Kornimate/medical-research-clean huggingface dataset:
nutritional intervention and outcomes in elderly after hip fracture surgery

Conditions: Elderly Patients; Malnutrition; Hip Fractures; Nutritional Intervention; Perioperative Outcomes; Survival

Summary: hip fracture is one of the most frequently occurred injury in the elderly and usually requires surgical treatment. malnutrition is common in elderly patients with hip fracture and is associated with worse outcomes. this study is designed to test the hypothesize that, in elderly patients with malnutrition or at risk of malnutrition and scheduled for hip-fracture surgery, perioperative nutritional intervention may reduce early complications and improve long-term survival.

elderly patients with hip fracture have a high rate of malnutrition. in a cohort study of hip fracture patients aged 70 years or older, 18.8% have malnutrition and 44.6% are at risk of malnutrition. increasing evidence suggest that preoperative nutritional status has a significant impact on clinical outcomes of elderly patients following surgery. for example, preoperative malnutrition or risk of malnutrition is associated with increased delirium, increased non-delirium complications, prolonged hospital stay, high mortality, and even worse long-term survival after surgery. we speculate that perioperative nutritional intervention may reduce postoperative delirium and improve early and long-term clinical outcomes in elderly hip-fracture patients. the purpose of this study is to observe the effect of perioperative nutritional intervention on early postoperative delirium and complications as well as long-term survival in the patients with malnutrition or at risk of malnutrition who are scheduled for hip-fracture surgery.

Eligibility criteria:
inclusion criteria: * age ≥70 years old; * hospitalized for hip fracture, scheduled to undergo hip-fracture surgery within 48 hours; * classified as malnutrition or at risk of malnutrition according to the short form mini-nutrition assessment (mna-sf); * provide written informed consents. exclusion criteria: * pathological fracture; * history of schizophrenia, epilepsy, parkinson's disease, or myasthenia gravis before surgery; * unable to communicate due to coma, severe dementia, or language barrier; * unable to eat due to any disease in the gastrointestinal system; * severe hepatic dysfunction (child-pugh class c), renal failure (requirement of renal replacement therapy), respiratory failure (requirement of respiratory support), cardiac insufficiency (new york heart association classification ≥iv), or american socisty of anesthesiologists classification ≥iv; * preexisting organ injury before surgery (delirium, acute kidney injury, myocardial injury, etc.); * other conditions that are considered unsuitable for study participation.

Keywords: elderly patients malnutrition hip fractures nutritional intervention perioperative outcomes long-term survival
long term safety and efficacy of fixed dose combination gsp 301 nasal spray (ns) in the treatment of perennial allergic rhinitis (par)

Conditions: Perennial Allergic Rhinitis

Summary: to evaluate the long term safety and efficacy of gsp 301 ns compared to 2 placebo ns formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)


Eligibility criteria:
inclusion criteria: 1. aged ≥12 years and older inclusive of either sex. 2. documented clinical history of par (for at least 2 years preceding the screening visit \[visit 1\]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce par. documentation of a positive result within 12 months prior to the screening visit (visit 1) is acceptable. exclusion criteria: 1. pregnant or lactating women. 2. history of anaphylaxis and/or other severe local reaction(s) to skin testing. 3. history of positive test for hiv, hepatitis b or hepatitis c infection. 4. documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. 5. subjects with an active pulmonary disorder or infection. 6. subjects with posterior subcapsular cataracts or glaucoma
nephronic reduction after neonatal acute renal failure in preterm

Conditions: Neonatal Acute Renal Failure in Preterm

Summary: the aim of this study is to evaluate the signs of nephronic reduction in preterm infants who have presented neonatal acute renal failure. the investigators hypothesize that signs of nephronic reduction would appear earlier in former preterm with neonatal acute renal failure than in control preterm infants.

50 former preterm infants who presented acute renal failure will be evaluated between 3 to 10 years. they will be compared to 25 control former preterm infants without renal dysfunction for signs of nephronic reduction. at inclusion, in order to analyse renal function, all infants will have blood sampling, renal echography and blood pressure measurement. urine sample will also be collected. two months later, parents will be informed on the results.

Eligibility criteria:
inclusion criteria: * for both group of cases (50 infants having presented acute renal failure in preterm) and group of control cases (25 infants without this) :former preterm infant born before 33 weeks of gestational age between january 2003 and june 2010 and hospitalized in the neonatal intensive care unit of nantes university hospital. * specific to cases: neonatal acute renal failure: serum creatinine\>130 micromol/l from the third day of life. * control cases: no such renal dysfunction exclusion criteria: * no parental consent * other causes of renal failure: congenital uropathy, congenital nephropathy * congenital cardiopathy, polymalformative syndrome

Keywords: preterm infants acute renal failure nephronic reduction
salivary proteome and sensitivity to bitterness

Conditions: Healthy

Summary: this study aims to establish whether the protein composition of healthy males contribute to their sensitivity to the bitterness of caffeine.


Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * smokers * currently suffering from oral pathologies * sensory aversion to bitterness

Keywords: sensitivity to caffeine
indication to transplant patients with high risk b cells lymphoma in metabolic complete remission?

Conditions: Lymphoma, B-Cell

Summary: the autograft of patients with prognostically unfavourable b-cells lymphoma cells in first remission remains controversial, in particular since the association of rituximab with chemotherapy. even though many randomized and non-randomized studies have been conducted, their is still no standard procedure . recently, the use of early tep (positron emission topography) answer, after 2 in 3 cures of chemotherapy allowed to select the poor-responder patients who remain candidate to autograft in front-line. nevertheless, in good-responder patients, the benefits of an intensification therapy ins term of long-lasting disease control remains discussion. this institutional retrospective study aims at comparing the outcome of early metabolic responder patients who received an intensification treatment to those who received a standard chemotherapy.


Eligibility criteria:
inclusion criteria: * patients with high risk big b cells lymphoma * age \> 18 years exclusion criteria: * not applicable
a study to evaluate the pharmacokinetics, pharmacodynamics, and safety of tocilizumab (tcz) administered to participants with giant cell arteritis (gca).

Conditions: Giant Cell Arteritis

Summary: this study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (tcz) administered by intravenous (iv) infusion every 4 weeks (q4w) to participants with giant cell arteritis (gca).


Eligibility criteria:
inclusion criteria: * diagnosis of gca as classified according to protocol-specified criteria; * participants entering period 1 must be receiving treatment with tcz 8 mg/kg iv q4w. exclusion criteria: * treatment with any other investigational agent besides tcz within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening; * evidence of serious uncontrolled disease; * known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections; * active tb requiring treatment within the previous 3 years.
acceptance and feasibility of hepatitis c screening strategies in social insertion centers

Conditions: Hepatitis C Virus

Summary: hepatitis c virus (hcv) infection is one of the leading causes of chronic liver disease worldwide. it is a progressive disease that without treatment leads to the development of cirrhosis in approximately 10-20% of patients. with this study the investigators intend to evaluate the efficacy defined as the rate of hcv diagnostic tests performed within a decentralized diagnostic strategy by means of home self-testing compared to the one performed in situ in the population served in social insertion centers (cis) with alternative prison sentences, in order to study the prevalence and characteristics associated with hcv infection in this population, which is known to be at risk for this disease, and to offer them treatment and cure.

a randomized study will be designed in which all persons attending the social insertion center to serve alternative sentences to prison will be invited to participate on a voluntary basis, with prior informed consent. in order to study the prevalence of these persons compared to persons in open system, the latter will be offered, with prior informed consent, to take the diagnostic test in situ at the cis premises. all persons will be given a survey with sociodemographic and clinical variables to identify predictor factors. people with alternative sentences to prison will be informed of the study and, according to the randomization code, will be: a) given an envelope with all the necessary material to carry out the test at home and send it to the hospital for processing or, b) be tested on site at the cis premises by the cis nurse, who will also send it to the hospital for processing within 30 days by the central laboratory of the university hospital of the canary islands.

Eligibility criteria:
inclusion criteria: * all persons attending the social insertion center for the first time with alternative sentences to prison and in open system. * signed informed consent. exclusion criteria: * refusal of the patient to participate in the study. * minors under 18 years of age and over 79 years of age.
impact on quality of hospital care during pre- and post- rotavirus (rv) vaccination introduction in belgium

Conditions: Infections, Rotavirus

Summary: this study aims to investigate whether a change in the pattern of hospitalisation was observed in paediatric wards over the last 6 years (june 2004 - may 2010), whether a change in staff workforce availability was observed in paediatric wards over the last 6 years (during a whole year or during specific time periods of the year) and if changes of any of the variables measured during the observation period could be linked to the introduction of rotavirus vaccination.

this retrospective study will use data extracted from hospital databases during the period of the 1st of june 2004 until the 31st of may 2010. a coded list of all hospitalisations and of the different infection tests performed in children will be generated, together with a list of full time equivalents (fte) in paediatric ward and the number of sick leave days of the working personnel.

Eligibility criteria:
inclusion criteria: * all children aged ≤15 years being hospitalised (with overnight stay or day clinic) for whatever reason during the study period exclusion criteria: * not applicable

Keywords: belgium quality of hospital care rotavirus vaccination
postoperative melatonin administration and delirium prevention in patients undergoing vascular and cardiac surgery

Conditions: Cardiac Surgery

Summary: the investigators plan to evaluate the effect of postoperative melatonin administration on postoperative delirium in patients undergoing vascular and cardiac surgery. a total of 302 patients older than 60, undergoing elective vascular surgery will be randomly divided into 2 groups: treatment and control. during the first 5 postoperative days patients will receive sublingually either melatonin 5 mg or placebo at 9:00 pm. the patients will be assessed for the signs of delirium, quality of sleep and severity of pain daily for the first postoperative week. screening of delirium will be performed by the specially trained research assistant and based on the confusion assessment method and the validated chart review. diagnosis of delirium will be confirmed by the psychiatrist. incidence of delirium will be compared between the groups.


Eligibility criteria:
inclusion criteria: * non-emergent vascular surgery, with an expected length of stay ≥ 48hours, asa categories i to iv, signed informed consent, age \>60 exclusion criteria: * lack of informed consent, asa category v, history of psychiatric illness (schizophrenia, psychosis, bipolar disorder, major depression), mini mental state examination score (mmse) ≤ 24, history of autoimmune disease, liver cirrhosis, minimally invasive procedures (endovascular aneurysm repair ), history of chronic insomnia, chronic benzodiazepines and/or hypnotics use ( \> 3 times /week during a month prior to surgery), treatment with tricyclic antidepressants within a month prior to surgery, history of seizures, allergy to placebo ingredients or melatonin ( wn pharmaceuticals.ltd), melatonin consumption in the last months prior to surgery.

Keywords: cardiac surgery, delirium, melatonin
depression in alzheimer's disease-2

Conditions: Alzheimer's Disease; Depression

Summary: the purpose of this study is to learn whether treating individuals with alzheimer's disease and depression with the anti-depressant medication sertraline (zoloft) is helpful to people with alzheimer's disease and to their families and caregivers.

participants are randomly assigned to treatment with sertraline (range 25-125 mg per day) or identical placebo for 24 weeks. there are 8 scheduled in-person visits in the 24 weeks. visits include neuropsychological testing. caregivers are asked to are the patient on a daily affect diary for 6 weeks during the study period. telephone followup is done at weeks 36 and 48. both groups receive caregiver support/education.

Eligibility criteria:
inclusion: * ability of the participant, caregiver or surrogate to provide written informed consent. * dementia due to alzheimer's disease * stable treatment for alzheimer's disease * ability for the participant's caregiver to accompany the participant to study visits and participate in the study. exclusion * presence of a brain disease that might otherwise explain the presence of dementia * clinically significant hallucinations or delusions * current treatment of antipsychotics, anticonvulsants, and other antidepressants, benzodiazepines, or other psychotropic medications * need for hospitalization or residence in a nursing facility

Keywords: alzheimer's disease depression
use of multiple doses of convalescent plasma in mechanically intubated patients with covid-19

Conditions: COVID-19

Summary: this study will assess the feasibility and safety of administering multiple doses of convalescent plasma to covid-19 positive patients admitted to the intensive care unit (icu) receiving mechanical ventilation. donor plasma will be obtained from covid-19 recovered patients. all plasma used in this protocol will be collected following the guidelines issued by the food and drug administration (fda) and the ministry of health in panama. every patient recruited will receive one or two plasma units infused on days 0, 2, 4, 6, and 8. the primary objective of this study is feasibility. feasibility will be assessed based on the proportion of subjects who consent and receive at least one dose of convalescent plasma more than once. the investigators will evaluate the safety and feasibility of this study by accounting for any related adverse event. the secondary study endpoints are overall survival at days 14, 28, and 60 after the first dose of convalescent plasma. respiratory status and overall clinical status will be reviewed during follow-up until day nine and on days 14, 28, and 60.

from historical and anecdotal data on convalescent plasma, it seems its administration is safe in cases of coronavirus infection. now, the high mortality of covid-19, particularly in elderly and vulnerable persons such as critically ill patients, suggests that the benefits of its use in those at high risk for death outweigh the risks. however, for all cases where convalescent plasma administration is considered, a risk-benefit assessment must be conducted to assess individual variables. this study proposed the follow-up of 30 intubated patients due to covid-19 who have been admitted to the icu and have consented to receive five doses of one or two units of convalescent plasma. every patient will have a follow-up from the consent day to day 60. the study team will monitor and record: vital signs, daily ventilatory requirements, and assessment of clinical status, including new medical conditions and adverse events.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. hospitalized with covid-19 respiratory symptoms and confirmation via covid-19 sars-cov-2 real time-polymerase chain reaction(pcr) testing. 3. subject or proxy (including by phone) is willing and able to provide written or digital informed consent and comply with all protocol requirements. 4. intubated 5. consent to storage of specimens for future testing. exclusion criteria: 1. contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products). 2. severe multi-organ failure, and hemodynamic instability. 3. other documented uncontrolled infections. 4. severe disseminated intravascular coagulopathy (dic) needing factor replacement, freshfrozen plasma, cryoprecipitate. 5. on dialysis. 6. active intracranial bleeding. 7. clinically significant myocardial ischemia.

Keywords: convalescent plasma critically ill sars-cov-2 covid-19 neutralizing antibodies
language matters: exploring the impact of language concordance on fertility treatment progression

Conditions: Infertility; Infertility (IVF Patients); Infertility Assisted Reproductive Technology; Ovulation Ind

Summary: currently, patients presenting to the fertility and reproductive medicine center meet with an english-speaking provider and communicate through an interpreter, as none of the physicians speak spanish. however, this study pi is a native spanish speaker and certified bilingual clinician. thus, this study is looking to evaluate whether or not the use of an interpreter delays completion of testing and initiation of fertility treatment. the medically indicated testing, procedures, and course of treatment will not be altered as a result of participation in the study. participants will be asked to complete a survey in their preferred language to gauge satisfaction and communication efficacy. this proposed study is significant as it seeks to address a critical gap in the understanding of how language concordance between healthcare providers and patients influences treatment outcomes in fertility care. with spanish being the most commonly spoken non-english language in the u.s., evaluating the impact of spanish language skills in medical care is both timely and essential. this research will shed light on whether spanish-speaking patients experience better treatment progression and outcomes when cared for by language-concordant providers versus when interpreters are used in fertility care. this prospective study will be conducted at washington university's fertility and reproductive medicine center over a 12-month period. the investigators aim to enroll a total of 70 spanish-speaking patients, based on previous patient trends at the center 35 will be randomized to the intervention group (being evaluated and treated by a spanish-speaking provider), and 35 will be randomized to standard of care (communicating with an english-speaking provider through an interpreter).


Eligibility criteria:
inclusion criteria: * must be greater than 18 years old * preferred language must be spanish speaking * must be seeking fertility treatment exclusion criteria: * preferred language english * not currently seeking fertility care * less than 18 years old

Keywords: spanish speaking spanish infertility infertility work-up ivf
a study of jnj-73763989 in adult participants with renal impairment

Conditions: Renal Impairment

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk) of a single subcutaneous (sc) dose of jnj-73763989 in adult participants with renal impairment compared with healthy participants with normal renal function.


Eligibility criteria:
inclusion criteria: * must have stable renal function defined as a less than (\<) 20 percent (%) change in serum creatinine concentrations between screening and day -1 * concomitant medications should be stable for the previous 1 month and throughout the duration of the study * women, except for postmenopausal women, must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hcg\]) at screening and urine (beta-hcg) pregnancy test on day -1 * must sign an informed consent form (icf) indicating they understand the purpose of, and procedures required for the study and are willing to participate in the study * participants with kidney disease without dialysis using benzodiazepines, tricyclic antidepressants, and prescription opiates with a positive urine test for drugs prescribed by their physician may be included following prior discussion with the sponsor exclusion criteria: * have kidney disease requiring dialysis * renal transplants, systemic lupus erythematosus, or participant with malignancy * known allergies, hypersensitivity, or intolerance to jnj-73763989 or its excipients * received an experimental drug (including investigational vaccines) or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the administration of the study drug is scheduled * preplanned surgery or procedures that would interfere with the conduct of the study