Kornimate/medical-research-clean huggingface dataset:
a study of mitomycin c, irinotecan, and cetuximab

Conditions: Colorectal Cancer

Summary: colorectal cancer (crc) is one of the more common cancers in the united states with over 145,000 new cases expected in 2005. surgery is the main treatment for crc. however for some who relapse after surgery, or are unable to have surgery, chemotherapy is the primary treatment for this more advanced crc. some chemotherapy drugs are given to the patient by themselves, but many are given in combination with other chemotherapy treatment drugs and they seem to work better together than by themselves. this study will investigate the effectiveness of the combination of three chemotherapy drugs in patients who have been previously treated for their crc and it has returned. this study will also evaluate any rash that is associated with the drug cetuximab. the three therapy drugs are mitomycin c, irinotecan, and cetuximab.

we propose a phase ii trial which combines mitomycin c, irinotecan and cetuximab in patients with previously treated metastatic colorectal cancer with wild type non mutated k-ras. the goals of this investigation are to develop an effective systemic therapy for previously treated patients with crc with wild type k-ras, to further explore the relationship of mitomycin c induced topoisomerase 1 gene expression and response to irinotecan, and to define and characterize the biology of cetuximab induced skin rash.

Eligibility criteria:
inclusion criteria: 1. pathologic diagnosis of colorectal cancer. 2. clinical and/or radiologic evidence of metastatic disease. 3. one previous systemic treatment for metastatic disease. 4. age \> 18. 5. presence of at least one measurable lesion. 6. adequate hematopoetic (absolute neutrophil count \> 1500/mm3, platelet count \> 100,000/mm3), renal (serum creatinine \< 1.5 mg/dl), and hepatic function (bilirubin \< 1.5 and transaminases \< 5.0 x upper normal limit). 7. ecog performance status 0-2. 8. life expectancy \> 3 months. 9. patients must be informed of the investigational nature of this study and provide written informed consent in accordance with the institutional and federal guidelines prior to the initiation of therapy. exclusion criteria: 1. no recognized brain metastasis. 2. no previous treatment with mitomycin c or cetuximab. 3. no other systemic malignancy requiring treatment within the past one year. 4. pregnant or lactating women may not participate. women/men of reproductive potential must agree to use an effective contraceptive method. 5. patients must have no other serious medical or psychiatric illness that would limit the ability of the patient to receive protocol therapy or provide informed consent.
efficacy and safety of topiramate in the treatment of sleep-related eating disorder

Conditions: Sleep-Related Eating Disorder

Summary: the purpose of the study is to learn about the safety and effectiveness of oral (taken by mouth) topiramate in treating sleep-related eating disorder (sred).

this is a single center, 13-week, outpatient, randomized, double-blind, placebo-controlled, parallel group, pilot study of topiramate in subjects with sleep-related eating disorder (sred). the primary objective of this study is to investigate the efficacy and safety of topiramate compared to placebo in the treatment of sleep-related eating disorder. sred is a disorder that consists of out of control eating during the night with little or no awareness of the events. in this study we are comparing topiramate to placebo. a placebo is a pill that looks exactly like the study drug, but it does not have any active drug in it. topamax (topiramate) is approved by the u.s. food and drug administration (fda) as a therapy for epilepsy, but topiramate has not been approved by the fda for sred.

Eligibility criteria:
inclusion criteria: * adults 18-65 * diagnosis of sred * must be able to swallow capsules and follow instructions exclusion criteria: * women who are pregnant or lactating * other sleep disorders * kidney or liver disease * night shift workers * previous history of topiramate or topamax use for any condition

Keywords: sleep-related eating disorder topiramate parasomnia
targeting microbiota in female overactive bladder syndrome

Conditions: Microbiota; Urinary Bladder, Overactive

Summary: the aim of this study is to compare the urinary viral microbiome and bacterial microbiome between overactive bladder syndrome (oab) patients and healthy controls in order to determine a possible alteration in the urinary microbiome which may predispose women for oab, and also in order to determine a possible influence of the urinary viral microbiome on the urinary bacterial microbiome which may predispose the individual to oab. furthermore, we aim to compare the urinary bacterial microbiome to the vaginal, rectal, urethral and salivary bacterial microbiome within the same individual and between the two groups in order to determine a possible route of colonization of the urinary bladder.


Eligibility criteria:
inclusion criteria (case group): * symptoms of overactive bladder (urgency with or without urinary leakage, usually with frequency and nocturia) exclusion criteria (case group): * pregnant or lactating females * neurological conditions (such as ms, parkinson, spinal cord injury, stroke..) * pelvic organ prolapse (stage ≥ 3) * lower urinary tract surgery within past 6 months * known history of interstitial cystitis or pain associated with oab * recurrent urinary tract infections \> 3/year * acute urinary tract infection * urinary retention (with or without required self- catheterization) * stress urinary incontinence or mixed urinary incontinence * bladder cancer * renal insufficiency * urinary tract stones inclusion criteria (control group): without symptoms of overactive bladder or any other form of lower urinary tract symptoms * age-matched to case group (+/- 5 years) * bmi-matched to case group (18,5- 24,9 kg/m2 normal weight; 25- 29,9 kg/m2 overweight; 30- 34,9 kg/m2 obesity grade i) exclusion criteria (control group): as case group plus any form of lower urinary tract symptoms including oab
effect of thera-band versus swiss ball exercises on postural stability in post mastectomy lymphedema

Conditions: Post Mastectomy Lymphedema

Summary: the purpose of the study is to determine the effect of thera-band exercises versus swiss ball exercises on postural stability in unilateral post mastectomy lymphedema.

the need for this study develops from the lack of information in the published studies about the effectiveness of thera-band exercises and swiss ball exercise on balance in unilateral post mastectomy lymphedema. lymphedema is a chronic and progressive condition associated with functional impairment of the body segment. the asymmetry between hemi corp related to the range of motion, muscle strength, sensory stimuli and volume, reduce the ability to perceive and integrate information on the maintenance of the center of gravity and postural balance. the damage in the balance of patients with breast cancer is pointed out in the literature and is related to factors related to surgical intervention, adjuvant treatment, or even unilateral asymmetry caused by upper limb lymphedema. core stability exercises improve neuromuscular system performance that causes the optimal lumbar-pelvic -hip chain mobility and good acceleration and deceleration, appropriate muscular balance, proximal stability and good function. progressive resistance training interventions designed to increase strength and reduce the falls in elderly were effective in reducing both rate of falls and risk of falling, especially when some form of balance exercise was an integral part of the program. the present study is designed to investigate the effect of thera-band exercises versus swiss ball exercises on balance in unilateral post mastectomy lymphedema.

Eligibility criteria:
inclusion criteria: * patients are females. * patient with post mastectomy unilateral lymphedema. * their age will range from (30-50) years. * patients will be given their informed consent. exclusion criteria: * musculoskeletal disorders that will impair performance during training and tests. * uncontrolled cardiovascular or pulmonary diseases. * neurological and renal disorders. * metabolic or vascular disease with a neurological component such as diabetes. * malignant conditions. * primary lymphedema. * psychiatric illness, severe behavior or cognitive disorders. * uncooperative patients. * pregnancy.
lormetazepam versus midazolam in critically ill patients: a retrospective cohort trial

Conditions: Critical Illness

Summary: the aim of this retrospective cohort study is to evaluate the effect of lormetazepam versus midazolam on hospital mortality, intensive care unit outcomes and sedation management. the hypothesis is that patients receiving midazolam have a 5% higher hospital mortality in comparison to patients receiving lormetazepam.

sedation is an integral part of modern intensive care medicine and has seen a tremendous development throughout the last years. current guideline recommendations are targeted at an awake critically ill patients (target richmond agitation-sedation scale 0/-1) as early deep sedation has been shown to negatively affect the outcome. nevertheless, is an adequate and individualized anxiolysis still an important intervention that can be achieved via process optimization, modifications to the infrastructure of the ward and pharmacologic therapy. bolus application of benzodiazepines is a recommended pharmacologic measure to achieve proper anxiolysis. midazolam is currently the most commonly used benzodiazepine in european intensive care units. midazolam accumulates after repetitive application due to its pharmacokinetic properties, which increases the likelihood for side effects and makes targeted sedation increasingly difficult. lormetazepam is used with increasing frequency as it is eliminated independent of the patients age and has few relevant metabolites. it is therefore thought to be better suited for targeted sedation management, which in turn would be beneficial for the patients. the aim of this retrospective cohort study is to evaluate the effect of lormetazepam versus midazolam on hospital mortality, intensive care unit outcomes and sedation management.

Eligibility criteria:
inclusion criteria: * intensive care unit patients at the charité - universitätsmedizin berlin * age ≥ 18 years * intensive care unit length of stay ≥ 48 hours * duration of mechanical ventilation \> 0 hours * midazolam or lormetazepam application during the icu stay exclusion criteria: * number of application \< 2 * midazolam and lormetazepam application during the intensive care unit stay * neurosurgical intensive care unit patients
shoulder surgery traditional vs accelerated rehabilitation trial

Conditions: Rotator Cuff Tear; Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Summary: this is a randomised controlled trial involving patients who have a double-row arthroscopic rotator cuff repair. null hypothesis: there is no difference in outcome between standard rehabilitation and accelerated rehabilitation after arthroscopic rotator cuff repair. following surgery, they will be randomised to one of two groups: 1. standard rehabilitation, with enforced sling use for 6 weeks and a structured exercise programme. 2. accelerated rehabilitation with no requirement to use a sling and a structured exercise programme. the primary outcome measure will be the oxford shoulder score at 6 months. we will also collect data on postoperative pain, range of shoulder movement and other subjective outcome measures. all patients will have mri scans at 6 months postoperatively to assess the integrity of the repair, allowing comparison of failure rates between groups.

this is a randomised controlled trial involving patients who have a double-row arthroscopic rotator cuff repair. we wish to compare clinical and radiological outcomes for patients undergoing standard rehabilitation protocols versus accelerated rehabilitation. a double-row repair will be used in this study as it has been shown in laboratory testing to be stronger and withstand significantly more cyclical loads before failure. patients who have failed conservative treatment for their rotator cuff tears will be offered inclusion in the study. baseline scores and measurements will be taken prior to surgery. after a successful surgical repair has been confirmed, patients will be randomised to one of two rehabilitation programmes. one programme will mandate use of a sling for 6 weeks, and another will not require use of a sling after the immediate postoperative period. all patients will be followed up for one year, at intervals of 6 weeks, 3 months, 6 months and 12 months, using subjective outcome measures, objective measures of movement and an mri scan to assess the integrity of the repair at 6 months.

Eligibility criteria:
inclusion criteria: * adults aged over 40 with a degenerate full-thickness posterosuperior rotator cuff tear undergoing arthroscopic rotator cuff repair (+/- concomitant procedures such as biceps tenotomy and subacromial decompression). exclusion criteria: * other musculoskeletal disease affecting same limb * massive rotator cuff tear * subscapularis tear * incomplete cuff repair * repair under tension * non-english speaker * inability to follow postoperative instructions / restrictions

Keywords: shoulder arthroscopy rotator cuff repair
intraoperative frozen section pathology to guide surgical treatment for lung adenocarcinoma (ectop-1015)

Conditions: Lung Adenocarcinoma; Surgical Procedure, Unspecified; Pathology

Summary: this study is one of eastern cooperative thoracic oncology projects (ectop-1015). the goal of this clinical trial is to confirm the concordance rate between intra-operative frozen section pathological diagnosis and post-operative paraffin embedded pathological diagnosis, and use this result to guide surgical treatment for early stage (ct1n0m0) lung adenocarcinomas.


Eligibility criteria:
inclusion criteria: * patients who sign the informed consent form and are willing to complete the study according to the study protocol; * no previous history of cancer or pulmonary surgery; * solitary lesions or multiple lesions with only one not manifesting as pure ground-glass opacity (ggo) on ct scan; * peripheral clinical t1n0m0 patients that are eligible for surgery; * non-small cell lung cancer is pathologically diagnosed before or at surgery; * no radiation therapy or chemotherapy before surgery. exclusion criteria: * patients with clinical stages other than t1n0m0; * the lesion cannot be completely resected; * previous history of cancer; * patients having received radiation therapy or chemotherapy.

Keywords: intraoperative frozen section pathology surgical treatment lung adenocarcinoma
mr based survival prediction of glioma patients using artificial intelligence

Conditions: Glioma

Summary: this registry aims to collect clinical, molecular and radiologic data including detailed survival data, clinical parameters, molecular pathology (1p/19q codeletion, mgmt methylation, idh and tertp mutations, etc) and conventional/advanced/new mr sequences (t1, t1c, t2, flair, adc, dti, pwi, etc) of patients with primary gliomas. by leveraging artificial intelligence, this registry will seek to construct and refine algorithms that able to predict patients' survivals in the frame of molecular pathology or subgroups of gliomas.

non-invasive and precise prediction for survivals of glioma patients is challenging. with the development of artificial intelligence, much more potential lies in the preoperative conventional/advanced mr imaging (t1 weighted imaging, t2 weighted imaging, flair, contrast-enhanced t1 weighted imaging, diffusion-weighted imaging, and perfusion imaging) could be excavated to aid prediction of patients' prognosis in the frame of molecular pathology of gliomas. the creation of a registry for primary glioma with detailed survival data, molecular pathology, radiological data and with sufficient sample size for deep learning (\>1000) provides opportunities for personalized prediction of survival of glioma patients with non-invasiveness and precision.

Eligibility criteria:
inclusion criteria: * patients must have radiologically and histologically confirmed diagnosis of primary glioma * life expectancy of greater than 3 months * must receive tumor resection * signed informed consent exclusion criteria: * no gliomas * no sufficient amount of tumor tissues for detection of molecular pathology * patients who have any type of bioimplant activated by mechanical, electronic, or magnetic devices * patients who are pregnant or breast feeding * patients who are suffered from severe systematic malfuctions

Keywords: prognosis radiomics deep learning machine learning
playphysio: making physio fun

Conditions: Cystic Fibrosis in Children

Summary: a study to examine if the gamification of routine airway clearance can improve the quality of live for young people living with chronic health conditions.

cf experts agree that there is a discrepancy between objective and self-reported adherence. thus, an intervention focusing on both long-term, sustainable monitoring as well on enhancing and sustaining an efficient rate of respiratory physio is urgently needed. the device under investigation here is devoted exactly to this twofold task. playphysio®(pp) is a gamification system developed by will jackson, who has a background in product and software design but more importantly is the father of an adolescent girl with cf. the pp is an electronic monitor which can be attached to the outside of an opep device. it senses patients' use of the opep device to enable the individual completing their existing airway clearance therapy to play mobile games throughout their treatment. pp enables the individual to pick from a number of games to play whilst completing their normal prescribed airway clearance treatment. the games have been designed so that the ideal treatment technique is encouraged and the individual's treatment routine is supported with the counting of treatment breaths and prompting a pause to carry out their fet and cough. the aim of pp is to enhance treatment adherence through its innovative element: gamification. it also offers objective monitoring of cf physio adherence through its technology. the pp app offers positive feedback following the completion of treatment sessions, keeps a record of treatments done and shares this information with the cf physiotherapy team. a previous study of an earlier pp device have found good adherence over a 24 week period, however only 17/30 participants completed the trial. qualitative data found positive outcomes with 2 participants making the following observations. this was an earlier prototype and changes have been made since that time to both the device and the games. "i rely on the playphysio for breathing into his pep device properly. i can't imagine having to go back to the continuous monitoring and timing that used to be required before having playphysio®" "i rely on playphysio®. it has reduced my stress and time to get him to do it properly". children with cf who are using a play physio device, compared with those not using a play physio, will have a better experience of airway clearance leading to improved quality of life.

Eligibility criteria:
inclusion criteria: subject has confirmed diagnosis of cystic fibrosis as determined by the investigator under care of alder hey cystic fibrosis team (local or network care) subjects 6 years-11 years, 8 months of age, inclusive, on the date of the informed consent using a compatible opep device for daily airway clearance exclusion criteria: incompatible device for airway clearance outside of recruiting age
a real-world study to evaluate the clinical performance and safety of da vinci sp surgical system for single-port gynecological surgeries(spim-rws-gyn)

Conditions: Gynecological Surgeries

Summary: study name：a real-world study to evaluate the clinical performance and safety of da vinci sp surgical system for single-port gynecological surgeries study purpose：this clinical trial is a real-world study to evaluate the clinical performance and safety of da vinci sp surgical system ("sp single-port robot" for short) for single-port robotic surgeries of gynecological benign and malignant tumors in the real world, providing a real world evidence for clinical application of the product in the chinese population. study design：retrospective + prospective, real-world study english name: da vinci sp surgical system model and specification: sp1098 manufacturer: intuitive surgical, inc.


Eligibility criteria:
inclusion criteria: 1. female patients who have received or plan to receive gynecological surgeries with the sp single-port robot such as radical hysterectomy, salpingectomy/oophorectomy, vaginal hysterectomy, total hysterectomy, myomectomy, ovarian cystectomy, deep endometriosis resection, pelvic and abdominal lymphadenectomy, sentinel lymph node resection by image development, uterus/vagino-sacral colpopexy, and high uterosacral ligament suspension. 2. patients who voluntarily participate in the study and sign the icf (or exempt from signature of the icf as approved by the ec). exclusion criteria: 1. patients with missing data on the primary endpoint in retrospective cases; 2. patients having any contraindications of single-port robot surgery; 3. the intraoperative anatomy demonstrate that minimally invasive surgery is not suitable; 4. patients who are considered inappropriate to participate in this study by investigators.

Keywords: radical hysterectomy salpingectomy/oophorectomy vaginal hysterectomy total hysterectomy myomectomy ovarian cystectomy deep endometriosis resection pelvic and abdominal lymphadenectomy sentinel lymph node resection by image development uterus/vagino-sacral colpopexy high uterosacral ligament suspension