cyrilzakka/clinical-trials huggingface dataset:
Odense Androgen Study: Study of Androgens, Body Composition, and Muscle Function in Danish Men

Objective:

* To define a reference-population of healthy young men (20-29 years old).
* To establish reference-intervals for:

  1. Total, bioavailable and free serum androgens (testosterone, dihydrotestosterone, androstenedione) and serum estrogens (estradiol, estrone).
  2. Total and free IGF-1.
* To study the influence of physical activity, alcohol intake, tobacco and abuse of anabolic steroids on serum levels of androgens.
* To identify the androgens (or estrogens) that primarily reflect the following parameters:

  1. Muscle mass, muscle strength, muscle power, oxygen uptake, and hematocrit.
  2. Bone mineral density and bone metabolism.
  3. Total and visceral fat mass.
  4. Lipid- and glucose metabolism and glucocorticoid metabolism.
  5. Sexual function and quality of life.
* To study the modifying effect of birth weight, the AR gene CAG-repeat polymorphism, and the level of IGF-1 on associations between serum androgens and the measures above:

Ethics, design and schedule:

The local ethic review board approved a population-based, cross-sectional study planned for the inclusion of 800 Caucasian men, 20 to 29 year old, living in the County of Funen. The only exclusion criteria were opioid drug addiction, cancer, and severe chronic disease. A basic questionnaire was mailed to 3000 men, randomly drawn from the Danish Central Personal Registry. Adequately answered questionnaires were returned from 2,199 men, who subsequently received an invitation to participate. Informed consent was obtained from 783 men. The examinations started in March 2002 and terminated in May 2003. Within subject variation was determined for all study parameters in 20 men. The men included matched the men answering the questionnaire on all questionnaire items and demographics. All analyses have been performed, except for the additional serum sex hormone assays, IGF-1 assays and AR gene analyses.

A sequential rule-out from the reference population was performed on the following criteria:

1. testicular pathology: bilateral cryptorchidism, varicocele, testes volumina \< 10 ml (each), history of spermatic cord torsion.
2. severe chronic disease.
3. regular medication or abuse of anabolic steroids.
4. body mass index \< 19 kg/m2.
5. safety serum parameters: luteinizing hormone (LH) \<1.0 U/L or \>8.4 U/l, alanine-amino-transferase (ALAT) \>70 U/l and thyrotropin (TSH) \>6.0 mU/l.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-29 years
* Residence: County of Funen, Denmark

Exclusion Criteria:

* Opioid drug addiction
* Cancer
* Severe chronic disease
Effect of Dermal Rejuvenation on the UVB Response of Geriatric Skin

The objective of this study is to examine the ability of dermal rejuvenation therapies to protect geriatric skin from ultraviolet light (UVB)-induced carcinogenesis. Skin cancers (including basal cell carcinoma and squamous cell carcinoma) are the most common types of malignancy and are related to UVB exposure in sunlight. UVB-irradiation of skin causes specific DNA damage to keratinocytes that can lead to cancer-causing mutations if they are allowed to persist in proliferating cells. Moreover, the incidence of skin cancers is much greater in elderly over younger individuals. The objective of the present study is to build upon our previous data and test the effect of a non ablative Nd:YAG laser (LaserGenesis) of a localized area of skin on dermal IGF-1 production and UVB-mediated keratinocyte effects. Treatment of skin using a non ablative high-peak power microsecond pulsed 1064 nm Nd:YAG laser (Cutera's LaserGenesisTM laser) leads to papillary dermal heating. The laser targets the microvasculature and stimulates collagen production while protecting the epidermis. Generally, Laser Genesis is used clinically to improve irregularities in the contour, texture, and color of the skin. Laser Genesis is also used to help treat photoaging by increasing collagen formation, suggesting that it stimulates fibroblast activity and thus possibly increases levels of protective IGF-1.


Eligibility Criteria:
Inclusion Criteria:

* Only subjects older than 65 years will be enrolled.
* Subject's skin type must be "Fair", Fitzpatrick type I or II.

Exclusion Criteria:

* Subjects who have underlying diseases that could affect wound healing (eg, diabetes mellitus)
* on medications that are known photosensitizers,
* or have a history of abnormal scarring (eg, keloids) will be excluded.

Subjects will be asked the screening questions below as part of the inclusion/exclusion criteria

* How old are you?
* Do you regularly use tanning beds?
* Are you being treated with light therapy?
* Have you had any diseases that got worse when you went in the sun?
* Are you taking any medications that warn you to stay out of the sun?
* Have you ever had a reaction to medications that were applied to your skin?
* When cuts or wounds on your skin heal, are the scars abnormally large or take a long time to heal?
* Do you have diabetes mellitus or have you ever had high blood sugar?
Smartphone Flicker Fusion Test for Patients With Optic Disorders.

The purpose of this project is to validate a quick, easy-to-use and administer smartphone flicker fusion test. The app (called eyeFusion) can potentially be used to easily and quickly collect critical flicker fusion measurements on patients admitted with optic disorders as part of the clinical care process.

The smartphone app developed is a flicker fusion that presents the subject with a series of stimuli consisting of a flickering pattern of bars above or below a static rectangle. For each stimulus presentation, the user has to tap the region that is flickering. The duration of the app is less than 2 minutes.

This study will assess the validity of the test construct in measuring flicker fusion thresholds, and serve as a foundation for further iterative designs of the app and future validation and characterization studies.

Eligibility Criteria:
Inclusion Criteria:

Control

* Age matched 18-80 years of age.
* Healthy normal controls with no known eye disorders.

Exclusion Criteria:

* Scotoma or any other ocular disorder

Inclusion Criteria - Patients

* Age 18-80
* Clinically associated scotoma

Exclusion Criteria - Patients

-Any other ocular disorder
Cognitive Training for Diabetes Self-Management

The overall objective of this study is to determine the effects of a comprehensive cognitive rehabilitation intervention on biological, cognitive, and diabetes self-management outcomes.

Aim 1: Test the efficacy of the MAPSS-DM intervention for improving cognitive function, A1C, and DM-SM. Based on preliminary data, the working hypothesis is that compared with the control group, persons who receive the intervention will have improved memory, executive function, and perceived cognitive function, greater use of cognitive strategies, and improved DM-SM immediately post-intervention and at three and six-months post-intervention.

Aim 2: To explore changes in glycemic variability and their association with changes in cognitive function. The working hypothesis here is that MAPSS-DM participants will exhibit less glycemic variability post-intervention as compared with baseline and glycemic variability will mediate improvements in cognitive test performance.

Eligibility Criteria:
Inclusion Criteria:

* age 50 years old or greater
* T2DM diagnosis for 2 years
* access to phone and Internet
* Score of ≥10 on the Perceived Deficits Questionnaire (PDQ)
* A1C of \>7%.

Exclusion Criteria:

* a diagnosis of dementia/head injury
* score of \>5 on the Mini-Cog
* inability to speak English, and T1DM diagnosis
Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma

This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall trauma.

The purpose of this study is to evaluate the efficacy of liposomal bupivacaine to provide analgesia via paravertebral intercostal nerve block following significant blunt chest trauma, minimizing adverse outcomes, length of stay and overall narcotic use. The primary outcome of the study is to compare requirements between the bupivacaine group and a standard-of-care group.

Eligibility Criteria:
Inclusion Criteria:

* Anticipated length of stay of at least 72 hours
* Blunt chest wall trauma with two or more rib or sternal fractures
* Demonstrated ability to achieve \> 50% predicted inspiratory capacity based on ideal body weight using IS within the first 24 hours of admission

Exclusion Criteria:

* Known allergy to bupivacaine
* Respiratory failure requiring intubation within 24 hours prior to enrollment
* Known or suspected atrioventricular nodal blockade process requiring cardiology evaluation or pacemaker placement
* Hemodynamic instability (defined as new intravenous vasopressor or inotrope requirement or mean arterial pressure \< 55 mmHg)
* Signs of active myocardial ischemia or non-ST elevation MI
* \> 20 rib fractures
* Weight \< 50 kg or \> 150 kg
* Pregnancy
* Incarceration
Trial Comparing Efficacy of Treatments for Hidradenitis Suppurativa

The purpose of this research study is to further evaluate the efficacy of two treatment regimens for the treatment of hidradenitis suppurativa. This is a randomized controlled study. Patients will be randomly assigned to an arm of the study.

Histological studies suggest that HS is a disease of the follicles with apocrine involvement as a secondary event. The investigators have identified in a previous study that the Nd Yag laser is highly effective for decreasing the inflammation, pain, suppuration and frequency of recurrence of HS. Oral antibiotic therapy with Clindamycin and Rifampin has also been reported in previous studies to be a highly effective treatment regimen for HS and is commonly used by physicians in medical management of HS. The investigators would like to compare the efficacy of NdYag laser treatment combined with antibiotics versus treatment with antibiotics alone. The goal is to evaluate the success of these two treatment regimens on existent HS lesions as well as prevention of recurrence. There will be approximately 18 people in this research study at Henry Ford Health System (HFHS).

Eligibility Criteria:
Inclusion Criteria:

1. Be at least 16 years old and weigh a minimum of 80lbs. Weight requirement is for the purpose of maintaining safe clindamycin and rifampin dosing regimens.
2. Be otherwise healthy
3. Have a diagnosis of HS
4. Patients must have Hurley stage II HS, with one or more widely separated recurrent abscesses, with tract and scarring. Involvement should be bilateral and symmetric on axillae, inguinal regions or inframammary regions
5. Agree to abide by the Investigator's guidelines regarding photosensitizing drugs
6. Be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form
7. Agree to follow and undergo all study-related procedures

Exclusion Criteria:

1. Patients with HS Hurley stage I and III will be excluded from participation in the study
2. Patients who are currently pregnant will not be able to take part in the study due to the unknown effects of antibiotics
3. Concomitant use of systemic or topical treatments for HS not involved in current study. Patients must discontinue all forms of oral therapy as systemic and topical antibiotics and retinoids for 2 weeks prior to the start of any treatment
4. Exacerbation of the patient's original condition expressed clinically by a shift from Hurley Stage II to Stage III
5. Patient is unable to take antibiotic therapy
6. Any reason the investigator feels the patient should not participate in the study
Evaluation of an MRI-compatible Vital Signs Sensor System

This study is to determine the possibility of assessing the level of anxiety in MRI patients by means of the respiration rate (RR) and heart rate (HR) indicators acquired by a fiber-optic sensor system. The mean RR and/or HR values recorded at the beginning and the end of an MRI scanning will be referred to the State Trait Anxiety Inventory (STAI) scores completed before and after the MRI scanning, respectively.

The main purpose of the study is to determine the possibility of assessing the level of anxiety by means of the respiration curve and/or ballistocardiographic (BCG) signal acquired from MRI patients using a fiber-optic sensor system. In many patients, the MRI examination causes enormous stress due to limited space in the scanner, isolation during the examination and high noise levels. Usually, anxiety or stress triggers an increase in respiration rate (RR), leading to hyperventilation in extreme cases. There are also frequent cases of disturbances in heart rate (HR). Thus, the symptoms of claustrophobia can be detected by monitoring respiration activity and heart work.

The fiber-optic sensor system consists of a sensor mat, an interrogator and a personal computer (PC), and records respiratory and BCG signals in patients during MRI. The metal-free sensor mat is placed under the patient's back, does not pose a threat to the patient and has no influence over the quality of imaging. The interrogation module detects the optical signal including vital signs, and the PC with software developed for signal processing and visualization enable the MRI operator to monitor patient's RR and HR.

Up to 200 MRI patients in different age, weight, and gender will be participated in the study. They will be asked to complete the State Trait Anxiety Inventory (STAI) questionnaire in order to estimate anxiety level before and after the MRI scanning. Relations between the STAI X-1 scores and the mean RR and/or HR values recorded at the beginning and the end of the MRI scanning will be analyzed using descriptive statistic methods. The research scheme includes also the collection of the STAI X-2 scores before the MRI scanning. Finally, the values of the physiological parameters, which may indicate a dangerous level of anxiety will be determined. Positive results of the clinical evaluation will predestine the fiber-optic sensor system to be implemented in routine MRI procedures.

Eligibility Criteria:
Inclusion Criteria:

* MRI patients

Exclusion Criteria:

* Same as in MRI procedures
Community Engaged Colon Cancer Screening Patient Navigator Program

The goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in Northern Nevada. A successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention.

The goal of the project is to increase colorectal cancer screening within the priority population of female and male adults age 50 to 85 in Northern Nevada. A successful community-based cancer patient navigator program will be modified in partnership with the community into a multi-level screening intervention. A well-tested behavioral change theory (the health belief model; HBM) will guide the intervention and the relative efficacy of a) the theory's constructs and b) evidence-based intervention practices on increasing screening rates will be examined. Although increased screening rates are associated with program navigators, it is unclear which program components are related to the outcome. In addition, there is ambiguity surrounding a) the temporal impact of the HBM on cancer screening and b) the relationships among the model's constructs. A quasi-experimental time-series design will be used to evaluate the outcome objective of increased screening rates by comparing screening rates one year pre- and post-intervention and whether navigated patients are better prepared for screening than non-navigated patients. A minimum of 315 participants (to correspond with a power level of .80) in the navigator program will be surveyed on knowledge about colorectal cancer, and satisfaction with and usefulness of the program. The anticipated contribution of the project will be to increase community efficacy, colorectal cancer screening in the project area, and to reduce cancer morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Insurance, no history of colon cancer,

Exclusion Criteria:

* No experience of relevant GI symptoms
Hs-CRP and NLR as Markers of Perioperative Stress

The stress response to surgery is a result of tissue injury with local and systemic inflammation that contributes to the postoperative outcome. Anesthesia is known to effect perioperative stress response Regional anesthesia modifies stress response through afferent blockage whereas general anesthesia affects the stress response via central modulation. High sensitive C-reactive protein and neutrophil to lymphocyte ratio are used for evaluation of inflammation. The aim of this study was to document the value hs-CRP and NLR in perioperative stress response in two different anesthesia methods applied to term pregnant women undergoing elective ceserean section (C/S).

The stress response to surgery is a result of tissue injury with local and systemic inflammation that contributes to the postoperative outcome. Anesthesia is known to effect perioperative stress response. Regional anesthesia modifies stress response through afferent blockage whereas general anesthesia affects the stress response via central modulation. High sensitive C-reactive protein and neutrophil to lymphocyte ratio are used for evaluation of inflammation. The degree of systemic inflammation has been determined by numerous pro- and anti-inflammatory cytokines.The cytokines control the release of C -reactive protein (CRP) which is an acute phase reactant produced by the liver. CRP is a widely used marker of inflammation and tissue damage. High sensitive C -reactive protein (hs-CRP), is a more sensitive assay for detection of inflammation measured by particle-enhanced immunonephelometry . A rapid increase in hs-CRP may indicate inflammation and tissue damage . Another well-known indicator of inflammation is neutrophil-to-lymphocyte ratio (NLR). NLR correlates strongly with elevated plasma levels of circulating proinflammatory cytokineS. The aim of this study was to document the value hs-CRP and NLR in perioperative stress response in two different anesthesia methods applied to term pregnant women undergoing elective ceserean section (C/S).

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women without chronic diseases at term (36-41 weeks of pregnancy)

Exclusion Criteria:

* refusal to participate,
* chronic diseases (diabetes mellitus, hypertension, heart disease, renal disease, hypo/hyperthyroidism)
* any infections,
* smoking
* contraindications for central neuraxial anesthesia.
* Pregnancies complicated with rupture of membranes, placenta previa, eclampsia/preeclampsia, and abruptio placenta
* fetal anomalies,
* abnormality detected at fetal well-being tests
Urinary Tract Infection in Pregnancy

* to describe the profile of uropathogenic E coli from Egyptian pregnant women with UTIs and a symptomatic bacteriuria.
* to determine the susceptibility pattern of our local isolated UPEC strains which is essential for optimal management of UTI.
* to evaluate the different virulence genes in UPEC isolates and their association with antibiotic resistance.
* to track common UPEC serogroups.
* to investigate the biofilm formation and the relationship between virulence genes and biofilm formation in UPEC strains isolated from patients.

Urinary tract infection represents the most common bacterial infection in pregnancy and the third common cause of human infection after respiratory and intestinal infections. The infection can be life threatening and associated with serious complications. UTI can be associated with defined symptoms'symptomatic' or without symptoms 'asymptomatic'. Asymptomatic bacteriuria is defined as the presence of \>100000 colony forming units/ml of urine of a single pathogen in two consecutive midstream clean catch urine specimen or on catheterization specimen from an individual without signs or symptoms associated with urinary or genital organs. Asymptomatic bacteriuria can lead to acute pyelonephritis in30%of pregnant women and complications such as early delivery, increase risk of hypertension, pre-eclampsia, low birth weight and postpartum endometritis. Ecoli accounts for most cases of symptomatic and asymptomatic bacteriuria in women, representing70 _90 %of the cases. The important virulence factors of uropathogenic ecoli can be broadly divided into two groups :bacterial cell surface factors and secreted factors. The emergence of drug resistant microorganism among Uropathogenic Escherichia coli strains increases the serious threat to global health. Ecoli often acquired genes coding for antibiotic resistance, beta-lactamase enzymes are the most frequent and play a key role, conferring resistance of bacteria to beta lactam antibiotic group such as penicillin and cephalosporins. Therefore, knowledge regarding local prevalence of uropathogenic ecoli and antimicrobial resistance is essential for optimal management of UTI.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women who diagnosed through clinical examination and urine analysis. 3 groups : group 1 pregnant women with cystitis Group 2 pregnant women with Pyelonephritis Group 3 pregnant women with asymptomatic bacteriuria

Exclusion Criteria:

* pregnant women on antibiotics _Patients with any anatomical abnormalities in the urinary tract
Evaluation of the Effectiveness of Resistance Training in Patients With Psoriatic Arthritis

The aim of this study was to assess the effectiveness of resistance training in improving functional capacity, muscle strength, quality of life and disease activity in patients with PSA.

The IG patients performed resistance exercises for the following muscles group: upper limbs, lower limbs and trunk. It was used a machine "leg extension" for the training on the lower limbs. For upper limbs we used a pulley triceps machine and front pull in addition to free weights (dumbbells).

In order to perform the exercise program the study followed all the recommendations established by the American College of Sports Medicine (ACSM) (Ratamess et al., 2009). It was carried out two exercises for major muscle groups and one exercise for small muscles. The exercises were divided in 3 sets of 12 repetitions for each muscle group. The intensity of the exercises were 60% of one-maximum repetition (1RM).

The exercise program involved pectoral exercises: crucifix and seat supine; biceps: alternated screw; triceps: triceps pulley; back: standing handsaw and pulled ahead; quadriceps: leg extensor and finally gluteo: standing hips extension.

Control Group (CG) The control group was kept in a waiting list while continued with the standard pharmacological treatment during all the study. The patients were instructed to maintain their daily activities and to avoid any other non-pharmacological treatment. The exercise program was offered to the control group in the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of psoriatic arthritis, according to the CASPAR criteria
* Between 18 and 65 years of age, of both genders who agreed and signed the consent form.
* Patients should be-modifying drugs (DMARDs) on stable doses for at least three months and doses of non-steroidal anti-inflammatory drugs and corticosteroids stable for at least 4 weeks

Exclusion Criteria:

Patients were excluded:

* Uncontrolled cardiovascular disease
* Decompensated diabetes mellitus; diseases
* Severe psychiatric
* Fibromyalgia
* Other medical conditions that most disabling EA
* History of regular exercise (at least 30 minutes 2 times per week) during the last 6 months
* Arthroplasties of the hip and / or knee in the last 12 months; AND
* Any other medical condition that prevents the patient from performing resistance exercises