Kornimate/medical-research-clean huggingface dataset:
efficacy of topical capsaicin cream for stable angina

Conditions: Stable Angina

Summary: the purpose of this study is to test the hypothesis that application of topical capsaicin in patients with stable angina will result in improved exercise tolerance and reduced cardiac ischemia.

patients with stable angina on medical therapy who are capable of exercising on a treadmill and have an interpretable ecg for ischemia will be enrolled in the study, which entails performing two treadmill tests approximately one week apart following topical treatment with placebo cream or topical capsaicin (randomized in crossover fashion). patients will be monitored for exercise tolerance, anginal symptoms, ecg for ischemia/arrhythmia, and hemodynamic responses.

Eligibility criteria:
inclusion criteria: * \> or = 3 month history of chronic, stable, angina triggered by physical effort or mental/emotional stress * documented stress-induced st depression, reversible perfusion imaging, or wall motion abnormality or cad \>50% * canadian cardiovascular (cv) class i-iii * receiving medical therapy for \> or = 2 months * ability to perform bruce protocol treadmill test * non-pregnant female exclusion criteria: * unstable angina * revasc within 2 months * myocardial infarction (mi) within 2 months * congestive heart failure (chf) hospitalization within 2 months * new york heart association (nyha) class iii or iv * left ventricular ejection fraction (lvef) \< 25% * abnormal ecg; acute changes on ecg * currently receiving treatment with investigational drugs/devices * uncontrolled hypertension * contraindication to exercise stress testing * allergy to red peppers or capsaicin * skin deformity, scar, or rash at application site * abdominal surgery within 3 months
cyanocobalamin as photosensitizing agent

Conditions: Keratoconus

Summary: is cyanocobalamin active as photosensitizing agent instead of riboflavin ? using cyanocobalamin with mix of external collagen to make crosslinking with cornea collagen to make rigid of cornea


Eligibility criteria:
inclusion criteria: * - is 20 years or older has been diagnosed with keratoconus; has no other active ocular disease; is not pregnant or nursing; exclusion criteria: * is under the age of 20 has best corrected visual acuity outside 20/400; pregnant or nursing at the time of enrollment in the study;
safety and efficacy of atg003 in patients with amd receiving anti-vegf

Conditions: Age-Related Macular Degeneration

Summary: this study is a double-masked, randomized, placebo-controlled study of the safety and preliminary efficacy of atg003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab. study hypothesis: mecamylamine could be effective in the treatment of neovascular amd.


Eligibility criteria:
inclusion criteria: * \> 55 years of age * clinical diagnosis of neovascular amd exclusion criteria: * confounding ocular condition

Keywords: wet amd, comentis, atg003, mecamylamine
does caudal block increase the incidence of urethrocutaneous fistula formation following hypospadias repair in infants?

Conditions: Hypospadias; Urethrocutaneous Fistula

Summary: this is a prospective randomized multi-center non-inferiority trial conducted through the pediatric regional anesthesia network study sites to determine if caudal block increases the incidence of urethrocutaneous fistula following distal or mid shaft hypospadias repair compared with penile nerve block.

small retrospective series are in conflict about whether there is an association between caudal block and urethrocutaneous fistulas after hypospadias repair. the most common alternative to caudal blockade is a penile nerve block. the investigators will test the following hypothesis: there is no difference in the incidence of urethrocutaneous fistula formation following single stage hypospadias repair with caudal anesthesia compared with penile nerve block. the investigators will use a prospective randomized controlled design where subjects will receive either a caudal block or a penile nerve block to provide postoperative analgesia. meatal anatomy will be graded by the urologist in the anesthetized child according to the hope (hypospadias objective penile evaluation) score, a validated scoring system. both the total score and the individual component scores will be recorded. the operating urologist will determine the presence or absence of a fistula at the postoperative visit about 12 weeks after surgery, with subsequent follow up at 6 months and again at 12 months.

Eligibility criteria:
inclusion criteria: * infants/ children with midshaft or distal hypospadias undergoing primary single stage repair in one of the pediatric regional anesthesia network participating centers. exclusion criteria: * prior hypospadias surgery, * proximal or penoscrotal hypospadias, * abnormal caudal anatomy or spinal dysraphism, * cyanotic congenital heart disease, * infection or rash at the block injection site.

Keywords: hypospadias caudal urethrocutaneous fistula penile nerve block
epidemiological study of post-operative chronic pediatric pain.

Conditions: Chronic Pain; Postoperative Pain

Summary: this study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.

chronic pain, defined as continuous or intermittent pain for 3 months or more, postoperative because in the territory of the surgical procedure and does not exist before the operation, is common in adults. its prevalence varies according to the surgeries between 10 and 50% of the operated adults. the factors potentially responsible for their occurrence are gradually being highlighted in the recent literature, which has made it possible to develop an appropriate analgesic management strategy. in pediatric surgery, acute pain has long been known and treated as early as possible using multimodal analgesic techniques. on the other hand, there are very few studies evaluating postoperative chronic pain 3 months after infant surgery, as was the case a few years ago in adults. this study aims to estimate prevalence and determine risk factors for chronic pain at 3 months post-operative in pediatric surgery.

Eligibility criteria:
inclusion criteria: all children between the ages of 6 and 18, who are scheduled for surgery or video-surgery, scheduled or urgent, in the pediatric surgery department of the bordeaux university hospital. all patients who consented to participate in the research. exclusion criteria: * all children operated on outpatient surgery. * children and parents with difficulties in understanding the questionnaires. * refusal of the child or one of the parents. * change of home planned during the post-operative follow-up period (3 months).

Keywords: pediatrics
impact of clinical evident portal hypertension on hcc with tace (chance-chess 2301)

Conditions: Hepatocellular Carcinoma; Portal Hypertension

Summary: the purpose of this study is to discuss the prognostic value of ceph among hcc patients underwent tace treatment, its impact on overall survival, and try to stratify patient cohorts for a better treatment strategy.

hepatocellular carcinoma (hcc) is the sixth most common cancer worldwide and the second leading cause of cancer-related deaths globally. transarterial chemoembolization (tace) is recommended as standard therapy for intermediate-stage hcc according to the current guidelines and is also the most widely used in advanced hcc in real-world practice. clinically relevant portal hypertension increases the risk of hepatic decompensation, which impairs survival in patients with hcc. the purpose of this study is to discuss the prognostic value of ceph among hcc patients who underwent tace treatment, its impact on overall survival, and try to stratify patient cohorts for a better treatment strategy.

Eligibility criteria:
inclusion criteria: 1. has a diagnosis of hcc confirmed by radiology, histology, or cytology; 2. received at least 1 tace treatment； exclusion criteria: 1. cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. ecog performance score \> 2; 3. history of spleen resection; 4. loss to follow-up.

Keywords: hepatocellular carcinoma transarterial chemoembolization clinical evident portal hypertension
tof-18f-fdg-pet/ct in patients with suspected pancreatic cancer

Conditions: Pancreatic Cancer; Pancreatitis; IPMN

Summary: aim of the prospective study is a better differentiation of benign and malignant lesions in the pancreas in patients with suspected pancreatic cancer using images 30 and 90 min p.i. (post injectionen) and a diagnostic ct (computed tomography) scan of the abdomen within the time of flight (tof)-18f-fdg-pet/ct and thus an improvement of the quality of pet/ct findings.

in the course of this the procedure follows the necessary steps of routine treatment: 1. assignment of the patient with a suspect of pancreatic cancer. 2. performing time of flight (tof)-18f-fdg-pet/ct with images 30 min and 90 min p.i. 3. performing a diagnostic ct of the abdomen with parenteral contrast medium and pancreatic protocol (in case of normal creatinine, gfr, and tsh levels) as well as oral contrast medium (in accordance with the esur-guidelines) as part of the pet/ct examination. 4. routine performance of the operation /fine needle puncture/biopsy 5. routine histopathological evaluation of the surgical specimen/biopsy for this study, a diagnostic ct of the abdomen with contrast medium (intravenous as well as oral) and with pancreatic protocol and without parenteral contrast medium in case of elevated creatinine or decreased tsh (thyroid-stimulating hormone) or gfr (glomerular filtration rate) levels is performed additionally within the routinely performed pet/ct for better differentiation of the target organ from adjacent structures. furthermore, early (30 min p.i.) and delayed (90 min p.i.) images and a tof-reconstruction following the pet/ct examination (without patient contact) should be performed for better differentiation between inflammatory and malignant lesions of the pancreas. the regional tracer-uptake should now be measured quantitatively by suv (standard uptake value) in the tof-pet/ct images over the fdg-accumulating lesions in the pancreas at those two times. in case of an increased fdg-uptake in the early images, the lesion will be assessed as benign/inflammatory and with an increase of the fdg-uptake in the delayed images as malignant. no fdg-uptake in the early as well as in the delayed images will be classified as benign. as a reference standard, the histopathological diagnosis is used. subsequently, a cut-off value of the suv should be determined by roc-analysis. according to current scientific evidence regarding the characterization of pancreatic masses by means of "time of flight"(tof)-technique, there are no studies in the literature.

Eligibility criteria:
inclusion criteria: * patients with suspected pancreatic cancer exclusion criteria: * persons under 18 years of age * patients with blood glucose level ≥160 mg/dl at the time of the pet/ct examination * patients who will not be operated or biopsied and in which thus there are no histopathological findings of the pancreas * pregnant women

Keywords: tof-18f-fdg pet/ct pancreatic lesions
pharmacokinetics & safety of diclofenac potassium oral solution in ped. subjects (2-12 yrs) with mild-mod. acute pain

Conditions: Pain

Summary: as part of the pediatric research equity act (prea) commitment, the objectives of the study are to characterize the pharmacokinetic (pk) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain.

this is an open-label study with pediatric subjects, ages 2-12 years, who will be dosed with diclofenac potassium oral solution, based on weight, every 6 hours as needed for the treatment of mild to moderate acute pain for up to 4 days. pk samples will be collected through 6 hours after the first dose. safety data will be collected throughout the study.

Eligibility criteria:
inclusion criteria: * male and female subjects between 2-12 years of age. * subjects must be post-op, having mild or moderate acute pain. other inclusions apply. exclusion criteria: * subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication. * subject has been taking analgesics for 48-72 hours prior to screening. * subject has a history of any gi event greater than 6 months before screening. * subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen. * subject is requiring treatment for pre-existing hypertension. other exclusions apply.

Keywords: pain moderate pain mild pain acute pain mild acute pain moderate acute pain mild or moderate acute pain nsaid nonsteroidal anti-inflammatory drug
biological characteristics of older women (> 70 years) with er positive, her2 negative early breast cancer

Conditions: Breast Cancer Female

Summary: this study is investigating the biological characteristics of early oestrogen receptor (er) positive, human epidermal growth factor receptor 2 (her2) negative breast cancer (bc) in older woman (aged \> 70 years) who were treated with adjuvant endocrine treatment (et). it will use surgical tissue previously collected as part of routine care from patients aged 70 years or older at diagnosis with er positive, her2 negative stage i-iii bc treated the royal marsden nhs foundation trust (rmh). the overarching aim of this study is to define the biological characteristics of early bc in older women in terms of tumour microenvironment (tme), molecular and genomic features. this analysis will include assessment of tumour infiltrating lymphocytes (tils), and gene expression profiling with nanostring using the breast cancer 360 (bc360tm) assay measuring ribonucleic acid (rna) expression signatures of genes involved in proliferation, endothelial, angiogenesis, cytotoxicity, stroma, inflammatory chemokines, and apoptosis. this analysis will examine various biological pathways, aiming to inform suitability for certain treatments including cyclin-dependent kinase inhibitors (cdki), chemotherapy, immunotherapy, or targeted treatments such as phosphoinositide 3-kinases (pi3k) inhibitors, or deoxyribonucleic acid (dna) damage response.


Eligibility criteria:
inclusion criteria: * post-menopausal women aged \>70 years at the time of diagnosis of invasive breast cancer. * er positive (allred score \>5/8), her2 negative early invasive bc. * stage i-iii bc. * surgical tissue available. * no pre-surgical systemic therapy (i.e., no pre-operative et or chemotherapy). * planned adjuvant et with an aromatase-inhibitor. * no adjuvant chemotherapy. * surgery was performed between 1st january 2014 and 31st december 2016. exclusion criteria: * pre- or perimenopausal. * er negative or her2-positive bc. * multifocal cancer where not all of foci er positive her2 negative * bilateral breast cancer. * stage iv breast cancer. * benign histology or dcis. * pre-surgical treatment. * prior chemotherapy for bc.
minocycline treatment for cystoid macular edema

Conditions: Minocycline; Cystoid Macular Edema

Summary: cystoid macular edema (cme) is one of sight-threatening, immune-related ocular diseases. the efficacy of current treatments for cme (anti-vegf, glucocorticoids and other agents) are limiting. minocycline, acting as a broad-spectrum antibiotic, is among tetracycline family and recently, its immunomodulatory and anti-apoptosis function has been replied to several immune diseases and degenerative diseases. this study aims to explore the efficacy and safety of minocycline for cme.


Eligibility criteria:
inclusion criteria: * participant diagnosed with cme. * participant aged from 18-60 years old. * participant that signed the informed consent document and is able to complete the following visits. exclusion criteria: * participant is allergy to minocycline or tetracyclines. * participant has no contraindications of minocycline or tetracyclines. * participant has an abnormal function of liver, heart, kidney and thyroid. * female that is pregnant, breast-feeding or planning to become pregnant. * participant that is currently using other medications.
a cognitive behavioral digital therapeutic intervention for glycemic control in type 2 diabetes mellitus

Conditions: Diabetes Type 2

Summary: randomized, controlled, pragmatic trial with open-label extension evaluating bt-001, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control.

the study intervention, bt-001 (the app), will be dispensed at enrollment to the immediate intervention app use arm of the trial. patients randomized to the delayed intervention app use arm will be provided a "control app" with diabetes control, and then the bt-001 app after 180 days. each participant is assigned to one 90-day treatment cycle of bt-001. over the 12-month intervention period, study participants will be able to opt into up to 3 additional treatment cycles of bt-001. study schema is included at the end of this section

Eligibility criteria:
inclusion criteria: * current (within 3 months prior to enrollment) hba1c \>=7.01% * possession of and ability to use android or iphone mobile phone * speaks and reads in english * willing to measure frequent fasting finger glucose measurements as part of the app utilization exclusion criteria: * current use of insulin other than a long-acting insulin analogue or human nph insulin * hba1c \>=11% * cognitive impairment or degenerative neuropsychiatric condition (e.g. alzheimer's, dementia, mixed dementia, other significant memory loss, schizophrenia), or any other condition that in the investigator's opinion may prevent patient from completing study activities * any terminal medical condition with life expectancy of \< 1 year.
physiological characteristics of high altitude climbers

Conditions: Hypoxia; Exercise; Sport Performance

Summary: climbing at high altitude and tolerating hypoxic environment require specific physiological adaptations. large intersubjects differences exist regarding the ability to adapt to high altitude and hypoxia. the present study aims to characterise the physiological responses to hypoxia in a group of elite climbers by comparison to sea level athletes. we hypothesised that elite climbers would show better physiological responses to hypoxia and more preserved performances compared to sea level.


Eligibility criteria:
inclusion criteria: * age between 18 and 40 * member of the national high altitude climbing group exclusion criteria: * any diseases incompatible with hypoxic exposure, exercise testing * pregnancy

Keywords: elite climbers near infrared spectroscopy
chlorhexidine vs povidone iodine in alcoholic solutions for prevention of central venous catheter infection

Conditions: ICU Patients Requiring a Central Venous Access

Summary: the best antiseptic solution for cateheter care remains unknown.high concentration in aquous solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone iodine in aquous solutions. no study has compare alcoholic formulations of low concentration of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central venous catheters. to compare the incidence of central venous catheter colonization after skin disinfection with either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine, 0.025% benzalkonium and 4% benzylic alcohol. to compare the incidence of catheter related bacteremia in the to study groups. to compare the local and general tolerance of the two antiseptic formulations


Eligibility criteria:
inclusion criteria: * patients over 18 yeras of age * requiring an internal jugular or sub-clavian central venous catheter for their care during at least 72 h * informed consent signed up exclusion criteria: * bacteriemic infection not under control * extensive cutaneous infection * women with childbearing potential

Keywords: central venous catheter skin disinfection antisepsis nosocomial infection catheter infection
clipless laparoscopic cholecystectomy using harmonic scalpel in cirrhotic patients a prospective randomized study

Conditions: Gall Bladder Stone in Cirrhotics

Summary: this study included group (a) (60 patients with liver cirrhosis and complaining of gall stone) in whom lc was done using traditional method (tm) by clipping both cystic duct and artery and dissection of gall bladder from liver bed by diathermy, and group (b) (60 patients with liver cirrhosis and complaining of gall stone) lc was done using harmonic scalpel (hs) closure and division of both cystic duct, artery and dissection of gall bladder from liver bed by harmonic scalpel. the intraoperative and postoperative parameters were collected included duration of operation, postoperative pain, and complications.

under general anesthesia, and same antibiotics (3rd generation cephalosporin) surgery was performed using conventional four ports umbilical port, port below xiphoid and two ports below right costal margin. pneumoperitoneum at pressure 12 mmhg was used. in group (a) lc was done using traditional method by dissection of calot's triangle and clipping of both cystic duct and artery by metal clips. then dissection of gall bladder from its bed by hook using electrocautery technique. finally we insert abdominal drain in morrison pouch. in group (b) lc was done using harmonic ace (ethicon endo-surgery) by dissection of calot's and then occlusion of both cystic duct and artery using harmonic ace. for closure of and division of cystic pedicle we set the instrument at a power 2 i.e. more coagulation. and when dissecting the gall bladder from the bed we set it to the level 5 i.e. more cutting power. and control of any bleeding from the bed using the active blade of harmonic ace. finally we insert abdominal drain in morrison pouch. the intraoperative parameter observed included duration of the operation, bile escape and volume of blood loss were recorded the patients started oral feeding 8 h postoperatively; abdominal ultrasound was done for all patients in both groups on day of discharge to show any collection or free fluid in the abdomen. the patients were usually discharged after removal of drain, and when the patient surgically free. postoperative pain was evaluated at 12 h, 24h, 48, 1 w after operation using a visual analog scale (vas)

Eligibility criteria:
inclusion criteria: * patients with liver cirrhosis with symptomatic gall bladder stone exclusion criteria: * patients above 80 years old, * patients with history of upper laparotomy, * patients with common bile duct stones * and pregnant females.

Keywords: cirrhotic liver, gall bladder stone