Kornimate/medical-research-clean huggingface dataset:
a randomised trial investigating the pharmacokinetic and pharmacodynamic properties of faster-acting insulin aspart in subjects with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe. the aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of faster-acting insulin aspart in subjects with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * male or female 18-64 years (both inclusive) at the time of signing informed consent * type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * body mass index 18.5-28.0 kg/m\^2 (both inclusive) exclusion criteria: * subject who has donated any blood or plasma in the past month or more than 500 ml within 3 months prior to screening * smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
clinical utility assay as a biomarker for gastroenteropancreatic and lung neuroendocrine tumors

Conditions: Gastroenteropancreatic Neuroendocrine Tumor; Lung Neuroendocrine Neoplasm

Summary: the purpose of this study is to evaluate how well an investigational blood test performs. the study will look at the sensitivity and specificity of a blood-based multitranscriptome assay (netest).


Eligibility criteria:
inclusion criteria: net cohort- * patients with histologically or cytologically proven diagnosis of any grade, any stage net of gep or lung origin; in the first stage of the study (initial 50 patients) only patients with stage iv, well-differentiated tumors (g1/g2) will be enrolled. * patients with stable or progressive disease, as documented on a scan (ct, mri); progression status will be documented on case report form (crf). * allowed prior therapies include: a.) surgery (tumor surgery at least four weeks prior to study entry); b.) locoregional therapy such as: chemoembolization, radio-embolization, radiofrequency ablation, radiotherapy at least six weeks prior to study entry; c.) any number of previous lines of systemic therapy, providing that cytotoxic therapies (chemotherapy, prrt) have been discontinued at least 4 weeks prior to study entry. non-net cohort - * healthy participants * patients with histologically or cytologically proven diagnosis of any grade, any stage gi malignancies. exclusion criteria: net cohort - * patients on treatment with cytotoxic agents (chemotherapy, prrt). * patients with renal insufficiency or congestive heart failure. * no other active malignancy within 3 years of enrolment except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission. non-net cohort * patients with gi malignancies with neuroendocrine differentiation.

Keywords: lung cancer pancreatic cancer
reoperation rate versus clinical recurrence after ventral hernia repair

Conditions: Ventral Hernia

Summary: the risk for recurrence after ventral hernia repair is often based on reoperation rates with short follow-up rather than recurrences identified by clinical examinations. the purpose of current study is find the real incidence of recurrences 3 years after ventral hernia repair and to compare with the reoperation rate.

all patients in a restricted area (all patients in the part of denmark called zealand) who had a ventral hernia repair in 2007 (appr. 1200 patients). the patients will be sorted by a questionnaire and if the patients are suspicious for recurrence they will be offered a clinical examination.

Eligibility criteria:
inclusion criteria: * primary ventral hernia repair performed in the region of zealand in denmark exclusion criteria: * patients who died and patients not resident in region zealand

Keywords: ventral hernia repair clinical reoperation
comparison of stop-bang and des-osa as predictive score for difficult intubation.

Conditions: Bariatric Surgery Candidate

Summary: the des-osa score and the stop-bang score were predictive scores for obstructive sleep apnea. this study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult intubation.

the des-osa score and the stop-bang score were predictive scores for obstructive sleep apnea. this study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult mask ventilation of tracheal intubation.

Eligibility criteria:
inclusion criteria: * bmi \> 30 kg m-2 * preoperative polysomnography exclusion criteria: * pregnant women * ent cancer

Keywords: sleep apnea syndromes perioperative period mass screening
early mobilisation of post cardiac surgery in geriatrics.

Conditions: Cardiac Disease

Summary: heart and blood vessel problems together referred to as cardiovascular diseases (cvd) include congenital heart disease, cerebrovascular illness, and coronary heart disease. following heart surgery, patients who are active in the postoperative phase stay in the hospital for shorter periods of time and experience fewer complications. after cardiac surgery, older adults who exercise during the recovery period experience fewer difficulties and hospitalizations. a total of 100 elderly patients-69 men and 31 women-who had undergone cardiac surgery and were up to 65 years old-voluntarily took part in the study. there were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (group a) and the control group (group b). older patients undergoing cardiac surgery also experienced improved balance as a result of early mobilization and functional exercises.

a total of 100 geriatric patients-69 men and 31 women-who had undergone heart surgery and were up to 65 years old-voluntarily took part in the study. there were fifty patients in each of the two groups that the participants were divided into: the early mobilization group (group a) and the control group (group b). the patients in early mobilization group underwent early mobilization and functional exercises program, while the patients served as the control group did not receive the therapy protocol applied in the early mobilization group

Eligibility criteria:
inclusion criteria: individuals who had previously had valve replacement procedures or coronary artery bypass grafting (cabg) and if all of these procedures were done by sternotomy were included in the study. the study's patients were all classified as geriatric, with ages ranging from 65 to 75. there were people of both genders in the sample. throughout their recovery, patients who were awake, conscious, and able to communicate vocally as well as those who were able to understand and complete scales and questionnaires. patients who signed consent forms voluntarily agreed to participate, as well as those who successfully passed the two-minute walk test (2mwt), which assesses how long it takes to walk for two minutes. exclusion criteria: * patients unable to complete the two-minute walk test (2mwt), scales, or questionnaires. individuals who suffered from stroke, extensive bleeding, renal failure or insufficiency, atrial fibrillation, the necessity for a second operation, or a serious infection of the sternal wound following surgery. those who struggle with vocal and auditory communication. individuals who underwent surgery and had a pacemaker inserted. those who have experienced a prior cerebrovascular accident. those who have suffered from neurological disorders like hemiplegia after heart surgery and mental health problems like intellectual incapacity.

Keywords: early rehabilitation geriatrics cardiac surgery
perioperative study of iparomlimab and tuvonralimab in resectable nsclc

Conditions: Non-small Cell Lung Cancer (NSCLC); II-IIIB

Summary: this project intends to study the efficacy and safety of iparomlimab and tuvonralimab with or without chemotherapyin the perioperative treatment of nsclc


Eligibility criteria:
inclusion criteria: * 1. voluntary participation，willing to participate in this study and has signed the informed consent form (icf). 2. age, ≥18 years old, both male and female. 3. eastern cooperative oncology group (ecog) performance status score of 0 or 1. 4. histologically or cytologically confirmed, treatment-naïve stage ii-iiib (n2 only) non-small cell lung cancer (nsclc) according to the 8th edition of the american joint committee on cancer (ajcc). only patients judged as t4 based on tumor size are allowed to be enrolled; other t4 conditions (e.g., invasion of the diaphragm, mediastinal involvement) are not permitted. 5. the primary nsclc is deemed resectable by multidisciplinary team (mdt) assessment, which must include a thoracic surgeon specializing in oncologic surgery. 6. ability to provide surgical or biopsy tumor tissue for biomarker analysis (e.g., genetic sequencing, pd-l1 testing). the following must be provided before enrollment: formalin-fixed paraffin-embedded (ffpe) tissue block from within the past 3 months, or 5-10 unstained tissue slides, or 2 core biopsy specimens, along with the relevant pathology report. fine-needle aspiration specimens are not acceptable. 7. at least one measurable lesion according to recist v1.1 criteria, as determined by the investigator. exclusion criteria: * 1. presence of confirmed egfr or alk positive mutations. 2. history of other malignancies within the past 5 years or concurrent malignancies, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery. 3. previous treatment with immune checkpoint inhibitors (e.g., pd-1/pd-l1 agents), other drugs targeting t-cell receptors (e.g., ctla-4), immune checkpoint agonist antibodies (e.g., anti-icos, cd40, cd137, gitr, ox40 antibodies), or anti-tumor immune cell therapy. 4. history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation: (except for corneal transplantation). 5. presence of congenital or acquired immunodeficiency (e.g., hiv infection). 6. history of severe allergic reactions to other monoclonal antibodies. 7. as determined by the investigator, any other factors that may affect study outcomes or lead to premature termination of the study, such as alcohol or drug abuse, other serious diseases (including psychiatric conditions) requiring concomitant treatment, significant laboratory abnormalities, or social or family factors that may impact patient safety.
the role of deep cerebral vein variation in patients with angiographic negative subarachnoid hemorrhage

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: the incidence of rosenthal basilar vein (bvr) variants (deep venous drainage variants) was relatively increased in patients with an-sah compared with patients with aneurysms. however, the inclusion criteria for an-sah patients in these studies were different. some studies have investigated both pan-sah and npan-sah, while some studies have only investigated pan-sah patients. however, we believe that npan-sah may be the bleeding caused by non-bvr variation. although previous studies did not find any association between npan-sah and bvr variants, the results in their study were different, which may be due to the limited number of cases.


Eligibility criteria:
inclusion criteria: patients with negative subarachnoid hemorrhage diagnosed by dsa exclusion criteria: 1. in patients with aneurysms, external ventricular drainage (evd) alone or decompression craniotomy alone or conservative treatment was performed 2. have a history of trauma or prior brain injury (stroke, cerebral hemorrhage, etc., with associated chronic changes on ct) 3. patients with loss of imaging data and severe comorditions prior to onset of sah
treatment convenience in patients treated with dabigatran for stroke prophylaxis in atrial fibrillation (spaf)

Conditions: Atrial Fibrillation

Summary: describe patient and physician assessed factors for patient well-being when treated with pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous antithrombotic treatment (switcher)


Eligibility criteria:
inclusion criteria: * written informed consent prior to participation * female and male patients 18 years of age or older with a diagnosis of non-valvular atrial fibrillation. * at least 6 months of continuous vitamin k antagonist (vka) treatment for stroke prevention prior to baseline assessment. * patients switched to pradaxa® according to summary of product characteristics, therapeutic positioning report from spanish competent authorities and visa from each autonomous community. exclusion criteria: * contraindication to the use of pradaxa® or vka as described in the summary of product characteristics (smpc) * patients receiving pradaxa® or vka for any other condition than stroke prevention in non-valvular atrial fibrillation. * current participation in any clinical trial of a drug or device
acute and persistent pain in icu patients

Conditions: Critical Care; Acute Pain; Chronic Pain

Summary: approximately 20,000 patients are treated in intensive care units (icu) in finland annually. during icu stay many diagnostic and other procedures as well as immobilization and underlying diseases may cause pain. therefore the incidence of pain in icu patients can be high. acute pain may cause several detrimental effects including respiratory distress, tissue hypoxia, immunosuppression and anxiety. after discharge many survivors of critical care have lower health-related quality of life, symptoms of post-traumatic stress disorder or persistent pain. only few studies with a focus on acute or persistent pain in icu patients have been made, hence the incidence and risk factors for icu-related pain is not very well known. some of the identified risk factors for persisting pain may be increased age, sepsis or inadequate pain management during icu stay. opioids are most often used for analgesics in intensive care. because they may have several adverse effects the use must be based on validated pain scales. many factors such as sedation, relaxation or delirium of the patient complicates the management of the pain. this prospective observational study aims to determine the incidence and risk factors for acute and persistent pain in icu patients as well as and the use of analgesics during intensive care.

this prospective observational study aims to determine the incidence and risk factors for acute and persistent pain in icu patients as well as and the use of analgesics during intensive care. the recruitement process is finished, but the follow-up is on-going. patients are followed-up by subsequent questionnaires until 5 years after admission to the icu.

Eligibility criteria:
inclusion criteria: * not meeting the exclusion criteria exclusion criteria: * pregnant patients * age under 18 years * suffering from significant brain injury * elective neurosurgical patients * probable organ donors * suffering from significant cognitive impairment * presumed death under 48h
long term follow-up observational study after clinical trials of amg531 (romiplostim) in patients with untreated aplastic anemia

Conditions: Aplastic Anemia

Summary: to evaluate the long-term efficacy and safety after the end of romiplostim treatment by observation \[up to 5 years\] of patients who were registered for study 531-003/531-004 in immunosuppressive therapy-naïve patients with aplastic anemia.


Eligibility criteria:
inclusion criteria: * patients whose written consent to participate in this research was obtained among patients registered for study 531-003/531-004 * of the patients who died before their consent to participate in this research was obtained among those registered for study 531-003/531-004, patients whose legally authorized representatives such as their family had given the consent or patients whose legally authorized representatives had not refused in the disclosure of information by opt-out * of the patients who died before their consent to participate in this research was obtained among those registered for study 531-003/531-004, patients, patients for whom the consent process exemption was approved by the ethics review committee, etc. of the participating medical institutions at the participating medical institutions in the countries without the opt-out system exclusion criteria: * patients who are judged by the investigator or sub-investigator to be unfavorable for participation in this research

Keywords: aplastic anemia
oral enteral nutrition tube feeding on stroke survivors

Conditions: Cerebrovascular Accident

Summary: the goal of this clinical trial is to explore clinical effect of intermittent oro-esophageal tube feeding in dysphagic stroke survivors. the main questions it aims to answer are: can intermittent oro-esophageal tube feeding improve psychological status in dysphagic stroke survivors? can intermittent oro-esophageal tube feeding improve social interaction in dysphagic stroke survivors? patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given intermittent oro-esophageal tube feeding as nutrition support and the control group will be given nasogastric tube. the study lasts 15 days for each patient. researchers will compare the social functioning scale, social support questionnaire, patients health questionnaire-9, general anxiety disorder-7 to see if the intermittent oro-esophageal tube feeding can help improve the symptom.

stroke is happening increasingly more. the goal of this clinical trial is to explore clinical effect of intermittent oro-esophageal tube feeding in dysphagic stroke survivors. the main questions it aims to answer are: can intermittent oro-esophageal tube feeding improve psychological status in dysphagic stroke survivors? can intermittent oro-esophageal tube feeding improve social interaction in dysphagic stroke survivors? patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given intermittent oro-esophageal tube feeding as nutrition support and the control group will be given nasogastric tube. the study lasts 15 days for each patient. researchers will compare the social functioning scale, social support questionnaire, patients health questionnaire-9, general anxiety disorder-7 to see if the intermittent oro-esophageal tube feeding can help improve the symptom.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * meeting the diagnostic criteria of stroke; * any degree of dysphagia at admission; * steady vital signs, without severe cognitive impairment or sensory aphasia. * transferred out within three weeks of hospitalization in the neurology department. exclusion criteria: * complicated with other neurological diseases; * damaged mucosa or incomplete structure in nasopharynx; * tracheostomy tube plugged; * unfeasible to the support of parenteral nutrition; * simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
population pharmacokinetics of imatinib in cml patients in iran

Conditions: Chronic Myelogenous Leukemia

Summary: the purpose of this study is to determine population pharmacokinetics and differences and variation of pharmacokinetics parameters of imatinib as a tyrosine kinase inhibitor in treatment of chronic myeloid leukemia patients in iranian population.

patients with chronic myeloid leukemia who receive imatinib as treatment in iran entered in this study then population pharmacokinetics parameters is determined.

Eligibility criteria:
inclusion criteria: * patient in chronic phase of myeloid leukemia * no liver and renal failure exclusion criteria: * multiple dug treatment * previous treatment of interferon * patients in blast or accelerated phase

Keywords: cml
treatment of lambert-eaton myasthenic syndrome (lems) with 3, 4 dap

Conditions: Lambert Eaton Myasthenic Syndrome (LEMS)

Summary: lambert eaton myasthenic syndrome (lems) is rare neurological disorder that results in muscle weakness and limited reflex activity. more than half of lems cases are associated with a malignancy, usually small cell lung cancer, and tend to progress more quickly than cases not coupled with malignant cells. 3,4diaminopyridine (3,4dap)is a drug that has been demonstrated to be effective in treating the weakness associated with lems as it increases strength and improves autonomic symptoms in lems patients. it is not currently approved by the fda for use in the united states. the investigators plan to use 3,4dap to treat patients with lems here at the columbia university mda/als research center.


Eligibility criteria:
inclusion criteria: * be diagnosed with lems or a type of cms likely to respond to 3, 4-dap. * if female of childbearing age, have negative pregnancy test, and be willing to practice and effective form of birth control during the study. * tested and found by ecg not to have a prolonged qtc syndrome. * agrees to have a second ecg at the time of peak drug effect. has understood and signed the informed consent. exclusion criteria: * is known to have a sensitivity to 3, 4-dap. * has a history of past or current seizures or of severe asthma, or has an epileptiform eeg. * is believed by the investigator to be unable to comply with the protocol. * is unable to give informed consent. * no patient will be excluded based on race, ethnicity, gender, or hiv status
awareness program on knowledge regarding prevention of hypertensive crisis

Conditions: Hypertension

Summary: to determine the effect of planned awareness program on knowledge regarding prevention of hypertensive crisis in hypertensive patients. current literature is mainly on hypertension (htn) control limited accessible studies on hypertension crises but these studies lack the detailed awareness program regarding prevention of hypertension crisis in diagnosed hypertension patients.

hypertension crisis(elevation of bp to 180/110mmhg or greater) is the very extreme form of poorly controlled hypertension that can develop in individuals with known pre-existing htn and in patients who are not aware that they have hypertension.

Eligibility criteria:
inclusion criteria: - diagnosed hypertensive patients exclusion criteria: * language barrier * not willing to participate * unable to understand teaching program

Keywords: knowledge hypertension crisis planned awareness program