Kornimate/medical-research-clean huggingface dataset:
gcsf adjunct therapy for biliary atresia

Conditions: Biliary Atresia

Summary: the investigators propose to test the hypothesis that gcsf therapy enhances the clinical outcome of kasai operated biliary atresia (ba) patients. in this study, investigators will conduct a dose determination for gcsf use in post kasai subjects to support a future phase 2 efficacy study. the first 3 post kasai ba subjects with liver biopsy-confirmed ba will be given 5 ug/kg/d of gcsf in 3 daily subcutaneous doses starting on post kasai day 3. a second group of 3 subjects will be assigned to the 10 ug/kg/d dose after the 5ug/kg/d dose has been proven to be safe. the levels of circulating hematopoietic stem cells and a 1-month safety profile will be analyzed.

in ba, neonatal fibrous obliteration of the biliary tract obstructs biliary drainage and promotes biliary fibrosis. ba is the leading cause of pediatric chronic end-stage liver disease and pediatric liver transplantation. relief of cholestasis by the kasai portoenterostomy is only partly successful with continued progression of fibrosis to hepatic insufficiency and, for long term survival, with eventual need for liver transplantation in the majority of the patients. in animal models of liver injury, gcsf enhances hematopoietic stem cell hsc mobilization and engraftment in the liver with associated improved liver repair response and attenuated hepatic necrosis and fibrosis. randomized controlled trials of gcsf intervention for chronic liver failure in adult patients with acute hepatic decompensation showed improved short-term survival and hepatic indices such the model for end-stage liver disease (meld) scores. the investigators propose that post kasai gcsf therapy attenuates biliary fibrosis and progression to cirrhosis. the objectives are meant to demonstrate that kasai-gcsf sequential therapy improves biliary drainage, and delays the progression of hepatic insufficiency. toward this goal, investigators will first evaluate in post kasai subjects the maximum tolerated dose of gcsf in mobilizing circulating cd34+ hematopoietic stem cells, with the limiting dose based on gcsf-related severe adverse effects. a one-month safety of gcsf will be tested with the 2 standard doses of 5 ug/kg/d and 10 ug/kg/d.

Eligibility criteria:
inclusion criteria: 1. completed the preliminary work up for cholestasis with suspected or inconclusive diagnosis of ba 2. gestational age \> 36wks 3. weight \> 2 kg 4. age \>-2 weeks-\<180 days at diagnosis 5. serum direct bilirubin \> 2 mg/dl ggt \> 100 u/l 6. kasai operated patients for type 3 or 4 anatomy of ba 7. cholangiogram/porta hepatis findings diagnostic of ba 8. liver biopsy supporting ba diagnosis exclusion criteria: 1. having access to liver transplantation for immediate kasai failure 2. prior kasai patients 3. major cardiac, renal, cns malformations with poor prognosis 4. intracranial hemorrhage 5. history of recent tpn use within the last 2 weeks of surgery 6. gi tract obstruction 7. laparoscopic kasai repair

Keywords: biliary atresia granulocyte colony stimulating factor gcsf
results of cervical segmental mobilization in patients with chronic lateral epicondylitis

Conditions: Epicondylitis of the Elbow; Servical Segmental Mobilization

Summary: the aim of our study was to investigate the effect of cervical segmental mobilization on pain, functionality, grip strength and quality of life in patients with chronic lateral epicondylitis. it was planned as a randomized controlled experimental study.


Eligibility criteria:
inclusion criteria: * being between the ages of 25-44 * being diagnosed with le by a physician * not having any defined pathology in the cervical region * no neurological problems in the upper extremities * no history of cervical surgery exclusion criteria: * those with a history of infection, tumor, trauma in the cervical area * fibromyalgia patients * congenital or acquired deformities of the upper extremity * history of shoulder or elbow surgery or dislocation * cervical radiculopathy * having had wiplash

Keywords: lateral epicondylitis servical segmental mobilization pain quality of life grip strenght functionality
neuromodulation of executive function in the adhd brain

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tdcs) on executive function and inhibitory control in patients with adhd compared to healthy controls.

this study aims to determine the transient, modulatory effects of transcranial direct current stimulation (tdcs) on executive function and inhibitory control in patients with adhd. deficits in these cognitive functions are core to adhd, and cause significant impairment and morbidity. the study will also include a cohort of healthy controls for comparison.

Eligibility criteria:
inclusion criteria 1. male and female subjects 18-66 years of age 2. healthy volunteers or volunteers with a diagnosis of adhd in adulthood, meeting the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) \[american psychiatric association, 2013\] criteria, including at least 5 moderate inattentive or impulsive-hyperactive symptoms, and onset of two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12. 3. patient will be either off stimulant medications or, if undergoing treatment with stimulants, will be asked to discontinue two days prior to the experiment, under physician-guided protocol, and allowed to resume afterwards. subjects may resume stimulant use between the two study visits so long as they discontinue use two days prior to the second study visit. if fatigue is problematic in subjects discontinuing medication, they will be allowed to continue with the study if they are able to follow the suggested taper plan (50% of the dose day one, 25% dose day 2, stop day of visit (day 3)). 4. english-speaking exclusion criteria 1. current or past history of clinically unstable psychiatric conditions such as suicidal or homicidal behavior or psychotic disorders. 2. pregnant or nursing females. 3. inability to participate in testing procedures 4. contraindication to tdcs: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, vp shunt, pacemakers, pregnancy. 5. additional exclusion criteria for healthy controls: 1. diagnosis of psychiatric of neurological disorder 2. ongoing treatment with any psychotropic medications.

Keywords: executive function
total pancreatectomies in germany - epidemiology, trends,

Conditions: Pancreas Disease

Summary: the purpose of this study was to evaluate the real-world mortality rates of total pancreatectomy across germany and to understand the impact of hospital caseload on surgical outcomes.

this retrospective observational study analyzed routine data from the nationwide german diagnosis-related group statistics, covering the years 2010 to 2020. the data included all inpatient episodes from acute care hospitals. the study focused on mortality rates associated with total pancreatectomy and examined how these rates varied with the complexity of the surgeries and the volume of procedures performed by different hospitals. the mortality rates for total pancreatectomy in germany were found to be more than three times higher than those reported by specialized pancreatic centers. mortality rates increased significantly with the complexity of the total pancreatectomy procedures, especially those involving arterial resections. hospitals with lower total pancreatectomy caseloads had higher mortality rates compared to high-volume centers. results showed that total pancreatectomies are associated with high mortality rates, particularly in hospitals with lower surgical volumes. the findings suggest that the promising outcomes from specialized centers cannot be generalized to all hospitals performing pancreatic surgeries, highlighting the need for a thorough understanding of the learning curve and specialization in pancreatic surgery to reduce mortality risks.

Eligibility criteria:
inclusion criteria: * total pancreatectomy between january 2010 and december 2020 * 18 years or older exclusion criteria: * postmortem pancreatectomy (ops code 5-525.4) * removal of a pancreas transplant (ops code 5-525.3)

Keywords: specialization pancreatic surgery total resection volume-outcome-relationship
safety, tolerability and fat absorption using enteral feeding in-line enzyme cartridge (relizorb)

Conditions: Exocrine Pancreatic Insufficiency

Summary: protocol alct-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis. subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral feeding in-line digestive enzyme cartridge (relizorb) connected to enteral pump sets.

protocol alct-0000497 consists of three distinct study periods as follows: 1. in period a (7 days), subjects will receive peptamen 1.5 enteral feedings at home. 2. in period b (11 days), subjects will be randomized to either group a (active investigational then placebo control) or group b (placebo control then active investigational) and receive impact peptide 1.5 on days 1 and 9. during the 8-day washout period between days 1 and 9, subjects will receive peptamen 1.5. 3. in period c (9 days), subjects will use relizorb during nocturnal enteral feedings with impact peptide 1.5.

Eligibility criteria:
inclusion criteria: 1. confirmed cf diagnosis with 2 clinical features 2. documented history of epi 3. enteral formula use minimum of 4x/week 4. written informed consent or assent, as applicable exclusion criteria: 1. uncontrolled diabetes mellitus 2. signs and symptoms of liver cirrhosis or portal hypertension 3. lung/liver transplant 4. active cancer currently receiving cancer treatment 5. crohn's or celiac disease, infectious gastroenteritis, sprue, lactose intolerant, inflammatory bowel disease 6. dios or fibrosing colonopathy
evaluate safety and pharmacokinetics of inf904 in subjects with moderate to severe chronic spontaneous urticaria or hidradenitis suppurativa

Conditions: Chronic Urticaria, Idiopathic; Hidradenitis; Hidradenitis Suppurativa

Summary: the study duration for an individual subject includes screening (14 days), the treatment period (28 days) and the observational follow-up period of 28 days, in total 70 days ± 6 days. all subjects will receive imp for 28 days followed by one end of study (eos) visit, 4 weeks after eot visit.


Eligibility criteria:
inclusion criteria: * signed informed consent. * subjects must be 18 years or older at the time of signing the informed consent. exclusion criteria: * subjects with known severe or life-threatening hypersensitivity reaction to any other csu/hs treatment according to national cancer institute-common terminology criteria for adverse events (nci-ctcae). * subjects who have any other skin disease that may interfere with assessment of csu or hs. * subjects who have an active infection or history of infection(s) as follows: 1. any infection requiring systemic treatment within 14 days prior to baseline. 2. a history of opportunistic, recurrent, or chronic infections that, in the opinion of the investigator, might cause this study to be detrimental to the subject. * subjects with known progressed liver disease (child-pugh b or c)
an epidemiological investigation on the correct wearing of face mask

Conditions: Respiratory Infectious Diseases

Summary: the purpose of this study was to explore the relationship between the transmission of respiratory diseases and the correct wearing of masks, as well as the factors affecting the correct wearing of masks. the research is beneficial to the prevention of respiratory diseases and moves the barrier of prevention and control forward. it is of great significance to covid-19 's practical prevention and control.

1. overall design：this study uses the methods of cross-sectional survey and chance sampling. 2. sign the informed consent form. 3. investigation on the basic situation of personnel: the gender, age and education level of the subjects were analyzed as the factors influencing whether the mask was worn correctly or not. 4. investigation on the types of wearing masks： 1) the types of masks worn by the subjects were recorded as the basis of stratified statistics. 2) mask suitability testing： 1. visual inspection whether the mask is close to the face with obvious gaps. 2. breathing test whether it can blow the cotton wool under the eyes when the subject taking a deep breath. 3. spray test the ft-30 qualitative fitness test system of 3m company was used to test the suitability and correctness of wearing mask. in the spray test, all subjects underwent a sensitivity test to prove their ability to smell the bitterness of the reagent, and then were randomly divided into a hood group and a direct spray group. in order to objectively reflect the overall situation of the subjects, it is necessary to cover many ages and educational levels of men and women. each subject participated in the study for about 5-6 minutes, and the total duration of this study was about 3 months.

Eligibility criteria:
inclusion criteria: 1. healthy people with autonomous behavior ability and language expression ability who are older than or equal to 7 years old, persons under the age of 18 need to obtain the consent of their legal guardians； 2. the subjects and / or their legal guardians have the ability to understand the contents of the study and to participate in all the research processes with the subjects； 3. people who volunteered to take part in the study； 4. there was no respiratory infection in nearly one month. exclusion criteria: 1. people with a history of allergies, including those who are allergic to pollen, dust mites, etc； 2. people with any history of drug allergy； 3. people who have participated in the experiment are not allowed to participate in this study for the second time; 4. pregnant women； 5. the healer after covid-19 's infection； 6. after questioning, it was found that the subjects were the factors that affected the study, such as dysosmia, or those who had decreased olfactory ability due to disease, or facial paralysis, which affected the judgment of the test； 7. those who are participating in clinical trials of other drugs / devices； 8. subjects with poor compliance or unwilling to cooperate with the operation as required； 9. the researchers believe that any other situation that may affect the evaluation of the study.
effects of perioperative b&o suppositories on post-op pain and morphine use after laparoscopic prostatectomy

Conditions: Pain

Summary: this study is evaluating the effect of a belladonna and opium suppository administered intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate cancer. this is a blinded randomized study. 50% of patients will receive the suppository, 50% of patients will not. neither you or your surgeon will know which group you are in.

all patients undergoing lrp at virginia mason medical center between november 1, 2008 and july 30, 2009 were offered the opportunity to participate in a randomized double blind clinical trial. operating surgeons were blinded to suppository placement which was administered after induction of anesthesia. all patients underwent a standardized anesthesia regimen. post-operative pain was assessed by a visual analog scale (vas) and post-operative narcotic use was calculated in intravenous morphine equivalents.

Eligibility criteria:
inclusion criteria: * patients scheduled for laparoscopic radical prostatectomy at virginia mason, who do not have chronic pain or allergies to opioid analgesics are eligible for this study. exclusion criteria: * women are excluded due to the absence of a prostate. * children are excluded due to the absence of prostate cancer in this group. * patients meeting any of the following will not be eligible for the study: * patients at risk for complications from anticholinergic agents including those with a history of glaucoma, bronchial asthma, convulsive disorder, or high risk for delirium * history of previous allergies or adverse reactions to belladonna and opium and/or opioid analgesics * history of chronic pain or chronic use of opioid and nonopioid analgesics * history of alcohol or opioid dependency/abuse within last three months
treatment with pyrotinib-based therapy in lapatinib resistant her2-positive metastatic breast cancer

Conditions: Breast Cancer

Summary: this is a multicenter, observational, single-arm real world study to evaluate the efficacy and safety of pyrotinib after lapatinib progression.

her2-positive breast cancers account for 15%-20% of all breast cancers. the development of her2 targeted therapies have greatly improved the survival of her2-positive breast cancer patients. lapatinib has shown effectiveness in treating her2-positive metastatic breast cancers, but therapies after lapatinib progression are still controversial. this study is aimed to evaluate the efficacy and safety of pyrotinib after lapatinib progression.

Eligibility criteria:
inclusion criteria: * female and 18-70 years old * metastatic or locally recurrent her2-positive breast cancer * patients received pyrotinib-based therapy after lapatinib failure in treatment for metastasis * complete and accurate medical data exclusion criteria: - incomplete medical data
association between galectin-3 and post-operative atrial fibrillation after coronary artery bypass graft

Conditions: Post-operative Atrial Fibrillation; Cardiovascular Diseases; Post-pericardiotomy Syndrome

Summary: the goal of this observational study is to test the association between high levels of galectin-3 and the occurrence of post-operative atrial fibrillation after isolated coronary artery bypass grafting (cabg). the main question\[s\] it aims to answer are: * is galectin-3 an accurate biomarker to predict higher risk of developing post-operative atrial fibrillation? * are high levels of galectin-3 associated to other post-operative complications and major adverse cardiovascular events? participants will be enrolled during pre-operative evaluation and a peripheral blood sample collection will be performed in the 24h before cabg. participants will then be followed for a period of 12 months (daily during hospitalization and 3 appointments after hospital discharge) to determine whether patients with higher levels of galectin-3 will have worse outcomes.

prospective, observational, single-center cohort study including patients undergoing coronary artery bypass graft (cabg) surgery. patients will be enrolled during preoperative evaluation. a peripheral blood sample will be collected within 24 hours before surgery and patients will be followed during hospitalization and for 12 months after discharge.

Eligibility criteria:
inclusion criteria: * patients undergoing coronary artery bypass graft surgery exclusion criteria: * inability to sign the free and informed consent form * renal dysfunction with estimated glomerular filtration rate less than 30ml / min / 1.73m² or dialysis therapy * moderate to severe left ventricular dysfunction (ejection fraction \< 40%) * patients with previous atrial fibrillation * pregnancy * concomitant valve surgery

Keywords: post-operative atrial fibrillation galectin-3
ultrastructure of atrial myocytes in patients in sinus rhythm and with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the aim of this work is to study the prevalence of t-tubular system in left and right myocytes from patients in sinus rhythm and whether this is altered in paroxysmal and permanent atrial fibrillation. furthermore, since current information is lacking on the key ca2+-handling proteins ryr, ncx, and serca-2a from patients in atrial fibrillation (af), it will be investigated whether a regulation of these proteins could be an underlying cause of the disease. mitochondrial function will also studied. 1. the investigators hypothesize that both structure of sarcolemma and localization of key ca2+-handling proteins are altered in patients with atrial fibrillation compared with patients in sinus rhythm. 2. the investigators hypothesize that mitochondrial function is altered in patients with atrial fibrillation compared with patients in sinus rhythm.


Eligibility criteria:
inclusion criteria: * sinus rhythm, permanent atrial fibrillation or paroxysmal atrial fibrillation * selected for open heart surgery * informed consent exclusion criteria: * not given informed consent

Keywords: atrial fibrillation atrial cells myocardial tissue t-tubules immunofluorescence
evaluation of tendon-to-bone healing potential in arthroscopic rotator cuff repair through biological stimulation

Conditions: Rotator Cuff Tear

Summary: evaluation of clinical and radiological outcomes in patients undergoing arthroscopic rotator cuff repair with standard treatment compared to patients receiving biological stimulation with micro-perforations or with the combination of micro-perforations and use of artelon® tissue reinforcement, a synthetic device based on degradable polyurethaneurea. the investigators believe that this kind of tendon-to-bone healing stimulation with the two proposed methods can increase the repair quality by significantly decreasing the lesion recurrence rate (currently described for 15% of patients) and can improve various parameters such as pain, range of motion and strength, thereby hastening the return to daily activities and psycho-physical well-being.


Eligibility criteria:
inclusion criteria: * a medium rotator cuff tear (from 1 to 3 cm, according to cofield classification) with an indication for arthroscopic repair * signed informed consensus exclusion criteria: * previous fractures * diabetes * subscapularis tears * tears \ 3 cm * reduced passive range of motion * infections * known mental or neurological disorders unwilling or unable to follow the post-surgery instructions * conditions that contraindicate arthroscopic rotator cuff surgery * patients without complete osteogenesis * pregnant or breastfeeding women

Keywords: rotator cuff tear artelon®