Kornimate/medical-research-clean huggingface dataset:
supported ventilation in ards patients

Conditions: Acute Respiratory Distress Syndrome; Mechanical Ventilation; Tidal Volume

Summary: acute respiratory distress syndrome (ards) is characterized by acute bilateral pulmonary infiltrates and impairment of oxygen uptake. for example, pneumonia can cause the development of ards. despite modern intensive care treatment, mortality in ards patients remains high (40%). invasive mechanical ventilation (mv) is the mainstay of ards treatment. controlled mv is the conventional ventilation strategy to ensure lung protective ventilation (low tidal volumes) and recovery of the lungs. however, among disadvantages of controlled mv are the development of respiratory muscle atrophy (due to disuse) and the need for high dose sedatives to prevent patient-ventilator asynchrony. the use of high doses of sedatives and respiratory muscle weakness are associated with increased morbidity, worse clinical outcomes and prolonged mv. besides controlled mv, a patient can be ventilated with supported ventilation. supported mv decreases the likelihood to develop muscle atrophy, improves oxygenation and hemodynamics, and lowers consumption of sedatives. however potential disadvantages of supported ventilation include generation of too high tidal volumes, especially in patients with high respiratory drive. a previous study in healthy subjects has shown that titration of neuromuscular blocking agent (nmba) can decrease activity of inspiratory muscles, while maintaining adequate ventilation. it is hypothesized that low dose nmba may enable supported mv with adequate tidal volumes, in patients with high respiratory drive.


Eligibility criteria:
inclusion criteria: * age \> 18 year * informed consent * ards according to the berlin definition * rass -4/-5 * tidal volume \> 8 ml/kg during supported ventilation * double balloon esophageal emg nava catheter exclusion criteria: * recent use of muscle relaxants / nmbas (\< 3 hours) * pre-existent neuromuscular disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including auto-immune diseases * phrenic nerve lesions * elevated intracranial pressure or clinical suspicion of elevated intracranial pressure (i.e. neurotrauma) * open chest or abdomen * pregnancy * systolic blood pressure \< 90 mm hg / map \< 65 mm hg

Keywords: ards mechanical ventilation tidal volume nmba
lenalidomide, dexamethasone and medi-551 in untreated multiple myeloma

Conditions: Myeloma

Summary: this research study is being done to see if combining the investigational chemotherapy drug, medi-551 with the known anti-myeloma drugs, lenalidomide and dexamethasone will reduce your myeloma cancer stem cells.

to explore the effect of lenalidomide, dexamethasone and medi-551 on multiple myeloma cancer stem cells (cscs). myeloma cscs will be assessed by a clonogenic assay from the bone marrow and flow cytometry from peripheral blood.

Eligibility criteria:
inclusion criteria: * age 18 to 100 years at the time screening * symptomatic, previously untreated (with exception of corticosteroids) secretory myeloma * written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations * patient must agree to take lenalidomide with low dose dexamethasone as their initial therapy. * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. * life expectancy of \>6 months * serum creatinine ≤ 2 * anc≥1000 * platelets ≥ 50,000 * total bilirubin ≤ 2 x upper limit of normal (uln) * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 3 x uln * able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin) exclusion criteria: * any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of patient safety or study results. * concurrent enrollment in another clinical study, except for non-interventional, observational studies. * any chemotherapy, immunotherapy, biologic, investigational, for treatment of multiple myeloma other than lenalidomide and dexamethasone. * previous monoclonal antibody (mab) or other treatment specifically directed against cluster of differentiation antigen 19 (cd19). * history of serious allergy or reaction to any component of the medi-551 formulation that would prevent administration. * previous systemic cancer therapy for myeloma. * any active secondary malignancy. * human immunodeficiency virus (hiv) positive serology or acquired immune deficiency syndrome. * active hepatitis b as defined by seropositivity for hepatitis b surface antigen. or patients with positive hepatitis b core antibody titers. * patients with hepatitis c antibody will be eligible provided that they do not have elevated liver transaminases or other evidence of active hepatitis. * documented current central nervous system involvement by multiple myeloma. * previous medical history or evidence of an intercurrent illness that may, in the opinion of the investigator, compromise the safety of the patient in the study. * diagnosis of plasma cell leukemia * diagnosis of poems syndrome * diagnosis of amyloidosis * diagnosis of non-secretory myeloma
safety and efficacy extension study of daclizumab high yield process (dac hyp) in participants with multiple sclerosis who have completed study 205ms201 (nct00390221) to treat relapsing-remitting multiple sclerosis

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the primary objective of the study was to assess the safety and immunogenicity of extended treatment with dac hyp. this evaluation included the following major components: * an assessment of safety and immunogenicity of extended treatment with dac hyp when administered to ms subjects who had completed 52 weeks of active therapy with dac hyp in study 201. * an assessment of safety and immunogenicity during a 6-month washout period from dac hyp. * an assessment of safety and immunogenicity during reinitiation of therapy with dac hyp after a 6-month washout period. * an assessment of safety and immunogenicity of dac hyp when administered to ms subjects who previously received placebo during study 201. the secondary objective is to assess the durability of the effect of dac hyp on multiple sclerosis (ms) disease activity as measured by brain magnetic resonance imaging (mri) scans and clinical ms relapses.

this study, an extension to study 205ms201 (nct00390221), will evaluate the long-term safety, efficacy, and immunogenicity of dac hyp in ms. in study 205ms201, study treatment was scheduled to stop at the week 52 visit. this extension study will provide for the initiation of active therapy with dac hyp among participants who received placebo during weeks 0 through 52 in 205ms201. in addition, participants who received active therapy with dac hyp during weeks 0 through 52 in study 205ms201 will continue dac hyp therapy or resume dac hyp therapy after a 6-month washout period in this study.

Eligibility criteria:
key inclusion criteria: * participated in study 205ms201 (nct00390221) for at least 52 weeks and was compliant with the 205ms201 protocol in the opinion of the investigator. key exclusion criteria: * subjects with any significant change in their medical status from 205ms201 that would preclude administration of dac hyp, as determined by the investigator * any subject who has permanently discontinued study treatment in study 205ms201 except subjects who were unblinded during evaluation of an adverse event (ae) and found to be on placebo * planned ongoing treatment with any approved or experimental treatment for ms except for the protocol-allowed use of concomitant interferon-beta note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: ms multiple sclerosis
clinical efficacy and adverse reactions of antipsychotic treatment

Conditions: Metabolic Disturbance; Hyperprolactinemia; Schizophrenia

Summary: the goal of this clinical trial is to explore the potential of metformin in managing olanzapine-induced metabolic disturbance and hyperprolactinemia in patients with schizophrenia. the main questions it aims to answer are: 1. the effect of metformin on olanzapine-induced metabolic disturbance 2. the effect of metformin on olanzapine-induced hyperprolactinemia participants will receive metformin 1500 mg/day for 8 weeks and assessments every 2 weeks.

the study was conducted in an inpatient setting, with the dosage of olanzapine remaining consistent throughout the study duration. all participants were administered 1500 mg/day of metformin for eight weeks. vital signs were measured daily. physical and neurological examinations were carried out on a weekly basis. every two weeks, all participants underwent an assessment for general psychopathology. blood samples were collected in the morning after an overnight fast at the beginning of the study and then every two weeks following the commencement of metformin treatment. serum prolactin levels were determined through electrochemiluminescence immunoassays. fasting serum levels of glucose, total cholesterol, high-density lipoprotein cholesterol (hdl-c), low-density lipoprotein cholesterol (ldl-c), and triglycerides were measured using enzymatic colorimetric assays. serum insulin and leptin levels were measured using electrochemiluminescence immunoassay kits.

Eligibility criteria:
inclusion criteria: * aged between 18 and 60 years * diagnosed with schizophrenia under the diagnostic and statistical manual of mental disorders-fourth edition criteria * had been consistently treated with a stable dose of olanzapine for a minimum of three months exclusion criteria: * exclusion criteria encompassed any mental disorder other than schizophrenia, ongoing substance abuse, and medical conditions that could interfere with glucoregulatory and endocrine assessment such as diabetes mellitus and other endocrine disorders. additionally, severe cardiovascular, hepatic, or renal diseases, malignancy, epilepsy, and pregnancy were also reasons for exclusion.

Keywords: schizophrenia olanzapine metabolic disturbance prolactin
intestinal glucagon-like peptide-1 (glp-1) and the physiological role in eating in humans

Conditions: Appetite and General Nutritional Disorders

Summary: the aim is to further establish a physiological role for glp-1 as an endogenous satiety signal by examining the effect of the specific glp-1 receptor antagonist exendin (9-39) on appetite and food intake in healthy male subjects.

understanding the exact mechanisms by which glp-1 inhibits eating can be crucial in order to convert its anorectic action into useful, safe and effective drugs. so far, it is however not clear to what extent glp-1 is a hormonal regulator of eating or whether the observed effects are rather a pharmacological phenomenon. by applying classical algorithms from endocrinology several criteria must be fulfilled before a hormone can be considered an endogenous physiological satiety signal. one is that exogenous administration of a selective antagonist should prevent the eating-inhibitory effect of glp-1. at present, cholecystokinin (cck) is the only peptide in humans identified to fit these criteria. for intestinal glp-1, it has not been investigated whether a specific glp-1 receptor antagonist can block the eating-inhibitory effect in humans. the availability of a specific glp-1 receptor antagonist, exendin (9-39), now makes it possible to further investigate this pathway. exendin (9-39), is a powerful tool available for human use to characterize of endogenous glp-1 as a physiological regulator of different biological functions. the molecule has been used to document that endogenous glp-1 is an important incretin hormone and a regulator of antro-pyloro-duodenal motility. the role of endogenous glp-1 in regulating food intake and appetite has, however, not been investigated before.

Eligibility criteria:
inclusion criteria: 1. healthy male subject with a bmi of 19-25 m2/kg 2. stable body weight for at least three months 3. normal eating habits 4. age between 18 and 45 years 5. sufficient understanding of the german language 6. subjects understand the procedures and the risks associated with the study 7. participants must be willing to adhere to the protocol and sign the consent form exclusion criteria: 1. participation in another clinical trial (currently or within the last 30 days) 2. smoking 3. substance abuse 4. regular intake of medications (except for oral contraceptives) 5. chronic or acute medical condition including clinically relevant abnormality in physical exam or laboratory values 6. history of gastrointestinal disorders 7. food allergies

Keywords: glp-1 satiation peptides food intake
clinical effects of radiofrequency in fibromyalgia

Conditions: Fibromyalgia

Summary: the aim of this study is to analyze the effects of a single-session of radiofrequency in patients with fibromyalgia in comparison to a placebo group.

the aim of this study is to analyze the effects of a single-session of radiofrequency on peripheral vascular blood flow of the skin of the hands and core body temperature in patients with fibromyalgia in comparison to a placebo group. also, to study the clinical effects of the intervention on subjective pain perception, pain threshold to pressure and electrical pain threshold and intensity.

Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia in accordance with the american college of rheumatology criteria for classifying fibromyalgia (2016 revision) by a rheumatologist of the public health system of andalusia (spain) * age from 18 to 70 years * no other rheumatic diseases * absence of regular physical activity * limitation of usual activities due to pain on at least 1 day out of the previous 30 exclusion criteria: * male sex * presence of cardiac, renal or hepatic insufficiency; * severe physical disability * pregnancy or lactation * active infections * psychiatric illness * active tumor. * treatment with vasoactive drugs or anticoagulants or a history of drug use * skin disorders * any other non-pharmacological therapy

Keywords: radiofrequency therapy peripheral blow flow core body temperature pain central sensitization peripheral nervous system thermography
collection of blood and urine specimens from volunteers utilizing health examination services

Conditions: Chronic Diseases; Hypertension; Diabetes; Obesity; Chronic Renal Failure

Summary: in summary, the researchers want to construct a longitudinal data bank using voluntary health examination participants. researchers in the national taiwan university hospital (ntuh) campus can utilize these data to clarify the effects of several genetic and environmental factors on various common diseases in taiwan in the future.


Eligibility criteria:
inclusion criteria: * persons who sign informed consent exclusion criteria: * age below 18 years

Keywords: chronic diseases, such as hypertension, diabetes, obesity, chronic renal failure, and so on
use of seamguard to prevent leak and bleeding in gastrointestinal surgery

Conditions: Leak on Lineal Stapled Anastomoses; Bleeding on Lineal Stapled Anastomoses

Summary: the purpose of this study is to determinate the utility of staple-line reinforcement on lineal gastrointestinal anastomoses. hypothesis: seamguard device will decrease the incidence of leak and bleeding in digestive lineal stapled anastomoses.


Eligibility criteria:
inclusion criteria: * all patients who will need a lineal stapled anastomoses (colon cancer in cecum, for example) exclusion criteria: * circular anastomoses * bariatric surgery

Keywords: seamguard staple-line reinforcement leak bleeding
a long term study of lanthanum carbonate in patients requiring dialysis who have ived lanthanum carbonate in previous studies defined by the protocol.

Conditions: Kidney Failure, Chronic

Summary: the purpose of this study is to assess the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment.


Eligibility criteria:
inclusion criteria: * patients who participated in lam-iv-301, lam-iv-303, lam-iv-307 or lam-iv-308 and received lanthanum carbonate * patients must continue to require treatment with a phosphate binder for hyperphosphatemia * male or non-pregnant female who agrees to use an effective contraceptive method while on study treatment and for 30 days thereafter exclusion criteria: * patients withdrawn from lam-iv-301, lam-iv-303 or lam-iv-307 prior to randomization * patients withdrawn from lam-iv-301, lam-iv-303, lam-iv-307 or lam-iv-308 due to adverse events termed "possible" or "related" to study medication * pregnant or lactating women
study of ipilimumab (mdx-010) monotherapy in patients with previously treated unresectable stage iii or iv melanoma

Conditions: Melanoma

Summary: the purpose of this clinical research study is to compare the best overall response rate (borr)(as per modified who criteria) in patients with previously treated, therapy-refractory, or -intolerant, stage iii (unresectable) or stage iv melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. the safety of this product will also be evaluated.


Eligibility criteria:
inclusion criteria: * patients with previously treated, therapy-refractory or -intolerant, stage iii (unresectable) or stage iv melanoma

Keywords: stage iii (unresectable) stage iv melanoma
study to evaluate the long-term safety, tolerability and efficacy of dalfampridine.

Conditions: Post-ischemic Stroke

Summary: this is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-er.

this is an extension study to evaluate the long-term safety, tolerability, and efficacy of two dose strengths of dalfampridine-er twice daily tablets when administered for at least 12 months to subjects with chronic post-ischemic stroke walking deficits who have completed the controlled, double-blind study dalf-ps-1016.

Eligibility criteria:
key inclusion criteria: * completion of the dalf-ps-1016 study * providing informed consent to continue into the dalf-ps-1029 long-term extension study * sufficient ambulatory ability to independently complete the two minute walk test (2minwt) and 10 meter walk test (10mwt) at the time of enrollment into the extension study key exclusion criteria: * seizures, new onset strokes (or other significant neurological event precluding long-term continuation) occurring during the antecedent dalf-ps-1016 study * calculated creatinine clearance of ≤ 50 ml/minute at the time of enrollment into the long-term extension study
the pharmacokinetics of azithromycin prophylaxis for cesarean delivery

Conditions: Endometritis

Summary: pkaz is a single institution study designed to evaluate the optimal dosing parameters for azithromycin for pre-surgical cesarean prophylaxis. hypothesis: pre-operative administration of azithromycin results in maternal and neonatal tissue concentrations that adequately treat microbes commonly involved in post-cesarean infections.


Eligibility criteria:
inclusion criteria: * women 19 years and older * term (37 weeks and greater) * singleton gestation * scheduled cesarean section * non-laboring * intact membranes exclusion criteria: * \< 19 years of age * preterm (\< 37 weeks) * multifetal gestation * laboring or ruptured membranes * known fetal anomaly * oligo- or polyhydramnios * macrolide allergy * macrolide exposure within 2 weeks * medical co-morbidities * hepatic or renal impairment * taking medications that prolong the qt interval * currently taking nelfinavir, efavirenz, or flucanozole * structural heart defects or arrythmia

Keywords: pregnancy cesarean section antibiotic
observational usage and efficacy study of candesartan in heart failure treatment in france

Conditions: Heart Failure; Cohort Study

Summary: the purpose of this study is to describe the way candesartan is used in heart failure treatment in france (treatment initiation and monitoring), treatment stops occurrence and reasons for and patients clinical evolution


Eligibility criteria:
inclusion criteria: * outpatients to whom candesartan has been initiated for less than 30 days or during the consultation to treat heart failure exclusion criteria: * patients included in a clinical trial the last 30 days before consultation * patients unable to answer the questions for linguistic or cognitive reasons * patients who will be difficult to follow during the one year study

Keywords: candesartan heart failure cohort study france
translating data science to palliative care

Conditions: Alzheimer's Disease and Related Dementias

Summary: this research study is intended to 1) better understand seriously ill adults' and their family care partners' (fcp), particularly for persons living with dementia (plwd), barriers to accepting community-based palliative care (cbpc); 2) develop an intervention to address barriers; and 3) pilot test whether the intervention has an impact on cbpc uptake. the intervention will consist of 1) a set of informational material describing the benefits of cbpc for the cbpc team to use when presenting cbpc to members of a medicare advantage plan and their fcp; and 2) processes for tailoring information delivery so that eligible members and their fcp receive information about cbpc that reflects their individualized risk as identified by the medicare advantage program's validated 12-month mortality risk algorithm. the clinical trial portion of the study refers to the pilot test (aim 3 as described below).

aim 1. engage family care partners (fcps) and community based palliative care (cbpc) team members to identify barriers to cbpc. aim 1 will incorporate the perspectives of cbpc team members and medicare advantage (ma) plan members and fcps of person living with dementia (plwd) and those with other diagnoses who refused cbpc services. aim 2. develop and obtain feedback on a) informational materials for cbpc team members to use when speaking with ma members and fcps about cbpc and b) processes for tailoring information delivery based on a members's algorithm-identified risk profile. most participants will be recruited from aim 1 participants. additional participants will be recruited as necessary. aim 3. conduct a pre-post trial to determine the feasibility and acceptability of the materials and using them in existing clinical workflows for their a) impact on cbpc enrollment for cbpc-eligible individuals, including plwd, and b) end-user satisfaction.

Eligibility criteria:
inclusion criteria: * vns health total medicare advantage plan member * identified as eligible for community-based palliative care by the vns health total palliative care team during the study period (6-month period prior to introduction of the intervention and the 6-month period following the intervention) * 18 years of age or older exclusion criteria: * non-vns health total medicare advantage plan member * vns health total plan members not identified as eligible for community-based palliative care by the palliative care team during the study period (6-month period prior to introduction of the intervention and the 6-month period following the intervention) * under 18 years of age

Keywords: palliative care community based palliative care family care partner algorithm