Kornimate/medical-research-clean huggingface dataset:
different patterns of target delineation in sbrt for locally advanced pancreatic cancer

Conditions: Treatment

Summary: the purpose of this study is to compare the efficacy and safety of two target delineation methods in sbrt for lapc, so as to determine whether the target delineation method based on recurrence pattern can obtain better survival benefits.


Eligibility criteria:
inclusion criteria: * age 18-75 * patients with a pathological diagnosis of pancreatic ductal adenocarcinoma or clinical diagnosis of pancreatic cancer after clinical multiple disciplinary team * patients with a clinical staging of locally advanced pancreatic cancer * no anti-tumor treatment related to pancreas before sbrt * performance status is acceptable, ecog score is 0 or 1 * patients who voluntarily accepted the clinical trial program after informing the existing treatment plan exclusion criteria: * patients who have previously received relevant treatments in the pancreas and its surrounding areas, such as radiotherapy, chemotherapy, and local treatment * severe liver and kidney dysfunction * obstructive jaundice * moderate or mass ascites * patients with other malignant tumors, acute infection or other severe infection * patients with gastrointestinal ulcers and incomplete recovery, or patients with acute peptic ulcer * gastroscopy or imaging examination indicates that the tumor invaded the duodenum or stomach * patients who have participated in other clinical trials for less than three months * patients who are judged by researchers as unsuitable for this clinical trial

Keywords: sbrt locally advanced pancreatic cancer target delineation
pf-07284892 in participants with advanced solid tumors

Conditions: Solid Tumor

Summary: the purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of pf-07284892 as a single agent and in combination with lorlatinib, encorafenib and cetuximab, or binimetinib and evaluate the pharmacokinetics, safety, and preliminary clinical activity of single agent and each combination therapy.


Eligibility criteria:
inclusion criteria: * age ≥18 years at the time of informed consent * histological or cytological diagnosis of alk-positive advanced nsclc, crc with braf v600e mutation, or ras- mutant, nf1-mutant or braf class 3 mutant solid tumor. participants with ros-positive nsclc are also eligible for part 1 and 2 (other ros1-positive solid tumors may be considered after discussion with the sponsor). * documentation evidence of biomarker mutation status * part 3: alk-positive nsclc with prior lorlatinib and no prior platinum-based chemotherapy (cohort 1); with prior lorlatinib and prior platinum-based chemotherapy (cohort 2); or with no prior lorlatinib (cohort 3). braf v600e mutant crc participants resistant to brafi plus egfri (cohort 4 ); refractory to brafi plus egfri (cohort 5); or brafi plus egfri naïve (cohort 6). ras- mutant, nf1-mutant or braf class 3 mutant solid tumors who have received prior soc (cohort 7). exclusion criteria: * brain metastasis larger than 4 cm * active malignancy within 3 years * systemic anti-cancer therapy or small molecule therapeutics within 2 weeks prior to start of study treatment. antibody based agents within 4 weeks prior to start of study treatment. mitomycin c or nitrosoureas within 6 weeks prior to start of study treatment. * for participants who may get lorlatinib or encorafenib on study, history of interstitial lung disease * for participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (rvo) or concurrent neuromuscular disorder associated with elevated creatine kinase (ck)

Keywords: colorectal cancer non-small cell lung cancer b-type raf proto-oncogene (braf) mutation ras mutation anaplastic lymphoma kinase (alk)-positive neurofibromatosis type 1 (nf1) ros1
effect of aromatase inhibitors on breast magnetic resonance imaging (mri)

Conditions: Breast Cancer

Summary: this study is a primary investigation to determine the usefulness and safety of a short course of a relatively high dose of letrozole (a medication used to decrease the female hormone estrogen which is produced locally inside the breast after menopause) in improving the performance of of breast mri (magnetic resonance imaging). the inhibition of estrogen in the breast by letrozole might help better identifying of suspicious areas in the breast and could assist radiologists in distinguishing between benign breast areas and cancer tissue. this might help reducing the rate of call backs and unnecessary biopsies for patients. we expect to enroll 20 healthy postmenopausal women in this study.

a breast mri will be performed in the standard way for diagnosis and to serve as a baseline. a second mri will be performed within a month and following administration of letrozole 12.5 mg daily for three days to reduce breast estrogen levels and in anticipation of lowering breast gadolinium dye uptake.

Eligibility criteria:
inclusion criteria: * women are eligible to participate if they are 40 years or older and have been menopausal (had no menstrual bleeding during the past 12 months) exclusion criteria: * history of bilateral mastectomy, osteoporosis or renal impairment.

Keywords: letrozole breast mri postmenopausal women
special drug use investigation for adoair metered-dose inhaler (pediatric)

Conditions: Asthma

Summary: to investigate possible problems or questions in safety and efficacy of adoair 100 diskus and adoair 50 aerosol 120 in japanese pediatric patients with bronchial asthma for a long term under the practical use conditions. in this special drug use investigation, the following items shall be handled as the priority investigation items for information collection. 1. systemic effects accompanying steroid administration; influences on adrenocortical function, influences on bone metabolisms (fracture, osteoporosis, etc.), cataract, glaucoma 2. events related to nervous system, musculoskeletal system and circulatory system; tremor, headache, cramp, tachycardia, etc.


Eligibility criteria:
inclusion criteria: * adoair must be used for the first time * adoair used for a long-term exclusion criteria: * patients with hypersensitivity to salmeterol and fluticasone * patients with infection which salmeterol and fluticasone is not effective * patients with deep mycosis
reliability of pachymetry measurement with fd-oct, ora, confoscan 4 and ultrasound

Conditions: Keratitis

Summary: the purpose of this study is to assess the repeatability, reproducibility, and agreement of central corneal thickness measured by fourier domain optical coherence tomography (fd-oct, optovue, usa) with anterior corneal module, 20mhz ultrasound pachymetry equipped with ocular response analyzer (ora, reichert ophthalmic instruments, usa) and 10mhz ultrasound pachymetry (usp).

corneal thickness measurements are clinically important. variation in corneal thickness affects the accuracy of applanation tonometry. a meta-analysis by doughty and zaman showed that a 10% change in central corneal thickness may result in an approximately 3.4-mmhg change in intraocular pressure.1 accuracy of corneal thickness measurement is also important in considering eligibility for refractive surgery, and the amount of correction that can safely be performed. underestimation of corneal thickness may lead to eligible patients being excluded for primary or enhancement refractive procedures. overestimation may lead to over-ablation and inadvertent thinning of the stroma, thereby increasing the risk of iatrogenic keratectasia. hence, studies assessing corneal thickness measurements by various instruments are of high clinical relevance.2-9 fourier domain optical coherence tomography (fd-oct, optovue, u.s.a), confoscan 4 (cs-4, nidek, usa) and ocular response analyzer (ora, reichert, usa) are non-invasive medical devices that have recently received fda approval for measurement of the cornea thickness. however, the repeatability and reproducibility of these instruments remains unproven in the clinical settings. to our knowledge, this is the first study to describe agreement, repeatability and reproducibility in corneal pachymetric mapping between fd-oct, ora, cs-4 and conventional ultrasound (us), which has been the current reference corneal pachymetric mapping system for the majority of refractive surgeons.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * patients who had history of prior ocular surgery, ocular abnormalities other than cataract or refractive error or were unable to cooperate in the examination were excluded.
study of the efficacy of sharp debridement for the management of chronic wounds

Conditions: Wounds

Summary: standard care of care and up to twelve (12) weekly debridements. subjects randomized into the weekly debridement group will receive up to twelve (12) debridement during the twelve (12) weeks of the study. there will be two (2) subject groups in the study. subjects will be randomized into either the monthly debridement group or the weekly debridement group.

the primary objective of this study is to evaluate subjects enrolled and randomized to the weekly sharp debridement group. the major secondary objectives are incidence of complete wound closure at week 12, rate of healing, ulcer recurrence, wound characteristics, and microbiologic information.

Eligibility criteria:
inclusion criteria: 1. subject must have evidence of a full-thickness cutaneous wound of at least 30 days duration. 2. subject must be at least 18 years of age. 3. subject must have a minimum life expectancy of at least 1 year to be determined by the investigator. 4. the study ulcer must be from 1 cm2 to 20 cm2 in size. 5. the study ulcer must have been present for at least 30 days at study day -7. 6. the subject's glycosylated hemoglobin (hba1c) must be equal to or less than 10.0% for subjects with diagnosed diabetes at study day 0. 7. the subject, legal guardian or authorized representative must have understood, signed and dated the irb approved informed consent form. 8. the subject must be available for evaluation on a weekly basis for the twelve (12) weeks of the study. visits at week 13 and week 14 are required for initial wound healing, which is achieved in study week 11 or 12. the investigator will evaluate both groups at week 16. subjects must be available for evaluation at week 16. 9. the subject's tcpo2 must be equal to or greater than 25 mm of mercury in the periwound area and abi greater than 0.7. exclusion criteria: 1. subject whose ulcer has healed 30% or greater from the evaluation study day -7 to the post-debridement study day 0 as determined by wound measurements using aranz silhouette 2. a history of alcohol or substance abuse, within the previous year, which could, or in the judgment of the investigator, would interfere with study compliance or protocol requirements. 3. participation in clinical trials evaluating investigational pharmaceuticals, biologics or devices within 30 days of admission to the study. 4. subject with a history of receiving any of the following within the last 30 days: systemic corticosteroids exceeding a total daily dose of 20mg, immunosuppressive agents, radiation therapy or chemotherapy. anticipated use of the above during the study period will also exclude a subject from entry into the study. topical and inhaled corticosteroids are not prohibited. 5. subjects with medical comorbidities known to affect wound healing such as end stage renal disease, severe hepatic insufficiency, vasculitis, and hiv will be excluded from this study

Keywords: sharp debridment patients with full thickness wounds of greater than 30 days duration
probiotics for the prophylaxis of migraine

Conditions: Migraine

Summary: this study aims to understand the efficacy of two probiotic interventions as prophylaxes of migraine symptoms in individuals diagnosed with episodic migraine. the primary outcome measure will be migraine days per month, but secondary outcome measures such as use of analgesia, the wider impact of migraine (as assessed through the hit-6 score) will also be assessed. finally adverse effects will be evaluated. the study will have three arms: two arms including the two different probiotic preparations and a third placebo arm.


Eligibility criteria:
inclusion criteria: 1. age between 18 - 65 years. 2. signature of informed consent by the patient. 3. patients with confirmed migraine, diagnosed by a neurologist 4. patient-indicated frequency of migraine attacks (or days) of at least 4 per month. 5. fairly predictable and stable pattern of migraine attacks (frequency, duration, intensity) exclusion criteria: 1. patients diagnosed with chronic migraine 2. migraine patients suffering from medication-dependent headaches. 3. patients suffering from cluster or tension-related headaches. 4. patients who used antibiotics up to two weeks before the start of the study. 5. patients who have taken other probiotics in the previous two months. 6. patients with chronic use of non-steroidal anti-inflammatory drugs. 7. patients with inflammatory bowel disease (due to increased intestinal permeability). 8. patients who are pregnant, breastfeeding or who do not commit to using an effective method of contraception during the course of the study.

Keywords: probiotic migraine
danshen-jiang-fu granule prepared by danshen from different producing areas for primary dysmenorrhea

Conditions: Primary Dysmenorrhea; Traditional Chinese Medicine

Summary: this trial aims to compare the effect of danshen-jiang-fu granule prepared by danshen (salvia miltiorrhiza) from different producing areas (shandong and sichuan) for the relief of primary dysmenorrhea.


Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria of primary dysmenorrhea in the primary dysmenorrhea consensus guideline; * meeting the diagnostic criteria of hanning-xueyu(blood stasis due to cold accumulation) zheng according to gynecology of chinese medicine; * with regular menstrual cycles lasted 21 to 35 days, with menstruation lasting 3 to 9 days in the last 6 months; * course of dysmenorrhea over 6 months; * experienced menstrual pain scoring varying from 3cm to 6cm on a 10-cm vas during the baseline menstrual period (one period prior to present menstrual period with treatment); * without history of pregnancy; * with agreement of informed consent and a working phone. exclusion criteria: * history of abdominal surgery; * with other acute or chronic painful conditions diagnosed or suspected; * use of hormonal contraceptives, or intra-uterine device; * use of analgetic drugs or other analgetic treatment in the last 2 weeks; * known allergy to danshen (salvia miltiorrhiza), paojiang (roasted ginger), xiangfu(rhizoma cyperi) or wuyao(lindera aggregata); * prone to allergy in daily life; * who can not complete treatment adherence to the protocol; * attending in other trials in the last 3 months.
search for biomarkers in human glaucoma: lymphocytes alterations and rate of progression

Conditions: Glaucoma, Open-Angle

Summary: the aim of this study was to evaluate the lymphocyte phenotype in primary open- angle glaucoma (poag) patients compared to healthy subjects of the same age, in order to confirm the importance of immune responses in glaucoma and the possible correlation to the severity of the disease.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary open-angle glaucoma * age between 19 an 85 years old exclusion criteria: * age less than 19 or more than 85 yrs * positive history for (a) neurodegenerative diseases, (b) autoimmune diseases, (c) cancer, (d) viral infection and (e) diabetes, (f)systemic inflammation

Keywords: glaucoma immunology immunophenotype
proof of concept trial to confirm that the recovery of patients treated in the intensive care unit requiring mechanical ventilation is beneficially affected by the environmental simulation of daytime and night time alternation as well as by the nutrition protocol corresponding to the daily rhythm

Conditions: Critical Illness; Mechanical Ventilation

Summary: the purpose of this study is to determine whether the environmental simulation of daytime and night time alternation as well as by the nutrition protocol corresponding to the daily rhythm are beneficially affect the recovery of patients treated in the intensive care unit (icu) requiring mechanical ventilation.

the homeostasis of human body is significantly disturbed when organs' work-relax periods are not harmonized. intensive care unit (icu) patient's circadian rhythm is almost inevitably upset as a result of their disease and/or medical intervention. there are numerous animal studies prove that circadian rhythm and periodic dynamics are directly related to healing time and hence, mortality rate. although, one of the main messengers of circadian synchronization is melatonin, it is overridden by temperature, and a number of other factors from e.g. the digestive tract. if the circadian rhythm is disturbed, the function of different organ systems becomes desynchronized and chaotic. icu environment and patient-care activities brings major drawbacks as well mainly by necessary presence of noise and light. it has been shown that icu settings have an impact on patients' sleep, which can easily lead to delirium and circadian disruption. there are significant data showing strong correlation between delirium and icu length of stay/ mortality. the focus of this study is the environmental modulation at the icu with controlled light, noise and nutrition conditions. controlled light conditions are created with artificial light during daytime and sleeping mask during night time. earplugs are used during night time for controlled noise conditions. nutrition is carried out only during daytime both in case of enteral and parenteral feeding.

Eligibility criteria:
inclusion criteria: * male or female, 18 years or older * requiring treatment at the intensive care unit including mechanical ventilation * admission at the intensive care unit was done within 24 hours before randomization * written and signed patient information sheet and informed consent form obtained by the study participant or by his/her legal representative exclusion criteria: * traumatic brain injury * multiple trauma * severe damage of the eye/optic nerve * blindness * post cpr * unlikely to survive 24 hours * involvement of the central nervous system (trauma, bleeding, infection, ischemia, etc.) * intracranial space occupying process * increased intracranial pressure * narcolepsy * huntington's disease * hypothermia * pregnancy

Keywords: circadian rhythm critical illness mechanical ventilation environmental modulation
prevalence of sleep apnea in patients presenting for hip or knee replacement surgery

Conditions: Sleep Apnea, Obstructive

Summary: the study hypothesis is that the prevalence of obstructive sleep apnea in patients presenting for total knee or total hip arthroplasty is higher than generally suspected. the study will include just one arm and results will be compared to a literature control group. participants referred for preoperative evaluation will be screened using a standard questionnaire. those at high risk of obstructive sleep apnea will then undergo a formal overnight sleep study (polysomnography).

the study hypothesis is that the prevalence of obstructive sleep apnea in patients presenting for total knee or total hip arthroplasty is higher than generally suspected. the study will include just one arm and results will be compared to a literature control group, a study performed by harrison et al. and published in the december 2003 issue of the journal of arthroplasty. participants referred for preoperative evaluation will be screened using a standard questionnaire. those at high risk of obstructive sleep apnea will then undergo a formal overnight sleep study (polysomnography). the berlin questionnaire is being used for screening.

Eligibility criteria:
inclusion criteria: * 18 years old and older * planned total hip or total knee arthroplasty * referral to the internal medicine preoperative evaluation clinic exclusion criteria: • none
for easy, fast and comfortable colonoscopy, which position

Conditions: Colonic Diseases, Functional; Prone Position; Endoscopy

Summary: colonoscopy is one of the most common endoscopic procedures today. however, it sometimes can be a serious challenging situation both for the clinicians and patients. in this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way.

colonoscopy and colonoscopic screening are the most common routine studies to reduce the incidence of colorectal cancer.in this process, the most important problem for the endoscopist and the patient is pain, loop formation, (the reason why the device is not able to progress in the bowel) and in some patients it takes a long time due to these reasons and the risk of complication development.the subject of what should be the most ideal position in colonoscopy has previously been studied in some specific subgroups.there is not enough study on what should be the ideal position in colonoscopy. in this study, the investigators tried to determine which colonoscopic position allows easy, fast and comfortable way.

Eligibility criteria:
inclusion criteria: * adult patients aged for 18 to 80 years, * colonoscopy indications (iron deficiency anemia ,malignancy screening in patients over 50 years of age,secret blood positivity in stool, rectal bleeding,patients describing hematoconia, chronic diarrhea, constıpatıon exclusion criteria: * patients with previous colon surgery * serious comorbid disease (congestive heart failure ef\< %30 , advanced chronic obstructive pulmonary disease,terminal period cancer with a life expectancy of less than 5 years, those who have not had appropriate bowel cleaning,endoscopic treatment during colonoscopy or removal of diagnostic lesions,other sedatives for sedation other than midazolam

Keywords: colonoscopy insertıon tecnique prone left supine dynamic
effectiveness of oral hyaluronic acid in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study was a randomized, double-blind, placebo-controlled study evaluating the efficacy of an oral liquid ha supplement (a+ha) in symptoms relief and improvement of quality of life in knee osteoarthritis patients with mild knee pain.

subjects were initially screened at the randomization/baseline visit (week 0). eligible subjects were randomized at the same visit into the treatment period and received the assigned treatment in a double-blind fashion for 8 weeks. during the 8 weeks treatment period, there were three follow-up visits requested (week 2, week 4 and week 8). efficacy was measured by using western ontario and mcmaster universities osteoarthritis index (womac) and the short form-36 (sf-36).

Eligibility criteria:
inclusion criteria: * male or female age \>= 40 years old * diagnosed with knee oa which met the definition of ahlbӓck classification12 and had knee joint symptoms within 30 days prior to enrollment exclusion criteria: * had administered glucosamine one month prior to enrollment * had known allergy to oral ha * bmi ≧40 kg/m2 * knee oa was caused by occupational hazard or sports injury * patients with known other causes of arthritis (infectious rheumatoid or psoriatic arthritis), bony or soft tissue malignancy or peripheral neuropathy involving the lower extremities, cardiopulmonary disease which limited walking more than knee pain, knee instability defined as a report of knee buckling or locking within the past month of the study knee, major neurological deficit that affected gait, psychiatric illness that limited informed consent or parkinsonism * women in pregnancy * wheel chair users
non-interventional surveillance of effectiveness of symbicort® maintenance and reliever therapy (symbicort® smart) in the treatment of moderate and severe asthma

Conditions: Asthma

Summary: this is a 3-month non-interventional, observational study on patients with moderate and severe asthma.


Eligibility criteria:
inclusion criteria: * patients with moderate and severe asthma on symbicort smart treatment exclusion criteria: * under 18 years old

Keywords: asthma