Kornimate/medical-research-clean huggingface dataset:
naproxen for pain control with intrauterine device insertion

Conditions: Contraception

Summary: the purpose of this study is: 1. to evaluate whether 550 mg of naproxen sodium reduces pain scores with iud insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome). 2. to evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale compared to placebo (secondary outcomes). 3. to establish if prophylactic naproxen sodium is acceptable for routine use prior to iud insertion. hypothesis: the administration of naproxen sodium, 550mg orally, 1 hour prior to iud insertion will lead to a reduction in pain scores associated with iud insertion compared to placebo.


Eligibility criteria:
inclusion criteria: * age 18 years or older * premenopausal * presenting for insertion of any iud type (i.e. mirena, paragard, skyla) * english-speaking or non-english speaking with appropriate translator available exclusion criteria: * currently pregnant or pregnant within the last 4 weeks * not eligible for iud insertion per pplm's clinical protocols * presenting for iud removal and reinsertion * any diagnosis of chronic pain (including fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis) * pain medications taken within 12 hours of enrollment * misoprostol usage within 24 hours of enrollment * any known allergy or contraindication to non-steroidal anti-inflammatory drugs (including active renal disease, active hepatic disease, gastric ulcer disease or gastritis, and bleeding disorders)

Keywords: contraception naproxen intrauterine devices pain control
microendoscopic discectomy vs transforaminal endoscopic lumbar discectomy vs open discectomy

Conditions: Lumbar Disc Herniation

Summary: in our study, a multicenter randomized controlled，single blind trial will be performed to evaluate the effectiveness and safety of these three procedures for the treatment of symptomatic lumbar disc herniation.

lumbar disc herniation (ldh) is one of the most common diseases in the department of orthopedics, which produced medical and economic burdens to families and society. in spite, the majority of the patients with disc herniation can be relieved or even cured via conservative treatment; there are still a considerable number of invalid patients who eventually still need to be undergoing a surgical operation treatment. three main methods for intervertebral disc surgery are adopted in our routine work. one procedure is open discectomy (od), which has been always a gold standard for treatment of ldh. and the other two procedures are microendoscopic discectomy (med) and transforaminal endoscopic lumbar discectomy (teld) respectively. med and teld have been developed as alternatives to od. od can compress the nerve root or spinal cord through removal of the protrusion. however, it destroys the rear structure of spine, causing segmental instability and long-term distress. compared with od, med and teld procedures are smaller incisions or less dissection (or both), lower blood loss, less postoperative pain, shorter hospitalisation and earlier return to work. however, the steep learning curves of mid inhibit the development of surgery specialists; for example, optimal surgical management requires many years of experience. these deficiencies need more educational effort at a higher priority than accorded so far. there are inconsistent outcomes about the efficacy and safety in the previous studies; all of the recent researches do not yield conclusive results.

Eligibility criteria:
inclusion criteria: 1. all forms of disc herniation were included in the study 2. history of concordant radicular leg pain refractory to conservative treatment for longer than 6 months 3. leg pain must be greater than back pain exclusion criteria: 1. cauda equine syndrome, 2. progressive neurologic deficit, 3. bilateral lower extremity symptoms, 4. low back pain more than leg pain 5. systemic infection or localized infection at the anticipated entry needle site 6. combined with lumbar infection, fracture of lumbar vertebra, tumor, ⅱ°and above spondylolisthesis, lumbar spinal stenosis, lumbar scoliosis is larger than 15 degree 7. with severe heart, brain, lungs, and other organs disease or mental illness 8. history of opioid abuse or patients currently on long acting opioid 9. history of the operation on lumbar 10. pregnancy
elu001 in pediatric subjects who have relapsed and/or refractory cbfa2t3-glis2-positive aml

Conditions: Acute Myeloid Leukemia; AML, Childhood; Relapsed Pediatric AML; Refractory Pediatric AML

Summary: this research study was planned to focus on a rare type of acute myeloid leukemia (with the subtype cbfa2t3::glis2 that overexpresses folate receptor alpha (frα) (a protein on the surface of leukemia cells)) that has relapsed or is refractory. relapse means the cancer has come back after treatment. refractory means the cancer does not respond to treatment.

this study was planned as a dose escalation safety study to identify the maximum tolerated dose (mtd) and/or the recommended phase 2 dose (rp2d). this study will also evaluate the tolerability of elu001. elu001 is not a drug approved by the fda (food and drug administration) yet.

Eligibility criteria:
key inclusion criteria: patients must meet the following criteria to enroll in this study: * infants (\>1 month) and children (≤9 years) at time of enrollment. * relapsed or refractory cbfa2t3::glis2 positive aml * cns1 or cns2 during screening * performance status: lansky ≥ 50 * adequate organ function including liver, kidney, and heart key exclusion criteria: patients who meet any of the following are not eligible to enroll in this study: * cns3 disease * aml associated with congenital syndromes such as down syndrome, fanconi anemia, bloom syndrome, kostmann syndrome or diamond-blackfan anemia, or bone marrow failure associated with inherited syndromes. * acute promyelocytic leukemia. * clinically significant active or chronic corneal disorder, particularly corneal epitheliopathy or any eye disorder that may predispose patient to this condition, or unable to comply with an age-appropriate ophthalmologic examination. * prior treatment with folate receptor-targeting anti-cancer agent(s) ≤ 21 days (or 2 half-lives must have elapsed before enrollment, whichever is longer), or received investigational anti-cancer treatment ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, prior to starting study drug, whichever is shorter.

Keywords: cbfa2t3-glis2 cbfa2t3::glis2 refractory folate receptor alpha acute myeloid leukemia elu001 exatecan c'dot drug conjugate c-dot c'dot childhood nanoparticle folate receptor aml relapsed
postoperative cognitive dysfunction in elderly urologic oncology patients (pocd)

Conditions: Postoperative Cognitive Dysfunction; Postoperative Delirium; Frailty

Summary: postoperative cognitive changes are more common in elderly patients, which can result in poor quality of life, loss of workforce, disability, early retirement, physical-social dependence, increased health care cost and premature mortality. postoperative cognitive complications are also quite common in extensive oncological surgeries. in this study, our aim is to evaluate the relationship between the development of postoperative cognitive dysfunction (pocd) in geriatric urologic oncology patients with brain injury and inflammatory markers \[s100 β, neuron specific enolase (nse), interleukin 6 (il-6) and high mobility group box-1 (hmgb-1 protein)\].

the incidence of pocd changes by age group, type of surgery, testing neuropsychological tests, timing of tests, and the method used for diagnosis. in non-cardiac surgery over the age of 60; the incidence of pocd was 26% in the postoperative 1st week and 10% in the postoperative 3rd month. although old age is an important risk factor, pocd incidence of up to 36.6% has been reported in a younger period. major cancer surgery is an important risk factor for development of pocd. numerous biomarkers such as; s100β, nse, human il-6, hmgb-1 protein; have been evaluated in studies to determine the diagnosis, prognosis, stage and treatment of pocd. in this study, our aim is to evaluate the relationship between the development of postoperative cognitive dysfunction (pocd) in geriatric urologic oncology patients with brain injury and inflammatory markers. (s100β, nse, human il-6 and hmgb-1 protein).the hypothesis of our study is that postoperative brain injury and inflammatory markers (s100β, nse, human il-6 and hmgb-1 protein) will be higher in patients who develop pocd compared to patients who do not develop pocd in geriatric urologic oncology surgery.

Eligibility criteria:
inclusion criteria: * patients over the age of 65 who are planned to undergo major urooncological surgery. exclusion criteria: * patients who refuse to participate in the study. * patients with severe hearing-vision problems. * patients with serious neurological-psychiatric disorders. * patients with language barrier. * patients with missing in any interventions. * patients with blood samples that are not suitable for the elisa.

Keywords: postoperative cognitive dysfunction frailty s 100β nse il-6 hmgb-1 protein nirs geriatric anesthesia
safety and exploratory efficacy study of ucmscs in patients with ischemic heart disease (seesupihd)

Conditions: Acute Myocardial Infarction; Myocardial Infarction; Ischemic Cardiomyopathy

Summary: the purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with ischemic heart diseases.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ischemic cardiomyopathy caused by acute occlusion or severe stenosis of anterior descending artery; * lvef (left ventricular ejection fraction): 25-45%; * age between 18 and 70, borh gender; * women of childbearing age agreed to take contraceptive measures during the whole study period; * no psychiatric illnesses and speaking dysfunction; * informed consent. exclusion criteria: * structural heart disease, valvular heart disease, refractory hypertension(unstable blood pressure control), lvef\<24%; * serious primary diseases of the liver, kidney and hematopoietic system, abnormal liver function(glutamic-pyruvic transaminase(alt), glutamic-oxaloacetic transaminase (ast) is 2 times higher than the normal value), creatinine(cr) is higher than the upper limit of the normal value; * patients suffered from severe arrhythmia; * patients suffered from stent thrombosis; * patients receiving immunosuppressive therapy; * patients have tumor or other lethal diseases (expectation of life\<6 months); * women who plan to be pregnant or are pregnant or nursing; * allergic constitution(allergic to more than two kinds of drugs,food, or pollen); * other clinical trial participants within 3 months; * investigators judge other conditions not suitable for inclusion.
ethanol induces skeletal muscle autophagy

Conditions: Alcoholic Liver Disease

Summary: in this study we plan to demonstrate that ethanol induces skeletal muscle autophagy to degrade maa adducts.

hypothesis: ethanol mediated modification of skeletal muscle proteins to form maa adducts that in turn induce skeletal muscle autophagy. patients with alcoholic steatosis, hepatitis and cirrhosis (n=10 each) will be recruited from the liver transplant nutrition clinic or the hepatology inpatient service and their body composition quantified using anthropometry, bioelectrical impedance analysis, ct image analysis and dexa if available. control subjects. controls will be recruited by advertisement. all control subjects will have a normal clinical history, physical examination, and screening chemistries. they will not have any significant medical conditions requiring the use of medications. their nutritional status within 20% of normal as defined by ideal body weight.

Eligibility criteria:
inclusion criteria: alcoholic liver disease: * clinical, biochemical, imaging criteria and liver biopsy where available * age 18 - 65 years old controls: * serum liver transaminases (i.e. alt and ast) 40 iu/l * normal liver ultrasound * age 18 - 65 years old exclusion criteria: for both groups - alcoholic liver disease and controls: * poorly controlled diabetes mellitus (hba1c\>9.5 g/dl) * untreated hyper- / hypo- thyroidism * patients on dialysis, renal disease with serum creatinine 1.5 mg/dl * active intravenous drug use * history of bowel surgery or gastric bypass surgery * medications known to alter muscle protein metabolism (i.e. corticosteroids, tamoxifen, high-dose estrogen, testosterone or anabolic steroids) * metastatic disease, advanced cardiac or pulmonary disease * pregnancy * coagulopathy- inr \>1.4 and platelet count \<80,000/ml.
change of neutrophil gelatinase-associated lipocalin(ngal) following sodium phosphate bowel preparation(pilot study)

Conditions: Acute Kidney Failure

Summary: oral phosphate purgative is the preferred bowel regimen on the basis of better tolerability, cost effectiveness, and efficacy. there are also numerous reports of patients with even previously normal renal function developing acute and chronic kidney disease after use of oral phosphate purgative. several uncontrolled case reports and case series suggest a potential link between oral phosphate and acute kidney injury and/or chronic kidney disease1. its use is contraindicated in patients with preexisting renal disease because of the risk for developing acute renal failure, so called acute phosphate nephropathy, or electrolyte disturbance. since most of the outpatients who are going to undergo a colonoscopy are exposed to this agent, it is important to detect or prevent vulnerable patients. we would seek a sensitive and rapid diagnosis method of acute kidney injury following sodium phosphate bowel preparation. within a few hours, ngal mrna is highly upregulated after kidney injury, such as renal ischemia-reperfusion and cisplatin nephropathy, ngal induction precedes the elevation of classical markers for kidney damage such as serum creatinine. the investigators will investigate the change of ngal following sodium phosphate bowel preparation.


Eligibility criteria:
exclusion criteria: * who takes ace-inhibitor, arb * has a renal or heart disease * has a serum electrolyte disturbance

Keywords: acute kidney failure colonoscopy neutrophil gelatinase-associated lipocalin
communication effectiveness in cancer treatment

Conditions: Malignant Neoplasm

Summary: this pilot research trial studies communication effectiveness in cancer treatment. studying how well patients and their doctors communicate about the treatment being given for cancer may help improve the decisions that patients and physicians make together.

primary objectives: i. to assess the feasibility of measuring discrepancies between patient and physician perceptions about the intent of therapy. secondary objectives: i. to explore possible correlation between various patient satisfaction indicators and discrepant patient perceptions about their care. ii. to gather exploratory data on patient characteristics that might correlate with discrepant patient perceptions about their care. outline: patients complete questionnaires, including the functional assessment of cancer therapy-treatment satisfaction (facit-ts-g), the functional assessment of cancer therapy-spiritual well being (facit-sp12), the medical outcomes study social support survey (mos-sss), and the distress thermometer (dt). doctors also complete a questionnaire. patients' medical records may be reviewed, if necessary. after completion of study, patients are followed up for 5 years.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of cancer * patients must have been in active therapy for cancer for at least one month or have a scheduled surgical treatment of their cancer * ability to understand and the willingness to sign an institutional review board (irb)-approved informed consent document
a safety and tolerability study of pur118 in subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to determine whether pur118 is safe and tolerable in a population of subjects with cystic fibrosis.


Eligibility criteria:
inclusion criteria: * males or non-pregnant, non-lactating healthy female. * age 18 to 55 years of age (inclusive) on day of signing informed consent. * subject has a bmi of 17 or greater. * subject has a confirmed diagnosis of cystic fibrosis documented by a compatible clinical or radiographic presentation, and definitive accepted lab and clinical criteria (e.g., sweat chloride \> 60 meq/l or 2 disease causing cftr mutations) or is regularly attending a consultant led clinic where the diagnosis of cystic fibrosis is not in doubt. * subject has an fev1 ≥ 45% of predicted at screening. * subject has an oxygen saturation \>92% on room air as determined by pulse oximetry at screening. * subject is a non-smoker or ex-smoker has not smoked for at least six months prior to screening. * subject is otherwise medically stable without clinically significant abnormal screening results that depart from their usual baseline level of health as a subject with cf. * must be willing and able to communicate in english and participate in the whole study. * must provide written informed consent. exclusion criteria: * subject has unstable lung disease, as defined by a change in medical regimen during the preceding 2-weeks, or a significant new finding on chest radiograph (pneumothorax, lobar/segmental collapse), or in the opinion of the investigator, has had a decline in pulmonary status within the last year not considered a part of the usual, chronic progression of cf lung disease and part of their baseline health condition as a subject with cf. * subject has had an exacerbation of respiratory symptoms within the past 30 days that required initiation of a new or altered respiratory therapy. * subject had either an upper or lower respiratory illness within the 30 days prior to dosing days, or has symptoms from such an illness that have not resolved. * subject has a history of lung transplantation. * females of child bearing potential who are pregnant, or lactating. females who are sexually active and either not surgically sterile or not willing to use an acceptable form of contraception * clinically significant abnormal biochemistry, haematology or urinalysis not consistent with cf as judged by the investigator * failure to satisfy the investigator of fitness to participate for any other reason.

Keywords: lung diseases respiratory tract diseases fibrosis
implementation of a "remission" consultation in the management of patients treated for localized breast cancer

Conditions: Breast Neoplasms

Summary: the main objective of this study is to describe the evolution in quality of life (qlq-c30) for patients receiving breast cancer care at 3, 6 and 12 months after a "remission" consultation.

the secondary objectives of this study are: a. to describe changes in body image (image body scale version f) at 3, 6 and 12 months after a "remission" consultation. b. to describe changes in psychological distress (visual analog scale) at 3, 6 and 12 months after a "remission" consultation. c. to assess the time of resumption of work (date of last chemotherapy - date of the actual resumption of work) after a "remission" consultation. d. to evaluate the acceptance rate for the "remission" consultation. e. to describe the modes of the observed management, their distribution and the characteristics of the patients according to different monitoring arrangements.

Eligibility criteria:
inclusion criteria: * the patient is receiving care for localized breast cancer and finished her adjuvant treatment (chemotherapy, radiotherapy) * the patient has completed his/her adjuvant therapy in the last 6 months (chemotherapy, radiotherapy). exclusion criteria: * the patient is participating in another study * the patient is under judicial protection * it is impossible to correctly inform the patient * the patient has a metastatic form of the disease at diagnosis
corneal topography asymmetry indices changes after corneal refractive surgery

Conditions: Myopia

Summary: to evaluate the changes that occur in the corneal indices after corneal refractive surgery either prk or lasik.

retrospectively review the medical records of all patients who underwent refractive surgery referred from the out-patient clinic of tanta university hospital between september 2015 and september 2020 . data collection will include: preoperative and postoperative evaluation: age, sex, uncorrected distance visual acuity (udva), corrected distance visual acuity (cdva), manifest and cycloplegic refraction, slit lamp biomicroscopy, fundus examination. data of corneal tomography keratometric using scheimpflug camera (pentacam oculus- germany) :that includes the following indices 1. average keratometric value (k mean) in diopters 2. maximum simulated keratometry (kmax) in diopters 3. index of surface variance (isv) in microns 4. index of vertical asymmetey (iva) in microns 5. radii minimum (r min) in microns 6. index of height asymmetry (iha) in microns 7. index of height decantation (ihd) in microns 8. aberration coefficient (abr) the data of the pentacam will be collected pre-operative and analyzed at 1 month, 3 months and 6 months with recording of the complications.

Eligibility criteria:
inclusion criteria: * patients who underwent refractive surgery either prk, lasik with age between 19 and 35 years old exclusion criteria: * kertoconus. * corneal scarring. * previous corneal infections. * minimum corneal thickness at the thinnest location less than 400 µm. * history of uveitis or ocular allergy. * pre-existing glaucoma. * data not available
an efficacy and safety study of beloranib in obese subjects with type 2 diabetes mellitus

Conditions: Obesity; Type 2 Diabetes

Summary: the purpose of this study is to evaluate efficacy and safety of zgn-440 (beloranib) in obese adult subjects with type 2 diabetes mellitus.

phase 2, randomized, double-blind, placebo-controlled, parallel dose arms study with 12-month randomized treatment.

Eligibility criteria:
inclusion criteria: * obese with bmi ≥30 kg/m2 * type 2 diabetes mellitus * hba1c of 7-11% * fasting glucose \<15.5 mmol/l * treated with diet and exercise alone or with a stable regimen of metformin, sulfonylurea, pioglitazone, dpp-4 inhibitor, glp-1 receptor agonist, sglt-2 inhibitor or any combination of these agents * female subjects must be surgically sterile, post-menopausal or using long-acting contraception, which includes intrauterine devices or use of an implanted or injectable contraceptive exclusion criteria: * current or recent use of insulin * severe hypoglycemia within the prior 6 months * metabolic disorders or genetic disorders linked to obesity (e.g., prader-willi syndrome)