Kornimate/medical-research-clean huggingface dataset:
efficacy of dietary sodium restriction of improving vascular endothelial function in middle aged and older adults

Conditions: Hypertension

Summary: the investigators hypothesize that reducing salt in the diet will improve the function of blood vessels in middle aged and older adults with moderately elevated systolic blood pressure, by increasing the amount of bh4 and nitric oxide in your blood vessels and reducing the amount of oxidative stress.

the improvement in blood vessel function will be determined over a 10 week period. subjects will be randomly assigned to either a 'low salt' condition (placebo pills + 1200 mg dietary sodium) or a 'normal salt' condition (2300 mg sodium chloride pills + 1200 mg dietary sodium) and monitored for 5 weeks. after the initial set of 5 weeks, the subjects are switched into the opposite condition, completing the cross-over study design. during weeks 1-4 and 6-9, subjects are monitored weekly with 24 hour urine collections and diet logs. the assessment of the primary outcome (blood vessel function) is completed during weeks 5 and 10. bh4 and ascorbic acid are also administered during weeks 5 and 10 to measure the effects of sodium intake on endogenous bh4 levels and vascular oxidative stress.

Eligibility criteria:
inclusion criteria: * 50-79 years of age * sbp 130-159 mmhg exclusion criteria: * have been sick with an infection in the past two weeks * are currently sick or have ongoing health problems such as kidney or cvd * have lost more than 11 lbs. in the last 3 months * are taking any type of antioxidants * smoke or have alcohol problems * have blood glucose levels higher than 126 mg/dl * have resting sbp below or less than 100 mmhg or greater than 159 mmhg * have a resting diastolic blood pressure greater than 99 mmhg * have a bmi greater than 40 kg/m\^2 * are presently consuming less than 9 or greater than 18 grams of salt / day * have a baseline fmd of greater than 6% * are taking any of the following types of drugs: blood thinners, anti-seizure medications, ant-inflammatory drugs * participate in any high endurance athletic training * taking hormone replacement therapy * have not been post-menopausal for at least 1 year
one-year, open extension to evaluate the treatment of patients with castration-resistant prostate cancer with yonsa™

Conditions: Metastatic Prostate Cancer

Summary: this is an open-label, single-arm, multi-center extension study to evaluate safety in patients with mcrpc of yonsa 500 mg (4 x 125 mg qd) with methylprednisolone (4 mg bid). patients will have successfully completed an 84-day treatment with abiraterone acetate in a previous trial. results from the final visit of the previous study will be used to determine patient's eligibility for this study. patients in this study will be eligible to receive open-label yonsa with methylprednisolone for up to 12 months. pharmacodynamic parameters of serum testosterone and psa levels will be monitored. disease progression will be assessed by pcwg2 criteria.


Eligibility criteria:
inclusion criteria: * successful completion of 84 days of treatment with yonsa in churchill pharmaceuticals clinical trial, chl-aa-201 * last dose of yonsa or zytiga within 45 days prior to treatment in this study * written informed consent obtained prior to any study-related procedure being performed * has in the investigator's opinion, the potential to gain clinical benefit with yonsa treatment * ongoing therapy with a gnrh agonist or antagonist and serum testosterone level \<50 ng/dl at screening * life expectancy of at least 9 months at screening * subject is willing and able to comply with all protocol requirements assessments * agrees to protocol-defined use of effective contraception. exclusion criteria: * serious concurrent illness, including psychiatric illness, that would interfere with study participation * inability to swallow tablets whole * known hypersensitivity to yonsa, methylprednisolone, or any excipients in study medications * moderate to severe hepatic impairment (child-pugh classes b and c)
combination probiotic: bb-12 with lgg (different doses) in treating children with autism spectrum disorder

Conditions: Autism Spectrum Disorder; Gastrointestinal Symptoms

Summary: this protocol is a blinded randomized controlled study of the effects of bb-12 with lgg at different doses in 70 healthy children with autism spectrum disorders at lower and higher doses over an 56-day period and a 28- day observation period. the study is being conducted in order to assess safety and tolerability of the probiotic (bb-12 with lgg) at 2 different doses of bb-12 with lgg. identifying effects on behaviors in healthy children with asd using srs-2 and abc, gi symptoms using gi symptom severity index, and relevant biomarkers of inflammation, microbiota, and metabolites. primary testing and procedures will be conducted at the university of texas health science center at houston and memorial hermann. biomarker identification includes integrative analysis of plasma metabolome and stool microbiota will be conducted with the collaboration of dr. ruth ann luna and dr. jim versalovic at alkek center for metagenomics and microbiome research, department of molecular virology \& microbiology of baylor college of medicine.


Eligibility criteria:
inclusion criteria: * healthy children with autism spectrum disorders (4 - 16 years old) and gastrointestinal symptoms, based on the gi severity index, with no other recognized illness will be enrolled in this study. there will be no selection on the basis of age, race, or gender. although the investigators anticipate the majority of subjects will be male and/or pre-pubertal, in females of childbearing potential, a pregnancy test (urine) will be performed on females participating (at each visit). exclusion criteria: * pregnancy or breastfeeding * subjects taking immunosuppressive medications, including oral corticosteroids * a history of positive result of hiv, hepatitis b, and/or hepatitis c test * abnormal lab test results (section 5.2) * gastrointestinal diseases such as celiac disease, inflammatory bowel disease * subjects with an allergy to antibiotics * presence of fever or a pre-existing adverse event monitored in the study * use of probiotics in the last 30 days * acute diarrheal illness within the past 30 days * recent (within 2 weeks) or current use of oral antibiotics /anti-fungals current use of oral laxatives * subjects with implanted prosthetic devices including prosthetic heart valves * the investigators will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the study period.

Keywords: autism spectrum disorder, asd, gastrointestinal symptoms, constipation, diarrhea
the use of tdcs in the orofacial pain

Conditions: Orofacial Pain

Summary: the trial´s main goal is to explore the use of transcranial direct current stimulation (tdcs) as a treatment option for persons suffering from orofacial pain. the aim of the trial is to further investigate the efficacy and longevity of tdcs in treating chronic pharmacoresistant orofacial pain. a prospective, randomized, double-blinded, two-arm, sham-controlled design will be utilized. primarily, the analgesic effect's intensity and duration will be assessed. secondarily, the associated reduction of symptoms of anxiety and depression will be investigated, as well as the impact on the general quality of life. anodal stimulation (6 sessions in 2 weeks, 2ma, 20 min, cathode over the opposite fp area) of m1 contralateral to the pain location will be employed. washout periods of 48-72 hours will be kept between applications to improve neuroplasticity changes' induction, which is estimated to reflect in the effect retention. eight major evaluation points will be employed in 26 weeks, and a daily numeric rating scale (nrs) self-assessment. the trial will potentially improve the quality of life, reduce the health burden caused by chronic orofacial pain, and provide further data on the use of tdcs in this setting, thus, enabling an additional route to manage the symptoms of pain in the future.


Eligibility criteria:
inclusion criteria: * diagnosis of orofacial pain by a pain medicine specialist according to icop (international classification of orofacial pain) and ichd3 (international classification of headache disorder) * stable analgesic therapy one month before the stimulation series exclusion criteria: * changes to the analgesic therapy in 6 months following the stimulation series * non-compliance with the follow-ups * general contraindications to tdcs - pregnancy, unstable cardiovascular disorders, epilepsy and intracranial masses

Keywords: orofacial pain tdcs trancranial direct current stimulation nibs non-invasive brain stimulation
safety and efficacy of a hematinic agent in the treatment of postpartum patients

Conditions: Postpartum Anemia

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of vit45 compared to the current standard of care in postpartum patients.

this is an open label phase iii randomized active control study of postpartum patients with anemia. patients will be randomized to either active control or the investigational agent and followed for up to 6 weeks.

Eligibility criteria:
inclusion criteria: * female subjects able to give consent * post partum patients * baseline hgb \< /= 10 g/dl * agree to practice birth control exclusion criteria: * participation in previous clinical trial of this investigational agent * known hypersensitivity reaction to active control * significant vaginal bleeding * history of anemia other than iron deficiency anemia * anticipated need for surgery during the study * active severe infection or malignancy * known positive hepatitis b antigen of hepatitis c viral antibody * known hiv antibodies * received an investigational drug within 30 days of screening * alcohol abuse within past 6 months * hemochromatosis or other iron storage disorders * significant cardiovascular disease * any laboratory abnormality, medical condition or severe psychiatric disorder which in the opinion of the investigator woud put the subject's disease management at risk or may result in the subject being able to comply with the study requirements

Keywords: anemia postpartum
microflora and metabolomics of crohn's disease patients

Conditions: Crohn Disease

Summary: the purpose of this study is to explore the microflora characteristics of different ecological loci and multiple metabolic pathways in crohn's disease patients with different disease course states.

this study aims to investigate the characteristics of microflora in the oral and tongue base, small intestinal stomy and lower respiratory tract, as well as the characteristics of multiple metabolic pathways such as bile acid metabolism and amino acid metabolism in crohn's disease patients with different course states.

Eligibility criteria:
inclusion criteria: 1. individuals who were clear and signed the informed consent. 2. male and female. exclusion criteria: 1. any one who can not provide accurate information. 2. any one who denies the study.

Keywords: crohn's disease microbiota metabonomics
surgical success after laparoscopic vs abdominal hysterectomy

Conditions: Metrorrhagia; Menorrhagia; Leiomyoma; Adenomyosis; Pelvic Pain; Endometriosis; Pelvic Inflammatory Disease

Summary: the purpose of the proposed pilot study is to investigate the effectiveness, cost, safety, and long-term impact on quality of life of laparoscopic hysterectomy (lh) in relation to abdominal hysterectomy (ah) for the treatment of benign gynecologic disease in women through a randomized surgical trial.

the overall hypothesis is that neither mode of hysterectomy will be consistently superior to the other with respect to each of the three domains of complications, cost, and patient-centered outcomes. the overall goal of the study is to determine which clinically relevant factors may impact the choice of lh compared to ah. the results of the study may be useful for clinicians, patients, hospital administrators and health policy makers.

Eligibility criteria:
inclusion criteria: * women undergoing hysterectomy for benign indications within 8 weeks of enrollment * women \>18 years of age * non-emergent surgery * non-pregnant exclusion criteria: * candidate for vaginal hysterectomy * uterine size \>14 weeks by clinical exam or \>300 ml by ultrasound measurement * history of cancer of reproductive tract * requires concomitant pelvic organ prolapse (pop) surgery * requires surgery for urinary incontinence * has acute angle glaucoma * has severe cardiac/respiratory disease * desires supracervical hysterectomy

Keywords: comparative effectiveness surgical success
behavioral modification and vesicare versus vesicare alone for urge incontinence in patients with overactive bladder

Conditions: Overactive Bladder

Summary: this study will help determine if behavior modification performed in conjunction with oral vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms than oral vesicare anticholinergic therapy alone.

overactive bladder symptoms are commonly treated with oral anticholinergic medications that work by stopping muscles from tightening or behavioral modification. this study will help determine if behavior modification (fluid regulation, pelvic exercises, timed voiding) performed in conjunction wth oral vesicare anticholinergic therapy, is more effective for treating overactive bladder symptoms than oral vesicare anticholinergic therapy alone.

Eligibility criteria:
inclusion criteria: * female patients \> 18 years of age * oab symptoms for \> 3 months * symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void causing incontinence. * may or may not be accompanied by urinary frequency * may be accompanied by stress urinary incontinence where stress incontinence does not predominate exclusion criteria: * male patients * underlying cortical or spinal cord pathology including sci, ms, or * parkinson's disease * urinary retention with post-void residual \> 150cc * current treatment or treatment within the last 3 months with anticholinergic medications * patients not able to complete the questionaires or voiding diaries in english * pregnancy * active urinary tract infections * bladder cancer or unevaluated hematuria * known diagnosis of narrow angle glaucoma * severe constipation * history of reduced renal function (crcl\<30ml/min) * history of liver disease * current treatment with cytochrome p450 inhibitor medications

Keywords: urinary incontinence overactive bladder urinary frequency
intermediate vision in patients with clareon iols compared to eyhance iols

Conditions: Pseudophakia

Summary: compare visual outcomes in patients with bilateral clareon monofocal iols versus bilateral eyhance iols.

this is a non-interventional prospective, comparative study of the outcomes for patients following successful, uncomplicated cataract surgery. all patients will have had bilateral implantation of an eyhance iol (dib00/diu\*\*\*) or clareon iol (cna0t0) at the time of uncomplicated cataract surgery. these patients will then be assessed post-operatively to compare distance and intermediate visual acuities and a defocus curve in patients with bilateral clareon monofocal iols versus bilateral eyhance iols. patients will be assessed for corrected binocular distance and intermediate vision.

Eligibility criteria:
inclusion criteria: 1. adults, 40 years of age having already undergone uncomplicated cataract removal by phacoemulsification with a clear corneal incision in both eyes. 2. implantation of bilateral clareon intraocular lenses or eyhance intraocular lenses (dib00/diu\*\*\*). 3. able to comprehend and willing to sign informed consent and complete all required testing procedures 4. best corrected distance visual acuity (bcdva) projected to be 0.10 logmar (minimum angle of resolution) or better 5. clear intraocular media 6. minimum of two weeks post yttrium aluminum garnet laser capsulotomy to treat pco exclusion criteria: 1. any corneal abnormality, other than regular corneal astigmatism (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study 2. any complication during cataract surgery (capsular tear, vitrectomy, etc) 3. history of or current retinal conditions in either eye that would confound the results of this investigation in the opinion of the investigator (e.g. retinal detachment, epiretinal membrane, retinal ischemia, retinal inflammation, etc) 4. amblyopia or strabismus in either eye 5. history of or current anterior or posterior segment inflammation of any etiology 6. any form of neovascularization on or within the eye 7. glaucoma (uncontrolled or controlled with medication) 8. optic nerve atrophy 9. subjects with diagnosed degenerative eye disorders 10. postoperative cdva worse than 0.10 logmar (20/25 snellen) in either eye. 11. subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)

Keywords: clareon eyhance pseudophakia
utility of cable tie to decline reloads in laparoscopic anterior resection of rectal cancer

Conditions: Modification of Rectal Cancer Surgery

Summary: during the laparoscopic anterior resection of rectal cancer, transecting the mobilized rectum in the narrow pelvic was difficult and sometimes need 2-3 reloads of the endoscopic linear cutter. also the angles between the 2-3 staple line threaten the next anastomosis. this study was to explore the cable tie to facilitate the transection of rectum and decline the usage of the reloads.

in the modern laparoscopic colorectal surgery, application of endoscopic stapler was necessary and popular, especially in rectal cancer. in the anterior resection of rectal cancer, usage of stapler increase the anal preservation. however during the laparoscopic anterior resection, transecting the mobilized rectum in the narrow pelvic was difficult, even with the flexible linear cutter. 1 reloads of the stapler was unable to transect the rectum completely, and need 2-3 reloads, especially in some fat patients, which was uneconomic.also increased reloads increase the staple line, and 2 or 3 staple line threaten the next anastomosis, and increasing anastomotic leak rate. this study was to explore the cable tie to facilitate the transection of rectum and decline the usage of the reloads. during the operation, after mobilization the rectum, the disinfected cable tie was introduced into the pelvic cavity.then the rectum was bundled by the tie which was much easier as the tie is auto-locked. pulling the tie and the rectum would be explored clearly, and then the endoscopic linear cutter was introduced to transect the rectum. the tie made the rectum folded not applanate, that the cutter was able to transect the rectum easily and with less reloader.

Eligibility criteria:
inclusion criteria: 1. rectal cancer patients; 2. the tumor located 5-12cm from the anal verge, that an anterior resection was needed. 3. the cancer has no organ invasion. exclusion criteria: patients refuse
hems for mechanical thrombectomy

Conditions: Ischemic Stroke

Summary: elapsed time from the onset of stroke symptoms to the point of revascularization is the key determinant of the optimal outcome of acute ischemic stroke. pharmacological treatment is less effective if the thrombus occluding the artery is big enough and mechanical thrombectomy is required to gain recanalization. mechanical thrombectomy can be done only in comprehensive stroke centres. there are 5 comprehensive stroke centres in finland which causes regional inequality when it comes to reaching mechanical thrombectomy in a reasonable time limit. the aims of the study is to measure the effect of dispatching a helicopter emergency medical services unit on the treatment delays of a stroke patient with large vessel occlusion. the hems unit is dispatched to both: getting patient directly to the comprehensive stroke centre as well as to interfacility tranfers.


Eligibility criteria:
inclusion criteria: - all adult patients transferred for mechanical thrombectomy from the south ostrobothnia hospital district to the tampere university hospital exclusion criteria: * the neurologist on call at the tampere university hospital deems the patient unable to benefit from mechanical thrombectomy
a clinical research of car t cells targeting her2 positive cancer

Conditions: Breast Cancer; Ovarian Cancer; Lung Cancer; Gastric Cancer; Colorectal Cancer; Glioma; Pancreatic Cancer

Summary: chimeric antigen receptor t cells (car-t) therapy has not yet been fully explored in solid tumors. human epidermal growth factor receptor-2(her2) is widely expressed in cancers. investigators have developed anti-her2 car-modified t cells and validated the efficiency targeting her2-positive cancer in preclinical studies. this study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. in addition, car-t cells persistence, tumor elimination and disease status after treatment will be evaluated.


Eligibility criteria:
inclusion criteria: 1. relapsed or refractory her2 positive cancer. 2. kps\>60. 3. life expectancy\>3 months. 4. gender unlimited, age from 18 years to 80 years. 5. assessable lesions with a minimum size of 10mm by ct scan or mri. 6. acceptable organ function hematology: * absolute neutrophil count greater than 800/mm\^3 without the support of filgrastim. * white blood cell (wbc) (\> 2000/mm\^3). * platelet count greater than 50,000/mm\^3. * hemoglobin greater than 9.0 g/dl. chemistry: * serum alanine aminotransferase (alt)/aspartate aminotransferase (ast) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis). * serum creatinine less or equal to 3 times the upper limit of normal * total bilirubin less than or equal to 3 times the upper limit of normal. 7. no other serious diseases(autoimmune disease, immunodeficiency etc.). 8. adequate cardiac function(lvef≥40%). 9. no other tumors. 10. patients volunteer to participate in the research. exclusion criteria: 1. allergic to cytokines. 2. uncontrolled active infection. 3. acute or chronic gvhd. 4. mods. 5. treated with t cell inhibitor. 6. hiv affected. 7. other situations improper for the research.

Keywords: her2 car-t safety efficiency refractory and relapsed cancer
pascal for tricuspid regurgitation - a european registry

Conditions: Tricuspid Regurgitation

Summary: this study aims to investigate the safety and efficacy of the pascal leaflet repair system in the treatment of tricuspid regurgitation in a commercial use setting including all consecutive patients at the participating centers in an observational fashion.

tricuspid regurgitation (tr) is associated with high morbidity and mortality, but many patients are ineligible for surgical treatment due to age and co-morbidities. as a consequence, transcatheter treatment techniques have evolved over the last years. leaflet repair is one of the most commonly used techniques and has recently gained commercial approval for dedicated tr treatment. the pascal (edwards lifesciences, irvine, usa) offers the possibility for independent leaflet grasping and a central spacer can bridge larger coaptation gaps. the hitherto evidence is mainly based on compassionate use data. this study aims to report the first commercial use in a multicenter study with a large patient cohort und long-term follow-up. aim of the study is to investigate safety and efficacy of the pascal leaflet repair system in the treatment of tr in a commercial use setting. study design is a multicenter, single-device, retro- and prospective, observational registry. all consecutive patients undergoing treatment with the pascal system for tricuspid regurgitation in a commercial setting are included.

Eligibility criteria:
inclusion criteria: * patients treated with the pascal system for tricuspid regurgitation in a commercial setting exclusion criteria: * patient age \< 18 years