Kornimate/medical-research-clean huggingface dataset:
incidence, prevalence, and symptom burden associated with advanced renal cell carcinoma in commercially insured population (pharmetrics)

Conditions: Carcinoma, Renal Cell

Summary: information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom burden is limited in commercially insured adult patients. additionally, limited information exists on economic burden of adverse events associated with treatments for advanced/metastatic renal cell carcinoma. an objective of the current study is to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic rcc in a us "real-world" setting. another objective is to quantify the economic burden of severe adverse events with agents used in management of first line advanced/metastatic rcc (sunitinib, sorafenib, bevacizumab, and pazopanib). this study will employ a retrospective cohort design. analyses of health insurance claims data from a large commercially insured population will be employed in the current study. study subjects will consist of all persons, aged ≥18 years, with evidence of advanced rcc between january 1, 2000 and december 31, 2009; these persons will be identified based in part on case-ascertainment algorithms. analyses will be directed at estimating annual rates of incidence and prevalence of advanced/metastatic rcc, as well as symptom burden and costs of common severe adverse events associated with treatments used in management of advanced/metastatic rcc (sunitinib, sorafenib, bevacizumab, and pazopanib).


Eligibility criteria:
inclusion criteria: * two or more medical encounters with a diagnosis of kidney cancer (icd-9-cm 189.0) or malignant neoplasm of the renal pelvis (189.1), and * two or more medical encounters with a diagnosis of distant secondary malignant neoplasm (icd-9-cm 197.xx-199.0, excluding 198.0 \[kidney metastasis\]) on different days \<120 days apart (the date of the earliest such encounter will be designated the "index date"). exclusion criteria: * evidence of receipt of chemotherapeutic agents indicated or used in the treatment of advanced tcc, or * evidence of cystoscopy, biopsy of the bladder, or radical cystectomy * evidence of any other primary cancer

Keywords: retrospective database analysis economic burden
woebot for substance use disorders

Conditions: Substance Use Disorders

Summary: phase 1 of this study aims to develop a digitally-delivered substance use disorder program through the woebot app-based platform (w-suds) and evaluate the effectiveness of, patient satisfaction with and the acceptability of w-suds as a substance use management tool.


Eligibility criteria:
inclusion criteria: * all genders * 18-65 years * must have access to a smartphone and able to download the w-suds app * committed to engage with app and complete assessments * be willing to provide email address (to distribute incentives) * be literate in english (as w-suds conversational and video materials will be in english) * endorse a substance use concern according to the dast-10 and/or audit-c scale cutoffs for problematic use exclusion criteria: * pregnancy (as w-suds will not be specifically developed to address the unique needs of this population) * suicide attempt or within the past year * drug or alcohol overdose within the past year
bicarbonate administration in ckd

Conditions: Chronic Kidney Disease; Metabolic Acidosis

Summary: low serum bicarbonate levels, even within the normal laboratory range, are strongly associated with increased risks of hypertension, endothelial dysfunction, cardiovascular disease and death. the current proposal will investigate whether bicarbonate administration in patients with chronic kidney disease (ckd) will improve the health and function of arteries and reduce the size of the left ventricle of the heart. overall, the proposed research will provide important new scientific evidence upon which physicians can base recommendations to patients with ckd to decrease the risk of developing cardiovascular diseases.


Eligibility criteria:
inclusion criteria: * age ≥ 21 years * serum bicarbonate 22-25 meq/l on 2 separate measurements (at least 1 day apart) * ckd stage 3b or 4 at time of screening (egfr 15-44 ml/min/1.73m2) * blood pressure \<130/80 mm hg prior to randomization * bmi \< 40 kg/m2 (fmd measurements can be inaccurate in severely obese patients). * able to provide consent * stable anti-hypertensive regimen for at least one month prior to randomization * not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin). exclusion criteria: * use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda) * uncontrolled hypertension * serum potassium \< 3.3 or ≥ 5.5 meq/l at screening * new york heart association class 3 or 4 heart failure symptoms, known ef ≤30%, or hospital admission for heart failure within the past 3 months * factors judged to limit adherence to interventions * anticipated initiation of dialysis or kidney transplantation within 12 months * current participation in another research study * pregnancy or planning to become pregnant or currently breastfeeding * chronic use of supplemental oxygen * use of immunosuppression in past 3 months * metal implant or implanted electrical device (patient will be unable to get mri)
duration and efficacy of azstarys on adult adhd symptoms and executive function in early evening

Conditions: Adult Attention Deficit Hyperactivity Disorder

Summary: this is a single-site study. one purpose of this trial is to extend the safety and efficacy evidence basis for azstarys in adults with adhd. this open-label, treatment study will examine the efficacy of azstarys on adhd symptoms using the aisrs 18-item total score on the aisrs-expanded; the adult adhd investigator symptom rating scale. the investigators will also examine executive function later in the day (early evening, about 12 hours after first morning dosing).


Eligibility criteria:
inclusion criteria: * adults ages 18-60 years, inclusive at the time of consent * able to provide signed informed consent * any gender * subjects with a current primary dsm-5 diagnosis of adhd of predominantly inattentive presentation, or combined presentations) as confirmed by the acds version 1.2.5, subjects who are not receiving any pharmacological treatment for adhd must have an aisrs 18 item total score of aisrs expanded of ≥ 28 at screening. subjects who were previously receiving pharmacological treatment for adhd at screening must have a minimum total aisrs 18 item of aisrs expanded score of ≥ 22 at screening * dysthymia and anxiety disorders in remission but stable on psychiatric medication for three weeks or more at the discretion of principal investigator will be allowed- medication for these disorders to remain constant for the duration of the protocol. * subjects who are stimulant naïve. exclusion criteria: * known hypersensitivity to serdexmethylphenidate, methylphenidate, or product components. * concurrent treatment with a monoamine oxidase inhibitor (maoi), or use of an maoi within the preceding 14 days. * lifetime bipolar disorder, psychotic disorders, autism, intellectual disability except mood disorders accepted under the inclusion criteria at the discretion of the principal investigator. * active suicidality within past year, or history of suicide attempt in past 2 years * any history of severe past drug dependence determined by the mini (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty) * concurrent substance abuse and/or history of substance use within 6 months * use of any prescribed benzodiazepine * any unstable medical or neurological condition; clinically significant medical abnormalities such as cardiovascular abnormalities, and any chronic condition of the central nervous system. * any psychotropic medication usage * known nonresponse to mph treatment * history of allergic reaction or sensitivity to mph * female of childbearing age, who are breastfeeding, pregnant, planning to be pregnant or men planning to make a woman pregnant during the study or for one-month post study * pi/clinician discretion
the feasibility of using anesthesia and suspended ventilation to immobilize liver tumors during radiotherapy

Conditions: Liver Cancer

Summary: liver tumors are hard to treat with radiation because the liver moves every time you breathe. the purpose of this study is to test a new and possibly more accurate way of treating liver tumors. when a person is asleep under anesthesia, it is safe to stop breathing motion for a while. the liver will stop moving and radiation can be given to a liver tumor. the study is being done to see if radiation can be given to liver tumors safely and accurately in this way.


Eligibility criteria:
inclusion criteria: * patient eligible to receive external beam intensity modulated radiotherapy for liver cancer * age:21\<80 * kps \> or = to 80 * able to tolerate immobilization cradle positioning * able to give informed consent * histologically confirmed diagnosis of solid tumor malignancy * liver metastases visualized on ct imaging (obtained within approximately 6 months from enrollment). * target lesion ≤ or = to 8 cm in maximal diameter * in the case of multiple liver metastases, only one lesion will be targeted per treatment session. typically the target lesion will be the lesion which is progressing or the cause of symptoms. the target lesion will be picked in consultation with the referring physician. exclusion criteria: * lymphoid primary histology (lymphoma/leukemia) * single metastasis in an operable patient. operable lesions will only be considered for enrollment in the protocol if the patient refuses resection of the metastasis. * target lesion \> 8 cm in maximal diameter * cirrhosis of the liver (child's c) * liver function enzymes (ast, alt) \> 3x normal , obtained within 1 month of treatment. * \< 500 cc uninvolved liver * unable to tolerate intravenous ct contrast * serum hemoglobin \< 9.0 (obtained within 1 month of treatment) * presence of untreated brain metastases * severe pulmonary disease (o2 dependent, unable to walk a flight of stairs) * unstable cardiac status * unstable angina * significant abnormal 12 lead ekg (non sinus arrhythmia or ischemia unsuitable for general anesthesia) * congestive heart failure * abnormal kidney function (serum creatinine \> 1.5) obtained within 1 month of treatment * platelet count \<70.000. (obtained within 1 month of treatment). * inr \> 2.0 (obtained within 1 month of treatment) * marker seed placement not possible * implanted defibrillator/pacemaker * evidence of increased intracranial pressure * significant ascites * morbid obesity * pregnancy

Keywords: anesthesia suspended ventilation
determination of gentamicin dosing in neonatal patients

Conditions: Infection

Summary: the purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (uniject) is appropriate.

this study aims to verify dosages of gentamicin for use in uniject, chosen based on a consideration of gentamicin pharmacokinetics, safety, efficacy, target population body weight, cost, feasibility and acceptability.

Eligibility criteria:
inclusion criteria: * infants with culture proven sepsis * infants 2000-2499 at birth * infants \> 2500 gm at birth * infants \< 2000 gm at birth * in study site areas: pakistan, bangladesh and india exclusion criteria: * infants w/o culture proven sepsis

Keywords: meningitis neonatal deaths gentamicin uniject aminoglycoside
comparison of ptns and biofeedback for fecal incontinence

Conditions: Fecal Incontinence

Summary: until recently, there is no definite treatment for fecal incontinence that is proven to be effective with low morbidity. the efficacy of biofeedback therapy for incontinence has not been proven on the randomized controlled trials. sacral nerve stimulation is too expensive although some prospective studies showed the therapeutic potential. recently, posterior tibial nerve stimulation has been reported to be effective with lower cost in comparison with sacral nerve stimulation. this study is designed to show the efficacy of posterior tibial nerve stimulation compared with biofeedback therapy for fecal incontinence.

this prospective randomized controlled trial is designed to compare the efficacy of biofeedback and posterior tibial nerve stimulation for fecal incontinence. primary endpoint is weekly episodes of fecal incontinence at 1 week after each treatment. sample size was calculated as 50 patients. outcomes include weekly episodes and severity of fecal incontinence, quality of life and anal function. outcomes will be assessed using bowel diary, fisi questionnaire, fiql questionnaire and anorectal manometry at 1,8,16 and 24 weeks after each treatment for 6 weeks.

Eligibility criteria:
inclusion criteria: * patient with 2 or more weekly episodes of fecal incontinence * patient who understands and accepts to sign the informed consent form exclusion criteria: * patient with gas incontinence only * major injury in anal sphincter * anorectal operation history within 24 months * previous spinal injury, tumor or surgery * presence of neurological disease * peripheral vascular disease * severe comorbidity * psychiatric disorder * legally prohibited for clinical trial * pregnancy or breast feeding * previous disease or disability expected to influence the assessment of postoperative quality of life

Keywords: fecal incontinence posterior tibial nerve stimulation biofeedback quality of life
electroacupuncture to assist ventilator weaning in severe stroke

Conditions: Severe Stroke; Electroacupuncture

Summary: the purpose of this study is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke

disuse atrophy of the major respiratory muscles and diaphragmatic dysfunction often develop during mechanical ventilation, and cause difficulties in ventilator weaning. electroacupuncture was indicated to promote activities of diaphragm and improve diaphragmatic function. our aim is to evaluate the efficacy of electroacupuncture in assisting ventilator weaning in patients with severe stroke. 100 eligible patients will be randomly assigned to receive electroacupuncture or sham electroacupuncture treatment one session per day until the success of ventilator weaning (up to 21 days). the primay outcome is the ventilation duration within 21 days after enrollment.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years and ≤ 75 years ; 2. within 7 days after the onset of stroke (ischemic or hemorrhagic), confirmed by a computed tomography (ct) or magnetic resonance imaging (mri) scan of the brain; 3. gcs on admission ≤ 12 or nihss on admission ≥ 11 or apacheⅱ ≥ 15; 4. received mechanical ventilation; 5. written informed consent is able to be obtained directly from the patient or an appropriate surrogate, based on local ethics committee recommendations. exclusion criteria: 1. expected to be ventilated for \< 24 h; 2. already ventilated for \> 72 h; 3. gcs \<5; 4. with unstable vital signs and requiring the use of vasoactive agents; 5. concomitant medical illness that would interfere with the outcome assessments and/or follow-up; 6. had spinal cord injury above t8 level, or lower motor neuron impairment, or neuromuscular junction impairment，or chest wall deformities, or chest wall injuries within 6 months, or chest or abdominal surgery within 4 week, or were pregnant; 7. had acute skin injury on the selected acupoints; 8. currently participating in other investigational trials.

Keywords: ventilator weaning severe stroke electroacupuncture
international travel patterns and risk behaviour of breast cancer, lymphoma patients and bone marrow transplant recipients

Conditions: Breast Cancer; Lymphoma

Summary: this study also aims to raise awareness among both patients and health-care providers about the importance of pre-travel health consultation and preventive interventions prior to international travel. through appropriate health counseling, cancer patients will have less risk of having travel -related health complications and thus have a better quality of life and overall improved sense of wellbeing.


Eligibility criteria:
inclusion criteria: * hematopoietic stem cell transplant (hsct) recipients * age \>18 years * status post bone marrow transplant within last five years breast cancer patients: criteria 1 and criteria 2 and/or 3 * female age \>18 years and current or past history of breast cancer * received systemic chemotherapy in the last five years * metastatic breast cancer disease (stage iv) lymphoma: criteria 1 and criteria 2 and/or 3 * age \>18 years and current or past history of lymphoma * received systemic chemotherapy within 5 years * had active disease at any time within the last 5 years exclusion criteria: * patients age\< 18 years * breast cancer and lymphoma patients in clinical remission in the past 5 years * patients unable to fill the questionnaire due to language barriers

Keywords: autologous bone marrow transplant breast lymphoma international travel questionnaire hematopoietic stem cell transplant (hsct) recipients
the effect of palm olein, olive oil and lard and on risk markers of cardiovascular disease

Conditions: Cardiovascular Disease; Metabolic Syndrome

Summary: the aim of this study is to compare the effects of a diet rich in palm olein, a fraction of palm oil, to a diet rich in olive oil and a diet rich in danish lard on plasma total-, ldl and hdl cholesterol as well as triacylglycerol (tag), fasting insulin and glucose, c reactive protein and plasminogen activator inhibitor 1 in healthy men. the investigators hypothesis is that palm olein and olive oil will have the same effect on plasma total cholesterol, ldl- and hdl concentration and maybe also on the secondary outcome parameters that are related to cardiovascular disease risk. this may be caused by the differences in the sn-positioning of palmitic acid in palm olein. this difference may cause the palmitic acid in palm olein to be more prone to soap formations and excretion than palmitic acid from other sources, e.g. lard. this study is a double blinded, randomized, controlled 3 x 3 week crossover intervention study, without washout periods. the participants receive the three test foods in random order, decided by draw of lots. blood samples are drawn in duplicate (on two following days) before and after each dietary period.


Eligibility criteria:
inclusion criteria: 1. all participants must give their informed consent in writing, after having received oral and written information about the study 2. age: 18-65 y 3. bmi: 18.5 - 30 mg/m2 4. men 5. healthy (no known diseases, incl. hypertension, hypercholesterolemia, diabetes and psoriasis) 6. no use of dietary supplements or blood donations two month prior to and during the intervention exclusion criteria: 1. current or previously cardiovascular disease 2. diabetes mellitus or other severe chronic disease, including severe allergies and psoriasis 3. hypertension 4. known or suspected abuse of alcohol, drugs or medication 5. own request: all participants have the right to withdraw from the intervention at any given time without explanation 6. compliance: participants may be excluded from the intervention if they do not follow the study guidelines 7. side effects (there are no side effects expected in this study since all test fats are commercial available and use in households world wide)

Keywords: cvd palm olein olive oil lard healthy men metabolic syndrome risk of cardiovascular disease and metabolic syndrome
image quality of eosedge for radiographic evaluation of hip implant

Conditions: Hip Osteoarthritis; Hip Prosthesis Infection

Summary: eosedge is a precise, low dose imaging system that delivers full body, high-quality images covering the full set of musculoskeletal and orthopedic exams. the objective of the study is to evaluate the quality of the focused pelvis/hip x-ray images on eosedge compared to those performed on dr (current practice) to perform a preoperative radiographic evaluation of hip implant, a sufficient image quality on focused x-ray images performed on eosedge would allow (1) to avoid the passage on two different radiographic systems (saving time) (2) to reduce the patient's x-ray radiation dose


Eligibility criteria:
inclusion criteria: * patient 18 years of age or older * came to the imaging department to perform a preoperative assessment for hip replacement or revision exclusion criteria: * patient under guardianship or curatorship * patient participating in an interventional study * patient unable to read and/or write

Keywords: eos radiography hip hip replacement image quality
effect of ultrasound guided embryo transfer on pregnancy rates

Conditions: Infertility

Summary: to assess the effect of transabdominal ultrasound guided embryo transfer on the pregnancy rates versus clinical touch technique

a total of 90 patients undergoing treatment with icsi were divided into 2 groups: group 1 (45 patients), had ultrasound guided embryo transfer and group 2 (45 patients), underwent embryo transfer using the clinical touch technique

Eligibility criteria:
inclusion criteria: * age (20-39) * male factor infertility * ovarian factor infertility * unexplained infertility exclusion criteria: * tubal factor infertility * endometriosis * fsh \> 16 iu/l on cycle day 3 * less than 2 embryos grade a * difficult embryo transfer

Keywords: embryo transfer, transabdominal ultrasound, ivf, icsi
study comparing association between sorafenib and interleukin-2 (il-2) versus sorafenib in 1st line therapy in advanced (adv) renal cell carcinoma (rcc)

Conditions: Metastatic Disease; Renal Cell Carcinoma

Summary: the rosorc trial is a randomized study comparing the efficacy of a new association (sorafenib and il-2) versus the standard therapy (sorafenib) in patients affected by different histotypes of metastatic rcc. this study is a first line therapy for the advanced disease. the primary objective is the progression free survival (pfs) in the 2 arms of therapy and the secondary objective is the overall survival (os) and the response rate (rr) and the safety profile of the combination compared to sorafenib alone.

patients will be allocated in 2 groups: arm a - sorafenib 400 mg twice daily continuously and low dose of il-2 administered s.c. arm b - sorafenib alone at the same dosage used in the previous arm the trial is stratified according to the mskcc prognostic model (low intermediate high risk) and histology (clear cell vs other histotypes). the main inclusion criteria are: cytohistological diagnosis of rcc, measurable disease as recist criteria, signed written informed consent, life expectancy of greater than 3 months. the efficacy and safety analysis will be performed on an intent to treat population. the anticipated median pfs time in the control arm is 6 months and we will expect an increase of 3 months in the experimental arm. the sample size is 128 patients, 64 in each arm (1:1 randomization) the study started in november 2006 and is a multicenter italian trial.

Eligibility criteria:
inclusion criteria: * cytohistological diagnosis of rcc * written informed consent * measurable disease according to recist criteria * age \>= 18 years * karnofsky ps \>= 60% * life expectancy of greater than 3 months exclusion criteria: * prior medical treatment for metastatic rcc * brain metastasis or spinal cord compression * chronic treatment with corticosteroids * uncontrolled hypertension

Keywords: sorafenib rcc metastatic disease