cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α in Subjects, Aged 35-65 Years of Age, to Improve the Signs of Aging, by Comparing to a Placebo

A clinical study with approximately 15 subjects, aged 35-65 years of age, who must have crow's feet and at least one other type of facial fine lines/wrinkles in order to evaluate the efficacy of Activated Silk™ 27P-α to improve the signs of aging, by comparing to a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals, between the ages of 35 - 65 years of age, with no known medical conditions that interfere with study participation, are the priority.
* Subject has signed a written Informed Consent prior to Day -7.
* 100% of subjects have crow's feet and at least one of the following: forehead lines/wrinkles (e.g. vertical lines between eyebrows, horizontal lines above the eyebrow), marionette lines, nasolabial folds.
* 50% of subjects have self-perceived sensitive skin.
* 20% of the subjects are not 100% Caucasian.

Exclusion Criteria:

* Subject is pregnant, nursing, or planning to become pregnant.
* Subject is currently using medication likely to affect the response to investigational formulation.
* Subject had a fever in the last 12 hours prior to the start of the study.
* Subject has a pacemaker or significant medical history of hepatic, renal, cardiac, pulmonary, digestive, hematological, neurological, locomotor or psychiatric disease; cancer; multiple sclerosis; high blood pressure; thrombosis; phlebitis; insulin-dependent diabetes; or any such related medical condition(s) that may interfere with the completion of the study.
* The Subject used a form of retinol on their face in the past six months.
* The Subject used any prescription skincare products on their face in the last six months.
* The Subject has received any laser, chemical peel, or other facial resurfacing treatment such as microdermabrasion, dermablading or microneedling in the past four weeks.
* The Subject received Botox, Dysport, other muscle relaxers or injectable skin fillers in the face during the past six months.
* Subject has a known allergy or sensitivity to any ingredient in the aqueous skincare formulation provided for their use in the trial .
* Subject is currently participating in another study utilizing facial products.
* Subject is blind, visually impaired or decisionally impaired.
Bicycling and Mortality Among Individuals With diabetesNutrition (EPIC)

The primary aim of the study is to study the relationship between overall bicycling and all-cause mortality and secondarily cardiovascular disease mortality among individuals with diabetes from European countries. A secondary aim will be to study the relation of change in bicycling to all-cause mortality and cardiovascular disease mortality.

AIMS The primary aim of the study is to study the relationship between overall bicycling and all-cause mortality and secondarily cardiovascular disease mortality among individuals with diabetes from European countries. A secondary aim will be to study the relation of change in bicycling to all-cause mortality and cardiovascular disease mortality.

METHODS Study design and setting The study is a nested cohort study in European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. In EPIC, 29 centers in 10 western European countries have collected information on nutrition, lifestyle, anthropometrics and medical history from more than 521 000 study individuals participating in this prospective cohort study. Dietary, medical history and lifestyle were assessed by questionnaires. Blood samples from the participants were taken at the study centers. Baseline (first examination) information was collected 1992-2000 and second examination for exposure has since been obtained at least once in every cohort. Exposure data has subsequently, to the two examinations, been linked to information on vital status and on cause of death were obtained through record linkages with national, regional or local registers, regional health departments, physicians or hospitals, active follow-up or health insurance.

Study population This nested prospective cohort study, sampled individuals with prevalent diabetes in the EPIC cohorts at the baseline assessments in the years 1992-2000. Self-reported and confirmed diabetes (validated by a second source (at least 1), including repeated self-report, contact with physician, linkage to register later point, intake of diabetes medicine, registration of diabetic chiropody, baseline glycated hemoglobin\>=6.0%, five annual blood glucose measurements or two blood glucose measurements per year for five consecutive years) cases were included in the analyses. No information is available to distinguish between type 1 and type 2 diabetes across the population but type 1 is rare by comparison. The nested cohort for this study comprised 12,848 individuals with self-reported and/or confirmed diabetes. Mean (SD) follow-up time was 14.6 (4.8) years. Among the 12,848 prevalent diabetes cases, 5,809 cases were confirmed at baseline as described above.

For further detail, please see the predefined statistical analysis plan (SAP). It can be accessed through the url: http://aktivsundhed.dk/images/docs/SAPMRL.pdf

Eligibility Criteria:
Inclusion Criteria:

* Confirmed or self-reported diabetes at first examination

Exclusion Criteria:

* None
Sham LaserCap vs. LaserCap SD vs. LaserCap HD+

Androgenetic alopecia (AGA) is a prevalent disease, occurring in 80% of Caucasian men and 50% of Caucasian women by age 701. Treatments for AGA are limited, and presently the only FDA-approved medications for AGA are topical minoxidil and oral finasteride1.

In addition to medical therapies, FDA-cleared medical devices are now utilized for the treatment of AGA as of 20072. These devices, termed low level laser therapy (LLLT), come in multiple forms including combs, helmets and sports cap wearable devices2. These home-use, wearable devices utilize the \~650 nm wavelength laser light to stimulate the hair follicle mitochondria and thereby promote hair growth, a process termed "photobiomodulation"3.

Recent meta-analyses investigating photobiomodulation and LLLT for AGA have noted an increase in fluence or energy delivered per cm is associated with increased hair density3. However, randomized control trials (RCT) with direct comparison of LLLT devices of different fluences has yet to be performed. Accordingly, in the present study we aim to investigate if increasing fluence in LLLT devices is associated with increased hair density by comparing sham LaserCap to LaserCap SD (1.15 J/cm2, low fluence) and LaserCap HD+ (3.93 J/cm2, high fluence) in RCT.


Eligibility Criteria:
Inclusion criteria:

* 25 years and older
* Men and women with AGA, untreated or with 6-month washout of previous treatments
* Men: Norwood stage IIa - V
* Women: Ludwig I-1 - II-2, or frontal pattern
* All patients: Fitzpatrick skin types I to IV

Exclusion criteria:

* Men: Norwood stage Va, VI, VII
* Women: Ludwig stage III, advanced
* All patients: Fitzpatrick skin types V, VI
* Current use or within the past six month of other treatment for AGA, including topical and oral minoxidil, topical and oral finasteride and dutasteride
* Age 0-25 years
Hellenic Registry of Ovation Alto™ Abdominal Stent Graft System

This is a Hellenic Registry including both retrospective and prospective subjects receiving the Ovation Alto™ Abdominal Stent Graft System ("Ovation Alto™ Abdominal Stent Graft System Post-Market Study") in the treatment of abdominal aortic aneurysms (AAA). The Ovation Alto™ Hellenic Registry is intended to expand the clinical knowledge base by collecting data on subjects treated with the Ovation Alto™ Abdominal Stent Graft System in actual clinical practice during the first post-operative year.


Eligibility Criteria:
Inclusion Criteria:

* Subject is \> 18 years of age
* Both IFU and non-adherence to IFU
* Subject intends to electively receive the Ovation Alto™ Abdominal Stent Graft System
* Subject has the ability and willingness to comply with all follow-up exams as indicated in clinical investigation plan

Exclusion Criteria:

* Subject's current participation in a concurrent randomized control trial (RCT) or investigational device/drug study which could confound study results.
* Life expectancy less than 1 year
* Pregnancy
* Subjects with poor renal function as indicated by a serum creatinine \> 2.5mg/dl.
Proprioceptive Exercises in Stringed Instrument Performers

Musculoskeletal problems that occur in musicians are usually in the form of soft tissue injuries affecting muscles, tendons, nerves and ligaments. These injuries can cause pain, weakness and sensory changes, making it impossible to play the instrument.It is aimed to include 50 adult musicians who meet the inclusion criteria from among the performers in Elazığ Culture and Music Association, Fırat University State Conservatory Department, State Classical Turkish Music choir and musicians who are actively performing instruments within the borders of Elazığ province. Pain, posture, upper extremity function and performance will be evaluated in this study.

Musculoskeletal problems that occur in musicians are usually in the form of soft tissue injuries affecting muscles, tendons, nerves and ligaments. These injuries can cause pain, weakness and sensory changes, making it impossible to play the instrument.It is aimed to include 50 adult musicians who meet the inclusion criteria from among the performers in Elazığ Culture and Music Association, Fırat University State Conservatory Department, State Classical Turkish Music choir and musicians who are actively performing instruments within the borders of Elazığ province. the aim of this study is to investigate the effects of proprioceptive training on upper extremity function and performance in musicians (stringed instrument performers). Upper Extremity Function Assessment, Upper Extremity Performance Assessment, Posture Assessment, Pain Assessment will be evaluated. Proprioceptive training will be applied 3 days a week for 8 weeks. The training will be prepared to increase the stabilization of the muscles in the shoulder, shoulder girdle and back that are active for long periods of time due to performance.

Eligibility Criteria:
Inclusion Criteria:

* Stringed instrumentalists
* Individuals between the ages of 18-65
* Musicians who have been performing for 3 years or more
* Musicians who play an instrument for at least 1 hour per day
* Musicians who want to be involved in the study as volunteers
* Musicians from whom informed consent was obtained will be included.

Exclusion Criteria:

* Upper extremity injury or surgery before the study (last 1 year)
* Individuals who are pregnant
* Individuals with psychological, neurological or systemic diseases were excluded from the study. The experimental groups of these string players will be ensured to participate regularly in the proprioceptive training protocol.
Safety and Efficacy Study of JV-GL1 in Patients With Open-Angle Glaucoma or Ocular Hypertension

The aim of this research study is to assess the safety and feasibility of lowering intraocular pressure (IOP) using an experimental study drug, JV-GL1.

This is an open-label, dose escalation and dose expansion, study in adult participants with open-angle glaucoma or ocular hypertension. The study is divided into 2 parts:

Part 1 of the study is a dose escalation, sequentially testing escalating doses of JV-GL1.

Part 2 of the study will be randomized 2:2:1 (Experimental Dose A: Experimental Dose B: Active Control), treating additional subjects at the selected JV-GL1 doses or Latanoprost for 28 days.

Eligibility Criteria:
Inclusion Criteria:

* bilateral open-angle glaucoma or ocular hypertension

Exclusion Criteria:

-
Assessment of Chilbains Occuring During Covid-19 Infection

Some patients infected by covid-19 develop skin manifestations. These manifestations are still not well known and there pathophysiology remain unclear. Among them, acral manifestation resembling to chilblains appears frequent and quite specific. The aim of this project is to better characterize the cutaneous manifestations occurring during Covid-19 infection with a special focus on chilblains. These acral manifestation could be due to a direct viral effect, but also to microthrombosis or vascularitis. Understanding the pathomechanisms involved could provide interesting clue for understanding not only the skin manifestations but also some of the other systemic symptoms associated to covid-19 infection. This study plan to characterize these acral manifestations by analyzing the clinical and dermoscopic patterns and to correlate them with the non-invasive vascular explorations but also immune and coagulopathy explorations that are done in the CHU of Nice in covid-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients with proven covid infection (using PCR, serum antibody or lung TDM) and presenting at least one cutaneous lesions that occurred during the infection.
Mucoderm or Connective Tissue Graft for Treatment of Gingival Recessions

Coronally advanced flap plus connective tissue graft (CTG) is the gold standard therapy for root coverage. The bioabsorbable porcine collagen matrix (CM) has been widely used in periodontal and mucogingival surgery as a substitute for CTG and has achieved similar results. The CM has the advantage of no need of a second surgical area and availability overcoming the limitations of donor site in autograft.

The aim of this study is to investigate the use of Mucoderm® in root coverage procedures combined with extended coronally positioned flap (ECAF), test group (TG), in comparison to the connective tissue graft associated with the ECAF, control group (CG).


Eligibility Criteria:
Inclusion Criteria:

* CEJ without significant damage;
* localized bilateral RT1 gingival recession ≥3 mm in the same arch

Exclusion Criteria:

* previous periodontal surgical treatment on the involved sites;
* smokers
* pregnants or lactating
* compromised systemic health and contraindications for periodontal surgery
The ICALIC International Multicentric Study

This study will evaluate the ease of use of the new calorimeter (Q-NRG (COSMED, Italy)) in intensive care unit (ICU) patients compared to currently used calorimeters (i.e. Quark RMR 1.0(COSMED, Italy) or Deltatrac Metabolic Monitor (Datex, Finland)), as well as the stability and the feasibility of the measurements in various clinically relevant situations.

Time needed to prepare and start indirect calorimetry (IC) measurement will be compared as the measure of the ease of use of the calorimeter.

Background and Aims:

This study aims at evaluating the ease of use of the new calorimeter for the measurement of energy expenditure (EE) in intensive care unit (ICU) patients. EE in ICU patients is highly variable depending on the severity of the disease and treatments. Clinicians need to measure EE by indirect calorimetry (IC) to optimize nutritional support for the better clinical outcome. However, indirect calorimeters available on the market have insufficient accuracy for clinical and research use. Difficulties of handling and interpretation of results often limit IC in ICU patients. An accurate, easy-to-use calorimeter has been developed to meet these needs.

The Study Device:

The new calorimeter (Q-NRG, COSMED) is capable of IC measurements in mechanically ventilated patients without warm-up and limited calibration. The disposable in-line pneumotach flow meter and direct sampling of respiratory gas from the ventilator circuit enables the accurate measurement of oxygen consumption volume (VO2) and CO2 production volume (VCO2) to derive the energy expenditure. The software interface to manage the device and the collected data provides easy-to-use, user-friendly interface. Q-NRG does not bear the European Commission Conformity Mark (CE Mark), but has been approved by the Swiss authority for medical devices (Swissmedic) for use in this study. Q-NRG will be used in the way it is intended to be used as described in the instruction manual.

Currently used indirect calorimeters at each study center will be used as the comparator.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated adult ICU patients

Exclusion Criteria:

* Fraction of inhaled oxygen (FIO2) \> 70%
* Positive end expiratory pressure (PEEP) \>10cmH2O
* Peak ventilatory pressure \> 30cmH2O
* Presence of air leaks from thoracic drain tube
* Changes in vasoactive agent dose (\>20%, \<1 hr before and/or during IC)
* Agitation or change in sedative dose (\>20%, \<1 hr before and/or during IC)
* Change in body temperature (\>0.5°C, \<1 hr before and/or during IC)
* Expected duration of ICU stay \< 24 hours
* Expected survival of the patient \< 24 hours
Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver) as regard weight loss, complications rat and cost

Eligibility Criteria:
Inclusion Criteria:

* obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity
* patients fit for laparoscopic surgery
* give approval to share in the study

Exclusion Criteria:

* patients refused to share in the study
* patients unfit for surgery
* patients aged less than 18 and older than 65
* patient with previous upper abdominal surgery either for obesity or other diseases
* revisional bariatric procedures
Calfactant for Direct Acute Respiratory Distress Syndrome

This study will determine if administration of an suspension of calfactant, a lung surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome within 48 hours of requiring mechanical ventilation can decrease the mortality in patients with lethal disease and shorten the course of respiratory failure in patients with sub-lethal disease.

Recruitment limited to direct adult respiratory distress syndrome patients who have been intubated \<48 hours. Origin of ARDS must be infectious pneumonia, aspiration of stomach contents, near drowning, smoke inhalation without pulmonary burn, inhaled industrial gas.

Eligibility Criteria:
Inclusion Criteria:

1. Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas
2. Less than 48 hours of mechanical ventilation
3. Informed consent

Exclusion Criteria:

1. Pre-existing lung disease
2. coma
3. limited therapeutic goals (do not resuscitate, etc.)
4. failure of another vital organ
Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation

The National Marrow Donor Program (NMDP) has established a system for registering, matching, and tracking unrelated donor cord blood units (CBUs) and transplant outcomes. Study subjects are donors who enroll through collaborating cord blood banks. This study creates uniform collection, screening, testing and storage requirements for cord blood units. The purpose of standardization is to improve efficiency in the selection of cord blood units for transplantation.

The NMDP Cord Blood registry is organized as a network of member cord blood banks and transplant centers whose interactions are managed by the NMDP's Center for Cord Blood. Banks agree to comply with uniform collection, screening, testing and storage requirements. Upon approval of membership, cord blood banks submit detailed information on each stored CBU for registration into a proprietary computer system. A transplant center, working on behalf of potential recipients, submits search requests to the NMDP and receives electronic reports detailing potentially suitable CBUs. From these reports, the transplant center selects a CBU(s) for further testing, which includes at a minimum confirmation of the CBUs Human Leukocyte Antigen (HLA) typing data. Upon final selection of the desired CBU for transplantation, arrangements are made for timely shipment of the unit to the transplant center. Following transplantation, recipient outcome data are submitted by the transplant center for addition to the study database.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy

Exclusion Criteria:

-
Prospective Analysis of Restorelle in the Treatment of Uterine Prolapse

The purpose of this study is to determine the long term performance of Restorelle system for the treatment of uterine prolapse.

This study is being done to evaluate the performance of the Restorelle system, which uses Smartmesh - an ultra-lightweight mesh for uterine prolapse management. Most patients undergo a hysterectomy i.e. removal of the uterus when they have a prolapse. However, this has often been found to be an unnecessary operation. The investigators are studying the use of the Restorelle mesh system to preserve the uterus when there is a uterine prolapse.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is female.
2. Subject is at least 18 years of age.
3. Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh.
4. Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater.
5. Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 2 or higher (i.e. response of "somewhat", "moderately" or "quite a bit").
6. Subject is willing to provide written informed consent.
7. Subject is willing and able to comply with follow-up regimen.

Exclusion Criteria:

1. Subject is pregnant or intends to become pregnant in the future.
2. Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical).
3. Subject has undergone any previous repair for pelvic organ prolapse.
4. Subject has undergone a hysterectomy.
5. Subject lacks competency of the English language.
Fractional Laser and Steroid Ointment to Improve the Old Scar After Thyroidectomy

This clinical study was conducted to assess the effects of LADD combined with a fractional ablative carbon dioxide laser and a topical steroid for the treatment of post-thyroidectomy hypertrophic scars.

Thyroidectomy results in unsightly scarring at the anterior neck of the patient. A clinical study was conducted to assess the effectiveness of five courses, applied every 4 weeks, of laser-assisted drug delivery (LADD) combining a fractional ablative carbon dioxide laser and topical 0.05% clobetasol propionate to the treatment of post-thyroidectomy hypertrophic scars in patients. Assessments of the scars by the patient themselves according to the patient and observer scar assessment scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients had presented a persistent hypertrophic scar at the neck region for more than 1 year after their thyroidectomy.

Exclusion Criteria:

* Systemic chronic disease or a history of autoimmune disease or human immunodeficiency virus infections.