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Adrenal Mass

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3541. Once-A-Month Steroid Treatment for Patients With Focal Segmental Glomerulosclerosis

distribution- baseline and 8 months Eye examinations for cataracts and glaucoma - baseline and 8 months Bone density scan (DEXA scan) of the lower spine and hip - baseline, 4 and 12 months Magnetic resonance imaging (MRI) of the hips Psychological evaluation and quality of life evaluation - baseline, 1, 2 and 8 months Blood tests for adrenal gland function - baseline, 4 and 8 months Blood and urine tests - 10, 12, 15, and 18 months Patients who achieve remission (whose urine protein levels decrease (...) Ages Eligible for Study: Child, Adult, Older Adult Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria INCLUSION CRITERIA: Adults and children. Biopsy proven FSGS, including idiopathic FSGS and collapsing FSGS, but excluding HIV-associated FSGS and secondary FSGS associated with morbid obesity, sickle cell anemia, reflux nephropathy, chronic tubular injury, congenital renal anomalies, and reduced nephron mass. Glomerular filtration rate will be estimated using 4 variable MDRD GFR

2000 Clinical Trials

3542. Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer

resectable on CT scan and physical exam Documentation of previously resected primaries must be based on pathologic results of the resected tumor Histological documentation of synchronous disease must be based on 1 of the following: Biopsy of primary colorectal tumor before study Suspicious lesion on barium enema, colonoscopy, or sigmoidoscopy, and a liver biopsy positive for adenocarcinoma consistent with the primary colorectal tumor Measurable disease Clearly defined liver mass measuring at least 2 cm (...) or at least 3 liver masses on CT scan or MRI No evidence of extrahepatic disease on CT scan and physical exam No portal vein occlusion or ascites PATIENT CHARACTERISTICS: Age: 18 and over Hepatic: Bilirubin no greater than 2 times normal Other: No other malignancy within the past 5 years except inactive nonmelanomatous skin cancer, carcinoma in situ of the cervix, or grade 1 bladder cancer Not pregnant or nursing Fertile patients must use effective contraception Chemotherapy: At least 1 year since prior

1999 Clinical Trials

3543. Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

disease greater than 1 cm Nonmeasurable disease includes the following: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Lesions in a previously irradiated area PATIENT CHARACTERISTICS: Age: 18 to 69 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Hepatitis B surface antigen and hepatitis (...) PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 1 prior dose of rituximab Chemotherapy: No more than 1 prior cycle of chemotherapy At least 3 weeks since prior chemotherapy No other concurrent chemotherapeutic agents Endocrine therapy: No chronic use of oral corticosteroids for ongoing medical condition No concurrent hormonal therapy except for non-lymphoma-related conditions (e.g., insulin for diabetes) Other concurrent corticosteroids for adrenal failure, diffuse alveolar hemorrhage

2001 Clinical Trials

3544. Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis

University Information provided by: FDA Office of Orphan Products Development Study Details Study Description Go to Brief Summary: OBJECTIVES: I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis. Condition or disease Intervention/treatment Phase Osteoporosis Drug: human parathyroid hormone Not Applicable Detailed Description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer (...) provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 29 Years to 67 Years (Adult, Older Adult) Sexes Eligible for Study: Male Accepts Healthy Volunteers: No Criteria PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5) No family history of male osteoporosis No other

1999 Clinical Trials

3545. Heart Disease Risk Factors in Major Depression

resistance in each patient and control, we will apply the hyperinsulinemic euglycemic glucose clamp procedure. This is the gold standard method for measuring the insulin sensitivity since it reflects the direct human body glucose metabolic response to a known insulin infusion. Moreover, it is essential to use this technique in patients with major depression as data indicate that other alternative procedures give unreliable results in the context of hypercortisolism. Condition or disease Adrenal Gland (...) . Subjects should not have significant underlying illnesses known to affect insulin sensitivity, and should have a body mass index between 20 and 30 kg/m2. EXCLUSION CRITERIA Pregnancy Existing diabetes mellitus Body mass index less than 20 or greater than 30 kg/ m2 Existing cardiovascular diseases and other end organ diseases Existing peripheral vascular disease HIV infection Patients who are on B-blockers, thiazides, and/or glucocorticoids and cannot discontinue these medications. Subjects who

2000 Clinical Trials

3546. Combination Chemotherapy Plus Thalidomide in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

nonmeasurable: Bone lesions Leptomeningeal disease Ascites Pleural or pericardial effusions Abdominal masses unconfirmed by imaging techniques Cystic lesions Previously irradiated brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant (...) concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except steroids for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes) or intermittent dexamethasone as an antiemetic Radiotherapy: Prior radiotherapy for brain metastasis allowed if neurologically stable and off steroids No concurrent palliative radiotherapy Surgery: Not specified Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you

2001 Clinical Trials

3547. Gefitinib in Treating Patients With Malignant Mesothelioma

/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions No known brain metastases Performance status - CTC 0-1 Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN No symptomatic congestive heart failure No unstable angina pectoris No cardiac (...) agents (including bleomycin) allowed No prior systemic cytotoxic chemotherapy for malignant mesothelioma No concurrent chemotherapy At least 1 week since prior CYP3A4 inducers (e.g., dexamethasone, glucocorticoids, progesterone) No concurrent CYP3A4 inducers (e.g., dexamethasone) No concurrent hormonal therapy (e.g., tamoxifen) except steroids for adrenal failure or hormones for non disease-related conditions (e.g., insulin for diabetes) See Disease Characteristics At least 4 weeks since prior

2001 Clinical Trials

3548. Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid

Drug: Cholic Acids 10-15 mg/kg body weight/day taken orally. Other Names: Cholic Cholic Acid Cholic Acid Capsules Outcome Measures Go to Primary Outcome Measures : Determination of changes in synthesis of atypical bile acids in urine by mass spectrometry (FAB MS) [ Time Frame: 12 months ] Secondary Outcome Measures : Change in Liver Function Test (serum transaminases) [ Time Frame: Standard of Care ] Change in Liver Histology (for patients in whom biopsy was performed) [ Time Frame: Standard (...) Disorders, Nervous System Metabolism, Inborn Errors Metabolic Diseases Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases Liver Diseases

2000 Clinical Trials

3549. Carboxyamidotriazole in Treating Patients With Metastatic Kidney Cancer

/pericardial effusion Abdominal masses not confirmed and followed by imaging Cystic lesions Performance status - CTC 0-2 WBC at least 2,000/mm^3 Platelet count at least 75,000/mm^3 Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2.5 times ULN Creatinine no greater than 2.0 mg/dL Not pregnant or nursing Fertile patients must use effective contraception No baseline neuropathy or cerebellar dysfunction greater than grade 1 At least 4 weeks since prior immunotherapy No prior (...) carboxyamidotriazole No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF) Concurrent epoetin alfa allowed At least 4 weeks since prior chemotherapy No concurrent chemotherapy No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes) At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy See Disease Characteristics At least 4 weeks since prior surgery Contacts and Locations Go to Information from

2000 Clinical Trials

3550. Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2

Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging Cystic lesions No CNS metastases Performance status - ECOG 0-2 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) Creatinine no greater than 1.5 times ULN LVEF at least 45% (by echocardiogram or MUGA) Not pregnant or nursing Fertile patients must use effective contraception HIV negative No concurrent (...) immunologic disease (e.g., autoimmune disease) No history of allergy to murine products No prior murine antibodies No prior anthracyclines No more than 1 prior chemotherapy regimen for lung cancer At least 4 weeks since prior chemotherapy No concurrent chemotherapy No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes) At least 6 months since prior radiotherapy No concurrent

2000 Clinical Trials

3551. Trastuzumab in Treating Patients With Previously Treated, Locally Advanced, or Metastatic Cancer of the Urothelium

for potentially curative surgery or radiotherapy Measurable disease At least 1 unidimensionally measurable lesion of at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan The following lesions are considered nonmeasurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Primary bladder masses Relapsed from or failed to achieve a complete or partial (...) in situ of the cervix HIV negative No known autoimmune disease No prior trastuzumab (Herceptin) At least 14 days since prior radiotherapy At least 30 days since prior chemotherapy Prior doxorubicin allowed provided cumulative dose is no greater than 300 mg/m^2 Prior epirubicin allowed provided cumulative dose is no greater than 600 mg/m^2 No concurrent chemotherapy No concurrent hormonal therapy except: Steroids given for adrenal failure Hormones administered for nondisease-related conditions (e.g

2000 Clinical Trials

3552. Megestrol and Exercise in Treating Patients With Cancer-Related Weight Loss

in patients who have cancer-related weight loss. Condition or disease Intervention/treatment Phase Cachexia Fatigue Unspecified Adult Solid Tumor, Protocol Specific Drug: megestrol acetate Procedure: physical therapy Phase 2 Detailed Description: OBJECTIVES: I. Determine the effect of megestrol and progressive resistance training on lean body mass, total body weight, functional capacity, appetite, and fatigue in patients with weight loss due to advanced malignancy. OUTLINE: This is a multicenter study (...) hyperalimentation No contraindications to megestrol No dementia or mental incompetence No known AIDS Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent adrenal steroids (other than for replacement), anabolics, appetite stimulants, or progestational agents Intermittent corticosteroids as antiemetic or premedication for cancer treatment allowed At least 6 weeks since prior megestrol Radiotherapy

2000 Clinical Trials

3553. Combination Chemotherapy and Radiation Therapy With or Without Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

or vertebral body documented by CT scan, MRI or transesophageal ultrasound T4 involvement of the mediastinum may also be accepted by CT or MRI criteria if, in absence of the above organ involvement, there is soft tissue extension directly into the mediastinal space; radiographic criteria for involvement of main pulmonary artery or vein is allowed only if there is a mediastinal soft tissue mass Patients must not have malignant pleural effusions; NOTE: the only exception is pleural effusion only on CT scan (...) must be > 800 cc based on the quantitative split function testing within 42 days prior to registration WBC >= 3,000/ul ANC >= 1,200/ul Platelet count >= 100,000/ul All patients must have a CT of upper abdomen to exclude metastatic disease involving the contralateral chest, liver or adrenals (if chest CT is performed including complete liver and adrenals in the report, a separate CT of upper abdomen is not necessary) within 42 days prior to registration All patients must have a Zubrod Performance

2001 Clinical Trials

3554. Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

neuroblastoma are also eligible All patients must have completed therapy including intensive induction followed by ASCT and radiotherapy to be eligible for ANBL0032; radiotherapy may be waived for patients who either have small adrenal masses which are completely resected up front, or who never have an identifiable primary tumor; examples of such therapies include: Following treatment per A3973 protocol Following treatment per Pediatric Oncology Group (POG)-9341/9342 protocol Following treatment per CCG3891

2001 Clinical Trials

3555. Karenitecin in Treating Patients With Relapsed or Refractory Non-Small Cell Lung Cancer

disease Ascites Pleural/pericardial effusion Abdominal masses not confirmed and followed by imaging techniques Cystic lesions Tumor lesions in a previously irradiated area Controlled CNS metastases allowed if patient is neurologically stable and off steroids PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal (...) for diabetes) No concurrent steroids except for adrenal failure Radiotherapy: See Disease Characteristics Prior radiotherapy for symptomatic lesions or those that might produce disability (e.g., painful bone metastases) allowed if other measurable disease present At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery: See Disease Characteristics Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor

2001 Clinical Trials

3556. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

scan The following are not considered measurable: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Primary bladder masses Progressive disease after interferon alfa and/or interleukin-2 for metastatic RCC OR intolerance to these therapies No prior or concurrent CNS metastases Negative MRI of the brain within the past 28 days Must have HLA-identical (6/6 (...) sargramostim (GM-CSF) Concurrent epoetin alfa allowed Chemotherapy: No other concurrent chemotherapy Endocrine therapy: At least 28 days since prior hormonal therapy (e.g., megestrol, corticosteroids, or anti-estrogen therapy) Concurrent steroids allowed for adrenal failure, graft-versus-host disease, or other nondisease-related conditions (e.g., insulin for diabetes) Radiotherapy: At least 14 days since prior radiotherapy Surgery: At least 14 days since prior surgery Other: At least 28 days since prior

2001 Clinical Trials

3557. Effects of Dietary Carbohydrate and Fat on Hormones

Clinical Center (CC) Study Details Study Description Go to Brief Summary: This study will try to determine if intake of dietary fats or carbohydrates influences the tendency to gain weight or accumulate body fat. It will examine how the hormones that regulate weight may change with a shift from a balanced diet to one that is low in fat or carbohydrate, irrespective of caloric intake. Men and women between the ages of 18 and 40 years with a body mass index of 30 to 49 kg/m2 may be eligible (...) , pituitary, ovarian/testicular and adrenal problem Acute infections Irregular menstrual cycles (greater than 7 day menses, intervals greater than 35 or less than 21 days) A weight change of greater than 2% within the past 2 months. Use of prescription medications or other drugs/supplements including acetaminophen or alcohol that would, in the judgement of study investigators, interfere with study objectives Major (greater than 3 hours/week) athletic/physical exercise activities. Eating patterns

2001 Clinical Trials

3558. Risk of Coronary Heart Disease in Women With Polycystic Ovary Syndrome

, physical exam, and hormone studies was made. In addition, information on the number of pregnancies, number of live births, menstrual history, and history of surgical or natural menopause was obtained. Women with evidence of thyroid, adrenal or pituitary disease were excluded. The grant was renewed in 1996 to determine whether women with PCOS have evidence of an increased prevalence rate of subclinical atherosclerosis. Within the PCOS population the investigators performed five studies to further (...) -to-hip ratio and body mass index (BMI). Fourth, they assessed differences in body composition between PCOS cases and control women, including intra-abdominal fat as measured by computed tomography (CT) of the abdomen and sagittal diameter, and percent body fat as measured by dual energy x-ray absorptiometry (DEXA). They evaluated the relationship between subclinical atherosclerosis and body composition separately for cases and for controls. Previous studies had clearly shown that PCOS women were

2000 Clinical Trials

3559. Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer

Clinical stage T1-2, N0-1 must be medically inoperable No distant metastases on history and physical exam, CBC, screening profile, CT or MRI of brain, CT of chest and abdomen (including adrenals and liver), and bone scan No pleural effusions Atelectasis not clearly distinguishable from tumor mass allowed provided all tumor and atelectasis together represent a volume that can be safely treated to the total dose delivered to gross disease Diffuse pulmonary infiltrates thought to represent benign disease

1999 Clinical Trials

3560. Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma

by physical exam, radiograph, CT, or MRI (sonography and barium studies alone not acceptable) Measurable liver disease defined as: Mass greater than 3.5 cm on CT, MRI, or ultrasound OR Histologically documented lymphomatous hepatomegaly more than 5 cm below the costal margin The following disease manifestations are not considered measurable: Ascites or pleural effusion Bony disease (lytic lesions on x-ray should be documented and followed) CNS lesions Bone marrow involvement No lymphomatous involvement (...) Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon only on Protocol CLB-8691 allowed Chemotherapy: Prior oral cyclophosphamide only on Protocol CLB-8691 allowed No concurrent chemotherapy Endocrine therapy: No chronic steroids for other health problems No concurrent steroids for any condition including documented CNS metastases, adrenal failure, or septic shock Nonsteroidal hormonal drugs for nondisease related problems allowed (e.g., insulin

1999 Clinical Trials

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