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Endocrine Manifestations of HIV

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181. Personalized Nutrition for Pre-Diabetes

: Blood glucose levels are rapidly increasing in the population, as evident by the sharp incline in the prevalence of prediabetes and impaired glucose tolerance estimated to affect, in the U.S. alone, 37% of the adult population. Chronic hyperglycaemia is a significant risk factor for type II diabetes mellitus (TIIDM), with up to 70% of prediabetics eventually developing the disease. It is also linked to other manifestations, collectively termed the metabolic syndrome, including obesity, hypertension (...) in the last 3 month Use of anti-diabetic and/or weight-loss medication People under another diet regime and/or a dietitian consultation/another study Pregnancy, fertility treatments Chronic disease (e.g. HIV, Cushing syndrome, CKD, acromegaly, hyperthyroidism etc.) Cancer and recent anticancer treatment Psychiatric disorders Coagulation disorders IBD (inflammatory bowel diseases) Bariatric surgery Alcohol or substance abuse Contacts and Locations Go to Information from the National Library of Medicine

2017 Clinical Trials

182. COMBOPROFEN for Treatment of Muscular Pain Associated With Delayed Onset Muscle Soreness (DOMS)

for hepatitis B, C or HIV. Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological or neurological disease or other chronic diseases. Twelve lead ECG obtained at screening with PR ≥ 220 msec, QRS ≥120 msec and QTc ≥ 440 msec, bradycardia (<50 bpm) or clinically significant minor ST wave changes or any other abnormal changes on the screening ECG that would interfere with measurement of the QT interval. Having undergone major surgery during (...) Neuromuscular Diseases Nervous System Diseases Musculoskeletal Pain Pain Neurologic Manifestations Signs and Symptoms Vitamins Ascorbic Acid Ibuprofen Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antioxidants

2017 Clinical Trials

183. Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Neuralgia Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms Diabetes Complications Diabetes Mellitus Endocrine System Diseases (...) , or ketoacidosis requiring hospitalization within past 3 months. Subjects with history of severe renal impairment. Impaired hepatic function. Known history of significant cardiovascular condition. History of Huntington's disease, Parkinson's disease, Alzheimer's disease, Multiple Sclerosis, or a history of seizures, epilepsy, or strokes. HIV infection, hepatitis, or other ongoing infectious disease that the investigator considers clinically significant. Concomitant use of antiepileptic drugs, non-steroidal

2017 Clinical Trials

184. A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347

or within 3 months prior to Screening and read by a qualified radiologist. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). Participants with a history of autoimmune disorders and other conditions that compromise or impair the immune system (...) of active infections within 28 days prior to the screening visit Subjects with a history of or current positive results for any of the following serological tests: Hepatitis B surface antigen (HepBsAg), Hepatitis B core antibody (HepBcAb), Hepatitis C antibody (HCVAb) or human immunodeficiency virus (HIV). Subjects with a history of thromboembolic events or current positive result for anti-cardiolipin antibody History of TB or active, latent or inadequately treated TB infection. All positive TB test

2017 Clinical Trials

185. Pre-Operative Trial (PGHA vs. PGH) for Resectable Pancreatic Cancer

). Symptomatic evidence of gastric outlet obstruction. Inability to adhere to study and/or follow-up procedures. History of allergic reactions or hypersensitivity to the study drugs. Known or suspected HIV infection Active or history of autoimmune disease or immune deficiency. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis (...) .: No Additional relevant MeSH terms: Layout table for MeSH terms Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Paclitaxel Albumin-Bound Paclitaxel Gemcitabine Hydroxychloroquine Antibodies, Monoclonal Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites

2017 Clinical Trials

186. Glucose-dependent Asprosin Dynamics

criteria for participants without hypoglycemia unawareness Age between 18 and 75 years BMI between 20 und 35 kg per m2 Persons with manifest diabetes mellitus type 1 and diagnosis according to according to DDG guidelines 2011 oGTT, HbA1c more than 6.5 percent in the absence of adulteration of the HbA1c, over 200 mg per dl in the 2 hour value of the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice. Inclusion criteria for participants without (...) hypoglycemia unawareness Persons who are not aware of hypoglycemia symptoms at glucose levels above 50 mg per dl Age between 18 and 75 years BMI between 20 und 35 kg per m2 Persons with manifest diabetes mellitus type 1 and diagnosis according to DDG guidelines 2011 oGTT, HbA1c more than 6.5 percent in the absence of adulteration of the HbA1c, over 200 mg per dl in the 2 hour value of the oGTT, fasting glucose more than 126 mg per dl, spontaneous glucose more than 200 mg per dl at least twice. General

2017 Clinical Trials

187. A Phase 4 Post-marketing Study of Intramuscular Injections of BLB-750 in Healthy Adult Subjects

is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress. The participant has poorly controlled, clinically significant manifestations of neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, endocrine, or other disorders, which may impact their ability to participate as participants or may potentially (...) [ADEM] and multiple sclerosis), or convulsions. The participant has a functional or anatomic asplenia. The participant has a rash, other dermatologic conditions or tattoos that may interfere with the evaluation of local reaction. The participant has a past or present history of infection with the Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV). The participant has a known hypersensitivity to any component of BLB-750. The participant has a history of severe

2017 Clinical Trials

188. Phase IIb Study Evaluating Immunogenic Chemotherapy Combined With Ipilimumab and Nivolumab in Breast Cancer

is allowed between the time point for biopsy and study entry. Measurable metastatic disease according to RECIST Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Signed Informed Consent Form Women or men aged ≥ 18 years A minimum of 12 months from adjuvant/neoadjuvant chemotherapy with antracyclins to relapse disease A maximum of one previous line with chemotherapy in the metastatic setting Chemotherapy is considered as preferred treatment Previous endocrine and targeted therapy (...) .) is not considered a form of systemic treatment. Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) are permitted provided that they meet all of the following conditions: Rash must cover less than 10% of body surface area. Disease is well controlled at baseline and only requiring low potency topical steroids No acute exacerbations of underlying condition within the last 12 months (not requiring PUVA [psoralen plus ultraviolet

2017 Clinical Trials

189. A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function

significantly alter the absorption, distribution, or excretion of AG-120. Treatment with strong cytochrome P450 (CYP)3A4 inhibitors or inducers within 14 days prior to AG 120 dosing or during the study. Subjects with hepatic impairment (Cohorts 1a, 2a) Clinical evidence of moderate to severe ascites. Significant history or clinical manifestation of any significant metabolic/endocrine, allergic, dermatologic, renal, hematologic, pulmonary, immune, cardiovascular, gastrointestinal, genitourinary, neurologic (...) , clinical laboratory tests, and Investigator's assessment. Key Exclusion Criteria: All subjects: Significant acute, new-onset illness (eg, flu, gastroenteritis) within 2 weeks prior to dosing. Positive test for drugs of abuse and/or positive alcohol test at Screening or prior to dosing. Medical history of clinically significant ECG abnormalities or a family history of prolonged QT interval syndromes. History of immunocompromise, including positivity for HIV, or active viral hepatitis B or C. Use of over

2017 Clinical Trials

190. Adipose Stem Cells for Traumatic Spinal Cord Injury

level within 6 months of study Evidence of current superficial infection affecting the index spinal level at the time of enrollment On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis (...) , and syphilis Fever, defined as temperature above 100.4 F/38.0 Celsius, or mental confusion at baseline Significant improvement between the time of adipose tissue harvest and the time of injection, defined as improvement from AIS grade A or B to AIS grade C or greater. Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension > 90 mmHg diastolic and/or 180 mmHg systolic), neurological (e.g. stroke, TIA) renal, hepatic or endocrine

2017 Clinical Trials

191. Feasibility Study of New Method of Diagnostic and Prediction of Painful CIPN

System Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Neurologic Manifestations Signs and Symptoms (...) for more than 14 days of the month Pain rated 50 or higher on a scale of 0 to 100, with 0 = no pain at all and 100 = worst pain imaginable. Pregnant or nursing HIV-positive Do not speak or read English 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

2017 Clinical Trials

192. AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain

history, physical exam and/or radiographic imaging that could be the source of lumbar back pain. Has a history of an endocrine or metabolic disorder that affects the spine (eg, Paget's disease). Has a compressive pathology due to stenosis or frankly herniated disc or sequestered discs. Has symptomatic involvement of more than one lumbar disc, in the opinion of the investigator. Has an intact disc bulge/protrusion or focal herniation at the symptomatic level >3 mm, the presence of disc extrusion (...) of life. Has a positive screen for Hepatitis B Surface Antigen, Hepatitis C antibodies, or human immunodeficiency virus (HIV) by antibodies or nucleic acid test. Is an immediate family member (by birth) of any other subject participating in this study. Has a history of cancer that does NOT have documentation to support a complete and curative treatment. Has participated within the previous 3 months in an interventional clinical study or is concurrently enrolled in any non-interventional research

2017 Clinical Trials

193. A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)

remission at week 16, and follow-up will be performed until week 24 for safety and sustained efficacy. Patients will receive either the subcutaneous preparation of 162 mg tocilizumab weekly or matching placebo injections. Expected Results. In case of a positive result of this study, the benefits for patients with new-onset PMR will manifest in a reduction of the burden of GC intake in this elderly population with increased risk of GC-related adverse events. Study Design Go to Layout table for study (...) uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (include uncontrolled diabetes mellitus) or gastrointestinal disease (including complicated diverticulitis, ulcerative colitis, or Crohn ́s disease) Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT, AST, or both > 1.5 x the upper limit of age-determined normal (ULN) or total bilirubin > ULN Serum creatinine > 1.6 mg/dL (141 μmol/L) in female

2017 Clinical Trials

194. A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus

using BILAG 2004 Index and No worsening from baseline defined by an increase of < 0.30 points from baseline on a Physician's Global Assessment (PGA) visual analog scale (VAS) from 0-3 Proportion of subjects with SLEDAI 2K score improvement of ≥ 4 points from Baseline [ Time Frame: Weeks 24 and 52 ] The SLEDAI 2K score measures disease activity through assessment of 24 lupus manifestations using a weighted score of 1 to 8 points. A manifestation is recorded if it is present over the previous 30 days (...) activity. This tool assesses the changing severity of clinical manifestations of SLE using an ordinal scale scoring system that contain 9 systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal and hematological). Activity in each organ system is scored as: A=most active disease; B=intermediate activity; C=mild, stable disease; D=previous involvement, currently inactive; E=no previous activity. Percentage of subjects

2017 Clinical Trials

195. A Study to Evaluate the Renal Protective Effect (Urine Albumin-to-Creatinine Ratio (UACR)), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria

Drug Product: No Studies a U.S. FDA-regulated Device Product: No Keywords provided by Astellas Pharma Inc ( Astellas Pharma Korea, Inc. ): Glimepride Metformin Ipragliflozin Type 2 Diabetes Mellitus ASP1941 Additional relevant MeSH terms: Layout table for MeSH terms Diabetes Mellitus Diabetes Mellitus, Type 2 Albuminuria Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Proteinuria Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Metformin (...) has uncontrollable psychiatric disorder(s) with medication. Subject abuses drug or alcohol at Visit 1. Subject has lactic acidosis or has history of lactic acidosis. Subject who has been known to have Hepatitis B, Hepatitis C or Positive Human immunodeficiency virus (HIV). Subject is unable or unwilling to adhere to any of the protocol requirements such as hospital visits and dose instruction specified in this study. Subject with rare hereditary problems of galactose intolerance, the Lapp lactase

2017 Clinical Trials

196. Eltrombopag for People With Fanconi Anemia

with FA for 6 months with EPAG to assess safety and efficacy at improving hematological manifestations of FA. Responders at 6 months will be able to continue EPAG on the extension part of this protocol for an additional 3 years. During this time frame we anticipate further improvement of peripheral blood cells counts that will eventually result in the discontinuation of EPAG after a tapering period. Translational studies will explore EPAG effects on DNA repair activity, apoptosis, global transcriptome (...) [ Time Frame: At baseline, 3 and 6 months ] Multicolor flow cytometry of bone marrow cells [ Time Frame: At baseline, 3 and 6 months ] Impact of EPAG on other organ systems commonly involved in FA (e.g. skin lesions, endocrine dysfunction, and incidence of new head/neck, oropharyngeal, gastrointestinal, anogenital or skin cancers by clinical assessment) [ Time Frame: At baseline, 3 and 6 months ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate

2017 Clinical Trials

197. Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: Patients with psoriasis must have a baseline ophthalmologic exam to rule out (...) ocular manifestations Rash must cover less than 10% of body surface area (BSA) Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%) No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high

2017 Clinical Trials

198. A Study of BGB-A317 as Monotherapy in Relapsed or Refractory Classical Hodgkin Lymphoma

and other mechanisms as manifested by apparent increase of existing tumor masses or appearance of new tumor lesions. Subjects are allowed to continue study treatment if there is suspicion of pseudo-progression, provided they are asymptomatic and have radiographic progression only, until a second consecutive CT scan demonstrates PD at which time study treatment will be discontinued permanently. Subjects will be evaluated for AEs (all Grades per National Cancer Institute Common Terminology Criteria (...) , myasthenia gravis, systemic lupus erythematosus (SLE), connective tissue disease, scleroderma, inflammatory bowel disease including Crohn's disease and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome. Note: Subject is permitted to enroll if he/she has vitiligo, eczema, type I diabetes mellitus, endocrine deficiencies including thyroiditis managed with replacement hormone and/or physiologic corticosteroid. Subject with rheumatoid arthritis

2017 Clinical Trials

199. Study of Triple Combination of Atezolizumab + Cobimetinib + Eribulin (ACE) in Patients With Recurrent/Metastatic Inflammatory Breast Cancer

to initiation of study treatment; however, the following are allowed: a. Endocrine therapy (SERM, aromatase inhibitor, fulvestrant) b. Palliative radiotherapy for bone metastases > 1 week prior to study treatment c. Stable brain metastasis and asymptomatic treated CNS metastases are allowed, patient must show stable disease by CNS radiographic study >/= 4 weeks from completion of radiotherapy and >/= 2 weeks from discontinuation of corticosteroids AEs from prior anticancer therapy that have not resolved (...) hormone are eligible for the study. b. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. (continuing from #8) c. Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: i. Rash must cover < 10% of body surface area. ii. Disease is well controlled at baseline and requires

2017 Clinical Trials

200. Intermittent Dosing Of Selumetinib In Childhood NF1 Associated Tumours

Phase 2 Detailed Description: Neurofibromatosis type 1 (NF1) is a common autosomal dominant, progressive disorder with an incidence of 1 in 3,500 of the population. NF1 is characterized by diverse, progressive cutaneous, neurological, skeletal and neoplastic manifestations with no standard drug treatment options available. Patients with NF1 have an increased risk of developing tumours of the central and peripheral nervous system including plexiform neurofibromas (PN) (27%) and optic gliomas (15-20 (...) risks of foetal and teratogenic adverse events of an investigational agent. Pregnancy tests must be obtained prior to enrolment on this study for girls of reproductive potential. The need to commence pregnancy testing will be at the discretion of the treating physician to facilitate taking in to account factors such as precocious puberty, endocrine status and medications which can affect pubertal status. Males or females of reproductive potential may not participate unless they have agreed to use

2017 Clinical Trials

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