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Adrenal Mass

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3421. Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Histologically* confirmed follicular non-Hodgkin lymphoma (NHL) Previously untreated disease WHO classification grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II disease NOTE: *Bone marrow biopsies as the sole means (...) of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine-needle aspirates are not acceptable for diagnosis Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry Measurable disease by physical examination or imaging studies Any tumor mass > 1 cm is acceptable No nonmeasurable disease only, including any of the following: Bone lesions Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Bone marrow (involvement by NHL should

2007 Clinical Trials

3422. AS900672-Enriched in Ovulation Induction

Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Oligo-anovulation defined by a menstrual period of 35 days to 6 months Spontaneous menses or a positive response to progestin within the prior 6 months or response to clomiphene citrate evidenced by ovulation within the prior 6 months Age between 18 and 36 years, inclusive, at time of informed consent signature Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m^2), inclusive No clinically significant (...) or requiring treatment Ovarian cyst with a mean diameter of >25 mm on the day of randomization History or suspicion of ovarian, uterine or mammary cancer Adrenal congenital hyperplasia, partial or complete enzymatic block Use of metformin or other insulin sensitizing agents related to infertility within the prior 2 months Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds that are structurally similar to any of the other medications administered during the trial Any

2007 Clinical Trials

3423. Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Followed by Radiation Therapy and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

Leptomeningeal disease Ascites Pleural or pericardial effusion Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a previously irradiated area Patients must be considered unresectable or inoperable AND be deemed candidates for combined modality therapy by a medical oncologist and a radiation oncologist Considered to be poor-risk with NCI CTC performance status (PS) 2 OR PS 0-1 and ≥ 10% weight loss within the past 3 months Patients with tumors (...) radiotherapy No concurrent hormones or other chemotherapeutic agents except steroids given for adrenal failure, hormones administered for non-disease-related conditions (e.g., insulin for diabetes), and intermittent use of dexamethasone as an antiemetic No concurrent palliative radiotherapy Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided

2007 Clinical Trials

3424. Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

autonomic failure in type 1 diabetic volunteers. Condition or disease Intervention/treatment Phase Type 1 Diabetes Drug: Dehydroepiandrosterone Drug: Placebo Early Phase 1 Detailed Description: DHEA is the acronym for dehydroepiandrosterone, a steroid hormone produced naturally from cholesterol in the adrenal glands of males and females. It is also sold as an over-the-counter dietary supplement, and seems to have anticorticosteroid effects. DHEA antagonizes the effects of corticosterone on hippocampal (...) Criteria Inclusion Criteria: 28 (14 males, 14 females) Healthy volunteers aged 18-45 yr. 28 (14 males, 14 females) Type 1 diabetic patients aged 18-45 yr. HbA1c < 11.0% Has been diagnosed Type 1 DM No major diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc) Body mass index < 40kg/m-2 Exclusion Criteria: - pregnancy Medical history- Hepatic Failure/Jaundice Renal Failure Acute Cerebrovascular/ Neurological deficit Physical Exam- Pneumonia Fever greater than 38.0

2008 Clinical Trials

3425. An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAjectâ„¢ and Regular Human Insulin in Patients With Type 1 Diabetes Mellitus

, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Male or female patients with type 1 diabetes must present with the following: Established diagnosis of type 1 diabetes for more than 1 year. HbA1c values of not more than 10.5%. Three months on a stable insulin regimen that meets the current standard of care and that includes at least two daily insulin injections. Age: 18 to 70 years. Body Mass Index: 18 - 38 Kg/m2. Exclusion Criteria: Patients (...) of the patient in the study to be inappropriate or unsafe. Current significant diseases of the adrenal gland, pituitary gland or thyroid at the discretion of the investigator. Glomerular Filtration Rate < 40 ml/min. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number

2007 Clinical Trials

3426. An Open Label, Multi-Center, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Insulin VIAjectâ„¢ and Regular Human Insulin in Patients With Type 2 Diabetes Mellitus

insulin regimen that meets the current standard of care. Age: 30 to 70 years. Body Mass Index: Not more than 45 Kg/m2. Exclusion Criteria: Patients presenting with any of the following will not be included in the study: Type 1 diabetes mellitus as determined by the investigator. Patients being treated with a thiazolidinedione for less than 3 months. History of frequent severe hypoglycemia within the prior six months. History of known hypersensitivity to any of the components in the study medication (...) , in the opinion of the investigator, render the participation of the patient in the study to be inappropriate or unsafe. Current significant diseases of the adrenal gland, pituitary gland or thyroid at the discretion of the investigator. Glomerular Filtration Rate < 40 ml/min. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer

2007 Clinical Trials

3427. Behavioral Insomnia Therapy With Chronic Fatigue Syndrome

neurologic diseases (e.g., multiple sclerosis, neuromuscular diseases, epilepsy or other diseases requiring ongoing medication that could cause fatigue, stroke, head injury with residual neurologic deficits) diseases requiring systemic treatment (e.g., organ or bone marrow transplantation, systemic chemotherapy, radiation of brain, thorax, abdomen, or pelvis) untreated major endocrine diseases (e.g., hypopituitarism, adrenal insufficiency) being on medications with known fatigue side effects (...) ) terminal conditions severe obesity as defined as a body mass index (weight in kilograms/height in meters)2 > 40 elective surgery planned during the trial We will exclude those who meet DSM-IV criteria currently or in the past 5 years for psychotic or melancholic Major Depression, bipolar disorders, schizophrenia, or eating disorders, alcohol or substance abuse or dependence (e.g., dependence on benzodiazepines or any other substance) We will exclude those meeting criteria for Narcolepsy, Restless Legs

2007 Clinical Trials

3428. Menopur&#174; Versus Follistim&#174; in Polycystic Ovarian Syndrome (PCOS)

Years (Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Pre-menopausal females between the ages of 18 and 42 years Diagnosed with polycystic ovary syndrome (PCOS), using criteria adopted as the 2003 Rotterdam PCOS Consensus (2 out of 3, excluding other etiologies [congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome]) Oligo- or anovulation Clinical and/or biochemical signs of hyperandrogenism Polycystic ovaries Body mass (...) for assisted reproductive technology (ART) with respect to uterus and adnexa Signed informed consent Exclusion Criteria: Gestational or surrogate carrier, donor oocyte Presence of any clinically relevant systemic disease (e.g., uncontrolled thyroid or adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, insulin-dependent diabetes mellitus, uterine cancer) Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption

2008 Clinical Trials

3429. Does Bone Structure Explain the Increased Fracture Risk in Type II Diabetes Patients? A Pilot Study

that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin Body mass index (BMI) of 19-35 Able to move without walkers and without a history of long periods (>3 months) of inactivity Additional Inclusion criteria for fracture participants: Fractures of the proximal humerus and femur as well as the ankle and foot should have occurred after the onset of diabetes and should have been caused by a low energy trauma such as falling from standing height. All fractures (...) with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of Vitamin A supplements 6 months prior Diabetic patients on rosiglitazone or pioglitazone medications high energy trauma, e.g., due to motor vehicle accidents Pathological fractures of other origin, i.e., tumor, tumor-like lesions as well as focal demineralization visualized on radiographs History of fluoride, bisphosphonate, calcitonin or tamoxifen use History of unstable cardiovascular disease

2008 Clinical Trials

3430. Metformin and Lifestyle Intervention in Women With Polycystic Ovary Syndrome

: D.B.I. 500 mg. 1 1/2 tables BID Placebo Comparator: Placebo Every patient will be given diet and exercise counseling in both arms. Intervention arm will receive metformin Drug: Placebo Diet counseling and exercise Outcome Measures Go to Primary Outcome Measures : Body mass index,Normalization of menses,Pregnancy,Hirsutism,Waist to hip ratio, Testosterone, Androstenedione, DHEAS,Progesterone, FSH, LH,Glucose, OGTT,Insulinemia,Total HDL and LDL Cholesterol, Triglycerides,Uric acid, Prostate specific (...) ) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Women in reproductive age With polycystic ovary syndrome defined by hyperandrogenism (elevated serum testosterone concentrations), and oligomenorrhea (cycles of 35 days or longer), or amenorrhea (no menses in the last 6 months) after negative screening pregnancy test Exclusion Criteria: Pregnancy Cushing' s syndrome Late onset congenital adrenal hyperplasia Androgen-secreting tumors Uncontrolled thyroid

2008 Clinical Trials

3431. Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

) with low serum estradiol (<20 pg/ml). The lumbar vertebral BMD T-score is between -1and -2.5 SD. The body mass index (BMI) is between 19 and 29 kg/m2. Completed informed consent and signed informed consent form. Exclusion Criteria: Have diseases which may affect bone metabolism, e. g., hyper-or hypocalcemia, hyperthyroidism, osteogenesis imperfecta, malignancy, chronic gastrointestinal disease, extensive Paget's disease, alcoholism, and renal or hepatic impairment. Has taken drug therapy (...) for osteoporosis within the previous six months (excluding calcium supplements) prior to this study. Chronic or continued use of hormone replacement drugs or medications that may affect bone calcium metabolism, for example, phosphate-binding antacids, many diuretics, adrenal or anabolic steroids, heparin, anticonvulsants, fluoride in excess of 1 mg/day and supplements of vitamin D or A in excess of RDAs. Vitamin D deficiency (1, 25-dihydroxyvitamin D is lower than the normal range of: 25.1 pg/mL ~ 66.1 pg/mL

2008 Clinical Trials

3432. Prevention of Obesity in Women Via Estradiol Regulation

-pituitary-adrenal (HPA)axis activity will be amplified during sex hormone suppression; altered HPA axis activity leading to cortisol excess causes abdominal fat accumulation. Finally, it is hypothesized that E2 add-back therapy will lessen these responses. Participants will be randomized so that half of the women in each treatment arm will participate in an exercise training program, consisting of progressive resistance exercise to prevent the decline in fat-free mass (FFM) and the increase in fat mass (...) of learning the mechanisms by which E2 influences energy balance and fat patterning. This study uses gonadotropin releasing hormone (GnRH) analog therapy to determine the effects of chronic (5-month) sex hormone suppression on resting energy expenditure (REE), altered hypothalamic-pituitary-adrenal (HPA) axis activity, and fat gain. It is hypothesized that REE will be reduced in response to chronic sex hormone suppression, promoting fat gain. It is also hypothesized that stress-induced hypothalamic

2008 Clinical Trials

3433. Insulin Resistance, Polycystic Ovary Syndrome, and Bone Research Study

syndrome (PCOS). Condition or disease Intervention/treatment Phase Polycystic Ovary Syndrome Drug: rosiglitazone Drug: drospirenone/ethinyl estradiol Phase 4 Detailed Description: The purpose of this study is to: 1) to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover. OCPs are the first-line therapy (...) . [ Time Frame: Baseline and 6 months ] Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria. Secondary Outcome Measures : Total Fat Mass at Baseline and 6 Months [ Time Frame: Baseline and 6 months ] DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass. Total Testosterone at Baseline and 6 Months [ Time Frame: Baseline and 6 months ] Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass

2008 Clinical Trials

3434. Rituximab, Cladribine, and Temsirolimus in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

disease, defined as at least one of the following: A lymph node or tumor mass that is >= 2.0 cm in at least one dimension by positron emission tomography (PET)/computed tomography (CT), CT, magnetic resonance imaging (MRI), or plain radiograph imaging Splenic enlargement may be used as a measurable parameter if the spleen is palpable >= 3 cm below the left costal margin Diffuse infiltration of an organ such as the stomach, bone marrow, peripheral blood, liver, lungs, or bowel by lymphoma without (...) a discrete mass would constitute assessable, but not measurable, disease Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3 Life expectancy >= 12 weeks Absolute neutrophil count (ANC) >= 1,500/mm³ Platelet count (PLT) >= 100,000/mm³ Serum creatinine =< 2.0 mg/dL Serum total bilirubin (or direct bilirubin if total is abnormal) =< institutional upper limit of normal (ULN) with or without secondary liver involvement Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x

2008 Clinical Trials

3435. Effects of Fludrocortisone and Hydrocortisone in Healthy Volunteers With Aldosterone Induced Suppression

Posted : March 2, 2012 Sponsor: Rennes University Hospital Information provided by (Responsible Party): Rennes University Hospital Study Details Study Description Go to Brief Summary: Septic shock (associated with relative adrenal insufficiency) is characterized by decreased arterial responsiveness to catecholamines. The association of hydrocortisone and fludrocortisone has demonstrated an improvement in survival in septic shock patients. If hydrocortisone has shown to increase vascular (...) for eligibility information Ages Eligible for Study: 20 Years to 30 Years (Adult) Sexes Eligible for Study: Male Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Men between 20 and 30 years Body Mass Index between 18 kg/m² and 25 kg/m² Normal clinical examination Normal biological variables Normal electrocardiogram and echocardiography Written, voluntary informed consent Non smoker since at least a year Non-inclusion Criteria: Any history of significant allergy Subjects with abnormal renal

2008 Clinical Trials

3436. Pilot Study:Role of Dietary Fiber in PCOS Anovulation

, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 45 Years (Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Women with PCOS between the ages of 18-45 years and with a body mass index of less than or equal to 45 Less than or equal to 8 periods annually elevated serum free testosterone concentrations (...) normal thyroid function tests and serum prolactin exclusion of late-onset adrenal hyperplasia acceptable health based on interview, medical history,physical examination, and lab tests ability to comply with the requirements of the study ability and willingness to provide signed, witnessed informed consent Exclusion Criteria: Diabetes mellitus Clinically significant pulmonary,cardiac ,renal,hepatic,neurologic,psychiatric,infectious,and malignant disease high blood pressure current or recent(within 2

2008 Clinical Trials

3437. Mifepristone for Treatment of Uterine Fibroids

the treatment as well as all side effects of mifepristone Agreeing to have ultrasound examinations in every follow-up or evaluation visit Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination. Exclusion Criteria: Pregnancy or desire to become pregnant Breastfeeding Hormonal contraception or any hormonal therapy received in the last three months Signs or symptoms of pelvic inflammatory disease Adnexal masses Abnormal (...) or unexplained vaginal bleeding Suspected or diagnosed malignant neoplastic disease Signs or symptoms of mental illness Adrenal disease Sickle cell anemia Hepatic disease Renal disease Coagulopathy Any other severe or important disease Any contraindication to receiving antiprogestins Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please

2008 Clinical Trials

3438. Donor T Cells, Low-Dose Aldesleukin, and Low-Dose GM-CSF After Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

-dose sargramostim (GM-CSF) SC every other day for 3 doses beginning within 24 hours after each infusion of ATC-CD20Bi. Patients also receive tacrolimus and mycophenolate mofetil as standard graft-vs-host disease prophylaxis. Treatment continues in the absence of unacceptable toxicity. Some patients with well-defined or evaluable masses receive indium I 111 (^111I)-labeled ATC-CD20Bi IV and ^111I-labeled unarmed ATC and then undergo whole-body imaging for trafficking studies. After completion (...) No uncompensated major thyroid or adrenal dysfunction Not pregnant or nursing Persistently elevated systolic blood pressure (BP) ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg must be controlled with antihypertensive agents for at least 7 days prior to initiation of cell therapy Patients with essential hypertension that is controlled with medication are eligible PRIOR CONCURRENT THERAPY: Prior total dose of doxorubicin or daunorubicin must have been less than 450 mg/m^2 unless an endomyocardial biopsy shows less than

2007 Clinical Trials

3439. Prospective, Randomized, Controlled, Clinical Study on Tolerability and Efficacy of hMG-IBSA

Mass Index (BMI) 20-28 kg/m2 early follicular phase FSH level < 9 IU/l. Exclusion Criteria: ascertained or presumptive hypersensitivity to the active principle and/or their ingredients primary ovarian failure ovarian cysts or enlargement not due to polycystic ovarian syndrome oocyte donation abnormal bleeding of undetermined origin patients who have exhibited poor response or requiring doses of more than 300 IU daily in previous treatment cycles or those who have received similar therapies (...) (previous treatment cycles) in the 30 days prior to the beginning of the present study uncontrolled thyroid or adrenal dysfunction neoplasia severe impairment of the renal and/or hepatic functions diabetes and active thrombophlebitis, cardiopathies and epilepsy presence of clinically significant systemic disease or any contraindication of being pregnant and/or carrying out a pregnancy to term presence of any anatomical abnormality of the reproductive system being pregnant or breastfeeding menopause

2007 Clinical Trials

3440. Melatonin Versus Placebo and the Effect on Appetite in Advanced Cancer Patients

Cancer Center Information provided by (Responsible Party): M.D. Anderson Cancer Center Study Details Study Description Go to Brief Summary: The goal of this clinical research study is to evaluate the effectiveness of melatonin for the management of poor appetite and weight loss in advanced cancer patients. The effectiveness of melatonin on weight gain, keeping/gaining of lean muscle mass, improved appetite, and side effects will also be evaluated. Condition or disease Intervention/treatment Phase (...) as not post-menopausal for 12 months or no previous surgical sterilization. Patients who cannot take Megace because of past history or elevated risk of DVT, adrenal insufficiency, impotence, hyperglycemia, CHF, menorrhagia, etc. Patients who have persistent anorexia/cachexia after treatment with Megace has failed Exclusion Criteria: Patients who have dementia or delirium on entry into study as determined by the palliative care specialist using DSM-IV-criteria Patients who are currently taking melatonin

2007 Clinical Trials

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