Kornimate/medical-research-clean huggingface dataset:
efficacy of pre-operative oral pregabalin in ambulatory inguinal hernia repair for post operative pain

Conditions: Inguinal Hernia; Postoperative Pain

Summary: the study carry out is to determine whether the use of oral pregabalin premedication to assess the analgesic efficacy, opiod sparing, adverse effect and clinical value in post-operative pain management.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of inguinal hernia * patient undergo operation under daycare basis * asa i-ii * written consent exclusion criteria: * asa \> ii * allergic reaction against gabapentin and/or pregabalin * history of recurrent hernia repair. * patient who has taken analgesia prior to the surgery * liver failure * renal failure * pregnancy

Keywords: clinical diagnosis of inguinal hernia patient undergo operation under daycare basis asa i-ii written consent
pharmacokinetics of antimalarials in breastfeeding ugandan mother-infant pairs

Conditions: Malaria,Falciparum

Summary: lactating women requiring treatment for uncomplicated malaria will be identified and invited for sampling. the decision to treat them with first-line treatment will have been made by the clinician, not by a member of the study team. the study team will not make any adjustments to the prescribed treatment. artemether-lumefantrine comprises six doses of medication, with the initial two doses given 8 hours apart on day 1, and dosing 12-hourly on day 2 and day 3. intensive pharmacokinetic sampling will be undertaken after dose 5, as indicated in the schema under section 5: plasma and breastmilk samples will be obtained pre-dose and at 2, 4, 6, 8 hours after dose. in addition, sparse sampling will be undertaken on either of these occasions; at pre-dose and between 1 to 6 hours after the first dose; a trough (pre-dose) sample after the dose 3 or dose 4 and lastly at 5, 7, and up to 14-days after the first dose. a heelprick sample will also be obtained from the breastfed infants at maternal trough (prior to maternal dose) and at a random timepoint (once per infant) over the 8-hour pharmacokinetic sampling visit to characterize concentrations of these drugs over an 8-hour dosing interval. in addition, a single heelprick sample will be obtained from the infant whenever the mother returns after treatment for the late sampling time points (5, 7, and 14 days post the first dose). due to the long half-life of lumefantrine of approximately 6 days plasma sampling will be performed up to day 14 to characterise the terminal elimination of the drug. concentrations of total plasma and breastmilk lumefantrine and desbutyl-lumefantrine will be determined.

the endpoints of this study relate to the amount of antimalarial drug present in maternal blood, breastmilk and infant blood. the study is not powered for antimalarial efficacy, and therefore formal assessment of parasitological clearance is not required. the participants will be followed up until 30-40 days after completion of antimalarial therapy, and if recurrent symptoms occur, management will be as clinically indicated. details regarding further clinical investigations and management required by either mother or infant during the follow-up period will be recorded on the crf.

Eligibility criteria:
inclusion criteria: 1. a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study. 2. participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. woman is aged 18 years or older, and mothers between the age of 14-17, who are considered emancipated minors. 4. receiving treatment for uncomplicated malaria 5. breastfeeding at enrolment exclusion criteria: 1. severe maternal or infant illness which in the opinion of the patient's clinician would interfere with her participation in the study 2. breastfed infant is aged over 12 months 3. partner objection to participate in the study 4. maternal objection to infant participation
propofol and sevoflurane for catheter-related bladder discomfort

Conditions: Catheter Site Discomfort; Complications; Anesthesia; Urinary Bladder Neoplasms

Summary: the investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.

the mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. propofol and desflurane are most widely used as an anesthetic agent. propofol and desflurane are known to block the muscarinic receptor in different ways. the investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.

Eligibility criteria:
inclusion criteria: * patients scheduled for transurethral bladder excision under general anesthesia * asa i-iii exclusion criteria: * foley catheter less than 18 fr. * patients with obstruction of urinary tract * patients with neurogenic bladder * patients with severe obesity * patients with neurologic disorder * patients with chronic pain * patients with allergic history to propofol or sevoflurane
person centered nursing homes: impact assessment of centered person care in nursing homes

Conditions: Health Services for the Aged; Quality of Life; Mood

Summary: cohort observational study. the study will assess differences in quality of life, well-being and mood between persons living in a nursing home following usual care and persons living in nursing homes following a centered person care model. initially, the follow up will last 6 months, with the possibility to be extended.


Eligibility criteria:
inclusion criteria: * persons living in nursing homes * consent from the person (or legal representative, if the person is not able) exclusion criteria: * terminal illness * living temporary in a nursing home
incidence and resolution of eribulin-induced peripheral neuropathy

Conditions: Locally Advanced or Metastatic Breast Cancer

Summary: study e7389-m044-504 is an observational, post-authorization, single-arm, prospective, multicenter cohort study conducted to characterize and determine the incidence of eribulin-induced peripheral neuropathy (pn), and the frequency and time to resolution of eribulin-induced pn in adult participants treated with eribulin in a real-life setting with locally advanced or metastatic breast cancer (mbc) who have progressed following at least one and up to three chemotherapeutic regimens for advanced disease.


Eligibility criteria:
inclusion criteria: * locally advanced or mbc with progression after at least one chemotherapeutic regimen for advanced disease eligible for treatment with eribulin according to fachinformation. prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless participants were not suitable for these treatments * 1-3 prior chemotherapeutic regimens for advanced disease * age \>=18 years at the time of informed consent * ability to understand and willingness to respond to questions related to their health * decision for the participant to start treatment with eribulin has been made prior to inclusion in this study. * signed written informed consent exclusion criteria: * previous treatment with eribulin in any line of treatment * contraindication according to the fachinformation of eribulin * pregnancy or lactation * participation in an interventional clinical trial at the same time

Keywords: locally advanced or metastatic breast cancer peripheral neuropathy chemotherapy-induced peripheral neuropathy eribulin
active symptom monitoring in patients undergoing radiation therapy for thoracic malignancies

Conditions: Symptom Monitoring; Radiation Therapy

Summary: this study seeks to achieve two aims: * to assess the implementation of noona software for continuous symptom monitoring for a diverse population of patients with thoracic malignancies who are undergoing radiation and * to validate remote collection of standardized pro measures using noona software.


Eligibility criteria:
inclusion criteria: * biopsy confirmed cancer. radiographically apparent (i.e. not histologically or cytologically confirmed) malignancy of the thorax is allowed. * currently planning to receive radiotherapy with or without chemotherapy for greater than one fraction. * ability to understand and willingness to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable). * age 18 years or older exclusion criteria: -unable to reliably access and use a device compatible with noona software.
comparison of vortic catch v basket catheter and ordinary basket catheter for the removal of bile duct stones

Conditions: Randomized Study

Summary: investigators will perform randomized trial of the removal ability with vortic catch v basket catheter versus ordinary basket catheter for bile duct stones (≧ 10 mm).


Eligibility criteria:
inclusion criteria: * patients with suspected of having, or known to have, common bile duct stones (≧ 10 mm) * endoscopic papillary balloon dilation (eplbd) was performed. exclusion criteria: * septic shock * coagulopathy (international normalized ratio 1.3, partial thromboplastin time greater than twice that of control), * \<platelet count 50,000 / l * suspected or confirmed malignancy
correlation between pressure differences and micro-vascularization changes in bedridden paraplegic patient

Conditions: Pressure Ulcer; Bedsore; Spinal Cord Injury; Paraplegia

Summary: paraplegic patients have defective wound healing for sore below the level of spinal lesion. defect of vascularization of the healing zone certainly participate to this effect. therefore, this study want to measure, in a clinical settings, the interface pressure (e.g. the pressure between the patient body and the surface he/she is lying on) to assess the correlation between mechanical stress in term of pressure applied over time and tissue oxygenation which represent micro-vascular function. the aim of this clinical trial is to correlate the variations of pressure intensities and changes in micro-vascularization. the measure are recorded when paraplegic patient came into the hospital for pressure ulcer related surgery. the patient is laying on his/her mattress on top of a flexible pressure mapping device. the micro-vascularization parameters are measured at the area displaying the peak pressure a few minutes after the beginning of the pressure interface recording and one hour later at the same area. the data generated during this monocentric study will help to achieve a better understanding of the relation between pressure and micro-vascularization. in the mid term, it will provide a better and more patient adapted pressure ulcer prevention.


Eligibility criteria:
inclusion criteria: * educated consent signed, * older than 18, * paraplegia for at least 6 months, * surgery planned for pressure ulcer resection, exclusion criteria: * dementia, * stade iv arteritis non-revascularisable, * patient with no health insurance, * pregnant women or breast-feeding, patient unable to give his or her educated consent, ward of the state (art. l.1121-6, l.1121-7, l.1211-8, l.1211-9), * patient taking part in another study which could impact the local micro-vascularization.

Keywords: pressure ulcer interface pressure pressure mapping device monitoring microvascularization
mortality post-tavi and correlation with haemodynamic parameters.

Conditions: Aortic Valve Stenosis

Summary: until a few years ago the only interventional option available for severe aortic stenosis was surgical aortic valve replacement. about a decade ago, a novel percutaneous technique was applied for the first time in humans, the transcatheter aortic valve implantation (tavi). initially this procedure was reserved for those patients deemed too high risk for surgical intervention. as technology progressed in this domain, the indication for tavi expanded to a broader population of patient with severe aortic stenosis. to-date there are no long-term data for mortality and this is the central question this study will explore in correlation with haemodynamic parameters. essentially, this study will explore the effect of tavi in the long term. all patients that had a tavi within the rbh\&hh nhs foundation trust between january 2008 and december 2017 will be included in the study. this is a retrospective study.

aortic valve stenosis is the most prevalent valvulopathy in the developed world countries. until a few years ago the only interventional option available for severe aortic stenosis was surgical aortic valve replacement. about a decade ago, a novel percutaneous technique was applied for the first time in humans, the transcatheter aortic valve implantation (tavi) as a keyhole procedure. initially this procedure was reserved for those patients deemed too high risk for surgical intervention. as technology progressed in this domain, the indication for tavi expanded to a broader population of patient with severe aortic stenosis. as the experience broadens there are no long-term data for mortality and this is the central question this study will explore in correlation with haemodynamic parameters. essentially, this study will explore the effect of tavi in the long term. all patients that had a tavi within the rbh\&hh nhs foundation trust between january 2008 and december 2017 will be included in the study. this is a retrospective study and will not change anything in the patients' standard of care.

Eligibility criteria:
inclusion criteria: * all patients with tavi within the royal brompton \& harefield nhs foundation trust exclusion criteria: * none
positron emission tomography (pet) imaging with zirconium-89 (89zr)-trastuzumab for prediction of her2 targeted therapy effectiveness

Conditions: Breast Cancer

Summary: our goal is to investigate the use of 89zr-trastuzumab as a her2 imaging agent to determine which patients are likely to respond to targeted her2 agents as single agent therapy. we are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89zr-trastuzumab-pet/mri, evaluating the relationship between tumor 89zr-trastuzumab uptake and in vitro positivity of her2, assessing the relationship between 89zr-trastuzumab uptake and response to her2 therapy.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age. * diagnosis of her2 positive breast cancer as defined by to american society of clinical oncology (asco)/college of american pathologists (cap) 2018 guidelines: immunohistochemistry (ihc) 3+ or single prove in situ hybridization (ish) with average her2 copy number \>= 6 or dual probe ish with both average her2 copy number \>= 4 and her2 to cep17 ratio \>=2 * patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-her2 agent * eastern cooperative oncology group (ecog) performance status of 0 and 1 * ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (muga) scans exclusion criteria: * inability to provide informed consent * pregnancy * inability to lie still for the imaging study * weight over 350 lbs., due to the scanner bore size * contraindication for mri study (e.g. non-removable metal implants or certain tattoos)

Keywords: 89zr-trastuzumab, her2 imaging
short term effects of electronic cigarettes in tobacco dependent adults

Conditions: Smoking; Nicotine Dependence

Summary: this is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled co levels, and quantitative tobacco cigarette consumption in active tobacco smokers. subjects recruited from the winchester chest clinic (wcc), adult primary care clinic (pcc) and the smilow cancer hospital smoking cessation service will be randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine e-cigarette.


Eligibility criteria:
inclusion: * smoking 1 or more tobacco cigarettes per day. * residence within reasonable driving distance to new haven.. exclusion: * unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia. * unstable medical conditions requiring hospitalization. * acute myocardial infarction or acute cerebrovascular accident within the past 30 days. * unstable angina. * history of allergic reactions to adhesives. * women of childbearing potential who are pregnant, nursing, or not practicing effective contraception. * current use of an electronic cigarette. * subject unable or unwilling to complete study protocol for any reason.
a study to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (lucent 3)

Conditions: Ulcerative Colitis

Summary: this study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (uc). the study will last up to 3 years. participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.


Eligibility criteria:
* inclusion criteria * participants from study amac (nct02589665) or ambg (nct03524092) who have had at least one study drug administration and have not had early termination of study drug. * female participants must agree to contraception requirements. * exclusion criteria * participants must not have developed a new condition, including cancer in the originator study. * participants must not have any important infections including, but not limited to, hepatitis b, hepatitis c, hiv/aids, and active tuberculosis (tb) during either originator study * participants may not have received surgery for uc in the originator study or are likely to require surgery for treatment of uc during the study. * participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.

Keywords: inflammatory bowel disease
a clinical trial comparing short-term efficacy and safety of exubera and lantus

Conditions: Diabetes Mellitus, Type 2

Summary: to compare short-term efficacy and safety of exubera vs lantus in patients with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2 exclusion criteria: * severe asthma, severe copd * smoking
evaluation of the surface topography for monitoring scoliosis patients aged 10-13 years

Conditions: Scoliosis

Summary: the main objective of the study is to investigate the correlation between the measurement of the cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface topography. the device used in this research to the topography examination is three-dimensional morphometry device of axs medical society : the biomod l.

for usual follow-up visit, patients will have a x-ray examination of the spine and the surface topography. the measurement of the angle of scoliosis is achieved by two independent operators for both methods. patients then have a follow-up visit at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * patient with idiopathic scoliosis, * body mass index bmi below or equal to 25, * cobb angle measured on radiographs between 10 and 25 degrees, * parental authorization. exclusion criteria: * patient with secondary scoliosis (neurological, prader willi syndrome...)

Keywords: topography cobb angle
a study of avastin (bevacizumab) and xeloda (capecitabine) as maintenance treatment in patients with metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: this 2 arm study assessed the efficacy and safety of maintenance treatment with avastin (bevacizumab) + xeloda (capecitabine), after initial treatment with xeloda + oxaliplatin + avastin, in patients with metastatic colorectal cancer. patients were randomized into one of 2 groups to receive 1) xeloda + oxaliplatin + avastin until disease progression or 2) xeloda + oxaliplatin + avastin for 6 3-week cycles, followed by xeloda + avastin until disease progression. xeloda was administered at a dose of 1000 mg/m\^2 orally twice a day on days 1-14 of each cycle, oxaliplatin at a dose of 130 mg/m\^2 intravenously (iv) on day 1 of each cycle, and avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ 18 years of age. * histologically confirmed colon or rectal cancer, with unresectable metastatic disease. * at least 1 measurable lesion. * outpatient, with eastern cooperative oncology group (ecog) performance status = 0-1. exclusion criteria: * previous treatment with avastin. * previous systemic treatment for advanced or metastatic disease. * clinically significant cardiovascular disease. * daily chronic treatment with high doses of aspirin (\> 325 mg/day) or non-steroidal anti-inflammatory drugs.
the effect of mindfulness compassionate living practice on hemodialysis patients

Conditions: Hemodialysis Patients

Summary: there are studies evaluating the effects of mindfulness-based practices on individuals receiving hd treatment. no studies have been found on how mindfulness compassionate life application reduces stress, increases self-efficacy and quality of life in individuals receiving hd treatment. considering the stress situations experienced by individuals receiving hd treatment, it is thought that the evidence-based effect of mindfulness compassionate living application on individuals\&#39; stress, self-efficacy and quality of life is important. the population of the research will consist of 90 hemodialysis patients who were treated in bingöl state hospital dialysis unit during the specified date range. sample size of the research; calculated using the gpower computer program. with the power analysis, it was calculated that at the α = 0.05 level, the effect size would be strong 150, 153 (d = 0.8) and the power of the study would be 90%, and that at least 68 patients should be included in the sample. patients who meet the research criteria and agree to participate in the research will be randomly assigned to one experimental and one control group.

introductory information form prepared by the researcher in line with the literature and containing the socio-demographic data of hemodialysis patients, perceived stress scale (pss) to evaluate stress, self-efficacy-efficacy scale (sees) to evaluate self-efficacy, sf-12 quality of life scale to evaluate quality of life. , self-compassion scale short form (pss-k) will be used to evaluate self-compassion, and conscious mindfulness scale (bips) will be used to evaluate conscious mindfulness.

Eligibility criteria:
inclusion criteria: * being diagnosed with chronic renal failure * being over 18 years of age, * being willing to participate in the study * being open to communication and collaboration exclusion criteria: * having a diagnosis of acute renal failure, * having a current hospital stay, * lack of openness to communication and collaboration,

Keywords: hemodialysis patients mindfulness life quality self-efficacy