Kornimate/medical-research-clean huggingface dataset:
global utilization and registry database for improved preservation of donor lungs

Conditions: Interstitial Lung Disease; COPD; Cystic Fibrosis; Pulmonary Fibrosis; Pulmonary Arterial Hypertension; Emphysema

Summary: the objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor lung that were preserved and transported within the lungguard system, as well as retrospective standard of care patients

guardian-lung is a post-market, observational registry of adult and pediatric lung transplant recipient patients whose donor lungs was preserved and transported within the lungguard. the data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria. about 500 male and female subjects (including pediatric patients) meeting the study inclusion and exclusion criteria will be enrolled into the study at about 5 clinical sites. candidates that fit the eligibility criteria and have had their donor lungs transported with a paragonix product or a standard of care method can be enrolled. the baseline characteristics and outcomes of the two groups will be compared.

Eligibility criteria:
inclusion criteria: * donor and donor lungs matched to the prospective recipient based upon institutional medical practice * registered male or female primary lung transplant candidates including pediatric candidates exclusion criteria: * donor and donor lungs that do not meet institutional clinical requirements for transplantation * patients who are incarcerated persons (prisoners) * patients who have had a previous major organ transplant (heart, lungs, liver, kidney, pancreas) * patients who are receiving multiple organ transplants
an observational real-world study evaluating severe tricuspid regurgitation patients treated with the abbott triclip™ device (bright)

Conditions: Tricuspid Valve Regurgitation

Summary: the bright eu pas study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the abbott triclip™ device (bright eu post-approval study).

the triclip™ bright eu post-approval study (pas) study is designed to confirm the safety and performance of the triclip™ device in a contemporary real-world setting. the bright pas study is a prospective, single arm, open-label, multi-center, post market registry, conducted to satisfy condition of ce marking for the triclip™.

Eligibility criteria:
inclusion criteria: 1. subjects (\>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy. 2. subjects eligible to receive the triclip™ per the current approved indications for use. 3. subject must provide written informed consent prior to study procedure. exclusion criteria: 1. subjects participating in another clinical study that may impact the follow-up or results of this study.
relationship of metabolic syndrome and its components with thyroid cancer

Conditions: Thyroid Cancer

Summary: the purpose of this study is to investigate the association between metabolic syndrome (ms), body mass index (bmi), hyperglycemia, dyslipidemia, hypertension and thyroid cancer. screen for the risk factors that affect the incidence of thyroid cancer.


Eligibility criteria:
inclusion criteria: 1. patients undergone thyroid surgery 2. signed the informed consent exclusion criteria: 1.patients with no surgery

Keywords: metabolic syndrome fasting plasma glucose
single-dose crossover study to investigate pharmacodynamics of azd3199

Conditions: Asthma; Airway Obstruction

Summary: the purpose of this study is to investigate the pharmacodynamics of single doses of azd3199 in asthmatic patients.


Eligibility criteria:
inclusion criteria: * asthmatic patients with pre-bronchodilatory fev1 above 60% of predicted normal and above 1.5 liters. * men and post-menopausal women above 18 years of age. * reversible airway obstruction in response to classical beta2-agonist (salbutamol) * non/ex-smokers exclusion criteria: * any clinically significant disease or disorder other than asthma * any clinically relevant abnormal findings at screening examinations * treatment with systemic glucocorticosteroids within the past 30 days * inhaled corticosteroid use if dosing is not kept constant

Keywords: asthma airway obstruction beta2-agonist efficacy inhalation
phase 3 trial in subjects with metastatic melanoma comparing 3 mg/kg ipilimumab versus 10 mg/kg ipilimumab

Conditions: Melanoma

Summary: the purpose of this study is to determine whether giving ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving ipilimumab at a dose of 3 mg/kg


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * unresectable stage iii or stage iv melanoma * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * brain metastases with symptoms or requiring treatment * history of autoimmune disease
biomarkers and epigenetic markers associated with pain in patients with symptomatic atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common sustained arrhythmia and the number of patients with af is expected to increase substantially in the coming decades. one third of patients with af report no af-associated symptoms, but up to one-fourth report severe symptoms. it is unclear why patients' experience of af-related symptoms varies so much. we have previously shown that patients with symptomatic af exhibit lower pain tolerance than patients with asymptomatic af, as well as impaired pain inhibitory control and facilitated summation of pain, indicating that pain sensitisation may be of importance in symptomatic af. in patients with chronic pain conditions, several biomarkers and epigenetic markers associated with generation and /or maintenance of chronic pain have been identified. previous research of biomarkers and epigenetic markers associated with pain is sparse in patients with af. the objective is to study levels of biomarkers and epigenetic markers in blood in patients with symptomatic paroxysmal af (n=100), in relation to severity of af symptoms, and compared to age- and sex-matched controls without af (n=100). blood will be obtained before and after af ablation and levels of biomarkers, epigenetic markers and cardiac and inflammatory markers, analysed. patients will complete an af-specific symptom and a generic health-related quality of life questionnaire. in the future, biomarkers and epigenetic markers associated with pain may be used as a tool for evaluation of patients with af and have an impact on individualized management. another possibility is a rationale for future studies of novel analgesics that neutralize biomarkers or antagonizes its receptors.


Eligibility criteria:
inclusion criteria: * on waiting list for af ablation (only symptomatic subjects are offered ablation) * paroxysmal af and persistent af (af that is continuously sustained beyond 7 days, including episodes terminated by cardioversion after ≥7 days) * written informed consent exclusion criteria: * previous pulmonary vein isolation * cognitive or psychiatric condition * diabetes mellitus * ischemic heart disease * heart failure * asthma * pregnancy * previous/current drug or alcohol abuse * previous neurological or concomitant musculoskeletal disorders * continuous analgesic medication

Keywords: atrial fibrillation symptoms quality of life pain
investigating the relationship between parents and their children with adhd and conduct disorder

Conditions: Observation

Summary: this study aims to uncover mechanisms of action underlying any long-term change in youth antisocial behavior by considering the role of child and family characteristics as mediators and moderators of change. the study design is qualitative interviews to be conducted face-to-face with parents of children previously diagnosed with conduct disorder and attention deficit hyperactivity disorder (adhd) but no longer meet diagnostic criteria. questions will be asked to understand participants' parenting experience over time (before, during and after their children's treatment).


Eligibility criteria:
inclusion criteria: * parents of children who participated in previous study "supplements and social skills intervention" conducted by singapore institute of mental health child guidance clinic. * children no longer meet the criteria for conduct disorder and adhd, as measured by antisocial process screening device (apsd) callous-unemotional score of 7 or less, and who do not meet the cut-off for rule-breaking and aggressive behavior determined by child behavior checklist (cbcl). these data were collected from a previous study. exclusion criteria: * children who still meet the requirements of conduct disorder and adhd as defined above. * parents who did not indicate that they wish to be contacted for follow-up studies.
post marketing observational study on paricalcitol iv administered to venezuelan patients

Conditions: Chronic Kidney Disease Stage V; Hemodialysis

Summary: this study was designed to evaluate the effectiveness, safety, and impact on quality of life when paricalcitol (zemplar® intravenous \[iv\]) is administered in venezuelan patients on hemodialysis who are at risk of developing secondary hyperparathyroidism associated with stage v chronic kidney disease.


Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years old with documented diagnosis of stage v chronic kidney disease, on hemodialysis at study baseline * subjects who have been previously treated with vitamin d or its metabolites or naïve to paricalcitol * subjects in whom the use of paricalcitol is clinically indicated and documented by applicable and routine standard of healthcare (i.e. laboratory assessments and clinical evaluations) according to the criteria of the attending physician and in accordance with the approved label of the product in venezuela * subjects that provide written informed consent form stating his/her authorization and willingness to participate in the study and allowing the use and discussion of his/her personal and/or health information before entering the study * female subjects with reproductive potential must use an approved contraceptive method (intrauterine device, birth control pills or barrier device) during and for three (03) months after discontinuation of treatment exclusion criteria: * subjects with severe hyperparathyroidism (parathyroid hormone \[pth\] \> 3000 pg/ml) * subjects with hypercalcemia, adjusted according to serum albumin, hyperphosphatemia, or subjects with calcium-phosphorus product (ca x p) ≥ 70 * known hypersensitivity and/or toxicity of vitamin d, its metabolites and/or other components of zemplar® iv (paricalcitol) * subjects who have participated in clinical trials within 30 days before the start of the study or who are currently enrolled in a clinical trial or under treatment with any investigational product * subjects who cannot tolerate or cannot take phosphate binders that do not contain calcium and/or aluminum * subjects who in the opinion of the investigator, for any reason (including medical reasons) are not eligible and/or appropriate for therapy with synthetic analogs of vitamin d and/or unwilling to complete the study visits

Keywords: venezuelan patients depressive symptoms health related quality of life
the effect of baby care training given to fathers after birth

Conditions: Mothers; Fathers

Summary: the aim of this study is to provide infant care training to fathers and to measure father-infant attachment and maternal postpartum depression and quality of life.

objective: the aim of this study is to provide infant care training to fathers and to measure father-infant attachment and maternal postpartum depression and quality of life. design: the data for the study were collected using the introductory information form (iif) and the father-infant attachment scale (fias) for fathers, edinburgh postpartum depression scale and postpartum quality of life scale for mothers. participants and setting: a total of 64 fathers and 64 mothers, including 32 in the intervention group and 32in the control group who met the inclusion criteria of the study were included randomly.

Eligibility criteria:
inclusion criteria: * the mother and father are over 18 years old, * parents becoming parents for the first time, * the newborn is healthy, born at term, with the mother and father, * parents' knowledge of turkish, * mothers who accepted to participate in the study and received baby care training by participating in the pregnant class, * parents' willingness to participate in the research. exclusion criteria: * having a baby born as a result of a risky pregnancy, * the newborn is in intensive care, * presence of diagnosed psychiatric disease in the mother and father.
cystatin d fibrinogen like protein 1

Conditions: Fibrinogen Like Protein 1

Summary: to detect role of cystatin d and fibrinogen like protein 1 in rheumatoid arthritis asses relationship between disease activity and cystatin d and fibrinogen like protein 1


Eligibility criteria:
inclusion criteria: * adult patient diagnosed for rheumatoid arthritis exclusion criteria: * patient with overlap syndrome indiviuals with other auto immune diseases
study to gain information on the drug xarelto for the prevention of brain attack and blockage of an artery in the non-central nervous system due to irregular heartbeat in taiwanese patients suffering from decreased renal function

Conditions: Non-valvular Atrial Fibrillation (NVAF)

Summary: in this study researchers want to learn more about on the safety of the drug xarelto. the study will enroll patients for whom the treating doctor are prescribing xarelto for the prevention of brain attack or the prevention of blockage of an artery in the non-central nervous system. only patients suffering from decreased renal function and irregular heart beat will be considered. the study plans to include 500 taiwanese adult male and female patients with the age above 20 years. patients will be followed up based on routine medical practice over a period of 12 months and information on their well-being and any medical events will collected.


Eligibility criteria:
inclusion criteria: * female and male patients ≥ 20 years of age * diagnosis of non-valvular atrial fibrillation (nvaf) * patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice * previously documented crcl of 15-50 ml/min within 6 months before enrollment (last available value) exclusion criteria: * contraindications for rivaroxaban according to the local market authorization/ summary of product characteristics * patients participating in an investigational program with interventions outside of routine clinical practice. * planned treatment with other anticoagulants * expected renal-replacement therapy within the next 3 months

Keywords: stroke
investigating the effects of tube feeds on glycemia and sleep in adults with cystic fibrosis-related diabetes

Conditions: Cystic Fibrosis Related Diabetes; Hyperglycaemia; Insomnia; Cardiometabolic Diseases; Circadian Rhythm Disorders

Summary: the goal of this at-home, remote study is to understand how tube feeding affects blood sugars and sleep in adults living with cystic fibrosis related diabetes (cfrd).

the study is a 10-day home-based, observational study of 30 adults with cfrd receiving hen (targeting 15 receiving overnight and 15 daytime hen) aimed at concurrently phenotyping glucose, sleep, and circadian rhythms. the remote study is designed to reduce participant burden while allowing for safe and robust objective data and specimen collection and to inform future clinical trial design. the objective of the proposed pilot and feasibility clinical study is to assess the feasibility of remotely phenotyping glycemia, sleep, and circadian rhythms of adults living with cfrd receiving hen and to generate preliminary data to power a future clinical trial.

Eligibility criteria:
inclusion criteria: adult men or non-pregnant women volunteers (age 18-79) able and willing to give consent and comply with procedures currently on routine home enteral nutrition (at least 3 months) known diagnosis of cf related diabetes (cfrd) and clinically stable with no significant changes in therapies within the prior 3 months concomitant medications: a. no initiation of an investigational drug within prior 28 days b. no initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, cayston®) within prior 28 days c. no acute use of antibiotics (oral, inhaled or iv) or acute use of systemic corticosteroids for respiratory tract symptoms within prior 14 days d. no starting/stopping modulator therapy in the prior 3 months exclusion criteria: blind, deaf, or unable to speak english pregnant, nursing, or plan on pregnancy current use of melatonin and unwilling to stop during the study with skin condition that precludes wearing sensors within the last 4 weeks, acute cf exacerbation requiring iv antibiotics or hospitalization major changes in diet or physical activity level in the last 4 weeks untreated sleep and circadian disorders

Keywords: cystic fibrosis related diabetes tube feeds circadian rhythm diabetes home enteral nutrition circadian misalignment nutrition
safety and efficacy of procalcitonin guided antibiotic therapy in adult intensive care units (icu's)

Conditions: Sepsis; Severe Sepsis; Septic Shock

Summary: this is a randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and safety (mortality).

antibiotics are prescribed widely in intensive care units and are linked with high costs and the occurence of antimicrobial (multi)resistance. the optimal duration of antibiotic treatment is poorly known and often based on consensus guidelines. saps is a multicenter, prospective, randomized, controlled open-label trial evaluating the equivalence/efficacy and safety of procalcitonin-guided treatment of infections in icu patients versus a standard-of-care approach. all patients that are admitted to the icu and for whom systemic antibiotics are prescribed for presumed or proven bacterial infections are eligible for this trial. patients will be randomized and stratified according to clinical diagnosis of severe sepsis and septic shock. any patient over the age of 18, admitted to the icu and receiving antibiotics for an assumed infection can be enrolled into this trial. informed consent has to be obtained in writing from the patient of his/her relatives prior to inclusion. in the intervention group daily procalcitonin levels be performed and will generate a non-binding stopping advice when predefined stopping-rules have been reached. the ultimate decision to stop antibiotics will be at the discretion of the physician in both groups.

Eligibility criteria:
inclusion criteria: * age over 18 years old * receiving antibiotics for no more than 24 hours for an assumed or proven infection * informed consent exclusion criteria: * failure to obtain written consent to participate * patients receiving prolonged antibiotic therapies (\> 3 weeks, e.g. endocarditis, cerebral/hepatic abscess) * patients with severe infections due to viruses or parasites (e.g. dengue, toxoplasma gondii, plasmodium spp.) * patients infected with mycobacterium tuberculosis * patients entering the icu for post-operative observation and/or on antibiotic prophylaxis with an estimated length of stay less then 24 hrs. * patients suffering from cystic fibrosis * severely immunocompromised patients such as patients with hiv and with a cd4 count of less than 200 cells/mm, neutropenic patients (\<500 neutrophils per ml) or patients with solid organ transplantation * moribund patients

Keywords: procalcitonin antibiotic therapy antibiotics sepsis infections biomarker
dexmedetomidine verses propofol for paediatric mri brain

Conditions: Brain Diseases

Summary: mri though not painful requires deep sedation for children due to the loud noise created. with deep sedation comes respiratory depression so the interest in dexmedetomidine. for standardization mri brain was chosen and also for the fact that patients usually have history of convulsions where drugs like ketamine may not be a good option. patients were recruited after ethics committee approval. after pre-medication with intranasal midazolam 0.2 mg/kg body weight, intravenous access was established and then patients were divided in two groups. one group received intravenous propofol 2mg/kg and infusion of 100mcg/per kg body weight per minute. the other group received intravenous bolus of dexmedetomidine 1mcg/kg over 10 minutes and then a infusion of dexmedetomidine 1mcg/kg/hour. primary out come was to study the recovery time of patients sedated with dexmedetomidine compared to patients sedated with propofol for paediatric mri brain. secondary outcome were analysed in terms of time for induction,procedural disruptions due to awakening and haemodynamic stability . follow up was done on phone for any adverse events.

patients were evaluated on out patient department basis. on the day of mri nil per oral status of 6 hours was confirmed and consent taken from the parent. in recovery room after recording of vitals, children were given intranasal midazolam 0.2mg/kg body weight. the intravenous line was secured after the child was sedated. patients were then divided in two groups. in the mri console, the dexmedetomidine group received intravenous dexmedetomidine 1mcg/kg body weight over 10 minutes. an intravenous infusion of dexmedetomidine was then started at 1mcg/kg/hour. the propofol group received 2mg /kg of intravenous propofol and an infusion of 100mcg/kg/minute. mri monitoring included pulseoximetry, cardioscope, respiratory pattern and rate. oxygen was delivered by nasal prongs. primary outcome measured was the time for recovery. secondary outcomes were number of awakening during procedure, haemodynamic stability, induction time and any adverse events. after mri the children were observed in the recovery room and discharged after achieving 'modified aldred score' of 10. vitals and any adverse events were recorded during this phase.

Eligibility criteria:
inclusion criteria: * children posted for elective mri brain * american society of anaesthesiologist physical status i and ii exclusion criteria: * age less than 1 year and more than 7 years * american society of anaesthesiologist physical status iii and iv * emergency cases * upper respiratory tract infection * patients on digoxin and beta blockers * allergy to study drugs * body mass index more than 35

Keywords: anaesthesia mri brain