Kornimate/medical-research-clean huggingface dataset:
the ghana primary tube versus trabeculectomy study

Conditions: Glaucoma

Summary: medical treatment of glaucoma in west africa is often unsuccessful because of the cost of medications, disease severity and poor compliance. surgical treatment is likely to be a more practical solution. the purpose of this study is to compare the safety and efficacy of the aurolab glaucoma drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical study.


Eligibility criteria:
inclusion criteria: * age 18 to 85 years, inclusive * open angle glaucoma. including primary open angle glaucoma, pseudoexfoliative and pigmentary glaucoma * intraocular pressure 18 - 40 mmhg on maximal tolerated or maximal affordable medical therapy * informed consent given and consent form signed. exclusion criteria: * unwilling or unable to give consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits * pregnant or nursing women * no light perception vision * previous incisional intraocular surgery, other than uncomplicated clear corneal cataract surgery * previous ocular laser in study eye * iris neovascularisation or proliferative retinopathy * primary angle closure or primary angle closure glaucoma * iridocorneal endothelial syndrome or anterior segment dysgenesis * epithelial or fibrous downgrowth * aphakia * chronic or recurrent uveitis * steroid-induced glaucoma * severe posterior blepharitis * unwilling to discontinue contact lens use after surgery * previous cyclodestructive procedure * glaucoma secondary to penetrating keratoplasty, trauma, retinal disease/surgery or neovascular disease * conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease precluding a superior trabeculectomy * need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery
effects of chronic sleep restriction in young and older people

Conditions: Aging; Sleep Deprivation; Metabolic Syndrome

Summary: the purpose of this study is to examine the consequences of chronic sleep restriction on nighttime sleep, daytime alertness, performance and memory functions, and metabolic and cardiovascular function, and to determine if the consequences of chronic sleep restriction differ between healthy young and older adults.

it has long been recognized that sleep patterns change with age. a common feature of aging is the advance of the timing of sleep to earlier hours, often earlier than desired. polysomnographically-recorded sleep in older people shows an increased number of awakenings, a reduction of stages 3 and 4 (sws) sleep, and a flattening of rem sleep distribution throughout the night. these age-related changes are found in even healthy individuals who are not taking medications and who are free from sleep disorders. in addition to these sleep disturbances, many older individuals curtail their sleep voluntarily, reporting similar rates of sleep restriction (sleeping less than 7 or less than 6 hours per night) as young adults. whether voluntary or not, insufficient sleep has medical, safety and metabolic consequences. in fact, converging evidence in young adults suggests that sleep restriction per se may impair metabolism, and that reduced sleep duration is associated with weight gain, obesity, diabetes, cardiovascular disease, and mortality. the study begins with 21 days of outpatient study in which the participants will be required to sleep for 10 hours each night in order to ensure they are well-rested. this will be followed by a 39-day inpatient study. the study will begin with 3 "sleep satiation" days during which all participants will be scheduled to sleep for 12 hours per night and have a 4 hour nap each afternoon. this is followed by 3 baseline days in which the participants will follow the same sleep-wake schedule they were following at home. following this, the participant will undergo 3 weeks of chronic sleep restriction while living on a non-24-hour schedule. the participant will live on a schedule that is equivalent to 5.6 hours of sleep per 24 hours. following these 3 weeks, the participant will be scheduled to again sleep for 10 hours per night for 10 nights.

Eligibility criteria:
inclusion criteria: * healthy exclusion criteria: * chronic or acute medical condition * medication use * depression * history of psychiatric illness * sleep disorder

Keywords: aging sleep sleep deprivation performance memory metabolism
salivary drug concentration exploratory study of cetylpyridinium chloride buccal tablets

Conditions: Pharyngitis Acute; Gingivitis

Summary: the study is a single-arm, open-label study to explore the salivary concentration of cetylpyridinium chloride buccal tablets after single-dose administration in healthy subjects

primary objective: to observe the concentration of the investigational product in the saliva of healthy subjects. secondary purpose: to observe the safety of the investigational product in healthy subjects.

Eligibility criteria:
inclusion criteria: 1. subjects who have fully understand the objective, character, methods and potential adverse reactions of the trial, voluntarily participate in the study, and sign the informed consent form before enrolled into the study. 2. healthy subjects aged 18-45 (both inclusive) with an appropriate ratio of male to female. 3. subjects who had no parenthood plan from the signing of the informed consent form to one month after completing study, and agreed to take effective and appropriate contraceptive measures voluntarily by themselves and their partners during this period. 4. subjects those who be able to communicate well with investigators, and be able to understand and comply with the requirements of this study. exclusion criteria: 1. allergic to any ingredients of this product or excipients (sucrose, hypromellose, carbomer 934p, tartrazine aluminium lake, menthol,magnesium octadecanoate, povidone k 30) 2. pregnant or breastfeeding women 3. participants with abnormal salivary secretion, such as patients with xerostomia and diabetic dry mouth 4. usage of oral stimulants, salivary gland stimulants, other treatments or saliva substitute treatment that may affect salivary gland secretion within 7 days before screening 5. those who cannot tolerate venipuncture or have a history of haemorrhage or needle fainting 6. those who on special diet, who cannot comply with the standard diet of the study center, who have difficulty swallowing, who are lactose intolerant, or who have galactosemia or glucose/galactose absorption disorders 7. those who indicated as abnormal with clinical significance in screening laboratory examination, physical examination, vital signs or electrocardiogram inspection based on judgement of clinical study doctor. 8. the subjects may not be able to complete the study following protocol due to other reasons or investigators judge that they are not suitable participants.

Keywords: salivary drug concentration
the study of genes localization for female pelvic floor dysfunction

Conditions: Female Pelvic Floor Dysfunction

Summary: female pelvic floor dysfunction (fpd) is due to defects in the pelvic support structures, degradation, damage or dysfunction. the main problem of which is pelvic organ prolapse(pop), urinary incontinence(ui) and genital tract injury. although it does not pose a serious threat to life, but affect the patient's quality of life seriously in the physical, psychological, social behavior and other aspects. with the growing aging population, the incidence rate has gradually increased, and increasing demands for people's quality of life simultaneously, more and more attention was raised to pfd as common chronic diseases. in recent years, the basic research, epidemiology, prevention, diagnosis and treatment of pfd have made great progress, especially in developing gynecological urology theory and reconstructive pelvic surgery. but overall the basic research of pfd is lagging behind, especially susceptibility gene localization and functional studies did not get enough attention.


Eligibility criteria:
inclusion criteria: 1. female aging from 30 to 70-year old; 2. preoperative diagnosis of gynecologic malignancies; 3. have the ability to comply with research programs; 4. voluntarily participate in the study and signed an informed consent form exclusion criteria: 1. patients with severe cardiovascular diseases, kidney, liver and other vital organs diseases, bone marrow disease and mental illness; 2. patients suffering from autoimmune diseases; 3. patients with acute infectious disease or infection early phase of infection; 4. patients with urinary tract infection; 5. patients with infection or erosion of ano-genital skin; 6. for any other reason, the researchers considered unsuitable for inclusion.

Keywords: female pelvic floor dysfunction pelvic organ prolaps urinary incontinence massively parallel sequencing
accelerated enhanced recovery following minimally invasive colorectal cancer surgery (recovermi)

Conditions: Colorectal Cancer

Summary: the goal of this clinical research study is to learn if recovermi care can help to shorten the time that patients are in the hospital after surgery and if it can help them recover sooner. recovermi includes the following parts: * preoperative education * early oral intake * early mobilization * telemedicine

study groups: if you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. this is done because no one knows if one group is the same, better, or worse than the other group. * if you are assigned to group 1, you will receive standard enhanced care after your surgery. * if you are assigned to group 2, you will receive routine care after surgery, but you will also receive accelerated recovery, early discharge, and telemedicine. participants will be loaned an ipad to use for video-conferencing and text messaging in this study. this is an investigational study. the study doctor can explain how recovermi is designed to work. up to 32 participants will be enrolled in this study. all will take part at md anderson.

Eligibility criteria:
inclusion criteria: 1. patient has histologically proven colorectal cancer or polyp(s) that is planned to be treated by surgical resection performed with curative intent. 2. patient is \>/= 18 years and younger than 80 years. 3. elective minimally invasive operation. 4. no planned ostomy creation at time of enrollment. 5. serum creatinine \<1.5 measured within 30 days of surgery. 6. ability to speak, read, and understand english. exclusion criteria: 1. strong, self-reported history of postoperative nausea and vomiting. 2. history of congestive heart failure. systolic heart failure defined as ejection fraction (ef) \ 40% plus systemic manifestation of heart failure.

Keywords: colorectal cancer colorectal cancer surgery polyp(s) accelerated enhanced recovery recovermi fluid diary questionnaires surveys recovermi device
consolidation pet-based and donor-based after salvage therapy in patients with hl in relapse or refractory

Conditions: Hodgkin's Lymphoma

Summary: pet-based consolidation and donor-based therapy after rescue in patients with hodgkin's lymphoma refractory at first line therapy, or relapse early or late, undergone a second line chemotherapy.

this is a prospective observational study in which patients with positive pet scan after salvage therapy are candidates to a sequential scheme "auto-allotransplantation" in case of availability of a donor . in the event of unavailability of a donor , the same patients are candidates for a double high-dose chemotherapy with autologous stem cell support.

Eligibility criteria:
inclusion criteria: * patients confirmed hodgkin's lymphoma at refractory at first line therapy, relapse early or late; * age \> 18 years; * life expectancy \> 3 months; * cardiac, pulmonary, renal and liver functions with normal range; * written informed consent. exclusion criteria: * any psychological, familiar or geographical conditions that could potentially hinder the compliance to the protocol; * renal failure as creatinine\> 1.2 mg/dl or creatinine clearance \<60 ml/min; * ast/alt or bilirubin\> 2.5 times the norm; * hcv positivity with signs of ongoing viral replication (hcv pcr + ast\>1.5-2x normal); * heart disease clinically significant: eg. severe hypertension not controlled, multifocal uncontrolled cardiac arrhythmias, symptomatic ischemic heart disease or congestive heart failure class nyha class iii-iv (annex 2), previous acute myocardial infarction; * ventricular ejection fraction \<45%; * decompensated diabetes mellitus not controlled by insulin therapy; disease with significant pulmonary function defined as fev1 \<65% of predicted or dlco \<50% of predicted value; * hiv positive patients; * patients with uncontrolled infection; * neoplasia in the last 3 years except carcinoma in situ uterus, neck and basal skin cancer or prostate cancer in early stage localized exeresi treated with surgery or brachytherapy with curative intent, a good prognosis dcis breast treated with surgery alone; * drug addiction or alcoholism.

Keywords: hodgkin's lymphoma stem cell reinfusion
t-dm1 in her2-positive metastatic/relapsed breast cancer

Conditions: Breast Cancer

Summary: this is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of t-dm1 in metastatic/relapsed her2-positive breast cancer as part of the establishment of hospital medical record collection system to evaluate drug effectiveness by health insurance review \& assessment service (hira). the medical records in approximately 1,000 patients of her2-positive locally-advanced unresectable or metastatic breast cancer, who have received kadcyla(trastuzumab emtansine, t-dm1) previously, will be collected.

t-dm1 therapy has shown a survival benefit in previously trastuzumab-treated her2-positive locally-advanced unresectable or metastatic breast cancer patients from clinical trials. however, the real-world efficacy and safety of t-dm1 in korea were not evaluated outside the controlled clinical trials. therefore, this large multicenter retrospective analysis was designed to evaluate the real-world efficacy and safety of t-dm1 under the korea national health insurance system. the medical records in approximately 1,000 patients with relapsed or de novo metastatic breast cancer, who have received t-dm1 between aug 03, 2017 and dec 31, 2018 will be collected. eligibility criteria included age ≥ 19 years, histologically confirmed her2-positive, relapsed after primary surgery or initially metastatic breast cancer, and previous trastuzumab treated. efficacy was evaluated by overall survival, progression free survival, time to progression, objective response rate, disease control rate, duration of response and time to next treatment. safety was evaluated by hematologic or non-non hematologic toxicities and adverse events of special interest with t-dm1 therapy.

Eligibility criteria:
inclusion criteria: 1. age ≥19 years at the time of study registration 2. participants must have histologically confirmed her2-positive breast cancer 3. locally advanced unresectable or metastatic patients 4. patients who have received t-dm1 therapy between aug 2017 and december 2018 under the korea national health insurance system exclusion criteria: • patients who have received t-dm1 therapy outside of the korea national health insurance system
postoperative hip precautions after total hip arthroplasty via the posterior approach: a prospective randomized trial

Conditions: Osteoarthritis; Degenerative Joint Disease

Summary: the purpose of this study is to determine if hip precautions, which are instructions that limit functional use of a hip replacement after surgery, affect the rate of dislocation in the first six weeks after primary total hip replacement surgery. the impact of hip precautions on a patient's return to activities of daily living and overall patient satisfaction will also be investigated. the overall cost effectiveness of hip precautions will be determined.

this study examines the necessity of postoperative hip precautions in patients after primary total hip arthroplasty via the posterior approach. precautions are instructions that limit the functional use of the hip and are given for the first six weeks after surgery, with the goal of preventing an instability event resulting in dislocation. the hip precautions that will be investigated in this study are: no hip flexion past 90º, no crossing the legs, and no twisting at the waist.

Eligibility criteria:
inclusion criteria: * patients undergoing a primary total hip arthroplasty via the posterior approach by participating attending surgeons at this institution * index diagnosis of noninflammatory arthritis * patients must be able to understand and comply with study procedures exclusion criteria: * allergy or intolerance to the study materials * history of previous surgeries on the affected joint other than arthroscopy; i.e. revision tha or open surgeries

Keywords: total hip arthroplasty hip precautions posterior approach
real world efficacy, safety of nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy

Conditions: Pancreatic Adenocarcinoma Metastatic

Summary: the objectives of the study are to evaluate the efficacy (primary endpoint: overall survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice

nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid was shown to be effective after gemcitabine-based treatment in patients with metastatic pancreatic adenocarcinoma in the phase iii napoli-1 randomized trial. nanoliposomal irinotecan is authorized in combination with 5-fluorouracil (5-fu) and leucovorin (lv), as it has shown an improvement in overall survival (median +1.9 months, hr = 0.67) compared to 5-fu/lv alone, without degradation of quality-of-life scales. however, patients included in clinical trials regularly differ from patients in routine practice, and a real-life study is fundamental in this poor prognosis situation where quality of life preservation is paramount

Eligibility criteria:
inclusion criteria: * 18 years or older * histological or cytological confirmation of pancreatic ductal adenocarcinoma * measurable lesion(s) * progression after gemcitabine-based treatment administered in a neoadjuvant, adjuvant protocol (only if remote metastases developed within 6 months of the end of adjuvant treatment), locally advanced, or metastatic phase. they may have already received irinotecan and/or fluorouracil. * performance status (ps) 0 or 1 * oral consent * health insurance exclusion criteria: * symptomatic brain metastases (cerebral edema, corticosteroids, progressive disease) * thromboembolic events within six months of inclusion; * class iii or iv congestive heart failure, ventricular arrhythmia, uncontrolled hypertension. * patient under legal protection * hypersensitivity to irinotecan * breast feeding

Keywords: pancreatic adenocarcinoma
efficacy of metronidazole prophylaxis against clostridium difficile-associated diarrhea in high risk adult patients

Conditions: Clostridium Difficile Diarrhea

Summary: the purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced clostridium difficile diarrhea among patients at high risk for this infection.

clostridium difficile infection or c. diff (cdi) is an infection that causes severe diarrhea. risk factors for this infection include hospitalization, the use of antibiotics, along with medications that decrease the acid in the stomach. this infection leads to a disease which is difficult to treat and can cause serious complications including death in rare cases. this infection also increases medical costs by prolonging hospital stays. metronidazole (known by the brand name flagyl) is an antibiotic that has been available for decades and has been used to treat this disease. flagyl is approved by the food and drug administration for the treatment of c. diff infection. recent research by the investigators group has shown that hospitalized patients who took flagyl had a decreased chance of getting c. diff infection. however, high quality studies are needed to better evaluate whether the investigators can prevent c. diff infection in high risk patients with the use of flagyl. the purpose of this study is to assess if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced clostridium difficile diarrhea among inpatients at high risk for this infection. high risk patient population are as defined below: taking a broad spectrum antibiotics (piperacillin/tazobactam-zosyn; ciprofloxacin).

Eligibility criteria:
inclusion criteria: * inpatients \>55 * proton pump inhibitor / histamine-2 blocker * on broad spectrum antibiotics (zosyn and/or ciprofloxacin). these two antibiotics are selected based on current hospital formulary/use * anticipated hospital stay \>48 hours * mental capacity (able to give informed written consent). exclusion criteria: * admission for cdi * existing diarrhea at admission * passed prophylactic window (\>48 hours on broad spectrum antibiotics) * unable to take po at the time of evaluation for study entry * no more than 14 days of broad spectrum antibiotics anticipated * medications with serious interactions/contraindications to that would be taken together with metronidazole (ex. warfarin, disulfiram, phenytoin, calcineurin inhibitors) * inflammatory bowel disease * admission for colonic bowel surgery or h/o total/subtotal colectomy) * hospice * mortality expected \<7days * previous cdi in the past 6 months * intensive care admission due to the difficulty of monitoring them * allergy to metronidazole or other antibiotics in protocol * patients with neuropathy * history of heavy ethyl alcohol intake(greater than 3 drinks daily) or intake in past 24 hours,solid organ transplant.

Keywords: clostridium difficile infection diarrhea flagyl metronidazole