Kornimate/medical-research-clean huggingface dataset:
a study with lanadelumab in persons with hereditary angioedema (hae) in poland

Conditions: Hereditary Angioedema (HAE)

Summary: the main aim of this study is to learn about how many persons with hae type i or type ii are attack-free when treated with lanadelumab in real life, how many attacks occur and how many of these attacks need rescue treatment and about the nature of hae attacks. participants will need to visit their doctor 5 times in total as part of this study. the visits are planned every 6 months. participants will also be asked to fill out questionnaires as part of this study.


Eligibility criteria:
inclusion criteria participant eligibility is determined according to the following criteria prior to entry into the study: * in the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. * the participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. * hae participant (aged greater than or equal to \[\>=\] 12 years old.) qualified to treatment with lanadelumab in the ndp and receiving treatment according to the summary of product characteristics for takhzyro. * male or female participants, aged \>=12 years old. exclusion criteria any participant who meets any of the following criteria will not qualify for entry into the study: * currently participates or plans to participate in any interventional clinical trial. * any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study. participants should be included in the study only once. data erroneously collected from participants for which written consent is not available, will not be included in or will be deleted from the database.
a study to explore the effect of moringa oleifera (e-hs-01) on flow mediated dilatation and hemodynamics

Conditions: Endothelial Function

Summary: the present study is designed to evaluate the modulatory effect of ip on the vascular endothelial function. to assess its vasodilatation potential, change in flow mediated dilation (fmd) and blood flow velocity (bfv) will be assessed in healthy adult male population.


Eligibility criteria:
inclusion criteria: 1. healthy, physically active male volunteers aged between 20 to 35 years. 2. body mass index (bmi) ≥ 20 and ≤ 29.9 kg/m2. 3. participants with low to moderate physical activity as defined by a six-point scale score of ≥1 to ≤ 4. 4. participants with systolic blood pressure (sbp) ≤ 139 and diastolic blood pressure (dbp) ≤ 89 mm hg. 5. ability to read and provide written, personally signed, and dated informed consent to participate in the study. 6. ready to abstain from alcohol, caffeine, and vigorous physical activity (as assessed by six point scale) for 24 hours prior to every study visit. 7. ready to abstain from beet root, moringa, and spinach for 48 hours prior to every study visit. exclusion criteria: 1. participants with history of pulmonary disorders (asthma, chronic obstructive pulmonary disease (copd), pulmonary fibrosis, pneumonia, etc) 2. participants having fasting blood glucose (fbg) levels ≥ 125 mg/dl. 3. participants currently on/or having history of taking antihypertensives / diuretics. 4. smokers and tobacco users. 5. participants with heavy alcohol consumption, defined as more than 14 standard alcoholic drink (sad)/week or more than 4 sad in a day. (note - a standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (\~5% alcohol), 8.5 ounces of malt liquor (\~9% alcohol), 5 ounces of wine (\~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; \~40% alcohol). 6. participants currently on performance enhancing supplements. 7. history/symptoms of coronary artery disease, myocardial infarction etc. 8. participants with any other condition which in the view of the investigator is likely to interfere with the study or put the participants at risk.
pd-1 inhibitor combined with bevacizumab and folfiri regimen in the second-line treatment of advanced colorectal cancer

Conditions: MSI-H Advanced Colorectal Cancer

Summary: msi-h is a biomarker for solid tumors benefiting from immunotherapy. recent clinical studies have confirmed that pd-1 inhibitors have a good effect on msi-h advanced colorectal cancer for first- or second-line treatment. the overall effective rate is 30% to 40%. however, about 30% of patients are resistant to pd-1 inhibitors. whether pd-1 inhibitors and existing chemotherapeutics and anti-vascular drugs have synergistic effects is worth studying. this study is a phase ii prospective clinical study of pd-1 inhibitor combined with bevacizumab and folfiri regimen in the second-line treatment of unresectable recurrent or metastatic msi-h colorectal cancer.


Eligibility criteria:
inclusion criteria: * 1. recurrent or metastatic unresectable colorectal adenocarcinoma confirmed by histology and/or cytology; 2. first-line oxaliplatin-containing chemotherapy has disease progression during chemotherapy or within 6 months after chemotherapy; 3. msi-h patients confirmed by pathology, msh2(-) or msh6(-), for mlh1(-) or pms2(-) patients need pcr confirmation; 4. according to the recist 1.1 standard, there is at least one measurable lesion； 5. sufficient bone marrow function, liver and kidney function； 6. age greater than 18 years old， less than or equal to 75 years old； 7. ecog score 0 or 1; expected survival time greater than 3 months; signed informed consent. exclusion criteria: * 1. for patients who have been treated with pd-1 in the first-line treatment, bevacizumab is allowed in the first-line treatment; 2. other malignant tumors have been diagnosed within 5 years before the first use of the study drug, except for effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, and/or effectively resected in situ cervical cancer and/or breast cancer; 3. suffer from any active autoimmune disease or have a history of autoimmune disease; 4. are suffering from an active infection that requires systemic treatment; 5. the hiv test result is positive; 6. known to be allergic to certain components of the research drug or similar drugs; 7. use clinical investigational drugs within 4 weeks before the start of study administration; 8. major surgery has been performed within 4 weeks before the start of the study administration and has not fully recovered; 9. the patient has a bleeding disorder, and the investigator judges that there is a risk of hemorrhage; 10. uncontrolled cardiac clinical symptoms or disease heart function, such as severe arrhythmia, uncontrollable hypertension; 11. according to the judgment of the investigator, the subject has other factors that may cause him to be forced to suspend the study.
a second dose of measles vaccine (mv) in the second year of life

Conditions: Child Mortality; Child Morbidity

Summary: this study evaluates the non-specific effects on child mortality and morbidity of a second dose of measles in the second year of life. half of the study participants will receive a second dose of measles vaccine at 18 months of age while the other half will receive a second dose of measles by 4 years of age or at the end of the study.


Eligibility criteria:
inclusion criteria: * children need to have received the third dose of inactivated vaccines (penta, pcv13 and ipv) before measles vaccination. exclusion criteria: * having severe malformations that impairs their health * having received a second dose of measles vaccine * severely ill (requiring hospitalization) upon clinical examination
efficacy and safety of azd7009 in the treatment of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the current study is designed to assess the efficacy and safety of iv azd7009 in conversion from af


Eligibility criteria:
inclusion criteria: * clinical indication for cardioversion of atrial fibrillation. effective oral anticoagulation according to local routines or a tee without any finding of intracardial thrombus or signs of thrombogenecity exclusion criteria: * clinically significant sinus and/or av node dysfunction. serum or plasma potassium \ 5.0 mmol/l. qtc(bazett) \>450 ms. any qrs duration \>150 ms
the effect of progressive relaxation exercises applied to caregivers on caregiving burden and meaning of life

Conditions: Hemiplegia

Summary: this randomised controlled experimental type study will be conducted with family members who care for the relatives of hemiplegic patients who are hospitalised in manisa merkezefendi and turgutlu state hospital physical therapy services.

the population of the study will consist of the caregivers of hemiplegic patients receiving treatment in the clinic on the specified dates in turgutlu state hospital and manisa merkezefendi state hospital physical therapy service. the sample will consist of individuals who meet the inclusion criteria. individuals in turgutlu state hospital will constitute the intervention group of the study and individuals in manisa merkezefendi state hospital will constitute the control group of the study. the aim of this study was to determine the effect of progressive relaxation exercises applied to family members caring for hemiplegic patients on caregiving burden and meaning of life. in the intervention group, those who agree to participate in the study will be asked to fill in the patient and patient relative form, cheltanhams patient classification scale, caregiving burden scale and meaning and purpose of life scale, which include personal information and information about the patient. relaxation exercises will be explained and demonstrated by the researcher (funda aktürk) once a day for 1 month starting from the hospitalisation to the clinic and will be played on the computer. you will be asked to perform these exercises after listening to the video (cd). relaxation exercises are exercises based on stretching and relaxing your muscles. before the application, in the middle of the application (15th day) and at the end of the application, all forms except the introduction form will be filled in again. in the control group, those who agree to participate in the study will be asked to fill in the;patient and patient relative form, cheltanhams patient classification scale, caregiving burden scale and meaning and purpose of life scale, which include personal information and information about the patient. the control group will be asked to fill in the forms at the same time as the intervention group without any intervention. if requested, progressive relaxation exercises will be applied to the control group after the end of the study

Eligibility criteria:
inclusion criteria: * family members who have no communication problems, * who are 18 years of age or older, * whose patient will be hospitalised in the clinic for at least one month, * who agree to participate in the study will be recruited. exclusion criteria: * individuals who have communication problems, * the caregiver is not a family member, * are 18 years of age or younger, * the patient stays in the clinic for less than one month, * has previously received progressive relaxation training, and who do not agree to participate in the study will be included.

Keywords: progressive relaxation exercise burden caregiver the meaning of life
phase ii randomized study of tin mesoporphyrin for neonatal hyperbilirubinemia

Conditions: Glucosephosphate Dehydrogenase Deficiency; Hyperbilirubinemia; Hemolytic Disease of Newborn

Summary: objectives: i. compare the efficacy of preventive vs. therapeutic tin mesoporphyrin in direct coombs' test-positive abo hemolytic disease of the newborn and glucose-6-phosphate dehydrogenase deficiency in infants living in greece. ii. assess the safety of tin mesoporphyrin in high-risk newborns.

protocol outline: patients are stratified by gestational age and sex, and randomly assigned in pairs per stratum. one group receives a preventive dose of tin mesoporphyrin. another group receives a therapeutic dose of tin mesoporphyrin according to the plasma bilirubin concentration. patients in either group may be treated concurrently with phototherapy or exchange transfusion if clinically indicated.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- hyperbilirubinemia associated with either of the following: direct coombs' test-positive abo hemolytic disease of the newborn glucose-6-phosphate dehydrogenase deficiency --prior/concurrent therapy-- no maternal phenobarbital in last month of pregnancy --patient characteristics-- performance status: not specified hematopoietic: not specified hepatic: not specified renal: no congenital renal abnormality cardiovascular: no congenital heart abnormality pulmonary: no asphyxia requiring assisted ventilation at delivery other: gestational age more than 210 days birth weight at least 1500 g no other major congenital abnormality, i.e.: central nervous system chromosomal gastrointestinal no evident or suspected congenital infection, e.g.: cytomegalovirus herpes rubella syphilis

Keywords: glucose-6-phosphate dehydrogenase deficiency hematologic disorders hemolytic disease hyperbilirubinemia neonatal disorders rare disease
nasoseptal double flap versus rescue flap in endoscopic transsphenoidal pituitary surgery

Conditions: Pituitary Adenoma

Summary: this paper investigates the outcomes of two surgical techniques-nasoseptal double flap and nasoseptal rescue flap-used in endoscopic transsphenoidal surgery for pituitary tumors. the nasoseptal flap technique has significantly reduced the incidence of postoperative cerebrospinal fluid (csf) leaks but can cause nasal morbidity.

the study aims to compare nasal morbidity and function between the two techniques in patients undergoing this type of surgery. each patient's nasal morbidity, olfaction, and postoperative complications will be assessed using various tools.

Eligibility criteria:
inclusion criteria: * all consecutive patients with symptomatic pituitary macroadenoma * tumor size ≥ 2 cm exclusion criteria: * -absent sphenoid pneumatization. * temporal or frontal extension. * recurrent pituitary tumor after previous surgery. * previous nasal surgery. * associated nasal disease e.g. rhinosinusitis. * unfit for general anesthesia. * refusal of surgical intervention or signing consent.

Keywords: pituitary surgery double nasoseptal flap rescue nasoseptal flap nasal morbidity transsphenoidal pituitary surgery
respiratory muscle stretching in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: objective: the investigators studied the effects of respiratory muscle stretching in an 8-week pulmonary rehabilitation program. methods: this was a simple-blind parallel controlled trial, conducted an out-patient clinic. twenty six patients with copd (mean age 68 ± 6 y, percent of predicted fev1 47 ± 16) were randomized to either respiratory muscle stretching group plus exercise training (rms), and exercise training group (sham), in an 8-week exercise program that had 3 sessions per week. the investigators measured inspiratory and expiratory muscle strength (by maximal inspiratory and expiratory pressure - pim and pem), exercise capacity (by 6-minute walk distance), dyspnea and quality of life.


Eligibility criteria:
inclusion criteria: * subjects between 40 and 75 years of age referred by a physician to the pulmonary rehabilitation program * with a clinical and spirometric diagnosis of moderate to severe copd according to the global initiative for chronic obstructive lung disease (gold), in a stable condition (without exacerbations or infections for at least a month) * former smokers exclusion criteria: * patients with a known history of asthma, or severe and/or unstable heart disease * any other pathological condition that could impair their physical activities

Keywords: copd diaphragm muscle stretching exercises dyspnea respiratory muscle stretching pulmonary rehabilitation exercise training improved exercise capacity, dyspnea, quality of life
pilocarpine and brimonidine in patients with monofocal lenses

Conditions: Presbyopia; Pseudophakia

Summary: the current study aims to assess the use of pilocarpine and brimonidine to improve near visual acuity in patietns with monofocal intraocular lenses. thirty-three subjects with be enrolled and baseline visual acuity with be measured at near and distance. this will be compared to visual acuity after drop administration over 6 hours. a quality of life questionnaire will also be evaluated.

this research study will try to find out if pilocarpine and brimonidine can help people with intraocular lens implants read without reading glasses. thirty-three subjects will take part in this research study. baseline visual acuity with be measured at near and distance. this will be compared to visual acuity after drop administration over 6 hours. a quality of life questionnaire will also be evaluated.all subjects will take part at massachusetts eye and ear infirmary (meei).

Eligibility criteria:
inclusion criteria: * individuals must meet all of the inclusion criteria in order to be eligible to participate in the study. men and women between ages 60 years and above with monofocal intraocular lenses bilaterally corrected for distance and +/- 0.5d sphere vision who need only +/- 2.5 d correction for reading. given the age group selected only post menopausal women will be evaluated. exclusion criteria: * individuals meeting any of the exclusion criteria at baseline will be excluded from study participation including: allergies to proparacaine, pilocarpine or brimonidine, eye infection or inflammation, glaucoma, retinal tear or retinal disease, eye surgery within the past 30 days, use of eye drops within the last seven days, participated in any other research study within the past 30 days. patients using contact lenses.
feasibility of laryngeal mask airway gastro on patients undergoing endoscopic retrograde cholangiopancreatography for pancreas and bile duct disorders

Conditions: Bile Duct Disorder; Endocrine Pancreas Disorder

Summary: this trial determines the feasibility of laryngeal mask airway gastro (laryngeal mask airway) when used on patients who are undergoing endoscopic retrograde cholangiopancreatography for pancreas and bile duct disorders. laryngeal mask airway is a device that helps patients breathe while they are asleep during procedures.

primary objectives: i. to determine the successful completion of endoscopic retrograde cholangiopancreatography (ercp) with the laryngeal mask airway (lma) gastro. secondary objectives: i. to determine gastroenterologist satisfaction with the lma gastro. ii. to determine anesthesia provider satisfaction with the lma gastro. iii. to determine the rate of unsuccessful lma gastro placement. iv. to determine the ability of lma gastro to provide adequate oxygenation and ventilation throughout the procedure. v. to determine and describe the rate of adverse events. outline: patients wear laryngeal mask airway gastro after receiving general anesthesia and falling asleep. patients then undergo standard of care endoscopic retrograde cholangiopancreatography. patients also complete a 5-minute interview following ercp procedure.

Eligibility criteria:
inclusion criteria: * adult patients undergoing elective ercp with general anesthesia exclusion criteria: * patients with propofol allergy * patients at increased aspiration risk * patients with abnormal head/neck pathology preventing lma gastro placement * patients with surgical or radiation treatment to the head/neck making lma gastro placement difficult * esophagectomy patients * patients already intubated upon arrival to endoscopy suite * patients undergoing endoscopic ultrasound (eus) * patients with body mass index (bmi) 35 kg/m\^2 * non-english speaking patients
effectiveness of a virtual intervention for professionals to improve their attitudes towards patient empowerment.

Conditions: Chronic Disease

Summary: the empodera study aims to assess the effectiveness of a community of practice (cdp) virtual in improving attitudes of primary care professionals on the empowerment of patients with chronic diseases.

main objective: to assess the effectiveness of a community of practice (cdp) virtual in improving attitudes of health professionals in primary care on the empowerment of patients with chronic diseases. methodology: design: cluster randomised controlled. scope: primary care centers (pcc) belonging to the regions of catalonia, madrid and canary islands. population: primary care health professionals (family doctors and nurses). sample size: 270 healthcare professionals and 1382 patients. randomization: randomization unit: pcc; unit of analysis: primary care health professionals. 9 pairs of pcc by region will be randomly selected and randomly assigned to the intervention or control group. randomization will be performed after the selection of professionals and patients. intervention: the intervention group will be offered participation for 12 months in a virtual cdp based on a web 2.0 platform. the control group will receive usual training. measurements: the primary outcome will be measured by patient-provider orientation scale (ppos) questionnaire at baseline and 12 months. secondary outcomes: sociodemographic of professionals; sociodemographic and clinical characteristics of patients; patient activation measure (pam) questionnaire for patient activation; outcomes regarding use of the cdp. analysis: a linear mixed-effects regression to estimate the effect of participating in the cdp will be estimated. additionally, an analysis of how the cdp is functioning through techniques of social network analysis and control charts will be performed.

Eligibility criteria:
inclusion criteria: clusters: * primary care centres (pcc) with electronic record system with more than 1 year of implementation * pcc belongs to the automonous comunities of canary island, catalonia and madrid healthcare professionals: * acceptance to participate * stable contract with the primary care centre * physician or nurses exclusion criteria: clusters: - primary care centres where its directors do not accept to participate in the trial healthcare professionals: * students * medical and nursing residents

Keywords: patient empowerment patient involvement patient participation healthcare professional attitudes chronic diseases
smart and fit for kidney transplantation

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Summary: this study is a randomised controlled intervention trial for patients with chronic kidney disease who are on the waiting list for a kidney transplantation (n=200). the aim of this study is to test the effectiveness of intensive individual nutritional and exercise support combined with comprehensive rehabilitation before transplantation in comparison to a control group.

patients are randomised to either the intervention or control group at the beginning of the study. both groups are evaluated at the beginning after 6 months and after 12 months regarding their body composition, physical performance, blood values, quality of life and nutritional status. the control group only receives support via app during the study period (1 year), through which they receive detailed information about dialysis. in addition to access to the app, the intervention group receives individual recommendations for nutrition and exercise as well as a three-week inpatient rehabilitation.

Eligibility criteria:
inclusion criteria: * patients must be on dialysis * patients ≥ 18 years of age * patients who own a smartphone * patients must be willing to undergo inpatient rehabilitation within the project period * signed informed consent and data protection regulation exclusion criteria: * patients who are not psychologically or physically able to take part in exercise promotion measures and/or nutritional counselling as well as psychological offers * patients who have already participated in a similar project

Keywords: transplantation prehabilitation exercise and nutritional support