Kornimate/medical-research-clean huggingface dataset:
trial of efficacy and safety of ns-229 versus placebo in patients with eosinophilic granulomatosis with polyangiitis

Conditions: Eosinophilic Granulomatosis With Polyangiitis; Churg-Strauss Syndrome

Summary: this study will enroll male and female subjects who are 18 years of age or older with eosinophilic granulomatosis with polyangiitis.

the purpose of this randomized, double-blind study is to investigate the efficacy and safety of ns229 compared with placebo over a 28-week study treatment period in subjects with eosinophilic granulomatosis with polyangiitis (egpa) receiving background corticosteroid therapy with or without mepolizumab/benralizumab therapy. during the treatment period corticosteroid dose will be tapered. the key outcomes in the study focus on evaluation of clinical remission, defined as birmingham vasculitis activity score (bvas)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent prior to participation in the study. * male or female subjects aged ≥18 years at the time the informed consent form is signed. * diagnosis of egpa: subjects who have been diagnosed with egpa based on the history or presence of eosinophilia plus at least a history or presence of 2 of additional features of egpa. * subjects receive background ogc dose of ≥7.5 mg/day with or without stable treatment with mepolizumab/benralizumab. * use of adequate contraception. * other inclusion criteria may apply. exclusion criteria: * current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis * imminently life-threatening egpa at the time of screening. * history or presence of any form of cancer within 5 years prior to screening. * serious liver, renal, blood, or psychiatric disease * severe or clinically significant cardiovascular disease uncontrolled with standard treatment * active systemic infections (including tb, pneumonia, pneumocystis pneumonia, sepsis, and opportunistic infections) * parasitic infection: subjects with a known parasitic infestation within 6 months prior to screening. * hiv positive status * active hepatitis due to hepatitis b virus or hepatitis c virus * known history or presence of venous thromboembolism/venous thrombotic events (deep vein thrombosis and/or pulmonary embolus) * laboratory parameter exclusions: 1. estimated glomerular filtration rate of \<30 ml/min/1.73 m2 by chronic kidney disease epidemiology collaboration equations 2. wbc count \<4 × 109/l 3. absolute lymphocyte count \<500 cells/mm3 4. absolute neutrophil count \<1000 cells/mm3 5. platelet count \<120,000/mm3 6. hemoglobin \<8 g/dl (\<80 g/l) * subjects who are pregnant, breastfeeding, or planning to become pregnant during the time of study participation * history of clinically significant drug or alcohol abuse within the last 6 months * other exclusion criteria may apply.
evaluation of video-assisted instructions of nasal self-packing in patients with hht

Conditions: Hereditary Haemorrhagic Telangiectasia

Summary: inserting nasal self-packings is a secure method leaving patients more self-confident. we provide a video on https://www.youtube.com/watch?v=laiolyfsj-e demonstrating how to use nasal self-packings.

inserting nasal self-packings is a secure method leaving patients more self-confident. in hht centers, patients often learn how to use them, but these centers are rare. providing a video on https://www.youtube.com/watch?v=laiolyfsj-e demonstrating how to use nasal self-packings may also help patients without access to hht centers.

Eligibility criteria:
inclusion criteria: * age above 17 years old exclusion criteria: * patients younger than 18 years old * unable to provide informed consent

Keywords: hereditary hemorrhagic telangiectasia video-assisted teaching nasal self-packing
phase i study of oral darinaparsin (zio-101-c)in advanced solid tumors and non-hodgkin's lymphomas

Conditions: Advanced Cancer

Summary: the study of dariniparsin (zio-101-c) in advanced solid tumors and non-hodgkin's lymphomas


Eligibility criteria:
inclusion criteria 1. patients with non-hodgkin's lymphomas that are refractory to standard therapies for their condition.(as of protocol amendment 6.0 dated 8/26/2009) 2. men and women of ≥ 18 years of age. 3. ecog performance score ≤ 2 (see appendix 4). 4. eligible subjects with lymphomas must have measurable disease as defined by the revised international working group response criteria (appendix 7) 5. life expectancy ≥ 12 weeks. 6. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements, to be conducted \<2 weeks prior to baseline: * creatinine ≤ 2x upper limit of normal (uln) or a calculated creatinine clearance ≥ 50 cc/min * total bilirubin ≤ 2x uln * alanine transaminase (alt) and aspartate transaminase (ast) ≤ 3x uln * granulocytes in peripheral blood ≥1 x 109/l, hemoglobin ≥8.5 g/dl, and platelets ≥50,000 /µl 7. written informed consent in compliance with ziopharm policies and the human investigation review committee (iec/irb) having jurisdiction over the site. exclusion criteria 1. new york heart association (nyha) functional class ≥3 myocardial infarction (see appendix 5) within 6 months. 2. uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; a qtc ≥450 msec; or a ≥grade 2 atrioventricular (av) block or left bundle branch block (lbbb); or documented history of prolonged qtc. 3. pregnant and/or lactating female. (women of childbearing age must use effective contraception from screening through the duration of study participation.) 4. uncontrolled systemic infection (documented with microbiological studies). 5. metastatic brain or meningeal tumors. 6. patients with seizure disorder requiring medication (such as anti-epileptics). 7. history of confusion or dementia or neurological condition that could mask a potential adverse response to study drug which may include transient ischemic attack, parkinson's disease, thrombotic or hemorrhagic stroke, alzheimers, and other neurological disorders. 8. anticancer chemotherapy or immunotherapy during the study or within 4 weeks of study entry (mitomycin c or nitrosureas should not be given within 6 weeks of study entry). 9. radiotherapy during study or within 3 weeks of study entry. 10. surgery within 4 weeks of start of study drug. 11. investigational drug therapy outside of this trial during or within 4 weeks of study entry. 12. history of invasive second primary malignancy diagnosed within the previous 3 years except for stage i endometrial/cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer. 13. substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results. 14. any condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the study. 15. arsenic allergy.

Keywords: arsenic cancer
risk factors for postoperative nausea and vomiting in surgical patients undergoing patient-controlled intravenous analgesia.

Conditions: Nausea and Vomiting, Postoperative

Summary: the purpose of this study is to identify the risk factors for postoperative nausea and vomiting (ponv) in surgical patients undergoing patient-controlled intravenous analgesia (pcia).

our study was a retrospective study, including patients who underwent surgery at peking union medical college hospital from july 1, 2023 to october 31, 2023 and underwent pcia. patient characteristics, past medical history, surgical information, intraoperative medication information, postoperative analgesia follow-up information were obtained through the electronic medical record system. the patients were divided into pcia-ponv group and non-pcia-ponv group depending on the occurrence of nausea and vomiting during pcia, and all patients was also divided into pcia-pov group and non-pcia-pov according to whether vomiting occurred. multivariate logistic regression analysis was used to identify the risk factors for pcia-ponv and pcia-pov.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hospitalized patients * undergoing general anesthesia during surgery exclusion criteria: * day surgery patients * accepting pcia for less than 24 hours * medical record information is missing or unavailable.
cognitive behavioral therapy, guided self help versus individual therapy

Conditions: Anxiety Disorders; Major Depression; Stress Disorders; Primary Insomnia

Summary: background: studies show that about 1 out of 3 patients in primary care suffer primarily from mental health disorders, such as anxiety disorders and depression. cognitive behavior therapy (cbt) has been shown to be an effective treatment of these disorders. despite the strong evidence for cbt there is a lack of evidence-based psychological treatment in primary care. for various reasons, the progress of research has not affected clinical practice. for successful implementation of cbt in primary care cost-effective therapies, access to therapists with proper training and supervision, evidence-based manuals and management that support the implementation is needed. aim: the aim of this trial is to evaluate a stepped care model with cbt in primary care. all patients are first treated with self-help cbt (n = 400). patients that do not improve after treatment (9 weeks) are randomized to individual cbt or continued self-help treatment. based on published studies 2/3 is expected to be improved after self-help and therefore do not undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to individual cbt (n = 67) or continued self-help treatment (n = 67).


Eligibility criteria:
inclusion criteria: * have an anxiety disorder diagnosis (obsessive compulsive disorder, social phobia, panic disorder, generalized anxiety disorder), or/and major depression, or/and maladaptive stress reaction, or/and primary insomnia clinician severity rating scale 2-6 exclusion criteria: * a higher score than 6 on the clinician severity rating scale
mri in evaluation of cesarean section scar niche

Conditions: Cesarean Section; Dehiscence

Summary: to evaluate cesarean section scar and the lower uterine segment in non pregnant woman by mri to : 1. assess the clinical symptoms like postmenstrual spotting or prolonged menstrual bleeding, dysmenorrhea, chronic pelvic pain and dyspareunia and its relation to the presence of cesarean scar defects and its characteristics . 2. development of scoring system and correlating it with the symptoms .

with increasing cesarean section rate nowadays, the risks of cesarean scar defect (csd) should increase. csd is defined by ultrasound imaging as a triangular hypoechoic defect in the myometrium at the site of the previous cesarean section scar. however, patients with csd are sometimes asymptomatic. yet, some patients with csd can have symptoms of abnormal uterine bleeding, pelvic pain, infertility, uterine rupture, and potential risks of adverse pregnancy outcome .there is an association between the size of a niche and postmenstrual spotting. women with a history of cs, the depth and shape of the niche were not significant factors, while a larger niche volume was described in women with postmenstrual spotting. in women with gynecological symptoms, the niches were significantly wider in women with postmenstrual spotting, dysmenorrhea or chronic pelvic pain, and the prevalence of postmenstrual spotting or prolonged menstrual bleeding was higher with a larger diameter of the niche .magnetic resonance imaging (mri) has recently shown a promise tool for evaluation of uterine scar thickness. as opposed to ultrasonography (usg), which is the current gold standard for this purpose, mri reduces observer dependence and has a superior multiplanar capability. mri can be used for assessment of lower uterine segment. it provides accurate tissue characterization, independent of patient body mass index .

Eligibility criteria:
inclusion criteria: 1. previous lower uterine segment cesarean section before . 2. at least 6 months after the last cesarean section . 3. still regularly menstruating . 4. absence of other gynecological disease or intrauterine lesions like endometriosis , uterine fibroid . exclusion criteria: 1. post menopausal women . 2. hysterectomy . 3. presence of other gynecological disease like endometriosis , uterine fibroids . 4. any general contraindication to mri as presence of any paramagnetic substance as pacemakers or in severely ill patients or those with claustrophobia, arrhythmic patients . 5. intrauterine devices . 6. bleeding tendency.
cytokine changes after colorectal cancer resection

Conditions: Colorectal Cancer

Summary: based on our previous research, this study aims to determine reliable surgical stress response markers in patients undergoing radical resection of colorectal cancer.

every surgical intervention represents a stress for patient's organism. during the operation, numerous changes in the patient's metabolism take place, that are termed surgical stress response. leading cause of surgical stress response is tissue destruction that always accompanies operations. surgical stress response is effected through activation of hypothalamus-pituitary-adrenal axis and through sympathetic activation. the consequences of surgical stress response are numerous. surgical stress response is essential to uneventful postoperative recovery. on the other hand, excessive surgical stress response may lead to serious postoperative complications, such as heart and kidney failure, venous thrombosis, disruption of operative wound and wound infection. in prior studies the investigators have shown the kinetics of postoperative serum interleukin changes after radical resection of gastric cancer. this study aims at determining reliable markers of surgical stress response severity in patients undergoing radical resection of colorectal cancer.

Eligibility criteria:
inclusion criteria: * pathohistologically verified colorectal cancer exclusion criteria: * distant metastases noticed before or during surgery * history of autoimmune diseases or immunodeficiencies * use of immunomodulatory drugs within 1 year prior to surgery

Keywords: colorectal cancer surgical stress response interleukins
detection of right ventricular dysfunction by 2d strain during acute respiratory distress syndrom (ards)

Conditions: Acute Respiratory Distress Syndrome; Right Ventricular Dysfunction; Right Heart Failure; Acute Cor Pulmonale

Summary: acute respiratory distress syndrome (ards) and mechanical ventilation can lead to right ventricular dysfunction and ultimately right ventricular failure by increasing pulmonary vascular resistances and pressure load. this can be prevented by modifying ventilator settings, using vasopressors or inotropes or even by prone positionning.but to do so, right ventricular dysfonction has to be detected. echocardiography has emerged as a first line tool to diagnose right heart failure. recently, strain analysis showed promising results to detect early right ventricle abnormalities in other settings such as pulmonary hypertension or scleroderma. we therefore decided to determine whether 2d strain could help detect early right ventricular dysfunction in ards.


Eligibility criteria:
ards group inclusion criteria: * need for mechanical ventilation * ards criteria met: respiratory failure not fully explained by cardiac failure, pao2/fio2\<200, bilateral opacities on chest imaging, all symptoms appeared within 1 week exclusion criteria: * predictable duration of mechanical ventilation shorter than 48 hours * contraindication to transesophageal echocardiography ali group: inclusion criteria: * need for mechanical ventilation * ali criteria met: respiratory failure not fully explained by cardiac failure, pao2/fio2\<300, bilateral opacities on chest imaging, all symptoms appeared within 1 week exclusion criteria: * predictable duration of mechanical ventilation shorter than 48 hours control group: inclusion criteria: * need for mechanical ventilation for a non-respiratory cause exclusion criteria: * need for fio2\>30% * known cardiac abnormalities * cardiac drugs intake during last 24 hours
assessment of empathetic process by scanpath study of an artwork

Conditions: Alzheimer Dementia; Parkinson Disease; Fronto-Temporal Dementia

Summary: analysis of gaze patterns during social cognition tasks and standardised exploration of a specific artwork, between elderly subjects without cognitive disorders and subjects with neurodegenerative diseases such as fronto-temporal dementia, alzheimer's dementia or parkinson's disease


Eligibility criteria:
inclusion criteria: * male or female. * 60 years old and above. * sufficient written and oral expression in french. * benefit from french or monaco social security. * written informed consent signed by the patient. * for the control group: voluntary subjects, without cognitive impairment. * for the ftd / ad / pd groups: patients diagnosed with one of these diseases, and volunteers to participate in the study. exclusion criteria: * general anaesthesia within 3 months. * ophthalmological problems preventing a video-oculography examination. * oculomotor disorders such as "fixation disorders" or "ocular tracking disorders". * history of stroke. * cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.

Keywords: eye-tracking empathy social cognition theory of mind scanpath gaze
programming implantable cardioverter defibrillators in patients with primary prevention indication

Conditions: Shock

Summary: although shock therapy is effective in terminating ventricular tachycardia (vt), it can be painful to the patient and repetitive shocks can decrease a patient's quality of life. previous studies have suggested that one or more sets of aggressive device parameter settings may reduce the total number of shocks in primary prevention patients. in addition to shock therapies, antitachycardia pacing (atp) is also available in icds to treat vt. the provide trial aims to prospectively study the effect of high detection rates, prolonged detection intervals, aggressive svt discriminators, and extensive atp therapy in prolonging the time to first shock in primary prevention patients.


Eligibility criteria:
inclusion criteria: * primary prevention indication for icd/ crt-d exclusion criteria: * no prior documented history of spontaneous vt/vf

Keywords: reducing shocks
poem trial: multi-center study comparing endoscopic pneumodilation and per oral endoscopic myotomy (poem)

Conditions: Achalasia

Summary: the aim of the study is to compare the efficacy of per-oral endoscopic myotomy (poem) to the efficacy of pneumodilation as the initial treatment of symptomatic idiopathic achalasia. it is hypothesized that poem has a higher long-term efficacy than pneumodilation in treatment of therapy-naive patients with idiopathic achalasia.


Eligibility criteria:
inclusion criteria: * between 18 and 75 yr of age * manometric diagnosis of achalasia * eckardt score \> 3 * informed consent exclusion criteria: * severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk previous treatment, except treatment with nitroderivatives, ca++ channel blockers or sildenafil, or dilation with savary bougies or balloons of 2 cm diameter or smaller. pseudo-achalasia mega-esophagus (\> 7 cm) and/or sigmoid-like esophagus previous esophageal or gastric surgery (except for gastric perforation) not capable to fill out questionnaires (f.e. due to language barrier) not available for follow-up esophageal diverticula in the distal esophagus malignant or premalignant esophageal lesions patients with liver cirrhosis and/or esophageal varices pregnancy
impact of beta-3 agonist on psychological distress and blood flow of the bladder in women with overactive bladder syndrome

Conditions: Overactive Bladder Syndrome

Summary: we will get the impact of mirabegron on psychological distress, urethra and bladder blood flow and c reactive protein.

background/purpose: pharmacologic treatments for female overactive bladder syndrome (oab) include antimuscarinics and beta-agonist. similar efficacy has been reported between antimuscarinics and beta-agonist. antimuscarinics has been found to be beneficial for patients with psychological distress. however, the impact of mirabegron on psychological distress in female oab remains unknown. in addition, some animal studies found that beta-3 agonist can improve arterial blood flow, bladder ischemia and might improve bladder function; however, there is still lack of human study. besides, c reactive protein was found to be elevated in female oab. nonetheless there is no study mentioning about the impact of mirabegron on c reactive protein. thus, the aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein.

Eligibility criteria:
inclusion criteria: * all oab female patients * \>20 years exclusion criteria: * allergy to mirabegron, urinary tract infections
safety & pharmacokinetics study of azacitidine (sc and oral) in subjects with mds, cmml, aml, lymphoma and multiple myeloma

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes; Lymphoma; Multiple Myeloma; Leukemia, Myelomonocytic, Chronic

Summary: the purpose of this study is to compare the amount of drug that gets into the bloodstream between different tablets taken by mouth and an injection under the skin.


Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosis of mds or cmml * diagnosis of aml, multiple myeloma, hodgkin's or non-hodgkin's lymphoma for whom standard curative or palliative measures do not exist or are no longer effective * ecog performance status 0-2 * use of acceptable birth control * standard safety inclusion for serum creatinine, ast, alt, bilirubin * serum bicarbonate greater than or equal to 20 meq/l * platelet count greater than or equal to 25,000/ul * hemoglobin greater than or equal to 500/ul * signed informed consent exclusion criteria: * diagnosis of acute promyelocytic leukemia * treatment with demethylating agents within 21 days prior to cycle 1, day 1 * treatment with any anticancer therapy (standard or investigational) within 21 days prior to cycle 1, day 1 or ongoing adverse events from previous treatment * hypersensitivity to azacitidine or mannitol * active, uncontrolled infection * presence of gi disease, malignant tumors or other conditions known to interfere with adme * known or active hiv, viral hepatitis b or c * breastfeeding or pregnant females * current or uncontrolled cardiac disease

Keywords: acute myeloid leukemia myelodysplastic syndromes lymphoma multiple myeloma chronic myelomonocytic leukemia (cmml)