Kornimate/medical-research-clean huggingface dataset:
kangaroo care reduces infant pain caused by vaccination

Conditions: Infant; Pain; Kangaroo Mother Care; Nursing; Evidence-based Practices

Summary: the aim of this randomized controlled study determine the effect of kmc on pain in infants during vaccination.

infants undergo many painful procedures from the time they are born. kangaroo mother care (kmc) is one of the nonpharmacological methods that are effective in alleviating pain. the aim of this randomized controlled study determine the effect of kmc on pain in infants during vaccination. the study subjects were 128 healthy, 1-month-old infants and their mothers. a sociodemographic questionnaire, the neonatal infant pain scale (nips), a pulse oximeter, and a chronometer were used in collecting the data. this study indicate that kmc reduced crying duration, heart rate, and pain in vaccinated infants, whereas it increased oxygen saturation levels in the blood.

Eligibility criteria:
inclusion criteria: * the consent of the parents to participate in the application of the study, * the infant being 1 month old * parents and infants being healthy exclusion criteria: * the consent of the parents not to participate in the application of the study, * the infant not being 1 month old * the parents and infants not being healthy.

Keywords: infant pain kangaroo mother care nursing evidence-based practices
transesophageal echocardiography in embolic stroke of undetermined source

Conditions: Embolic Stroke of Undetermined Source; Ischemic Stroke

Summary: the esus concept was introduced recently to describe a non-lacunar stroke of undetermined etiology. the following etiological workup is required in this setting: head ct or mri, 12-lead ecg, transthoracic echocardiography, continuous cardiac monitoring for at least 24 hours after stroke, vascular imaging (ultrasound, magnetic resonance angiography, ct angiography, catheter angiography). transesophageal echocardiography (tee) is considered not to be required. however, aortic arch atheroma as diagnosed by tee in the setting of recent ischemic stroke is a major aortic source of embolism, as supported by numerous well conducted studies. the european association of echocardiography considers that tee is the gold standard for the diagnosis and the characterization of aortic atheroma. it is also the method of choice for the diagnosis of infectious endocarditis. the aim of this work was to evaluate the rate of patients with a therapeutic modification induced by tee (mainly anticoagulation and surgery), in consecutive patients admitted with esus at our institution stroke unit.


Eligibility criteria:
inclusion criteria: * presenting with a new onset of ischemic stroke * meeting the esus criteria (embolic stroke of undetermined source) * comprehensive transthoracic echo prior to the tee exclusion criteria: * esus criteria not met * contraindications to tee * tee failure * pregnant or breastfeeding woman * person under legal protection * no medical insurance coverage

Keywords: embolic stroke of undetermined source transesophageal echocardiography cardiac source of embolism ischemic stroke
neurogenic mechanisms in burning mouth syndrome

Conditions: Burning Mouth Syndrome

Summary: burning mouth syndrome (bms) is characterized by a bilateral burning sensation in the anterior tongue, hard palate and lips in the absence of any clinical or laboratory findings. the term syndrome implicates the simultaneous presence of oral dryness (xerostomia) and altered taste (dysgeusia) in addition to the burning sensation in the oral mucosa. bms is most often seen in women and is more frequent during menopause. the etiology and pathogenesis are still unclear but recent studies suggest that bms is a neuropathic pain condition. the objectives of the study are: * to clarify potential neurogenic mechanisms behind bms using immunohistochemistry (ih) to characterize the localization and distribution of peripheral nerve fibres, neuropeptides like substance p, calcitonin gene-related peptide, nerve growth factor, nerve growth factor receptor, pgp 9.5 neuronal marker and trpv1 as well as inflammatory/structural changes. * to perform a randomized double blind cross-over intervention study to examine the efficacy and safety of topical application of capsaicin oral gel (on the tongue) to relieve the burning sensation in patients with bms.

data which support the hypothesis that bms is a neuropathic pain condition include amongst others a recent clinically controlled study that has shown up-regulation of trpv1-positive nerve fibres in tongue mucosa in patients with bms. the vanilloid receptor-1 (trpv1) is a voltage-dependent cation channel expressed by the unmyelinated c-nociceptive nerve fibres and the receptor may be activated by capsaicin (from chili peppers), heat and h+. capsaicin binds to the trpv1 receptor causing depolarization of the c-nociceptors. prolonged activation of these neurons by capsaicin depletes pre-synaptic substance p and makes them unable to report pain.

Eligibility criteria:
inclusion criteria: * non-smoking female patients with burning mouth syndrome (n=26) * healthy aged-matched control group (n=10) exclusion criteria: * pregnancy and lactation (inclusion requires negative pregnancy test) * women who do not use safe anticonception * patients with know allergy/hypersensitivity to capsicum and other capsaicinoid-containing products * active infection which requires antibiotic treatment * use of mouthrinse. the use of these is stopped 14 days before inclusion * patients who are able to give informed consent due to physical or mental disabilities

Keywords: burning mouth syndrome neuropathy inflammation tongue mucosa tongue innervation dysgeusia
evaluation of cardiovascular risk after preeclampsia in general practitioners and patients

Conditions: Patients Hospitalized for Pre-eclampsia

Summary: pre-eclampsia is a disease characterized by placental damage leading to a cascade of complications during pregnancy. it is initially manifested by high blood pressure and the presence of albumin in the urine. it can lead to emergency hospitalization in severe cases and cause major complications or even death in the mother and the fetus. several studies observing the outcome of patients with pre-eclampsia have shown an increased long-term cardiovascular risk in these patients, justifying regular medical follow-up with the treating physician and specialists, mainly cardiologists. the main objective of this research is to describe the cardiovascular risk assessment actions implemented by the treating general practitioner in the year following pre-eclampsia (blood pressure measurement in the office, self-measurement of blood pressure, abpm, cardiological consultation, biological monitoring of blood (creatininemia, ldl, fasting glycemia) or urine (albuminurie/creatininurie ratio), and screening and management of possible smoking).


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years hospitalized for preeclampsia at the nancy regional maternity hospital exclusion criteria: * fetal death in utero; * adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice); * person deprived of liberty by a judicial or administrative decision; * person subject to psychiatric care under constraint by virtue of articles l. 3212-1 and l. 3213-1 of the public health code.

Keywords: pre-eclampsia cardiovascular risk
sentinel lymph node detection in patients with stage ib-iii melanoma using msot and icg

Conditions: Melanoma, Stage I; Melanoma, Stage II; Melanoma Stage III

Summary: in this study the investigators try to identify the sentinel lymph node in patients with stage ib-iii melanoma in a non-invasive manner without the use of a radioactive tracer by using the new msot technology.

over the past few decades, melanoma has been one of the fastest-growing cancers and the incidence rate of melanoma is still increasing. standard treatment for melanoma is wide (re)excision. sentinel lymph node (sln) biopsy (slnb) is recommended for patients with melanoma of ajcc stage pt1b or higher according to dutch guidelines. slnb provides essential staging information that impacts on the clinical management of patients with melanoma, and the presence of sln metastasis indicates a significantly worse prognosis. however, the overall complication rate of slnb is high. currently, lymphoscintigraphy using 99mtc-nanocolloid technetium-99m-nanocolloïd (tc99m) is the gold standard to identify the sentinel lymph node. however, there are various disadvantages of using 99mtc-nanocolloidtc99m: the involvement of radioisotopes represents a radioactive burden for patients and caregivers, the lymphoscintigraphic imaging has poor spatial resolution, and the involvement of radioisotopes is expensive and creates logistic challenges. therefore, in this study the goal is to identify the sentinel lymph node in a non-invasive manner without the use of a radioactive tracer. the investigators try to reach this goal by using the fluorophore dye indocyanine green (icg) and multispectral optoacoustic imaging (msot). msot is a new, but increasingly used, imaging modality that has emerged the field of optical imaging. msot is based on a highly powerful pulsed laser in different wavelengths. photo absorbing molecules absorb laser light in a specific wavelength, undergo thermal expansion and create soundwaves which can be detected by special transducers. the msot combines conventional ultrasonography with optoacoustic imaging which gives both anatomical and biological information and is currently available in the university medical centre groningen (umcg).

Eligibility criteria:
inclusion criteria: * patients with grade ib- iii melanoma scheduled for slnb and/or surgical excision. * patients must be \> 18 years old and be able to give informed consent. * skintype i-iv following fitzpatrick skin classification (msot less reliable in skin types \>iv) exclusion criteria: * apparent hyperthyroidism or autonomous thyroid adenoma of the thyroid gland * prior surgery or radiotherapy on involved lymph nodes / area * major surgery within 28 days before tracer administration * pregnant or nursing women, fertile women will need a negative pregnancy test prior to inclusion * history of iodine allergy or anaphylactic reactions to insect bites * hypersensitivity to icg or poorly tolerated icg in the past * unexplained allergic reaction in the past * skin type \>iv following fitzpatrick skin classification (msot less reliable)
injury prevention in danish youth handball

Conditions: Adherence, Sports Injury Prevention Exercises; Athletic Injuries

Summary: the primary aim of this hybrid-effectiveness-implementation cluster randomised study is to investigate if a supported implementation of an injury prevention exercise program (happy program) involving a train-the-trainer workshop and coach support during the season is superior to an unsupported implementation of the happy program involving the availability of the program on webpages, in improving adherence (volume, frequency, duration) of the happy program among coaches for young (11-17 years of age) danish female and male handball players during one handball season. secondary aims are to investigate if the supported implementation is superior to the unsupported implementation in improving behavioural outcomes among the coaches and in reducing the risk for new ankle, knee, and shoulder injuries among young (11-17 years of age) danish female and male handball players during one handball season. further, the investigators aim to evaluate how and why adherence and behavioural determinants towards use of the happy program might improve (or not).


Eligibility criteria:
inclusion criteria: * playing in youth teams from the age groups under (u)13, u15, and u17 * playing in handball club with at least four teams in the desired age groups exclusion criteria: -
micardis® / micardisplus® program for therapy optimization with telmisartan in cardiovascular diseases (protekt)

Conditions: Hypertension

Summary: study to evaluate efficacy and tolerability of micardis®/micardisplus® under usual daily-practice prescribing-conditions with emphasis on effects on endorgan damage in the clientele of cardiologists, nephrologists, and diabetologists


Eligibility criteria:
inclusion criteria: * age \>= 18 years exclusion criteria: * age \< 18 years
surufatinib combined with toripalimab and chemotherapy in the treatment of non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: a phase ii study to assess the efficacy and safety of surufatinib combined with toripalimab and chemotherapy as a first-line treatment in patients with advanced non-squamous non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: 1. voluntary provision of informed consent. 2. males or females aged 18-75. 3. histological or cytologically confirmed nsclc, metastatic or non-resectable (stage iiib-ⅳ). 4. at least one lesion can be measured by imaging. 5. eastern cooperative oncology group (ecog) performance status (ps) of 0-1. 6. life expectancy ≥ 12 weeks. 7. none previous chemotherapy or targeted therapy(arm:wild-type genotype). 8. patients should be confirmed acquired egfr t790m mutation and received adequate egfr-tki treatment(arm:egfr mutation). 9. female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment. exclusion criteria: 1. histological or cytologically confirmed small cell lung cancer (sclc), including lung cancer mixed with sclc and nsclc. 2. diagnosed with other malignant diseases other than nsclc within 5 years. 3. have participated in other interventional clinical research treatments now or within 4 weeks. 4. have previously received multi-targeted kinase inhibitors therapy. 5. have active autoimmune diseases requiring systemic treatment within 2 years. 6. received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks. 7. clinically uncontrollable pleural effusion/abdominal effusion. 8. vaccinated vaccines or attenuated vaccines within 4 weeks before the group; 9. pregnant or breastfeeding females. 10. other serious hazards to the safety of patients.
post-marketing surveillance of gsk biologicals' cervarix™ when administered to healthy females in sri lanka

Conditions: Human Papillomavirus Infection

Summary: this pms study aims to collect safety and reactogenicity data of cervarix in the local population as per the licensing requirement of the sri lankan regulatory authority.

subjects who received one or two doses of cervarix prior to the start of this pms study can also be enrolled in the study. these subjects would receive either 2 doses or 1 dose respectively after being enrolled in the study. since there is lack of clarity regarding the pms study requirement (both from regulatory agency and ethics committee), it was decided that gsk will submit local psurs on a regular basis as desired by local regulatory agency. the same is communicated to regulatory agency and if they want something more they are requested to revert back with specific requirements.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they and/or their parent(s)/ lar(s) can and will comply with the requirements of the protocol should be enrolled in the pms study. * a female aged 10 years and above at the time of the first vaccination. * written informed consent obtained from the subject. for subjects below the legal age of consent, written informed consent must be obtained from the parent(s)/lar(s) of the subject and informed assent must be obtained from the subject. where subject/subject's parent(s)/lar(s) are illiterate, the consent form will be countersigned by an impartial witness. * subjects of childbearing potential must not be pregnant. absence of pregnancy should be verified as per the investigator's clinical judgement. exclusion criteria: * subjects with contraindication according to the locally approved pi. * child in care. * previous administration of more than two doses of cervarix. * previous vaccination with a hpv vaccine other than cervarix. * planned administration of another hpv vaccine other than cervarix during the pms study.

Keywords: healthy females post-marketing surveillance (pms) human papillomavirus vaccine sri lanka cervarix
cap/iri plus cetuximab compared to cap/ox plus cetuximab in patients with metastatic colorectal cancer.

Conditions: Metastatic Colorectal Cancer

Summary: a randomized phase ii-study to evaluate the safety and efficacy of capecitabine plus irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in first-line treatment of patients with metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic colorectal cancer. * egf-receptor testing. * no prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an interval ³ 6 months). * no prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against the egf-pathway. * no prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start of study treatment. * measurable disease (diameter ³ 20mm, diameter ³ 10mm with spiral-ct). * male and female patients ³ 18 years, £ 75 years. karnofsky ps ³ 70%. life expectancy ³ 3 months. effective contraception if risk of conception exists. * adequate bone marrow, liver and renal function (leucocytes ³3.000/µl, neutrophils ³1.500/µl, platelets ³100.000/µl, hemoglobin ³9g/dl, bilirubin £1,5x uln, asat and alat £3x uln (£5x uln with liver metastasis), serum creatinine £1,5x uln). * written informed consent. exclusion criteria: * concurrent treatment of colorectal cancer (except study medication). * egf-receptor testing not possible. * known dpd-deficiency (no particular screening necessary). known gilbert-meulengracht-syndrome (no particular screening necessary). * known or expected contraindication against study medication. * participation in other studies during 30 days before study entry. * prior myocardial infarction, severe renal insufficiency (creatinine clearance £30ml/min). * previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment and no sign of disease during 5 years). * known or suspected cerebral metastasis. * history of inflammatory bowel disease. symptomatic peritoneal carcinomatosis. * drug or alcohol abuse. lack of adequate legal capacity. * breast-feeding or pregnant women. * concurrent medication with sorivudine and analoga, anticoagulation with cumarine or derivatives.

Keywords: capecitabine irinotecan cetuximab oxaliplatin colorectal cancer
a study of tamiflu (oseltamivir) for treatment of influenza with a focus on (h1n1) 2009 flu strain

Conditions: Influenza

Summary: this randomized, double-blind, multi-center study of tamiflu (oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. patients with (h1n1) 2009 influenza strain or influenza a are eligible for this study. patients will be randomized to one of four treatment regimens. patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. the dose will be body weight-adjusted for pediatric patients.


Eligibility criteria:
inclusion criteria: * pediatric, adolescent and adult patients \>/=1 year of age * fever \>/=37.8 degrees c or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis) * positive rapid diagnostic test for pandemic (h1n1) 2009 virus or influenza a in the 24 hours prior to the first dose of study drug * \</=96 hours between onset of influenza-like illness and first dose of oseltamivir exclusion criteria: * currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration * history of chronic renal failure or clinical suspicion of renal failure at baseline * clinical evidence of hepatic compensation at the time of randomization * known hiv infection * vaccination with live attenuated influenza vaccine (laiv) in the two weeks prior to first dose of study medication
functional magnetic stimulation enhances gastrointestinal motility in patients with chronic constipation

Conditions: Constipation

Summary: the purpose of this study is to evaluate the effects of functional magnetic stimulation (fms) on gastrointestinal motility in patients suffering from chronic constipation due to non-neurological issues.

the goal of this pilot study is to evaluate the usefulness of fms as a noninvasive method to stimulate the gi motility in individuals with non-neurological constipation by adopting a 5-week conditioning protocol performed in a hospital outpatient setting. fms has demonstrated the ability to generate significant rectal pressure and enhance gi transit in normal and spinal cord injury subjects. with proper abdominal muscle conditioning, fms may improve colonic motility partly due to improved abdominal muscle tone.

Eligibility criteria:
inclusion criteria: * age 18-80 * constipation defined by the rome ii criteria exclusion criteria: * past history of abdominal surgery * past history of diabetes mellitus * past history of hypothyroidism * past history of inflammatory bowel disease * past history of significant psychiatric disturbances * past history of drug abuse * past history of cardiac pacemakers * past history of metal implants * patients who cannot travel to keep the follow up * patients who are prisoners * patients who are mentally handicapped * patients who are pregnant

Keywords: constipation gastric emptying
rule out of acs in primary care using a decision rule for chest pain including hs-troponin i poct

Conditions: Chest Pain; Myocardial Infarction; Acute Coronary Syndrome

Summary: the goal of this clustered, diagnostic randomized controlled trial is to study a clinical decision rule including a high-sensitive troponin i point of care test in patients with chest pain in primary care. the main questions it aims to answer are: 1. can unnecessary referrals to secondary care be reduced by the use of a clinical deci-sion rule in patients with new onset, non-traumatic chest pain in primary care? compared to current daily practice. 2. what is the accuracy (sensitivity, negative prediction value) of the clinical decision rule for excluding acs and mace at 6 weeks and 6 months?

this clustered, diagnostic randomized controlled trial will included patients with acute chest pain consulting their general practitioner. practices in the intervention group will use a clinical decision rule consisting of the marburg heart score and a high-sensitive troponin i point of care test to exclude acute coronary syndrome (acs) and decide upon referral. practices in the control group will apply usual care following local guidelines. an independent endpoint committee consisting of a cardiologist and general practitioner will adjudicate the final diagnosis. primary endpoints are acs and major adverse cardiac events. a delayed reference standard of 6 months will be used. for high sensitive troponin i measurement, the siemens atellica vtli immunoassay analyser is used.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * acute chest pain * seen by general practitioner exclusion criteria: * \<1 hour since onset of symptoms * inability to speak or understand dutch * hemodynamic instability

Keywords: chest pain primary care general practice myocardial infarction troponin point of care test