Kornimate/medical-research-clean huggingface dataset:
a trial of hrs8179 on brain swelling after large hemispheric infarction

Conditions: Brain Swelling, Large Hemispheric Infarction

Summary: the primary objective is to explore if hrs8179 could improve midline shift at 72 hours (or at time of decompressive craniectomy or comfort measures only, if earlier) in participants with large hemispheric infarction. the secondary objective is to explore if hrs8179 could improve acute neurologic status, functional outcomes, treatment requirements and safety.


Eligibility criteria:
inclusion criteria: 1. fully understand and voluntarily participate in this research, and sign the informed consent form (the informed consent form can be signed voluntarily by the person or legal representative); 2. aged 18\~80, regardless of gender; 3. a clinical diagnosis of acute ischemic stroke in the middle cerebral artery (mca) territory; 4. nihss ≥ 10 points at screening; 5. a large hemispheric infarction is defined as: lesion volume of 80 to 300 cm3 on magnetic resonance imaging (mri) diffusion-weighted imaging (dwi), or computed tomography perfusion (ctp). 6. the study drug initiated must be no later than 10 hours when stroke onset; exclusion criteria: 1. the investigator judges that the subject may withdrawn the supportive treatment on the first day; the investigator believes that there is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.3. there are clinical signs of brain hernia; 2. ct/mri suggested that the anterior septal/pineal excursion was \>2 mm due to brain edema; 3. ct/mri indicates cerebral hemorrhage (excluding small ecchymosis/punctate hemorrhage);
a dose-escalation study in subjects with advanced malignancies

Conditions: Solid Tumors and Hematologic Malignancy

Summary: this is an open label, dose escalation study using a 3 + 3 design to determine if incb024360 (study drug) is safe, well-tolerated and effective in patients with advanced malignancies. patients will be enrolled and treated in cohorts of three and each observed a minimum of 28 days before the next group is enrolled and may begin to receive study drug. for subject safety, the first subject in each cohort will be administered drug for one week before the next two subjects in the cohort can begin drug administration. doses will be escalated unless a dose-limiting toxicity (dlt) is observed in one of three subjects. an expanded cohort of up to 15 patients may be recruited to further explore safety at the 'maximum tolerated dose' or at a lower, pharmacologically active, dose.


Eligibility criteria:
inclusion criteria: * subjects with neoplastic disease refractory to currently available therapies or for which no effective treatment is available * subjects with life expectancy of 12 weeks or longer. * subjects with eastern cooperative oncology group (ecog) performance status of 0, 1 or 2. exclusion criteria: * subjects who received any anti-cancer medications in the 21 days prior to receiving their first dose of study medication or 6 weeks for mitomycin-c or nitrosoureas. * subjects with history of brain metastases or spinal cord compression. * subjects who have undergone a bone marrow or solid organ transplant. * subjects who have had major surgery within 4 weeks prior to study entry or had minor surgical procedure within 7 days prior to initiating treatment. * subjects with a history of any gastrointestinal condition * is receiving any compound that is known to be a potent inducer or inhibitor of cyp3a4 * subjects with an active autoimmune process or is receiving therapy for an autoimmune disease * subjects treated with a serotonin reuptake inhibitor within 3 weeks prior to study entry

Keywords: refractory, advanced malignancies
efficacy of intense pulsed light in the treatment of recurrent chalazia

Conditions: Chalazion

Summary: the purpose of the present study was to investigate the efficacy of intense pulse light and meibomian glands expression in cases of recurrent chalazion after surgery.

we hypothesized that ipl application on the skin adjacent to eyelids after chalazion surgery will result in better meibomian gland function and lower recurrence. to date, it has not been previously reported the outcomes of the use of this technology for the management of chalazions recurrence. the purpose of the present study was to investigate the efficacy of intense pulse light and meibomian glands expression in cases of recurrent chalazion after surgery.

Eligibility criteria:
inclusion criteria: * all patients had chronic unilateral recurrent chalazia that failed to resolve after conservative treatment that included warm compresses and antibiotic and steroid ophthalmic ointments. exclusion criteria: * (1) any intraocular inflammation, ocular infection, allergy, ocular surgery, or ocular trauma in the past 6 months; (2) any eyelid diseases or structural abnormality; (3) any systematic diseases may lead to dry eye or mgd; (4) skin cancer or pigmented lesion in the treatment zone.

Keywords: chalazion ipl meibomian gland function
a trial to evaluate efficacy of reinduction with nadofaragene firadenovec in subjects with cis ± high-grade ta/t1 and no complete response to first nadofaragene firadenovec dose.

Conditions: Bladder Cancer; Ta/T1; CIS

Summary: in this phase 4 trial (000439), subjects with nmibc cis (± high-grade ta/t1) who have not responded to their first dose of nadofaragene firadenovec (commercial adstiladrin received before trial entry) will be offered reinduction when entering the trial.


Eligibility criteria:
inclusion criteria: * diagnosed, as documented, with cis ± high-grade disease ta/t1 and absence of progression after first dose of nadofaragene firadenovec within the last 5 months from instillation. * diagnosed, as documented, with: * low risk of disease progression as assessed at the discretion of the investigator * previous bacillus calmette guerin (bcg) therapy (bcg exposed) with no maximum limit to the amount of bcg administered exclusion criteria: * current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. examples of increased risk of muscle-invasive include but are not limited to: * presence of lymphovascular invasion and / or micropapillary disease as shown in the histology of the biopsy sample * subjects with t1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor * current and prior systemic or local therapy for bladder cancer since first dose of nadofaragene firadenovec * current or prior investigational treatment for bcg-unresponsive nmibc or any other investigational drug (drug used in a clinical trial, i.e drug used in a ferring sponsored non-interventional study does not apply) since first dose of nadofaragene firadenovec * clinically significant and unexplained elevated liver or renal function tests * history of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤pt2 upper tract urothelial carcinoma at least 24 months after nephroureterectomy. also subjects with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance are excluded
effect of stellate ganglion block on internal mammary artery dynamics

Conditions: Anesthesia

Summary: this study aims to assess the effect of a stellate ganglion block on the flow and diameter of the internal mammary artery using the pulsatility index and transient time flowmetry(ttfm) in patients undergoing coronary artery bypass grafting.

the internal mammary artery (ima) is the preferred graft for myocardial revascularization because of its superiority over venous grafts owing to long term patency, lower mortality rates and improved post-operative outcomes. however, conduit spasm is a recognized complication of coronary artery bypass surgery mainly affecting the arterial conduits, a major concern that can lead to acute myocardial ischemia and may contribute to reduce graft patency. topical application or systemic administration of many pharmacological agents has been shown to reverse or prevent graft spasm, but side effects are reported with the use of these agents. various vasodilators that have been tried included various organic nitrates, calcium channel blockers, sodium nitroprusside (snp) and papaverine. over the last few years, there were some studies, which investigated the effect of regional anesthesia techniques such as thoracic epidural anesthesia (tea) and stellate ganglion block (sgb) for sympatholysis and studied its effects on internal mammary artery diameter . the stellate ganglion block with local anesthetics have been widely used to provide pain relief to treat vascular spastic disorders of upper limbs, chronic pain conditions and treatment of refractory angina. the stellate ganglion block has also been used for increasing radial artery (ra) blood flow and preventing ra spasm by sympathetic blockade in coronary artery bypass surgery. in our study, two groups will be compared regarding ima blood flow and diameter. the ima pulsatility index and diameter will be measured before and after the stellate ganglion block during both the preoperative and intraoperative periods in both groups. transit-time flowmetry (ttfm) will be used intraoperatively to assess ima flow. additionally, topical nitroglycerin will be applied intraoperatively in both groups, regardless of whether they received the stellate ganglion block.

Eligibility criteria:
inclusion criteria: * age: 18 to 65 years. * patients who will be slated to undergo elective coronary artery bypass graft surgery under cardiopulmonary bypass in the department of cardiothoracic surgery. exclusion criteria: * patient not willing to participate in the study. * age more than 65 years. * ejection fraction \< 45%. * history of strokes / transient ischaemic attacks and vertebro basilar insufficiency * history of glaucoma. * history of allergy to local anaesthetic drugs. * emergency coronary artery bypass graft or reoperations. * pre-existing contralateral phrenic nerve palsy. * patients with existing coagulopathy. * allergy to nitroglycerin.
pharmacological modulation of the intrarenal pressure during endourological procedures in the upper urinary tract

Conditions: Kidney Stone; Unexplained Haematuria; Benignant Tumour Mass in the Upper Urinary Tract

Summary: the purpose of the study is to examine the effect of endoluminally administrated isoproterenol on pelvic pressure increase during flexible ureterorenoscopy in 14 humans. we propose that isoproterenol has potential of reducing intrarenal pressure during ureterorenoscopies. lower intrarenal pressures may have the advantage of facilitating the procedure and reducing intraoperative complications as bleeding and infections.


Eligibility criteria:
inclusion criteria: * indication for ureterorenoscopy * age\> 18 years * normal blood pressure exclusion criteria: * malignant disease in the upper urinary tract * heart disease * allergy to isoproterenol * use of α-blocking or β-blocking medicine * use of calcium-antagonists * use of nsaids the last 48 hours * present stone or jj-stent in the ureter * neurologic disease in the bladder * pregnancy * nursing mothers

Keywords: kidney stone ureteroscopy
lidocaine subcutaneous infusion for control of treprostinil related site pain

Conditions: Pulmonary Arterial Hypertension

Summary: treprostinil subcutaneous (under the skin) infusion is a very good medication for treating pulmonary arterial hypertension but infusion site pain may be very severe in some patients. the investigators plan to treat patients receiving treprostinil with a subcutaneous infusion of lidocaine (a local anesthestic) to treat the pain.


Eligibility criteria:
inclusion criteria: * pah * treprostinil treatment for at least 3 months * severe infusion site pain exclusion criteria: * pregnancy/breastfeeding * decompensated heart failure * chronic liver disease * abnormal electrolytes * heart block (2/3 degree), sino-atrial block, idioventricular rhythm * systolic systemic bp \<90mmhg * bradycardia hr \<55 * adverse reaction to lidocaine or other amide local anesthestic * interacting medications (anti-arrhythmics, cyp1a2 inhibitors)

Keywords: remodulin treprostinil
a retrospective pharmacokinetics and pharmacogenomics research of imatinib in gastrointestinal stromal tumor treatment

Conditions: Gastrointestinal Stromal Tumors; Germline Mutation; Somatic Mutation; Plasma Concentration

Summary: for patients of gist (gastrointestinal stromal tumor), imatinib has been widely used in gist with kit or pdgfra sensitive mutations. from clinical points of view, individual differences often occur between different patients, leading diverse effect in adr and drug effect. meanwhile, the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic and other factors. in this research, we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations, plasma trough concentration and drug effect, the association between adme-associated snp, target/receptor/pathway-associated snp, trough concentration and tki adverse effect. furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.

the plasma concentration of imatinib were established. the adme-associated snps included are cyp3a4, cyp3a4, cyp1a1, cyp2c9, cyp2c19, abcb1, abcg2, abcc4, slc22a1, slco1b3 and so on. the target/receptor/pathway-associated snp s included kit, pdgfra, pdgfrb, flt1, flt3, mapk1, shc1, ccl5, cxcl14 and so on. the somatic mutations included are kit, pdgfra, braf and so on.

Eligibility criteria:
inclusion criteria: * the main patient entry criteria included: age≥ 18 years; histologically and cytologically proved gist; eastern cooperative oncology group performance status (ecogps)≤2; adequate hematological,renal,and hepatic functions. exclusion criteria: * uncontrolled systemic disease,and other chemotherapy at the time of inclusion. the protocol was approved by the ethical committee of cancer center of sun yat-sen university (ccsu), and written informed consent was obtained form each patient.

Keywords: gastrointestinal stromal tumor (gist) imatinib pharmacogenetics pharmacokinetics precision medicine somatic and germ-line mutations
efficacy of indacaterol 150 µg versus formoterol

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the study will be a 12 week treatment (84 days), parallel group, randomized, double blind, double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (fev1). patients will be enrolled after giving informed consent and then begin a screening/run-in period for 14 days. patients will be randomized to one of two treatment groups using an allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of 12 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of copd (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2009) and: * post-bronchodilator fev1 \<80% and ≥40% of the predicted normal value * post-bronchodilator fev1/fvc (forced vital capacity) \<70% * smoking history of at least 10 pack-years exclusion criteria: * patients who have had a copd exacerbation in the 6 weeks prior to screening * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular comorbid conditions other protocol-defined inclusion/exclusion criteria may apply

Keywords: copd indacaterol formoterol
large segmentation radiotherapy ± deep inspiration breath hold(dibh) for left breast cancer

Conditions: Breast Cancer

Summary: the study is a single-center, prospective, non-randomized controlled study. the primary objective is to examine the clinical outcomes of utilizing deep inspiration breath hold (dibh) in conjunction with hypo-fractionated radiotherapy for patients diagnosed with left-sided breast cancer with a particular focus on its potential to reduce the incidence of cardiac-related clinical and subclinical events.participants will revieve large segmentation sadiotherapy ± dibh for left breast cancer and be followed up to gather their clinical cardiac imformation.


Eligibility criteria:
inclusion criteria: 1. 18-70 years old, female, life expectancy \> 5 years 2. ecog 0, 1, 2 points 3. pathologically diagnosed with left breast cancer and underwent breast-conserving surgery or modified radical mastectomy 4. the patient will receive radiation therapy to the entire breast or chest wall ± the lymphatic drainage area above and below the clavicle ± the lymphatic drainage area in the axilla. 5. no prior neoadjuvant chemotherapy or breast reconstruction. 6. no active cardiac disease, myocardial infarction, or congestive cardiac failure at baseline. 7. patients can hold their breath for at least 30 seconds after training 8. patients who can be followed up and agree to follow the plan. 9. sign the consent form. exclusion criteria: 1. lesions were observed on both sides of the breast. 2. diagnosis could not be confirmed by pathology. 3. distant metastasis was identified. 4. the patient had undergone neoadjuvant chemotherapy or breast reconstruction surgery. 5. severe cardiac insufficiency; myocardial infarction or uncorrected unstable cardiac arrhythmia or uncorrected unstable angina within the last 3 months; or pericardial disorders 6. the patient's new york heart association (nyha) cardiac classification is within categories 2-4. 7. a history of chronic lung disease, including conditions that may contribute to ductal dilatation, such as chronic obstructive pulmonary disease (copd) and interstitial pneumonia. 8. previous mediastinal radiotherapy. 9. previous or concurrent second primary malignant tumor (except skin cancer that is not a malignant black pigmented tumor, papillary/follicular carcinoma of the thyroid, carcinoma in situ of the cervix, and contralateral non-invasive breast cancer). 10. irradiation of the lymphatic drainage area of the internal breast is required.

Keywords: breast cancer heart toxicity dibh dose prediction
thermal cures in the treatment of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a chronic, progressive disease with a high prevalence in france, with significant public health consequences. the benefit of spa treatments on the quality of life in this population has not been evaluated. the methods of study in clinical pharmacology can be a scientific methodological model for the evaluation of thermal practices and it is in this perspective that investigators want to lead this project.

multiple sclerosis (ms) is a chronic, progressive disease with a high prevalence in france, and its consequences in terms of public health are important. in this disease, the alteration of the quality of life (qol) is constant and multifactorial : pain, fatigue, decrease in functional capacities, sleep disorders, cognitive disorders, vesico-sphincterian disorders, anomolytic disorders. -rectal and genito-sexual. the benefit of thermal cures on the quality of life in this population has not been evaluated, even if there is some literature in the literature suggesting a benefit of hydrotherapy on equilibrium or on pain.

Eligibility criteria:
inclusion criteria: * patient with primary or progressive secondary-phase ms * showing edss \<7 severity criteria * patient with ms for whom an indication of spa treatment has been made, * patient agreeing to participate in this study and therefore accepting the constraints related to the design "immediate cure-deferred cure", * patient receiving the general social security scheme, * patient having given written consent to participate in the study exclusion criteria: * patient does not meet the inclusion criteria, * patient with relapsing remitting ms * patient unfit according to the investigator to complete the rating scales * patient with heat intolerance called "uhthoff effect" * patient with a contraindication to the spa treatment: urinary or faecal leakage, wound, thrombophlebitis less than three months old, unstabilized cardio respiratory disease. * patient with serious life-threatening condition (ie, cancer) * patient under tutorship or curatorship * patient participating in another interventional clinical research project

Keywords: multiple sclerosis spa treatment crenotherapy balneotherapy physical exercise
termination of persistent atrial fibrillation by catheter ablation

Conditions: Atrial Fibrillation

Summary: this is a prospective, multicenter, cohort study aims to demonstrate the role of termination of af in ablation for persistent atrial fibrillation, and evaluate the clinical outcomes in patients with or without af termination.


Eligibility criteria:
inclusion criteria: 1. aged 18 to 80 years old; 2. persistent af; 3. nonresponse or intolerance to ≥1 antiarrhythmic drug. exclusion criteria: 1. with uncontrolled congestive heart failure; 2. having significant valvular disease and/or prosthetic heart valve(s); 3. with myocardial infarction or stroke within 6 months of screening; 4. with significant congenital heart disease; 5. ejection fraction was \<40% measured by echocardiography; 6. allergic to contrast media; 7. contraindication to anticoagulation medications; 8. severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (copd); 9. left atrial (la) thrombus measured by pre-procedure transesophageal echocardiography; 10. having any contraindication to right or left sided heart catheterization; 11. previous atrial fibrillation ablation; 12. presence of an implanted cardioverter-defibrillator; 13. any cardiac surgery within the past 2 months; 14. poor general health; 15.life expectancy less than 6 months.