Growth Hormone Deficiency
Explore growth hormone deficiency research studies. Find trials aligned with HIPAA and IRB standards.
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Found 124 Actively Recruiting clinical trials
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Healthy Volunteer
This study consists of two parts: the first part is the study in healthy volunteers, and the second part is the study in AGHD patients. The first part consists of two phases. Phase Ia is a single-ascending dose study in healthy male volunteers, and Phase Ib is a multiple-ascending dose study healthy male or female volunteers. The second part is Phase Ic,which is a a single-ascending dose study in AGHD patients. Phase Ia:GenSci134 was tested in 7 predetermined single dose groups with placebo and positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 64 healthy adult male volunteers. Phase Ib:GenSci134 was tested in 3 predetermined multiple dose groups with placebo, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity in 36 healthy adult volunteers. Phase Ic :GenSci134 was tested in 2 predetermined dose groups with positive drug controls to explore the dosage, and to assess its safety, tolerability, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, immunogenicity, and exploratory endpoints in 16 AGHD patients.
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Healthy Volunteer
The primary objective of this clinical study is to characterize in Chinese toddlers ages 32 - 42 months old the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, and to assess a range of executive functions (inhibit, shift, emotional control, working memory, plan/organize) using the Global Executive Composite summary score obtained from the BRIEF-P standardized rating scale.
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Following a minimum 6 month observational period in which baseline growth is assessed, participants in the vosoritide and placebo groups will complete a minimum of 6 months of randomized treatment (maximum of 6 months of placebo treatment), followed by open-label treatment with vosoritide until they reach near-final adult height, or at least 16 years of age for females or 18 years of age for males, whichever comes later. Participants randomized to the hGH group will receive open-label hGH for a minimum of 4 years.
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The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.
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Subjects: SGA children from 6 months to 2 years old who meet the enrollment conditions shall be informed of the enrollment by the researcher and the subject's guardian, and the subject's guardian shall decide to participate in the test drug group or the control group. GH treatment group (n = 68): the subjects were given PEG-rhGH injection 0.2 mg / kg / week (initial dose), once a week, subcutaneously before going to bed for 104 weeks. Each follow-up, the researchers adjusted the dosage according to the IGF-1 results of the center and other individual conditions. Control group (n = 68): no treatment, only follow-up examination and growth and development related evaluation, and the follow-up time was 104 Week.
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Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.
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The purpose of this study is to learn about the safety of Somatrogon for the treatment of pediatric growth hormone deficiency (p GHD) in India. Pediatric GHD is a condition caused by too less amounts of growth hormone in the body. Children with GHD have a short height. GHD can be present at birth or develop later. The condition occurs if the pituitary gland makes too little growth hormone. This is a small gland at the bottom of the brain that releases hormones that affect growth and other body functions. This study is seeking for participants who are: * confirmed with p GHD. * given Somatrogon to be taken as an injection. The safety of Somatrogon injection will be checked based on side effects. These side effects can happen within 3 years after taking Somatrogon. A side effect is something (expected or unexpected) that you feel was caused by a medicine or treatment you take. The study doctor will collect side effect information and put the information on patient's case form. Follow-up of the patient's will be performed via clinic re-visit or over a call. It is not a rule for the participants to visit the clinic in this study. This study will help to see if Somatrogon is safe.
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Researchers are looking for a better way to treat children who have chronic kidney disease (CKD), which is long-term kidney disease, and proteinuria, a condition in which a person´s kidneys leak protein into the urine. The kidneys filter waste and fluid from the blood to form urine. In children with CKD, the kidney´s filters do not work as well as they should. This can lead to accumulation of waste and fluid in the body and proteinuria. CKD can lead to other medical problems, such as high blood pressure, also known as hypertension. Vice versa, hypertension and proteinuria can also contribute to worsening of CKD. Therefore, the treatment of CKD aims to control blood pressure and proteinuria. There are treatments available for doctors to prescribe to children with CKD and hypertension and/or proteinuria. These include "angiotensin-converting enzyme inhibitors" (ACEI) and "angiotensin receptor blockers" (ARB). Both ACEI and ARB can help improve kidney function by reducing the activity of the renin-angiotensin-aldosterone system (RAAS). The RAAS is a system that works with the kidneys to control blood pressure and the balance of fluid and electrolytes in the blood. In people with CKD, the RAAS is often too active, which can impair the ability of the kidneys to work properly and cause hypertension and proteinuria. However, ACEI or ARB treatment alone does not work for all patients with CKD as they only target the angiotensin part of the renin-angiotensin-aldosterone system. The study treatment, finerenone, is expected to help control RAAS overactivation together with an ACEI or ARB. So, the researchers in this study want to learn more about whether finerenone given in addition to either an ACEI or ARB can help their kidney function. The main purpose of this study is to learn how safe the treatment is when used of finerenone in addition to an ACEI or ARB in long-term. To see how safe the treatment is, the study team will collect information on medical problems which are also known as "treatment emergent adverse events" (TEAEs). And they will also collect levels of an electrolyte called potassium in the blood by taking blood samples, and measure blood pressure during the study. The secondary purpose of this study is to learn how well long-term use of finerenone can reduce the amount of protein in the participants' urine and benefit kidney function when taken with standard of care. To see how the treatment works, the study team will collect participants' urine samples to assess urinary albumin-to-creatinine ratio (UACR) and urinary protein-to-creatinine ratio (UPCR), which are important assessments for calculating the level of protein in the urine. Researchers will also collect blood samples to analyze serum creatinine and calculate estimated glomerular filtration rate (eGFR). A significant decline in eGFR indicates worsening kidney function. The study will include participants who had previously participated in FIONA study (NCT05196035). The participants will be aged from 1 year up to 18 years. The participants will be in the study for approximately 19 months. They will take study treatment for up to 18 months and will be follow up for 1 month. During this period, at least 12 visits are planned for patients who newly start finerenone, and at least 8 visits for patients who already received finerenone. In the visit, the study team will: * have their blood pressure, heart rate, temperature, height and weight measured * have blood and urine samples taken * have physical examinations * have their heart examined by an electrocardiogram and echocardiography (a sonogram of the heart) * answer questions about their medication and whether they have any adverse events, or have their parents or guardian's answer * answer questions about how they are feeling, or have their parents or guardian's answer * answer question about how they like the study medication, or have their parents or guardian's answer The doctors will keep track of any adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health about 30 days after the participants take their last treatment.
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Pituitary tumors represent a heterogeneous group of neoplasms by histotype. The pituitary adenomas are the most frequent heteroformation, among those affecting the pituitary gland, followed by meningiomas, craniopharyngiomas, germosomes and tumours secondary, such as metastases and lymphomas. Since these conditions are considered rare, the data epidemiology and prognosis to predict the natural history of these diseases can not be considered conclusive. Pituitary adenomas are a useful model for epidemiology in the study of pathology pituitary. Over the past 20 years, several attempts have been made to identify unique prognostic factors, which predict the outcome of these pathologies, but without To arrive at a definitive classification. The purpose of this study aims to collect clinical, biochemical, morphological and pathological data on the retrospective and prospective cohort of over 1600 patients undergoing neurosurgical removal of pituitary tumors in the last 20 years, to develop a prognostic classification.
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Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.
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