Kornimate/medical-research-clean huggingface dataset:
determining the clinical relevance of the interaction between aprepitant and etoposide

Conditions: Testicular Cancer

Summary: rationale: in pharmacokinetic studies, aprepitant was shown to be a moderate inhibitor of cyp3a4 activity. etoposide is metabolised by cyp3a4. objective: to investigate the absence of a clinical relevant interaction between aprepitant and etoposide in tc patients treated with (b)ep. study design: a single centre, prospective, paired observational pharmacokinetic study in 12 patients with tc who are treated with etoposide during 5 days in combination with cisplatin with or without bleomycin conform the standard bep or ep-protocol and who will be treated with aprepitant from day 3 until day 7 according to the routine antiemetic protocol. the effect of aprepitant on etoposide will be investigated within the same patient. in this study the patient will serve as its own control.


Eligibility criteria:
inclusion criteria: * patients with tc who will start or already started treatment with (b)ep * age of at least 18 years * patients from whom it is possible to collect blood samples * patients who are able and willing to give written informed consent prior to screening exclusion criteria: * patients who are co-treated with drugs that could interfere with the metabolism of etoposide (including drugs classified as a weak, moderate or strong cyp3a4 inhibitor or weak, moderate and strong inducers of cyp3a4 according to the table based on the flockhart table (appendix 1) less than 30 days prior to study or during the study. * creatininclearance \<40 ml/min * severe liver dysfunction (bilirubin\>uln)

Keywords: aprepitant etoposide pharmacokinetic interaction cyp3a4 clinical relevant interaction pharmacokinetics
the effect of application of tachosil® in pancreatoduodenectomy

Conditions: Pancreatic Neoplasm; Pancreatic Periampullary Cancer; Pancreatic Bordeline Tumor

Summary: fibrinogen/thrombin-coated collagen patch (tachosil®) is known to have the effect of strengthening tissue anastomosis and promoting suturing to prevent leakage. the purpose of this study is to compare the incidence of pancreatic fistula that is most crucial for surgical outcome and complications in pancreaticoduodenectomy with those of the control group and the tachosil® apply group. patients who were planned to undergo pancreaticoduodenectomy without a history of chronic pancreatitis are enrolled in this open-label, single-center, randomized, single-blind, phase 4 clinical trial.


Eligibility criteria:
inclusion criteria: * ecog performance score of 0-2 * periampulary cancer or borderline tumor that is able to resection on preoperative examination * patients without distance metastasis * bone marrow function: wbc at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, platelet count at least 125,000/mm3 * liver function: ast/alt less than 3 times upper limit of normal * kidney function: creatinine no greater than 1.5 times upper limit of normal * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients with distant metastases are not eligible * recurred periampulary cancer * pregnant and breastfeeding women * patients with active or uncontrolled infection * patients with uncontrolled heart disease * patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (liver cirrhosis, chronic kidney failure, heart failure, etc.) * patients who underwent other major abdominal organs surgery except for scheduled pancreatoduodenectomy (gastrectomy, colonic resection, etc.)
bevacizumab biosimilar plus folfox4 in the treatment of recurrent hcc after liver transplantation

Conditions: Post-orthotopic Liver Transplantation; Hepatocellular Carcinoma Recurrent

Summary: this study is a single arm, single center, prospective and open exploratory study. about 15 patients with recurrent hepatocellular carcinoma (hcc) after liver transplantation are expected to be enrolled.patients will be treated with bevacizumab and folfox4.treatment was continued until disease progression, development of intolerable toxicities, death, withdrawal of consent, initiation of new antitumor therapy, whichever occurred first.

bevacizumab biosimilar：7.5mg/kg，iv，d1，q2w folfox4： 1. oxaliplatin: 85 mg/m2 , iv, d1，q2w 2. calcium leovorin: 200 mg/m2 ,iv, d1、d2，q2w 3. fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intravenously 22 hours later， d1、d2, q2w

Eligibility criteria:
inclusion criteria: * adult patients with hepatocellular carcinoma who have received liver transplantation have postoperative radiographic or pathological evidence of recurrence; * have not received the first line of standard treatment or have received the first line of standard treatment failure; * at least one measurable lesion based on response evaluation criteria in solid tumors (recist) v1.1; * eastern cooperative oncology group (ecog) performance status (ps) score of 0 or 2; * child-pugh class a or b (child-pugh score ≤7 ); * adequate organ function; * a predicted life expectancy of at least 3 months. exclusion criteria: * allergy to the study drugs or their expedients or severe allergy to other monoclonal antibodies; * receipt of attenuated inactivated vaccines within 4 weeks of the start of the study or scheduled for such vaccination during the study; * evident concern of gi bleeding (local active ulcer, guaic test at least ++) or a history of gi bleeding within the preceding 6 months; * uncontrolled pleural or peritoneal effusion; * pulmonary tuberculosis, sarcoidosis, hiv infection, or active hbv or hcv infection; * uncontrolled cardiac arrhythmia (including qtc interval ≥500 ms); * hepatic encephalopathy; * known hepatocholangiocarcinoma, mixed hepatocellular and cholangiocellular carcinoma, fibrolamellar carcinoma, or a history of or concurrent cancer except cervical carcinoma in situ and cured basal cell carcinoma; * pregnant or lactating women or women contemplating pregnancy; * severe concomitant illness that jeopardizes patient safety or interferes with the completion of the study as deemed by the investigators; * esophageal or gastric variceal bleeding with portal hypertension within the past 6 months.
postoperative analgesia in laminectomy

Conditions: Postoperative Pain; Postoperative Laminectomy Pain

Summary: compare the analgesic effects of naproxen sodium codeine, paracetamol codeine and placebo on postoperative pain and tramadol (contramal) consumption during the first 24 hour after a lumbar disk surgery.

compare the analgesic effects of naproxen sodium codeine paracetamol codeine and placebo on postoperative pain intensity measured by the visual analogue scale, and evaluated tramadol consumption and related side effects.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) 1 or 2 status patients scheduled for an elective lumbar disc surgery exclusion criteria: * were known allergies to any of the drugs used in this study * peptic ulcer disease * hepatic and renal dysfunction, * emergency surgery * inability to provide informed consent

Keywords: naproxen sodium codeine paracetamol codeine disk surgery
"system medicine" approach for prevention strategies for comorbidities in infertile men

Conditions: Infertility; Male Infertility

Summary: by applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men.

by applying a "system medicine" approach, the project aims to identify new biomarkers and/or prognostic tools aimed at developing personalized strategies to prevent the onset of comorbidities in infertile men. the findings will provide new insights into the relationship between male infertility and somatic health, and shed light on the role of the microbiome in modulating the activity of the immune system. a "signature" of lack of immunological tolerance and biomarkers could be useful to predict future oncologic and non-oncological comorbidities in infertile men. this will let the development of a more clinically reliable and cost-effective personalized primary/secondary prevention strategy in a population at high risk of clinically relevant diseases.

Eligibility criteria:
inclusion criteria: * signature of the informed consent; * be adults aged \> 18; * caucasian race; * documented diagnosis of primary male infertility with pure male factor; exclusion criteria: * failure to obtain informed consent; * patients with a known history of haematological disease; * patients undergoing antibiotic treatments in the last 6 months

Keywords: infertility male infertility comorbidity
allopurinol, glucantime, or allopurinol/glucantime for cutaneous leishmaniasis in brazil

Conditions: Leishmaniasis

Summary: objective: compare the efficacy and side effects of allopurinol versus glucantime versus allopurinol/glucantime in patients in brazil with cutaneous leishmaniasis.

protocol outline: this is a randomized study. patients are stratified by participating institution. one group is treated with daily intramuscular injections of glucantime. patients with less than a complete response on day 21 continue treatment until lesions heal completely or for a maximum of 60 days. patients with progressive disease on day 40 are removed from study. the second group is treated with daily oral allopurinol. patients with a partial response on day 21 continue treatment until lesions heal completely. patients with stable or progressive disease on day 21 or unhealed lesions on day 56 cross to glucantime therapy. accrual into this group was closed in 6/96. the third group receives allopurinol and glucantime. patients are followed at 3, 6, and 9 months, then annually for at least 5 years.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- parasitologically confirmed cutaneous leishmaniasis (lesion of less than 3 months duration) no mucocutaneous leishmaniasis no prior leishmaniasis --prior/concurrent therapy-- no prior treatment for leishmaniasis --patient characteristics-- hepatic: no clinical or laboratory evidence of hepatic disease renal: no clinical or laboratory evidence of renal disease no hyperuricemia or gout cardiovascular: no clinical, electrocardiographic, or laboratory evidence of cardiac disease other: no allergy or other contraindication to allopurinol or glucantime; no concurrent medication that might interact with study drugs, e.g.: probenecid, warfarin, azathioprine; no skin rash; no malnutrition; no other medical contraindication to protocol therapy; no pregnant or nursing women

Keywords: dermatologic disorders environmental/toxic disorders immunologic disorders and infectious disorders leishmaniasis rare disease
an evaluation of the cosmetic appearance of metronidazole gel (metrogel®) 1%

Conditions: Rosacea

Summary: the purpose of this study is to determine the cosmetic appearance of metronidazole gel (metrogel®) 1% with commonly marketed facial foundations.

evaluate the relationship between treatment with metrogel® 1% and cosmetic performance with the subjects' usual cosmetic products. it is expected that the female subjects will be able to use their routine cosmetics after application without affecting the cosmetic product's performance or causing side effects.

Eligibility criteria:
inclusion criteria: * subjects with moderate rosacea (global severity score of 3), * subjects willing to stop their current rosacea medication for at least 2 weeks * subjects must have an established routine of cosmetics application (e.g. must have been using the same facial foundation for at least 3 months and it is not expected to change during the study) * subjects must be willing to use their routine facial foundation and not change products while on study exclusion criteria: * subjects who do not routinely wear facial foundation * subjects who failed to undergo a washout period of 14 days for the use of topical rosacea therapy, (for example: metronidazole, azelaic acid, sulfacetamide) * subjects who are unwilling to stop their current rosacea medications for 2 weeks

Keywords: rosacea, metronidazole
placebo controlled trial of bosentan in scleroderma patients

Conditions: Systemic Scleroderma; Pulmonary Hypertension

Summary: the purpose of this study is to determine whether the drug bosentan improves exercise tolerance in scleroderma patients.

pulmonary hypertension (pah) is a common and usually fatal form of lung disease in systemic sclerosis (ssc). multiple drugs have been approved for the treatment of new york heart association (nyha)class iii/iv pah in scleroderma. bosentan is an endothelin-1 antagonist which showed significant improvement in distance walked during 12 week clinical trials in pah patients (7). therapy for asymptomatic systemic sclerosis patients diagnosed incidentally with pah (world health organization (who) functional class i) remains controversial. we hypothesize that asymptomatic or minimally symptomatic patients with systemic sclerosis and normal resting pulmonary artery pressures who demonstrate an abnormal rise in pulmonary artery systolic pressure with stress doppler echocardiography testing represent a subset of patients who already have pulmonary vascular disease and who are at risk for the development of severe pah. we further hypothesize that early identification and treatment of such patients may retard the progression of that disease. hypotheses: 1. stress echocardiography identifies early pulmonary vascular disease by detecting exercise-induced pulmonary hypertension in patients with systemic sclerosis. 2. treatment of exercise-induced pah with bosentan will lead to improved exercise endurance in patients with systemic sclerosis. subjects will be recruited from those patients who have had an abnormal exercise test as part of an earlier study, exercise echocardiograms in scleroderma (irb# 03-363).

Eligibility criteria:
inclusion criteria: * ssc patients \> 18 with nyha functional class i/ii symptoms, informed consent, and who are willing to participate in the pulmonary hypertension assessment and recognition of outcomes in scleroderma (pharos) long term study (georgetown irb 04-227) * right heart catheterization with 1. normal mean pulmonary arterial pressure (pap) at rest 2. mean pap \> 30 with exercise 3. wedge pressure \< 18 * entry criteria for participating in the exercise echocardiogram study (georegtown irb 03-363) 1. diffusing capacity (dlco) \ 60%, or 2. fvc/dlco \> 1.6, or 3. a resting pulmonary arterial systolic pressure (pasp)\> 40mmhg exclusion criteria: * established resting pulmonary hypertension * congestive heart failure * diastolic dysfunction * pregnancy * inability to adequately walk/exercise * severe liver disease

Keywords: scleroderma systemic sclerosis bosentan pulmonary hypertension pharos phros exercise echocardiogram
effectiveness of five intraarticular strategies on knee osteoarthritis

Conditions: Osteo Arthritis Knee

Summary: background: current medical treatment strategies for knee osteoarthritis (oa) are aimed at pain reduction and symptom control. the non-arthroscopic joint lavage (najl) is included inside the therapeutic algorithm of knee oa when other therapies are contraindicated or have lost effectiveness. the large variety of potentially invasive interventions available (joint lavage included) has raised the need to assess their efficacy. the objective of this study is to compare the short-term effectiveness of five treatment strategies in patients with knee osteoarthritis (oa). methods: it was conducted a randomized prospective study involving 150 patients of whom 76.7% were females. the age range was 40-81 years. all patients had knee oa according to the american college of rheumatology criteria, with kellgren-lawrence radiographic grades ii and iii. patients were assigned to five groups, 1) non-arthroscopic joint lavage (najl) (n= 30), 2) najl plus hyaluronic acid (ha) (n= 32), 3) najl plus corticosteroid (cs) (n= 32), 4) ha (n= 31), 5) cs (n= 25). evaluations took place at baseline, one and three months after enrollment. demographic variables, western ontario and mcmaster university osteoarthritis index (womac) and lequesne scores were recorded. statistical analysis included mixed analysis of variance, post-hoc comparisons with sidak's adjustment, and multiple linear regression using as outcome womac total at 3 months. trial registration: the protocol of the study was approved by the "hospital universitario reina sofía" ethics committee, under the number 1996, in the minutes 208 of 29 may 2012.


Eligibility criteria:
inclusion criteria: * meeting american college of rheumatology (acr) criteria for knee oa, symptoms for at least three months despite conservative medical treatment, knee oa grade ii or iii on the radiological kellgren-lawrence scale, and voluntary collaboration. exclusion criteria: * ankylosis of joint; * total arthroplasty or previous osteotomy * infected injury; * treatment with dicumarinic drugs or alterations in blood coagulation, * venous insufficiency or episode of venous thrombosis; * administration of hyaluronic acid (ha) in the previous year, and/or corticosteroid (cs) infiltration or najl in the previous three months.

Keywords: corticosteroid hyaluronic acid joint lavage
effect of medically-tailored meal delivery service on changes in hemoglobin a1c (hba1c) in patients with diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the effect of medically-tailored meal delivery (10 meals per week for 3 months) on glycemic control in diabetic patients.


Eligibility criteria:
inclusion criteria: * adult men and women with non-insulin dependent diabetes. * ages 25 to 75 years. * fasting blood sugar of greater than 140 mg/dl, on no oral hypoglycemic agents and a hemoglobin a1c less than 13%. * stabilized patients on oral hypoglycemic agents for one month or longer prior to starting the study and a hemoglobin a1c between 7.5% - 13%. exclusion criteria: * insulin use. * substance abuse. * any documented medical problem that would inhibit full participation in the study. * bmi less than 25 or great than 40. * vegans or vegetarians * individuals with food allergies. * individuals currently on a commercial weight loss or diet program.
the effect of gladskin on disease severity and the skin microbiome, including staphylococcus aureus, in patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: colonization with staphylococcus aureus is related to inflammation in atopic dermatitis. gladskin is a product for topical use containing the proprietary enzyme staphefekt sa.100, which has the ability to specifically lyse the cell wall of s. aureus. the investigators hypothesize that staphefekt decreases s. aureus colonization of the skin and consequently decreases symptoms of atopic dermatitis.the goal of this study is to determine the effect of staphefekt on the use of topical corticosteroids in patients with atopic dermatitis. secondary goals are to retrieve information about the effect on clinical symptoms, quality of life, growth characteristics of staphylococcus aureus and the further microbiome.

this is a multi center intervention study with a placebo controlled, double blind and randomized design. after standardization of corticosteroid treatment (triamcinolone acetonide 0.1% cream), patients will be randomized in a 1:1 fashion to either treatment with staphefekt sa.100 for 12 weeks or treatment with a placebo for 12 weeks. topical corticosteroid use will be evaluated 2, 6, 12 and 20 weeks after start of the intervention. swabs of the skin, nose and throat will be collected at baseline, week 2, 12 and 20.

Eligibility criteria:
inclusion criteria: * atopic dermatitis of moderate and severe severity. defined by easi score of 7.1 to 50 performed by the researcher at visit 1 * topical corticosteroid use (of any type) * 18 years or older * able to read patient information and provide informed consent exclusion criteria: * use of systemic antibiotics or corticosteroids in the previous 2 months * use of methotrexate or oral immunosuppressive agents in the previous 3 months * use of topical antibiotics in the previous 7 days * use of light therapy in the previous 3 months * use of gladskin in the previous 7 days * contact allergy to components of the study drug (e.g., propylene glycol and glycerol) * clinically infected atopic dermatitis * existence of another skin condition, such as folliculitis or psoriasis that could interfere with the assessment of the eczema severity

Keywords: atopic dermatitis staphylococcus aureus microbiome staphefekt
internet-delivered cognitive-behavioral intervention for insomniac cancer survivors

Conditions: Insomnia; Cancer; Cancer Survivors

Summary: the main purpose of this study is to determine the treatment effects and acceptability of an internet-based cognitive-behavioral therapy intervention to improve the sleep of portuguese cancer survivors with insomnia.


Eligibility criteria:
inclusion criteria: * age 18+ years * provided informed consent * ability to read and write in portuguese * ability to use a computer and/or smartphone, and the internet * history of cancer * having completed primary cancer treatment (survivors who are on hormone and/or other long-term maintenance therapy agencies are eligible to participate) * subclinical or significant symptoms of insomnia (isi scores\&gt;=8) * ongoing sleep medication accepted if the dosage has been stable during the last 4 weeks exclusion criteria: * age ≤ 18 years * another unstable condition (e.g., sleep, psychiatric or medical condition) * pregnancy or breastfeeding * concurrent cbt-i * habitual night shift, or rotating shift-workers

Keywords: insomnia cancer cbti digital cbt-i internet intervention cancer survivors
patient-centered communication of life expectancy estimates in genitourinary malignancies

Conditions: Prostate Cancer Stage I; Kidney Cancer Stage I; Bladder Cancer Stage II; Prostate Cancer Stage II

Summary: investigators will conduct a randomized trial to determine if providing patient-specific life expectancy estimates during treatment counseling via a targeted, patient-centered communication approach improves shared decision making and reduces rates of overtreatment of genitourinary malignancies.

subjects in the intervention arm will be provided with life expectancy estimates specific to their age and health status. life expectancy estimates for prostate and kidney cancer patients will be estimated by age and charlson comorbidity score cutoffs, and life expectancy for bladder cancer patients will be determined using definitions as noted by cho et al. talking points will be provided to counseling physicians on how to meaningfully communicate life expectancy data. subjects will also complete a computer-based conjoint analysis exercise prior to the counseling visit; results will be used to help physicians understand how the subject values life expectancy compared with other decision attributes. the control arm will consist of the current standard of care for treatment counseling. the intervention will be randomized at the level of the patient after stratification by type of cancer. all participants will be asked to fill out a validated questionnaire to measure decisional conflict at the conclusion of their counseling visit. investigators will audiotape treatment counseling visits to allow for qualitative analysis of the quality of communication of life expectancy information. treatment choice will be documented to assess rates of aggressive versus non-aggressive treatment among patients with limited life expectancy.

Eligibility criteria:
inclusion criteria: * newly diagnosed clinical t1-2 prostate adenocarcinoma with gleason scores of 7 or less * newly diagnosed clinical t1a kidney cancer or renal masses \< 4cm * newly diagnosed clinical t2 nonmetastatic urothelial carcinoma of the bladder exclusion criteria: * under 18 years of age * subjects with difficulty communicating or dementia * non-english speakers

Keywords: conjoint analysis life expectancy patient-centered