Kornimate/medical-research-clean huggingface dataset:
radiation dosimetry study comparing 2 different patient setups in anal/rectal cancer patients

Conditions: Anal Cancer

Summary: the study compares two patient setups (standard prone vs. genital drop technique) with identical radiation treatment technique and parameters. after the two setups have been planned, the treating faculty reviews the setups and will choose the setup he feels that will give the patient improved dosimetry to the local regions and hopefully reduce toxicity and improve treatment tolerability.

this is a study of two different setups when treating a patient with standard of care radiation doses. the study compares two patient setups (standard prone vs. genital drop technique) with identical radiation treatment technique and parameters. after the two setups have been planned, the treating faculty reviews the setups and will choose the setup he feels that will give the patient improved dosimetry to the local regions and hopefully reduce toxicity and improve treatment tolerability. patients will not be randomized or stratified by demographic or disease risk assessment, but treatment will be tailored to stage specific current standards of care. an extra (non standard of care) ct is required to analyze the data.

Eligibility criteria:
inclusion criteria: * histologically proven anal cancer (squamous, basaloid, or cloacogenic carcinoma) or distal rectal cancer (adenocarcinoma variants) that traverse the dentate line and are eligible for definitive chemoradiation or preoperative radiation therapy, respectively. * any histological grade. * age: \>18 years. * gender: male patients with average external genitalia. * race: any. * language: english speaking only. * performance status: good (karnofsky performance status of \>60%). (ecog 0-2). * utmb patients * stages: early local disease to locoregionally advanced disease per the 2002 american joint committee on cancer (ajcc) staging system. * anal cancer: stages i-iiib (see section 11). * distal rectal cancers that pass the dentate line and into the anal canal only: stages iia-iiic (see section 11). exclusion criteria * histological variants other than those listed above in 4.a. * patients with cystocele or abnormal scrotal edema will be excluded. (although the genital drop technique may specifically benefit this group of patients, however this study is to be performed with average patient anatomy). * 2002 american joint committee on cancer (ajcc) staging system. (anal cancer: stage iv.; distal rectal cancer: stage iv, and tumor 2-node 0-metastasis 0 (t1-t2n0m0) patients). * performance status: poor (karnofsky performance status of \<60%). (ecog 3-4). * non-english speaking patients. * prior pelvic radiation. * prior pelvic malignancy. * anal cancer/rectal cancer surgery, except for biopsy at study site. * patient's mental condition and social support is such that he can neither understand the nature of the protocol nor comply with its requirements.

Keywords: anal cancer rectal imrt genital sparing drop technique
augmented care at worksite for diabetes prevention

Conditions: PreDiabetes

Summary: the purpose of the study was to evaluate the impact of augmented care at the worksite through a lifestyle intervention for diabetes prevention among employees with prediabetes who were slower to respond to a standard diabetes prevention intervention.

employees at the ohio state university (osu) with prediabetes participated in a standard lifestyle intervention (group lifestyle balance) for diabetes prevention. participants who did not achieve \>2.5% weight loss at week 5 of the intervention were stratified to the augmented intervention (group lifestyle balance plus) at week 5. the impact of the augmented intervention compared to the standard intervention was determined at 4, 12 and 18 months from baseline to determine if implementing early enhanced training helped participants achieve and maintain weight loss similar to those who received the standard intervention.

Eligibility criteria:
inclusion criteria: 1. benefits-eligible ohio state university (osu) employee 2. intend to be employed by osu through the length of the follow-up phase 3. body mass index: \>24 kg/m\^2 non-asians; \>22 kg/m\^2 asians 4. fasting blood glucose of 100-125 mg/dl or an a1c of 5.7-6.4% 5. blood glucose of 110-199 (if non-fasting in previous 2 hours) exclusion criteria: 1. blood glucose level of ≥ 200 mg/dl 2. conditions that would limit adoption of light/moderate physical activity (i.e., cardiac event, severe chronic obstructive pulmonary disease, advanced arthritis, poorly controlled hypertension) 3. chronic use of medications that affect blood glucose levels (i.e., corticosteroids) 4. concurrent participation in a structured weight loss program or counseling for bariatric surgery 5. pregnant or breastfeeding 6. score of ≥ 10 on the patient health questionnaire-8 indicating moderate to severe depressive symptoms 7. score of ≥ 27 on the binge eating scale indicating the potential for binge eating 8. unwilling to accept randomization 9. planning to move from the area or changing employment.

Keywords: hyperglycemia obese overweight
modified diaphragmatic plication rectifies dyspnea

Conditions: Phrenic Nerve Injury

Summary: traditional diaphragmatic plication (dp) surgery is employed to ameliorate respiratory function in patients with diaphragmatic paralysis, which is rather complicated. this study introduces a modified method of dp. the efficacy of modified diaphragmatic plication (mdp) in preventing, treating, and relieving dyspnea in patients with phrenic nerve resection or injury due to extensive surgical intervention or local tumor invasion will be evaluated.


Eligibility criteria:
inclusion criteria: * preoperative chest x-ray suggesting diaphragmatic eventration, for which therapeutic mdp was performed; * mediastinal tumors encircling the phrenic nerve that could not be dissected or phrenic nerve injury occurring during intraoperative dissection, for which prophylactic mdp was performed; * diaphragmatic eventration and dyspnea following mediastinal surgery, for which salvage mdp was performed. exclusion criteria: * congenital diaphragmatic deformity or diaphragmatic weakness due to poor general nutritional status; * morbid obesity with a bmi greater than 35 kg/m2; * neuromuscular diseases, including amyotrophic lateral sclerosis and myasthenia gravis; * a history of upper abdominal surgery; and (5) diaphragmatic calcification or fibrosis.
non-invasive blood pressure measurement in critically ill patients post cardiosurgical therapy

Conditions: Systemic Hypertension

Summary: the aim of the present study is to evaluate the accuracy of measuring beat-by-beat diastolic blood pressure from a non-invasive, cuffless and non-obtrusive watch-like optical device worn at the wrist.

given the prevalence of hypertension in society and the current limitations associated with oscillometric cuffs, the need for a continuous cuffless alternative for blood pressure home monitoring at a global scale is paramount. such a device would not only improve the global control of blood pressure, but more generally, it could have a larger social impact by improving the comfort and reducing the stress for the clinical management of hypertensive patients. in the present study the investigators seek to investigate, as a primary purpose, to evaluate the accuracy of non-invasive blood pressure measurements via a watch-like optical sensor and compare these to standard monitoring (arterial line).

Eligibility criteria:
inclusion criteria: * scheduled for cardiac or vascular surgery, with presence of a radial arterial line for perioperative management; * willing and able to provide informed consent. exclusion criteria: * (chronic) pace-maker/ defibrillator in situ at study inclusion; * known severe aortic stenosis (mean gradient \> 40 mmhg, valve area \< 1 cm2); * rhythmogenic heart disease (resting heart rate \> 120/min) at time of study inclusion; * emergency patient (i.e. unscheduled or).

Keywords: hypertension non-invasive blood pressure monitoring photoplethysmography
inhaled nebulized tobramycin in non-cystic fibrosis bronchiectasis

Conditions: Non-CF Bronchiectasis

Summary: the purpose of this study is to evaluate the effect of tobramycin inhalation solution (tis) once daily compared tot placebo in patients with non-cf bronchiectasis. the primary endpoint is a reduction of exacerbations of the disease during the treatment period. next to this parameter the investigators expect to show a significant beneficial effect on lung function parameters, qol, bacterial load of pathogens in sputum and tobramycin resistance.

see uploaded study protocol

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. the presence of chronic respiratory symptoms such as cough, dyspnoea, expectoration of sputum 3. confirmed non-cf bronchiectasis by (hr)ct 4. documented history of at least 2 pulmonary exacerbations treated with courses of antibiotics within 12 months before inclusion. 5. no course of antibiotics or maintenance antibiotics (except for macrolides) 1 month prior to the start of the study. 6. minimal one documented sputum or bal-fluid culture with gram-negative bacteria or s.aureus within 12 months. 7. growth of protocol defined pathogens in sputum at screening visit sensitive to tobramycin 8. tolerance of inhaled tobramycin exclusion criteria: 1. any exacerbation within the month prior to the start of the study 2. diagnosis of cystic fibrosis 3. active allergic bronchopulmonary aspergillosis (abpa) 4. any oral, iv or inhaled antibiotics (except for macrolides) within 1 month prior to the start of the study 5. any iv or im corticosteroids or change in oral corticosteroids (\> 10 mg) within 1 month prior to the start of the study 6. any change/start treatment regimens macrolides, hypertonic saline, inhaled mannitol or other mucolytics, corticosteroids within 1 month prior to the start of the study 7. change in physiotherapy technique or schedule within 1 month prior to the start of the study 8. severe immunosuppression or active malignancy 9. active tuberculosis 10. chronic renal insufficiency (egfr \< 30 ml/min), use of loop diuretics 11. have received an investigational drug or device within 1 month prior to the start of the study 12. serious or active medical or psychiatric illness 13. pregnancy and child bearing 14. history of poor cooperation or non-compliance 15. unable to use nebulizers 16. allergic for tobramycin
a study to learn how different forms of the study medicine called phenytoin are taken up into the blood in healthy adults

Conditions: Healthy

Summary: the purpose of this study is to understand how the different formulation of phenytoin is taken up into the blood in healthy adults. this study is seeking healthy adult participants. all the study participants will receive phenytoin 50 mg chewable tablets manufactured at ascoli and vega baja manufacturing site. we will measure how the phenytoin will be taken up into the blood in healthy adults following oral dosing of phenytoin. this will help us determine if the phenytoin 50 mg chewable tablets manufactured at ascoli and vega baja manufacturing site are similar or not.


Eligibility criteria:
inclusion criteria: 1. healthy male participants and female participants of non-childbearing potential aged 18 years or older determined by medical evaluation including detailed medical history, complete physical examination, blood pressure (bp) and pulse rate measurement, 12-lead electrocardiogram (ecg), and/or clinical laboratory tests. 2. body mass index (bmi) of 16-32 kg/m2; and a total body weight \>45 kg (100 lb). exclusion criteria: 1. evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 2. female participants of childbearing potential; pregnant female participants; breastfeeding female participants; male participants with partners currently pregnant; male participants able to father children who, with their partner(s) are at risk for pregnancy and are unwilling or unable to use a highly effective method of contraception. 3. history of hypersensitivity to phenytoin or its inactive ingredients. 4. any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 5. use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior to the first dose of study intervention. 6. current use of any prohibited concomitant medication(s). 7. history of febrile illness within 5 days prior to first dose.

Keywords: bioequivalence phenytoin healthy participants pharmacokinetic epilepsy
natural history study of exocrine pancreatic function in infants with cystic fibrosis (cf)

Conditions: Cystic Fibrosis

Summary: the purpose of the study is to evaluate the natural history of exocrine pancreatic function by assessing fecal elastase-1 (fe-1) in infants with cf during their first year of life.


Eligibility criteria:
key inclusion criteria: * participants with cf less than (\<) 6 months of age at the index date * participants not eligible to receive commercial kalydeco™ (based on local product labels) and are not receiving kalydeco or any other cystic fibrosis transmembrane conductance regulator gene (cftr) modulator key exclusion criteria: * participant whose mother took any cftr modulator while pregnant with the participant, or who has any history of exposure to a cftr modulator other protocol defined inclusion/exclusion criteria apply.
study to assess the feasibility in bile cfdna of resectable biliary tract carcinomas

Conditions: This Study Aims to Reveal the Effectiveness, Accuracy, and Feasibility in Bile

Summary: this study intends to use onconscreen plus 520 panel (burning rock, china) to conduct ngs testing in matched tissue, blood , and bile samples of patients with resectable biliary tract carcinomas（btc）. in order to explore thefeasibility in bile cfdna of btc，we will collect relevant clinical information and follow-up treatment information. this study aims to reveal the effectiveness, accuracy, and feasibility in bile, as compared to tissues and blood samples.

in this study, we will investigate the potential of bile for genomic alterations using matched tissue, plasma and bile from 20 resectable btc patients。the patient samples will be submitted for next-generation sequencing (ngs)，the results will include but will not be limited to genomic profling, tumor mutation burden (tmb), microsatellite instability (msi) status, homologous recombination repair deficiency (hrd)。patients will be followed-up for treatment responses until radiological confirmation of disease recurrence ,the molecular assay results will then be analyzed with clinical data including objective responses disease-free survival outcomes, among others, to reveal the effectiveness, accuracy, and feasibility in bile, as compared to tissues and blood samples. baseline tissues, plasma and sputum samples from 20 resectable btc patients with 520 panel sequencing (tissue 1000x, ,plasma cfdna 10000x，bile 10000x), in different methods will be compared.

Eligibility criteria:
inclusion criteria: 1. patients who are diagnosed with diagnosed with btc (including ihcc、ehcc、gbc)by histology or cytology 2. patients who signed informed consent form; 3. patients who agree and have the ability to follow the planned research visits, provide surgical tissue, blood, and bile samples, provide clinical information, and cooperate with other research steps. exclusion criteria: a.patients who be deemed unsuitable for enrollment by the researchers.

Keywords: resectable btc，tissue, blood , and bile samples，genomic alterations
interscalene and combined supra scapular and axillary nerve blocks in rotator cuff repair

Conditions: Disorder of Rotator Cuff

Summary: primary objective of this study is to prospectively compare and evaluate efficacy as well as note side effects of the interscalene block and combined suprascapular and axillary nerve block for ambulatory arthroscopic rotator cuff repair.

patients having elective arthroscopic rotator cuff repair will be randomized to one of the two groups. group 1: this group will receive interscalene block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia. group 2: this group will receive suprascapular and axillary nerve block (ultrasound guided and nerve stimulator aided) followed by a general anesthesia. performance time, quality and efficacy as well as any side-effects of the blocks will be evaluated in terms of pain scores in recovery room, after 4- 6 hours and the next morning, opioid usage and patient satisfaction. primary hypothesis: • combined suprascapular and axillary nerve blocks provide similar postoperative analgesia as compared to interscalene block for arthroscopic rotator cuff repair. secondary hypothesis • interscalene block is associated with more side effects and complications as compared to suprascapular nerve block and axillary nerve block.

Eligibility criteria:
inclusion criteria: * elective shoulder arthroscopic rotator cuff repair * asa i - iii (american society of anaesthesia classification) exclusion criteria: * asa iv or higher ( american society of anaesthesia classification) * obesity: bmi \>35 * narcotic abuse/ drug dependency * major neurologic deficits * allergy to local anesthetics * infection in the site of the puncture * mental impairment

Keywords: interscalene suprascapular axillary
vitamin and asthma study

Conditions: Asthma

Summary: the study looks at how vitamin d supplement will improve the severity of asthma and lung function as well as biomarkers in asthmatic children.


Eligibility criteria:
inclusion criteria: * history of asthma (under control)otherwise in good general health exclusion criteria: * poorly controlled asthma * taking daily multivitamin or vitamin d supplementation * taking oral steroid medication * history of bronchopulmonary dysplasia or chronic lung disease, extreme prematurity, congenital heart disease, significant renal dysfunction or primary kidney disease, endocrinologic abnormalities of calcium metabolism or parathyroid disorders

Keywords: asthma pulmonary function test vitamin d
study of quemliclustat and chemotherapy versus placebo and chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma

Summary: the purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.


Eligibility criteria:
inclusion criteria: * have histologically or cytologically confirmed pdac that is metastatic. * have not been previously treated for pdac in the metastatic setting. 1. prior neoadjuvant and/or adjuvant therapy for pdac is permitted if completed at least 12 months before randomization. 2. prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and aes have resolved to grade 1 or less before randomization. 3. prior and/or placement of a biliary stent/tube is permitted if any treatment-related aes have improved to grade ≤ 1 and the patient is not exhibiting any signs/symptoms of biliary obstruction. * eastern cooperative oncology group ps of 0 to 1. * at least 1 target lesion measurable by computed tomography (ct)/magnetic resonance imaging (mri) per recist v1.1. not within a field of prior radiation therapy. exclusion criteria: * previously treated for locally advanced, unresectable pdac. * history of brain metastases or leptomeningeal metastases. * prior treatment with a cd73 antagonist or inhibitor. * underlying medical conditions that, in the investigator or sponsor's opinion, will make the administration of study-specified therapy hazardous note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: quemliclustat cd73 inhibitor metastatic pancreatic ductal adenocarcinoma treatment naive pancreatic cancer prism-1
application and optimization of the international study group of pancreatic surgery (isgps) definition and grading criteria for postoperative complications of pancreatic surgery in laparoscopic pancreatic surgery

Conditions: Laparoscopic Pancreatic Surgery; Pancreatic Fistula; Postoperative Bleeding; Delayed Gastric Emptying

Summary: in recent years, with the continuous development of minimally invasive techniques, laparoscopic pancreatic surgery has also been widely used. although the postoperative mortality rate of laparoscopic pancreatic surgery has been decreasing as the technology continues to improve and mature, the complication rate reported varies widely among centers.the definition and grading criteria of isgps on postoperative complications of pancreatic surgery are mostly proposed based on open pancreatic surgery, and most of the data of the later related studies are also for open pancreatic surgery, while the applicability of the definition and grading criteria in laparoscopic pancreatic surgery is still lacking in systematic the study the main purpose of this study is to investigate the applicability of the isgps definition and grading criteria for pancreatic fistula, postoperative bleeding and delayed gastric emptying in laparoscopic pancreatic surgery.


Eligibility criteria:
inclusion criteria: 1. all patients underwent laparoscopic pancreatic resections at the department of pancreatic surgery of west china hospital of sichuan university and the department of minimal invasive surgery of shangjin nanfu hospital between january 2014 and july 2022. 2. all patients underwent laparoscopic pancreaticoduodenectomy (lpd), laparoscopic distal pancreatectomy (ldp), laparoscopic enucleation, laparoscopic middle pancreatectomy (lmp), laparoscopic duodenum-preserving resection of head of pancreas (ldprhp), or laparoscopic frey procedure. 3. patients whose demographic parameters, perioperative clinical variables, postoperative follow-up outcomes for 3 months and total hospital costs can be collected completely. exclusion criteria: 1. patients converted to laparotomy 2. patients underwent total pancreatectomy 3. patients underwent pancreatic pseudocyst drainage management 4. patients underwent pancreas biopsy
acute food intake effect of hemp protein (a fineh protein) trial - part 2

Conditions: Diabetes Prevention; Obesity Prevention

Summary: the objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control.

the objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control. the objectives of this trial are to investigate whether the effects of hemp protein on glycemic and appetite control are insulin-dependent by measuring 1) blood glucose, insulin and appetite for one hour following consumption, 2) blood glucose, insulin and appetite following a fixed energy meal to determine the "second meal effect" of hemp protein versus soybean protein and a non-protein control.

Eligibility criteria:
inclusion criteria: * normoglycemic (\<5.6 mmol/l) * body mass index (bmi) of 18.5-29.9 kg/m2. exclusion criteria: * restrained eaters * regularly skip breakfast * smokers * those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year.