cyrilzakka/clinical-trials huggingface dataset:
Serum Levels of 25-Hydroxy Vitamin D in Patients With Moderate and Severe Erectile Dysfunction

In present study, we aimed to investigate the association between erectile function severity of serum 25-Hydroxyvitamin-D and cut-off level to treat men with erectile dysfunction.

Investigators retrospectively analysed 130 patients admitted to the complaint of erectile dysfunction between aged between 18-80 years old from June 2017 to October 2018 at Cigli Region Training Hospital Urology department and Recep Tayyip Erdogan University Urology Department. International index of erectile function-5 (IIEF-5) Turkish validated short form quesstionaire was performed to all patients. Antropometric characteristics including weight, height, waist circumference, body mass index (BMI) and presence of comorbide diseases were recorded. After detailed history and physical examination performed all patients, overnight fasting in the morning between 08:00-10:00, blood samples from antecubital vein were performed and serum glucose, lipid profile, follicular stimulating hormon (FSH), Luteinizing hormone (LH), total testosterone, prolactin, estradiol, 25(OH)D level were analysed. Presence of uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled lipid metabolism disorders, neurological diseases, heamatological diseases, urinary tract infection, malignencies, chronic kidney failure, metabolic syndrome, psychiatric diseases and/or medical treatment, smoking, history of pelvic surgery, cardiac surgery and pelvic radiotherapy were accepted as exclusion criterias from the study. After IIEF-5 score adjust as 21 point, ROC analyse was used to calculate the cut-off value of 25(OH)D and level of 27.32 ng/mL was calculated as cut-off value. Patients were divided into two group according to 27.32 ng/mL level as a cut off value. Serum 25(OH)D level was lower than 27.32 ng/mL in group 1 (severe and moderate symptomatic group) and higher than 27.32 ng/mL in group 2 (mild symptomatic group).

Eligibility Criteria:
Inclusion Criteria:

* presence of erectile dysfunction

Exclusion Criteria:

* Presence of uncontrolled diabetes mellitus,
* Presence of uncontrolled hypertension,
* Presence of uncontrolled lipid metabolism disorders,
* Presence of neurological diseases,
* Presence of heamatological diseases,
* Urinary tract infection,
* Diagnosis of any malignencies,
* Chronic kidney failure,
* Presence of metabolic syndrome,
* Presence of psychiatric diseases and/or medical treatment,
* Smoking,
* History of pelvic surgery, cardiac surgery and pelvic radiotherapy
Effectiveness of Sealants on Molars

Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary dentition could slow the specific development of carious lesions in early childhood. In addition, this non-invasive approach could delay the conventional food and thus save financial costs for more complex treatments. Finally, the installation of AS could afford, as demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the caries process.

Currently, the real scope of sealants (AS) is poorly documented in temporary dentition and its effectiveness has not been demonstrated. Yet it seems reasonable that the AS in temporary dentition could slow the specific development of carious lesions in early childhood. In addition, this non-invasive approach could delay the conventional food and thus save financial costs for more complex treatments. Finally, the installation of AS could afford, as demonstrated in adult teeth, lowering the cariogenic bacteria prevalence engaged in the caries process.

Main objective: To evaluate the effect of AS on caries incidence in the deciduous dentition obtained over a period of three years, taking into account the risk of caries established initially.

Secondary objectives:

1. To assess the prevalence and caries attack sites at the end of each year
2. Estimate the retention rate (partial or complete) of the AS during the study
3. Determine the cost savings of treatment during the trial period

Eligibility Criteria:
Inclusion Criteria:

* Children who have at least two pairs (test / control) of healthy molars with occlusal surface or non cavitary initial injury.
* Children available for a follow-up 3 years
* Children being affiliated or beneficiary in a health insurance plan

Exclusion Criteria:

* Children involved in other research in the same field
* Child is exclusion period determined by previous research
* Children participating in research in the last three months its inclusion
* Parents do not understand French.
* Children deprived of liberty.
* Child participation Refusal
* Refusal to participate in either of the parents or legal representative
Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects

This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study. This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This study consists of 5 steps, 1 to 5. In steps 1 to 4 (at ascending doses of 50, 100, 200, and 400 mg), subjects will be randomly assigned in a 6:2 ratio (E6007: placebo) to receive single dose of the study drug under fasted condition. Following 3 days of washout period, subject will receive the study drug once daily for 7 days starting on the fifth day from the single dose administration.

For step 3 (200 mg), subjects will subsequently have at least 17 days of washout period before being escalated to step 5 (200 mg) to receive single dose of E6007 under fed condition, to evaluate food effect of the study drug.


Eligibility Criteria:
Inclusion criteria

Subjects must meet all of the following criteria to be included in this study:

1. Healthy Japanese male subjects aged 20 to 44 years at the time of informed consent.
2. Has voluntarily consented, in writing, to participate in this study.
3. Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.

Exclusion criteria

Subjects who meet any of the following criteria will be excluded from this study:

1. Has a clinically significant medical condition requiring treatment within 8 weeks before the initial study drug administration, or a history of clinically significant infection requiring treatment within 4 weeks before the initial drug administration.
2. History of surgical treatment such as resection of the liver, kidney, or Gastrointestinal tract, that may affect the Pharmacokinetic profiles of study drugs.
3. Ineligible for study participation in the opinion of the investigator or sub-investigator.
Using a Telemedicine Approach in a Genome-wide Association Study of Atopic Dermatitis - Searching for Novel Biomarkers in Clinically Relevant Phenotypes

Atopic eczema is a common skin disorder affecting at least 2-3% of the western population. Atopic eczema cannot be cured and therefore treatment aims to alleviate the symptoms of the disease. Today, many different medical treatments are available: from mild hormone creams to harsh systemic treatments. The treatment chosen depends in part on the severity of the eczema and on the treatment response of the individual. This practice may mean that some people with eczema undergo unnecessary treatment courses with associated side effects. We know today that eczema has a hereditary component, and different areas have been identified in the hereditary material that appear to play a role. Although it is thought that variations in specific areas of the inheritance material may influence how eczema is expressed in the individual, the significance of these variations is far from clarified. The investigators want to increase the knowledge about atopic eczema, about the disease and how in the future we can organize the treatment of eczema based on knowledge of our genetic material. In this study, the investigators want to elucidate whether there is a correlation between specific variations in the genetic material and how the eczema is clinically expressed. In addition, the investigators want to assess whether reports with specific information about the individual's genetic material in relation to his or her lifestyle can help retain participants in research projects.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent has been signed
* 18 years or older
* Resident in the USA or Denmark
* AD meeting the UK Diagnostic Criteria for Atopic Dermatitis
* At least one visible AD lesion at the time of recruitment (as confirmed remotely through photo upload in screening)
* Smartphone user with daily access to internet (WIFI or 3G/4G)
* Willing to donate a DNA sample
* Confirmed intention to comply with study protocol procedures

Exclusion Criteria:

* Female subjects that are pregnant (or plan to become so during the study period) or lactating
* Active dermatological condition that may confound the diagnosis of AD and/or the assessment of disease activity
* Unable to speak or understand English or Danish
* Overlap with participation in interventional trials
* No visible AD at time of screening
* Any other reasons that in the investigator's opinion could:
* Impede a subject's ability to complete the study period
* Influence the objectivity or quality of the findings of the study
Artificial Intelligence in Computed Tomography for Quantifying Lung Changes of Bronchiectasis Patients

Bronchiectasis is a chronic respiratory disease characterized by permanent bronchiectasis.The incidence and prevalence of bronchiectasis have assumed continuously grows in global. Chest computed tomography (CT) remains the imaging standard for demonstrating cystic fibrosis (CF) airway structural disease in vivo. However, visual scoring systems as an outcome measure are time consuming, require training and lack high reproducibility. Our objective was to validate a fully automated artificial intelligence (AI)-driven scoring system of CF lung disease severity.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with bronchiectasis (according to the Chinese consensus, patient's previous chest CT examination must show bronchiectasis)

Exclusion Criteria:

* Patients with CT data and medical records missing
Efficacy of Acetaminophen Alone Versus Combination of Acetaminophen/Ibuprofen After Cesarean Section

The investigators aim to compare the analgesic efficacy of intravenous acetaminophen alone versus combination of acetaminophen/ibuprofen (Maxigesic®IV) in multimodal analgesia after cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective cesarean section
* Gestational age \> 37+0 weeks

Exclusion Criteria:

* Emergency cesarean section
* Multiple pregnancy (e.g. twins, triplets)
* Body weight \< 50 kg
* Preeclampsia
* History of hypersensitivity to acetaminophen or ibuprofen
* History of upper gastrointestinal tract bleeding or gastric ulcer
* Underlying liver disease
* Underlying kidney disease or GFR \< 90 mL/min/1.73m2
* Heart failure or severe hypertension
* History of asthma
* Chronic use of barbital or tricyclic antidepressants
School-based Randomized Trial of SunSmart Interventions

The objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. The intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure.

Childhood sun exposure not only increases melanoma risk, but may establish lifetime patterns of exposure and protection. Individuals receive a substantial proportion of lifetime exposure to ultraviolet radiation (UVR) during childhood, and severe sunburns before age 20 may increase lifetime risk of developing melanoma. The objective of this study is to test a novel classroom-based intervention to motivate youth to limit their sun exposure. The intervention will make the process of learning about sun exposure more person-centered using individual dosimetry readings and feedback that will lead to individual plans for reducing sun exposure. Building on the previously existing SunSmart program the investigators have been conducting in 20 local Los Angeles schools in partnership with USC's Joint Education Project (JEP), this study will implement a Randomized Controlled Trial among 5th-6th graders (aged 10-14), comparing this new education-feedback approach to the existing SunSmart education-only program, testing knowledge, attitudes and behavior before and after the intervention. In a subset of students, the investigators will collect real time UV exposure data using personal dosimetry as a Gold Standard measure of change in UV exposure behaviors. The study design randomizes at least 18 schools to 9 intervention or 9 non-intervention (control) schools, and students within each school all have pre- and post-tests. The investigators will also select classrooms from each school across conditions to have students wear dosimeters pre- and post- Intervention/Control. Using a hierarchical cluster analysis with the school unit taken as random and students as repeated measures within school, the investigators will test the primary hypothesis that improvements in sun exposure behaviors are significantly higher than baseline at post-test in the Intervention than Control group, and that this may even occur without significant differences in sun exposure knowledge and attitudes between the two groups. The investigators will additionally test the hypothesis that total UV exposures obtained from UV dosimetry are significantly lower than baseline in the Intervention than control group after Intervention.

Eligibility Criteria:
Inclusion Criteria:

* Child in classrooms from selected schools in the Los Angeles metropolitan area.

Exclusion Criteria:

* All children will participate in the educational activities, unless they opt out of pre- and post-test questionnaires or are absent from school for any of the education sessions.
Rest Easy: Is Bed Rest Really Necessary After Surgical Repair of an Ankle Fracture?

After a patient has fractured an ankle that then requires surgery, the recommendation is to remain in bed, with the operated leg elevated on pillows for 48 hours. This is a precautionary measure, as yet unsubstantiated by research, which is thought to minimize ankle swelling that can inhibit the healing of the surgical wound. However, prolonged bed rest can lead to other complications such as blood clots in the lungs or leg veins, or chest infections such as pneumonia. Prolonged bed rest is also known to cause weakness and a loss of fitness such that recovery may be slower. In this research the investigators will be randomly allocating patients to mobilize within 24 hours post operatively or to rest in bed for 48 hours with their leg well elevated. The investigators will measure length of stay and wound healing and integrity at 14 days. This study aims to investigate whether getting patients out of bed within 24 hours of surgery can accelerate recovery and reduce acute hospital length of stay without affecting wound healing. If bed rest for 2 days is not necessary, there will be benefits for the patient in terms of general health and ability, and for the hospital in terms of cost savings through shorter lengths of stay and patient through put. The investigators already know that early mobilization is beneficial following other types of orthopedic surgery such as hip fractures. This study aims to investigate if early mobilization following surgical management of ankle fractures is safe with specific regard to wound integrity and wound outcomes. This study will also investigate the effect of earlier mobilization on the length of time spent in the acute hospital and for those discharged directly home, the amount and type of support required. If early mobilization is found to be safe for wound healing and results in shorter in-hospital stays, this research will provide the confidence to endorse a change to current clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* patients who have had internal fixation of a fractured ankle closed without plastic surgery intervention and without follow up hyperbaric oxygen therapy

Exclusion Criteria:

* living in nursing home,
* previously non-ambulant,
* concommitant injuries which do not allow early mobilisation, plastics involvement for wound closure, hyperbaric oxygen therapy
Virtual Reality for Appendectomy Pain

To determine the impact of VR-Biofeedback and VR-Distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix.


Eligibility Criteria:
Inclusion Criteria:

* Age 8 - 18 years
* Able to read, understand, and speak English
* Patients in the immediate postoperative period following laparoscopic appendectomy for ruptured appendix

Exclusion Criteria:

* Outside of age range (\<8 or \>18 years)
* History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
* History of vertigo, dizziness, and/or seizure disorders
* Conditions that would preclude the application of the VR headset, such as craniofacial deformities
* History of chronic pain, frequent opioid use and/or active cancer therapy
Tooth Loss Rate and Its Associated Factors: a Retrospective Cross-sectional Study With up to 50 Years of Follow-up.

This study will evaluate, in an adult population (n=448) previously diagnosed with gingivitis and/ or periodontitis, the tooth loss rate and its potential associated factors such as diabetes, smoking, bruxism, cardiovascular diseases, and also the effect of supportive periodontal therapy on these factors, with an up to 50 years of follow-up period.

Significant results of the present study will help in the future reduction of tooth loss among periodontally involved patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years.
* Patients diagnosed with generalized chronic periodontitis or gingivitis.
* At least 10 years of follow-up after 1st visit.
* All treatments and recall sessions were done by the same operator at the same specialized dental clinic.

Exclusion Criteria:

* Patients with healthy periodontal status.
* Patients with orofacial anomalies and syndromes.
* Patients receiving periodontal treatments by different operators.
* Patients receiving periodontal treatments at different clinics.
* Patients receiving bisphosphonate therapy.
* Patients receiving chemotherapy or radiotherapy.
* Patients receiving a hormonal therapy.
* Patients with a history of refractory periodontitis or repeated abscess formation.
* Patients with debilitating diseases that could impair the immune system (HIV/AIDS, cancer, or autoimmune diseases).
NIBP Validation Study

The purpose of this study is to compare measurements of blood pressure (BP) between the Philips non-invasive blood pressure (NIBP) system (including NIBP cuff and portable patient monitor) and invasive radial arterial line (A-line) in critical care patients.

This is a multicenter, multi-phase, prospective, non-randomized, self-controlled, observational study to evaluate the validity of Philips non-invasive blood pressure technology.

This study is designed for the purpose of establishing equivalence of the Philips NIBP system with the gold standard arterial line.

Main Phase will be considered complete when the number of pre-defined subjects and data points are achieved per subject group.

* Subject Group 1: Neonates, Infant, Children \<3 years of age Minimum of 24 subjects and 180 data points
* Subject Group 2: children 3-12 years of age Minimum of 41 subjects and 205 data points
* Subject Group 3: Adolescent/Adult \>12 years of age Minimum of 124 subjects and 620 data points

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted into the Neonatal Intensive Care Unit (NICU), Pediatric Intensive Care Unit (PICU), Intensive Care Unit (ICU), or Operating Room (OR)
* Adult aged 18 years and older, or parent/legal guardian of minor, willing and able to understand and provide informed consent/assent
* Indication for NIBP cuff
* Indication for radial arterial line

Exclusion Criteria:

* Inability to place the study device appropriately due to patient's anatomy or condition
* Known pregnancy or lactating women (self-report)
* Patients treated with an intra-aortic balloon pump
* Aortic and mitral regurgitation (\> 2nd degree)
* Measurements taken in the lateral position
* Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s)
* If valid SBP reference measurements for lateral difference is \> 15 mmHg
* If valid DBP reference measurements for lateral difference is \> 10 mmHg
* At the Principal Investigator's discretion, subject does not qualify to participate in the study for any reasons that are not mentioned above
Efficacy Evaluation of Normothermic Perfusion Machine Preservation in Liver Transplant Using Very Old Donors

The purpose of this study is to evaluate the impact of normothermic machine perfusion in liver transplantation using grafts of brain death donors older or equal than 70 years

Mean donor age for liver transplantation in Tuscany, Italy, is increasing and is actually 71 years. Old donors are a valuable resource but their use has been related to a major incidence of primary non function (PNF), delayed graft function (DGF) and ischemic type biliary lesions (ITBL).

Ischemia-reperfusion injury is a major reason for the development of these complications and and old grafts are more susceptible than younger ones.

Normothermic machine perfusion (NMP) is a novel and promising technique that allows preservation in a more physiological environment. It is our belief that the use of NMP might reduce the impact of ischemia-reperfusion injuries in older grafts thus reducing the incidence of complications and providing a better outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patient on waiting list for liver transplant
* Signed informed consent
* Age between 18 and 70
* Eligibility for liver transplant as for University of Pisa Liver Transplant Center Protocol
* Capacity and willingness to participate to the protocol

Exclusion Criteria:

* No signed informed consent
* Age under 18 or over 70
* Presence of disease that may influence results
* Patient participation to other studies
* Re-liver transplant
* ABO incompatible OLT
* Multiorgan transplant
* Liver transplant for acute liver failure or trauma
* MELD (model for end stage liver disease) \>24
* Patient not suitable to participate on investigators's opinion