Kornimate/medical-research-clean huggingface dataset:
cooperative study of factor viii inhibitors

Conditions: Blood Coagulation Disorders; Hematologic Diseases; Hemophilia A; Hemorrhagic Disorders

Summary: to test the efficacy of prothrombin complex concentrates (factor ix) in the treatment of hemophiliac patients who had inhibitors to factor viii.

background: despite major advances in the treatment of patients with hemophilia, a serious remaining challenge was presented by the occurrence of circulating inhibitors to factor viii. because of lack of information on the natural course of patients with factor viii inhibitors, the relative efficacy of various modes of therapy was not established. the division of blood diseases and resources decided to sponsor a clinical investigation which would evaluate populations of hemophilia patients for factor viii inhibitors, follow up these patients to provide information on the natural history of the inhibitor in the hemophilia patients, and make available a reference center to monitor results and attain uniformity. treatment of a patient with a severe inhibitor and consequent bleeding remained a problem. management included protracted treatment with factor viii, use of immunosuppressive agents and prothrombin complex (or factor ix) concentrates. the rationale for factor ix was that it bypassed the defect in factor viii caused by the inhibitor. this method of therapy attracted wide popularity, but the success was greatly debated. it was intended at the very outset of the factor viii study that therapeutic trials involving patients with inhibitors would not be a prime function, but that such studies would be monitored if necessary. a controlled trial of factor ix concentrates therapy was strongly advised by the dbdr advisory committee. accordingly, during fiscal year 1978, a protocol for a double-blind control study was developed by the factor viii inhibitor group. the trial began in the spring of 1978, and the intervention terminated about one year later. design narrative: double-blind study; patients served as their own controls. a total of 51 patients each received a single large dose of konyne, proplex, or diluted albumin (as a control). joint bleeding of the elbow, knee, and ankle was evaluated six hours after each dose.

Eligibility criteria:
males with hemophilia, not stratified as to ethnic group.
a single-patient study using ags 006

Conditions: Pancreatic Cancer

Summary: argos therapeutics, inc., (argos) proposes to study ags-006 in a subject with newly diagnosed resectable pancreatic cancer. the ags 006 immunotherapeutic may potentially offer a desired additional option to conventional treatments for pancreatic carcinoma.

single-patient, open-label clinical study: * events during pre-treatment period: 1. resection of pancreatic cancer, 2. rna acquisition from tumor specimen, 3. rna amplification, 4. infectious disease testing, 5. autoimmune disease testing, 6. two blood draws for immune response monitoring, 7. production leukapheresis, and 8. dendritic cell electroporation with rna and immunotherapeutic production; * events during induction period: 1. administer investigative treatment every 2 weeks for a total of five doses, followed by dosing every 4 weeks for a total of four doses, 2. two induction period blood draws (week 6 and week 12) for immune response monitoring, and 3. one leukapheresis (week 14) for immune response monitoring; * events during booster period: 1. dose every 3 months until progression or 2 years after first ags treatment, 2. potentially, one leukapheresis for immune response monitoring 12 months from the first dose, and 3. one blood draw 2 weeks following dosing at week 36 (1st booster dose) (approximately week 38); and, * events during study close-out: 1. close-out upon progression or 28 days following immune response monitoring 2 years after first dose

Eligibility criteria:
inclusion criteria: * a male subject 18 years of age or older with newly diagnosed resectable pancreatic cancer who, in the opinion of the investigator, is suitable for participation in the study will be eligible for inclusion if all of the following criteria apply: 1. able to abstain from taking prohibited prescription or prohibited non-prescription drugs. 2. ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the protocol requirements. 3. voluntary informed consent given to participate in the study. exclusion criteria: 1. any serious medical condition such as cardiopulmonary disease, circulatory compromise, hepatic or renal dysfunction, or other illness considered by the investigator to constitute an unwarranted high risk for investigational treatment. 2. active autoimmune disease including, but not limited to: 3. active, acute, or chronic clinically significant infections including human immunodeficiency virus (hiv) and viral hepatitis. 4. known hypersensitivity to dimethyl sulfoxide (dmso). 5. body weight less than 30 kg.
number of participants diagnosed with sarcoidosis by bronchoscopic transbronchial needle aspiration after covid- 2019 .

Conditions: Sarcoidosis; COVID-19

Summary: the goal of this observational study is to learn about sarcoidosis development after covid-19 infection. the main question it aims to answer is: * prevalence of sarcoidosis among patients previously infected with covid-19. participants will: * provide previous positive rt-pcr for covid-19 * have computed tomography of the chest with suggestive findings of sarcoidosis * have bronchoscopic guided biopsies and pathological analysis to detect number of patients with sarcoidosis.

this prospective cross sectional study was performed on a total of 55 patients with mediastinal and /or hilar lymphadenopathy with or without lung infiltrates referred to bronchoscopy unit , chest department, ain-shams university hospital for biopsy taking and diagnosis. all patients were subjected to the following : history taking , clinical examination , radiological assessment by computed tomography (ct )chest , fiberoptic bronchoscopy where biopsies were taken either by conventional-trans-bronchial needle aspiration (c-tbna) , endo-bronchial ultrasound (ebus-tbna) or direct forceps biopsies and sent for histopathological examination and if the patient had past history of covid-19 infection with previous positive reverse transcriptase- polymerase chain reaction assay (rt-pcr).

Eligibility criteria:
inclusion criteria: * all adult patients with previous positive rt-pcr for covid -19 and ct chest findings of mediastinal and or hilar lymphadenopathy with or without lung infiltrate will be included. . exclusion criteria: * patients younger than 18 years old patients * patients refuse to participate in the study * patients previously diagnosed as sarcoidosis

Keywords: sarcoidosis covid-19 sars-cov-2 granulomatous disease
parent artery reconstruction for cerebral aneurysms using a novel flow diverter with surface modification

Conditions: Cerebral Aneurysm; Cerebral Aneurysm Unruptured

Summary: the primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms

the investigation is a prospective, multi-center, single arm clinical study. the trial is anticipated to last from march 2023 to january 2025 with 143 subjects recruited in around 10 china centers. the population for this study is subjects with wide-necked intracranial aneurysms who are suitable candidates for flow diverter implantation. patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after offering informed consent form. the study consists of six visits including preoperative screening, operation date, 7days or at discharge, 30 days, 180 days, and 1 year. the primary endpoint is success aneurysm occlusion at 1 year post procedure.

Eligibility criteria:
inclusion criteria: 1. age 18 years to 75 years, male or non-pregnant female. 2. unruptured wide-necked cerebral aneurysms confirmed by preoperative imaging (wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2). 3. parent vessel with a diameter range of 1.75-6.0 mm. 4. those who voluntarily participate in the study and sign informed consent form. exclusion criteria: 1. subject with target aneurysms are blood blister-like aneurysms, pseudoaneurysms, arteriovenous malformation, moyamoya disease-related aneurysm, or multiple aneurysms that cannot be treated with a single stent. 2. severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel. 3. subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy. 4. known sensitivity to antiplatelet medications, anticoagulant medications, radiographic contrast agents, anesthetic, nickel, platinum-tungsten alloy, platinum-iridium alloy, and poly-n-\[tris(hydroxymethyl)methyl\] acrylamide (poly-ntma). 5. severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dl (except dialysis)) or blood coagulation disorders before operation. 6. platelet count is less than 100×109/l, international normalized ratio (inr) is more than 1.5. 7. hospitalized surgical treatment within the previous 30 days or planned within the next 180 days after operation. 8. severe neurological deficit that renders the patient incapable of living independently (modified rankin score ≥3). 9. the survival expectation is less than 1 year. 10. all subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements 11. inapplicable for this study at the investigators' viewpoints.

Keywords: flow diverter endovascular therapy
assessing the impact of vr-based observational mindfulness meditation on stress reduction in adults

Conditions: Stress; Anxiety; Depression

Summary: this study investigates the impact of a mindfulness-based intervention using virtual reality (vr) and artificial intelligence (ai) coaching on stress reduction. participants will engage in vr-based observation mindfulness activities guided by an ai coach. the study aims to evaluate the effectiveness of this intervention compared to a standard relaxation process by measuring self-reported stress levels, physiological biomarkers (e.g., heart rate), and participant satisfaction. the research could inform the development of future digital mental health interventions.

this study employs a randomized controlled design to assess the effectiveness of a vr-based mindfulness intervention for stress reduction. participants are randomly assigned to either the experimental group, which undergoes vr-based observation mindfulness activities guided by an ai coach, or the control group, which experiences standard relaxation exercises. pre-intervention data, including self-reported stress levels (measured via pss-10, dass-21, and stai) and baseline heart rate, are collected. following the intervention, participants complete post-intervention measurements to evaluate changes in stress levels, physiological responses, and satisfaction with the vr program. the experimental group participates in mindfulness activities designed to enhance attention to detail and present-moment awareness through object observation within the vr environment. the ai coach facilitates the session by prompting reflective and observational questions, fostering deeper engagement. the control group undergoes relaxation exercises with no active mindfulness engagement. all procedures are conducted in a controlled laboratory setting, ensuring consistency and minimizing external variables. the study collects objective (heart rate and heart rate variability) and subjective (self-reported stress and satisfaction) data to evaluate the intervention's efficacy. the findings aim to provide insights into the feasibility and benefits of integrating vr and ai technologies in stress reduction interventions. the results will also contribute to the development of more engaging and accessible digital mindfulness practices for diverse populations.

Eligibility criteria:
inclusion criteria: * adults aged 18 years and older. exclusion criteria: * those with visual or hearing impairments that prevent interaction with vr content.

Keywords: mindfulness virtual reality meditation observe activity
study on the association of gstp1 and other gene polymorphisms with platinum-induced myelosuppression

Conditions: Non-small Cell Lung Cancer

Summary: this study intends to design a retrospective and prospective, cohort study to explore the association between genetic polymorphism of gstp1 a313g rs1695 or others and adverse effects of platinum drugs, aiming to explore the risk factors of myelosuppression caused by platinum drugs, and provide data support for optimizing anti-tumor chemotherapy regimen, improve medication safety and improve the compliance of chemotherapy in patients.

patients with pulmonary malignant tumors receiving platinum-containing chemotherapy regimen were included in the retrospective and prospective bidirectional cohort study to collect the basic information of the subjects, including gender, age, smoking history, primary site, basic liver and kidney function, chemotherapy regimen, etc. the polymorphisms of glutathione s transferase (gstp1 a313g) were detected by sanger dideoxy termination sequencing. to study the risk factors related to myelosuppression during chemotherapy, and to preliminarily explore the characteristics of myelosuppression caused by combination chemotherapy with platinum.

Eligibility criteria:
inclusion criteria: 1. patients with non-small cell lung cancer with clear imaging or pathological evidence 2. using a chemotherapy regimen containing platinum 3. conducted blood routine and biochemical tests 4. signed informed consent exclusion criteria: 1. blood routine and other relevant tests were not performed 2. suffering from primary bone marrow system disease 3. other reasons for not meeting the experimental requirements
comparing salmeterol/fluticasone easyhaler and seretide diskus (saimi)

Conditions: Asthma

Summary: the purpose of this study is to compare absorption of salmeterol and fluticasone from salmeterol/fluticasone easyhaler test products to the commercially available product seretide diskus


Eligibility criteria:
main inclusion criteria: 1. written informed consent (ic) obtained. 2. males and females, 18-60 (inclusive) years of age. 3. normal weight defined as body mass index (bmi) 19-30 kg/m2 (bmi = weight/height2). 4. weight at least 50 kg. main exclusion criteria: 1. evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gi, pulmonary, metabolic, endocrine, neurological or psychiatric disease. 2. any condition requiring regular concomitant treatment. 3. any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study. 4. known hypersensitivity to the active substance(s) or the lactose. 5. pregnant or lactating females and females of childbearing potential not using proper contraception. 6. blood donation or loss of significant amount of blood within 90 days prior to first study treatment administration. 7. administration of another investigational medicinal product within 90 days prior to first study treatment administration.
effect of transversus abdominis plane block with compound lidocaine on pain after gynecological surgery

Conditions: Postoperative Pain

Summary: purpose: to explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine on postoperative pain after gynecological laparotomy.

poor post-surgical pain control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. recently, the multimodal analgesia strategies to minimise opioid-related side effects are highly desirable in open surgical procedures. the transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. compared with ropivacaine, compound lidocaine injection has a better and longer analgesic activity since it contains menthol and ethanol with appropriate concentrations. however, whether compound lidocaine injection is efficiency in the transversus abdominis plane block for abdominal open sugery lacks investigations. herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (usg-tap) block with compound lidocaine injection for postoperative analgesia in patients undergoing gynecological laparotomy.

Eligibility criteria:
inclusion criteria: 1. subject is scheduled to undergo gynecological laparotomy under general anesthesia 2. subject's american society of anesthesiologists physical status is i-ii. 3. the subject's parent/legally authorized guardian has given written informed consent to participate. exclusion criteria: 1. subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure. 2. subject has a diagnosis of insulin dependent diabetes. 3. subject is allergy and contraindication to local anesthetics or any components of local anesthetics. 4. subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery. 5. subject has any contraindication for the use of patient-controlled analgesia (pca). 6. subject is pregnant or breast-feeding. 7. subject is obese (body mass index \>30kg/m\^2). 8. subject is incapacity to comprehend pain assessment and cognitive assessment.

Keywords: compound lidocaine ropivacaine pain intensity transversus abdominis plane block
assessment of different forms of creatine

Conditions: Dietary Modification

Summary: the purpose of this study is to examine the pharmacokinetics of creatine nitrate supplementation.

creatine nitrate contains several nutrients that may increase anaerobic exercise performance. theoretically, dietary supplementation of creatine nitrate during resistance training can improve the quality of training leading to greater changes in strength, power and fat free mass. endothelial function measured by flow-mediated dilation (fmd), a non-invasive vascular health parameter that can be measured via ultrasonography, is a predictor of cardiovascular disease risk which precedes traditional risk markers. diet, physical activity and pharmaceutical interventions can all impact vascular function and health. the purpose of this study is to determine the acute vascular response of creatine nitrate supplementation on fmd by analyzing the pharmacokinetics of creatine nitrate supplementation.

Eligibility criteria:
inclusion criteria: * you are an apparently healthy and recreationally active male between the ages of 18 and 40; exclusion criteria: * you have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmia and/or cardiovascular disease; * you are currently using prescription medications; * you have a history of smoking; * you drink excessively (i.e., 12 drinks per week or more); * you have a recent history of creatine supplementation within six weeks of the start of supplementation;
conservative treatment of early adhesive capsulitis

Conditions: Adhesive Capsulitis

Summary: a prospective, multicentre, randomized controlled study comparing the efficacy of conservative treatment for early adhesive capsulitis

this clinical trial evaluated the most common protocols for the treatment of adhesive capsulitis in secondary hospitals. to compare the efficacy of manipulation under anesthesia and supervised home conservative treatment of early adhesive capsulitis.

Eligibility criteria:
inclusion criteria: * patients in our hospital who need manual release of periarthritis of shoulder or home rehabilitation treatment; * unilateral and primary periarthritis of shoulder * age ≥40 years old and ≤80 years old, regardless of gender. * forward flexion movement is more than 50% limited compared with the contralateral. * duration of disease ≤3 months exclusion criteria: * patients with a previous history of shoulder joint surgery * patients who did not complete the follow-up within the specified time * patients with other shoulder diseases. * patient with systemic immune disease. * patients who have participated in clinical trials or are conducting other clinical trials within 3 months before screening * patients with serious primary cardiovascular diseases, lung diseases, endocrine and metabolic diseases, or serious diseases affecting their survival, such as tumor or aids, are considered not suitable for admission. * patients with serious liver diseases, kidney diseases, hematological diseases, such as kidney function (bun, cr) more than the upper limit of normal, liver function (alt, ast, tbil) more than 2 times the upper limit of normal. * patients with viral hepatitis, infectious diseases, abnormal blood coagulation mechanism and other diseases that researchers consider inappropriate for surgery. * pregnant or lactating women, or those planning to get pregnant during the test, with positive urine hcg test results before the test; menstruating women should wait until their period is over before undergoing surgery. * patients with severe neurological and mental diseases. * suspected or true history of alcohol and drug abuse.

Keywords: manipulation under anesthesia supervised home rehabilitation
ipod games in hepatic encephalopathy

Conditions: Hepatic Encephalopathy; Cirrhosis

Summary: to see if using ipod games can improve mental functioning


Eligibility criteria:
inclusion criteria: * cirrhosis proven by biopsy, radiology or endoscopy * age 18-70 * able to give informed consent * cognitive dysfunction defined by impaired performance on standard cognitive tests exclusion criteria: * illicit drug or alcohol use within 3 months * trans-jugular intra-hepatic porto-systemic shunt (tips) placement * need for psychoactive medications apart from continuous anti-depressants or methadone * any focal neurological deficit or neuro-muscular disease * inability to function with an ipod * inability to understand english for mri: inability to perform brain mri is an exclusion

Keywords: hepatic encephalopathy covert hepatic encephalopathy cirrhosis
endoscopic ultrasound guided radio frequency ablation of pancreatic neuroendocrine neoplasms

Conditions: Pancreatic Neuroendocrine Tumors, WHO Grade I-II

Summary: a national multicenter prospective study to investigate the feasibility and efficacy of endoscopic ultrasound guided radiofrequency ablation of neuroendocrine pancreatic tumors, who grade 1-2 of 3 cm or less in diameter.


Eligibility criteria:
inclusion criteria: * age above 18 * eus fine needle biopsy (fnb) proven pancreatic neuroendocrine tumor (pnet), who 2019 grade 1-2 in patients with functioning or non-functioning tumors. also men1 patients are eligible: * pnet 2-3 cm in largest diameter (based on mri or ct) with a ki-67 \<5%, or: * pnet \< 2cm with ki-67 \<10% that has shown progression during surveillance, or: * pnet 1.5-2 cm with ki-67 \<10% in patients age \< 60 years of age, whether progression is detected or not. * distance from the main pancreatic duct ≥2 mm, or \<2mm with a prophylactic stent in the main pancreatic duct. * patient in good general condition, ecog performance status 0-2 (see appendix) * signed written informed consent exclusion criteria: * pregnancy. * life expectancy \< 1 year * severe hemostasis disorders * pancreatic and/or biliary ductal dilation * evidence of active pancreatitis * metastatic disease, including local lymph node metastases * use of anticoagulants that cannot be discontinued * inr \>1.5 or platelet count \<50.00 * distance from the main pancreatic duct \<1 mm, and placement of a pancreatic stent is not possible * patient being managed for another malignant lesion which is progressive or under treatment