Kornimate/medical-research-clean huggingface dataset:
treatment of children with short stature at an age of 3-7 years who were born small for gestational age

Conditions: Growth Disorders

Summary: the primary objective is to evaluate, if genotonorm (genotropin) increases linear growth in short children born sga. safety of the drug is a main objective as well. the growth promoting effect of two different dosages is compared. the effect of long-term treatment on final height is evaluated (according to several amendments)


Eligibility criteria:
inclusion criteria: * birth length below -2 sd * height at start below - 2 sd exclusion criteria: * any endocrine or chronic disease * any known syndrome with short stature
registry to evaluate the efficacy of zotarolimus-eluting stent

Conditions: Coronary Artery Disease

Summary: the objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the zotarolimus eluting stent (zes) and to determine clinical device and procedural success during commercial use of zes. the investigators will compare 2nd generation ze (endeavor resolute, active prospective arm) with 1st generation zes (endeavor sprint, retrospective arm).


Eligibility criteria:
inclusion criteria: * the patient agrees to participate in this study by signing the informed consent form. * alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form. exclusion criteria: * there are no exclusion criteria for this registry.

Keywords: zotarolimus drug eluting stent endeavor resolute
ultrasound method to measure fibrosis of the liver in children

Conditions: Chronic Liver Disease; Non-Alcoholic Fatty Liver Disease; HCV Coinfection; HBV; Drug-Induced Liver Injury

Summary: hypothesis: the investigators hypothesize that sonoelastography (se) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease. specific aims: to measure liver stiffness with sonoelastography in pediatric and adolescents with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care.


Eligibility criteria:
inclusion criteria: * patients scheduled for random liver biopsy for routine staging of liver fibrosis * pediatric patients patients (ages 1-21) * girls or boys * suspected liver disease * consent to participate in the study exclusion criteria: * pregnancy * acute illness/cognitive impairment resulting in inability to cooperate with ultrasound * patients that do not consent to ultrasound guided liver biopsy. * contraindications to liver biopsy (e.g. low platelets defined as a platelet count of less than 50,000, and hemophilia/coagulopathy as an inr higher than 1.5.)

Keywords: sonoelastography, diffuse liver disease, chronic liver disease, nash, nafld, elevated transaminases, liver biopsy, fibrosis, metavir
a open-label drug-drug interaction study of telotristat etiprate and midazolam in healthy subjects

Conditions: Drug Interactions

Summary: this study is designed to evaluate the effects of telotristat ethyl on the pharmacokinetics of midazolam in healthy male and female subjects.


Eligibility criteria:
inclusion criteria: * healthy adult males and females ≥18 to ≤55 years of age at screening. * body mass index ≥18.0 to ≤2.0 kg/m\^2 * acceptable vital signs at screening: systolic blood pressure = 90-140 mm hg, diastolic blood pressure = 50-90 mm hg, heart rate = 40-100 beats per minute * willingness to adhere to the restrictions outlines in the protocol * able to comprehend and sign the informed consent form. exclusion criteria: * presence of any clinically significant physical, laboratory, or ecg finding that may interfere with the study in the opinion of the investigator * use of any medications, herbal tea, energy drink, herbal products, or supplements * receipt of any investigational agent or study drug within 30 days or 5 half-lives of study start * receipt of any protein- or antibody-based therapeutic agent within 3 months of study start * prior exposure to telotristat etiprate * use of tobacco, smoking cessation products, or nicotine products within 3 months of study start * history of major surgery within 6 months of study start * history of acute narrow angle glaucoma * history of renal disease, or significantly abnormal glomerular filtration rate (\<90 ml/min as calculated using the cockcroft-gault equation) at screening * history of hepatic disease, or significantly abnormal liver function tests * history of any clinically significant psychiatric, renal, hepatic, pancreatic, cardiovascular, neurological, endocrinologic, hematological, or gi abnormality * history of any active infection within 14 days prior to first dosing * history of alcohol or substance abuse within 2 years prior to screening * positive hepatitis panel (including hepatitis b surface antigen and hepatitis c virus antibody) or positive human immunodeficiency virus antibody screens * concurrent conditions that could interfere with safety and/or tolerability measurements * donation or loss of \>500 ml of blood or blood product within 3 months * women who are breastfeeding or are planning to become pregnant during the study * positive serum pregnancy test (females only) * positive urine screen for selected drugs of abuse and cotinine * consumption of alcohol within 48 hours prior to study start * consumption of caffeine- and/or xanthine-containing products * consumption of grapefruit, seville oranges, and grapefruit- or seville orange-containing products within 72 hours prior to study start * unable or unwilling to communicate or cooperate with the investigator for any reason * use of any drugs or substances that are known to be substrates, inducers, or inhibitors of cyp3a4 within 30 days prior to the first dose
acupuncture and gabapentin for hot flashes among breast cancer survivors

Conditions: Hot Flashes

Summary: overall objectives: the overarching goal is to compare the effectiveness of acupuncture and gabapentin to their respective placebo controls in the treatment of hot flashes in breast cancer patients. the investigators primary specific aim will focus on determining the magnitude of response to placebo acupuncture versus placebo pills on hot flashes (hfs).


Eligibility criteria:
inclusion criteria: 1. women 18 years or older with a history of stage i, ii or iii breast cancer for at least 12 months. 2. have been seen by an oncologist within the previous 6-month period and determined to be free of disease by clinical examination and history; 3. experienced at least two hot flashes daily over the seven-day screening period as based on the daily hot flash diary. 4. hot flashes have been present for at least a month before study entry. 5. willing to use non-hormonal contraceptives during the duration of the study if patient is premenopausal. exclusion criteria: 1. having metastatic breast cancer ( iv) 2. currently on chemotherapy or radiation therapy as adjuvant treatment 3. started hormonal therapies such as tamoxifen or aromatase inhibitors within the last 4 weeks; or plan to change or terminate hormonal therapies in the next 14 weeks. 4. started or changed with treatments for hot flashes, such as ssris or clonidine within the last 4 weeks; or plan to change or terminate these therapies in the next 14 weeks. 5. current use of estrogen and/or progestin. 6. pregnancy 7. breast feeding 8. bleeding disorder or current use of warfarin or heparin by patient history because of the use of needles. 9. previous use of gabapentin for hot flashes. 10. current use of any anti-convulsant. 11. renal dysfunction defined as serum creatinine concentration above 1.25 times the upper limit of normal 12. known allergy to gabapentin.

Keywords: hot flashes for breast cancer patients
frequency of elevated fecal calprotectin levels in psoriatic arthritis.

Conditions: Psoriatic Arthritis; Inflammatory Bowel Diseases

Summary: background.recent epidemiologic studies have shown an association between psoriasis, psoriatic arthritis (psa) and inflammatory bowel diseases (ibd). recently, measurement of fecal calprotectin (fc) demonstrated a good sensitivity and specificity for intestinal inflammation. primary objective of present study was to evaluate the presence of occult bowel inflammation in patients with psa as expressed by elevated levels of fc. secondary objectives were to investigate the correlation between the levels fc and clinical and laboratory features, and the outcome of cf-positive patients in terms of ibd development.

a number of studies evaluated the presence of occult intestinal inflammation by using fc assay in patients with axial spa. in 2000, a study conducted in psa patients without bowel symptoms showed at mucosa biopsies the presence of microscopic changes, increase in lamina propria cellularity, consisting of plasma cells and lymphocytes, and lymphoid aggregates.present prospective case-control study was designed to investigate occult intestinal inflammation by using fc assay in consecutive patients with psa at onset, and who had no abdominal symptoms. five italian centers contributed to patients recruitment adopting the same inclusion and exclusion criteria over a 3 year period. fc levels were measured at baseline with bühlmann fcal turbo, switzerland® kit. this automated method is a particle enhanced turbidimetric immunoassay employing polyclonal antibodies. the manufacturer cut-off for fc positivity was 50 μg/g, with a sensitivity of 100% and a specificity of 53.1%. the number of patients developing ibd was evaluated at the end of follow-up. clinical and laboratory data collection was centralized and two experts statisticians performed the data analysis. statistical analysis. all demographic, clinical, and laboratory data were collected and descriptive statistics, presented as mean value and standard deviation, were calculated using microsoft ® office excel for windows and ©2019 minitabs, llc for windows. chi-square test was used for categorical variables. fc test sensitivity, specificity, positive (ppv) and negative (npv) predictive values were calculated. bayes's theorem was used to calculate the 95% confidence interval (95%ci). correlations were calculated using spearman's correlation (rs). p values ≤ 0.05 were accepted as statistically significant. the median follow-up was 30 months.

Eligibility criteria:
inclusion criteria: * age \>18 years * absence of any abdominal symptoms or diarrhoea * non-steroidal anti-inflammatory drug (nsaids) interruption 10 days before enrollment * corticosteroids (cs) at stable low dose (prednisone 10 mg/day or equivalent) during the preceding 2 weeks were permitted in both groups. exclusion criteria: * age \< 18 years * previous diagnosis of cd or uc or current diagnosis of infectious colitis * previous therapy with traditional dmards or any biologic therapies * cs at high doses.
patient experiences following urinary diversion as part of surgery for advanced and recurrent rectal cancer

Conditions: Patient Satisfaction; Quality of Life; Patient Participation

Summary: the outcomes of patients who undergo radical surgery for locally advanced and recurrent rectal cancer have improved vastly, but there is a lack of emphasis on the quality-of-life outcomes of these patients. this study will assess the patient experience of having a stoma for urinary diversion as part of surgery for advanced pelvic malignancy. this will be assessed at regular intervals both before and after surgery with the goal of increasing awareness of patient beliefs and concerns with regards to their stomas and to devise interventions that will improve their quality-of-life.

considerable progress has been made in the management of advanced and recurrent pelvic cancer over the last few decades. however, much emphasis has been placed on surgical and hospital-related outcomes. in recent years, there has been an increased focus on patient quality-of-life following major abdominopelvic surgery. however, there is a lack of updated evidence on how patients manage and perceive their stomas. managing a stoma is a difficult task for patients and can adversely effect their quality-of-life. this study will investigate specifically the impact of managing a urostomy or ileal conduit. patients will be contacted via an anonymized, opt-in sms or email to answer a questionnaire, having previously been provided with a patient information leaflet. this will take approximately 5 minutes to complete and will be carried out just prior to and at 1, 3, 6, 9 and 12 months post-operatively. all of this data will be collated and published as part of a wider investigation in to patient quality-of-life following major abdominal and pelvic surgery. this study will be carried out in 35 countries.

Eligibility criteria:
inclusion criteria: * histologically-proven advanced rectal cancer * has undergone urinary diversion/reconstruction * aged 18 years or older * able and willing to give written, informed consent * able to access email/internet exclusion criteria: * strong evidence of metastatic or peritoneal disease * palliative exenteration * non-rectal origin of primary tumour * colonic obstruction * inability to answer online questionnaire

Keywords: rectal cancer locally advanced and recurrent rectal cancer advanced pelvic cancer urinary diversion for rectal cancer quality of life
the von willebrand disease (vwd) international prophylaxis study

Conditions: Von Willebrand Disease

Summary: the von willebrand disease prophylaxis network (vwd pn) is an international study group formed with the goal of investigating the role of prophylaxis in clinically severe vwd that is non-responsive to other treatment(s).

the most common indications for vwd prophylaxis included joint bleeding, epistaxis, gastrointestinal (gi) bleeding, and menorrhagia. thus, an effort to establish optimal treatment regimens for these indications, through a period of prospective evaluation, is the primary focus of this research. other goals include a retrospective study of the effect of prophylaxis on bleeding frequency, and a retrospective natural history study of gi bleeding in vwd.

Eligibility criteria:
inclusion criteria: type 1: eligible for participation if * ≤20% rco and/or ≤20% fviii; and * ddavp non-responsive, defined as occurrence of bleeding episodes not responding satisfactorily to desmopressin, or deemed non-responsive a priori by the investigator; and * bleeding indication criteria are met type 2: eligible for participation if * ddavp non-responsive, defined as occurrence of bleeding episodes not responding satisfactorily to desmopressin, or deemed non-responsive a priori by the investigator; or type 2b; * bleeding indication criteria are met type 3: eligible for participation if * bleeding indication criteria are met bleeding indication criteria: * joint bleeding: documentation of at least two apparently spontaneous bleeding episodes in the same joint in the six months prior to enrollment; or three or more apparently spontaneous bleeding episodes in different joints in the six months prior to enrollment. * gi bleeding: history of two or more severe gi bleeding episodes associated with either a drop in hemoglobin of ≥ 2 g/dl or requiring red blood cell transfusion or treatment with vwd concentrate. * failure to identify other causes of bleeding. * menorrhagia: a diagnosis of menorrhagia; prospectively completed pictorial blood assessment chart score \>185 or required treatment with a vwd product for menstrual bleeding on one or more occasions in the year prior to enrollment. * normal cervical cytology (pap) within the six months prior to enrollment for females ≥ 18 years of age. * epistaxis 1. three or more bleeding episodes in a six-month period that required treatment with vwd concentrates or red cell transfusions.

Keywords: von willebrand disease vwd prophylaxis
transcutaneous auricular neurostimulation for icu patients with traumatic brain injury

Conditions: TBI (Traumatic Brain Injury)

Summary: the overarching goal of this pilot study is to assess the feasibility and safety of transcutaneous auricular neurostimulation (tan) in icu patients with tbi and to determine the effect of tan on serum markers of inflammation. exploratory analyses will examine effects on such physiological parameters as blood pressure, heart rate, and intracranial pressure (icp), as well as measures of neurological function.

this is a single-center, open-label, nonrandomized investigation. tbi patients with a post resuscitation glasgow coma scale (gcs) score of 12 or less (commonly described as moderate or severe tbi) and acute traumatic intradural blood on head ct scan will be screened upon admission to the icu at parkland memorial hospital. it is expected that all or almost all subjects will be in the neuroscience or surgical icu. consent for participation will be sought from the subject's legally authorized representative. exception from informed consent or waiver of consent will not be part of this study. tan will begin as soon as feasible after subject enrollment. immediately prior to this intervention, vital signs, neurologic status, and other clinical parameters will be recorded, and pre-tan blood will be collected for measurement of serum inflammatory markers. tan will be administered for 30 minutes under the supervision of a member of the research team. after 30 minutes (just prior to stopping tan), the same clinical parameters that were recorded at baseline will again be recorded then tan will be stopped. approximately two hours after tan has ended, a post-tan blood sample will be collected for measurement of the same inflammatory markers as in the pre-tan blood sample. at each timepoint for blood collection, additional blood may be collected for banking and future analyses. patients will undergo research blood draws and tan stimulation for a maximum of 10 days. research-related procedures will not exceed this 10-day period.

Eligibility criteria:
inclusion criteria: 1. post-resuscitation gcs score 12 or below and acute trauma-related intradural blood on head ct scan after tb 2. age 18 years or older (pediatric trauma patients are not routinely transported to parkland) 3. consent from legally authorized representative exclusion criteria: 1. hemodynamic instability 2. expected imminent mortality because of overwhelming neurological and/or systemic injury 3. unclear neurological status because of paralytic medications or intoxication with ethanol or other drugs 4. presence of other electrical stimulation devices (pacemaker, cochlear prosthesis, neurostimulator, etc.) 5. abnormal ear anatomy or ear infection 6. participant is pregnant or lactating 7. any other significant medical or psychosocial problems that, in the opinion of the investigator, would potentially cause harm to the participant, impact their ability to participate, or influence the results of the trial

Keywords: transcutaneous auricular neurostimulation (tan)
efficiency study of the eus-fna needles with and without a side port in pancreatic masses

Conditions: Pancreatic Tumor

Summary: for diagnosis of pancreatic tumors, endoscopic ultrasound (eus) and eus-guided fine needle aspiration (eus-fna) are well established techniques in clinical practice. we hypothesize that a fna needle with a side port could improve the diagnostic yield. the aim of this prospective randomized study is to determine whether there is a difference in diagnostic yield in patients with pancreatic masses for evaluation.

for diagnosis of pancreatic tumors, endoscopic ultrasound (eus) and eus-guided fine needle aspiration (eus-fna) are well established techniques in clinical practice. in the case of eus, an ultrasonic transducer located at the tip of the echoendoscope allows the endoscopist to visualize the wall of gastrointestinal tract as a series of definable layers corresponding to histology, and also enables detailed images of areas outside of the digestive tract. eus has a significant clinical impact because it allows assessment of submucosal gi lesions, loco-regional staging of gastrointestinal malignancy, tissue diagnosis by eus-fna and staging of pancreaticobiliary lesions, non-small-cell lung carcinoma, and mediastinal disease. in prospective trials, eus-fna has been clearly established to be an important diagnostic tool with excellent safety profile. olympus has recently made commercially available a new 22 gauge fna needle with a side port at the needle tip to facilitate the process of fna and increase the diagnostic yield. there have been preliminary unpublished retrospective data that suggested the yield might be raised. however, there are no prospective multicenter randomized controlled studies to ascertain the validity of the assumption. the aim of this prospective randomized study is to determine whether there is a difference in diagnostic yield between ez-shot 2 (model: na-220h-8022) and ez-shot 2 with side port (na-230h-8022) in patients with pancreatic masses for evaluation. we hypothesize that a fna needle with a side port could improve the diagnostic yield.

Eligibility criteria:
inclusion criteria: 1. all patients referred for eus-fna of pancreatic masses; 2. informed consent is obtained for performance of eus-fna. exclusion criteria: 1. presence of active gastrointestinal bleeding
gentamicin bladder instillation in individuals with spinal cord injury having chronic urinary tract infections

Conditions: Neurogenic Bladder; Spinal Cord Injuries

Summary: participants will undergo daily gentamicin bladder instillations to determine if its use will reduce the rate of symptomatic urinary tract infections (utis) as well as the use of oral and intravenous antibiotics in adults with chronic spinal cord injury (sci) who have recurrent utis. participants are randomized into one of three groups: 1) gentamicin and saline instillation 2) saline only instillation 3) standard of care, no instillation.

the purpose of this study is to determine if twice daily bladder flushing with an antibiotic solution will decrease the rate of utis and the use of oral medications used to treat utis. the occurrence of utis in the sci population is high, with a rate of about 2.5 episodes per year. the inability to effectively empty the bladder increases the risk of utis, which are the most common medical complication after sci. this study will help us understand the effectiveness of a local bladder therapy on preventing utis and improving bladder function in individuals with sci.

Eligibility criteria:
inclusion criteria: * at least 18 years of age; * non-progressive spinal cord injury; * stable medical condition; * bladder dysfunction as a result of spinal cord injury * history of recurrent utis (defined as 3 or more within the past year or 2 or more within the past 6 months). exclusion criteria: * signs or symptoms of serious uti that requires the use of systemic antibiotics; * use of any urine-acidifying agent, bladder irrigant, or systemic antibiotic within the previous 2 weeks; * participants colonized with gentamicin-resistant bacteria on baseline urine culture or a gentamicin allergy/sensitivity; * participants with known hearing loss and/or renal disease; * pregnant at the time of enrollment or planning to become pregnant during the time course of the study.

Keywords: bladder spinal cord injury urinary tract infection