Kornimate/medical-research-clean huggingface dataset:
mirabegron and ureteral stent-related pain (map) trial

Conditions: Nephrolithiasis

Summary: ureteric stents are used often following ureteroscopy for prevention of obstruction from edema and/or stone fragments. up to 75% of patients experience pain following stenting, as well as lower urinary tract symptoms (luts) such as finding blood in the urine, voiding often, the need to urinate quickly resulting in a significant source of morbidity. the negative impact of stents results in a significant impact on health related quality of life. there is no standard of care for managing ureteric stent pain and lower urinary tract symptoms following surgery. a combination of α-blockers, antimuscarinics, acetaminophen, nonsteroidal anti-inflammatory drugs and opioids are currently the mainstay for treatment of post-operative pain and luts following stenting. mirabegron is a beta-agonist that mediate relaxation of the detrusor muscle and has been useful in treating overactive bladder (oab) which has similar symptoms to patients with an ureteric stent in place. our goal is to assess if mirabegron can improve symptoms and decrease the need for additional pain medications. the investigators hypothesize that mirabegron is effective in decreasing ureteral stent related luts and pain.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years old 2. first ureteroscopic treatment for the ureteric or renal stone 3. retrograde semi-rigid or flexible ureteroscopy 4. placement of a 6fr, 22-28cm hydrophilic coated ureteric stent 5. follow-up 7 days post operatively at st. michael's hospital 6. patient who can read and understand english exclusion criteria: 1. bilateral ureteral stents 2. stent in situ prior to ureteroscopy 3. pregnancy or breast feeding, or planning on becoming pregnant in the upcoming weeks 4. patients with congenital renal abnormalities (eg: pelvic kidney, ureteric duplication) that may impair proper stent placement 5. patients with urinary diversion or stone in a transplant kidney 6. patients with a history of interstitial cystitis/painful bladder syndrome, prostatitis, pelvic pain due to other conditions (eg: endometriosis), or neurogenic bladder 7. indwelling foley catheter 8. patients currently taking antimuscarinics, mirabegron, or α-blockers 9. patients with contraindications to receiving mirabegron (ie: urinary retention, end-stage renal disease, uncontrolled hypertension, known qt prolongation) 10. significant cognitive impairment 11. patients with contraindications to opioid use (hypersensitivity, mao inhibitor use within 14 days, severe respiratory depression, acute or severe asthma, gi obstruction, paralytic ileus, gi stricture) 12. suspected or confirmed ureteral perforation 13. stent placement without tether 14. untreated urinary tract infection 15. antegrade ureteroscopy 16. opioid addiction 17. plan for stent removal at another centre other than st. michael's hospital 18. moderate to severe cardiovascular disease and cerebrovascular disease 19. signs of hepatic dysfunction including significant liver function test elevation 20. patients who cannot read and understand english
weekly docetaxel and four weekly carboplatin in non-small cell lung cancer carbo-tax

Conditions: Lung Neoplasms

Summary: the purpose of this study is: * to assess the efficacy of the combination in terms of objective (clinical and radiological) response rate * to assess the time to progression of the disease; assess the safety profile of the combination, and assess the survival time.


Eligibility criteria:
inclusion criteria: * histologically/cytologically confirmed inoperable locally advanced or metastatic non-small cell lung cancer * ecog performance status is 0-2 * at least one measurable lesion in two dimensions by means of ct scan * no brain metastases * no prior chemotherapy for this malignancy, * acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a platelet count ≥ 100.000mm3 and hb ≥ 9g/100ml), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance measured in 24 hours urine ≥ 60 ml/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (alt, ast) ≤ 2.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis) exclusion criteria: * concomitant use of another anti-cancer therapy * chemotherapy, radiotherapy or curative surgery * evidence of intracerebral metastasis * unstable medical condition that makes the patient to take part in a clinical study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural or peritoneal effusion; or presence of serious uncontrolled infection, diarrhea, ileus, interstitial pneumonia, pulmonary fibrosis. * presence of other tumours different from basal cell carcinoma of the skin, with disease free survival less then 3 years. * pregnancy or breastfeeding. in women of childbearing potential and in men, an adequate contraceptive method must be used * social or psychological condition that render the patient inadequate for the follow-up of the study * contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
composite health assessment risk model (charm) for older adults (bmt ctn 1704)

Conditions: Hematologic Malignancy

Summary: prospective observational multicenter study of allogeneic hematopoietic stem cell transplantation (hct) in recipients 60 years and older to assess important determinants of health status to be combined into a composite health risk model to improve risk assessment of non-relapse mortality (nrm).

at baseline, standardized geriatric assessment (ga) tools incorporating subject reported data and bedside testing will be collected. hct-comorbidity index (ci) scores will be assigned and c-reactive protein (crp) and albumin will be measured locally. serial measures at 3, 6, and 12 months for frailty, skilled facility admission, and quality of life (qol) using promis measures for physical function, depression and anxiety will be determined. graft versus host disease (gvhd) through one year, serious toxicities through day 100, cognitive status at day 100 and causes of death will be captured.

Eligibility criteria:
inclusion criteria: 1. subject is \> 60.0 years old at time of enrollment. 2. hematological malignancy as an indication for allogeneic transplantation. 3. eligible for allogeneic transplantation based on institutional standards 4. first allogeneic transplant planned. any conditioning regimen and allogeneic donor is acceptable. 5. able to speak and read english. spanish, and mandarin will be acceptable when sites have ability to perform healthcare provider tests in those languages. 6. written informed consent exclusion criteria: 1. prior allogeneic hct
home-based mental health evaluation (home)

Conditions: Suicide and Self-harm

Summary: the purpose of this project is to investigate the effectiveness of the home-based mental health evaluation (home) program, which is an innovative and culturally-relevant suicide prevention intervention for veterans aimed at increasing treatment engagement and decreasing suicide risk following psychiatric hospitalization, a period of heightened suicide risk.

the purpose of this project is to investigate the effectiveness of the home-based mental health evaluation (home) program, which is an innovative and culturally-relevant suicide prevention intervention for veterans aimed at increasing treatment engagement and decreasing suicide risk following psychiatric hospitalization, a period of heightened suicide risk. the research project employs a multi-site two-arm interventional trial design to study the effectiveness of the home program. effectiveness of the treatment will be evaluated by comparing veterans receiving the home program at two active treatment sites, denver and philadelphia department of veterans affairs medical centers (vamcs), to with those receiving care at two control sites, houston and portland vamcs. the current protocol describes procedures as they will occur at all sites, including those completed locally at the denver vamc, which is the lead site for the study.

Eligibility criteria:
inclusion criteria: 1. age between 18-89 2. able to provide a phone number and the location of a residence at which they can be reached 3. planned location of discharge is a safe environment for the home provider to visit\* 4. agree to receive the home program intervention (active site participants only) 5. ability to adequately respond to questions regarding the informed consent procedure exclusion criteria: 1. receiving services from the mental health intensive case management (mhicm) or domiciliary program or being directly transferred to further inpatient or residential treatment 2. enrolled in other intervention studies that may affect the outcome of this study, or where this study may affect the outcome of the other study, until the subject has completed their participation in the other study 3. current involvement in the criminal justice system as a prisoner or ward of the state.

Keywords: treatment engagement
a study evaluating the safety and efficacy of treating sinus infection with levofloxacin 750 mg for 5 days.

Conditions: Maxillary Sinusitis

Summary: the purpose of this study is to evaluate the effectiveness and safety of a once-daily administration of 750 milligrams levofloxacin (an antibiotic) for five days, in treating bacterial sinus infections.

acute bacterial sinusitis is a common diagnosis for which an antibiotic is prescribed in outpatients. some types of bacteria that cause sinusitis are resistant to penicillin and certain other classes of antibiotics, but may be treatable with the antibiotic levofloxacin. this will be an open-label, multi-center, non-comparative clinical trial involving outpatients with protocol-defined acute bacterial sinusitis suitable for treatment with oral antibiotics. at the preliminary visit, a sinus radiograph will be obtained to confirm the clinical diagnosis of sinusitis, and the investigator will perform a nasal exam. sinus puncture and placement of an indwelling sinus catheter into an affected maxillary sinus will be performed on all eligible patients at the first visit. patients meeting the study criteria will receive 750 milligrams levofloxacin tablets once daily for 5 days. the primary objective is to establish the rate and extent of bacteriological eradication, defined as eradication of pathogens from the maxillary sinus, and to establish the effectiveness and safety of once-daily 750 milligrams levofloxacin for the treatment of acute bacterial sinusitis in adults. levofloxacin 750 milligram tablet orally once a day for 5 days

Eligibility criteria:
inclusion criteria: * clinical signs and symptoms of acute maxillary sinusitis for 5 to 28 days * visible nasal purulence evident on physical examination * ct scan or standard sinus x-ray (waters' projections) performed within 5 days prior to the first dose of study drug, showing total sinus opacification or an air-fluid level * agree to a maxillary sinus puncture and catheter placement * if female, using birth control exclusion criteria: * chronic sinusitis * need for hospitalization or intravenous antibiotics * history of head, neck, or nasal cancer or surgery * previous allergy, serious adverse reaction to, or failed therapy with, levofloxacin or any other member of the quinolone class * presence or history of serious complications of sinusitis * previous antimicrobial therapy within 7 days of study entry

Keywords: maxillary sinusitis infection
phase ii study of 2-weekly railiri versus folfiri as second-line treatment in advanced colorectal cancer patients

Conditions: Colorectal Carcinoma

Summary: this study is designed to compare the efficacy and safety of two-weekly railiri regimen with folfiri regimen in the treatment of advanced colorectal cancer patients in the second-line setting.


Eligibility criteria:
inclusion criteria: * aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma * eastern cooperative oncology group performance status of 0 to 1 * life expectancy of ≥ 3 months * patients who had failed first-line treatment with either xelox (capecitabine combined with oxaliplatin) or folfox (5-fluorouracil/leucovorin with oxaliplatin) * at least one measurable disease lesion according to the response evaluation criteria in solid tumors (recist 1.1) criteria * have adequate bone marrow, hepatic, and renal function exclusion criteria: * patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction * patients with symptomatic brain metastases * active clinical severe infection * previously received irinotecan or raltitrexed * dihydropyrimidine dehydrogenase (dpd) enzyme adequate
comparative effects of buteyko breathing techniques and papworth method in asthmatic patients

Conditions: Asthma

Summary: asthma is an inflammatory condition which is characterized by coughing, sneezing, and shortness of breath. the ratio of asthma is increasing day by day around the globe. according to an estimate, more than 300 million people are affected from this chronic respiratory disorder throughout the world. the asthma is diagnosis on basis of sign and symptoms as there is no gold standard of evaluating the asthma. there are basically two treatment strategies for asthma involving medical management and physiotherapy treatment. in medical treatment, steroid drugs and bronchodilators are given to asthmatic patients. now a day, the physiotherapy treatment has gained much importance. there are numerous physiotherapy approaches available for rehabilitating asthma patients such as breathing techniques, yoga, and relaxation exercises. buteyko technique includes three steps (control pause, shallow breathing and combination of step 1 \& 2). while, papworth method includes five steps (breathing, education, relaxation, combination of breathing and relaxation exercise and home exercises). the randomized clinical trials will be conducted for this study and data will be calculated using simple random sampling technique. the study will be carried out in clinical private (farooq clinic) setting khushab and thq khushab for a period of 10 months after approval from research and ethical committee. firstly, consent will be taken from the study participants. screening will be done using who quality of life scale questionnaire and asthma control test adult scores. lung spirometry values (fvc, fev1, \& fev1/fvc) and oxygen saturation will be evaluated at baseline, 2 weeks, and 4 weeks. patients will be divided into two groups. group a \& group b. buteyko breathing technique will be performed to group a patients and papworth method will be performed to group b. chest physiotherapy will be performed to both groups as a conservative treatment at baseline, 2 weeks, and 4weeks


Eligibility criteria:
inclusion criteria: * diagnosed asthmatic patients * age group 20-60 years * both genders * lung function (fev predicted \< 80% \& fev1/fvc \< 75%) * nighttime awakening 3-4 times/month * symptoms \> 2 days/week exclusion criteria: * unstable asthmatic patients * acute upper respiratory infection * history of radiation * taking any oral steroid, mental disorder

Keywords: asthma, breathing exercises humans oxygen saturation, patients
single-stage correction of acute angle coxa vara

Conditions: Coxa Vara

Summary: correction of sever degree of coxa vara in single-stage correction.

the technique described in this article illustrates how to fully correct acute angle developmental coxa vara (neck shaft angle 30 degrees) to obtain better radiological and functional outcomes. gt transfer subtroch. valgus osteotomy

Eligibility criteria:
inclusion criteria: * acute coxa vara exclusion criteria: * osteopenic oi

Keywords: coxa vara proximal femur osteotomy subtrochanteric valgus osteotomy wagner technique tension band wiring. greater trochanter transfer
accelerated radiotherapy and concomitant chemo-radiotherapy in hnscc

Conditions: Oral Cancer; Oropharynx Cancer; Hypopharynx Cancer; Larynx Cancer

Summary: this is a multicentric randomized phase iii trial comparing conventional radiotherapy with concomitant chemotherapy versus accelerated radiotherapy with concomitant chemotherapy versus very accelerated radiotherapy in patients with stage iii-iv head and neck squamous cell carcinoma. the main end point is the event free survival.

this is a multicentric randomized phase iii trial comparing conventional radiotherapy with concomitant chemotherapy (arm a) versus middle accelerated radiotherapy with concomitant chemotherapy (arm b) versus very accelerated radiotherapy alone (arm c) in patients with stage iii-iv head and neck squamous cell carcinoma (hnscc). the main end point is the event free survival. the treatments are bras a : conventional radiotherapy given once daily, delivering 70 gy in 7 weeks (5 fractions of 2 gy per week) and chemotherapy: 5fu : 600 mg/m²/d, paraplatin : 70 mg/m²/d, d1-4 and d22-25 and d43-46 bras b: middle accelerated radiotherapy delivering 70 gy in 6 weeks and chemotherapy: 5fu : 600 mg/m²/d, paraplatin : 70 mg/m²/d, d1-5 and d29-33 * first part : radiotherapy given once daily delivering 40 gy in 4 weeks and 20 fractions of 2 gy * second part : radiotherapy given twice daily with "concomitant boost" delivering 30 gy in 20 fractions in 2 weeks (1,5 gy x 2 / day) bras c: very accelerated radiotherapy given twice daily delivering 64.8 gy in 3.5 weeks in 36 fractions of 1.8 gy

Eligibility criteria:
inclusion criteria: * squamous cell carcinoma of oral cavity, oropharynx, hypopharynx or larynx * stage iii-iv (uicc 1997): t2, t3 or t4 with n0-n3 or t0 with n2-n3 * not resectable * karnofsky ps \>= 70 * renal/liver/cardiac functions and blood counts compatible with the use of paraplatin and 5-fu * informed consent signed exclusion criteria: * distant metastasis * contra-indication to concomitant chemotherapy * history of cancer * history of head and neck radiotherapy

Keywords: head and neck squamous cell carcinoma radiotherapy chemotherapy
the associations between dietary choline, genetics and anxiety/depression

Conditions: Choline Deficiency; Anxiety; Depression

Summary: the associations between dietary choline, genetics and anxiety/depression

choline, previously considered to be a vitamin, is an essential nutrient involved in a plethora of biological pathways. choline status is thought to be associated with depression and anxiety, however, the lack of evidence regarding the exact mechanism of its action warrants further investigation. this study aims to explore the associations between dietary choline and depression and anxiety in healthy individuals and how these may differ according to genetics, specifically phosphatidylethanolamine n-methyltransferase gene involved in endogenous and exogenous choline metabolism. establishing these associations could reinforce the need for future intervention trials that could in turn establish causality and determine the mechanistic effects of dietary choline and the pemt gene activity on depression/anxiety

Eligibility criteria:
inclusion criteria: * overall healthy males * pre-menopausal females of 18-50 years of age. exclusion criteria: * individuals with a current clinical diagnosis of anxiety and depression * pregnant or lactating * post-menopausal women * individuals suffering with chronic disease (cardiovascular disease, type-2 diabetes mellitus and cancer) * individuals using choline, lecithin or soy supplements, * obese individuals with a body mass index (bmi) \>30 kg/m2.
itic (imiquimod therapy in cervical intraepithelial neoplasia)-trial

Conditions: Cervical Intraepithelial Neoplasia

Summary: the present primary therapy of cervical intraepithelial neoplasia (cin) grade 3 and persistent cin 2 represents conisation. surgical treatment can cause perioperative (infection, bleeding in in 5-10%) and postoperative (increased risk of preterm labor) complications, as well as incomplete resections (20%) and risk of recurrence in 5-17%. imiquimod is an immunomodulating drug, that has been reported to be effective in human papilloma virus-related disease, such as vulvar intraepithelial neoplasia (vin), vaginal intraepithelial neoplasia (vain), and anal intraepithelial neoplasia (ain). the present randomised, placebo controlled, double blind study evaluates the efficacy of a topical treatment with imiquimod for 16 weeks in 60 patients with histologically confirmed cin 2/3.


Eligibility criteria:
inclusion criteria: * caucasian women aged 18 years and older with proven hpv-associated cin 2/3 * colposcopy with fully visible transformation zone and lesion * safe contraception * signed informed consent * negative urine pregnancy test * able to communicate well with the investigator, to understand and comply with the requirements of the study * signed the written informed consent exclusion criteria: * women who are pregnant or lactating or become pregnant during the conduct of the study * symptoms of a clinically relevant illness in the 3 weeks before the first study day * history of hypersensitivity to the trial drug or to drugs with a similar chemical structure * participating in another clinical trial within 30 days * malignancy * immunosuppression (medication, illness) * hiv- or hepatitis infection