Kornimate/medical-research-clean huggingface dataset:
dexamethasone solution and dexamethasone in mucolox™

Conditions: Oral Lichen Planus; Mucous Membrane Pemphigoid; Pemphigus Vulgaris; Chronic Graft-versus-host-disease

Summary: topical steroid therapy is considered the first line of treatment for oral inflammatory ulcerative diseases with current treatment regimens requiring multiple application or rinses daily. using mucolox™ as a vehicle to deliver topical dexamethasone to the oral mucosa has the potential to effectively prolong contact time between the medication. the primary objective of this study is to determine the clinical efficacy and tolerability of compound dexamethasone at 0.5 mg/5 ml in mucolox™ for the treatment of oral inflammatory ulcerative diseases as measured by a reduction in oral symptoms between patients treated with compounded dexamethasone 0.5mg/5ml solution in mucolox™ (group a) and patients treated with topical commercial dexamethasone 0.5mg/5ml solution only (group b). and mucosa, leading to improved clinical outcomes due to the need for less frequent application.


Eligibility criteria:
inclusion criteria: * age 18 years and older. * patients with symptomatic biopsy proven oral inflammatory ulcerative diseases (worst vas sensitivity score ≥ 7 over the last week). * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients already on topical or systemic steroids. * inability to comply with study instructions. * uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements. * vas sensitivity score \< 7. * pregnant women. a urine pregnancy test will be performed for women of child bearing potential. * allergy to fluconazole.
a study of mabthera (rituximab) in patients with rheumatoid arthritis who have had an inadequate response to a single anti-tnf inhibitor.

Conditions: Rheumatoid Arthritis

Summary: this single arm study will evaluate the safety and efficacy of mabthera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-tnf alpha therapy. all patients will receive mabthera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of mabthera between weeks 24 and 48. the anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-80 years of age; * moderate to severe active rheumatoid arthritis; * inadequate response to previous or current treatment with 1 anti-tnf agent; * receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for \>=4 weeks. exclusion criteria: * previous treatment with mabthera; * use of an anti-tnf alpha agent within 8 weeks of study start; * concurrent treatment with any dmard other than methotrexate; * active infection, or history of serious recurrent or chronic infection.
plasma and urine samples from patients with hormone-refractory prostate cancer enrolled on clinical trials calgb-9480 or calgb-9583

Conditions: Prostate Cancer

Summary: rationale: studying samples of blood and urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this laboratory study is measuring plasma and urine biomarkers in patients with advanced prostate cancer that did not respond to hormone therapy.

objectives: primary * correlate plasma and urine vascular endothelial growth factor (vegf) levels with survival duration in patients with advanced hormone-refractory adenocarcinoma of the prostate previously enrolled on calgb-9480. * determine whether plasma chromogranin a (cga) and plasma interleukin-6 (il-6) levels predict survival duration in these patients. * determine whether plasma human kallikrein 2 (hk2) levels are prognostic for overall survival of these patients. secondary * determine the prognostic significance of plasma and urine vegf levels, plasma cga levels, plasma il-6 levels, and plasma hk2 levels in relation to overall survival of these patients. * correlate plasma vegf levels with urine vegf levels in these patients. * correlate plasma cga levels with previously measured serum prostate-specific antigen (psa) and plasma vegf levels in these patients. * correlate plasma hk2 levels with psa changes after treatment with suramin to determine if hk2 may have predictive value, independent or additive to measures of disease response in these patients. * correlate plasma hk2 levels with psa levels in these patients. outline: plasma from patients is collected for measurement of the following biomarkers: vascular endothelial growth factor (vegf), chromogranin a, interleukin-6, and human kallikrein 2. urine is collected for vegf measurement.

Eligibility criteria:
* registration to calgb 9480 or 9583 * samples collected and shipped appropriately * institutional review board (irb) review and approval at the institution where the laboratory work will be performed is required

Keywords: recurrent prostate cancer stage iii prostate cancer stage iv prostate cancer adenocarcinoma of the prostate
internal radiation therapy in treating patients with prostate cancer

Conditions: Prostate Cancer

Summary: rationale: internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. purpose: this clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.

objectives: primary * to assess the feasibility of high-dose rate (hdr) brachytherapy (without the use of external-beam radiotherapy) as definitive treatment for patients with intermediate-risk prostate cancer. * to assess acceptable toxicity, defined as treatment related toxicity (urinary and rectal), no worse than that seen by patients treated with conventional therapy (grade 3 urinary toxicity \< 10% and grade 3 rectal toxicity \< 10%). secondary * to achieve adequate dosimetric coverage of the prostate comparable to current standards. * to assess the effect of treatment on sexual function. outline: patients undergo 4 high-dose rate brachytherapy treatments over 2 days. patients complete bladder, bowel, sexual function, and quality of life questionnaires, including the international index of erectile function (iief) questionnaire, the international prostate symptom score index (ipss), and the mskcc prostate quality of life questionnaire at baseline and then at every follow-up visit. after completion of study treatment, patients are followed every 3 months for 1 year.

Eligibility criteria:
disease characteristics: inclusion criteria: * intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria: * psa 10-20 ng/ml * gleason score ≥ 7 * stage ≥ t2b and \< t3 * less than 20% risk of seminal vesicle involvement or lymph node involved based upon the kattan nomogram (pre-treatment risk with imrt) * prostate size \< 60 cc by mri or ct imaging * international prostate symptom score index ≤ 15 exclusion criteria: * evidence of definitive extracapsular extension/seminal vesicle invasion or pelvic adenopathy by mri (endorectal coil) and dre (digital rectal examination) * suspected extracapsular disease will not be considered an exclusion criteria * psa \> 20 ng/ml * presence of distant metastases patient characteristics: * wbc ≥ 3,500/mm³ * platelet count ≥ 75,000/mm³ * hemoglobin ≥ 10 g/dl * creatinine ≤ 1.5 mg/dl * liver function tests ≤ 1.5 times normal * inr ≤ 2.5 * able to complete quality of life questionnaires * able to give informed consent * no active perineal infections * no history of urethral stricture * no prior history of pelvic malignancy * no prior history of lymphoma disease, ulcerative colitis, or anal fissures * no contraindications to general anesthesia * no pacemaker prior concurrent therapy: * no prior transurethral resection of the prostate * no prior pelvic radiotherapy * no prior treatment for prostate cancer except for hormone therapy

Keywords: adenocarcinoma of the prostate stage iib prostate cancer stage iia prostate cancer
evaluation of scout ds in subjects with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the primary objective of the trial is to collect scout ds and hemoglobin a1c measurements of subjects who have been diagnosed with type 2 diabetes.

previous studies have excluded subjects with type 2 diabetes. the primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the scout ds diabetes screening algorithm.

Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 18 years 2. self-reported diagnosis of type 2 diabetes exclusion criteria: * not diagnosed with type 2 diabetes * diagnosed with type 1 diabetes * known to be pregnant (self reported) * receiving dialysis or having known renal compromise * scars, tattoos, rashes or other disruption/discoloration on the left volar forearm. * known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Keywords: type 2 diabetes adults 18 years and older taking control of your diabetes health fair
risk factors for aki in patients undergoing vats for pulmonary resection

Conditions: Acute Kidney Injury; Surgery; Lung Cancer

Summary: this study aims to investigate the potential factors contributing to the development of acute kidney injury (aki) in patients undergoing pulmonary resection with video assisted thoracoscopic surgery (vats) for lung malignancy. the study will focus on demographic data, laboratory parameters, perioperative fluid management, and haemodynamics. the research will be conducted at sbü ankara atatürk sanatorium training and research hospital. the study will involve patients who have given informed consent and will undergo vats with standard anaesthesia monitoring. anaesthesia management will follow our routine protocol in our clinic. patients will be divided into two groups based on whether they have a more than 25% decrease in estimated glomerular filtration rate (t-gfh) and/or a 1.5-fold increase in serum creatinine and/or a 6-hour urine volume of less than 0.5 ml/kg/h. the patients will be divided into two groups based on this definition, and the risk factors between these groups will be analysed. the preoperative routine blood values, demographic data (age, gender, height, weight, and bmi), asa physical status, smoking and alcohol habits, comorbidities, and regular medication use will be recorded. intraoperative urine output and haemodynamic parameters will also be monitored. routine blood gas analysis, blood urea nitrogen (bun), glomerular filtration rate (gfr), albumin, haemoglobin, sodium, potassium, chlorine, and magnesium will be measured and recorded, along with urine output and t-gfh. patients will be evaluated in the hospital on the day the surgeon calls for a postoperative check-up and on the 30th postoperative day to see if there are any complications.


Eligibility criteria:
inclusion criteria: * over 18 years of age, under 65 years of age, * american society of anesthesiologists (asa) physical status 1-3, * data of patients who will undergo wedge resection, segmentectomy or lobectomy with elective vats due to lung malignancy will be examined prospectively. exclusion criteria: * patients with a body mass index (bmi) less than 18.5kg/m2 or greater than 35 kg/m2, * those with impaired renal function (the upper limit of the creatinine reference range is more than 50%; 1.3 mg/dl for men and 1.1 mg/dl for women), * a radiological examination was performed using radiocontrast material in the preoperative period, * clinically and radiologically diagnosed with congestive heart failure and treatment has been started, * having a history of pulmonary edema, * those who have used steroids and non-steroidal anti-inflammatory drugs for a long time (exceeding 30 days), * intubated to intensive care unit, * in need of massive peroperative blood transfusion, * patients with deficiencies in the parameters examined will be excluded from the study.

Keywords: acute kidney injury lung cancer video assisted thoracoscopic surgery
an evaluation of hip preservation outcomes

Conditions: Hip Arthroscopy; Femoroacetabular Impingement

Summary: the purpose of this study is to assess outcomes of hip preservation surgeries including open and arthroscopic treatment of femoroacetabular impingement (fai).

the purpose of this study is to assess outcomes of hip preservation surgeries including open and arthroscopic treatment of femoroacetabular impingement (fai). data will be prospectively and retrospectively collected on about 10,000 patients undergoing hip preservation at yale-new haven hospital. patients who are candidates for surgical intervention of the hip are potential participants. the primary objective of this study is to determine whether hip arthroscopy reduces or improves post-operative outcome measures compared to pre-operative measures (including patient reported outcomes \[pros\], revision surgery, conversion to total hip arthroplasty, and return to sport) in patients with fai and labral tears. the secondary objective of this study is to be able to better gauge (by assessments of patient satisfaction and psychometric thresholds of success) the progress made by recent advancements in arthroscopic hip preservation procedures with longitudinal follow-up. the focus of this clinical trial will be the data collected prospectively.

Eligibility criteria:
inclusion criteria: * candidates for surgical intervention of the hip * participant and/or guardian has given informed consent and assent as applicable. exclusion criteria: * documented history of pre-existing hip conditions (scfe, lcpd, acetabular fractures) * has language or cognitive barriers preventing understanding of study and consent and assent documents * prior revision surgeries * patients from the trauma/emergency department * individuals with unusable x-rays
a multiple dose study of debio 1450 [intravenous (iv) and oral] in healthy volunteers

Conditions: Bacterial Infections

Summary: debio 1450-103 is a trial to study the pharmacokinetics (pk) of an experimental drug called debio 1450 in healthy adult volunteers. originally, part a was registered separately (in nct02214355). the registrations have been revised so all parts of this single trial (parts a-c) are now included in this single registration (nct02214433). the primary purpose of each part is provided below: * 10 volunteers participate in part a to assess the pk of a single oral dose of debio 1450 (tablet formulation) under varying gastric conditions * 40 volunteers participate in part b to assess the safety, tolerability and pk of multiple ascending doses of debio 1450, administered sequentially iv and orally, once or twice daily. * an additional 10 volunteers participate in part c which is designed to assess the absolute bioavailability of various formulations of debio 1450 under varying gastric conditions the dose administered during part a is based on the safety, tolerability and pk data from study debio 1450-102 \[nct02162199\], a single ascending dose (sad) study, in which single oral doses up to 800 mg/day are being investigated. doses are adjusted during parts b and c based on the available safety and pk data from preceding cohorts.


Eligibility criteria:
inclusion criteria: * meets protocol-specified criteria for qualification and/or contraception * is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications * voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures exclusion criteria: * has a history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters * has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding) 3. the analysis of results

Keywords: antibiotic antibiotic resistant bacterial infection
effects of aliskiren and amlodipine on the renin-angiotensin system (ras) and lipid/carbohydrate metabolism in obese patients with hypertension

Conditions: Hypertension; Abdominal Obesity

Summary: part 1 determined: aliskiren, amlodipine and angiotensin ii concentrations in interstitial fluid of fat and skeletal muscle; aliskiren and angiotensin ii concentrations, and renin activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren, amlodipine and angiotensin ii concentrations, and renin activity and concentration in plasma. part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone system (raas) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine.


Eligibility criteria:
inclusion criteria: part 1: * male and female patients 20 to 65 years of age with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women) * for patients with a history of treated hypertension, mean sitting systolic blood pressure (mssbp)/ mean sitting diastolic blood pressure (msdbp) had to be ≥ 120/80 mmhg and ≤ 160/100 mm hg. for patients with newly diagnosed, untreated hypertension mssbp/msdbp had to be ≥ 135/85 mmhg and ≤ 160/100 mm hg * pulse rate 40 - 90 bpm part 2: * male and female patients 18 to 65 years of age , with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women) * systolic and diastolic blood pressure and pulse rate were assessed after the patient had rested for at least five (5) minutes. vital signs had to be within the following ranges: 1. patients with history of treated hypertension: mssbp/msdbp ≥ 135/85 mmhg and \< 160/100 mmhg at baseline 2. patients with newly diagnosed, untreated hypertension: mssbp/msdbp ≥ 135/85 mmhg and \< 160/100 mmhg at screening and baseline. exclusion criteria: part 1 * hypertension grade 2 (mssbp ≥ 160 mmhg) or grade 3 (msdbp ≥ 110 mmhg and/or mssbp ≥ 180 mmhg) who classification * current treatment with three or more antihypertensive drugs. part 2 * hypertension grade 2 (mssbp ≥ 160 and/or msdbp ≥ 100 mmhg). * current treatment with three or more antihypertensive drugs. other protocol-defined inclusion/exclusion criteria applied

Keywords: aliskiren renin-angiotensin system (ras) hypertension abdominal obesity
systemic organ communication in stemi

Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

Summary: despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and ppci techniques, st-segment elevation myocardial infarction (stemi) continues to confer a substantial burden of morbidity and mortality. within the stemi population, there is a spectrum of higher and lower risk patients. the aim of this cohort study is to collect prospectively and systematically clinical research data from stemi patients. this cohort study is an open-end observational study to identify master switches in myocardial ischemia.


Eligibility criteria:
inclusion criteria: * patients suffering from stemi exclusion criteria: * \< 18 years

Keywords: stemi infarction coronary artery disease comorbidities diabetes anemia
development/testing of summit: a tool to help patients manage pain while tapering opioids

Conditions: Chronic Pain

Summary: there are nearly one million veterans being treated with long-term opioid therapy (ltot) for chronic pain. numerous short and long-term harms associated with ltot and mounting evidence suggest they have modest or no benefit. yet, currently available resources to support veterans to taper are inadequate. primary care, where most ltot in vha is prescribed, is overburdened and straining to meet the challenge of caring for patients with chronic pain. a scalable, relatively inexpensive tapering intervention to support primary care and/or to extend the reach of resource-intensive specialty clinics would be of great benefit to veterans who are not deriving sufficient benefit from ltot. as such, the goal of this study is to develop and test an interactive, theory-informed, multi-component mobile website to enable veterans to safely taper opioids while managing their pain.

the investigators will conduct a 9-month, randomized, two-arm, parallel, open-label, feasibility trial of the multicomponent mobile website called summit. eligible participants will be randomized to summit versus a pain monitoring app. outcome measures will be collected over 9 months. to ensure rigor and successful future implementation, the investigators will: 1) develop an evidence based program with features proven to maximize engagement and retention; 2) ensure that the program includes mechanisms to address the diverse obstacles veterans report when consider opioid tapering (e.g. fear of pain flares and abandonment by the system); 3) employ a user centered design - with meaningful input from veterans and primary care providers throughout the development and testing phases; and 4) adhere to recently published guidelines for mobile health interventions.

Eligibility criteria:
inclusion criteria: inclusion criteria for veterans will be primary care patients who are dispensed 84 consecutive days of a stable dose of opioids (reflecting three consecutive 28-day prescriptions) through primary care and who report stable levels of pain intensity over the past month. exclusion criteria: exclusion criteria will be veterans on liquid methadone or buprenorphine for opioid use disorder (oud) and those who have transitioned to buprenorphine (transdermal or sublingual) for chronic pain, have hearing or visual impairments (not corrected with hearing aids or glasses), psychiatric conditions, cognitive impairments, or participating in a concurrent pain or opioid-related research study.

Keywords: m-health