cyrilzakka/clinical-trials huggingface dataset:
Effect of DHEA on Skin Aging in Postmenopausal Women

The purpose of the study is to determine the response of skin parameters related to skin aging to the local action of DHEA in postmenopausal women.

Humans, along with the others primates, are unique among animal species in having adrenals that secrete large amounts of the inactive precursor steroids dehydroepiandrosterone(DHEA)and especially its sulfate DHEA-S. The marked reduction in the formation of DHEA-S by the adrenals during aging results in a dramatic fall in the formation of androgens and estrogens in peripheral target tissues, a situation that has been proposed to be associated with age-related diseases including skin atrophy, insulin resistance and obesity. Moreover, much attention has been given to the benefits of DHEA administered to postmenopausal women, especially on the bone, skin, vagina and well being after oral as well as percutaneous administration of the precursor steroid.

Therefore this study proposes to study the effect of 0.3% DHEA cream during a period of 12 months administered twice daily to postmenopausal women. During the study several biological and clinical parameters will be evaluated. In summary, these include blood steroid levels, distribution of hormonal receptors in the skin, sebaceous gland activity, skin hydration, skin wrinkles and finally skin genomic evaluation.

Subjects will be evaluated at specific time intervals for the above mentioned parameters as well as tolerability and adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal women who have taken hormonal replacement therapy for at least two years but not during the last 6 months prior to the study.
* Aged between 60 and 65.

Exclusion Criteria:

* Significant dermatologic, metabolic and endocrine disease.
* Diagnosis of cancer or history of hormone-dependant cancer.
* Over exposure to sun or tanning session during the previous two months.
* Narcotic addiction, alcoholism or smoking.
Evaluation of a Cardiac Coherence Session to Reducing Patients' Anxiety During a MRI Examination

The present project aims at conducting a proof of concept study to explore the pertinence of a single session of cardiac coherence, carried out in patients prior to an MRI examination and presenting anxiety in relation to this examination, to reduce their level of anxiety and thus improve the course of the examination.

Although Magnetic Resonance Imaging (MRI) is considered to be biologically safe and painless, the examination is often perceived by patients as difficult to bear, causing a great deal of anxiety due to the various constraints: the upper half of the body, including the head, positioned in a tube with a circumference of approximately 70 cm, relatively long duration, immobilization and even restraint. However, all these conditions are necessary to obtain good quality images, which are essential for the interpretation of the examination for diagnostic purposes by the clinicians.

The anxiety of patients linked to the performance of an MRI examination and its negative effects are documented in the literature. According to some authors, 71% of the professionals surveyed stated that anxiety was a common problem in their MRI centre and 19% stated that it regularly disrupted the examination. It is estimated that 10% of the motion artefacts present on MRI examinations are caused by anxiety-related motor agitation, making image quality difficult to exploit. Thus, every day, many MRI examinations are cancelled, interrupted, or of poor quality due to movement and difficult to interpret. All these examinations must therefore be rescheduled, with delays that can be several months long.

Among these non-drug methods, cardiac coherence seems promising. This method is recent, non-invasive, of short duration, very easy to implement and requires little training for users.

The present study hypothesize that a single session of cardiac coherence, carried out in patients prior to an MRI examination and presenting anxiety in relation to this examination, could make it possible to reduce their level of anxiety and thus improve the course of the examination.

Eligibility Criteria:
Inclusion Criteria:

* Person affiliated to or benefiting from a social security scheme;
* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
* Patient to undergo an MRI examination of the upper half of the body
* Patient over 18 years old
* Patient with a high level of anxiety (score ≥ 4) in relation to MRI

Non-inclusion Criteria:

* Patient under legal protection or under another protection regime (guardianship, curatorship).
* Sedated or unconscious patient
* Patient performing an emergency MRI examination
* Patient with a level of French language that does not allow sufficient understanding for the completion of questionnaires

Exclusion criteria:

- STAI Y-A score \< 46 (insignificant or low anxiety)
Safety and Efficacy Study of Fluzone® Vaccine Combined With Different Doses of JVRS-100 Adjuvant

This study is designed to assess safety, tolerability and immunogenicity of Fluzone® vaccine with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy adults 18-49 years of age.

The purpose of this trial is to evaluate the safety and tolerability of graded, ascending doses of JVRS-100 adjuvant when administered in combination with a vaccine antigen.

Eligibility Criteria:
Inclusion Criteria:

* able to understand the study and provide written informed consent
* be age 18 to 49 years
* be in good general health, without significant medical history, physical examination findings, or abnormal laboratory results
* be available for the study duration, including all planned follow-up visits
* female subjects of child bearing potential must not be pregnant and agree to be correctly using an efficacious hormonal method of contraception or intrauterine device for at least 1 month before the study and during the study

Exclusion Criteria:

* have allergy to eggs or other components of the vaccine
* have had an influenza vaccine within 3 years preceding the screening visit
* have a history of severe reaction of any kind to conventional influenza vaccines
* have or suspected immunodeficiency disorder, including leukemia, lymphoma, generalized malignancy, or treatment with immunosuppressive medications, including corticosteroids, alkylating agents, antimetabolites, or radiation therapy
* have a history of an autoimmune disorder, including systemic lupus, rheumatoid arthritis, scleroderma, other collagen vascular disease, multiple sclerosis, etc. Psoriasis limited to cutaneous manifestations is not an exclusion criterion.
* have prior history of anaphylaxis to foods, hymenoptera stings, vaccines or drugs
* have had transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within 3 months of the Screening Visit or anticipated through the study period
* have received another vaccine within 30 days preceding the screening visit or anticipated through the study period
* have participation in another clinical trial within 60 days of the screening visit
* have a positive serum or urine pregnancy test prior to vaccination or plan on a pregnancy during study period
* have abnormalities on laboratory assessment
* be seropositive to HIV or HCV or positive for HBsAg
* be positive for anti-nuclear antibodies
* have a physical examination indicating any clinically significant medical condition
* have a body temperature \>38.1°C (100.6°F) or acute illness within 3 days prior to vaccination
* intention to travel out of the area prior to the study visit on Day 28 of the study
* have a history of excessive alcohol consumption, drug abuse, significant psychiatric illness
* have the intention to increase normal exercise routine, participate in contact sports or strenuous weight lifting or to initiate vigorous exercise from Screening until after Day 28 of the study
Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD)

This is a phase 2 randomized, double -masked study comparing the efficacy of EYP-1901 at two dose levels: 2060 ug and 3090 ug against Aflibercept.

This study is evaluating the two doses of 1901 against Aflibercept in a randomized study.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of wAMD in the study eye, with disease onset any time prior to the Screening Visit.
* Previously treated with at least two anti VEGF intravitreal injections (i.e., bevacizumab, ranibizumab, aflibercept or faricimab) for wAMD per standard of care in the study eye within 6 months prior to the Screening Visit.
* BCVA ETDRS letter score of 35 letters (20/200 Snellen equivalent) to 85 letters (20/20 Snellen equivalent) in the study eye at the Screening Visit and on Day 1.

Exclusion Criteria:

* Central subfield thickness (CST) \> 350 µm in the study eye at the Screening Visit or Day 1.
* Any concurrent intraocular condition in the study eye (e.g., cataract or glaucoma).
* Historical or active intraocular inflammation (grade trace or above) in the study eye, other than expected findings from routine cataract surgery.
Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus

The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.


Eligibility Criteria:
Inclusion Criteria:

Patient

* Patients with Type 1 or Type 2 diabetes mellitus (according to American Diabetes Association or World Health Organization \[WHO\] guidelines) with glycosylated hemoglobin (HbA1c) ≤ 12.0% at screening (Visit 1). Patients should be on diet, exercise, and/or pharmacological treatment for diabetes. Treatment for diabetes must have been stable for at least 3 month.

Ocular

* Patients with visual impairment due to DME in at least one eye who are eligible for laser treatment in the opinion of the investigator. If both eyes are eligible, the one with the worse visual acuity, as assessed at Visit 1, will be selected by the investigator as the study eye.
* BCVA ≥ 39 and ≤78 letters in the study eye and, inclusively, using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/160) at screening.
* Concomitant conditions in the study eye are only permitted if, in the opinion of the investigator, they do not prevent improvement of visual acuity on study treatment.

Exclusion Criteria:

Patient Compliance/ Administrative

* Pregnant or nursing (lactating) women.

Ocular medical history

* Active intraocular inflammation (grade trace or above) in either eye at enrollment.
* Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye at the time of enrollment.
* History of uveitis in either eye at any time.
* Structural damage within 0.5 disc diameter of the center of the macular in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
* Uncontrolled glaucoma in either eye at screening.

Prior Ocular treatments

* Panretinal laser photocoagulation in the study eye within 6 months prior to randomization.
* Focal/grid laser photocoagulation in the study eye within 3 months prior to randomization.
* Treatment with anti-angiogenic drugs in either eye.

Systemic conditions or treatments

* History of stroke within 6 months prior to enrollment.
* Renal failure requiring dialysis.
* Untreated diabetes mellitus.
* Blood pressure systolic \> 160 mmHg or diastolic \> 100 mmHg.

Other protocol-defined inclusion/exclusion criteria may apply
Prothrombotic Factors and Anaesthesia in Prostate Cancer

This study aims to assess if different anesthetic techniques can affect coagulant factors in patients with prostate cancer undergoing elective laparoscopic radical prostatectomy (LRP).

The utility of anti-thrombotic prophylaxis in cancer patients undergoing laparoscopic radical prostatectomy (LRP) is still controversial. Moreover, different anaesthetic techniques could modify coagulant factors. Thus, in this study we will be to investigate the variations of pro- and anti-coagulant and fibrinolytic factors in two established types of anaesthesia in patients with prostate cancer undergoing elective LRP.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed cancer of the prostate
* histological Gleason score evaluation.

Exclusion Criteria:

* ASA \>2
* metabolic equivalent task \< 4
* BMI\>30
* no pre-operative pharmacological thromboprophylaxis and/or anti-coagulant therapy
* history of abnormal bleeding, or abnormal coagulant factors
* sepsis within the last 2 weeks
* previous new adjuvant treatments (chemo, hormone, and radiotherapy)
* non-steroid , anti-inflammatory and statins drugs for at least 2 wks before surgery
* venous or arterial thromboembolism within the last 3 months, peripheral venous disease
* neurological disease with extremity paresis
* chronic liver disease
* pre-operative haemoglobin concentration \< 9 mg dl-1
* prolonged duration of surgery (\>3 hrs)
* peri-operative blood transfusion
* not adequate material for laboratory testing
A Study of the Pharmacokinetics/Pharmacodynamics of GK Activator (2) in Type 2 Diabetes Patients With Hepatic Impairment.

This study will investigate the effect of hepatic impairment on the pharmacokinetics, pharmacodynamics, safety and tolerability of GK Activator (2) in type 2 diabetes patients with mild and moderate hepatic impairment. Patients with type 2 diabetes, and with normal hepatic function, or mild or moderate hepatic impairment, will receive a single dose of GK Activator (2) 100mg po before breakfast, for assessment of pharmacokinetic, pharmacodynamic and safety parameters. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes;
* normal hepatic function, or mild or moderate hepatic impairment.

Exclusion Criteria:

* type 1 diabetes, or latent autoimmune diabetes in adults;
* diabetic neuropathy, retinopathy or nephropathy;
* treatment with insulin or PPAR gamma agonist within 6 weeks of screening;
* clinically significant cardiovascular disease.
Rehab MATRIX: Impact of a Nursing-Led Acuity Algorithm on Patient Safety and Healthcare Quality

To determine whether implementation of Rehab MATRIX will improve patient safety, patient satisfaction and nursing indices.

The provision of efficient and conscientious nursing care is at the forefront of health care quality. Unfortunately, a lack of objectivity in the assignment of patients to nurses can lead to inequalities of care. Such inequalities translate to poor patient outcomes and diminished patient satisfaction. Furthermore, staff attrition related to nursing fatigue increases the cost of care due to a reliance on supplemental nurses. Rehab MATRIX is a patient assignment tool that objectively categorizes patients undergoing inpatient rehabilitation based on nurse identified acuity variables.

Eligibility Criteria:
Inclusion Criteria:

* Rehabilitation Nursing Staff within Six Study Centers
* Patient hospitalized within the Rehabilitation Unit during the study period

Exclusion Criteria:

* Other Nursing Staff
* Patients hospitalized on non-rehabilitation units
Honey As a Wound Care Modality in Treating Deep Neck Space Abscess

This study investigates the effectiveness of honey as a treatment for deep neck space abscesses, comparing it to standard wound care methods. Conducted as a randomized clinical trial, it aims to determine whether honey can offer a viable alternative or improvement in managing this condition. The research assesses outcomes related to healing, infection control, and overall patient recovery.

Deep neck abscess is one of the diseases in the field of otorhinolaryngology-head and neck surgery that has high morbidity, mortality, and costs. Management of deep neck abscesses involves incision and drainage, abscess exploration, systemic administration of broad-spectrum antibiotics, management of comorbid factors, and postoperative wound care until healing. Standard dressing for wound care has been time-consuming and costly. Honey is one type of dressing modality that has been widely used in wound care for various parts of the body and diseases. Honey is expected to be a more cost-efficient treatment modality that supports accelerated wound healing, leading to better outcomes and cost savings.

The research design used is a single-blind randomized controlled trial (RCT), where researchers randomly assign one intervention to respondents to compare the effects of honey and Prontosan on the wound healing process. The population and sample of the study include all patients with deep neck abscesses treated at Dr. Sardjito General Hospital, the teaching hospital of the Faculty of Medicine Gadjah Mada University and other hospitals equipped with board-certified Otorhinolaryngologists. The participants in the control group were treated with standard dressing, while participants in the study group were treated with standard dressing along with honey dressing.

Eligibility Criteria:
Inclusion Criteria:

* Deep neck abscess patients over 18 years old with or without comorbidities except for malignant diseases

Exclusion Criteria:

* Patients who refused intervention
* Patients who underwent vacuum-assisted closure (VAC)
* Patients with incomplete medical records
Senior PAMI: Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly

This is a prospective, randomized, multi-center, international trial comparing two reperfusion strategies in elderly (age \>= 70 years) patients with acute myocardial infarction: primary percutaneous coronary intervention (PCI) versus intravenous thrombolytic therapy. Clinical endpoints will be collected in the hospital, at 1 month, 6 months, and 1 year post-randomization. The primary endpoint is 30 day death or disabling stroke. The study null hypothesis is that there will be no significant difference in death or disabling stroke at 30 days post-randomization between patients treated with PCI versus thrombolytics.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 70
* Clinical symptoms \> 30 minutes
* Symptom onset \<= 12 hours
* ST segment elevation \>= 1 mm in 2 or more leads

Exclusion Criteria:

* Prior thrombolytics
* Cardiogenic shock
* Cerebrovascular accident (CVA)
* Prolonged cardiopulmonary resuscitation (CPR)
* Blood pressure (BP) \> 180/100 mm Hg
* Active bleeding
* International Normalized Ratio (INR) \> 1.4
* Acetylsalicylic acid \[aspirin\] (ASA) or heparin allergy
* History of neutropenia, thrombocytopenia, hepatic dysfunction, or renal insufficiency
* Peripheral vascular disease (PVD)
Long Term Follow-up on Menkes Disease Patients

This study will collect long term follow-up data regarding overall survival and neurological parameters from patients previously identified and/or enrolled in Protocols 09-CH-0059 and 90-CH0149 and Historical Control data on Menkes disease patients.

Primary Objective:

1. To provide additional clinical and safety data on long term following administration of Copper Histidinate treatment in patients treated with Copper Histidinate under Protocols 09-CH-0059 and 90-CH0149 and untreated patients previously identified and/or enrolled in Protocol 09-CH-0059.
2. To provide additional Historical Control data on Menkes disease patients.

Eligibility Criteria:
Inclusion Criteria:

* The subject must have been previously identified and/or enrolled under Protocols 09-CH-0059 or 90-CH-0149; or An untreated Menkes disease patients for whom data collection is incomplete under Protocols 09-CH-0059 (Amendment M); or Other untreated Menkes disease patients.
* Must sign and date an informed consent form by parent or legal guardian for this study prior to any assessment being done in this study. If the patient is \> 18 years of age, the patient must sign the informed consent.
* Male or female, aged 0 to \< 65 years of age.

Exclusion Criteria:

- Unwillingness/unable to participate in the study.
Evaluation of Some Parameters in University Students During the COVİD-19 Epidemic Process

The physical and mental effects of the COVID-19 pandemic have been examined by many researchers, but this study aims to evaluate in every aspect how university students who had to receive education with the distance education model due to the pandemic went through this process. Data regarding people's positive and negative habits from anthropometric characteristics and sleep quality, which is one of the sub-dimensions of healthy lifestyle behaviors, were evaluated, and the relationship between these parameters was examined in detail.

This study focuses on distance education, remote working, etc. during the pandemic period. It is compatible with the findings of studies on the subject and reveals that the nutrition and physical activity sub-parameters of the healthy lifestyle behaviors scale are related to anthropometric characteristics and sleep quality. Considering that the online working model has become widespread, from this perspective, for future studies, the effects of behavioral change strategies on individuals' sleep quality and anthropometric values can be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Students who are registered to Kırklareli University Faculty of Health Sciences and aged 18 years and older who agreed to participate in the study
* Those who are capable of filling out surveys online
* Those with internet access
* With the fully answered to the questionnaire and scale questions

Exclusion Criteria:

* Students who are not registered to Kırklareli University Faculty of Health Sciences
Development and Application of Intelligent Assessment System of Longshi Scale

The purpose of this study was to verify convenience and feasibility of the novel intelligent Longshi assessment system to provide an accurate and convenient evaluation tool for stroke survivors.


Eligibility Criteria:
1. Inclusion Criteria:

   1. Stroke survivors

      * age≥18 years
      * diagnosis of cerebral infraction or intracerebral hemorrhage
      * stable vital signs
      * willingness to participate in the study with informed consent
   2. Professional evaluators:

      * One to ten years of working experience
      * experience in rehabilitation scientific research or education related work for more than two years
      * association with Longshi Scale research
   3. Non-professional evaluators：

      * the family or caregiver of stroke survivors
      * ability to read and communicate
      * willingness to participate in the study with informed consent
2. Exclusion Criteria:

   1. Stroke survivors:

      * brain tumor, Parkinson's disease or active epilepsy within past three months
      * impaired cognitive functions
      * participation in any other clinical study
   2. Professional evaluators:

      * refusal to participate in the study
   3. Non-professional evaluators:

      * care for patients with serious mental health problems
      * refusal to participate in the study