Kornimate/medical-research-clean huggingface dataset:
randomized controlled trial of urine chemistry guided acute heart failure treatment (escalate)

Conditions: Heart Failure; Acute Heart Failure

Summary: this is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared to structured usual care in ed patients with ahf. participants will be recruited following an initial standard evaluation in the ed and randomized in a 1:1 fashion to structured usual care or protocolized diuretic therapy guided by urinary sodium.

a standardized protocol driven treatment pathway for hospitalized patients started in the first few hours of ed evaluation and utilizing objective measures of diuretic response is needed. the investigators believe this would maximize diuretic efficiency, facilitate quicker resolution of congestion, avoid whf and prolonged los, and reduce ahf readmissions. propr data suggests low urine sodium predicts length of stay and outcomes after initial diuretic dosing in the outpatient and inpatient setting. further, use of our pathway using spot urine sodium to titrate subsequent loop diuretic doses and maximize response in inpatients with ahf has shown compelling improvements in congestion and weight loss. however, a randomized trial is necessary to determine if initiating this protocol ,started in the ed, will improve ahf outcomes relative to structured usual care. specifically, the investigators hypothesize use of spot urine sodium guided diuretic therapy will result in significant improvement in days of benefit over the 14 days after randomization. days of benefit combines patient symptoms captured by global clinical status with clinical state quantifying the need for hospitalization and iv diuresis.

Eligibility criteria:
inclusion criteria: * age \> 18 * emergency department diagnosis of acute heart failure (ahf) * any one of the following: i. chest radiograph or lung ultrasound consistent with ahf ii. jugular venous distension iii. pulmonary rales on auscultation iv. lower extremity edema v. s3 gallop * \> 10 pounds of volume overload physician estimate or historical dry weight * iv diuretic ordered or planned to be during first 24 hours of ed or inpatient stay exclusion criteria: * end stage renal disease (esrd) requiring dialysis * need for immediate intubation * acute coronary syndrome - presentation consistent with myocardial ischemia and new st-segment elevation/depression * temperature \> 100.5ºf * end stage heart failure: transplant list or ventricular assist device * concurrent use of ototoxic medications including intravenous aminoglycosides and cisplatin * systolic blood pressure \< 90 mmhg at time of consent * lv outflow obstruction, severe uncorrected stenotic valvular disease or severe restrictive cardiomyopathy * greater than 2 doses of iv diuretic administered at the time of screening from the time of the hospital presentation leading to this admission (outside hospital time is included) * severe, uncorrected serum electrolyte abnormalities at the time of consent (serum potassium \ 150 meq/l) * lack of informed consent

Keywords: diuretic therapy emergency department
acupuncture combined with mirabegron in the treatment of oab

Conditions: Overactive Bladder

Summary: introduction: as conventional treatments for overactive bladder (oab) have not yet shown satisfactory results, new approaches are needed. therefore, this study aimed to investigate the efficacy and safety of acupuncture combined with mirabegron for the treatment of oab. methods: this prospective cohort study enrolled 80 oab patients who were then divided into control and treatment groups using a randomized number-table method. the control group was administered mirabegron alone (50 mg/day), while the treatment group was administered mirabegron orally along with acupuncture at the following points: guanyuan (cv4), zhongji (cv3), and sanyinjiao (sp6). the oab symptom score (overactive bladder syndrome score \[oabss\]), voiding, urgency, nocturia, incontinence, and incidence of related adverse events were compared between the two groups at baseline and after 4, 8, and 12 weeks of treatment.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of oab * good compliance * good communication skills exclusion criteria: * age \ 75 years * history of use of m-blockers in the recent 4-6 weeks * history of use of α-blockers in the recent 4-6 weeks * history of use of mirabegron in the recent 4-6 weeks * diagnosis with a combined urinary tract tumor * inability to cooperate with this study * pregnancy * postvoid residual urine volume \>150 ml

Keywords: overactive bladder mirabegron acupuncture nocturia incontinence
buprenorphine maintenance dose schedule and treatment setting - 2

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to evaluate the efficacy of treating opioid-dependent individuals with buprenorphine on a thrice-weekly schedule compared to daily dosing.


Eligibility criteria:
please contact site for information.

Keywords: opioid-related disorders
phase 3 trial to evaluate the efficacy and safety of ckd-202a

Conditions: Essential Hypertension

Summary: phase 3 trial to evaluate the efficacy and safety of ckd-202a(sacubitril∙valsartan)


Eligibility criteria:
inclusion criteria: * participants who are 19 years old or older. * participants who have voluntarily decided to participate in this clinical trial and signed icf. exclusion criteria: * participants with a history of secondary hypertension or suspected secondary hypertension. * participants with a orthostatic hypotension. * participants who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period. * participants with type 1 diabetes or poorly controlled diabetes. * participants who treated other clinical trial drugs within 4 weeks of screening visit. * participants with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening * pregnant women, lactating women, or subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug * participants who are unable to participate in this clinical trial at the discretion of the investigator.
datscan with prototype collimator

Conditions: Parkinson Disease

Summary: a collimator is an accessory to a spect/ct scanner. it can be compared to a camera lens or filter that enhances or improves photos. the prototype collimators are able to magnify target organs about four times compared to the current collimators. in this study we are validating a new collimator design, which will allow for quantitative measurement of dopamine receptors within the brain, not previously performed using a single photon gamma camera.

previously pet/ct has been used for this measurement but the l-dopa is not fda approved and thus of limited availability. datscan (i123 ioflupane) is an fda approved and clinically indicated biomarker, which has a high binding affinity for presynaptic dopamine transporters (dat) in the brains of mammals, in particular the striatal region of the brain. a feature of parkinson's disease is a marked reduction in dopaminergic neurons in the striatal region. by introducing an agent that binds to the dopamine transporters a quantitative measure and spatial distribution of the transporters can be obtained. the use of spect/ct (with the new validated collimators) and the fda approved datscan biomarker would allow for readily available diagnosis of parkinson's disease

Eligibility criteria:
inclusion criteria: * all patients referred exclusion criteria: * anyone who wishes to not participate and cannot lay on the table for an additional 30 minutes.
combination of rad001 with carboplatin, paclitaxel and bevacizumab in non-small-cell lung cancer (nsclc) patients

Conditions: Non Small Cell Lung Cancer

Summary: this 2 step study aims to establish a tolerable dose level and regimen of rad001 in patients with advanced nclc not previously treated with systemic therapy. in step 1 of this study, rad 001 is given in combination with carboplatin and paclitaxel and in step 2 rad001 is given in combination with carboplatin, paclitaxel and bevacizumab

this is a two-step, open-label, multi-center, dose escalation phase 1 study in which rad001 is administered in combination with carboplatin and paclitaxel (cp) in step 1 as well as carboplatin, paclitaxel, and bevacizumab (cpb) in step 2 in patients with advanced (unresectable or metastatic) nsclc not treated previously with systemic therapy for advanced disease

Eligibility criteria:
inclusion criteria: * age over 18 years * advanced non small cell lung cancer (stage iiib/iv) * ability to perform normal daily functions exclusion criteria: * chronic steroid treatment * prior treatment with chemotherapy for advanced lung cancer * prior treatment with mtor inhibitors * active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions * known sensitivity to platinum compounds, taxanes or bevacizumab * other cancers within the past 5 years * pregnant or breastfeeding women other protocol-defined inclusion/exclusion criteria may apply

Keywords: non small cell lung cancer nsclc advanced lung cancer rad rad001 chemotherapy carboplatin paclitaxel bevacizumab
parathyroidectomy in endstage renal disease

Conditions: Endstage Renal Disease

Summary: to test the hypothesis that total parathyroidectomy retards cardiovascular calcification, improves bone mineral density, reduces cardiac hypertrophy and arterial stiffening in end-stage renal disease patients on maintenance dialysis.

secondary hyperparathyroidism (shpt) in patients with end-stage renal disease contributes to increased cardiovascular morbidity and mortality via different mechanisms. uncontrolled hyperparathyroidism is associated with left ventricular hypertrophy and has been implicated in the development of cardiac interstitial fibrosis and diastolic dysfunction.

Eligibility criteria:
inclusion criteria: * endstage renal disease patients receiving either long-term hemodialysis or peritoneal dialysis treatment, with elevated intact parathyroid hormone (ipth) levels \> 500pg/ml on two or more occasions. * patients with parathyroid nodular or diffuse hyperplasia identified by ultrasound imaging or radioisotope scan. * patients who provide informed consent for the study. exclusion criteria: * patients with significant background valvular heart disease * patients who are unfit for general anaesthesia * patients with acute myocardial infarction within recent two months * patients with poor general condition * patients with plans for living related kidney transplant within 1 year * patients with previous history of parathyroidectomy * patients with calciphylaxis * patients with underlying active malignancy * patients with contraindication for mri

Keywords: parathyroidectomy cardiovascular bone endstage renal disease
a comparative study between anterior and posterior pyelotomy in transperitoneal laparoscopic pyelolithotomy

Conditions: Large Renal Stone

Summary: large renal pelvic stones are frequently managed with percutaneous nephrolithotomy (pcnl) but laparoscopic pyelolithotomy (lpl) can be an alternative procedure when performed by skilled surgeons to achieve excellent outcomes in terms of stone free status, operative time, postoperative kidney function, hospitalization duration, and complications. there are two methods for lpl surgery : transperitoneal (tlp) and retroperitoneal (rlp). rlp associated with shorter mean time for oral intake, and mean hospital stay after surgery. the surgical exposure in the transperitoneal route for lp is familiar to the majority of surgeons. also, a much larger working space is available and there are various established anatomical landmarks for performing the surgery effectively. this study introduces a modified technique that creates application of posterior pyelotomy in tlp to achieve the advantages of rlp

this is a randomized controlled clinical trial that aims to collect a sample within two years from the date of approval of the scientific research council at damascus university. the study will focus on a group of patients who will undergo a transperitoneal laparoscopic pyelolithotomy surgery. the patients will be randomly divided into two groups. the first group will undergo a traditional transperitoneal laparoscopic pyelolithotomy, which involves application of anterior pyelotomy. the second group will receive a modified transperitoneal laparoscopic pyelolithotomy, which involves application of posterior pyelotomy. the data will be compared between the two groups in terms of the mean duration of surgery ,mean time for oral intake ,and mean hospital stay

Eligibility criteria:
inclusion criteria: * patients with large renal pelvic stone \> 2 cm . * failure of minimally invasive approaches such as pcnl or eswl * stones that were neither amenable to eswl nor were ideally suitable for pcnl * patient's preference for a quick one-stage procedure. * negative urine culture exclusion criteria: * patients refusing study participation. * contraindication to general anesthesia. * contraindication to laparoscopic surgery. * patients with an intrarenal pelvis. * previous surgical on the same kidney. * associated anatomical deformity.

Keywords: pyelotomy laparoscopic pyelolithotomy, pelvic stone kidney stone
nab-paclitaxel and s-1 in patients with locally advanced pancreatic cancer

Conditions: Locally Advanced Pancreatic Cancer

Summary: this study is a single-arm, multi-center, open-label prospective phase ii clinical study designed to evaluate the efficacy and safety of nab-paclitaxel and s-1 in patients with locally advanced pancreatic cancer. a total of 60 subjects who meet the criteria will be treated with nab-paclitaxel and s-1. the primary endpoint is 6 months progression free survival rate, and secondary endpoints include objective response rate, overall survival, progression free survival and toxicities.


Eligibility criteria:
inclusion criteria: 1. patients have good compliance, can understand the research process of this study, and sign a written informed consent 2. patients with pathologically confirmed pancreatic adenocarcinoma. 3. patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer; 4. patients with locally advanced pancreatic cancer ( nccn version 1，2019 criteria). 5. ecog ps 0-1; 6. tumor size is measurable according to recist1.1 criteria 7. expected survival over 3 months; 8. bone marrow function: neutrophils≥1.5x109/l, platelets ≥100x109/l, hemoglobin≥ 90g/l; 9. liver and kidney function: serum creatinine≤1.5ult; ast and alt≤ 2.5 ult; total bilirubin ≤ 1.5 ult; 10. no contraindications to the use of s-1 and nab-paclitaxel. exclusion criteria: 1. ≥ grade 2 existing peripheral neuropathy; 2. any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer. 3. active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment. 4. severe, active co-morbidity, defined as follows: unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months transmural myocardial infarction within the 6 months of study registration uncontrolled hypertension, diabetes or arrhythmia. chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization. 5. not able to take medicine orally. 6. pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study; 7. participation in other clinical trial within 30 days before the first dose of the drug;
arch dimension and inclination of the upper and lower incisors changes

Conditions: Malocclusion, Angle Class I

Summary: it is intended to evaluate changes in arch dimensions and incisor inclination as well as changes in the wala ridge in no extraction patients treated with interactive self-ligating brackets (empower®) and passive (carriere slx®) at the end of the phase of alignment and leveling. for this, study models and profile radiographs taken before the start of treatment and at the end of the alignment and leveling phase will be evaluated. the parameters to be measured are: intercanine distance, arch depth, upper and lower incisor inclination, and wala ridge analysis


Eligibility criteria:
inclusion criteria: * complete permanent dentition, except third molars. * class i malocclusion, determined by angle anb 2 plus or minus 2 * visible alveolar teeth and ridges in plaster models, the latter being compatible and checked against the morphology of the wala ridge clinically presented by the patient. * little index with minimum irregularity 4-6 mm. * patients with x-rays of initial profile and at the end of alignment and leveling in good condition. exclusion criteria: * models in poor condition that do not allow measurements. * patients who do not wish to participate in the study * patients with cleft lip and palate * patients with craniofacial anomalies * patients with previous orthodontic treatment
clinical study of treatment of acute spinal cord injury by near infrared light irradiation

Conditions: Spinal Cord Injuries; Photobiology; Neurological Rehabilitation; Near Infrared Light Irradiation

Summary: the purpose of this study was to observe the therapeutic effect of near-infrared light irradiation on the treatment of acute spinal cord injury in humans, and whether it can promote the recovery of neurological function. half of the patients underwent laminectomy and decompression surgery, and the other half of the patients were implanted with irradiated fibers for irradiation after surgery.

the annual incidence of spinal cord injury has increased year by year, and there is currently no effective treatment. near-infrared light has been widely used in clinical medicine because of its bio-stimulating effect, convenient use, harmless to the body, easy to be accepted by patients, and convenient for clinical promotion. the near-infrared light biostimulation effect can enhance the activity of various enzymes, inhibit inflammatory cells, inhibit neuronal apoptosis, and promote nerve regeneration. it has been widely confirmed and widely used in the rehabilitation of central nervous system and peripheral nerve injury. however, the position of the spinal cord is deep, and the depth of illumination used by laser treatment equipment is generally difficult to reach. the implantable 360° scattering fiber the investigators developed was implanted in the surgical site together with the drainage tube for irradiation treatment without additional patient damage.

Eligibility criteria:
inclusion criteria: * diagnosed as acute spinal cord injury (asia grade a-c) (thoracic segment) requiring surgical laminectomy * the patient determined by the investigator to be eligible for the illuminating fiber implanted in this clinical trial * the patient fully understands the content and requirements of this clinical trial and is able to complete the follow-up according to the time specified in the protocol * voluntary participation in clinical validation and signing informed consent exclusion criteria: * the patient has a systemic infection or a local infection at the target surgical site * the patient has more than 2 segments of spinal cord injury, and the vital signs are unstable * a patient with a malignant tumor that does not involve the target surgical site * patient life expectancy is less than one year * pregnant or lactating women * the patient is too obese, bmi ≥ 40 * patients with other systemic diseases who are using corticosteroids, or patients with growth factors, or long-term use of non-steroidal anti-inflammatory drugs * patients have a history of endocrine diseases affecting bone metabolism (such as diabetes, metabolic bone disease, etc.) or autoimmune diseases (such as multiple sclerosis) * alcohol abuse within one year (average daily alcohol consumption \> 40g, equivalent to 50ml alcohol 50ml, or smoking ≥ 40 / day, or drug abusers) * participating in other drug or device clinical trials
a study comparing ly900014 to insulin lispro (humalog) in children and adolescents with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the reason for this study is to compare the study drug ly900014 to insulin lispro (humalog) in children and adolescents with type 1 diabetes (t1d).


Eligibility criteria:
inclusion criteria: * t1d for at least 6 months at the screening visit. * have been treated with only one of the following rapid-acting insulin analogs as part of an multiple daily injection regimen for at least the last 90 days prior to the screening visit: * insulin lispro u-100, or * insulin aspart * insulin glulisine or * fast acting insulin aspart * have been treated with only one of the following basal insulins for at least the last 90 days prior to the screening visit: * insulin glargine u-100 (once a day \[qd\] or twice a day \[bid\]), or * insulin detemir u-100 (qd or bid), or * insulin degludec u-100 (qd) * have a hba1c value ≤ 9.9% at the screening visit. exclusion criteria: * have current hypoglycemic unawareness or have had more than 1 episode of severe hypoglycemia within 6 months prior to the screening visit. * have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to the screening visit. * have been on a treatment regimen that includes regular human insulin, neutral protamine hagedorn (nph), afrezza® (insulin human) inhalation powder, any premixed insulins or use of diluted insulins within 90 days prior to the screening visit.

Keywords: prandial insulin multiple daily injections pediatric patients postmeal dosing
late phase ii clinical study of klh-2109 in patients with endometriosis

Conditions: Endometriosis

Summary: the purpose of this study is to evaluate the efficacy, safety, and dose-response relationship of klh-2109 compared to placebo in japanese patients with endometriosis.


Eligibility criteria:
inclusion criteria: * female patients with endometriosis exclusion criteria: * patients with clinically significant hepatic, renal, or cardiovascular dysfunction

Keywords: endometriosis