Kornimate/medical-research-clean huggingface dataset:
permacol paste in perianal crohn's disease

Conditions: Crohn Disease; Perianal Fistula

Summary: the purpose of this study is to collect data about the efficacy of permacol paste treatment in perianal crohn's disease.

this is an observational prospective cohort study aimed to assess the efficacy of permacol paste treatment in perianal crohn's disease, by evaluating the healing rate and quality of life of 20 patients prospectively indicated to permacol paste treatment during one year.

Eligibility criteria:
inclusion criteria: * age \> 18, any sex * diagnosis of cd at least 6 months earlier in accordance with clinical, endoscopic, histological an/or radiological criteria * presence of perianal fistulas with maximum 3 external openings and a maximum of 2 internal openings, assessed by physical examination and mri * non-active or mildly active luminal cd defined by a cdai \< 220 exclusion criteria: * cdai \> 220 * dominant luminal active cd requiring immediate surgical or medical therapy * fistula with \> 3 external openings and \> 2 internal openings * severe active proctitis and/or rectal stenosis * abscess or pelvic collection \> 2 cm diameter * concomitant rectovaginal fistulas * concomitant steroid treatment or treated with steroids in the last 4 weeks
a multicentre trial on the effectiveness of physical rehabilitation of patients with coronary artery disease: aerobic interval training versus moderate continuous training.

Conditions: Coronary Artery Disease (CAD);; Myocardial Infarction (MI); Percutaneous Coronary Intervention (PCI); Coronary Artery Bypass Grafting (CABG)

Summary: cardiac rehabilitation, including physical training, has become accepted treatment following myocardial infarction, coronary stent implantation and coronary bypass operation. besides modifying patients' risk profile for future coronary problems, the focus is on improving exercise capacity. the ability to be able to perform at a higher maximal level is a strong predictor for outcome (new cardiovascular events and mortality). the main purpose of this study is to evaluate whether aerobic interval training outweighs more classical moderate endurance training in improving exercise capacity. during interval training, patients perform exercise at high intensity, but for only a couple of minutes and then recover at a lower intensity. such intervals are repeated. preliminary evidence from smaller studies suggests that this type of training leads to a larger increase in exercise capacity, compared to the more traditional endurance training at moderate intensity. in addition, mechanisms that might explain how this improvement is achieved, as well as safety and impact on quality of life will be studied.


Eligibility criteria:
inclusion criteria: * patients with cad (post-pci, post-mi, post-cabg) and a left ventricular ejection fraction (lvef) \> 40% * the presence of cad is defined as prior angiographically documented stenotic lesion(s) of \> 75%, or documented myocardial infarction (biochemical, ecg, echocardiographic documentation). * patients are on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks * in practice, patients will have been hospitalized at least 4 weeks prior to participation in the training programme because of pci, mi or cabg exclusion criteria: * significant intercurrent illness last 6 weeks * known severe ventricular arrhythmia with functional or prognostic significance * significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing * recent cabg (\< 30 days) * other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.) * co-morbidity that may significantly influence one-year prognosis * functional or mental disability that may limit exercise * a habit of regular vigorous exercise or participation in a programme of exercise training less than 3 months before inclusion * acute or chronic inflammatory diseases or malignancy, the use of anti-inflammatory drugs or immune suppression * glomerular filtration rate (gfr) \<25ml/min/1.73m2 * hemoglobin \< 10g/dl * severe chronic obstructive pulmonary disease * participation in another clinical trial

Keywords: patients with recent coronary event
pilot study evaluating tumor microenvironment interaction in solid tumor patients

Conditions: Solid Tumor Cancer; Solid Tumor Malignancy; Cancer; Malignancy

Summary: this pilot study aims to compare pet/ct imaging using 68ga-fapi-46 to imaging results from standard mri or ct with contrast in patients with solid tumors undergoing biologic therapy. a total of 50 participants will receive an intravenous injection of 68ga-fapi-46 and undergo a pet/ct scan shortly after received the study drug. imaging will occur before starting standard antibody-based therapy. participants will then proceed with their treatment, and the study team will monitor them through chart reviews for up to 36 months to evaluate treatment response and any correlation with tumor uptake observed on pet/ct scans.

this is a pilot study to compare pet/ct uptake of 68ga-fapi-46 to uptake parameters determined by standard of care mri or ct with contrast. patients with a solid tumor diagnosis who are scheduled to undergo biologic therapy will be included in the study. following imaging, patients will begin standard of care antibody based therapy and standard of care follow-up. this study is an open label, single institution, pilot study to determine if 68-ga-fapi-46 can predict tumor uptake in patients with solid tumor and if the 68-ga-fapi-46 uptake in the tumor positively correlates with response to antibody based therapies. a total of 50 subjects will be enrolled in the study. imaging will take place prior to initiation of treatment. patients will then be administered an intravenous injection of 68-ga-fapi-46 after which subjects will undergo a pet/ct scan shortly after receiving the drug. subjects will then undergo treatment as determined by their primary team. the study team will chart review subjects for 36 months ± 6 months with the possibility of extending this follow-up depending on immunotherapy treatment duration to extract treatment response information as documented by their primary treatment team. total duration of active participation per patient may last approximately 45 days. the study will take around 84 ± 6 months from the time the study opens to accrual. the total duration per patient from time of enrollment to chart review is 36 ± 6 months.

Eligibility criteria:
inclusion criteria: * age ≥ 19 years. * biopsy confirmed diagnosis of solid tumor malignancy scheduled to undergo antibody-based therapy * subjects diagnosed with any stage of disease who will undergo immunotherapy treatment. * have acceptable kidney function and clinical lab values. exclusion criteria: * myocardial infarction (mi); cerebrovascular accident (cva); uncontrolled congestive heart failure (chf); significant liver disease; or unstable angina within 6 months prior to enrollment * females who are currently pregnant or breastfeeding * severe renal disease or anuria * inability to lie flat or remain still for the duration of the scan.

Keywords: immunotherapy anti-body based therapy abt antibody based therapy anti body based therapy cancer malignancy solid tumor
phase i study of the bbp-398 in patients with advance solid tumors

Conditions: Advanced Solid Tumor; Advanced or Metastatic Non-small Cell Lung Cancer

Summary: this is an open label, dose escalation and expansion, two-part phase i study for shp-2 inhibitor bbp-398 to evaluate the safety, tolerability, pharmacokinetics, determine mtd and/or rp2d, and preliminary anti- cancer activity in chinese subjects with advanced solid tumors and in chinese subjects with advanced or metastatic egfr-mutant nsclc.

the part a of this phase i trial is an abbreviated dose escalation study of bbp-398 following the usa mono dose escalation study (study nav- 1001, clinicaltrials.gov id nct04528836). the purpose of this part is to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity in chinese subjects with advanced solid tumors. the part b of this study is to explore the safety, tolerability and efficacy of bbp-398 in chinese subjects with advanced or metastatic egfr- mutant nsclc at mtd and/or rp2d. this phase i study will provide supportive data to enable chinese patients to join the combo dose escalation and expansion studies and/or other clinical trials of bbp-398.

Eligibility criteria:
inclusion criteria: 1. patients must have the ability to understand and the willingness to sign a written informed consent document 2 patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures 3. age ≥18, male or female 4.dose escalation: locally advanced or metastatic solid tumors dose expansion: advanced or metastatic egfr-mutant nsclc 5. patients must have measurable disease by recist v1.1. 6. patients must have an ecog performance status (ps) ≤2 7.patients with a life expectancy of ≥12 weeks. 8. patients must have adequate organ function exclusion criteria: 1. patients with a known additional malignancy that is progressing or requires active treatment 2. patients who have previously received a shp-2 inhibitor 3. patients who are hypersensitivity to shp-2 inhibitor or any ingredients 4. treatment with any of the related anti-cancer therapies prior to the first dose of bbp-398 within the stated timeframes 5. patients with known active hepatitis b, hepatitis c infection, or hiv infection. 6. patients with any of the cardiac-related issues or findings 7. patients with a history of cva, myocardial infarction or unstable angina within the previous 6 months before starting therapy. 8. patients with known central nervous system (cns) tumors 9. patients with known active cns metastases and/or carcinomatous meningitis. 10. patients with persisting toxicity related to prior therapy. 11. patients who have undergone major surgery within 4 weeks prior to study enrollment. 12. pregnant or breastfeeding female patients. 13. patients with inability to swallow oral medications or with gastrointestinal illness that would preclude the absorption of an oral agent.

Keywords: solid tumors, nsclc
the effect of chronic anemia on safety period of tracheal intubation in gynecology patients

Conditions: Chronic Anemia

Summary: 1. every individual receiving a general anesthetic is at potential risk for developing a ''cannot intubate-cannot ventilate'' situation following anesthetic induction. 2. building up of oxygen reserves assumes great significance as this provides a longer duration of non-hypoxic apnea should one be faced with an unanticipated difficult airway. 3. the main physiological functions of red blood cell hemoglobin are to deliver oxygen to the peripheral tissues. 4. during anemia, a reduction in blood oxygen content occurs as a result of reduced hb while arterial oxygenation and oxyhemoglobin saturation remain high. 5. previous studies about the duration of non-hypoxic apnoea focus on methods to improve the safety period of tracheal intubation. 6. to our knowledge, there is no literature about the duration of non-hypoxic apnoea of anemia patients. 7. the aim of this study was to assess the effect of chronic anemia on the duration of non-hypoxic apnoea during induction of anaesthesia.

after breathing for 3 minutes, anesthesia induction was conducted. the endotracheal tube position was confirmed after anesthesia induction. patients were left apneic with the endotracheal tube open to room air. the non-hypoxic apneic period was recorded as the time (in seconds) taken for the drop in pulse saturation to 90% or an apneic period of 10 min elapsed, whichever was earlier.

Eligibility criteria:
inclusion criteria: 1. patients scheduled to undergo general anesthesia 2. american society of anesthesiologists performance status 1-2 3. adults exclusion criteria: 1. individuals with significant cardiorespiratory or cerebrovascular disease, 2. difficult intubation 3. history of epilepsy 4. body mass index \>25 kg/m2, 5. and those who had smoking history in past 6 months

Keywords: anemia non-hypoxic apnoea tracheal intubation anesthesia
treatment of ulcerative colitis with a combination of lactobacillus rhamnosus and lactobacillus acidophilus.

Conditions: Ulcerative Colitis

Summary: in this trial we test the hypothesis that a probiotic containing lactobacillus acidophilus and lactobacillus rhamnosus is an effective therapy for patients with ulcerative colitis.

in the recent years there has been an increasing interest in the relationship between the gastrointestinal flora and gut function. several studies have shown promising results for the use of probiotics in patient with inflammatory bowel disease. in this trial approximately 100 patients with ulcerative colitis will receive treatment with probiotic or placebo for 8 to 10 months as adjuvant therapy. the trial is double-blind, randomised and controlled.

Eligibility criteria:
inclusion criteria: * patients with known ulcerative colitis * at least one prior flare of the disease * clinically and endoscopically active disease * age: 18 and above exclusion criteria: * changes in azathioprine dosage within the last three months * patients with toxic megacolon, peritoneal reaction or severe colonic bleeding * known immunodeficiencies * on-going infectious disease * on-going treatment with nsaid or cholestyramine * pregnant og lactating women

Keywords: ulcerative colitis probiotic placebo controlled trial lactobacillus rhamnosus lactobacillus acidophilus
treatment of complex pilon fractures

Conditions: Pilon Fracture

Summary: this project intends to compare patient outcomes between patients undergoing orif compared to pa, or ankle fusion, following an acute pilon fracture. limited literature comparing orif and ankle fusion as a primary procedure exists. particularly, no present literature exists examining the novel arthrodesis surgical technique utilized in this study in conjunction with opal sensor gait analysis data. this study will serve as a pilot study and assess patient gait, degree of pain, functional outcome scores, development of post-traumatic arthritis and/or infection, need for secondary surgery, and return to work time.


Eligibility criteria:
inclusion criteria: individuals receiving orif or pa for a multifragmented acute pilon fracture occuring at the joint surface over the age of 18 from 2018 to present at the university of kansas medical center (kumc) or emory university hospital. exclusion criteria: anyone under the age of 18 years. pregnant women.

Keywords: pilon fracture
rapid self-testing to prevent fentanyl overdose among young people who use drugs

Conditions: Accidental Overdose of Opiate

Summary: the research team will enroll 100 young adults who use cocaine, heroin, inject drugs, or purchase prescription medications on the illicit market in a pilot study to be known as the rhode island young adult prescription and illicit drug study (rapids). participants will be trained to use a take-home home rapid drug test to test for the presence or absence of fentanyl in their drug supply. half of the enrolled participants will be asked to test their urine for presence or absence of fentanyl, and the other half will be asked to test their drug residue for presence or absence of fentanyl. all participants will receive up to 15 take-home rapid drug tests for fentanyl. a follow-up survey will examine and compare utilization of the tests between the two groups. the study will be guided by the information-motivation-behavioral skills (imb) model of engagement in health behaviors. the imb model hypothesizes that if a person possesses the information, motivation, and behavioral skills to act, there is an increased likelihood that she/he will fulfill and maintain the desired behaviors (behaviors that will reduce accidental overdose).

the research team will administer a brief survey to ascertain behavioral, psychosocial, and clinical factors that may be related to non-prescription fentanyl (npf) exposure among young people who use illicit drugs. the researchers will also characterize knowledge of and perceptions towards drugs contaminated with npf, as well as the potential diversion of prescription fentanyl formulations (e.g., transdermal patches). after the interviewer-administered survey has been completed, participants will provide urine samples to determine recent exposure to npf and other illicit drugs. the research team will assess the acceptability and feasibility of "take home rapid drug tests" to test for fentanyl exposure among 100 participants from the target population. after the enrollment and baseline survey, participants will be provided with rapid drug tests that detect the presence or absence of fentanyl in their drug supply. half the participants will be asked to test their urine to see if they have been exposed to a fentanyl-contaminated drug. the other half will be asked to test the residue of the drug that they intend to use. study participants will then be asked to return in 2 weeks for a brief follow-up survey that will assess whether they used the self-tests, whether the technology was acceptable and easy to use, and whether and how a positive test result altered their drug-using and overdose prevention behaviors.

Eligibility criteria:
inclusion criteria * 18-35 years of age * resident of rhode island * able to complete interviews in english * self-reported heroin, cocaine, injection drug use, or counterfeit prescription pill use in the past 30 days exclusion criteria -participants who exclusively misuse medications obtained from a physician or diversion from someone else's prescription

Keywords: overdose prevention opioid overdose risk behavior harm reduction
a multicenter trial of the efficacy and safety of a new formulation of ibuprofen 800 mg every 6 hours in the management of postoperative pain

Conditions: Postoperative Pain

Summary: the purpose of this study is to study the efficacy of intravenous administration of ibuprofen compared to placebo in patients with postoperative pain and evaluate its tolerability and safety profile.

this is a phase iii, national, multicenter, randomized, double-blind, parallel groups, and placebo-controlled. patients will be randomized to receive either ibuprofen or placebo. stratified randomization will be used to assign eligible patients to a stratum according to type of surgery and centre. randomization sequence will be generated in the coordinating centre. blinding of the patient and study personnel evaluating response will be warranted by adequate drug labelling. all patients will receive morphine administered by patient controlled analgesia (pca) following a similar schedule in all centres: 1 mg bolus dose with a close time of 5 min and a maximum of 10 mg in an hour and a maximum of 30 mg in 4 hours.

Eligibility criteria:
inclusion criteria: 1. men or women between 18 and 80 years old. 2. being scheduled for elective single surgical site orthopaedic surgery (hip or knee joint replacement, corsed ligaments, column or shoulder surgery), or abdominal surgery (inguinal hernia, cholecystectomy, eventration or hiatus hernia) 3. being scheduled for general anaesthesia or regional anesthesia without regional analgesia after surgery. 4. having anticipated need for postoperative narcotic analgesia administered by patient controlled analgesia (pca). 5. expected to stay at the hospital for at least 24 h. 6. providing written informed consent for participating in this study. exclusion criteria: 1. use of nsaid within 12 hours prior to the first planned dose. 2. taking oral anticoagulants, lithium, combination of ace inhibitors, furosemide or aspirin. 3. anaemia (haemoglobin \<10 g/dl) and/or history or evidence of asthma or heart failure. 4. history of allergy or hypersensitivity to any component of iv ibuprofen, aspirin or aspirin related products, nsaid or cox-2 inhibitors. 5. pregnant or nursing. 6. weight less than 40 kg. 7. history of severe head trauma that required hospitalization, intracranial surgery or stroke within the previous 30 days, or any history of intracerebral arteriovenous malformation, cerebral aneurism or cns mass lesion. 8. history of congenital bleeding diathesis or any active clinically significant bleeding or underlying platelet dysfunction. 9. gastrointestinal bleeding that required medical intervention. 10. platelet count less than 80.000 determined within the 28 days prior to surgery. 11. pre-existing dependence on narcotics or receiving chronic treatment with opioids. 12. severe renal failure (calculated creatinine clearance \< 60 ml/min). 13. liver failure, alat or asat \>3 times upper limit of normality, or bilirubin \>2 g/dl. 14. diagnosed of bowel inflammatory disease. 15. not able to understand the requirements of the study, or to abide by the study restrictions or to return for the required assessments.
preoperative information with storybook for pediatric anesthesia

Conditions: Animation, Cartoons, Preoperative Care, Anesthesia, Pediatric

Summary: impacts of non-pharmacologic methods that help patients get prepared cognitively for processes of surgery and anesthesia on pediatric surgery patients' preoperational stress levels and anxiety levels had been examined in the scope of this comprehensive research project. in this project, a goal-oriented 8-9 minutes animation cartoon that is informative and educational had been developed, and pediatric surgery patients had been asked to watch this animation during preoperative period.


Eligibility criteria:
inclusion criteria: * pediatric surgery patient including inguinal hernia repair, circumcision and tonsillectomy. * without having previous emergency surgery and anesthetic experience, exclusion criteria: * their parents reported developmental delays, mental retardation, or chronic illnesses of the children * emergency surgery
validation of the conut software tool for screening clinical malnutrition in the university hospital la paz

Conditions: Malnutrition

Summary: nutrition department of university hospital la paz decided to implement some method of screening in our centre which allowed us to detect as many patients with malnutrition risk as possible. due to the large size of our centre, with about 1,500 beds and the few human resources in our unit, we chose to use the conut system (nutritional control), a 100% automatic method based on analytical parameters, very easy to use, low cost and whose validity is confirmed, characteristics that fulfilled our needs. the implementation of this nutritional screening method has led to a change in the ìnutritionafi culture of our centre respect to drm in most of our professionals: doctors and nurses and even in the management team, so all of them understand the importance of the process and know about the available tools and knowledge to indicate an adequate and early nutritional support.


Eligibility criteria:
inclusion criteria: * patients of both sexes * patients older than 15 years * patients admitted to the general hospital or traumatology area * patients who have signed the informed consent to participate in the study * patients who do not meet any exclusion criteria. exclusion criteria: * pregnant women. * patients whose physical and / or psychic capacity prevents them from providing all the data collected by the evaluated methods or who do not have a caregiver. * non-collaborating patients in data collection * patients in whom a hospital stay of less than 48 hours is expected. * patients who at the time of performing the analyzes are in the icu and oer