cyrilzakka/clinical-trials huggingface dataset:
Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I

Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. Furthermore, patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities. The study investigates the counter regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects.

As patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction and patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities this study investigates the counter-regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects. Patients will perform ergometer training with an individualized intensity and fulfill cognitive function testing (stroop test and fatigue inventories) before and after strenuous activity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Addison's disease and/or diabetes mellitus type I or healthy control with normal adrenal function and normal glucose regulation
* Age ≥ 18 years
* Ability to comply with the study protocol
* Capability to perform spiroergometry

Exclusion Criteria:

* Any contraindication for performing spiroergometry according to the guidelines of the German Cardiac Society:

  * acute myocardial infarction
  * instable angina pectoris
  * symptomatic arrhythmia
  * severe and symptomatic stenosis of the aortic valve
  * decompensated heart failure
  * acute pulmonary embolism
  * Acute myocarditis
  * Acute pericarditis
  * Acute aortic dissection
  * main coronary artery disease
  * valvulopathies
  * electrolyte disturbance
  * arterial hypertension (systolic blood pressure \> 200 mm Hg, diastolic BP \> 110 mm Hg)
  * Tachyarrhythmia or Bradyarrhythmia
  * Hypertrophic cardiomyopathy and other forms of obstructive heart disease
  * second or third degree atrioventricular block
* Fever
* Diabetes mellitus Type 2
* Diseases or medication influencing the endogenous levels of plasma catecholamines(e. g. pheochromocytoma, paraganglioma, antidepressants, levodopa)
* Glucocorticoid-pharmacotherapy
The Effect of Psoriatic Arthritis on the Functions of the Hand

This study was planned to evaluate the effect of psoriatic arthritis on the strength, proprioception, skill, coordination, and functional condition of the hand and to determine the correlate disease activity with these parameters.

Psoriatic arthritis (PsA) is a chronic, progressive, inflammatory arthritis that occurs as a condition associated with patients with psoriasis and may result in permanent joint damage and an increased risk of mortality. Synovial membrane inflammation characterized by increased vascularization and immune cell infiltration is an important feature of psoriatic arthritis. This inflamed synovial microenvironment leads to the formation of synovial pannus, entheseal inflammation, and joint damage. Although PsA is generally thought of as a benign arthropathy, structural damage has been shown with the progression of the disease, along with joint inflammation.As a result of the researches, it has been stated that tissue biomechanical stress and microtraumas that lead to the activation of abnormal natural immune responses in psoriatic arthritis can trigger joint inflammation. In parallel, inflammation is expected to be more common in peripheral joints, which are known to be more exposed to microtrauma. Studies have reported that hand joint involvement is frequently seen in patients with PsA and is an important cause of loss of function and that erosions in hand joints are associated with statistically significant loss of hand strength. Theoretically, either the mechanical effect of the fluid in the acute joint effusion or the components of the inflammatory fluid and the changing capsular compliance after chronic effusion and has been reported that problems may occur in proprioception due to causes such as pain, trauma, and fatigue. However, pain, decreased joint ROM and grip strength, muscle weakness, and hand deformities can affect hand fine hand skills and function. The hypothesis of this study is that supporting the clinical condition of the participants with parameters related to general hand function will be effective in predicting disease progression and disability. Accordingly, the aim of the researchers is to evaluate the effect of PsA on the grip and pinch strength of the hand, proprioception, skill, coordination and functional status, and to determine the relationship of disease activity with these parameters.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-65

Exclusion Criteria:

* Neurological diseases that caused sequelae at hand, upper extremity surgeries, neuropathies, traumas, and history of nerve damage
* Psychiatric disorders,
* Reluctance to continue evaluation
Long-term Survival and Renal Outcomes in Critically Ill Patients After Acute Kidney Injury: Swedish Multi-centre Cohort Study

The study evaluates how outcome varies among critically ill patients with and without acute kidney injury. Data from the Swedish Intensive care register and other Swedish national registers is used to compare how survival and post discharge renal function differ between critically ill patients with and without acute kidney injury.

Background: Acute kidney injury is common amongst intensive care patients and is associated with extremely high mortality and morbidity in terms of increased risk of developing Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD). Patients with CKD are at increased risk of cardiovascular, cerebro-vascular disease and long term increased risk of death. Those patients who progress to ESRD have a 20% mortality risk per year in Sweden. Outcome after acute kidney injury in the Swedish critical care population has never previously been described.

Method: This cohort study uses Swedish national healthcare registers to investigate the epidemiology of acute kidney injury. The Swedish Intensive Care Register (SIR) provides the population base, with data extraction between 2005 and 2011. The information obtained is cross-matched by the Swedish board for health and welfare (Social Styrelsen) with other national registries. All data are returned anonymized and individual patients can not be identified in any way. Additionally analysis is performed on a group and not on an individual basis. The key to this data is held by Swedish board for health and welfare. The other national registries include the Swedish Cause of Death Register (Dödsregister), the Swedish renal register (Svensknjurregistret) and the in and out-patients registers (Öppen- slutenvårdsregister) these are used to obtain data on all cause mortality, co-morbidities, Pre and Post ICU CKD and ESRD. Epidemiological methods are used to analyse the data.

Investigators aim to describe outcome in terms of long-term mortality (up to five years) and renal morbidity (incidence of CKD and ESRD) in critically ill patients with and without de novo AKI in Sweden.

Eligibility Criteria:
Inclusion Criteria:

All first admissions of adult patients registered on the Swedish Intensive Care Register between January 1st 2005 and January 1st 2011.

Exclusion Criteria:

Patients under 18. Subjects with incomplete records. Patients previously diagnosed with Chronic Kidney Disease or End Stage Renal disease.

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Development and Application-Smart Football for Movement Evaluation and Training in the Special Education Population

Children with disabilities are frequently ignored by the general population, hence the development of movement evaluation and training devices for use in special education settings are relatively overlooked. Usually the performance of these children is not stable and contains variations. Hence in order to get a complete picture of their sport performance, simply measuring movement time and distance is definitely not representative. With the rising attention from government regarding fitness and social participation of the disabled in recent years, developing a special-designed individual evaluation \& training plan is of great importance. To achieve this goal, a device which is able to record the complete process of movement, and contains algorithm that can pick up the movement characteristics of children with disabilities is needed. The purpose of this study is to design and develop a smart soccer ball system for use in children with intellectual disabilities(ID), and to compare the performance between children with ID and the typically developed.


Eligibility Criteria:
Inclusion Criteria:

1. Intellectual disabilities (ID) group:

   * children with mild to moderate intellectual disabilities.
   * able to walk independently
   * can follow simple commands
2. Typical developed children:

   * age-matched TD children

Exclusion Criteria:

1. fracture or receive orthopedic surgery within six months.
2. Participate in regular soccer training.
Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure

The goals of this study are to determine the (1) feasibility and (2) acceptability of the study procedures through a pilot randomized controlled trial of a values affirmation intervention targeting medication adherence in adults with heart failure enrolled in cardiac rehabilitation relative to usual care.

Heart failure (HF) represents a significant public health concern. Medication non-adherence is a modifiable contributor to costly hospital readmissions in older adults with HF. Educational interventions improve, but do not eliminate, non-adherence. Values affirmation interventions which invite individuals to reflect on core values may encourage better engagement in health behaviors by increasing the personal relevance of targeted behaviors. This study tests a values-affirmation intervention targeting medication adherence in older adults with HF enrolled in cardiac rehabilitation.

The objective of this study is to examine the feasibility and acceptability of study procedures and the values-affirmation intervention in a pilot randomized controlled trial. Participants will complete a baseline assessment including 30 days of medication monitoring using electronic medication monitoring devices. After the baseline medication monitoring period, participants will be randomly assigned to either the intervention or control condition. Intervention participants will be asked to complete a brief intervention with tailored education relevant to medication information, motivation, and behavioral skills in additional to their usual cardiac rehabilitation care. Control participants will continue with their usual care. Participants will be asked to continue using the medication monitoring devices and to complete a final assessment 30 days later.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure
* Enrolled in cardiac rehabilitation
* Read and understand English

Exclusion Criteria:

* Current participation in another medication-monitoring clinical or research protocol
* New York Heart Association class IV heart failure
* Diagnosis of Alzheimer's, dementia, or severe cognitive impairment indicated on screening
* Current suicidality or psychosis
Managing PPD at Gouverneur

A Stepped Care pathway for managing postpartum depression (PPD) in pediatric primary care settings will be used to (1) understand context for implementation feasibility (2) evaluate benefits for mother and child.

The proposed pilot project will be conducted as part of a quality improvement effort in the Department of Pediatrics at Gouverneur Health Services to improve management of postpartum depression during pediatric primary care visits. This project will test the feasibility of a stepped care approach to identifying and managing depression among mothers of infants (0-6 months). This study will provide preliminary data on the feasibility of the care management protocol, implementation and fidelity measures, and training/consultation methods within a real world pediatric care practice. These data will inform and support the preparation of a large-scale NIH grant.

Specific research questions include:

1. To pilot the feasibility of using a Stepped Care Approach to identify and mange maternal depression within primary care pediatric care visits, with a focus on mothers of infants 0-6 months.

   1. Train non specialty MH providers to systematically identify maternal depression.
   2. Assess how effective integration of maternal depression intervention is as part of well baby visits.
2. To o examine the impact of STRONG, a brief 3-session IPT-based preventive intervention, on maternal and child health outcomes (e.g., maternal depression symptoms, child receipt of acute care services). Secondary outcomes include maternal social support and parenting practices.


Eligibility Criteria:
Inclusion Criteria for Subjects

* PHQ-9 scores in the 10-19 range
* Women with infants 6 months and younger at time of screening

Inclusion Criteria for Providers

Exclusion Criteria:

* Active substance use
* Current treatment for depression
* Current/past history of schizophrenia, bipolar or other psychotic disorder;
* Suicidal/Homicidal risks;
* Women with difficulties speaking or understanding English;
* Women under the age of 18.
An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.


Eligibility Criteria:
Key Inclusion Criteria:

* Completion of the GWEP1521 Blinded Phase
Efficacy of Ultrasound Guided Superficial Cervical Plexus Block for Tracheal Reconstruction Surgery:

The essential goal for tracheal reconstruction is is the ability of the anaesthesiologist and surgeon to maintain control of the airway at all times. In the postoperative period the patient should maintain a flexed neck position to avoid any traction on the tracheal anastomosis. Thus, pain control is essential postoperatively so that patients will be awake and cooperative to maintain this position. \[1\].

Superficial cervical plexus block can be used in a variety of surgical procedures , including superficial surgery on the neck and shoulders and thyroid surgery as it results in anesthesia of the skin of the anterolateral neck and the ante-auricular and retro-auricular areas, as well as the skin overlying and immediately inferior to the clavicle on the chest wall Figures 1 and 6)\[2\].

Thus it can be used as an adjuvant to general anaesthesia to provide analgesia for patients undergoing tracheal resection and anastomosis to keep the patients awake and cooperative at the conclusion of the procedure.

The goal of the ultrasound (US)-guided technique of SCB is to deposit local anesthetic within the vicinity of the sensory branches of the nerve roots C2, C3, and C4 which combine to form the four terminal branches (the lesser occipital, greater auricular, transverse cervical, and supraclavicular nerves) and emerge from behind the posterior border of the SCM. Advantages over the landmark-based technique include the ability to visualize the spread of local anesthetic in the correct plane, which therefore increases the success rate, and to avoid a needle insertion that is too deep and the inadvertent puncture of neighboring structures\[3\].

Aim of the work To assess the efficiency of using ultrasound-guided SCB for providing intra and postoperative analgesia for patients undergoing tracheal resection and anastomosis under general anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

• ASA physical status I, II, and III adult patients undergoing elective tracheal resection and anastomosis under general anaesthesia were included.

Exclusion Criteria:

* Coagulation disorders
* Pregnancy.
* Age less than 18 years.
* Patient refusal.
* Emergency re-operation within
CVD Risk Factors and Sexual Identity in Women

To examine potential differences in the prevalence and pattern of risk factors for coronary heart disease in a sample of 500 self-identified lesbians and 500 heterosexual women, matched for age, socioeconomic status, and ethnicity.

BACKGROUND:

Coronary heart disease (CHD) is the leading cause of mortality among women living in the United States, regardless of race and ethnicity and is likely the leading cause of mortality among lesbians. However, in various reports since 1994, the National Institute of Mental Health, the Centers for Disease Control and Prevention, the American Medical Association, the American Public Health Association, and the Institute of Medicine (IOM) have pointed out that health care and health research affecting lesbian women are inadequate. As women, lesbians share many of the same health concerns of all women. However, as emphasized in the IOM Report on Lesbian Health "factors assumed to place women at risk for or to protect them against health disorders may not be present at the same levels or operate in the same way for lesbians". The IOM report also recognizes that "women who self-identify as lesbian may also experience stressors not commonly faced by heterosexual women" and that "it is important to understand the factors that are unique to lesbians and their impact on lesbians' health". Data which do exist from household surveys and studies utilizing convenience samples indicate that women who identify as lesbian may differ from heterosexual women in several important factors which contribute to the development of CHD. However, to date there has not been a comprehensive examination of CHD risk in a large sample of women who identify as lesbian or an examination of how their pattern of risk factors or overall risk for CHD may differ from a sample of demographically similar heterosexual women.

DESIGN NARRATIVE:

The study is a case-control, cross-sectional survey that includes both behavior (alcohol, smoking, substance use, physical activity) and physiological (lipids, blood pressure, adiposity) measures. Self-identified lesbian women will be age, education, and racially matched to heterosexual women. The study will test the hypotheses that the prevalence and pattern of coronary heart disease (CHD) risk factors are different between lesbians and heterosexual women. The study will also determine the absolute and relative risk estimates for CHD based on the Framingham multiple-risk-factor assessment equations, and test the hypothesis that lesbians are at increased risk of CHD compared to heterosexual women.

Eligibility Criteria:
Over 35 Years old no cvd
Pediatric Ventilatory Care in Finland 2010

This observational study includes questionnaires send to doctors in all units treating pediatric patients with mechanical ventilation in Finland. Additionally all units treating pediatric patients with mechanical ventilation are invited to perform a quality control-like follow up for 3 months. Patient identity data is not collected, and no interventions to treatment are made.


Eligibility Criteria:
Inclusion Criteria:

* Age under 16 years
* Mechanical ventilation during the follow up period
Smell Changes & Efficacy of Nasal Theophylline

This study evaluates the efficacy and safety of nasal theophylline irrigation in treating smell loss related to a viral respiratory infection. Half the participants will undergo nasal theophylline irrigation treatment while the other half will undergo placebo nasal irrigation with saline alone. All participants will have their sense of smell tested before and after 6 weeks of treatment. All participants will also be regularly asked about any potential side effects related to treatment. In addition, the first 10 participants will have their blood drawn to measure their theophylline level after 1 week of starting treatment to ensure it is not abnormally elevated.


Eligibility Criteria:
Inclusion Criteria:

* Subjective or clinically diagnosed olfactory dysfunction of 6 months to 36 months duration after a presumed viral upper respiratory infection
* Ability to read, write, and understand English

Exclusion Criteria:

* Dependence on theophylline for comorbid conditions such as asthma and chronic obstructive pulmonary disease
* History of an allergic reaction to theophylline or other methylxanthines
* Prior sinonasal or anterior skull base surgery
* Nasal polyposis
* History of neurodegenerative disease (ie. Alzheimer's dementia, Parkinson's disease, Lewy body dementia, frontotemporal dementia)
* Pregnant or breastfeeding mothers
* Current use of medications with significant (≥40%) interactions with theophylline, which include cimetidine, ciprofloxacin, disulfiram, enoxacin, fluvoxamine, interferon-alpha, lithium, mexiletine, phenytoin, propafenone, propranolol, tacrine, thiabendazole, ticlopidine, and troleandomycin
Histology of SMA-001 in the Abdomen

Silk Medical Aesthetics' Inc. device, SMA-001, is currently under development as a dermal filler to fill wrinkles and folds. This study is designed to collect short-term visual, photographic, and histological and safety data on small aliquots of the product as part of device development. It is an open label study involving up to three investigational sites and a maximum enrollment of 10 subjects. Juvéderm Ultra Plus XC, an FDA-approved dermal filler will serve as a control device. Briefly, the investigational product and the control device will be injected into the abdomen of patients intending to undergo abdominoplasty at a later date. The patients will be followed for 30 days post injection through visual observation. At 30 days post injection, the injected gel and associated tissue will be removed via biopsy during the abdominoplasty surgery and histology slides created for analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Female, 25-65 years of age
2. Abdominoplasty patients with sufficient skin quality (dermal thickness \& integrity, limited stretch marks/attenuated skin)
3. Able to follow study instructions and likely to complete all required visits, as assessed by the PI
4. Signed the IRB-approved Informed Consent form and the HIPAA form prior to performance of any study-related procedures

Exclusion Criteria:

1. Subjects with intrinsic skin disease or documented dermatologic conditions
2. Subjects with known bleeding disorders or on medications that may interfere with bleeding
3. Subjects currently taking immunosuppressive drugs, steroids, or anti-inflammatories
4. Subjects receiving injection of lipolytic drugs
5. Subjects with a history of keloid formation or hypertrophic scarring
6. Subjects with documented Type I or II Diabetes Mellitus.
7. Inability or unwillingness of the subject to complete the clinical protocol as described in the protocol and allow access to clinical records.
8. Subjects who are known to be pregnant at the time of enrollment or plan to become pregnant in the coming 30 days.
9. Subjects with documented active drug or alcohol abuse within the last 12 months prior to the study.
10. Subjects with systemic collagen disorders, such as Ehlers Danlos.
11. Subjects with known allergies to hyaluronic acid, silk, lidocaine, and/or Polyethylene Glycol.