Kornimate/medical-research-clean huggingface dataset:
safety & efficacy of alt-711 (alagebrium) in chronic heart failure

Conditions: Chronic Heart Failure

Summary: several lines of evidence have suggested that advanced glycation end-products (ages) play a role in the development and progression of heart failure. the age-crosslink breaker alagebrium improved cardiac function and symptoms in experimental preclinical and small human heart failure studies. these results have not yet been confirmed in a randomized controlled clinical trial. objective: to evaluate the safety and efficacy of alagebrium in subjects diagnosed with heart failure. this is a randomized, double-blind, placebo-controlled trial to assess the effects of 400 mg (2 x 100 mg bid) of alagebrium versus placebo over 9 months. 100 subjects will be studied (50 per treatment group) in approximately 6 centers. procedures: exercise testing (vo2 max; the primary variable), ecgs and blood sampling.


Eligibility criteria:
inclusion criteria: * nyha ii-iv heart failure * echocardiographic ejection fraction ≤ 45% (echo does not need to be repeated at the screening visit if a prior echo is on record which indicates an ejection fraction \< 40%) * duration of heart failure \> 3 months * stable heart failure medical therapy for \> 1 month * patients need to be able to understand content of and willing to provide informed consent exclusion criteria: * patient ≤ 18 years * history of myocardial infarction in previous 6 months * history of stroke/tia/rind in previous 6 months * severe valvular dysfunction * severe pulmonary disease * history of systemic inflammatory or collagen vascular disease * active and or treated malignancies within 12 months prior to inclusion * any significant condition either medical or non-medical that could lead to difficulty complying with the protocol * patients on cardiac resynchronisation therapy (crt) or scheduled for crt implantation * pacemaker therapy (unless rescue pacing at ≤ 40 bpm) or scheduled pacemaker implantation * history of valve replacement or surgery * uncontrolled diabetes mellitus (hba1c \> 9.5%) * clinically significant renal disturbance (smdrd calculated gfr≤30 ml/min/1.73m2; smdrd is calculated as 186 x serum cr (mg/dl)-1.154 x years-0.203 x (0.742 if female) x (1.210 if african american) * clinically significant liver disease (asat/alat \> 2,5 times the upper limit of normal) * severe anemia at baseline (hemoglobin \<10 g/dl or \<6.2 mmol/l) * use of any investigational drug(s) within 30 days prior to screening * pregnancy or active breast-feeding (urine pregnancy tests will be performed on all female subjects of childbearing potential)\* * active pericarditis/myocarditis * the inability of patients to undergo exercise testing

Keywords: chronic heart failure
effect of probiotics on immunosuppressive-drug-associated diarrhea among renal transplant recipients

Conditions: Renal Transplantation

Summary: the goal of this pilot project is to 1) examine whether oral administration of probiotics are helpful in reducing immunosuppressive drugs-associated diarrhea and adhering to the required dose of immunosuppressive drugs and 2) determine how this treatment works by examining fecal microbiome and immunological markers among living and deceased donor renal transplant recipients. the main questions it aims to answer are: 1. does low dose probiotics effective in reducing immunosuppressive drugs-associated diarrhea? 2. does probiotics effective in reducing inflammation? 3. is there any connection between fecal microbiome and immunological markers? participants will receive one probiotics capsule or placebo capsule daily for 6 months from the onset of diarrhea post-surgically. researchers will compare the data obtained through probiotics group and placebo group to answer the above mentioned research questions.


Eligibility criteria:
inclusion criteria: * received living or deceased donor kidney, subjects will be monitored peri-operatively * presence of mild to severe diarrhea (\> 3 times loose stools/day); include type 6 and 7 in the bristol stool chart. * has been on adjusted and/or maintenance dose of calcineurin inhibitors, antimetabolites and steroid regimen. treatment of rejection including administration of steroids, intravenous immunoglobulin/plasmapheresis, rituximab and anti- thymocytes are also acceptable in this research. exclusion criteria: * pregnant and lactating women * has been receiving probiotics treatment * recurrence of gastrointestinal diseases including inflammatory bowel diseases, diverticulosis, irritable bowel syndrome. had past surgical history of gastric bypass. * diagnosed with cancer * presence of infectious diarrhea, fever and high white blood cells (wbc) count. infectious diarrhea is defined by polymerase chain reaction (pcr) negative for community acquired diarrhea panel \[positive for sapo virus, noro virus, clostridium difficile (positive for toxin a and b), yersinia enterocolitica \[(positive for toxin a and b) and enteropathogenic e. coli (positive shiga toxins)\].

Keywords: probiotics immunosuppressive drugs renal transplantation diarrhea living donor deceased donor
ily robotic system vs manual flexible ureteroscopy for kidney stone treatment

Conditions: Kidney Stones; Urolithiasis

Summary: the goal of this clinical trial is to compare the efficacy, ergonomics, and safety of robotic versus manual flexible ureteroscopy (furs) for kidney stone treatment in adult patients undergoing laser lithotripsy. * does robotic-assisted lithotripsy using the ily® robot have the same efficacy as the manual furs in treating kidney stones? * is robotic flexible ureteroscopy associated with similar or improved safety outcomes, including perioperative and 30-day postoperative complication rates? * does the robotic system offer improved ergonomics, lower surgeon radiation exposure, and favorable intraoperative metrics compared to manual flexible ureteroscopy? researchers will compare the ily robotic system with manual furs to see if robotic intervention can match or improve clinical and ergonomic outcomes. participants will: * be randomly assigned to undergo laser lithotripsy with either the ily robot or manual flexible ureteroscopy * complete standard pre- and postoperative assessments * undergo evaluation for stone-free status using a non-contrast ct scan at 30 days postoperatively * undergo evaluation for postoperative complications


Eligibility criteria:
inclusion criteria: * males or females ≥ 18 years old * patients with a normal pelvicalyceal anatomy * patients with renal stone diagnosis confirmed by noncontrast computed tomography regardless of stone size, location, and multiplicity * asa score i-iii * intact mental and cognitive ability to provide informed consent and willingness to participate in the study with 30-day follow-up exclusion criteria: * children \< 18 and pregnant women * patients with anatomically anomalous kidneys, known case of stricture or stenosis, or recent 3-month history of ureteroscopy (dj stent placement only will be accepted) or known history of complicated ureteroscopy * patients in whom stone measurement was not feasible on ncct or those with concomitant ureteric stones. * asa score iv * mentally incapacitated patients unable to provide informed consent

Keywords: kidney stones manual flexible ureteroscopy furs ily robot robotic
evaluation of immunogenicity of covid-19 vaccine in chinese population

Conditions: COVID

Summary: the purpose of this study is to evaluate the immunogenicity and immune protection of covid-19, especially the recently prevalent strains, against the background of current immunization in chinese population


Eligibility criteria:
inclusion criteria: 1. he was infected with covid-19 from november to december 2022; 2. have not been infected with covid-19 (the subject said that he was not infected and signed the informed consent form); 3. those who agree and sign the informed consent form. exclusion criteria: 1. missing or incomplete questionnaires that affect research results; 2. individuals with combined dysfunction of important organs such as the heart, liver, and lungs; 3. mental and behavioral abnormalities; 4. intellectual disability; 5. under 18 years old or over 75 years old; 6. low understanding and communication skills.
cohort study in fujian province

Conditions: Chronic Disease

Summary: in this study, chinese residents aged 35 to 75 years old were recruited from fujian province. physical examination, questionnaire survey and biological sample collection were performed at baseline, and at least 4 years of follow-up were conducted. information on newly discovered cardiovascular metabolic illnesses and comorbidities was collected during follow-up, and repeated surveys similar to baseline were conducted. to explore the relationship between environment, diet and lifestyle and the risk of cardiovascular metabolic diseases and concomitant disorders.


Eligibility criteria:
inclusion criteria: * aged 35-75, having lived in fuzhou, putian, quanzhou, nanping, xiamen, zhangzhou, longyan, sanming, or ningde in fujian province for more than 6 months. exclusion criteria: * anyone diagnosed with coronary heart disease, stroke, or cancer. * anyone with a severe disability who is unable to participate in the study.

Keywords: cardiovascular and metabolic disease comorbidity
phase iii study of chondrocyte alginate gel suspension in pediatric patients with vesicoureteral reflux

Conditions: Vesicoureteral Reflux

Summary: objectives: i. determine the safety and efficacy of chondrocyte alginate gel suspension in pediatric patients with vesicoureteral reflux. ii. determine the long term efficacy of this treatment regimen in this patient population. iii. evaluate the short and long term avoidance of surgery or antibiotic therapy after this treatment regimen in this patient population. iv. estimate the risk:benefit ratio of this treatment regimen in these patients.

protocol outline: this is a multicenter study. patients undergo biopsy of the auricular cartilage for chondrocytes during cystoscopic evaluation on day 1. chondrocyte alginate gel suspension is injected into the submucosa of the bladder at the vesicoureteral junction between days 40-50. patients found to have post treatment reflux may be retreated once. patients are followed at 1, 3, and 12 months.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * confirmed grade 3 or 4 reflux in at least one ureter by voiding cystourethrogram breakthrough urinary tract infection despite standard antibiotic therapy or persistent reflux unlikely to resolve spontaneously * grade 3: 2 year reflux duration or 1 breakthrough infection grade 4: 1 year reflux duration or 1 breakthrough infection * coexisting grade 1 or 2 reflux or resolved reflux (i.e., contralateral to the existing grade 3 or 4 refluxing ureter) allowed * no reflux secondary to obstruction or neuropathic disease * no gross urological abnormalities (e.g., megaureter requiring ureteral tapering or duplicity of ureters) --prior/concurrent therapy-- * surgery: no prior surgery for correction of reflux no recent prior urological device implantation --patient characteristics-- * hematopoietic: no history of bleeding disorders * cardiovascular: no history of hypertension or cardiac disease * pulmonary: no history of pulmonary disease * other: no known allergies to contrast dyes, iodine, or shellfish no contraindications to general anesthesia no prior infections (other than utis) no immunodeficiencies no metabolic disease no social situation that would interfere with follow up not pregnant negative pregnancy test

Keywords: rare disease renal and genitourinary disorders vesicoureteral reflux
mannitol use during partial nephrectomy prior to renal ischemia and impact on renal function outcomes

Conditions: Renal Cancer

Summary: the purpose of this study is to determine if a medication called mannitol, can help the kidney maintain its function after kidney surgery. mannitol is used to cause an increase in urine production (it is a diuretic). for many years, mannitol has been given to patients in the hope it would improve the kidney's circulation, and in doing so reduce the impact of the surgery on the kidney. mannitol is given during the surgery before the blood supply to the kidney is stopped. the blood supply to the kidney is stopped in order to minimize any blood loss during the removal of the tumor, and also to assist the surgeons view of the kidney anatomy. once the tumor is removed the blood supply to the kidney is resumed. sometimes a side effect of this temporary reduction in blood supply to the kidney is the loss of some kidney function. this may happen either in the short term (right away) or long term (months or years later). in studies done on animals, mannitol was able to lessen this damage to kidney function. however, no human study has ever confirmed that mannitol has the same helpful effect in humans. there is some suggestion that it may have no effect. because sufficient research has yet to be done on humans, many surgeons do not give mannitol. a recent study, conducted at memorial sloan kettering which looked back at patients who had undergone partial nephrectomies, an operation where only the portion of the kidney that contains the tumor is removed and enables the normal, unaffected portion of the kidney to be preserved. the results of this study demonstrated no significant difference in kidney function when the investigators compared patients who were given mannitol to those who were not. the investigators hope that this study will help clarify the effectiveness or not of mannitol on kidney function. during the surgery to remove the kidney tumor, patients will receive either mannitol or a placebo. a placebo, is a harmless medication that has no effects. the impact of mannitol compared to the placebo will be assessed by routine blood tests and imaging (kidney scan) 6 months after your surgery.


Eligibility criteria:
inclusion criteria: * age \> or = to 18 years * scheduled for partial nephrectomy at mskcc (open or minimally invasive technique) during which renal ischemia is anticipated * preoperative egfr \> 45 cc/min/1.73m2 as measured by the ckd-epi study equation exclusion criteria: * allergy to mannitol * severe renal impairment (stage 3b) defined as egfr \< 45 cc/min/1.73m2 as measured by the ckd-epi calculation. * combined major surgical cases that include a partial nephrectomy.

Keywords: kidney mannitol placebo partial nephrectomy 12-079
the hypothalamic-pituitary-adrenal (hpa) axis as an effector system in weight regulation

Conditions: Obesity; Addison's Disease

Summary: replacing glucocorticoid in a dose dependent manner (including doses within the physiological range) to subjects with adrenal insufficiency will increase visceral fat accumulation independently of total fat mass.

to measure total fat mass by dexa scan, central (visceral) fat accumulation, insulin sensitivity by fsivgtt, lipid levels, and adipocyte gene expression in subjects with ai receiving increasing doses of hydrocortisone replacement (15 mg, 25 mg, and 40 mg per day in split doses) for 4-months at a time during ad-lib feeding.

Eligibility criteria:
inclusion criteria: * subjects with complete adrenal failure as defined as spontaneous serum cortisol of levels less than 5 g/dl after 12 hours without glucocorticoid replacement and peak serum cortisol of \< 5 g/dl 60 minutes after a 250 g acth stimulation test. * subjects who are at their usual weight (weight stable for at least 1 year) * subjects on stable replacement doses of any required hormone such as thyroid, sex hormones, mineralocorticoid replacement, growth hormone, and hydrocortisone for at least 6 months, and 4) have a normal body weight (bmi 19-27 kg/m2). exclusion criteria: * possible confounders on body weight and insulin resistance * age less than 18 to exclude those who might be experiencing alterations in cortisol production or weight as a result of adolescent growth. * subjects who exercise \> 30 minutes/day, 3 times a week. * smokers. * heavy alcohol drinkers (\> 2 drinks/ day). * subjects with medical diagnosis including diabetes, heart disease, and cancer. * subjects with psychiatric illness (i.e., depression, psychosis, bipolar, schizophrenia; or are taking medications for these disorders).
epic-p intervention

Conditions: HIV

Summary: this non-randomized, open-label study will address the following research aims in people who inject drugs (pwid): * to assess the feasibility and acceptability of the expanding prep implementation in communities of pwid (epic-p) intervention among high-risk pwid. * to determine the preliminary efficacy of the epic-p intervention in terms of increasing adherence to prep and primary hiv prevention among high-risk pwid.

a non-randomized, open-label design will be utilized to test the feasibility, acceptability, and preliminary efficacy of the expanding prep implementation in communities of pwid (epic-p) intervention among high-risk people who inject drugs (pwid) with opioid dependence (n=100). since the aim of this pilot study is to establish whether the epic-p intervention is feasible/acceptable among at-risk pwid in a community-based setting, proposed is a non-comparative design. with the hopes to target pwid who are not linked with existing harm reduction services, proposed is to recruit participants using respondent driven sampling (rds), a chain referral method with demonstrated success in recruiting hard-to-reach populations. initial rds participants, called "seeds," will be carefully recruited from the community where the study team leadership have built a well-established relationship. participants enrolled in the study will be assessed at baseline and will be followed for 9 months (with follow-up assessments at 3- and 6-months) by trained research assistants. importantly, structured interviews will be conducted at follow-up visits to examine the barriers and facilitators and feedback about optimal implementation of the epic-p intervention.

Eligibility criteria:
inclusion criteria: * residing in the greater new haven area; * confirmed hiv-negative; * reporting injection drug use (past 3 months) with substantial ongoing risk for hiv acquisition; * started on prep (within the last week). exclusion criteria: * not on prep; * not available during the full duration of the study; * cannot speak english; * unable to provide consent; * anyone actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of a consultant that is a licensed clinical psychologist.
a clinical trial to compare the pharmacokinetics of a pregabalin glars-nf1 tablet 150mg with immediate release formulation and to assess the effect of high fat diet in healthy male subjects

Conditions: Healthy

Summary: the purpose of this clinical trial is to compare the pharmacokinetic characteristics of gla5pr glars tablet 150mg and lyrica capsule 75mg. gla5pr glars tablet 150mg is a new formulation which is made by gl pharm tech. glars(geometrically long absorption regulated system) is new solution to sustained absorption by extending the absorption site. to overcome the shortcomings of the currently existing sustained release drug delivery technologies the investigators have recently developed a novel drug delivery system to enable a drug to be dissolved irrespective of the surrounding environment and further absorbed up to colon. the investigators coined this "geometrically long absorption regulated system(glars)".

basically, this system is a triple-layered tablet, comprised of upper and lower layers that swell and draw a sufficient amount of water, plus a highly water - soluble middle layer that rapidly draw water into the tablet core simultaneously. the water drawn into the tablet (about 3 to 4 times the weight of the tablet itself) functions as an additional media which enables additional and later drug release out of the dosage form. this serves to overcome the shortage of surrounding media that has been reported to be one of the key reasons for mal-absorption of a drug in colon. as the middle layer induces a rapid water draw into the tablet core, the penetrated water also diffuses to the upper and lower layers, which makes the tablet to rapidly swell and controls drug release. at virtually the same time, the swollen upper and lower layers form to surround a lateral side of the middle layer, which can, in turn, further control drug release. this relatively rigid swollen matrix structure makes drug release not affected by surrounding mechanical flux, which can provide relatively consistent in vivo drug release irrespective of degree of gastrointestinal motility.

Eligibility criteria:
inclusion criteria: * 20\~45 years old, healthy adult male subject * 17.5\~30.5kg/m2(bmi) and ≥ 45kg exclusion criteria: * sbp ≥ 140mmhg or dbp ≥ 90mmhg
the efficacy of b6 and metoclopramide combination in comparison with the other antiemetics

Conditions: Vomiting

Summary: this study investigates the effectiveness of combining vitamin b6 (pyridoxine) and metoclopramide compared to standard antiemetic treatments for managing nausea and vomiting. through a prospective, randomized controlled trial involving adult patients with diverse causes of nausea and vomiting, we aim to evaluate the frequency, severity, and tolerability of the b6 and metoclopramide combination. by elucidating its comparative efficacy against established antiemetics, this research seeks to provide evidence-based guidance for clinicians in selecting optimal treatment regimens tailored to individual patient needs, ultimately enhancing the management of nausea and vomiting across various medical conditions.

title: investigating the efficacy of b6 and metoclopramide combination versus alternative antiemetics: a clinical trial proposal introduction: nausea and vomiting are common symptoms across various medical conditions and can significantly impact patients' quality of life and treatment outcomes. while several antiemetic medications exist, finding the most effective regimen remains a clinical challenge. this proposal aims to investigate the efficacy of a combination therapy comprising vitamin b6 (pyridoxine) and metoclopramide compared to other antiemetics in managing nausea and vomiting. rationale: both vitamin b6 and metoclopramide have shown antiemetic properties through different mechanisms of action. however, the comparative efficacy of this combination therapy against other standard antiemetics remains largely unexplored. understanding the relative effectiveness of this combination could provide valuable insights into optimizing antiemetic strategies, particularly in patients with chemotherapy-induced nausea and vomiting (cinv), postoperative nausea and vomiting (ponv), and other related conditions. objectives: this prospective, randomized controlled trial aims to evaluate the efficacy of b6 and metoclopramide combination therapy compared to alternative antiemetic regimens in reducing the frequency and severity of nausea and vomiting episodes in adult patients. additionally, the study seeks to assess the safety profile and tolerability of the combination therapy. conclusion: by elucidating the comparative efficacy of b6 and metoclopramide combination therapy, this study endeavors to contribute to evidence-based decision-making in the management of nausea and vomiting. the findings could potentially guide clinicians in selecting the most appropriate antiemetic regimen tailored to individual patient needs, ultimately improving patient outcomes and quality of life.

Eligibility criteria:
inclusion criteria: * any patients with vomiting exclusion criteria: * patients vitally unstable

Keywords: vomiting b6 vitamin metoclopramide zofran
study to assess the longterm safety of sildenafil citrate in patients with pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension


Eligibility criteria:
inclusion criteria: * patients with pah who had completed the 12 week pivotal study exclusion criteria: * any other patients with pah that had not been included into the pivotal study