Kornimate/medical-research-clean huggingface dataset:
the effect of palliative care training on symptom management and quality of life in chronic heart failure

Conditions: Heart Failure; End of Life

Summary: palliative care is of great importance because of poor quality of life and high mortality risk in advanced heart failure. this study was planned as a randomized controlled trial to determine the effect of palliative care training on symptom management, rehospitalization, and quality of life among patients with heart failure.

patients were informed about the research and written informed consent was obtained. data were collected by face-to-face interviews within two days before discharge. patient information form and scales were applied to patients in the intervention and control groups. patients in the intervention group were received education after filling the forms. the training was given one by one at the hospital. one or two relatives of patients were included in the training. the patient was comfortably seated, and the room door was closed, face to face interaction was conducted. the patient and his/her relatives were allowed to ask questions during the training. the patient in the intervention group received at least 45 minutes of data collection from a case because of detailed training. it took about 15 minutes to collect data from a patient in the control group. in some patients, the training program was divided to be clearer. the patients were traced by telephone at the first, third, and sixth months after discharge. the investigator's phone number was presented to the patients and they were told that they could call at any time. continuous communication was ensured by giving the educator's phone number to the patients. the training was repeated by contacting the phone. the intervention group was retrained about symptoms they experienced during their telephone interview. the training was given to the experimental group as planned. no modifications/changes were made to the intervention during the study. special notes were taken for each patient. the effect of the education given on the quality of life and symptom management was evaluated with questionnaires. the intervention was adhered to as planned.

Eligibility criteria:
inclusion criteria: * 18-year-old or over, * class iii and iv heart failure patients according to new york heart association (nyha) classification, * patients without any communication problem to prevent participation in the research \[loss of hearing, visual impairment, lack of understanding/speaking in turkish\], can be contacted by telephone, are literate. * the patients who were diagnosed with heart failure at least six months ago accepted to participate voluntarily were also included in the study. exclusion criteria: * patients who wish to quit their study voluntarily during the study period and patients who died or worsened during the study period.

Keywords: heart failure palliative care rehospitalization symptom burden quality of life
effect of exercise-induced weight loss on energy metabolism

Conditions: Metabolism; Weight Loss

Summary: the e-mechanic ancillary study will measure changes in 24-hour energy expenditure and spontaneous physical activity in a subset of 60 obese individuals enrolled in the main study. we aim to determine if changes in energy metabolism might explain why people don't lose the expected amount of weight in an exercise program.

this is an ancillary study to e-mechanic, which is an national institutes of health study in 198 individuals with the objective to understand why certain people fail to lose weight in exercise programs. in e-mechanic changes in body weight, body composition, energy intake and energy expenditure are measured before and after 3 different exercise programs of 24 weeks in duration. the 3 exercise programs being compared are self-directed exercise, low dose exercise and high dose exercise. the goal of this ancillary study is to undertake comprehensive assessments of energy metabolism in a metabolic chamber in a group of 60 obese individuals enrolled in the main study. we will compare differences in the changes in 24h energy expenditure and spontaneous physical activity between the 3 exercise programs. we will also test if changes in energy metabolism might explain why people don't lose the expected amount of weight after 24 weeks of exercise.

Eligibility criteria:
inclusion criteria: * individuals enrolled in the e-mechanic main study (nct#01264406) with a body mass index (bmi) greater than or equal to 30 kg/m2. exclusion criteria: * not enrolled in the e-mechanic main study (nct#01264406). * have a body mass index (bmi) less than 30 kg/m2.

Keywords: energy metabolism weight loss exercise
visceral fat area as a prognostic biomarker in clear cell renal cell carcinoma: a multicenter study on postoperative survival

Conditions: ccRCC

Summary: this retrospective study included 1030 patients with clear cell renal cell carcinoma (ccrcc) who underwent radical or partial nephrectomy at wuhan union hospital from 2014 to 2023.


Eligibility criteria:
inclusion criteria: 1. primary clear cell renal cell carcinoma confirmed by histopathology; 2. patients≥18 years; 3. availability of preoperative abdominal computed tomography (ct) data; 4. patients with partial or radical nephrectomy.
does liposomal bupivacaine provide improved pain management for orif of midshaft clavicle fractures?

Conditions: Clavicle Fracture

Summary: to determine whether liposomal bupivacaine wound infiltration decreases pain scores and narcotic use when compared to bupivacaine alone after open reduction internal fixation of midshaft clavicle fractures.


Eligibility criteria:
inclusion criteria: * mid-shaft clavicle fracture treated with orif exclusion criteria: * unable to be contacted for 72 hours post surgery * other concurrent surgical procedures * chronic narcotic user
pharmacokinetics of advantage arrest in children

Conditions: Dental Caries

Summary: the purpose of this study is to characterize basic pk parameters (cmax, t1/2, auc) in healthy children to contribute to evidence for the safety of advantage arrest, consistent with guidance for industry--exposure--response relationships (april 2003).

this is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the gi tract or excreted. minimal amounts are absorbed through the oral mucosa. serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of advantage arrest. this is an open label exposure-response study with up to 50 healthy children ages 3-13 years of age. subjects will be treated with advantage arrest and have one blood sample withdrawn at a randomly assigned time point. a minimum of 3 subjects per time point at 2,4,6,24,48,96 and 168 hours. serum samples will be analyzed for f and ag.

Eligibility criteria:
inclusion criteria: * healthy. * at least one carious lesion. exclusion criteria: * oral mucositis * any ulcerative lesions * hypersensitivity to silver * hypersensitivity to fluoride. * sdf treatment within 3 months.

Keywords: child pharmacokinetics silver diamine fluoride
low level laser therapy for autoimmune thyroiditis

Conditions: Autoimmune Thyroiditis

Summary: introduction: chronic autoimmune thyroiditis (tca) is the main cause of acquired hypothyroidism, which requires continuous treatment with levothyroxine (lt4). a randomized, placebo-controlled trial including 43 patients with hypothyroidism caused by tca without nodules on ultrasonography study (us) was conducted from march 2006 to march 2009 (nct01129492). among them, 23 were submitted to low-level laser therapy (lllt) and 20 to placebo. the lllt was effective in improving the echogenicity, the volume and of the thyroid vascularization pattern by us. there was also improvement in the thyroid function and reduction of serum thyroid peroxidase antibodies (tpoab). although the results have shown promising and lllt has shown to be safe in many study models, the long-term lllt actions on the thyroid parenchyma are unknown. thus, the objective of this study is to perform biochemical tests and thyroid us six years after the clinical trial interventions to evaluate levothyroxine dose, serum levels of autoantibodies and, especially, the frequency and nature of nodules in the gland and then compare these variables between lllt and placebo groups. methods: this study will include the trial participants performed six years before. the levothyroxine dose and serum levels of thyrotropin (tsh), t3, t4, free t4, tpoab and anti-thyroglobulin antibodies (tgab) will be evaluated in these patients. the thyroid us will assess the texture (with particular attention to identifying nodules), echogenicity, volume, as well as vascularization of the gland. the us nodules features, such as dimensions, shape, margins, extracapsular invasion, echogenicity, texture, hypoechoic halo, calcification, internal content, vascularization pattern and resistivity index will be searched. regional lymph nodes and other characteristics will be also investigated. the uss will be carried out by only one examiner who will be blinded for the previously performed intervention (lilt or placebo). the same investigator will execute a fine needle aspiration (fna) of patients with thyroid nodules. the cytological analysis of the material collected from the nodules will be undertaken by a pathologist who will be also blinded for the treatment assignments. results: the following variables will be compared between the two groups: levothyroxine doses, antithyroid antibodies, us parameters, thyroid nodules (if detected) and in this case, the result of their respective fna.


Eligibility criteria:
inclusion criteria: all patients who have hypothyroidism caused by autoimmune thyroiditis included in the randomized, placebo controlled clinical trial (nct01129492) - exclusion criteria: all patients who have hypothyroidism caused by autoimmune thyroiditis included in the aforementioned trial (nct01129492) who underwent surgery and/or therapeutic administration of radioiodine for thyroid diseases during the period between the initial assessment of patients up to the present study.

Keywords: autoimmune thyroiditis lllt safety ultrasound
efficacy and safety of rapamycin versus vigabatrin in the prevention of tuberous sclerosis complex symptoms in infants

Conditions: Tuberous Sclerosis Complex

Summary: the purpose of the study is to evaluate the efficacy, tolerability, and safety of vigabatrin versus rapamycin as a preventive treatment in infants with tuberous sclerosis complex (tsc).

this is a two-arm, randomized, double-blind and double-dummy, placebo controlled study to evaluate the efficacy, tolerability, and safety of vigabatrin versus rapamycin as a preventive treatment in infants with tsc. the study consists of 3 phases for each patient: screening, core blinded phase, and open-label follow-up phase. patients who meet the eligibility criteria will be randomized to receive vigabatrin or rapamycin. the randomization ratio is 1:1. randomization will be stratified by the sex and the presence of epileptiform activity on baseline videoeeg (video electroencephalography) recording (yes versus no). approximately 60 infants are planned to be enrolled in the study.

Eligibility criteria:
inclusion criteria: * male or female aged from 4 up to 16 weeks (44-56 weeks of gestational age) at the day of randomization * parents/caregivers are willing to and able to give informed consent form for the participation in the study * parents/caregivers are willing to and able to comply with all study requirements * definite diagnosis of tsc according to the consensus criteria (northrup,2013) * at least 1 focus of cortical dysplasia disclosed on brain mri exclusion criteria: * history of seizures prior to randomization, * history of antiepileptic treatment, * history of treatment with mtor (mammalian target of rapamycin) inhibitor, * gestational age below 44 weeks at the day of randomization, * body weight lower than 3 kg at the day of randomization, * sega (subependymal giant cell astrocytoma) or other tsc-associated lesion requiring urgent surgical intervention * recent surgery within 1 month prior to the randomization * intercurrent infection at the date of randomization * known history of hiv seropositivity * live vaccination within 1 month prior to randomization\* * lack of first tbc and hepatitis b vaccinations * any significant clinical, laboratory , ecg or other abnormalities, comorbidity or concomitant treatment which, in the opinion of the investigator, may either put a patient at significant risk associated with the participation in the study or may influence the results of the study. * use of an investigational drug within 1 month prior to randomization.

Keywords: tuberous sclerosis complex, epilepsy, rapamycin, vigabatrin, tumors, prevention
iort on borderline resectable pancreatic cancer

Conditions: Borderline Resectable Pancreatic Cancer

Summary: this phase ii study investigates the efficacy of iort for patients with borderline resectable pancreatic cancer. the purpose of the study is to investigate whether the addition of iort, after folofirinox-base chemotherapy, and sbrt, increases the 3-year survival rate. a total of 101 patients will be enrolled, and these patients will receive iort of 10 to 20 gy, according to the resection status (to the tumor bed after resection, or to the tumor in situ in case of non-resection).

treatment outcomes of borderline resectable pancreatic cancer are still poor even after completion of folfirinox-based chemotherapy and radical resection. a growing body of literature is demonstrating that stereotactic body radiation therapy (sbrt) and intraoperative radiotherapy (iort), within a multimodal approach, allow to obtain better oncological outcome, at the price of low to negligible rates of morbidity and mortality. the investigators hypothesize that a "total neoadjuvant" scenario, with the best current therapy, based on up to 6 months of folfirinox (minimum 4), sbrt and iort (in situ or after surgery) would increase the disease-specific survival of borderline resectable pancreatic cancer patients. an historical cohort will be used as a comparison group. considering the intention-to-treat design and the institutional rates of chemotherapy completion and exploration/resection of borderline resection pancreatic cancer patients, a total of 100 patients will be enrolled in this phase ii trial. patients submitted to iort, will receive iort of 10 to 20 gy according to the resection status (to the tumor bed after resection, or to the tumor in situ in case of non-resection).

Eligibility criteria:
inclusion criteria: * • biopsy-proven, previously untreated borderline resectable pc, defined according to the nccn guidelines v1.2019; * age 18-80 years; * eastern cooperative oncology group (ecog) performance status 0 or 1; * adequate bone marrow function (absolute neutrophil count ≥1500 per cubic millimeter; platelet count ≥100.000 per cubic millimeter; hemoglobin level ≥10 g per deciliter), liver function (serum total bilirubin level ≤1.5 times the upper limit of the normal range), and renal function (creatinine clearance ≥50 ml per minute); * ability to understand the characteristics of the clinical trial; * written informed consent. exclusion criteria: * • ampullary, biliary, or duodenal adenocarcinoma; pancreatic adenocarcinoma in the background of an intraductal papillary mucinous neoplasia (ipmn), other uncommon pancreatic adenocarcinomas (acinar-cell, squamous, giant-cell osteoclastic-like); * invasive cancer in the last 5 years requiring radiation therapy to the upper abdomen or chemotherapy; * symptomatic heart failure or coronary artery disease; * pregnant or lactating women; * impaired mental state or language problems.

Keywords: pancreatic cancer borderline resectable pancreatic cancer intraoperative radiotherapy (iort) total neoadjuvant therapy
mepolizumab and physical activity in severe asthma

Conditions: Asthma; Asthma; Eosinophilic

Summary: severe asthma is a debilitating condition associated with frequent symptoms, life-threatening exacerbations and corticosteroid side-effects. exercise limitation due to exercise-induced bronchoconstriction, dynamic lung hyperinflation and comorbidity may be a strong determinant of the disease burden. mepolizumab is a monoclonal anti-interleukin-5 (il-5) antibody that reduces the rate of severe exacerbations, asthma symptoms and oral glucocorticoid requirement, and improves quality of life and work productivity in severe eosinophilic asthma. however, its impact on physical activity and exercise tolerance is unknown. we hypothesize that a 6-month treatment with mepolizumab is associated with an improvement in daily life physical activity and exercise tolerance in relation with enhanced ventilatory mechanics.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 years at the time of inclusion * asthma diagnosed for at least one year including a history of 1. fev1 and/or fvc reversibility of more than 12% and than 200 ml documented in the patient's record 2. or fev1 variability of more than 20% between two visits 3. or positive methacholine test * severe uncontrolled asthma monitored for at least six months in the investigation center with at least two assessments: 1. high-dose of inhaled corticosteroids (ics \>1,000 μg/day of beclometasone equivalent) in combination with another controller at a stable dosage for at least three months 2. acq-5 score \>1.5 and/or more than two severe exacerbations (i.e exacerbation requiring ≥ 3 days of systemic corticosteroids, hospitalization or admission at the emergency department) in the past year 3. blood eosinohils ≥300/mm3 within the 12 past months 4. decision to introduce mepolizumab according to regulatory approval 5. patient agreement to receive mepolizumab * body mass index (bmi) within the range \[18.5 - 35\] kg/m2. * able to give signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol exclusion criteria: * body mass index \ 35 kg/m2 * active smoker or active smoking during the last 6 months or cumulative \> 10 pack-years * all conditions responsible for physical disability (neurological, orthopedic, psychiatric, non-exhaustive list) or other condition limiting exercise in the investigator's opinion * any chronic respiratory or cardiac pathology which may interfere with the assessment of asthma according to the investigator's opinion * prior treatment with mepolizumab or benralizumab * bronchial thermoplasty during the past 12 months * contraindication to mepolizumab * non-coverage by the social security insurance * pregnant, breastfeeding, or lactating women * patient unable to receive information * refusal to sign the consent form * unwillingness or inability to follow the study procedures, in the opinion of the investigator * person deprived of the liberty person benefiting from a system of legal protection (guardianship...)

Keywords: severe asthma, physical activity exercise dyspnea
predicting pathological response within the 1st week of chemotherapy using diffuse optical spectroscopic imaging

Conditions: Breast Cancer

Summary: women with breast cancer who do not respond to chemotherapy may undergo months of treatment with little or no change in tumor size or overall outcome. the researchers have demonstrated a previously undescribed "metabolic flare" response observed very early in neoadjuvant treatment in breast cancer patients. the research can determine that this flare is predictive of overall therapy response and is due to both an inflammatory reaction and cell death induced by cytotoxic therapy.

the researcher can use diffuse optical spectroscopic imaging device to measure and predict the markers of the response in the first weeks of chemo-therapy. the oxyhemoglobin flare response can predictive of overall pathological response to chemotherapy in human subjects. these vascular changes can indicate the rapid transient increase and then decrease in oxyhemoglobin concentration in the first hours and days after therapeutic administration. the magnitude and time course of the flare response in patients receiving cytotoxic therapy will differ between pathological responders and non-responders. this oxyhemoglobin "flare response" can be observed in tumors where vascular dynamics are intact.

Eligibility criteria:
inclusion criteria: * female, not pregnant, not breastfeeding * greater than 21 years of age but less than 75 years of age * will be receiving neoadjuvant chemotherapy for breast cancer as prescribed by their oncologist exclusion criteria: * under 21 year of age * female pregnant or breastfeeding

Keywords: breast cancer
18850 - human photoallergy test

Conditions: Sunscreening Agents

Summary: to evaluate the potential of a test material to produce a photoallergic response.


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive; * be lightly pigmented (fitzpatrick skin type i, ii, iii); * have read and signed the written informed consent form and have completed a health insurance portability and accountability act (hipaa) authorization form in conformance with 45cfr parts 160 and 164; * be in general good health as determined by the subject's medical history and in the discretion of the investigator. exclusion criteria: * have a visible sunburn; * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; * have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products. * subjects who are employees of the cro and/or bayer or is a household member of an employee