Kornimate/medical-research-clean huggingface dataset:
the impact of quantitative neuromuscular monitoring in the pacu on residual blockade and postoperative recovery

Conditions: Muscle Weakness

Summary: neuromuscular blocking drugs (nmbds) provide anesthesiologists with powerful intraoperative tools, but their use carries the potential risk of serious postoperative complications. nmbd-induced muscle weakness that lingers into the postoperative period, known as postoperative residual curarization (porc), is present in as many as 40% of all patients that receive neuromuscular blocking agents. the post anesthesia care unit will be introducing monitoring as part of standard of care. this study will collect data about patients who receive nmbds and examine the impact of monitoring on incidences of porc. our study is designed to test the following hypotheses: hypothesis 1: the initiation of quantitative tof monitoring as part of the standard pacu entry evaluation will change practitioner behavior in a manner that decreases the incidence of porc in surgical patients at vumc. hypothesis 2: the initiation of the routine tof monitoring program will decrease the incidence of short- and long-term postoperative complications at vumc.

neuromuscular blocking drugs (nmbds) provide anesthesiologists with powerful intraoperative tools, but their use carries the potential risk of serious postoperative complications. nmbd-induced muscle weakness that lingers into the postoperative period, known as postoperative residual curarization (porc), is present in as many as 40% of all patients that receive neuromuscular blocking agents. physiological data suggest that porc impairs normal respiratory function, and compelling evidence suggests porc impairs clinical recovery in the immediate postoperative period and prolongs pacu length of stay. however, despite the widespread use of nmbds and the frequent occurrence of porc, limitations in the literature prevent an understanding of their full impact on clinical outcomes. this study will collect data about patients who receive nmbds and examine the impact of monitoring on incidences of porc. the incidence of porc and postoperative complications after the introduction of monitoring in the pacu will be determined by measuring tof ratios and tracking the postoperative outcomes in the surgical patients over time.

Eligibility criteria:
inclusion criteria: * surgical patients \> 18 years of age * received one or more nmbds during surgery * surgery took place during the first 120 days following the introduction of tof monitoring in the pacu exclusion criteria: * surgical patients \< 18 years of age * received no nmbds during surgery * transfer from the or to the pacu was delayed (by high pacu volume, for example) * had a procedure or has a preexisting condition that prevents accurate monitoring

Keywords: post operative residual curarization neuromuscular blocking drugs
obstetric antiphospholipid antibody syndrome : contribution of the evaluation of adamts13 made at the diagnosis of pregnancy on evaluation the risk of pre-eclampsia

Conditions: Antiphospholipid Antibody Syndrome in Pregnancy

Summary: study based on data concerning the first pregnancy treated and followed up after the diagnosis of oaps in the noh-aps cohort, according to clinical results already published; and on a thematic library collected and preserved at the time of the positive pregnancy test. adamts 13 will be explored in the available samples defined above: adamts13 antigen (presence of the molecule), adamts13 activity (vwf proteolysis activity of the molecule), global autoantibodies against adamts13 (plasma antibodies recognizing solid phase insolubilized adamts13), these 3 parameters for the description of adamts13 being measured using commercially available diagnostic kits, elisa type, technozyme® range, technoclone, vienna, austria. the clinical endpoint evaluated will be the occurrence (yes/no) of preeclampsia, which is assessed globally, all subtypes combined. then evaluated according to subtype: late preeclampsia from 34 weeks, early preeclampsia before 34 weeks, eclampsia (convulsions), hellp syndrome, preeclampsia associated with the birth of a small-for-gestational-age child (defined at percentile 10 of the tables adjusted for gestational age and sex; severe: defined at percentile 3), preeclampsia associated with a retro-placental hematoma, ...


Eligibility criteria:
inclusion criteria: * presence of frozen plasma samples from the positive pregnancy test blood sample. * adult patients, included in the noh-aps cohort, who have successfully initiated a new pregnancy after diagnosis of oaps. exclusion criteria: * absence of frozen plasma sample from the blood sample from the positive pregnancy test. * patient who objected to the use of their data.
window study of zd4054 in metastatic prostate cancer

Conditions: Prostate Cancer; Metastasis

Summary: this is a prospective study in which patients with castrate-resistant prostate cancer and bone metastases will undergo imaging, donate blood, bone marrow and urine samples, and where possible primary tumour and bone metastatic tissue, before and during treatment with zd4054, an orally active specific endothelin-a antagonist. the samples will be used primarily for biomarker studies, and it is hypothesized that these will inform on the mechanism of action of this drug. magnetic resonance imaging (mri) will be performed to evaluate emerging functional imaging endpoints as markers of early response in bone metastatic prostate cancer.


Eligibility criteria:
inclusion criteria: * histological confirmation of prostate adenocarcinoma * documented evidence of bone metastasis on bone scan or mri * biochemical progression of prostate cancer * surgically or medically castrate with serum testosterone ≤2.4nmol/l * ecog performance status 0 - 2 * life expectancy of 6 months or more. exclusion criteria: * radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment. * prior targeted cancer therapies (such as gefitinib, bevacizumab) * systemic radionuclide therapy within 12 weeks of starting study treatment. * current therapy, within 4 weeks of study entry with potent inhibitors of cyp3a4 (ketoconazole, itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem and verapamil), inhibitors of cyps 2d6 and 2c9 (quinidine and fluconazole), and potent p450 inducers (phenytoin, rifampicin, carbamazepine and phenobarbitone) * definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonists * ineligibility for mri scanning includes standard mri criteria (for example, metal implants such as cochlear implants, cardiac pacemakers, heart valves, aneurysm clips and metal fragments in eyes) and patients known to be allergic to gadolinium-based mri contrast agents

Keywords: castrate-resistant prostate cancer with bone metastasis
the effects of anabolic steroids and protease inhibitors on people living with hiv/aids

Conditions: HIV; AIDS; Lipodystrophy; Hyperlipidemia

Summary: the main aim of the study is to investigate the combined effects of using anabolic steroids and protease inhibitors on fat metabolism and body composition of people living with hiv/aids. we are seeking to answer the following questions: 1) are there any significant differences in serum blood lipids, lipodystrophy, in persons with hiv taking antiretroviral therapies and anabolic steroids versus antiretroviral therapies alone?

changes in body composition and wasting have been a constant concern for people living with hiv/aids. testosterone and its derivatives, anabolic steroids (as) are being used by persons with hiv/aids (pha's) to treat aids related wasting syndrome and also for bodybuilding purposes. some studies have shown that as had a positive impact on the weight and well-being of hiv seropositive individuals. it has been shown that protease inhibitors (pi's) in combination with other antiretroviral hiv therapies are associated with a symmetrical loss of subcutaneous fat from the body surface (lipodystrophy)in some phas. the mechanism for lipodystrophy is not well understood. however, it is associated with hyperlipidemia that contributes to central fat deposition, insulin resistance, and in some, type 2 diabetes. as well, increased visceral abdominal fat and loss of fat inthe arms, legs and face, and increased levels of serum lipids have been reported.the health effects of anabolic steroid therapy coupled with pis has not been examined before. this study is an observational study investigating the phenomenon of lipodystrophy in an hiv population already exposed to as and pis. a prospective observational design will be employed, with two groups recruited. one group will be taking as and pi's, the other will be taking pis only. the groups will be asked to completed quality of life nutrition and physical activity questionnaires. serum blood lipid characteristics will be compared, and body composition will be determined using mris, bia's and skinfold measurements.

Eligibility criteria:
inclusion criteria: * documented hiv seropositive status * 18 years of age or older * combination antiretroviral therapies for at least three months or more * able to comply with study procedures and protocol * signed informed consent exclusion criteria: * acute opportunistic infections at baseline * use of serum lipid lowering drugs * use of serum sugar controlling drugs * evidence of drug or alcohol use which may interfere with study participation * a recent illness with associate weight loss of greater than or equal to 10lbs

Keywords: hiv aids testosterone anabolic steroid body composition lipodystrophy mri bia skinfold measurements protease inhibitors
early mri detection of myocardial deterioration as a preventive, disease staging, and prognostic biomarker in insulin resistance

Conditions: Cardiomyopathies; Insulin Resistance; Non-ischemic Cardiomyopathy; Cardiac Fibrosis; Diabetes

Summary: the purpose of this study is to evaluate the relationship between insulin resistance (ir) and myocardial tissue abnormalities. the study will focus on a patient population, south asians, with a high prevalence of ir.

cardiac fibrosis has been linked to adverse outcomes in non-ischemic cardiomyopathy. fibrosis is also detectable in diabetic patients, but does not appear to closely track with insulin sensitivity. hence, fibrosis may be an independent risk factor for adverse outcomes in ir and diabetic patients. as a result, a critical need exists to develop a non-invasive tool to identify and treat the highest-risk patients. early detection of cardiac fibrosis and other cmr- detectable abnormalities in ir patients may help to 'stage' a patient's disease process and future risk of events, ultimately leading to an adjustment in the aggressiveness of their medical management and long-term monitoring accordingly. this project is aimed at reducing the mortality and morbidity associated with insulin resistance and diabetes, and the investigators believe this project could have a transformative impact on long-term diabetic care and shed new light upon the biology of diffuse cardiac fibrosis in insulin resistance and diabetes and its role in shaping the long-term cardiovascular risk for these patients.

Eligibility criteria:
inclusion criteria: - south asian exclusion criteria: * pregnant women * patients with prior diagnoses of diabetes * patients on insulin therapy * patients with known coronary heart disease or other non-ischemic cardiomyopathies

Keywords: south asian insulin resistance cardiac fibrosis mri diabetes cardiomyopathy
vascular and metabolic effects of fenofibrate/omega vs fenofibrate

Conditions: Hypertriglyceridemia

Summary: the investigators hypothesize that fenofibrate/omega will improve insulin resistance compared with fenofibrate


Eligibility criteria:
inclusion criteria: * hypertriglyceridemia exclusion criteria: * moderate or severe hypertension, uncontrolled diabetes (hba1c \> 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease

Keywords: insulin resistance
an efficacy and safety study of telaprevir in patients infected with both chronic hepatitis c virus (hcv-1) and human immunodeficiency virus (hiv-1)

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (peg-ifn-alfa-2a) and ribavirin (rbv) in the treatment of hepatitis c in patients infected with both chronic hepatitis c virus (hcv-1) and human immunodeficiency virus (hiv-1).

this is an open-label (both participant and investigator know the name of the medication given at a certain moment), single-arm, multicenter study in hcv treatment-naive and treatment-experienced patients infected with both chronic hcv-1 and hiv-1 to determine the efficacy and safety of telaprevir given with peg-ifn-alfa-2a and rbv. the study will consist of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up period of 24 weeks. all patients will receive 12 weeks of treatment with telaprevir given with peg-ifn-alfa-2a and rbv. at week 12 telaprevir dosing will end and patients will continue on peg-ifn-alfa-2a and rbv. the total treatment duration in this study will be 24 or 48 weeks depending on the patient's prior hcv treatment status, liver disease status, and individual on-treatment virologic response in this study (equal response guided therapy). the maximum total duration of participation in the study for an individual participant will be approximately 76 weeks (screening included). approximately 150 patients infected with both chronic hcv-1 and hiv-1 are planned to be enrolled.

Eligibility criteria:
inclusion criteria: * chronic (detectable hcv ribonucleic acid (rna) more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) hcv infection genotype 1 with hcv rna level greater than 1,000 iu/ml * confirmed diagnosis of hiv-1 infection greater than 6 months before the screening visit * cd4 count greater than 300 cells/mm3 at screening and no value less than 200 cells/mm3 within 6 months of screening visit * hiv-1 rna undetectable by an ultrasensitive assay at least once within 90 days of the screening visit * no hiv rna values greater than 200 copies/ml within 6 months of the screening visit * currently taking one of the permitted anti-hiv regimens for greater than or equal to12 weeks exclusion criteria: * anticipated need to switch anti-hiv regimen from screening through the telaprevir treatment period * infection or co-infection with hcv other than genotype 1 * contraindication to the administration of peg-ifn-alfa or rbv * hepatitis b virus (hbv) co-infection * acute or active condition of hiv-associated opportunistic infection within 6 months of screening

Keywords: chronic hepatitis c genotype 1 chronic hepatitis c treatment experienced with hcv-1/hiv-1 coinfection telaprevir pegylated-interferon-alfa-2a ribavirin hcv-1/hiv-1 coinfection hepatitis c
hypophosphatemia and bronchiolitis

Conditions: Hypophosphatemia; Bronchiolitis

Summary: bronchiolitis is a major public health problem and the leading cause of paediatric intensive care unit admission in infants. hypophosphatemia is common in adult intensive care units and was associated with an increase of the duration of mechanical ventilation and the length of stay. our hypothesis is that hypophosphatemia is common in bronchiolitis and could be a marker of severity.


Eligibility criteria:
inclusion criteria: * age \> 7 days and \< 3 months of life * admission to the pediatric intensive care unit from 01/11/2016 to 31/03/2020 * with a diagnosis of moderate to severe bronchiolitis according to has 2019 criteria exclusion criteria: * renal failure and tubulopathy * previous disorder of phospho-calcium balance * malignant pathology * lenght of stay less than 24 hours * history of cardiac, aortic or hepatic surgery

Keywords: hypophosphatemia bronchiolitis paediatric intensive care unit risk factor
a phase 1 study of bgb-b2033, alone or in combination with tislelizumab, in participants with advanced or metastatic solid tumors

Conditions: Metastatic Hepatocellular Carcinoma; Advanced Hepatocellular Carcinoma; Alpha-fetoprotein (AFP)-Producing Gastric Cancer; Extragonadal Yolk Sac Tumors; Glypican-3 (GPC3)-Positive Squamous Non-small Cell Lung Cancer; Metastatic Solid Tumor

Summary: this study is a first-in-human (fih) phase 1 study of bgb-b2033 to assess the safety, tolerability, pharmacokinetics (pk), pharmacodynamics, and preliminary antitumor activity of the bgb-b2033 in participants with advanced or metastatic hepatocellular carcinoma (hcc), alpha-fetoprotein (afp)-producing gastric cancer (gc), extragonadal yolk sac tumors, non-dysgerminomas, or glypican-3 (gpc3)-positive squamous non-small cell lung cancer (nsclc). the study will also identify the recommended phase 2 dose (rp2d) of bgb-b2033 alone and in combination with tislelizumab for subsequent studies. bgb-b2033 will be administered by intravenous infusion. the phase 1 study will be conducted in 2 parts: part a (monotherapy dose escalation and safety expansion) and part b (combination dose escalation and safety expansion).


Eligibility criteria:
inclusion criteria: 1. participants with any of the following unresectable locally advanced or metastatic tumor types: 1. hcc 2. afp-producing gc (serum afp \> 20 ng/ml or tumor tissue afp positive by a validated ihc assay according to local testing criteria) 3. germ cell tumor including extragonadal yolk sac tumors (located in mediastinum, vagina, brain, and retroperitoneum, etc) and non-dysgerminomas 4. gpc3-positive squamous nsclc 2. ≥ 1 evaluable lesion for dose escalation and ≥ 1 measurable lesion for safety expansion, per recist v1.1 3. ecog performance status score ≤ 1 4. adequate organ functions 5. tumor tissues will be required for certain parts of the study exclusion criteria: 1. prior therapy targeting glypican-3 (gpc3) or the t-cell costimulatory receptor 4-1bb (also known as cd137) 2. active leptomeningeal disease or uncontrolled, untreated brain metastasis 3. active autoimmune diseases or history of autoimmune diseases that may relapse 4. any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent 5. any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s). 6. certain comorbidities in the lung, heart, bleeding condition and infections. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hcc gc gpc-3 gpc3-positive squamous non-small cell lung cancer nsclc bgb-b2033 tislelizumab metastatic hepatocellular carcinoma advanced hepatocellular carcinoma alpha-fetoprotein (afp)-producing gastric cancer extragonadal yolk sac tumors squamous non-small-cell lung cancer non-dysgerminomas
alpn-101 (acazicolcept) in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this is phase 2, multinational, randomized, blinded study to evaluate the safety, tolerability, efficacy, immunogenicity, pharmacokinetics and pharmacodynamics of alpn-101 (acazicolcept) in adults with moderate to severe active systemic lupus erythematosus (sle)


Eligibility criteria:
key inclusion criteria summary * sle onset ≥ 6 months prior to screening * positive ana and/or elevated anti-dsdna and/or elevated anti-smith antibody test * active lupus at screening and baseline, as defined per-protocol and confirmed by the study's medical monitor, including a sledai score at screening of ≥ 6 and a clinical score at baseline of ≥ 4 * standard lupus medications must be stable prior to screening key exclusion criteria summary: * life-threatening or organ system-threatening lupus activity that is anticipated to require increased treatment during the study * proteinuria consistent with nephrotic syndrome * active lupus-related neuropsychiatric disease * drug-induced lupus * recent or serious ongoing infection; risk or history of serious infection * receipt of live vaccination within 8 weeks of day 1, or expected to require live vaccination during the study * prior diagnosis of, or fulfills diagnostic criteria for, another rheumatic disease that overlaps with lupus or another autoimmune or inflammatory disease that may confound clinical assessments or increase subject risk in the study * diagnosis of, or fulfills diagnostic criteria for fibromyalgia * functional class iv * serious lupus disease activity, which warrants immediate immunosuppressive therapy not appropriate for the study or which makes the possibility of receiving placebo or investigational agent an inappropriate risk

Keywords: cd28 icos autoimmune disease immune system disease immunosuppressive agent
combined intralesional triamcinolone injection with whole breast detection radical surgery

Conditions: Refractory Granulomatous Lobular Mastitis

Summary: granulomatous lobular mastitis (glm) is a rare, chronic benign inflammatory disease of the breast, of unknown etiology. pathologically, glm typically manifests as non-caseating granulomatous lesions with leukomonocytes, lymphocytes, neutrophils and multinucleated giant cells, located in the center of breast lobules. with a rapidly increasing morbidity in the last two decades, glm tends to occur in child-bearing women with a prolonged and recurrent course. intralesional injection and topical corticosteroids can effectively reduce the side effects, especially in patients suffering from concomitant skin lesions (e.g., fistula, skin erosions, ulcers).for patients with diffuse disease, recurrence, or ineffective conservative treatment, wide local excision can be applied.


Eligibility criteria:
inclusion criteria: * patients who were pathologically diagnosed as refractory granulomatous lobular mastitis. * lesions are extensively distributed to more than three quadrants or with abscesses, sinus, fistula and persistent wound infection (skin ulceration and pus). * patients voluntarily participate in studies with informed consent. exclusion criteria: * history of breast surgery. * patients who choose conservative treatment.

Keywords: granulomatous lobular mastitis corticosteroids surgery