cyrilzakka/clinical-trials huggingface dataset:
Plantar Pressure Analysis and Foot Biomechanics in Lipedema and Chronic Venous Disease

Chronic venous disease (CVD) are common vascular pathology characterized by a wide spectrum of clinical manifestations occurring with symptoms and/or signs that vary in type and severity. The pathophysiological mechanisms of CVD start from the development of venous hypertension, leading to endothelial dysfunction and venous wall dilatation. Lipedema is subcutaneous adipose tissue disorder characterized by enlargement of both lower extremities. Previous studies showed that foot deformities such as pes planus or cavus are at a high prevalence in CVD patients, and the authors indicated that foot disorders are an important risk factor that negatively affects venous disease. To the best of our knowledge, there is only one study investigating plantar arch abnormalities in lipedema patients based on clinical observation. Therefore, the study aimed to investigate plantar foot distribution and foot deformity in patients with CVD and lipedema.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with CVD or CVD combined with lipedema,
* The clinic (C) score of clinical, etiological, anatomical, pathophysiological (CEAP) classification was C1, C2 or C3 (C1: telangiectasia-reticular vein; C2: varicose vein; C3: edema)

Exclusion Criteria:

* C4, C5 or C6 (presence of skin changes or ulcer) in C score of CEAP classification
* undergone lower extremity orthopedic surgery within the last year,
* have peripheral artery disease
* patients who could not mobilize independently
Clinical Evaluation of Approved and Investigational Contact Lenses

This study is a multi-site, 5-visit dispensing, bilateral double-arm parallel group design, double-masked clinical trial using an investigational contact lens and a marketed contact lens. The objective is to evaluate comfort of the contact lenses when worn on a daily wear modality.


Eligibility Criteria:
Inclusion Criteria:

* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must be between 18 to 40 years of age at the time of consent.
* The subject's vertexed spherical equivalent distance refraction must be in the range of +8.00 to -12.00 in each eye.
* Subject wears habitual contact lenses a minimum of 4 days per week, eight hours per day.
* The subject must have best corrected visual acuity of 20/30 or better in each eye.
* The subject must be a habitual frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.
* The subject must be able to wear contact lenses for a minimum of 8 hours each day during the study.
* The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

* Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
* Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
* Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
* Any known sensitive/allergic to Ingredients of OPTI-FREE® PureMoist® solution.
* Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
* Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
* Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys

The aim of the study is to evaluate the feasibility of this bubble and surface oxygenation and to determine the optimal timing of surface oxygenation (continuous versus intermittent) as alternative for membrane-oxygenated kidneys, originating from DCD donors, during HMP on early graft function in clinical practice.

Kidneys originating from deceased donors after circulatory death (DCD), category 3 and 5 (controlled) will be preserved from procurement until transplantation on hypothermic machine perfusion conditions and prospectively randomized into 2 study groups: 1) intermittent surface oxygenation during HMP (surface oxygenation interrupted during organ transport (2-4h)(I-HMPO2 group), and 2) continuous surface oxygenation during HMP (surface oxygenation during the whole machine preservation period included organ transport)(C-HMPO2 group).

Eligibility Criteria:
Inclusion Criteria:

* Listed for a renal transplantation due to end stage renal disease
* Willingness to comply with the protocol procedures for the duration of the study included scheduled follow-up visits and examinations.

Exclusion Criteria:

* Multi-organ recipients
* Dual kidney transplantation
Evaluating Patient and Caregiver Satisfaction with the Informed Consent Process in Surgery

The goal of this observational study is to evaluate patient and caregiver satisfaction with the informed consent process in surgical practice at a tertiary care center in Nepal. The main questions it aims to answer are:

How satisfied are patients and caregivers with the current informed consent process in surgery? How well do patients and caregivers understand the informed consent information provided? Are there differences in satisfaction and understanding based on factors such as education level or family involvement? Researchers will compare the perceptions of patients and caregivers to understand if there are gaps in communication and satisfaction.

Participants will:

Complete a structured questionnaire assessing their understanding and satisfaction with the informed consent process.

Share their views on the type and quality of information provided during the consent process.

Rate their satisfaction on a 10-point scale based on their experience with the informed consent procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older undergoing major elective surgical procedures requiring regional or general anesthesia.
* Caregivers of eligible patients who provide informed consent on behalf of the patient.
* Willingness to participate and provide consent for the study.

Exclusion Criteria:

* Patients undergoing emergency surgeries.
* Patients who are unable to participate due to language barriers or cognitive impairment.
* Patients or caregivers who refuse to participate in the study.
Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia

This study evaluates the effects of a pain neuroscience education (PNE) and physical exercise (PE) program in women with fibromyalgia. The intervention group receives PNE and PE program supervised by a physiotherapist and a Family Doctor and the control group standard care, in primary care.

Objectives: To evaluate the effectiveness of a PNE and PE in patients with fibromyalgia (FM).

Design: Quasi-experimental, controlled, non-randomized study, in Primary Care facilities.

Intervention: 6 weekly sessions (2 hours each), and a reminder session one month later.

Main measurements: Compliance with FM criteria, assessed using the Widespread Pain Index (WPI) and the Severity of Symptoms (SS) questionnaires, impact of FM in daily life (Fibromyalgia Impact Questionnaire: FIQ) and quality of live. Assessments are made at baseline, one month following the 6th session, and during the 6- and 12-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Women with FM (2010 American College of Rheumatology Diagnostic Criteria for fibromyalgia)
* Women ≥ 18 years
* Agree to participate in the study and sign informed consent.

Exclusion Criteria:

* Oncological pain
* Motor control alteration that prevents the execution of the planned PE program
* Patients with associated pathologies that make it impossible to perform physical exercise program
* Any disabling mental illness or intellectual deficit that prevents understanding the contents of PNE program
A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease

This study seeks to evaluate the efficacy and safety of ABBV-8E12 in participants with early Alzheimer's disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* Subject who meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) clinical criteria for mild cognitive impairment or probable AD, and have:

  * Clinical Dementia Rating (CDR)-Global Score of 0.5
  * Mini-Mental State Examination (MMSE) score of 22 to 30, inclusive
  * Repeatable Battery for the Assessment of Neuropsychological Status-Delayed Memory Index (RBANS - DMI) score of 85 or lower
* Subject has a positive amyloid positron emission tomography (PET) scan.
* Subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4.
* The subject has an identified, reliable, study partner (e.g., family member).
* If using medications to treat symptoms related to AD, doses must be stable for at least 12 weeks prior to randomization.

Exclusion Criteria:

* Subject has any contraindications or inability to tolerate brain magnetic resonance imaging (MRI), PET scans or lumbar puncture.
* Subject has evidence of any other clinically significant neurological disorder other than early AD.
* In the opinion of the investigator, the subject has any clinically significant or uncontrolled medical or psychiatric illness, or has had an infection requiring medical intervention in the past 30 days.
* Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.
A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide

This is a single-centre, prospective, non-randomised volunteer study to be undertaken in the MediCentre, Heath Park, Cardiff, UK

This is a single-centre, non-randomised, prospective study involving at least 120 participants. The data collected in this study will augment the data collected in IU2019_AG_03 Volunteers will be enrolled sequentially until at least 120 scans have been recorded. Ideally, between 120 and 150 scans will be recorded.

Phase I Data collected from up to the first 80 participants in each of the six peripheral nerve block areas will be used as a training/verification set. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images.

Phase II The remaining 40 videos in each area (total minimum 120 participants) will be used for validation of these models.

The validation videos will be fed into the models created during Phase I of the study and the output anatomy highlighting will be recorded as a separate video, overlaid on the original ultrasound image. The overlay video will then be further split into 30-second segments.

A panel of three independent expert anaesthetists will be convened to review and score the segments for accuracy and performance to the endpoints agreed in Phase I of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.
Alternate Day Buprenorphine Administration, Phase IX - 14

The purpose of this study is to determine if four times a subjects' daily maintenance dose will hold for 120 hours without changes in agonist and antagonist effects.


Eligibility Criteria:
Please contact site for information.
F@ce 2.0 a Mobile Phone-supported and Family-centred Rehabilitation Intervention After Stroke in Uganda

The purpose of the present proposal is to implement and evaluate a new model for mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0) with regard to functioning in activities in daily living and participation in everyday life among persons with stroke and their families (in rural and urban areas) in Uganda.

The investigators' previous feasibility study suggested beneficial effects on self-efficacy and occupational performance and satisfaction of a mobile phone supported and family-centred rehabilitation intervention (F@ce1.0) after stroke in Uganda. The purpose of the present proposal is to implement and evaluate F@ce on functioning in activities in daily living (ADL) and participation in everyday life among persons with stroke and their families.

With recommendations on evaluation of complex interventions both outcomes and processes will be studied and hence both quantitative and qualitative methods will be applied. In a randomized controlled trial F@ce 2.0 will be evaluated compared to ordinary rehabilitation in urban/rural Uganda regarding; self-efficacy, perceived performance and participation in everyday activities, independence in ADL, health care utilization and the families´ perceived participation in everyday activities. Qualitative data will explore experiences of people with stroke and family members of participating in F@ce 2.0. This research program has a multidisciplinary perspective for sustainable rehabilitation, a prerequisite for better living conditions for people with stroke in low/middle income countries.

Eligibility Criteria:
Inclusion Criteria:

* stroke diagnosis identified with CT scan or clinical symptoms
* inhabitant in a rural part of Kalungu District, near Masaka Uganda, or Kampala with surroundings
* access to and ability to use a mobile phone
* ability to speak and express themselves in English and/or Luganda
* Modified Rankin Scale level 2 to 4.

Exclusion Criteria:

* none
A Study of Autonomic Dynamic Dysfunction to Predict Infections After Spinal Cord Injury.

The study is designed to investigate whether autonomic shifts (dysautonomia, sympatho-vagal instability) that develop after SCI have value in predicting SCI-associated infections (SCI-AI). SCI-AI impair outcomes by (1) reducing the intrinsic neurological recovery potential and (2) increasing mortality. Heart Rate Variability (HRV) data will be tracked in both the time and frequency domains to discriminate between the relative contribution of sympathetic and parasympathetic innervation to changes in HRV. The ability to predict infections will enable novel treatments thereby reducing infection-associated mortality and improving neurological and functional outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute isolated spinal cord injury (AIS A-D) planned for surgical stabilization and decompression, lesion may include more than 1 segment
2. Patients with acute isolated spinal fracture, lesion may include more than 1 segment
3. Legal age of the patient
4. Documented informed consent of the patient

Exclusion Criteria:

1. Non-traumatic spinal cord injury
2. Concomitant traumatic brain injury (TBI) (definition: i) patient with severe TBI (Glasgow Coma Scale ≤ 8) and ii) patients with intracranial pressure monitoring sensors)
3. Neoplasia and/or antineoplastic therapy
4. Pregnancy, lactation
Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism

The purpose of the study is to evaluate the effectiveness of clear aligners on the symptoms and signs reported by bruxism patients.

The aim of the investigators is to evaluate the effect of treatment on the masticatory muscles and the changes related to the tropism of the masseter muscles using Bruxoff ® device, before and after the beginning of the therapy. Bruxoff ® is a holter that assesses the contractions of the masseter muscles and the heart during sleep.

The plan is to compare treatment with clear aligners for bruxism and non-bruxism patients.

The results will allow the investigators to evaluate the progress of clear aligner therapy in bruxism patients and compare them with those of non-bruxism patients.


Eligibility Criteria:
Inclusion Criteria:

* Acceptance of the treatment plan with clear aligners;
* Acceptance of informed consent to the study;
* Subjects classified as bruxists based on the diagnostic criteria for sleep bruxism described by the American Academy of Sleeping Medicine.
* Subjects who don't meet the criteria of sleep bruxism by American Academy of Sleeping Medicine in good health.

Exclusion Criteria:

* Patients with morphological and structural alterations to the temporomandibular joint, e.g. Condillary hypertrophy;
* Medical history of neurological diseases, mental disorders and sleep disturbances e.g. restless leg syndrome and insomnia;
* Patients in therapy with myorelaxants or other medicines that affect chewing muscle activity;
* Patients with pacemakers;
* Patients with periodontal diseases;
* Patients with ongoing orthodontic therapy or with prosthetic rehabilitation
Delivery, Uptake and Acceptability of HPV Vaccination in Tanzanian Girls

The aims of this study are:

1. To determine feasibility of a school-based human papillomavirus (HPV) vaccination programme in Tanzania.
2. To measure the uptake and acceptability of two different vaccination strategies in rural and urban schools.
3. To examine the characteristics of accepters/refusers of vaccination and to identify reasons for acceptance, refusal or non-completion.
4. To measure the cost of implementing a school-based HPV vaccination programme in Tanzania.

Vaccines against human papillomavirus infection, the primary cause of cervical cancer, are an attractive cervical cancer prevention strategy for resource poor settings which lack the infrastructure for establishing and maintaining complex screening programmes.Feasibility and costs of setting up and sustaining an HPV vaccination programme will depend on whether it can be added onto an existing health programme within schools, if one exists, or whether it has to be established as a separate health intervention. Other factors will also affect vaccine coverage. For example, uptake and overall effectiveness will be critically dependent on parental and community acceptability of a vaccine that prevents a sexually transmitted infection and how the vaccine is promoted and delivered by health-care providers will influence its uptake and acceptability.

This study will determine feasibility, uptake and acceptability of different delivery strategies of school-based HPV vaccination in Tanzania, examine factors related to acceptance or refusal of vaccination and measure the cost of implementing a school-based HPV vaccination programme in Tanzania.

Three doses of quadrivalent human papillomavirus (HPV) vaccine, (Gardasil®; Merck \& Co) given at 0, 2 and 6 months, will be provided to 5000 primary school girls at 134 randomly selected schools in Mwanza Region in Tanzania. Selected schools will be randomly assigned to one of two delivery strategies (age-based or class-based) and coverage and acceptability of these vaccine delivery strategies will be compared. Qualitative research will be conducted before, during and after vaccination to examine barriers to vaccination and reasons for failure to complete vaccination as well as general community perceptions. To determine factors associated with refusal a case control study will be conducted on a 1:1 sample of 350 vaccine refusers and 350 accepters. The costs of introducing and scaling up HPV vaccines in schools will be estimated using established costing methods.

Eligibility Criteria:
Inclusion Criteria:

* female pupil
* attends selected school
* born in 1998 if enrolled in school selected for age-based delivery
* attending standard (class) 6 if enrolled in school selected for class-based delivery

Exclusion Criteria:

* has not previously received HPV vaccine
* has not participated in previous HPV vaccine trials
Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several tools exist to measure frailty, some based on physical tests and others on questionnaires, yet there is no agreement on which tool to recommend. This multi-center prospective cohort study is aimed at comparing various frailty assessment tools to determine which best predicts death or major complications after cardiac surgery or transcatheter intervention. The population of interest is elderly patients with severe aortic stenosis undergoing surgical or transcatheter aortic valve replacement. The frailty assessment tools under investigation include composite frailty scales, physical performance tests, muscle mass, and biomarker expression. The overall objective is to improve our ability to predict risk by measuring frailty using the optimal tool in elderly cardiovascular patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥70 years (a site-specific substudy at the JGH will enroll ages ≥21 years)
2. Severe AS
3. Referred for surgical or transcatheter AVR (with or without concomitant revascularization)
4. Signed informed consent

Exclusion Criteria:

1. Emergency surgery
2. Clinical instability: decompensated heart failure, active ischemia, unstable vital signs
3. Severe neuropsychiatric impairment
4. Not English or French speaking
5. Replacement of \>1 valve or aortic surgery
Heart Rate, Baroreflex Sensitivity and Cardiovascular Morbidity and Mortality in the Population

The aim of the present Paris Prospective Study III (PPS3) is (1) to assess the determinants of the regulation of heart rate and blood pressure variations and carotid properties (under different physiologic stimulations) and (2) to evaluate the respective contribution of heart rate, blood pressure variations and carotid properties to cardiovascular morbidity and mortality including sudden death during 10 years at least in healthy considered subjects.

Overall, 10 157 men and women have been recruited during May 2008 and June 2012 for an extensive clinical examination including a 2h holter electrocardiography (ECG), a carotid doppler echo tracking, a step test, as well as blood and DNA collections. Since then, the cardiovascular morbidity and mortality of the participants is being followed up for 10 years at least and will continue up to 2032.

Eligibility Criteria:
Inclusion Criteria:

* 50-75 years, French speaking, given consent for genetic analysis,
* written consent for participating in the study

Exclusion Criteria:

* \<50 years and \>75 years,
* no French speaking,
* current pregnancy,
* chronic severe disease,
* disagreement for genetic analysis,
* step test considered as non possible or non advisable by medical decision.