Kornimate/medical-research-clean huggingface dataset:
preoperative anxiety level, premedications and general anaesthetic proceedings

Conditions: Anxiety; Premedication; General Anaesthetic

Summary: although it seems obvious that the high level of preoperative anxiety may affect intraoperative anaesthetic requirements and recovery adversely, there are several contradictory studies about this subject. furthermore, the effects of anxiolytic premedication are actually disputed: sedative premedication is widely administered but little clinical evidence supports its use. we want to evaluate the effects of pre-procedure anxiety for propofol needs in patients receiving general anaesthetic procedure. we also want to know if premedication is useful according to the preoperative anxiety level, in order to determine if a sub-group of patients benefit from it.

this study will be carried out in solely at the institute of chu de reims, france (reims teaching hospital) from march 2017 to may 2017. selected patients will be over the age of 18, among those receiving general anaesthesia for surgery. demographic data and medical history will be collected after written consent. before the anaesthetic procedure, an apais questionnaire (anxiety evaluation form) will be filled out by each patient. the medical, anaesthetic and surgical care will not be changed. in the operating room, we will proceed with anaesthetic induction following a medical protocol according to the practice of our hospital (tci target controlled infusion or manual induction): the propofol infusion or injection is started with an initial effect-site concentration or dose and increased step by step until patients present the clinical en points defined as loc (loss of consciousness, i.e. no response to a verbal command). the effect-site concentration of propofol, induction time required for a loss of consciousness (loc), and preoperative incidents will be recorded by an anaesthetist student nurse and will be recorded in a data book. after surgery, we will record any secondary effect attributable to premedication. the day after surgery, patients will be assessed with the evan-g questionnaire. statistical analysis will be done in sub-groups with variance analysis. we will also do multivariate regression analysis according to the type of premedication, demographic data, preoperative variable and preoperative anxiety level. if the number of included patients allows it, we will do propensity score matching for premedication.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * surgery with general anaesthetic, programmed, in emergency or ambulatory * cognitive level adequate to submit apais - evang form * general anaesthetic induction procedure using propofol exclusion criteria: * asa 4 level * patient refusal * pregnancy * rapid sequence induction (isr) * general anaesthetic induction procedure using another drug than propofol (thiopental - etomidate)

Keywords: anxiety premedication general anaesthetic
interventions for depressed low income mothers and their infants

Conditions: Depression

Summary: this study will compare three interventions for depressed, low income mothers and determine which is most effective in treating maternal depression and in fostering development in infants.

poorly educated, low income mothers are at high risk for becoming depressed. the effects of living in poverty and being reared by a depressed parent can be detrimental to an infant's development. effective interventions to reduce maternal depression and strengthen the mother-infant relationships are needed. participants will be randomly assigned to one of three groups. group 1 mothers will receive 16 weekly sessions of interpersonal psychotherapy (ip) designed to directly treat maternal depression. group 1 participants will have monthly follow-up visits for 1 year. participants in group 2 will receive 16 weekly sessions of ip followed by 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants. group 3 mothers will be invited to attend informational meetings as well as be referred to local services available to people with depression. all mother-child pairs will be evaluated when the child is 12, 16, 24, and 36 months of age. evaluations will involve questionnaires, diagnostic interviews, developmental assessments, and video- and audio-taped measures.

Eligibility criteria:
inclusion criteria for mothers: * current diagnosis of depression * mother of an infant 9 to 11 months of age * low income, defined as less than $25,000 for a family of two or less than $31,400 for a family of three (add approximately $7,960 for each additional family member) exclusion criteria for mothers: * current substance abuse * severe mental or physical limitations that would interfere with the study

Keywords: mother-child relations infant child development poverty
to investigate pharmacokinetics (absorption, distribution, elimination), safety and tolerability of a single oral dose of 75 mg molidustat tablet in male and female subjects requiring hemo- or peritoneal dialysis compared to healthy subjects

Conditions: Renal Insufficiency, Chronic

Summary: the study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. in addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as the safety and tolerability of molidustat.


Eligibility criteria:
inclusion criteria: * male and female (without childbearing potential) * age: ≥18 and ≤79 years of age * body mass index (bmi): ≥18 and ≤34 kg/m2 * ethnicity: white * subjects with severe renal impairment on hemodialysis or peritoneal dialysis, and * healthy subjects exclusion criteria: * women of childbearing potential, pregnant or lactating women * use of medication within the 2 weeks preceding the study which could interfere with the investigational product * positive results for hepatitis b virus surface antigen (hbsag), hepatitis c virus antibodies (hcv ab), human immune deficiency virus 1 and 2 antibodies (hiv 1/2 ab) * exclusion periods from other studies or simultaneous participation in other clinical studies

Keywords: chronic kidney disease pharmacokinetics hemodialysis peritoneal dialysis erythropoietin
a study to learn about whether bayh006689 causes skin irritation when applied as a topical gel in healthy participants

Conditions: Pain; Healthy Volunteers

Summary: researchers are looking for a better way to treat muscle and joint pains. researchers have seen that medicines which help reduce pain and inflammation could be safer when applied directly to the skin, called topical application, than when taken by mouth. however, recent studies have found that using these medications on the skin can sometimes cause skin reactions such as redness, itching, or irritation in the area where the medication is applied. bayh006689 topical gel is under development for the treatment of muscle and joint pains. in this study, participants will be healthy and will not benefit from bayh006689. however, the study will provide information about how to test bayh006689 in future studies with people who have muscle and joint pain. the main purpose of this study is to check whether bayh006689 topical gel causes any irritation to the skin in healthy participants using a patch test called cumulative irritant patch test design. to do this, researchers will apply gel to participants' skin once a day for 21 days. skin reactions will be assessed using a scale which will provide a score for redness, swelling, and other signs of skin irritation. in this study, researchers will randomly assign 4 sites adjacent to each other, on the back of the participants' bodies just below the shoulder blades. the following treatment gels will be applied using a patch. * bayh006689 * placebo, which looks like the study drug, but does not have any medicine in it. * 0.2% sodium lauryl sulfate (is a common ingredient in personal care products and when in contact with skin it could cause some skin irritation) * 0.9% saline each participant will be in this study for 22 days, which includes: * a visit to the clinic within 21 days of the study start, to confirm if the participant can take part in the study. * participants will receive their assigned treatment gels at the identified skin site for 21 days. * an end of study visit on day 22, during which the researchers will remove the designed patches and assess any signs of skin irritation. during the study, the doctors and their study team will: * do physical examinations * check participants' health by performing urine tests * ask the participants questions about how they are feeling and what adverse events they are having an adverse event is any medical problem that a participant has during a study. doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.


Eligibility criteria:
inclusion criteria: * healthy adult * is 18 years of age or older * free of any systemic or dermatological disorder that may interfere with results or increase risk of adverse events (aes) exclusion criteria: * has a condition and/or is using medications that may interfere with the study results * pregnant or planning to get pregnant or breastfeeding * is currently participating in any clinical testing
using a transcutaneous electrical auricular stimulator to harness the cholinergic anti-inflammatory pathway

Conditions: Healthy Volunteers

Summary: persistent chronic inflammation is an important underlying event in multiple diseases including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. these disorders are characterized as inflammatory in part because of the important mediating role of pro-inflammatory cytokines in their pathogenesis. this study will investigate whether transcutaneous auricular electrical stimulation of the vagus nerve will affect and decrease the inflammatory cytokine response in healthy individuals.


Eligibility criteria:
inclusion criteria: 1. age between 18-60 years, 2. currently healthy with no medical problems 3. able and willing to give written informed consent and comply with the requirements of the study protocol. exclusion criteria: 1. history of any of the following: cardiac arrhythmia, coronary artery disease, autoimmune disease, chronic inflammatory disease, anemia, malignancy, depression, neurologic disease, diabetes mellitus, renal disease, malignancy, dementia, psychiatric illness including active psychosis, or any other chronic medical condition. 2. family history of inflammatory disease 3. treatment with an anti-cholinergic medication, including over the counter medications, 4. implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators. 5. current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine), 6. chronic inflammatory disorders 7. investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (day 0), whichever is the greater length of time, 8. any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention, 9. pregnancy or lactation (pregnancy status \& lactation will be determined via self-report), 10. implanted vagus nerve stimulator 11. inability to comply with study procedures 12. ear infection (otitis media or externa)

Keywords: inflammation, vagus nerve stimulation
modern technology for learning and psychosocial support in patients with abdominal aortic aneurysm

Conditions: Aortic Aneurysm

Summary: this study evaluates the effects of an ehealth tool and psychosocial support on anxiety, depression and health-related quality of life in patients undergoing surgical treatment for abdominal aortic aneurysm (aaa). participants in the intervention group will receive access to the ehealth tool and structured follow-up with a contact nurse, the control group will receive standard of care.

abdominal aortic anuerysm (aaa) is associated with a decreased health-related quality of life (hrqol) both at diagnosis and during surgical treatment, although recent studies report somewhat contradictory results. in qualitative research, it has been shown that the health care system fails to meet the patients' information need, as well as their need for psychosocial support during the care process. the aim of this study is therefore to evaluate the effects of an intervention comprising an ehealth tool with individualized information in combination with structured follow-up with a contact nurse on anxiety, depression and hrqol in patients undergoing surgical treatment for aaa. patients who are planned for elective surgical treatment, fulfil the inclusion criteria and none of the exclusion criteria will fill out questionnaires. the control group will receive information and follow-up per institution's standard of care. the intervention group will be given access to the ehealth tool, containing individualized information about the condition, surgical procedure and self-care. they will also receive structured follow-up by a contact nurse at discharge, 3 and 12 months postoperatively.

Eligibility criteria:
inclusion criteria: * ability to speak and understand swedish * planned for elective surgical repair of an abdominal aortic aneurysm exclusion criteria: * severe visual impairment or blindness * severe hearing impairment or deafness * diagnosed dementia * medical condition with a suspected life expectancy of \< 1 year.

Keywords: information literacy nursing care social support
vaccine therapy in preventing cervical cancer in patients with cervical intraepithelial neoplasia

Conditions: Cervical Cancer; Precancerous Condition

Summary: rationale: vaccines made from protein and dna may help the body build an effective immune response to kill abnormal cells in the cervix. the use of vaccine therapy may prevent cervical cancer. purpose: this phase i/ii trial is studying the side effects and best dose of vaccine therapy and to see how well it works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.

objectives: primary * determine the feasibility and toxicity of pngvl4a-sig/e7(detox)/hsp70 dna vaccine in preventing cervical cancer in patients with human papillomavirus (hpv)-16-positive grade 2 or 3 cervical intraepithelial neoplasia. * determine the effect of this vaccine on the histology of cervical tissue specimens from these patients. secondary * determine changes in lesion size and hpv viral load in patients treated with this vaccine. * determine the cellular, humoral, and local tissue immune responses in patients treated with this vaccine. * correlate measures of immune response with clinical response in patients treated with this vaccine. * correlate measures of immune response in patients treated with this vaccine with those observed in the preclinical model. outline: this is a phase i, dose-escalation study followed by a phase ii study. * phase i: patients receive pngvl4a-sig/e7(detox)/hsp70 dna vaccine subcutaneously once in weeks 0, 4, and 8 in the absence of disease progression or unacceptable toxicity. patients undergo colposcopy in week 8, 15 and 19 and a therapeutic loop electrosurgical excision procedure (leep) in week 15. cohorts of patients receive escalating doses of vaccine until the safest dose is determined. * phase ii: patients receive vaccine as in phase i but at the safest dose determined in phase i. patients also undergo colposcopy and leep as in phase i. after completion of the study treatment, patients are followed annually for 15 years. projected accrual: approximately 150 patients (approximately 12 will be treated in phase i and 25 will be treated in phase ii) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed cervical intraepithelial neoplasia (cin2/3) * human papillomavirus-16-positive disease patient characteristics: - age: \> 18 other * not pregnant * immunocompetent

Keywords: cervical cancer cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3
ex-po trial : evaluation of the occlusion pressure (po.1) in extubation failure

Conditions: Respiratory Failure

Summary: measuring bedside occlusion pressure in neurosurgical or surgical critically ill patients could tell us about the patient's respiratory drive, and therefore, tell us whether or not extubation will be successful.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, * hospitalized in surgical or neurosurgical intensive care units * patients under mechanical ventilation for more than 48 hours, * meeting the criteria for severability (spontaneous ventilation test), * free subject, without tutorship or curatorship or subordination, * patients benefiting from a social security scheme or benefiting through the intermediary of a third party, * no objection given by the patient and / or relative after clear and fair information about the study. exclusion criteria: * tracheostomized patients, * persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection, * pregnant and / or lactating women.
prediction of outcomes with a miniaturized transesophageal echocardiography probe in patients with acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: the superior vena cava respiratory collapse index (cvcs) is a haemodynamic parameter measured exclusively by transoesophageal ultrasound (tee), which is used to assess cardiac precharge-dependence status. this may be an important prognostic factor in ards because it is a sign of hypervolemia and right heart failure.


Eligibility criteria:
inclusion criteria: * patients hospitalized in resuscitation, emergency or intensive care units at the roger salengro hospital at lille university hospital. * with acute respiratory distress syndrome of intermediate or severe severity (1) for less than 24 hours. * mechanical ventilation with tracheal intubation or tracheostomy, in controlled assisted ventilation (vac) mode. * patient adapted to mechanical ventilation (no triggering of spontaneous ventilation cycle in vac mode verified by the equality between the respiratory rate prescribed on the ventilator and the actual respiratory rate of the patient). exclusion criteria: * patient under extracorporeal respiratory assistance at the time of inclusion. * anomalies or pathologies that make it dangerous or impossible to introduce an eto probe: * fistula, perforation, stenosis, varicose vein or diverticulum of the esophagus and / or stomach * history of esophageal and / or gastric surgery * caustic lesions of the esophagus and / stomach * tumor or history of oropharyngeal surgery * unstable lesions of the cervical spine * coagulopathy (thrombocytopenia \<50 109 / l and / or tp \<50%). * impossibility of measuring the diameter of the superior vena cava and cvcs in eto due to poor echogenicity. * pregnant woman. * therapeutic limitation measures limiting the treatment of organ failure.

Keywords: respiratory variations, superior vena cava prognosis.
weighted blankets after brain injury

Conditions: Acquired Brain Injury

Summary: a non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. this is a single centre study based in a community hospital in the uk. outcomes centre on determining the feasibility and acceptability of the study taking place in an nhs setting.

a non-blinded randomised controlled feasibility study of weighted blankets to help agitation and disturbed sleep after brain injury. this is a single centre study based in a community hospital in the uk. outcomes centre on determining the feasibility and acceptability of the study taking place in an nhs setting. 12 subjects will be randomised 1:1 to intervention or control; they will use the allocated linen for 7 consecutive days and nights. sleep will be measured using observations and actigraphs; behaviour and behavioural interventions will be recorded. participants (where possible) and staff members will be interviewed about their experience and opinions.

Eligibility criteria:
inclusion criteria * subjects capable of giving informed consent, or if appropriate, subjects having an acceptable individual capable of giving assent on the subject's behalf * aged over 18 years * admitted to king's lodge neurorehabilitation unit for inpatient rehabilitation after a brain injury * within weight limits to be suitable for weighted blanket use exclusion criteria * on end of life pathway * pain which could be exacerbated by weighted blanket * unable to remove * presence of open wound / pressure sore * allergy to blanket material * participant or consultee unable or unwilling to give informed consent / assent * known respiratory disorder such as asthma, chronic obstructive pulmonary disease, obstructive sleep apnoea which could be exacerbated by use of heavy blanket over chest * claustrophobia
remote observed dosing to increase suboxone compliance

Conditions: Opiate Dependence

Summary: the goal of this project is to test the feasibility, acceptability, and preliminary efficacy of using remote compliance monitoring in buprenorphine (suboxone®) treatment for opiate dependence. to that end, 10 opiate dependent subjects will be recruited through the university of pennsylvania's treatment research center, an outpatient substance abuse treatment facility. all subjects will receive buprenorphine (suboxone®) (16 mg/day, adjusted as needed according to individual requirements).


Eligibility criteria:
inclusion criteria: * voluntarily provide written informed consent prior to the conduct of any study-related procedure * male or female, 18 to 65 years of age, * meet dsm-iv criteria for current opioid dependence * females of childbearing potential and fertile males must use a reliable means of contraception * owns a smartphone with forward facing camera that allows for use of skype exclusion criteria: * university of pennsylvania student, employee, or affiliate * current diagnosis of aids * presence of ast and/or alt equal to or 3x upper limit of normal * total bilirubin and/or creatinine equal to or 1.5x upper limit or normal * current diagnosis of chronic pain requiring opioids * pregnant or lactating females * previous hypersensitivity or allergy to buprenorphine or eva-containing substances * current use of agents metabolized through cyp 3a4 such as azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin), and protease inhibitors (e.g. ritonavir, indinavir, saquinavir) * meet dsm-iv criteria for current dependence on any psychoactive substances other than opioids or nicotine (e.g. alcohol, sedatives) * current use of benzodiazepines other than physician prescribed * significant medical or psychiatric symptoms or dementia which in the opinion of the investigators would preclude compliance with the protocol, adequate cooperation in the study, or obtaining informed consent * concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in the study; and/or any pending legal action that could prohibit participation and/or compliance in study procedures * participated in a clinical study within the previous 8 weeks

Keywords: skype compliance remote dosing suboxone opiate opiates heroin oxycontin philadelphia