Kornimate/medical-research-clean huggingface dataset:
efficacy of melatonin in decreasing the incidence of delirium in end of life patients

Conditions: Delirium

Summary: the purpose of this study is to determine if melatonin administration to end-of-life patients is effective in preventing the development of delirium compared with those who do not receive this treatment. delirium is a difficult to control symptom commonly seen in patients at the end-of-life. a person who is delirious is unable to think clearly and cannot make sense of what is going on around him/her.

all patients over the age of 19 admitted to the tertiary palliative care unit and hospice residence who could meet the study requirements will be asked within 48 hours of admission for their interest in participating in the study. all those who interested in taking part will be referred to a research nurse for initial assessment for eligibility. for eligible patients who have consented to participate in the study, a research nurse who is not directly involved in the patient's care will approach the patient. a detailed subject information containing pertinent information on the study will be provided and ample time (up to 24 hours) will be given for consideration. the research nurse will explain the consent form to the patient and obtain consent signature if he/she agrees to participate. once formal consent obtained, the eligible patient will be enrolled in the study. patients will be assigned randomly to one of the two arms of the study and receive nightly doses of melatonin 0.5 mg or placebo. patients will be monitored for 14 days or until the development of delirium or the occurrence of death. patients will be assessed twice a day for delirium, around the end of each nursing shift, i.e. every 12 hours (at 0330 \& 1530h) for fourteen consecutive days or until the development of delirium. the diagnostic tool used to detect delirium is the confusion assessment method (cam). the primary outcome measure is incidence of delirium, defined according to the confusion assessment method (cam). data on harm will be collected. for example, adverse effects from melatonin such as excessive daytime drowsiness, headaches, nausea , transient depression have been reported in the medical literature. patients will also be monitored closely for the development any of these adverse effects during the treatment period.

Eligibility criteria:
inclusion criteria: * patients admitted to the test site * adult patients over 19 years of age * patients who can provide informed consent * patients who are able to tolerate oral medications exclusion criteria: * patients with existing delirium or dementia on admission * patients with poor clinical performance * patients taking melatonin prior to admission * patients taking medications that interact with melatonin * patients who are unable to provide informed consent * patients who are enrolled in any other research study involving drugs/devices

Keywords: melatonin delirium prevention end-of-life
influence of extracorporeal circulation during cardiac surgery on the development of postoperative thrombotic thrombocytopenic purpura (ttp)

Conditions: Cardiac Surgery

Summary: the purpose of this study is to determine whether extracorporeal circulation during cardiac surgery has an influence on adamts13-activity.


Eligibility criteria:
inclusion criteria: * cardiac surgery with or without (opcab) the use of extracorporeal circulation * patient agrees exclusion criteria: * no agreement * known ttp in medical history

Keywords: cardiac surgery adamts13 ttp extracorporeal circulation heart-lung machine
a clinical trial using metronomic oral low-dose cyclophosphamide alternating with low-dose oral methotrexate with continuous celecoxib and weekly vinblastine in children and adolescents with relapsed or progressing solid tumours.

Conditions: Survival Without Progression

Summary: to establish the anti-tumour effect of this metronomic combination regimen defined by progression-free survival (pfs) after two cycles of treatment (4 months) and 12 months of treatment, as well as response rate after any number of cycles of treatment ("best response"). to define the safety profile of the combination. to characterize pharmacodynamics of the drug combination with the use of angiogenic markers (cep, cec, microparticles).

multi-center, combination phase ii study, open-label, non-comparative, non-randomized. all progressive or recurrent solid tumours will be included in the phase ii study, provided there are no curative options anymore. total expected number of patients (minimum maximum): 54 to 90 (2-stage design)

Eligibility criteria:
inclusion criteria: * patients must have a histologically or cytologically confirmed malignant solid tumour. * progression or recurrence of the tumour radiologically established or confirmed within the 4 weeks prior to inclusion. * disease must be considered refractory to any line of conventional therapy or for which no effective conventional treatment exists. * age: ≥4 to 21 years of age at study entry * life expectancy: at least 8 weeks * ecog performance status ≤ 1 or lansky-play scale ≥ 70% * written informed consent of parent/guardian and patient assent * wash out of 4 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas, 2 weeks in case of vincristine alone; 6 weeks in case of prior radiotherapy (except palliative radiotherapy on non measurable lesions). * patients must have recovered from the acute toxic effects of all prior therapy before enrolment into the study * able to comply with scheduled follow-up and with management of toxicity * all patients with reproductive potential must practice an effective method of birth control while on study. * female patients aged \> 12 years must have a negative pregnancy test within 7 days before study treatment. * capable of swallowing oral medication exclusion criteria: * pregnant and breast feeding women. * uncontrolled intercurrent illness or active infection * inability to swallow oral medication. * patients on anticonvulsants will be allowed on study
parental project and premature ovarian insufficiency

Conditions: Primary Ovarian Insufficiency; Infertility

Summary: one of the main repercussions of poi is infertility. when the diagnosis of poi is announced, the question of fertility is addressed and the patient is often directed towards egg donation or adoption when she has a parental project. however, there are cases of spontaneous pregnancies after diagnosis. this study was conducted to determine the proportion of patients with poi who were able to realize a parental project after diagnosis in the long term and by what means.

the investigators propose to study patients with poi who were hospitalized in the endocrinology and reproductive medicine department of the pitié-salpêtrière hospital for the etiological assessment of ovarian failure and its consequences between december 31, 1982 and january 12, 2021. the investigators will only include patients who were admitted to the day hospital because we have a complete etiological workup and a complete history for them, which allows investigators to describe the population properly. the patients must be over 18 years old at the time of the survey in order to be able to evaluate the presence of a parental project only in adult patients. patients for whom there is no valid contact information in the computer file (postal address or valid email address or cell phone number) or whose last consultation was more than 2 years ago will be excluded. patients with turner syndrome will be excluded because they may have comorbidities, particularly cardiac, that contraindicate pregnancy. patients with poi secondary to oncological treatments (gonadotoxic chemotherapy or pelvic radiotherapy) will also be excluded because of the uncertain prognosis and the contraindications to pregnancy in case of hormone-dependent tumors.

Eligibility criteria:
inclusion criteria: * patients at least 18 years old at the time of the survey * patients with a diagnosis of pio according to the current definition: cycle disturbances of more than 4 months and fsh \> 25 on 2 measurements one month apart * patients having been hospitalized in day hospital (hdj) in the endocrinology and reproductive medicine department of the pitié-salpêtrière hospital for the etiological assessment of ovarian insufficiency and its repercussions between december 31, 1982 and january 12, 2021 * valid contact information available: address, cell phone, e-mail * patients who have been informed and do not object to participate in the study exclusion criteria: * turner syndrome * poi secondary to oncology treatments (chemotherapy, pelvic radiotherapy) * opposition to participating in the study

Keywords: spontaneous pregnancy adoption oocyte donation parental project
ondansetron vs prochlorperazine for nausea and vomiting in the emergency department

Conditions: Nausea and Vomiting

Summary: this study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.

nausea and vomiting can be common symptoms in the emergency department (ed). antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-ht3 antagonists. there have been limited studies on the use of these agents in the ed, and no direct comparisons to 5-ht3 antagonists have been published to date. inclusion criteria: patients presenting to the ed with at least one of the following * nausea * vomiting documented in the ed

Eligibility criteria:
inclusion criteria: * patients presenting to the ed with at least one of the following * nausea * vomiting documented in the ed exclusion criteria: * previous treatment in the ed with ondansetron, prochlorperazine, promethazine or metaclopramide * patients with missed last menstrual period * pregnancy * age \< 18 years old * treatment with antineoplastic agents within 7 days prior to randomization * irritable bowel syndrome * gastroparesis * suspected gastrointestinal bleed * suspected intestinal obstruction * preexisting motor disorder (restless-leg syndrome or parkinson's disease) * traumatic brain injury upon admission to ed * intracranial hemorrhage upon admission to ed * patients unable to read, write or communicate in the english language * patients leaving the ed against medical advice
a study to assess the anidulafungin and voriconazole concentration in lung following intravenous administration in healthy subjects

Conditions: Aspergillosis; Candidemia

Summary: the purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.


Eligibility criteria:
inclusion criteria: * healthy adult subjects willing to comply with the study requirement. exclusion criteria: * clinical significant disease. * sensitive to study medication. * not willing to comply with the study requirement.

Keywords: pk fungal infection
phase iii double blind trial of valproate sodium for prophylaxis of post traumatic seizures

Conditions: Post-Traumatic Seizure Disorder; Head Injuries

Summary: objectives: i. determine whether treating head injured patients with valproate sodium will reduce the risk of developing seizures as a result of the head injury. ii. determine the safety of valproate, the appropriate dose, and the effect valproate may have on the recovery of the brain's ability to compute numbers, solve problems, remember information, and control the movement of limbs after head injury.

protocol outline: this is a randomized, double blind trial involving 3 treatment groups. on day 1, controls receive phenytoin iv over 1 hour. on days 2 through 7, controls receive 2 doses each of phenytoin and placebo daily, intravenously. from day 8 through 6 months, controls receive placebo iv 4 times daily, then placebo tablets are administered. on day 1, the experimental group receives a loading dose of valproate sodium intravenously over 1 hour within 24 hours of injury. then, patients are divided into 2 subgroups. from day 2 through 1 month, one group of patients receives valproate iv 4 times daily over 1 hour until tablets are tolerated. patients receive placebo tablets by mouth 4 times daily from month 2 through month 6. on day 2, the other group of patients receives valproate iv 4 times daily and continues for 6 months until tablets (same dose) are tolerated. if patients remain seizure free between day 8 and 6 months, the number of valproate or placebo tablets are tapered over 1 week. each patient receives a full neuropsychological and psychosocial examination at 1, 6, and 12 months after injury. untreated observation of patients continues until 2 years after injury.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- any patient developing the following conditions within 24 hour postinjury: * cortical contusion * depressed skull fracture * subdural hematoma * epidural hematoma * intracerebral hematoma * penetrating head wound * seizures occurring subsequent to head injury --prior/concurrent therapy-- * no antiseizure medication prior to injury or between the injury and study drug loading * surgery: no prior neurosurgical operation for which the skull and dura mater were opened --patient characteristics-- * age: 14 and over * hematopoietic: no abnormal coagulation profile * hepatic: no history of chronic or alcoholic liver disease adequate liver function as indicated by alt less than 1.5 times the upper limit of normal * other: not pregnant no injuries greater than 24 hours old no history of seizures prior to injury no prior history of significant head injury or neurological condition requiring medical attention

Keywords: neurologic and psychiatric disorders rare disease seizures
clinical evaluation of the phototoxic potential of xenaderm ointment

Conditions: Healthy

Summary: the product is being tested to see if exposure to light causes toxic reactions on the skin.


Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * under 18 years of age

Keywords: wound healing phototoxicity healthy subjects
assessment effectiveness of the leap motion capture® system on the functionality of the upper limb in acquired brain injury

Conditions: Stroke; Treatment Adherence; Patient Satisfaction; Brain Injuries, Traumatic

Summary: the affectedness of the motor control of the upper limb, particulary, the hand and/or fingers, appears in many neurological diseases, what is going to impact on the functionality of the subject. the use of new technologies in the rehabilitation environment, has the target to reduce the impact on the disabling conditions. so that, the goal of this investigation is to evaluate the system use effectiveness of the leap motion controller® in the treatment on the upper limb on patients with neurological disease.


Eligibility criteria:
inclusion criteria: * people aged between 30 and 70 years old; * with a confirmed diagnosis of brain damage (\>6 months); * ul motor impairment with a fugl-meyer score≥16; * a modified ashworth scale score≤2 in the deltoid, triceps brachii, biceps brachii and in the wrist and finger flexor and extensor muscles of the upper limb exclusion criteria: * the inability to understand instructions and actively cooperate in the tasks indicated based on a score ≥ 24 in the mini-mental test; * refusal to participate in the study; * visual impairment not correctable by glasses.
oral symptom assessment scale (osas): validity and reliability

Conditions: Neoplasms

Summary: oral (mouth) symptoms are very common and often bothersome in patients with cancer. the best way to assess these symptoms is using a patient-rated symptom assessment scale. a new symptom assessment scale for oral symptoms has been developed and already tested in patients. the purpose of this study is to test the scale again to make sure it is reliable and accurate.

oral health is multifaceted and includes an individual's ability to speak, eat as well as to convey emotion without pain, embarrassment or discomfort. oral health contributes to an individual's general well-being. poor oral health in patients with advanced cancer can be associated with negative impacts on an individual's quality of life in terms of psychological and emotional distress (e.g. avoiding social interactions due to embarrassment) and physical distress (e.g. pain associated with mucositis). as well as this certain problems can be associated indirectly with mortality in patients with advanced cancer e.g. oral infection leading to systemic infection. in patients with advanced cancer oral symptoms are common, often multiple and of high-impact. routine screening for oral symptoms should be undertaken in all patients with advanced cancer in conjunction with regular examination of the oral cavity to ensure correct diagnosis and adequate treatment. a novel oral symptom assessment scale (osas) was designed and developed to measure the frequency, severity and distress (or bother) of twenty oral symptoms in patients with advanced cancer. this initial observational study provided provisional validation of the new assessment tool. this study aims to further investigate the reliability and validity of this novel oral symptom assessment tool in patients with advanced cancer. test-retesting will occur in patients deemed clinically stable. test- retesting will be undertaken to measure reliability on two occasions 24-48 hours apart. recruited patients will be asked to fill in the osas as well as the eortc qlq- c30 and eortc qlq-oh15 (a validated quality of life assessment with an oral health module) which will provide criterion (concurrent) validity.

Eligibility criteria:
inclusion criteria * any cancer diagnosis * age ≥ 18 years old * able to understand and speak english * signed witnessed consent form * in the 'stable' clinical phase exclusion criteria * in the judgement of the palliative care physician, study participation is not appropriate * unable to complete the study assessments in entirety i.e. in full at time 1 ( 0 hours) and at time 2 (24 hours later) * in the 'unstable', 'deteriorating' or 'terminal' clinical phase

Keywords: oral health oral care neoplasms palliative care
clinical biological and pharmacological factors influencing stroke outcome

Conditions: Stroke

Summary: in a previous suty, we have demonstrated that prior transient ischemic attack, treatment lipid-lowering drug or physical activity are associated to a better outcome of stroke. the aim of the study is to understand the mechanisms of this preventive neuroprotection by establishing link between biomarkers and preventive and neuroprotective measures.to answer to the question, we conduct a cohort study of stroke patients.

in the cohort, the severity of stroke (nihss) will be correlated with : * clinical factors, * pharmacological factors, * biological factors (inflammatory markers, hemostasis...)

Eligibility criteria:
inclusion criteria: * ischemic or hemorrhage stroke * hemispheric stroke * stroke dating from less 48h exclusion criteria: * non hemispheric stroke * malformative intracranial hemorrhage * traumatic intracranial hemorrhage * subarachnoidal hemorrhage

Keywords: inflammation coagulation neuroprotection drugs clinical neurology pharmacology biological factors
clinical study comparing two implant surface finishes in patients undergoing cementless total hip replacement

Conditions: Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Avascular Necrosis; Acute Fracture

Summary: prospective, randomized study of summit porocoat versus summit duofix ha in total hip arthroplasty

hydroxyapatite (ha) is a bioactive ceramic that resembles the natural inorganic mineral content of bone, and as such is a highly osteoconductive material. the purpose of this study is to compare an ha coated and uncoated prosthesis.

Eligibility criteria:
inclusion criteria: * primary total hip replacement * patient age less than or equal to 75 * sufficient bone stock to support prosthesis exclusion criteria: * previous hip replacement * significant angular/bony deformity * active joint sepsis * metal allergy * renal transplant * psychosocial disease * neurological disease/musculoskeletal disease that may affect weight-bearing

Keywords: total hip replacement
accelerated intermittent theta burst stimulation for depressive symptoms

Conditions: Depression and Suicide

Summary: this study evaluates an accelerated schedule of theta-burst stimulation for depressive symptoms in psychiatric inpatients. a small pilot study (n=22) will be carried out to demonstrate feasibility, using the fda-approved stimulation site for depression treatment (l-dlpfc). participants will be offered stimulation at the anterior cingulate cortex (acc).

this study intends to investigate whether modifying stimulation parameters enables typical 6-8 week long rtms protocols to be compressed to only five days. the influence of this accelerated protocol on the length of patient stay in the hospital will be investigated.

Eligibility criteria:
inclusion criteria: * over 18 years old * able to read, understand, and provide written, dated informed consent prior to screening. participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information. * currently diagnosed with major depressive disorder (mdd) and/or in a current major depressive episode, according to the criteria defined in the diagnosis and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) * currently an inpatient at stanford hospital * meet the threshold on the total hamd17 score of \>/=20 at screening/baseline. * qualifies and has access to outpatient rtms treatment exclusion criteria: * any structural lesion e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke effecting stimulated area or connected areas or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results. * metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear * history of epilepsy/ seizures (including history of withdrawal/ provoked seizures) * shrapnel or any ferromagnetic item in the head * pregnancy * autism spectrum disorder * active substance use (\<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines * any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation * cognitive impairment (including dementia) * current severe insomnia (must sleep a minimum of 4 hours the night before stimulation) * current mania * current unmanageable psychosis * iq \<70 * showing symptoms of withdrawal from alcohol or benzodiazepines * parkinsonism or other movement d/o determined by pi to interfere with treatment * more subcortical lesions than would be expected for age or a stroke effecting stimulated area or connected areas. * any other indication the pi feels would comprise data.