Kornimate/medical-research-clean huggingface dataset:
tablet-assisted training in exacerbated copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a public health problem with great morbidity. the main therapeutic strategy is inhalers. the objective of this study is to determine the efficacy of a tablet-assisted training in the use of inhalers in patients with copd including ventilatory re-education and video recordings of the patients themselves.

the importance of this pathology lies not only in its high prevalence, which is expected to increase due to the aging of society but also in its high mortality. in europe, it is estimated that 50% of adult patients do not use the inhaler correctly. the clinical development of copd includes periods of stability interspersed with symptomatic exacerbations, which usually involve hospitalization. during these hospitalizations, respiratory symptoms are worsening.nevertheless, in europe, it is estimated that 50% of adult patients do not use the inhaler correctly. thus, it is very important the pharmacological education in this patients.

Eligibility criteria:
inclusion criteria: * diagnosed of exacerbation of copd. * to possess pharmacological treatment in the form of inhalers. exclusion criteria: * inability to provide informed consent. * presence of psychiatric or cognitive disorders. * organ failure or cancer. * inability to cooperate. * patients who had experienced an exacerbation in the last month.

Keywords: education dry powder inhalers metered dose inhalers pulmonary disease chronic obstructive
transcatheter interventions for tricuspid insufficiency in italy

Conditions: Tricuspid Valve Insufficiency

Summary: this is an observational, multi-center, retrospective and prospective study collecting data about patients undergoing transcatheter tricuspid valve interventions in a real world clinical environment. the aim is to report clinical characteristics, procedural results and short- and long-term outcomes of patients undergoing transcatheter tricuspid valve interventions in italian centres.


Eligibility criteria:
inclusion criteria: 1. patients undergoing transcatheter treatment of tricuspid regurgitation (native valve -with or without previous surgical valve repair - or degenerated bioprosthesis) 2. patients who are willing and capable of providing informed consent, and participating in all follow-ups associated with this clinical investigation. exclusion criteria: 1. valve anatomy unsuitable for transcatheter tricuspid valve interventions. 2. subjects who are unable or not willing to complete follow-up visits and examination for the duration of the study.
pancreaticoduodenectomy in elderly pancreatic ductal adenocarcinoma patients

Conditions: Pancreas Cancer

Summary: we used the seer database to analyze the data of patients with pdac. the database includes patients of 18 registries in the usa from 1973-2013all the malignant cases were followed-up annually to determine vital status. the aim of our study is to make clearly the long-term survival of younger (age \<80 years) and elderly (age ≥80 years) pancreatic cancer patients underwent pd. sec-ond, find out the risk factors of poor prognosis in elderly patients.

database we used the seer database to analyze the data of patients with pdac. the database includes patients of 18 registries in the usa from 1973-2013, encompassing approxi-mately 28% of the usa population. all the malignant cases were followed-up annu-ally to determine vital status. patient population all the variables' definitions are encoded in the seer database. to identify the pdac cases, site codes (c25 pancreas, c25.0-c25.9) and histology codes (8140 adenocarcinoma, 8500 infiltrating duct carcinoma) based on the international classification of diseases for oncology, third edition (icd-o-3) were used.11 only cases that underwent pd and microscopically confirmed were included. outcome variables we only included those pdac patients that underwent pd with precise data available for the following variables: age at diagnosis, year of diagnosis, gender, race, tumor site, tumor size, regional nodes positive, regional nodes examined, grade, stage, vital status, and survival months. to clearly differentiate the difference of long-term survival between young and elderly patients, all cases were divided into two group age \ 4 cm. the lymph node ratio (lnr) is considered a robust prognostic factor after resection of pancreatic cancer and was es-timated using regional nodes positive divided by regional nodes examined.15 lnr was then categorized into three groups: 0%, 1-50%, \> 50%.

Eligibility criteria:
inclusion criteria: * patients with pancreatic ductal adenocarcinoma，treatment by pancreaticoduodenectomy.only cases that underwent pd and microscopically confirmed were included. exclusion criteria: * patients with no survival data.

Keywords: pancreatic ductal adenocarcinoma pancreaticoduodenectomy
association of anti-factor xa activity with venous thromboembolism in critically ill patients

Conditions: Thrombosis; Pulmonary Embolism; Enoxaparin

Summary: the goal of this observational study is to analyse the association between anti-factor xa activity (antixa) and the occurence of venous thromboembolism (vte; either deep vein thrombosis and/or pulmonary embolism) in critically ill patients who are admitted to an intensive care unit. the main questions it aims to answer are: * what is the association between antixa and vte? * what is the association between antixa and symptomatic, respectively incidental, vte? * how is pharmacological anticoagulation with enoxaparin related to measured antixa? * what is the association between antixa and bleeding complications. * what is the incidence of venous thromboembolism in patients treated at an intensive care unit? * how is the occurence of vte related to patient-centred outcomes such as mortality, quality of life, length of stay and days outside of the intensive care unit/hospital.


Eligibility criteria:
inclusion criteria: * age over 18 years at the time of intensive care unit admission * admission to a participating intensive care unit within the last 24 hours * expected discharge is later than 48 hours after enrolment exclusion criteria: * therapeutic anticoagulation, defined as enoxaparin dose of at least 100 ie/kg when given twice daily or of at least 150 ie/kg when given once daily * extracorporeal membrane oxygenation in place or planned within 48 hours of study enrolment * planned regular administration of vitamin k antagonists, unfractionated heparin, low molecular weight heparin other than enoxaparin, thrombin inhibitors or factor x inhibitors within the observation period * estimated life expectancy below 48 hours or comfort terminal care order in place * previously diagnosed heparin-induced thrombocytopenia * pre-operative admission for elective surgery * previous enrolment in the study
cell transplant in spinal cord injury patients

Conditions: Chronic Spinal Cord Injury

Summary: this study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. the hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.


Eligibility criteria:
inclusion criteria: * traumatic spinal cord injury * no concomitant systemic disease * no progress on physiotherapy for at least 6 months * duration of injury from 10 months to 3 years exclusion criteria: * non-traumatic spinal cord injury whether transverse myelitis or demyelination * concomitant systemic disease * progress can be observed on physiotherapy * acute injury or duration of injury less than 10 months

Keywords: spinal cord injury
chronic effect of fasting

Conditions: Overweight and Obesity

Summary: the aim of the study is to determine if time-restricted feeding (trf) is an effective dietary strategy to weight loss after 8 weeks intervention. trf will be compared with an intervention without restriction in time for feeding. both strategies will be with caloric restriction.

the participants of the study will be divided in two groups: (1) a group with caloric restriction and without restriction in time for feeding and (2) a group with caloric restriction and restriction in time for feeding. this second group will be subdivided according to the participant's preference: (2.1) first meal at 8 a.m. and last meal at 4 p.m. or (2.2) first meal at 12 p.m. and last meal at 8 p.m. the caloric restriction for all participants will be 513 to 770 kcal from estimated energy requirement.

Eligibility criteria:
inclusion criteria: * females; * aged between 18 and 59 years old; * body mass index equal or greater 25 kg/m²; * agree to sign the informed consent. exclusion criteria: * any chronic health conditions (e.g. chronic renal failure, autoimmune, heart, and liver disease); * thyroid diseases or medications for its treatment; * medications known to affect total energy expenditure; * use of steroids, immunosuppressants or non-steroidal anti-inflammatory drugs, weight-loss medications, oral hypoglycemic agents or insulin and any medications that influence metabolic and/or inflammatory parameters; * previous surgery for weight loss; * pregnancy or breast-feeding; * smoking; * alcohol use (\>2 doses/day).

Keywords: obesity overweight weight loss fasting
a quality of life and safety study with pimecrolimus cream, 1% in children (age 2-12 years) with atopic dermatitis

Conditions: Atopic Eczema

Summary: the study will evaluate the safety and effect of pimecrolimus cream 1% on quality of life of caregivers of south african children with mild to moderate atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: * male or female * age ≥2 years ≤12 years of age * atopic dermatitis on sensitive skin areas only ( i.e. face , neck and flexures ) * subjects in whom other treatment modalities are inadvisable according to the investigator's clinical opinion or have failed on other treatment modalities due to intolerance or inadequate response. * patients with a history of mild to moderate ad * subjects should present at visit 1 with a clear clinical diagnosis of mild to moderate ad. * subject's parents or legal guardian must have been informed of the study procedures and must have signed the informed consent form approved for the study prior to any study related procedures exclusion criteria: * subjects who have active viral infections at the site(s) of treatment. in the presence of other dermatological infections, the use of appropriate antimicrobial agents should be instituted. * subjects who present with systemic malignancy or active lymphoproliferative diseases/disorders (e.g., lymphoma, neoplastic disease, chronic lymphoproliferation). * subjects who present with clinical conditions other than ad that can, in the opinion of the investigator, interfere with the evaluation * subjects who are receiving photo-therapy (e.g., puva, uvb) or immunosuppressive therapy (e.g., cyclosporine, fk-506 \[tacrolimus\]). * subjects who have used investigational drugs within 8 weeks prior to first application of study medication or intended use of other investigational drugs during the course of this study. * subjects who have used, or are using 0.03% or 0.1% tacrolimus ointment. * pimecrolimus cream 1% is contraindicated in subjects who have known or suspected hypersensitivity to pimecrolimus or any components of the cream * subjects not medically stable or subjects with any condition which, in the opinion of the investigator, should render the subject ineligible for the study. * pregnancy and lactation (if applicable) * pimecrolimus cream 1% should not be used during pregnancy or lactation other protocol-defined inclusion/exclusion criteria may apply

Keywords: atopic eczema pimecrolimus children quality of life safety atopic dermatitis
perinatal depression treatment and child development

Conditions: Depression

Summary: the purpose of this study is to examine whether the successful perinatal depression intervention among mothers (thinking healthy programme, thp) has led to improved developmental outcomes in the children 6 years later. economic and human resources aspects of the intervention will also be evaluated to determine overall societal benefits from investment in such a program, feasibility of scaling up the intervention and its sustainability in the long-term. the primary hypothesis is that children of mothers who participated in the thp will have better cognitive outcomes and socio-emotional functioning when compared to children of mothers randomized to the control group.


Eligibility criteria:
inclusion criteria: * children of women who were eligible to participate in the thinking healthy programme exclusion criteria: * developmental disability, visual or hearing impairment

Keywords: depression cognitive behavior therapy child development
transversus abdominis plane block for postoperative analgesia in living donor hepatectomy

Conditions: Acute Pain

Summary: living donor organ transplantation has increased in recent years due to an increased need for organs. the objective of this study was to investigate the effects of a tap block on postoperative analgesia and opioid consumption in liver transplantation donors in whom a right lateral extending upper mid-line abdominal incision was used.

this prospective randomized controlled double-blinded study was conducted with 50 liver transplantation donors between 18-65 years who were scheduled to undergo right hepatectomy surgery. cases to whom tap block with ultrasound was applied after standard general anesthesia were determined as group 1 and cases to whom only standard general anesthesia was applied, were determined as group 2.

Eligibility criteria:
inclusion criteria: * liver transplantation donors exclusion criteria: * patients with a history of allergy to the drugs used in the study protocol, coagulation pathology, opioid tolerance

Keywords: transversus abdominis plane block living liver transplantation postoperative analgesia
a study of dasatinib in chronic phase philadelphia chromosome positive chronic myeloid leukemia

Conditions: Myeloid Leukemia, Chronic

Summary: the objective is to evaluate the cytogenetic response to dasatinib (bms-354825) administered for 24 weeks in subjects with imatinib resistant or intolerant chronic phase chronic myeloid leukemia (cml) once daily (qd) or twice daily. (bid)


Eligibility criteria:
inclusion criteria: * philadelphia chromosome positive or bcr-abl gene positive chronic phase chronic myelogenous leukemia (cml) subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate * performance status (general conditions) specified by the eastern cooperative oncology group: 0-2 * men and women, ages 20 to 75 * women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized exclusion criteria: * subjects who are eligible and willing to undergo transplantation at pre-study * women who are pregnant or breastfeeding * uncontrolled or significant cardiovascular disease * history of significant bleeding disorder unrelated to cml * adequate hepatic function * adequate renal function * medication that increases bleeding risk * medication that changes heart rhythms * subjects who are compulsory detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Keywords: imatinib resistant or intolerant chronic phase cml
creative music therapy in newborns with congenital heart disease

Conditions: Congenital Heart Disease; Mother Child Interaction

Summary: in the context of a clinical trial, the investigators will evaluate if parent-infant interaction can be improved by a family integrated, individualised, interactive resource- and needs-oriented music therapy approach in the dyads of infants with congenital heart disease and their parents. this intervention will be compared with the standard of care. infants allocated to the control group will receive standard care during admission. standard care includes involvement of a multi-professional team consisting of medical and nursing team, psychologists/psychiatrists, social workers, breastfeeding counsellor, speech therapist, nutritional counsellor and physiotherapists.

open label single-centre randomised controlled interventional trial. all infants with congenital heart disease (chd) and age \ 8) and risk of chd according to the risk stratification for congenital heart surgery (rachs-2). cmt will be conducted 3x/week with a minimum of ten sessions. the primary outcome is mother-infant interaction at age 6 months assessed using a video of a feeding interaction at home, coded in a blinded manner with the parent-child early relational assessment.

Eligibility criteria:
inclusion criteria: * all newborn infants with chd born \>35 weeks of gestational and \<28 days at diagnosis of chd irrespective of severity of the heart disease * admitted to neonatal intensiv care unit/pediatric intensiv care unit (nicu/picu) at the children's university hospital * infants with syndromes and /or confirmed chromosomal abnormalities exclusion criteria: - gestational age at birth \ 28 days at diagnosis of chd

Keywords: parental mental health magnetic resonance imaging
effect of morning vs. evening vaccination on hypoxia and bradycardia of preterm infants: a randomised controled trial

Conditions: Premature Birth; Intermittent Hypoxiema

Summary: hypoxia/bradycardia are common symptoms after vaccination of preterm infants. adults show diurnal variations in vaccination response, due to circadian regulation of the immune system. the investigators plan to investigate whether preterm infants also show differences in hypoxia/bradycardia rate upon morning vs. evening vaccination. hypoxia/bradycardia is recorded by pulse oximetry starting 24 hours before until 48 hours after vaccination; parents also kept a sleep-diary. 24 hours after vaccination interleukin-6, interleukin-1β and c-reactive protein get determined. to control vaccination response, pertussis- and haemophilus-titers are determined before vaccination and at 4 months corrected age.

intervention: first hexavalent vaccination given to very preterm infants either in the evening or in the morning. primary outcome: rate of desaturations (spo2 \<80%) and bradycardias (pulse rate \<100/min) in first 24 h following vaccination in evening vs. morning vaccination group secondary outcomes: cytokine levels (il 6, il 1ß, crp) measured 24 h after vaccination, pertussis- and haemophilus-titers as measured before and after vaccination, i.e. at 4 months corrected age, in evening vs. morning vaccination group

Eligibility criteria:
inclusion criteria: * gestational age: 26+0 to 30+6 weeks of gestational age exclusion criteria: * bronchopulmonary dysplasia * periventricular leukomalacia * intraventricular hemorrhage \>°2 * congenital malformations
hepar-p study to evaluate the safety and efficacy of a standardised extract of phyllanthus niruri for the treatment of non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease

Summary: this is a multi-center, double blind, parallel group placebo controlled randomised trial designed to determine the safety and efficacy of a standardised extract of phyllanthus niruri (epn 797) hepar-p capsule for the treatment of non-alcoholic fatty liver disease for a treatment period of 48 weeks


Eligibility criteria:
inclusion criteria: * male or non-pregnant females age 18 years or older * written informed consent obtained from patient or parents/ guardian * elevated serum aspartate aminotransferase (ast) and alanine aminotransferase (alt) levels but less than 2.5times the upper limit of the normal range * patients with liver biopsy confirmed possible or definite steatohepatitis within the past 12 months prior to enrolment into the trial * possible steatohepatitis with activity score ≥3 or definite steatohepatitis with activity score ≥5 * a score of at least 1 for hepatocellular ballooning exclusion criteria: * pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test * participation in any trial in which the patient received an investigational product within 30 days preceding the screening phase of this study * those persons directly involved in the conduct of the study * alcohol consumption of more than 20g per day for women or more than 30g per day for men for at least 3 consecutive months during the previous 5 years, as assessed with the use of the lifetime drinking history questionnaire and the interview version of the alcohol use and disorders identification test (audit) * history of cirrhosis, hepatitis c or other liver diseases * history of heart failure (new york association class ii to iv) * history of taking medications known to cause steatohepatitis * any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study
metabolomic analysis of hepatic insulin resistance

Conditions: Type 2 Diabetes; Obesity

Summary: this is a pilot study to show that it is possible to identify the specific types of fats in blood, adipose tissue, and liver tissue. the study doctors hope to use the analysis of these fats to learn more about nonalcoholic fatty liver disease (nfld). nonalcoholic fatty liver disease is the accumulation of fat in the liver of people who have minimal alcohol exposure. nonalcoholic fatty liver disease is associated with obesity and insulin resistance, and predicts development of type 2 diabetes. the study doctors are interested in looking at the relationship between liver fat and insulin resistance.


Eligibility criteria:
inclusion criteria: subjects eligible to participate in the study will be: 1. adults over age 18; 2. patients enrolled in the bariatric surgery clinic who are planning to undergo and have insurance approval for bariatric surgery; 3. insulin sensitive (based on homa-ir calculated from screening labs) or insulin resistant (based on homa-ir and or personal history of diet controlled diabetes) 4. able and willing to give informed consent. exclusion criteria the following will exclude subjects from study participation: 1. clinically significant medical issues outside of diabetes (eg, pregnancy, cardiovascular disease, uncontrolled pulmonary disease). if female and of child bearing potential, a pregnancy test will be performed and confirmed negative prior to participation in the study and prior to the scheduled glucose clamp procedure. 2. a history of hematologic (platelets \ 2x upper limit of normal), renal (creatinine \>1.5 mg/dl), pulmonary/ cardiac abnormalities (ie, abnormal electrocardiogram \[ekg\]). 3. use of anti-diabetes medication, anticoagulants, or medication that might alter lipids. if the subject has a history of diabetes, it should be controlled by diet alone. 4. inflammatory or celiac intestinal disease; 5. untreated thyroid disease; 6. excessive alcohol use, illicit drug use, or active untreated psychiatric disease.

Keywords: bariatric surgery, l liver insulin resistance,