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5,624 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Bone age less than equal to (</=) 9 years (females) or </= 11 years (males) as
determined by X-ray of the left hand and wrist using Greulich and Pyle method and
obtained within the 12 months prior to enrollment
- Prepubertal (Tanner I) males and females by physical examination
- Diagnosis of GHD (stimulated GH less than [<] 10 nanograms per milliliter [ng/mL]) by
two standard pharmacologic tests obtained up to 12 months prior to informed
consent/assent
- Normal thyroid function test within the 12 months prior to informed consent/assent
- Normal complete blood counts within 12 months prior to informed consent/assent
- Documentation of prior height and weight measurements, with height standard deviation
score (SDS) </= 5th percentile for idiopathic isolated GHD participants
Exclusion Criteria:
- Any previous rhGH treatment
- Short stature etiologies other than GHD
- Acute critical illness or uncontrolled chronic illness, which in the opinion of the
investigator and medical monitor, would interfere with participation in this study,
interpretation of the data, or pose a risk to participant safety
- Chronic illnesses such as inflammatory bowel disease, celiac disease, heart disease,
and diabetes
- Bone diseases such as achondroplasia or hypochondroplasia, intracranial tumor,
irradiation, and traumatic brain injury
- Participants receiving oral or inhaled chronic corticosteroid therapy (greater than
[>] 3 months) for other medical conditions other than central adrenal insufficiency
- Participants who require higher (2 times or greater than maintenance) doses of
corticosteroids for more than 5 days in the 6 months prior to enrollment in the study
- Participants with active malignancy or any other condition that the investigator
believes would pose a significant hazard to the participant if rhGH were initiated
- Females with Turner syndrome regardless of their GH status
- Prader-Willi syndrome regardless of GH status
- Born small for gestational age regardless of GH status
- Presence of scoliosis requiring monitoring
- Previous participation in another clinical trial or investigation of GH, treatment for
growth failure, or treatment with a biologic agent
- Participants with closed epiphyses
- Participants with a known hypersensitivity to somatropin, excipients, or diluent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 14 Years | A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency | NCT02311894 | Contradiction |
4,829 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | INCLUSION CRITERIA:
Patients with Cushing syndrome documented at the NIH will be recruited into this protocol
prior to surgery intended to cure Cushing syndrome selectively. Thus, patients undergoing
transsphenoidal exploration for resection of an adenoma, or unilateral adrenalectomy for an
adenoma, or resection of a tumor producing ACTH ectopically will be candidates for this
study. We will also recruit as many of the 500 patients treated since 1983 as possible, so
as to have a group of "late follow-up" patients. These individuals will participate
primarily by questionnaire.
Hematocrit about 30%. A CBC will be obtained prior to entering the study. Patients with
hematocrit above 30% will be accepted into the study; iron replacement will be given to
those patients with low TIBC.
Ages 18 - 85. Children less than 18 are being studied under other protocols and the
questionnaire has not been validated for younger individuals.
For the questionnaire portion of the protocol there is an additional inclusion criterion:
Patients must be able to read and write in English.
EXCLUSION CRITERIA:
There are no formal exclusion criteria, if the patient meets the inclusion criteria above.
All ethnic groups and both genders will be recruited. However, patients may be withdrawn
from the study by the PI if they are unable to meet study requirments, such as mailing
questionnaires.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Long Term Post Operative Follow-Up of Cushing Syndrome | NCT00029952 | Contradiction |
4,452 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- All patients presenting to the WRNMMC orthopaedic hand surgery clinic for complaints
of lateral elbow pain will be evaluated for inclusion in the study. Inclusions
criteria will be:
- Clinical diagnosis of lateral epicondylitis based on primary complaint of lateral
elbow pain and either (a) tenderness over the lateral epicondyle with direct
palpation, or (b) exacerbation of pain at the lateral elbow with resisted dorsiflexion
of the wrist
- Failure of previous trial of non-operative management of at least 4wks duration (to
include rest/light duty, non steroidal anti-inflammatory drugs , physical/occupational
therapy, home stretching regimen)
Exclusion Criteria:
- Age <18yo
- Pregnant or planning to become pregnant during study period (based on verbal
questioning)
- Steroid treatment (oral or injectable) within the previous 3mo
- Diagnosis of ipsilateral compressive neuropathy
- Allergy to Kenalog, lidocaine, or conductive ultrasound gel
- Diagnosis of inflammatory arthropathy or rheumatoid conditions
- Diagnosis of fibromyalgia, chronic fatigue syndrome, complex regional pain syndrome,
or other chronic widespread pain syndromes
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Corticosteroid Injection Verses High Energy Extracorporeal Shock Wave Therapy for Lateral Epicondylitis | NCT02613455 | Contradiction |
2,669 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- All patients fit for general anesthesia and presenting an inguinal hernia.
Exclusion Criteria:
- Not fit for general anesthesia, young age (>21 years), not wanting a mesh.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
| Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results | NCT02561910 | Entailment |
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