Kornimate/medical-research-clean huggingface dataset:
high-flow nasal oxygen therapy for exacerbation of chronic pulmonary obstructive disease.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: high-flow nasal oxygen (hfno) therapy has never been tested against noninvasive ventilation, the reference standard therapy for acute exacerbation of chronic obstructive pulmonary disease (copd), in randomized clinical trials. the aim of the present study is to compare the effects of hfno therapy on arterial blood gas variables over the first 24 hours of therapy, to those of noninvasive ventilation, in patients experiencing a moderate (i.e. with arterial ph within 7.25-7.35) exacerbation of copd.

as soon as admission to the intensive care unit, eligible patients who gave consent will be randomized to either hfno or noninvasive ventilation therapy for at least the first 24 hours. in the usual care group , noninvasive ventilation will be applied in alternance with standard nasal oxygen therapy. in the intervention group, hfno with be applied continuously over the first 24 hours. in both groups, an oxygen saturation, as assessed by finger pulse oximetry, of 88-92% will be targeted. the primary objective will be two-fold: to compare between groups 1) efficacy, assessed by the arterial ph at 24 hours, and 2) safety, assessed by the ratio of the arterial partial pressure in oxygen (pao2) over the inspired oxygen fraction (fio2) at 24 hours.

Eligibility criteria:
inclusion criteria: * age \> 18 * known chronic obstructive pulmonary disease (copd) * respiratory rate or presence of accessory respiratory muscles activity on physical exam * moderate exacerbation of copd as defined by an arteria ph between 7.25 and 7.35 and an arterial carbon dioxide partial pressure (paco2) equal or above 45 mm hg exclusion criteria: * age below 18 * pregnancy * known sleep apnea syndrome * patent treated by noninvasive ventilation at home * not affiliated to french scial security * contraindication to aither noninvasive ventilation or to high-flow nasal oxygen therapy * previous inclusion in the study

Keywords: respiratory failure oxygen therapy noninvasive ventilation
hip arthroplasty and vitamin d status

Conditions: Vitamin D Deficiency

Summary: it is essential that serum 25(oh)d changes following surgery be clarified, and the mechanism(s) underpinning these changes be identified. as such, the overarching hypothesis of this study is that elective total hip arthroplasty reduces serum total 25(oh)d.


Eligibility criteria:
inclusion criteria: * elective total hip arthroplasty for osteoarthritis * age 50+ * able and willing to sign informed consent * english speaking * willing to not alter vitamin d supplementation use for the duration of this study * willing to utilize sunscreen of spf-15 or higher when sun exposure for more than 15 minutes is expected exclusion criteria: * illnesses known to affect inflammatory marker status including, but not limited to, rheumatoid arthritis, systemic lupus erythematosis and mixed connective tissue disease * chronic diseases that could potentially affect dbp status, e.g., chronic kidney disease stage requiring dialysis, nephrotic syndrome and chronic hepatitis, * hip arthritis from causes other than osteoarthritis * treatment with medications with potential to affect vitamin d metabolism, (e.g., phenytoin, phenobarbital, teriparatide or active vitamin d analogues) or to potentially interfere with 25(oh)d measurement by hplc (atavaquone) within the preceding three months. * treatment with high dose vitamin d supplementation (50,000 iu weekly or more frequently) within the preceding three months. note; subjects on a stable daily vitamin d dose will be allowed to participate * surgical procedure within the preceding six months * use of tanning beds or salons or unwillingness to utilize sunscreen during periods of sun exposure of 15 minutes or longer

Keywords: vitamin d, vitamin d deficiency, hip arthroplasty
longitudinal evaluation study of vaginal stenosis with and without pelvic radiation therapy

Conditions: Malignancies; Stenosis of Vagina

Summary: this study evaluates the effects of treatment with a vaginal dilator to reduce vaginal stenosis in women receiving pelvic radiation therapy for pelvic malignancies.

vaginal stenosis can occur as a result of treatment for pelvic malignancies. women receiving pelvic radiation therapy using a vaginal dilator 5-7 times per week will have less vaginal stenosis than women using a vaginal dilator fewer times or not at all.

Eligibility criteria:
inclusion criteria: * pre and post menopausal women undergoing definitive (not palliative) treatments for a pelvic malignancy, including rectal, endometrial, cervical, or anal canal carcinoma. * treatments include radiation therapy, chemotherapy, surgery, or a combination of therapies. * may have early-stage or locally advanced (node positive) disease. * male partners of the female subjects are also consented for this study. exclusion criteria: * subject may not have evidence of metastatic disease. * prior pelvic radiation therapy * prior hysterectomy (not for current diagnosis) * diagnosis of prior malignancy, except non-melanoma skin cancer.

Keywords: vaginal length sexual dysfunction
impact of hepatectomy on hcc recurrence

Conditions: Hepatocellular Carcinoma Stage I; Recurrence

Summary: hepatectomy is the first option for the treatment of hepatocellular carcinoma(hcc) at cnlc ib stage. hcc patients who undergo curative hepatectomy may experience varying remnant liver volumes and thus leads to different oncological outcomes.

patients with hepatocellular carcinoma (hcc) who undergo curative hepatectomy may experience varying remnant liver volumes. the investigators aimed to evaluate whether the extent of liver resection has an effect on postoperative recurrence in hcc patients. a retrospective analysis was conducted on 197 patients who underwent hepatectomy for a solitary hcc lesion measuring ≥5 cm between january 2019 and june 2022. patients were divided into major hepatectomy (mah) group (n=70) and minor hepatectomy (mih) group (n=127) based on the extent of liver resection. recurrence-free survival (rfs) was compared between the two groups. propensity score matching was employed to mitigate potential biases in this research.

Eligibility criteria:
inclusion criteria: * histologically confirmed solitary hcc with a size of ≥5 cm * eastern cooperative oncology group score of 0 or 1 * preoperative indocyanine green retention rate at 15 minutes ≤15% and child-pugh a classification * no evidence of vascular invasion or extrahepatic disease. exclusion criteria: * not diagnosed with hcc or had an hcc measuring \<5 cm * had confirmed tumor metastases or macrovascular invasion based on radiological examinations * died within 90 days after surgery were excluded

Keywords: hepatocellular carcinoma recurrence hepatectomy
a study to assess the safety and efficacy of vilaprisan in japanese subjects with uterine fibroids and heavy menstrual bleeding

Conditions: Uterine Fibroids and Heavy Menstrual Bleeding

Summary: to evaluate the safety and efficacy of vilaprisan in japanese subjects with uterine fibroids and heavy menstrual bleeding (hmb).


Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosis of uterine fibroid(s) documented by ultrasound at screening * heavy menstrual bleeding (hmb) \>80.00 ml associated with uterine fibroid(s) * good general health * normal or clinically insignificant cervical smear * an endometrial biopsy performed during the screening period, without significant histological disorder * use of an acceptable nonhormonal method of contraception starting at visit 1 until the end of the study exclusion criteria: * pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment) * hypersensitivity to any ingredient of the study drug * any condition requiring immediate blood transfusion * any diseases, conditions, or medications that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug * any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results * abuse of alcohol, drugs, or medicines (e.g., laxatives) * use of other treatments that might interfere with the conduct of the study or the interpretation of the results * undiagnosed abnormal genital bleeding
study of different pain scores in single-port access (spa) laparoscopic hysterectomy versus conventional laparoscopic hysterectomy

Conditions: Uterine Myoma; Uterine Adenomyosis

Summary: purpose: the attempt to further reduce the operative trauma in laparoscopic hysterectomy led in new technique such as single-port access (spa) laparoscopic surgery. this new technique is considered as painless procedure and better cosmetic effect but there are not any publications to study a possible different pain score and cosmetic effect in new techniques versus conventional laparoscopic hysterectomy. in this randomized controlled study the researchers have investigated the pain scores and cosmetic satisfaction by modified body image scale and cosmetic scar scale.


Eligibility criteria:
inclusion criteria: * age 30-60, female * symptomatic (dysmenorrhea, palpable mass, pelvic pain or discomfort, urinary symptom, increasing size, menorrhagia) myomas or adenomyosis * suspected uterine myoma and/or adenomyosis on transvaginal ultrasonography (usg) * at least a 6-month thorough follow-up record available * informed consent exclusion criteria: * endometrial hyperplasia without myoma or adenomyosis * body mass index more than 30 * huge uterus defined by longitudinal uterine diameter larger than 10cm and anteroposterior diameter larger than 8cm in usg

Keywords: single-port laparoscopy hysterectomy pain cosmesis analgesics
activity treatment on vestibular rehabilitation

Conditions: Vestibular Disorder

Summary: in this study it was aimed to investigate the effects of home treatment program based standard activity on dizziness, balance and daily life activity in patients with dizziness complaint originated from chronic unilateral peripheral vestibular disorder and compare to effects of exercise-based home rehabilitation program.

the aim of this study was to assess the effects of an activity training programme on dizziness, imbalance, and level of independence in daily living activities in patients with chronic dizziness. 75 patients between 18-65 years of age who diagnosed chronic peripheral vestibular disorders and individuals with vestibular rehabilitation indications were included in our study. patients were randomly divided into 3 groups consist of 25 patients as an activity group, exercise group, and control group. education was given to each group. i̇n addition, the activity group was performed a training activities program, the exercise group was performed in the cawthorne-cooksey exercises program. therapy programs were prescribed once daily at home for 4 weeks. after demographic information was obtained from all patients, assessments were performed at the beginning and at the end of the treatment program (4 weeks). dizziness severity was assessed by the visual analog scale (vas), activities of daily livings were assessed by vestibular disorders activity questionnaire (vadl) and balance was assessed by sensory organization testing (sot).

Eligibility criteria:
inclusion criteria: * patients have dizziness complaint longer than 3 months, * history of at least one dizziness in a month * patient has been diagnosed chronic unilateral peripheric vestibular disorder exclusion criteria: * patients with diagnosed benign paroxysmal positional vertigo, had meniere's disease, had history of central nerve system impairments and/or psychiatric disorder, had uncontrolled hypertension and diabetes, had not understanding simple verbal instruction and following ability, not able to stand independent in the standstill position, had visual problems that cannot be treated with lenses or glasses, had movement limitation due to the orthopedic problem, using medication for dizziness.
caregivers' ecourse for recovery after hip fracture

Conditions: Hip Fractures; Family

Summary: in this two part study, we will seek 1. general feedback on the feasibility of an online education and skill development program for family/caregivers of older adults recovering from a surgically repaired low-trauma hip fracture. we will also 2. test its feasibility and acceptability with family caregivers.

this is a cross-sectional mixed methods study to obtain feedback from health providers and family caregivers on ecourse for the post-hip fracture period. for participants who access the course via the pi's website, participants will only be asked to provide feedback on the content, layout, and delivery of the ecourse.

Eligibility criteria:
inclusion criteria: * family/caregivers of older adults with hip fracture, health providers, older adults, and/or general public exclusion criteria: * adults less than 19 years of age

Keywords: education caregivers ecourse feasibility
european polyp surveillance trial

Conditions: Colorectal Neoplasms

Summary: this protocol describes the epos (ancient greek (επος) for "story") of a group of related clinical trials aiming at addressing one of the most important unsolved challenges in the prevention of colorectal cancer (one of our major cancer killers); the surveillance of patients with premalignant polyps in the large bowel. this project is timely because large scale colorectal cancer screening programmes are currently rolled out in most western countries. these programmes are diagnosing large numbers of individuals with premalignant polyps (adenomas and serrated polyps). this creates both a diagnostic and resource dilemma, because the optimal surveillance strategy for these individuals to reduce future cancer risk is currently unknown.. the epos trials will randomize or register more than 20,000 individuals in different european countries to different surveillance colonoscopy intervals to disentangle the most effective and cost-effective surveillance strategy for the population. subjects will be randomized according to their presenting polyp chracteristics the epos i trial randomizes patients with low-risk adenomas into 5 or 10-year surveillance; ; epos ii randomizes patients with high-risk adenomas into 3 or 5-yearly surveillance ; epos iii will include patients with serrated polyps in a one-arm study with surveillance after 5 and 10 years. the primary endpoint for all three trials is incidence of colorectal cancer after 10 years of follow-up. this epos trials are the largest in polyp surveillance ever conducted. they address a clinical problem affecting hundreds of thousand individuals in europe and the us each year, it has a large size, and should thus provide definitive results.


Eligibility criteria:
inclusion criteria: * cecal intubation (preferably documented by images/videoof the apendiceal orifice and the ileocecal valve; but not required). * adequate colonic cleansing, with boston bowel cleansing score equal or higher than 2 points in all colonic segments. * complete excision of all polyps at baseline colonoscopy findings (as judged by the trial endoscopists). exclusion criteria: * lack of consent * history of crc or adenomas * history of serrated polyps ≥ 10 mm in diameter at any colorectal location or ≥ 5 mm if located proximal to the splenic flexure * incomplete colonoscopy * incomplete endoscopic excision of polyps * genetic cancer syndrome (adenomatous or serrated polyposis syndrome; lynch or lynch-like syndrome) * inflammatory bowel disease * history of surgical colon resection for any reason * severe co-morbidity with reduced life expectancy (nyha 3-4) * on-going cytotoxic treatment or radiotherapy for malignant disease * long-lasting attention and nursing services (somatic or psychosocial, mental retardation).
chemotherapy decisions and outcomes in older women with newly diagnosed breast cancer

Conditions: Breast Cancer; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: studying how older women make treatment decisions and how these decisions affect the outcome of treatment may help doctors plan more effective treatments and improve patient quality of life. purpose: this clinical trial is studying how a patient's treatment preferences and decisions about chemotherapy affect the outcome of treatment in older women with newly diagnosed breast cancer.

objectives: * determine the relationship between preferences and chemotherapy decisions in women age 65 and over with operable, newly diagnosed breast cancer. * determine how factors that could be targets for intervention affect the relationship between preferences and chemotherapy decisions in these patients. * determine the relationships between preference-based chemotherapy decisions, quality of life, and satisfaction with treatment decisions in these patients. * determine the disease-free survival and competing causes of mortality of these patients. * determine the types of physician providers who care for older breast cancer survivors after initial cancer treatment is completed and explore how women decide about which physicians to see. * measure quality indicators for the survivorship phase of care and evaluate if quality varies by type of physician provider model. * determine if long-term patient-reported satisfaction varies as a function of physician model for providing follow-up care post-treatment. * determine whether physician-patient communication and coordination of care after treatment ends mediate follow-up quality and outcomes post-treatment. outline: this is a cohort study. patients participate in interviews over 30-45 minutes at baseline, at 6 months, and at 1 and 2 years. patients are followed annually for at least 5 years. projected accrual: a total of 1,296 patients will be accrued for this study within 18-24 months.

Eligibility criteria:
disease characteristics: * histologically confirmed primary adenocarcinoma of the breast * operable disease * invasive and unilateral tumor * no more than 20 weeks since diagnosis * t1-4 (tumor size ≥ 1 cm), n0, m0 or * t1-4, n1-3, m0 * no prior carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer * hormone receptor status: * any estrogen receptor status patient characteristics: age * 65 and over sex * female other * no other malignancy except those for which the patient has completed treatment and is considered to be at less than 30% risk of recurrence * history of non-melanoma skin cancer allowed * sufficient cognitive function to consent to and complete interviews * english or spanish speaking

Keywords: psychosocial effects of cancer and its treatment stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage ia breast cancer stage ib breast cancer estrogen receptor-negative breast cancer estrogen receptor-positive breast cancer
efficacy and safety of xeloda as sequential adjuvant therapy after chemotherapy in breast cancer

Conditions: Breast Cancer

Summary: select 600 cases of women with breast cancer of triple negative or her-2 positive or with more than 4 axillary lymph node metastasis. all the patients were accepted the chemotherapy of anthracycline and/or taxane. divide them into two groups randomly. then the experimental group will be treated with xeloda(1000mg/m2,orally,2 times/day) for six cycles (21 days/cycle,each taking two weeks suspending for one week) as sequential adjuvant therapy. and the control group will not receive any adjuvant therapy.finally the investigators will assess the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using medications.

the investigators will select 600 cases of women with breast cancer of triple negative or her-2 positive or with more than 4 axillary lymph node metastasis. all the patients were accepted the chemotherapy of anthracycline and/or taxane. divide them into two groups randomly. then the experimental group will be treated with xeloda(1000mg/m2,orally,2 times/day) for six cycles (21 days/cycle,each taking two weeks suspending for one week) as sequential adjuvant therapy. and the control group will not receive any adjuvant therapy.finally the investigators will assess the 5-year disease-free survival, 5 years and 10-year overall survival and safety of using medications.

Eligibility criteria:
inclusion criteria: 1. karnofsky ≥ 70 2. provision of informed consent 3. pathological confirmation of breast cancer and exclusion of other metastases. 4. pathological confirmation of triple negative or her-2 positive or with more than 4 axillary lymph node metastasis 5. the patients have finished the chemotherapy of anthracycline and/or taxane.and it's no more than 28 days from accepting the last chemotherapy. 6. laboratory criteria: plt ≥ 100\*109/l wbc ≥ 4000/mm3 hgb ≥ 10g/dl got,gpt,alp ≤ 2\*uln tbil,dbil,ccr ≤ 1.5\*uln exclusion criteria: 1. pregnant or lactation woman 2. bilateral breast cancer, inflammatory breast cancer or carcinoma in situ 3. accepted neoadjuvant treatment including chemotherapy, radiotherapy and endocrine therapy 4. history of organ transplantation 5. with mental disease 6. with severe infection or active gastrointestinal ulcers 7. with severe liver disease (such as cirrhosis), kidney disease, respiratory disease or diabetes 8. disease-free period of other malignant tumor is less than 5 years(except cured basal cell skin cancer and cervical carcinoma in situ) 9. with heart disease 10. experimental drug allergy

Keywords: breast cancer
monitoring pulmonary artery pressure by implantable device responding to ultrasonic signal (papirus iii)

Conditions: Heart Failure

Summary: the papirus iii study will continue to follow patients initially enrolled in papirus ii. pressure readings from the investigational device will continue to be collected and will be correlated to physiological changes during activities of daily living and protocol defined tests.

this is a small clinical trial to determine the feasibility of a device \& to test prototype device, where the primary outcome measure relates to feasibility and not to health outcomes.

Eligibility criteria:
inclusion criteria: * patient has been enrolled in the papirus ii study and has a remonchf pressure sensor implanted * patient is willing and able to provide informed consent, participate in the safety follow-up program and/or in the required tests associated with the clinical investigation (core study program) at an approved clinical investigational center and at the intervals defined by the clinical investigational plan. exclusion criteria: * patient enrolled in papirus ii but not implanted with a remonchf pressure sensor * patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study (with the exception of the papirus ii study). each instance would be brought to the sponsor to determine eligibility. * age \< 18 years * women of childbearing potential who are, or might be, pregnant at the time of the study