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Active clinical trials for "Adrenal Insufficiency"

Results 31-40 of 114

Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia

Adrenal InsufficiencyExcess Androgen1 more

Background: Congenital adrenal hyperplasia (CAH) is a genetic disorder of the adrenal gland. The adrenal gland is located in the abdomen and produces small amounts of hormones such as cortisol, aldosterone, and androgen. These hormones help control blood pressure, protect the body, and maintain good health, especially during development. People with CAH do not make enough cortisol and aldosterone, and make too much androgen. This can lead to serious medical problems. The standard treatment is to take pills that mimic the effects of cortisol and aldosterone. However, treatment with pills can have long-term side effects because of the higher doses needed, and may not work well for some people. A possible new treatment for CAH is to use a pump to deliver cortisol under the skin. Similar pumps are often used to give insulin to people with diabetes. Researchers think that a cortisol pump might be able to help the body use the cortisol more effectively than taking pills. They want to compare the results of a cortisol pump and standard pill treatments for CAH. Objectives: - To compare the effectiveness of a cortisol pump with standard cortisol pill therapy for CAH. Eligibility: - Men and women at least 18 years of age who have CAH (see more details in Eligibility section below). Design: This study will involve four inpatient hospital stays at the National Institutes of Health in Bethesda, MD over 6 months (spaced 2 months apart). The first and last stays will last about 5 days. The second and third stays will last about 3 days. Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. At the first study visit, participants will provide regular blood and urine samples. They will also have imaging studies. These studies will look at the bones, fat, and muscles in the abdomen and pelvis. Participants will receive a cortisol pump during the first visit. They will be shown how to use the pump. They will also learn what to do, if they need to take extra "stress dose" cortisol pills. At the second and third visits, the cortisol dose given with the pump will be adjusted as needed. Blood and urine samples will also be collected. No imaging studies are scheduled for these visits. The last study visit will have the same tests as the first visit. Participants will be offered the chance to continue with the pump treatment for 1 more year, or go back to their standard pill treatment. Study type: Interventional non-randomized trial Official title: A Pilot Study Assessing the use of Continuous Subcutaneous Hydrocortisone Infusion In the Treatment of Congenital Adrenal Hyperplasia Estimated enrollment: 8 Study Start Date: May 2013 Estimated Study Completion Date: December 2016 Sponsoring Institute: National Institute of Child Health and Human Development <TAB>ELIGIBILITY Inclusion criteria Men and women 18 years of age or older with classic congenital adrenal hyperplasia (21-Hydroxylase deficiency) High adrenal androgens in the blood, and One or more of the following conditions: obesity, fatty liver, risk for diabetes, low bone mass, inability to tolerate cortisol pills Exclusion criteria Pregnancy Breast feeding Use of inhaled or oral steroids for diseases other than CAH Use of estrogen-containing birth control pills Use of medicines that cross-react with hydrocortisone Use of stress dose steroids for illness during the last 30 days prior to joining the study

Completed18 enrollment criteria

Evaluation of Efficacy and Hypothalamus-pituitary-adrenal Axis Suppression Due to Corticosteroids...

TendinopathyAdrenal Insufficiency

The purpose of this study is to compare the efficacy and effects on the hypothalamus-pituitary-adrenal axis of a single intrabursal injection of two different types of corticosteroids (methylprednisolone and triamcinolone) in patients with calcific shoulder tendinopathy.

Completed10 enrollment criteria

Extension Study for Patients Entered Into Study Infacort 003

Adrenal Insufficiency

A Phase 3, open-label, single-group, non-randomised, observational study of the safety and biochemical disease control of Infacort® in neonates, infants and children with adrenal insufficiency and congenital adrenal hyperplasia who had completed study Infacort 003. All subjects who had satisfactorily completed study Infacort 003 were offered the opportunity to take part in Infacort 004.

Completed11 enrollment criteria

Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency

Adrenal Insufficiency

This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency

Completed10 enrollment criteria

Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

Central Adrenal InsufficiencyMifepristone

The researchers propose the use of mifepristone as an alternative way to test for Central Adrenal Insufficiency (CAI). They want to assess the feasibility of recruitment and the efficacy of the purposed method.

Terminated10 enrollment criteria

Treatment of Adrenal Insufficiency in Children

Adrenal Insufficiency

The study will be conducted in a total of 24 subjects before their 6th birthday, requiring replacement therapy for adrenal insufficiency due to either CAH, primary adrenal failure or hypopituitarism. The study will consist of three consecutive cohorts. Cohort 1 will include 12 subjects aged between 2 and < 6 years. If no safety concerns emerge, then 6 subjects aged 28 days to <2 years will be enrolled (Cohort 2). A review of accumulated data will be undertaken and only if again no safety concerns emerge, then 6 neonates aged from birth to <28 days will be enrolled (Cohort 3). The decision to continue after each cohort will be based on the recommendation of an Independent Data Monitoring Committee (IDMC).

Completed12 enrollment criteria

Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism...

Primary Adrenal InsufficiencySecondary Adrenal Insufficiency

This is a randomized, controlled, open, three-armed, multi-centre study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile, cardiovascular system, bone mass and quality of life in patients affected by primary or secondary adrenal insufficiency.

Completed6 enrollment criteria

Corticosteroid Therapy for Glucocorticoid Insufficiency Related to Traumatic Brain Injury

Traumatic Brain InjuryTrauma2 more

Traumatic brained injured (TBI) patients frequently suffered from glucocorticoid insufficiency that is associated with a raise in the rate of pneumonia. In a placebo-controlled, multi-center, double-blinded trial, treatment of glucocorticoid insufficiency (hydrocortisone associated with fludrocortisone) will be assessed for prevention of post trauma pneumonia in a population of severe TBI patients.

Completed7 enrollment criteria

Dehydroepiandrosterone Substitution in Adolescent and Young Women With Central Adrenal Insufficiency...

Adrenal Insufficiency

30 adolescent girls and young women between 13 and 26 years with central adrenal insufficiency and a grand shortage of DHEA are recruit. The clinical trial is double-blind to show that the substitution of the hormone DHEA stimulates secondary hair growth, enhances well being and mood of the patients. It should also normalize the serum content of DHEA, aldosterone and testosterone.

Completed16 enrollment criteria

Salivary Cortisol Measurement in Corticotrope Deficiency Substitution With Hydrocortisone.

Adrenal Insufficiency

Patients with adrenal insufficiency are most often overdosed with hydrocortisone. To date, there is no reliable marker that can reflect the quality of hydrocortisone substitution. Salivary cortisol is a good reflection of free plasmatic cortisol. However, salivary contamination with the oral intake of hydrocortisone has been described. The aims of the study are to: evaluate the frequency of salivary contamination by hydrocortisone taken in tablet form and determine its risk factors. evaluate the quality of hydrocortisone substitution in patients with corticotrope deficiency.

Completed12 enrollment criteria
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