Kornimate/medical-research-clean huggingface dataset:
burst spinal cord stimulation for neuropathic pain

Conditions: Neuropathic Pain

Summary: recently a novel stimulation design was developed, called burst stimulation. in a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. this permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. a study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.

patients receive three type of stimulation (burst, tonic and sham). we want to compare these different stimulation protocol to verify which one is the one the patient prefer the most and have the least side-effects (paresthesia)

Eligibility criteria:
all patients were selected after multidisciplinary discussion with a specialized pain physician, a psychological and psychiatric evaluation was performed to rule out psychogenic pain as well as other psychiatric morbidity contraindicating an implant. after authorization by the psychologist and psychiatrist an implant was offered. inclusion criteria * patients enrolled in this study must meet the following inclusion criteria: * patients able to provide informed consent to participate in the study; * patient is between the age of 18 and 75; * patient has failed back surgery syndrome; * patient has a simulator implanted at the dorsal column spinal cord powered by an eon/eon mini® internal pulse generator. * patient medication has remained stable for at least 4 weeks prior to baseline data collection; * patient agrees not to add or increase medication throughout the randomization trial period of the study; * patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits. exclusion criteria a patient will be excluded from participation in this study if they meet any one of the following criteria: * patient has current evidence of any psychiatric disorder, as documented by the dsm-iv-tr criteria with psychotic characteristics; * patient has a history of life-threatening severe illness or is suffering from severe chronic disease other than the indication for the study; * patient has history of substance abuse or substance dependency in the past 6 months prior to baseline data collection; * patient currently participating in another clinical study; * patient with demand-type cardiac pacemakers, an infusion pump or any other implantable neurostimulator device except for the spinal cord stimulator under study; * patient is not willing to maintain current medication regimen; * female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.

Keywords: tonic, burst and placebo stimulation
stereotaxis idiopathic ventricular tachycardia (vt) study

Conditions: Ventricular Tachycardia

Summary: this study will assess the outcomes of using magnetic navigation to treat ventricular tachycardia (vt) or premature ventricular contractions (pvcs) that occur for unknown reasons and are not related to structural heart disease.

during conventional ventricular arrhythmia ablation procedures, simply contacting the cardiac wall can significantly alter the electrocardiogram. induction of ventricular ectopy is important in determining the focus of the arrhythmogenic tissue during an electrophysiology (ep) procedure; however, instrumentation with stiff ablation catheters can temporarily eliminate vt during the mapping portion of the procedure making it difficult to track the arrhythmia prior to ablating the tissue responsible for its genesis. the catheters used with the stereotaxis magnetic navigation system (mns) are less stiff compared to manual catheters since no pull wires are required to deflect the distal tip. large external magnets positioned on either side of the ep procedure table create a magnetic field within the patient's chest. these large magnets (in direct relationship to the magnetic field) can be manipulated using specialized software. the physician controls the distal tip of the catheter by using the software while remotely using a catheter advancing system (quickcas®, stereotaxis, inc, st. louis, mo) to reach the desired location within the heart. the soft catheters may provide a unique quality to the electrophysiologist who may assist by providing accurate maps without temporarily eliminating the ventricular ectopy due to excessive mechanical forces applied to the cardiac tissue. this study will assess the physician's ability to appropriately map and ablate the ventricular substrate using remote magnetic technology. all devices are approved by fda and no off-label use of the products is mandated within the protocol.

Eligibility criteria:
inclusion criteria: * patients must be between 18 - 80 years of age * willing to provide written informed consent * present with ventricular ectopy of non-ischemic origin * able to be safely exposed to a static magnetic field * failure of at least 1 antiarrhythmic medication exclusion criteria: * presence of a mobile ventricular thrombus * unable to obtain percutaneous access to the left ventricle * contraindicated for short-term anticoagulation therapy * life expectancy less than 1 year * body habitus limits placement on the procedure table * previously failed ablation procedure for vt/pvcs

Keywords: vt ventricular tachycardia ablation magnetic navigation robotic
study of telitacicept in patients with refractory iga nephropathy

Conditions: IgA Nephropathy

Summary: the goal of this clinical trial is to explore the effectiveness and safety of telitacicept in adults with refractory iga nephropathy. the main questions it aims to answer are: * to evaluate the clinical efficacy of telitacicept in patients with refractory iga nephropathy. * to evaluate the safety and adverse reaction of telitacicept in patients with refractory iga nephropathy. participants will be subcutaneously injected with 240mg of telitacicept once per week. study subject: after 6 months of sequential treatment with renin-angiotensin system (ras) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory iga nephropathy.


Eligibility criteria:
inclusion criteria: 1. voluntarily sign the informed consent form. 2. iga nephropathy was confirmed by pathological biopsy. 3. age range: ≥ 18 years old, ≤ 70 years old, male or female. 4. during the screening period, the 24-hour urine protein of visit 1 and visit 2 should meet at least one ≥0.75g/24h, and the 24-hour urine protein ≥ 0.75g/24h at visit 3. 5. measured glomerular filtration rate or estimated gfr (using the ckd-epi formula) \> 35 ml/min/1.73 m2. 6. participants had received a basic regimen including ace inhibitors/arbs for 12 weeks prior to randomization, and the dose of ace inhibitors/arbs (within the maximum tolerated range) was stable for 4 weeks prior to randomization. exclusion criteria: 1. abnormal laboratory indicators of participants need to be excluded. 2. secondary iga nephropathy need to be excluded. 3. specific pathologic or clinical renal disease types, and iga nephropathy that may require hormone therapy. 4. patients who have experienced any of the following cardiovascular and cerebrovascular events within the 12 weeks prior to screening. 5. use of systemic corticosteroids within 3 months prior to randomization (except local, nasal inhalation, etc.) 6. immunosuppressants were used within 3 months prior to randomization. 7. patients requiring hospitalization for active infection or intravenous anti-infective therapy within 3 months prior to randomization. 8. previously or currently diagnosed active tuberculosis untreated latent tuberculosis. 9. herpes zoster hiv antibody positive or hcv antibody positive during the screening period. 10. those who currently have active hepatitis or have severe liver disease and medical history. 11. patients with malignant tumors. 12. pregnant and lactating women, and men or women with planned children during the trial period. 13. those who could not avoid the use of nephrotoxic drugs during the trial. 14. allergic to human biological products. 15. patients who have been given any of the clinical trial drugs 4 weeks prior to randomization or within 5 times the half-life of the experimental drug (whichever is longer). 16. patients deemed ineligible for the trial by the investigator.
nudging nutrition with monetary incentives environmental cues

Conditions: Obesity; Food Labeling; Health Behavior; Diet

Summary: the investigators hypothesize that monetary incentives and messaging, such as making nutritious foods relatively less expensive than less nutritious foods and framing the price difference in a positive or negative way, will influence purchasing behavior of households.

in this study, 239 loyalty card shoppers were recruited at hannaford grocery stores to participate in a study in which a 10% price difference between nutritious and less nutritious foods was introduced. and then framed as a subsidy, tax, or a combination of a tax and subsidy. to determine whether or not the framing of the price difference influenced purchasing behavior, the difference was framed as a subsidy on nutritious foods, a tax on less nutritious foods, and a combination of a tax and subsidy on less nutritious and nutritious foods, respectively. the purpose of this study was to examine the general impact of this price difference on purchases of nutritious and less nutritious foods, and whether or not the framing of the price difference had a differential effect on behavior.

Eligibility criteria:
inclusion criteria: * loyalty card shoppers at hannaford grocery stores exclusion criteria: * no children in household * less than 75% of food purchases made at hannaford grocery stores

Keywords: public policy food choice nutrition labeling fat tax vegetable subsidy behavioral economics health behavior
mesenchymal stromal cells for ischemic stroke

Conditions: Ischemic Stroke

Summary: the purpose of this study is to determine if mesenchymal stem cells given by iv is feasible and safe in patients with recent ischemic stroke and to decide the maximum tolerated dose when given between 3-10 days after an ischemic stroke.

this is a randomized, double-blind, placebo controlled study. . approximately 48 subjects will be enrolled in the trial, undergo a real or sham msc iv infusion and will be follow out to 1 year. there will potentially be 4 cohorts with the dose escalation at a 3:1 randomization schedule objectives: * the primary hypothesis' are that intravenous administration of allogeneic bone marrow derived mesenchymal stem cells is feasible and safe in patients with recent ischemic stroke and to determine the maximum tolerated dose (mtd) of iv mscs when administered sub-acutely between 3-10 days following ischemic stroke. * the secondary hypothesis is that allogeneic msc transplantation will improve functional outcome after recent ischemic stroke. safety and clinical efficacy points to be evaluated at day 7 clinic visit, day 30, day 60, day 90, and day 180. primary outcome or primary endpoint of the study is to define the safety or harm of the mscs

Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke 2. age 18 to 83 years 3. post stroke mrs \> 3 4. nihss of 7-25 5. deficits on the total nihss can be lower than 7 provided the patients have moderate aphasia or visual loss (2 on the best language or visual loss nihss subcomponent) \*criteria for mrs not used for this category of subjects 6. last seen normal st within 3-9 days prior to stroke. time of onset for wake-up stroke will be defined as the time the patient woke up with symptoms. 7. stem cell transplantation procedure must be performed between 3-10 days after stroke symptom onset exclusion criteria: 1. ischemic stroke, primary hemorrhagic or traumatic lesion of the brain or myocardial infarction within past 30 days prior to current stroke. 2. mechanical heart valve 3. uncontrolled seizure disorder, defined as a seizure within the last 6 months 4. developmental delay 5. chronic kidney disease 6. hepatic disease or altered liver function 7. pulmonary disease 8. cancer within 5 years prior to study 9. prior immunosuppression, including chemotherapy within last 3 years 10. known hiv 11. uncorrected coagulopathy or severe anemia 12. pregnancy 13. unable to undergo mri or ct scan 14. imaging shows clinically significant hemorrhage

Keywords: ischemic stroke stem cells msc allogeneic bone marrow
mrct evaluating ncx 470 vs. latanoprost in subjects with open-angle glaucoma or ocular hypertension

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: the objective of this clinical study is to evaluate the safety and efficacy of ncx 470 ophthalmic solution in lowering intraocular pressure (iop) in subjecs with ocular hypertension or open-angle glaucoma. subjects will be randomized in a 1:1 ratio to ncx 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.


Eligibility criteria:
inclusion criteria: * diagnosis of open-angle glaucoma or ocular hypertension in both eyes * qualifying iop at 3 time points through the day at 2 visits following washout of iop-lowering medication, if applicable * qualifying best-corrected visual acuity in each eye * ability to provide informed consent and follow study instructions exclusion criteria: * narrow anterior chamber angles or disqualifying corneal thickness in either eye * clinically significant ocular disease in either eye * previous complicated surgery or certain types of glaucoma surgery in either eye * incisional ocular surgery or severe trauma in either eye within the past 6 months * uncontrolled systemic disease
"oncologic results and risk factors for recurrence in patients with locally advanced rectal cancer and pathologic complete response after neoadjuvant treatment. results from an observational retrospective multicenter long-term follow-up study".

Conditions: Rectal Cancer, Adenocarcinoma; Rectal Cancer Stage II; Rectal Cancer Stage III; Distant Metastasis; Local Recurrence of Malignant Tumor of Rectum

Summary: pathologic complete response (pcr) after multimodal treatment for locally advanced rectal cancer (larc) patients is considered as the gold-standard of treatment success as it is associated to privileged oncologic outcome. nevertheless, data from multicenter high-volume cohorts with long term follow-up are scarce. this is a multicenter observational study using prospectively collected data from the spanish rectal cancer project database. the main objective of the study is to update long-term oncologic follow-up of those patients treated for larc with ncrt and surgery (either tme or subtotal tme; s-tme) who had obtained a pcr. secondary objective is to analyze demographic, clinical, operative and treatment variables in search of related factors to adverse oncologic outcomes, like distant recurrence or tumor-related deaths. the results are reported in accordance with the strobe (strengthening the reporting of observational studies in epidemiology) statement for observational studies. all calculations are performed using stata 13.1 (statacorp, texas, usa).


Eligibility criteria:
inclusion criteria: * patients with pathological confirmation of rectal cancer preoperatively, in any of its histological variants. * tumor located less than 12 cm from the anal margin. * radiological stage ii or iii (ct3-4 n0 and/or any t with positive cn). * neoadjuvant treatment with radio-chemotherapy. * radical surgery performed on a scheduled basis and with curative intent. * definitive pathology study with complete tumor regression. exclusion criteria: * patients operated on with palliative intent. * patients diagnosed with a hereditary colorectal cancer syndrome. * patients who presented synchronous metastases at the time of diagnosis, or concurrent malignancy of another origin. * patients who underwent emergency surgery.
a study to investigate weight management with ly3549492 compared with placebo in adult participants with obesity or overweight

Conditions: Obesity; Overweight

Summary: the main purpose of this study, performed under the master protocol w8m-mc-cwmm (nct06143956), is to evaluate the effects of ly3549492 in adults with obesity or overweight. participation in the study will last about one year.


Eligibility criteria:
inclusion criteria: w8m-mc-gn01: * assigned male at birth * assigned female at birth, who are of non-childbearing potential w8m-mc-cwmm: * have a bmi of * ≥ 30 kilograms per square meter (kg/m²) or * ≥ 27 kg/m² and \< 30 kg/m² with at least one weight-related comorbidity * have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss) exclusion criteria: w8m-mc-gn01: * have type 2 diabetes mellitus or type 1 diabetes mellitus * have a history of acute or chronic pancreatitis * have renal impairment * individuals who are of childbearing potential w8m-mc-cwmm: * have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening. * have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma. * have poorly controlled hypertension. * have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease. * have any of the following cardiovascular conditions within 3 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure. * have a history of symptomatic gallbladder disease within the past 2 years * have a lifetime history of suicide attempts.
application of 3d visualization and 3d printing in the hepatobiliary and pancreatic surgery

Conditions: Liver Diseases; Pancreatic Diseases; Biliary Tract Diseases

Summary: background:the aim of the study is to value the application of three-dimensional visualization and three-dimensional printing in the hepatobiliary and pancreatic surgery.method：from january 2016 to december 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.all the patients received abdominal ct scanning and 3d reconstruction. then we used the 3d reconstruction model and the 3d printed model based on the 3d reconstruction model in the operation planning and the operation.the clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.

from january 2016 to december 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.all the patients received abdominal ct scanning and 3d reconstruction. then we used the 3d reconstruction model and the 3d printed model based on the 3d reconstruction model in the operation planning and the operation.the clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.

Eligibility criteria:
inclusion criteria: * the hepatobiliary and pancreatic diseases exclusion criteria: * none of the hepatobiliary and pancreatic diseases

Keywords: three-dimensional image three dimensional printing
nonalcoholic fatty liver disease and cardiovascular disease: the correlation analysis and risk prediction model study

Conditions: NAFLD; Cardiovascular Diseases

Summary: nonalcoholic fatty liver disease (nafld) is the most common cause of chronic liver disease in the world. nafld is associated with a lot of comorbidity, such as diabetes, metabolic syndrome, coronary heart disease and chronic kidney diseases. however, the correlation between the nafld and cardiovascular disease (cvd) events remains controversial. this study is an observational study based on a big retrospective cohort in china to explore the prevalence of nafld in china, the risk factors associated with nafld, as well as whether patients with nafld are more prone to experience cvds and cvd events.


Eligibility criteria:
inclusion criteria: * males or females aged 18-75 exclusion criteria: * malignancy except primary liver cancer * pregnancy or breastfeeding * liver diseases of other etiology including hepatitis c virus infection ,autoimmune hepatitis,wilson's disease,hemachromatosis,drug-induced hepatitis,parenteral nutrition * excessive alcohol consumption * cases missing crucial data
qualite study - a study of fuzeon (enfuvirtide) in treatment-experienced patients with human immunodeficiency virus-1 (hiv-1) infection

Conditions: HIV Infections

Summary: this study will evaluate patient quality of life and tolerability of a haart (highly active antiretroviral therapy) regimen containing twice-daily subcutaneous injections of fuzeon in clinically stable, treatment-experienced patients with hiv-1 infection. all patients will use a 31-gauge thin-walled 8mm needle to administer fuzeon. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adults or adolescents at least 16 years of age; * hiv-1 infection; * clinically stable, treatment-experienced; * evidence of hiv-1 replication despite ongoing antiretroviral therapy; * cd4 + count greater than 50 cells/mm3. exclusion criteria: * previous use of fuzeon and/or t-1249; * active, untreated opportunistic infection; * inability to self-inject, unless a reliable caregiver is available to inject.
cytoprotective agent and peptic ulcer in dual antiplatelet :rct

Conditions: Gastric Ulcer Induced by Anti-platelet Agent; Duodenal Ulcer Induced by Anti-platelet Agent

Summary: * primary objective : to evaluate the efficacy of rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents * study design: single center, double-blind, randomized-control trial study * study drug: repamipide vs. placebo * assessment criteria the patients will be discharged from the study when one of the followings occurred, 1. peptic ulcer from upper endoscopy at 3 and 6 month follow up 2. clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy 3. anemia by cbc at 1,3 ,6,12 month with peptic ulcer from upper endoscopy 4. evidence of recurrent myocardial infarction from stent thrombosis


Eligibility criteria:
inclusion criteria: 1. age 18-70 year-old 2. had cardiovascular disease which needed clopidogrel and aspirin 3. stable enough for gastroscopy exclusion criteria: 1. gastroscopy revealed peptic ulcer 2. had contraindication for gastroscopy 3. not allowed for gastroscopy by cardiologist

Keywords: repamipide dual antiplatelet peptic ulcer
developmental outcomes

Conditions: Hypoxic-Ischemic Encephalopathy

Summary: determine whether the concentrations of uch-l1 and gfap measured in umbilical cord blood and in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits and/or death at 18-20 months.

children born with hypoxic ischemic encephalopathy (hie) and already enrolled in irb #504-2011 will be seen for a developmental follow-up at 18-20 months of age. the developmental assessment tool that will be used is called the bayley scales of infant and toddler development: 3rd edition (bayley-iii) screening test. the results of this test will then be compared to the child's hie biomarkers concentrations already obtained at birth.

Eligibility criteria:
inclusion criteria: * children already enrolled in irb#504-2011 * 18-20 months of age exclusion criteria: * none