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Endocrine Manifestations of HIV

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181. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock Full Text available with Trip Pro

). Rationale . Early effective fluid resuscitation is crucial for stabilization of sepsis -induced tissue hypoperfusion or septic shock . Sepsis -induced hypoperfusion may be manifested by acute organ dysfunction and/or ± decreased blood pressure and increased serum lactate. Previous iterations of these guidelines have recommended a protocolized quantitative resuscitation, otherwise known as early goal-directed therapy (EGDT), which was based on the protocol published by Rivers ( ). This recommendation

2016 European Respiratory Society

182. Phase 1 Study to Evaluate ASN002 Absorption, Metabolism, and Excretion of [14C] Following a Single Oral Dose in Healthy Male Subjects

cotinine) at Check in. Positive hepatitis panel and/or positive human immunodeficiency virus test. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to Check-in. Use or intend to use any medications/products known to alter drug absorption, metabolism, or excretion processes, including St. John's wort, within 14 days prior to Check in, unless deemed acceptable (...) , Gilbert's syndrome] is not acceptable) at Screening or Check in as assessed by the Investigator (or designee). Males will agree to use contraception as defined in the Protocol body Able to comprehend and willing to sign an ICF and to abide by the study restrictions. History of a minimum of 1 bowel movement per day. Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal

2018 Clinical Trials

183. Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy

or not clinically significant. Electrocardiogram (ECG), AST, ALT, and urinalysis values within the normal range for the testing facility or not clinically significant. Normal renal function: Glomerular filtration rate (GFR) calculated by Cockcroft-Gault formula > 60 ml/min. Negative pregnancy test within 1 week of Segment 1, Study Day 1. Negative urine test for substances of abuse per CRU standards. Negative serology tests for HIV, hepatitis B surface antigen, and hepatitis C virus antibody. Body Mass Index (...) ) Sharing Statement: Plan to Share IPD: No Layout table for additional information Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Keywords provided by Syntrix Biosystems, Inc.: Analgesia Additional relevant MeSH terms: Layout table for MeSH terms Neuralgia Diabetic Neuropathies Chronic Pain Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms Diabetes Complications Diabetes

2018 Clinical Trials

184. Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)

after treatment, have been off dexamethasone for 4 weeks prior to first study drug administration, and no ongoing requirement for dexamethasone or anti‐epileptic drugs Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient's participation in the study Known human immunodeficiency virus infection Known hepatitis B surface antigen-positive, or known (...) ) or investigational site as well as on the investigator Diagnosed or treated for another malignancy within 2 years before administration of the first dose of study treatment, or previously diagnosed with another malignancy and evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection Breast feeding or pregnant Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease

2018 Clinical Trials

185. Benznidazole Absorption, Metabolism and Excretion Study

or positive urine cotinine test result, or positive urine drug screen (confirmed by repeat) at screening or check-in. Positive hepatitis panel and/or positive human immunodeficiency virus test (Appendix 3). Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months prior to check-in. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 (...) evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is acceptable) at screening or check-in as assessed by the Investigator (or designee). Will agree to use contraception as detailed in Section 7.6. History of a minimum of 1 bowel movement per day. Able to comprehend and willing to sign an Inform Consent Form and to abide by the study restrictions. Exclusion Criteria: Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal

2018 Clinical Trials

186. Pharmacokinetics of Two Formulation of Pregabalin

diseases. Positive results for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV). Taking any drug known to induce or inhibit hepatic drug metabolism within four weeks prior to study drug dosing. Examples of inducers include: piperidines, carbamazepine, dexamethasone and rifampin. Examples of inhibitors include: cimetidine, diphenhydramine, fluvastatin, methadone and ranitidine. Taking any prescription medications within four weeks or any (...) Diabetic Neuropathies Epilepsy Epilepsies, Partial Neurologic Manifestations Nervous System Diseases Signs and Symptoms Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Brain Diseases Central Nervous System Diseases Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular

2018 Clinical Trials

187. Inpatient, Dose-Ranging Study of Staccato Alprazolam in Epilepsy With Predictable Seizure Pattern

to progress in the next 3 months Use of strong CYP 3A4 inhibitors; including azole antifungal agents (e.g., etoconazole, itraconazole), nefazodone, fluvoxamine, cimetidine, HIV protease inhibitors (e.g., ritonavir) Has severe chronic cardio-respiratory disease History of HIV-positivity. Pregnant or breast-feeding. Clinically significant renal or hepatic insufficiency (hepatic transaminases >2 times the upper limit of normal (ULN) or creatinine ≥ 1.5 x ULN). History of acute narrow angle glaucoma (...) ) measured while seated at screening or baseline. Significant hepatic, renal, gastroenterologic, cardiovascular (including ischemic heart disease and congestive heart failure), endocrine, neurologic or hematologic disease. Subjects who, in the opinion of the Investigator, should not participate in the study for any reason, including if there is a question about the stability or capability of the subject to comply with the trial requirements. Contacts and Locations Go to Information from the National

2018 Clinical Trials

188. BT1718 in Patients With Advanced Solid Tumours.

, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate. Surgery from which the patient has not yet recovered. At high medical risk because of non-malignant systemic disease including active uncontrolled infection. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV). Concurrent (...) in cancer cells. BT1718 has been designed to recognise and attach itself to the MT1-MMP protein. Once attached a segment of BT1718 is taken into the cancer cell which causes it to die (DM1 toxin). This is a first in human clinical study which has two phases. A 'dose escalation' phase where groups of patients will receive increasing doses of BT1718 to find a safe dose that best targets the cancer cells. In this phase it is expected that approximately 50-60 patients with advanced solid tumours

2018 Clinical Trials

189. Losartan and Nivolumab in Combination With FOLFIRINOX and SBRT in Localized Pancreatic Cancer

test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would (...) be considered for the exploratory arm, Arm 4. Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), such as significant cardiac or pulmonary morbidity e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifested by fever. Pregnant or lactating women. Women of childbearing potential with either a positive

2018 Clinical Trials

190. Phase 2b Study of KBP-5074 in Subjects With Uncontrolled Hypertension and Advanced Chronic Kidney Disease

at Screening or the end of the run-in period, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 × the upper limit of normal (ULN) or total bilirubin >2 × ULN; o Note: Patients with total bilirubin >2 × ULN and history of Gilbert's syndrome may be included. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) antibody; History of prescription drug abuse, illicit drug use, or alcohol abuse according (...) heart failure manifested by signs and symptoms that may require intravenous diuretic therapy (New York Heart Association Class III to IV) within 3 months prior to Screening, or presence of hemodynamically significant valve diseases and/or other hemodynamically significant obstructive lesions of left ventricular outflow tract; Major cardiac, cerebral, and/or carotid artery diseases, including, but not limited to, acute coronary syndrome, myocardial infarction, stroke, and/or transient ischemic attack

2018 Clinical Trials

191. Transarterial Chemoembolization in Combination With Nivolumab Performed for Intermediate Stage Hepatocellular Carcinoma

. Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV). Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lifes of previously used trial medication, whichever is longer. Previous treatment in the present study (does not include screening failure). Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment (...) or interpretation of patient safety or study results, including but not limited to: history of interstitial lung disease Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection) known acute or chronic pancreatitis active tuberculosis any other active infection (viral, fungal or bacterial) requiring systemic therapy history of allogeneic tissue/solid organ transplant diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form

2018 Clinical Trials

192. Amitriptyline in Treating Hypoglycemia

consent and willing to sign an approved consent form that conforms to federal and institutional guidelines Exclusion Criteria: Ongoing or recent history of major depressive disorder, or other ongoing major psychiatric disorders History of anti-depressant use within the last three months Insulin pump linked to a CGM with programmed automatic insulin adjustment or suspension History of advanced cardiac, liver, kidney or neurological disease Active malignancy Uncontrolled Human Immunodeficiency Virus (...) , Type 1 Hypoglycemia Unconsciousness Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Amitriptyline Amitriptyline, perphenazine drug combination Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents

2018 Clinical Trials

193. A Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics

Criteria: Age ≥ 18 years old The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2 Signed informed consent. Exclusion Criteria: Any clinically serious disease that has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that can interfere with the test results Having deep vein thrombosis or other thrombotic diseases. Having thrombocytopenia, mitral valve (...) prolapse, obvious heart murmur, or murmur. Extended QT interval during the screening period (calculated in Bazett's method, males >450 msec) Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive. Those who have a history of allergies to drugs , food or test drugs or similar drugs; Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study Those who took any drug within 14 days before the test (including Chinese

2018 Clinical Trials

194. Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome

) Additional relevant MeSH terms: Layout table for MeSH terms Syndrome Fatigue Fatigue Syndrome, Chronic Encephalomyelitis Myalgia Disease Pathologic Processes Signs and Symptoms Virus Diseases Muscular Diseases Musculoskeletal Diseases Central Nervous System Diseases Nervous System Diseases Neuromuscular Diseases Central Nervous System Infections Musculoskeletal Pain Pain Neurologic Manifestations Corticotropin-Releasing Hormone Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological (...) capacity for physical and mental activity manifest as profound fatigue along with a cascade of debilitating symptoms (including pain, cognitive dysfunction, orthostatic intolerance, sensitivities, and irregularities of the autonomic, immune and metabolic systems) that worsen with activity (referred to as post-exertional malaise or PEM), are not improved by sleep, and can persist for years. Patients are often unable to handle the activities of daily living and experience a loss of career and a very poor

2018 Clinical Trials

195. Effect of DMR in the Treatment of NASH

public health concern manifesting by premature cardiovascular disease, end stage diabetes complication and will likely become the first cause of end stage liver disease. Insuline resistance is the hallmark of NASH. Some recent studies both in animals and humans have demonstrated abnormal hypertrophy of the duodenal mucosa, changes in enteroendocrine cell density and number, endocrine hyperplasia, and alterations in gut hormone signaling highlighting the role of the upper intestine gut in glucose (...) of the following abnormalities: Serum albumin < 32 g/L. INR> 1.3. Direct bilirubin> 1.3 mg/L. ALT or AST > 5x ULN. Alkaline Phosphatase > 3x ULN. History of esophageal varices, ascites or hepatic encephalopathy. Splenomegaly. Human immunodeficiency virus. Contraindications to MRI as defined below. 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

2018 Clinical Trials

196. Carvedilol in Treating Hypoglycemia Unawareness

Mellitus β-blocker Additional relevant MeSH terms: Layout table for MeSH terms Diabetes Mellitus, Type 1 Hypoglycemia Unconsciousness Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Carvedilol Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular (...) (3 or more) or insulin pump therapy Negative pregnancy test Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines Exclusion Criteria: Major medical disorders (including liver disease, cardiovascular disease, kidney disease, chronic obstructive pulmonary disease, asthma, active malignancy or HIV) Overt diabetes complications (neuropathy, nephropathy, retinopathy) Presence of anemia Current or recent use of beta-blocker

2018 Clinical Trials

197. Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)

, barbiturates, benzodiazepines, cocaine, methadone, opiates, PCP Currently taking beta-blockers or medications that affect counterregulatory response to hypoglycemia Urinalysis: clinically significant abnormalities Clinically significant electrolyte abnormalities Smoking >7 cigarettes/day Heavy alcohol use History of chronic conditions (eg, chronic liver disease, cardiovascular disease, bleeding disorders, cancer, HIV/AIDS, seizures, systemic rheumatologic conditions) Surgeries involving endocrine glands (...) Unconsciousness Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Naloxone Diazoxide Narcotic Antagonists Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Antihypertensive Agents Vasodilator Agents

2018 Clinical Trials

198. TAK-659 and Paclitaxel in Treating Patients With Advanced Solid Tumors

opinion, make the patient not appropriate for this study Known human immunodeficiency virus (HIV) positive Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection Any treatment specific for systemic tumor control within 3 weeks prior to the initiation of the study drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 weeks for nitrosoureas or mitomycin C), or within 5 half-lives for targeted agents with half-lives and pharmacodynamic effects (...) Terminology Criteria for Adverse Events) version 5.0 [ Time Frame: Up to 4 years ] Adverse events (clinical manifestations and laboratory tests) and serious adverse events will be assessed by clinical symptoms and laboratory values, evaluation of vital signs, and performance of physical exam with a special attention to treatment-related fatigue, gastrointestinal symptoms, cardiovascular events, myelosuppression, and neurotoxicity. Incidence and grade of adverse events assessed by NCI CTCAE version 5.0

2018 Clinical Trials

199. Williams Syndrome Strength, Hormones, Activity & Adiposity, DNA Programming, Eating Study

Posted : November 29, 2018 Last Update Posted : November 29, 2018 See Sponsor: Massachusetts General Hospital Collaborators: Lipedema Foundation Williams Syndrome Association Information provided by (Responsible Party): Barbara R. Pober, Massachusetts General Hospital Study Details Study Description Go to Brief Summary: Williams syndrome (WS) is a rare microdeletion genetic disorder that has a broad phenotype including many endocrine and metabolic abnormalities. Dr. Pober and colleagues at MGH have (...) or abnormal fat distribution due to a known secondary cause (except WS) such as Cushing syndrome, HIV-infection, etc. 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): NCT03758651 Contacts Layout table for location contacts Contact: Barbara Pober, MD 617-726

2018 Clinical Trials

200. Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus

: Premenopausal women over 18, having given informed consent, and being covered by social insurance. Exclusion Criteria: Group Systemic Lupus Erythematosus and group autoimmune diseases Human Immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis C virus (HBV) sero-positivity; pregnant or lactating women; menopausal women; patient in remission of quiescent phase of her pathology; Healthy controls : HIV, HCV or HBV sero-positivity; pregnant or lactating women; menopausal women. Contacts (...) unknown even though genetic and environmental factors have already been identified. Estrogens, on one side, have been shown to negatively influence the incidence and severity of the disease while testosterone and progesterone on the other side are thought to be protective. Endocrine disruptors can potentially influence the occurrence and severity of the disease. Among these disruptors, soy isoflavones which are ubiquitous in modern processed food are known to be estrogenic and anti-androgenic

2018 Clinical Trials

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