatment has a role in controlling tumor growth prior to surgical removal.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with surgically resectable hepatocellular carcinoma (HCC)
The JenaValve ALIGN-AR Pivotal Trial

To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.

This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat symptomatic severe aortic regurgitation.

Eligibility Criteria:
Inclusion Criteria:

* Patient with severe aortic regurgitation (AR).
* Patient at high risk for open surgical valve replacement
* Patient symptomatic according to NYHA functional class II or higher
* The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.

Exclusion Criteria:

* Congenital uni or bicuspid aortic valve morphology
* Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
* Endocarditis or other active infection
* Need for urgent or emergent TAVR procedure for any reason
* Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
* Severe mitral regurgitation
Maximal Plantar Pressure and Comfort Evaluation of Orthopedic Stilettos

22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer.

Testing involves pedobar pressures and a validated comfort questionnaire.

22 women Testing "orthopedic" stilettos compared to standard stilettos and a comfy trainer testing involved pedobar pressures and a validated comfort questionnaire.

x rays with arthrosis 1. metatarsophalangeal joint (MTPJ), hallux valgus and Intermetatarsal (IM) angles will be recorded.

Clinically, weight, height, foot length, heel valgus, 1. MTPJ range of motion, pain, callus, hammertoes will be recorded.

Sole pressure in heel, arch and forefoot grids measured by in-sole pressure pedar-x (Novel) and possible Emed system (Novel).

3 working days in each type of shoe with Steps measured by pedometer Comfort assed as VAS according to: Mundermann,A., Nigg,B.M., Stefanyshyn,D.J., and Humble,R.N.: Development of a reliable method to asses footwear comfort during running. Gait Posture, 16:38-45, 2002.

Primary outcome is the foot sole pressures. Both VAS comfort and foot pressures will be regressed to see if age, BMI, shoe size, steps, shoe type, callus, index minus, hallux valgus etc has an effect.

16 needed for the pressure and 21 for the comfort score. 22 will be included to make sure the investigators have enough power.

Eligibility Criteria:
Inclusion Criteria:

* Foot healthy females used to wearing stilettos.

Exclusion Criteria:

* Shoe sized outside European 37-42.
* Sought doctor for foot or balance related issues
Blood Samples From Healthy Volunteers for Genetic Studies in the East Anglia Region of the United Kingdom

RATIONALE: Studying samples of blood from healthy volunteers in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between genes and the environment in healthy volunteers.

OBJECTIVES:

* To obtain blood samples and simple epidemiological information on a population-based series of adult individuals without cancer.
* To establish whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of cancer by comparing the frequency of alterations in these genes with the corresponding frequency in a comparable series of cancer patients.
* To examine the interactions between genetic and non-genetic risk factors.

OUTLINE: This is a multicenter study.

Participants complete a simple epidemiological questionnaire.

Participants undergo blood sample collection. DNA is extracted from these samples for polymorphism analysis of low penetrance cancer susceptibility genes in the following related clinical trials: MREC-SEARCH-CANCER, MREC-SEARCH-PROSTATE, and MREC-SEARCH-BREAST. They may also be used in the analyses of the following related clinical trials: MREC-SEARCH-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL.

PROJECTED ACCRUAL: A total of 2,000 male and 2,000 female participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cancer-free participants randomly selected from the age-sex registry of a general practice in the East Anglia region of the United Kingdom

  * Two general practices from each district within East Anglia participate (up to 10 total participating practices)

PATIENT CHARACTERISTICS:

* Identified by the participant's general practitioner as fit to contact for this study
* No prior diagnosis of cancer
* No serious mental illness or retardation

PRIOR CONCURRENT THERAPY:

* Not specified
Implementation of the Internet-based Aftercare Program 'GSA-Online Plus'

The purpose of this study is to implement the internet-based aftercare program 'GSA-Online plus' in several rehabilitation clinics with patients of different indications (psychosomatic, orthopedic and cardiovascular diseases). 'GSA-Online plus' is an internet-based aftercare program for patients with work-related problems or anxieties facing return to work after longterm sickness absence and inpatient rehabilitation. The patients have access to various exploratory and motivational videos on the study website until their inpatient rehabilitation ends. Afterwards, they start a 12-week writing intervention based on a psychotherapeutic concept, the psychodynamic 'Core Conflictual Relationship Theme Method (CCRT)'. Patients write weekly online diary entries which are answered by anonymous online therapists usually within 24 hours. In a previous randomised controlled trial the efficacy of the intervention was determined, whereas the current study focuses on the implementation and realization in a naturalistic setting (effectiveness).


Eligibility Criteria:
Inclusion Criteria:

* Referral (physician) or request (patient) to take part in the internet-based aftercare program
* Current or prospective employment within 4 weeks after inpatient rehabilitation
* Private internet access
* Informed consent
* Knowledge of the German language

Exclusion Criteria:

* Severe psychiatric or somatic disease
Effectiveness of an App for Mobile Phones (e-12HR) to Increase Adherence to Mediterranean Diet in University Students

This is a controlled, randomized and multicentric clinical trial aimed at university students and performed at the Faculties of Medicine and Pharmacy at the University of Seville (Spain). Its objective is to evaluate the effect of an intervention based on the use of an information and communication technology (ICT) tool, specifically an application for mobile telephones (called e-12HR), in the improvement of adherence to the Mediterranean diet.

Objective:

To evaluate the effect of an intervention based on the use of an information and communication technology (ICT) tool, specifically an application for mobile telephones (called e-12HR), in the increased adherence to the Mediterranean diet in a population of university students.

Design and setting:

A controlled, randomized and multicentric clinical trial with two parallel groups (control group and intervention group).

Study population:

322 university students (161 participants in each group) are necessary; of both genders, over the age of 18 years, who meet selection criteria.

Study setting:

Faculties of Medicine and Pharmacy at the University of Seville (Spain).

Statistical Analysis Discrete variables are presented as a number followed by percentages. Continuous variables are presented using means and standard deviations.

The data are tested for normality using the nonparametric Kolmogorov-Smirnov test.

Students t-test or the nonparametric Mann-Whitney U-test is used for the analysis of quantitative variables, and the chi-square test is used for the comparison of proportions.

The results are considered significant if p-value \< 0.05. Statistical analyses are performed using the SPSS statistical software package ver-sion 26.0 (SPSS Inc., Chicago, Illinois, USA).

Measurements and intervention:

Adherence to the Mediterranean diet is evaluated at seven (baseline), fourteen, twenty-one and twenty-eight days follow-up: the adherence to the Mediterranean diet index selected for the study is the Mediterranean Diet Serving Score (MDSS) index.

The advice on healthy diet recommendations (Mediterranean diet) is common to both groups.

There are two versions of e-12HR in the study: 'feedback' e-12HR and 'non-feedback' e-12HR (both versions of the application allow the collection of data on dietary intake in order to calculate the MDSS index).

Control group: use of 'non-feedback' e-12HR (in order to calculate the MDSS index).

Intervention group: use of 'feedback' e-12HR (in order to calculate the MDSS index; additionally, this version is designed to promote the Mediterranean diet).

Eligibility Criteria:
Inclusion Criteria:

* Both genders.
* Over the age of 18.
* Be a student at the Faculties of Medicine or Pharmacy (University of Seville).
* Possess a mobile telephone with Internet access and iOS or Android operating system.

Exclusion Criteria:

- Chronic pathologies, food intolerances or pregnancy (situations that could require specialized dietary recommendations).
Sedation Monitoring During Open Muscle Biopsy in Children

The purpose of this study is to compare sedation monitoring by bispectral index and comfort score during open muscle biopsies in children.


Eligibility Criteria:
Inclusion Criteria:

* infants, children, adolescents undergoing open muscle biopsy as diagnostic procedure

Exclusion Criteria:

* missing caregiver or patient consent
* intolerance of sedative agents in patients´medical history
* structural brain abnormalities