Kornimate/medical-research-clean huggingface dataset:
effectiveness of single step culture media and sequential culture media on blastulation rate

Conditions: Infertility

Summary: to compare the effectiveness of single step culture media and continuous uninterrupted culture media on blastulation rate

sequential culture media are designed to mimic the changing environment in the ovary ducts and the uterus in vivo. however, there are some differences between in vivo and in vitro culture conditions. hence, single step media are created which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. previous studies suggest higher blastulation rate in the single step media than the sequential media. this is an randomized controlled trial (rct) study comparing the blastulation rate of single step culture media and sequential culture media. stimulation protocol is antagonist. patient will be consulted on the day of ultrasound if they meet the inclusion criteria and sign the consent form. then, the nurse will open the letter containing the type of media for that case. the media is prepared inside the lab a day before oocyte pick-up. after oocyte pick-up, the oocyte-cumulus complex (occ) will be cultured for 2 hours at 37°c, 6% carbon dioxide (co2) and 5% oxygen (o2). meanwhile, sperm preparation will be performed using gradient technique. after 2 hours, occ will be denuded and will be cultured for 1 hour until intracytoplasmic sperm injection (icsi). oocytes after icsi will be cultured in groups of 3-4 oocytes in the same conditions of 37 ° c, 6% co2 and 5% o2. fertilization check procedure is at 16-18 hours after icsi. on day 3, the embryos will be evaluated in 66-68 hours after icsi, grade 1 embryos are identified with 7-9 blastomeres and fragmentation is from 0-10%. the patients will be informed about the embryo quality. if the embryos are not decided to have day 5 transferring, patient will be consulted to transfer on day 3. blastulation rate will not be recorded. for the sequential culture media group, embryos will be transferred to sequential blast medium. for the single step culture media group, embryos will be transferred to the new culture dish with the same medium. on day 5, embryo quality assessment will be at 116±1 hours after icsi. blastocyst grading is based on the expansion, inner cell mass quality, and trophectoderm quality. two good blastocyst will be transferred. after 11 days, beta-human chorionic gonadotropin (hcg) test will be required. if the beta-hcg result is positive, examination will be needed after 3 weeks and the luteal support will be given until 7 weeks.

Eligibility criteria:
inclusion criteria: * number of previous failure ivf cycles ≤2 * using gonadotropin-releasing hormone (gnrh) - antagonist protocol for ivf * using gnrh for oocyte triggering. * read and sign consent form to participate in the study and have not been recruited for any other researches. exclusion criteria: * oocyte donation cycles * abnormal uterine.

Keywords: ivf icsi culture media sequential
efficacy and safety study of cilostazol to prevent reoccurrence of stroke

Conditions: Cerebral Infarction

Summary: the study design is subject to relevant sfda regulations about clinical trials. this indication was approved in japan in 2003. from the end of may 2004 to the end of dec. 2004, 720 patients with previous cerebral infarction(see the inclusion criteria) were enrolled in to the study and received one of the two treatment regimens, cilostazol or aspirin, the ratio of patient number of each group is 1:1. for each patient, the chance of entering either of these two groups is the same. the treatment will continue till the end of 2005. during the treatment period, patients will be observed concerning some certain events, mainly reoccurrence of stroke. if the patient experiences reoccurrence of stroke, or other event that the doctors think it is not appropriate to continue the study medication, this patient would stop the treatment. patients were also required to take mri head scan before entering the study and on completion of the treatment.


Eligibility criteria:
inclusion criteria: 1. patients who had cerebral infarction within 6 months and 1 month before entry 2. within a few days of the onset of cerebral infarction onset, ct or mri showed evidence of infarction that could be responsible for this stroke onset 3. a modified ranking scale of less than 4 4. aged 18\~75 5. consent of the patients or their legal guardians - exclusion criteria: 1. history of intracranial hemorrhage 2. stroke secondary to cardiogenic embolism 3. serious damage of motorial function, dementia 4. serious complications or co morbidity(uncontrolled accelerated type of hypertension, bp\>180/120mmhg, diabetic acidosis, heart failure, renal failure, hepatocirrhosis, malignant tumor) 5. contraindication of cilostazol and aspirin 6. patients who need co medication of other antiplatelet agents, anticoagulants or fibrinolytic drugs 7. active peptic ulcer 8. pregnancy or breast feeding 9. judged to be inappropriate to enter the study by investigators. - -

Keywords: cerebral infarction prevention cilostazol aspirin stroke clinical trial
pre-hospital anti-fibrinolytics for traumatic coagulopathy and haemorrhage (the patch study)

Conditions: Wounds and Injuries; Acute Coagulopathy

Summary: the purpose of this research is to determine whether giving severely injured adults a drug called tranexamic acid (txa) as soon as possible after injury will improve their chances of survival and their level of recovery at six months. after severe injury, a person may have uncontrolled bleeding that places them at high risk of bleeding to death. coagulation (the formation of blood clots) is an important process in the body that helps to control blood loss. up to a quarter of people that are severely injured have a condition called acute traumatic coagulopathy. this condition affects coagulation and results in the break down of blood clots (fibrinolysis) that can lead to increased blood loss and an increased risk of dying. txa is an anti-fibrinolytic drug that might help to reduce the effects of acute traumatic coagulopathy by preventing blood clots from breaking down and helping to control bleeding. in australia, txa is approved for use by the therapeutic goods administration (tga) to reduce blood loss or the need for blood transfusion in patients undergoing surgery (i.e. cardiac surgery, knee or hip arthroplasty). recent evidence from a large clinical trial (crash-2) showed early treatment with txa reduced the risk of death in severely injured patients, however the majority of patients involved in the study were injured in countries where prehospital care is limited and rapid access to lifesaving treatments is limited compared to that available in countries like australia and new zealand. it is unclear whether txa will reduce the risk of death to the same degree when it is given alongside other lifesaving treatments that are available to patients soon after injury in these countries. the hypothesis is that txa given early to injured patients who are at risk of acute traumatic coagulopathy and who are treated in countries with systems providing advanced trauma care reduces mortality and improves recovery at 6-months after injury.


Eligibility criteria:
inclusion criteria: * adult patients (estimated age 18 years or older) * injured through any mechanism * coagulopathy of severe trauma (coast) score of 3 points or greater * first dose of study drug can be administered within three hours of injury * patients to be transported to a participating trauma centre coast score * entrapment (ie in vehicle) \[yes = 1, no = 0\] * systolic blood pressure \[\<90 mmhg = 2, \<100 mmhg = 1, ≥100 mmhg = 0\] * temperature \[\<32℃ =2, \<35℃ = 1, ≥35℃ = 0\] * major chest injury likely to require intervention (e.g. decompression, chest tube) \[yes = 1, no = 0\] * likely intra-abdominal or pelvic injury \[yes = 1, no = 0\] exclusion criteria: * suspected pregnancy * nursing home residents

Keywords: wounds and injuries acute coagulopathy tranexamic acid emergency medical services
ceti-ankle: cetilar®️ in patients with ankle injury or chronic trauma to the ankle

Conditions: Ankle Injury or Chronic Trauma to the Ankle

Summary: the purpose of this study is to assess the safety, tolerability and efficacy of cetilar®

after being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to cetilar® cream (about 5 g, twice per day) or placebo cream (about 5 g, twice per day).

Eligibility criteria:
inclusion criteria: 1. signing the patient information sheet and informed consent form 2. patients with reduced ankle mobility caused by injury or chronic trauma to the ankle 3. men or women aged ≥20 and ≤80 years 4. patients who mark the pain 4 cm on a vas 5. patients who are willing or able to follow doctor's instructions 6. patients not participating in other clinical trials within 30 days before the screening 7. patients who have received sufficient explanation for this clinical trial and agreed to participate exclusion criteria: 1. patients who received intraarticular injection treatment into the painful area within 3 months prior to the first visit 2. ankle surgery in the previous six months 3. topical nsaids application during the treatment period 4. bmi \> 32 5. systemic inflammatory diseases (e.g. fibromyalgia, etc.) 6. progressive serious medical conditions (such as cancer, aids or end-stage renal disease) 7. patients with major infections in the observation period 8. renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values) 9. liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range) 10. patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease 11. patients who received systemic steroid treatment within 1 month prior to their first visit 12. diabetic foot 13. pregnant or lactating women

Keywords: ankle injury chronic trauma ankle trauma cetilar
treatment adhesion in dialysis patients treated with cinacalcet

Conditions: Hyperparathyroidism; Chronic Kidney Disease

Summary: controlling secondary hyperparathyroidism (shpt) in maintenance hemodialysis (mhd) patients is cumbersome, partly due to patient's non-adherence to prescribed drugs. the main objective of this study was to assess whether an integrated care (ic) approach, in which adherence data are integrated in the decisional process, led to improved therapeutic control of secondary hyperparathyroidsm and higher percentages of bone metabolism targets as compared to a usual care (uc) approach, in which biological values represent the main stem of the decisional process. the predefined hypothesis was that patients of the ic group should reach the ipth targets using 25% less doses of cinacalcet at 6 months than those of the uc group.


Eligibility criteria:
inclusion criteria: * age \> 18 years * patients on hemodialysis since more than 3 months * patients with secondary hyperparathyroidism treated with cinacalcet-hcl at a stable dose (30mg/day or more) for at least 1 month before enrolment and indication to cinacalcet-hcl therapy (ipth in target values or over target values) * patients with secondary hyperparathyroidism with indication to be treated with cinacalcet-hcl (ipth ≥ locally pre-defined targets). in this case, patients should be treated at least 1 month with stable dose cinacalcet-hcl before enrolment exclusion criteria: * intolerance to cincalcet-hcl * inability to understand the protocol * mental diseases * patients suffering from cancer or having a short life expectancy (\<6 months) * patients planned for a parathyroidectomy * patients having had a parathyroidectomy * patient already enrolled in a cinacalcet-hcl protocol * symptomatic hypocalcaemia or total serum calcium \< 1.87 mmol/l

Keywords: compliance dialysis hyperparathyroidism
a clinical trial of icp-192 in treated patients with advanced solid tumors with fgf/fgfr gene alterations

Conditions: Advanced Solid Tumor

Summary: this is a phase ii clinical trial in treated patients with advanced solid tumors with fgf/fgfr gene alterations. the purpose of this study is to evaluate the efficacy and safety of icp-192.


Eligibility criteria:
inclusion criteria: 1. signed the icf and age ≥ 18 years old, either sex. 2. ecog ≤ 1. 3. life expectancy of at least 3 months. 4. part 1 (head and neck cancer cohort): patients with hnc cancer who have failed or cannot tolerate standard therapy, and with fgf/fgfr gene alteration 5. part 2 (other solid tumor cohorts): patients with other solid tumor who have failed or cannot tolerate standard therapy, and with fgf/fgfr gene alteration 6. at least one measurable lesion as the target lesion at screening assessed according to recist v1.1 criteria. exclusion criteria: 1. prior treatment with selective fgfr inhibitors or fgfr antibodies. 2. any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity. 3. previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. history and/or current evidence of extensive tissue calcification.
urine testing to detect kidney transplant rejection

Conditions: Kidney Transplantation; Kidney Disease; Kidney Failure, Chronic

Summary: the purpose of this study is to determine if analysis of urine samples for specific markers can predict transplant rejection in people who have received kidney transplants.

innovations in kidney transplantation have improved short-term outcomes for transplant patients. however, organ rejection remains as an important threat to the long-term survival of the transplanted organ. an increase in the serum creatinine level is often the first clinical indicator of kidney transplant rejection; however, this marker lacks sensitivity and specificity. rejection is currently diagnosed using an invasive transplant biopsy procedure; in addition to being expensive, transplant biopsies can result in bleeding from the transplant and even graft loss. in early studies, it has been observed that significant increases in the levels of perforin, granzyme b, and cd3 messenger rna (mrna) in urinary cells signal the development of acute transplant rejection. the purpose of this study is to evaluate whether the noninvasive procedure of measuring perforin, granzyme b, and cd3 mrna levels in urine samples can accurately diagnose and predict kidney transplant rejection, make transplant biopsy unnecessary, and provide an opportunity to initiate treatment for early rejection with the aim to minimize damage to the kidney. this study will last 3 years post-transplant. there will be a total of 14 study visits. blood and urine collection will occur at all visits. additional visits may be necessary for those participants who develop abnormal kidney function.

Eligibility criteria:
inclusion criteria: * scheduled to undergo primary or redo deceased- or living-donor kidney transplantation * ability to provide informed consent exclusion criteria: * requires combined organ transplantation * previously received a solid organ transplant (other than kidney transplant) or islet cell transplant * hcv infected * hiv infected

Keywords: allograft graft
an observational study to learn more about the safety of darolutamide in men with prostate cancer in korea

Conditions: Non-metastatic Castration-resistant Prostate Cancer; Metastatic Hormone-sensitive Prostate Cancer

Summary: this is an observational study in which participants receive a treatment which is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmcrpc) or metastatic hormone-sensitive prostate cancer (mhspc). nmcrpc is a prostate cancer that has not yet spread to other parts of the body and does not respond to lowering testosterone in the body. mhspc is a prostate cancer that has spread to other parts of the body and can be treated by lowering testosterone levels. this study looks at the safety of the study drug, darolutamide, in korean patients with nmcrpc or mhspc. darolutamide is currently available for doctors to prescribe to men with nmcrpc or mhspc. it works by attaching to the special molecules called androgen receptors (ar) within prostate cells and blocks hormones called androgens from attaching to ar, which helps delay cancer growth. to learn more about the safety of darolutamide, the researchers will study whether the participants have adverse events. an adverse event is any medical problem that a participant has during a study. doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. the researchers will also learn more about how well darolutamide is working in these participants. during this study, the researchers will collect information from the medical records of patients who have been prescribed darolutamide by their doctors. each participant will be in this study for 1 year. the whole study will last about 6 years. during this time, the participants will visit their doctor every 2 to 4 months as part of their usual care. at these visits, the doctors will do scans to check the patients' cancer and take blood samples. the patients will answer questions about any medications they are taking and whether they have any adverse events.


Eligibility criteria:
inclusion criteria: * male aged ≥19 years * patients with high risk nmcprc * castrate level of serum testosterone (\< 1.7 nmol/l \[50 ng/dl\]) * patients with mhspc * histologically or cytologically confirmed prostate cancer, and metastases detected on bone scanning, contrast-enhanced computed tomography(ct), or magnetic resonance imaging (mri). * be candidates for androgen-deprivation therapy and docetaxel * patients for whom the decision to initiate treatment with darolutamide as a first time was made as per investigator's routine treatment practice * written informed consent from subject or legal representative; assent from subject when appropriate exclusion criteria: * patients participating in an investigational program with interventions outside of routine clinical practice * participants with contraindication according to the locally approved prescribing information
the midas encore study

Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Summary: study objective: to compare patient outcomes following treatment with either the mild procedure or epidural steroid injections (esis) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.


Eligibility criteria:
inclusion criteria: 1. 65 years or older and a medicare beneficiary. 2. patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics. 3. lss with neurogenic claudication diagnosed via: 1. symptomatic diagnosis and 2. radiologic evidence of lss with unilateral or bilateral ligamentum flavum \>2.5mm confirmed by pre-op mri or ct performed within 12 months of baseline visit. 4. patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced. 5. available to complete 6 month and one year follow-up visits. exclusion criteria: 1. odi score \< 31 (0-100 odi scale). 2. nprs score \< 5 (0-10 nprs scale). 3. prior surgery at any treatment level. 4. history of recent spinal fractures with current related pain symptoms. 5. patients with grade iii or higher spondylolisthesis. 6. motor deficit or disabling back and/or leg pain from causes other than lss neurogenic claudication (e.g., acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.). 7. unable to walk ≥ 10 feet unaided before being limited by pain. in this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance. 8. patients previously randomized and/or treated in this clinical study. 9. patients that have previously received the mild procedure. 10. esi during eight weeks prior to study enrollment. 11. epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician). 12. on (or pending) workman's compensation or known to be considering litigation associated with back pain.

Keywords: lumbar spinal stenosis spinal stenosis neurogenic claudication
short-term effects of physiotherapy on lci

Conditions: Cystic Fibrosis

Summary: although some studies have brought some evidences about the efficacy of positive expiratory pressure (pep)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with cystic fibrosis (cf). the aim of this study is to investigate how pep-mask affects ventilation inhomogeneity in children and adolescents, with moderate to normal cf lung disease by the change in acinar airways (sacin), lung clearance index (lci) and conductive airways (scond) indexes derived from nitrogen multiple-breath washout test (n2mbw).

investigational device: pep-mask=positive expiratory pressure delivered through a face mask. standard operating procedures used for evaluating cf lung disease and ventilation inhomogeneity. sample size: based on preliminary data collected on seven subjects who performed nitrogen multiple-breath washout test before and after pep-mask, assuming a variation of 20% of sacin, the study requires a sample size of 18 subjects.

Eligibility criteria:
inclusion criteria: * cf diagnosis * patients hospitalized for a scheduled intravenous antibiotics cycle and regularly followed-up by the cf centre * ≥ 15 kilograms * fev1 ≥ 40%predicted * ability to perform nmbw test * ability to perform spirometry * willing to adhere to protocol procedures * patients in treatment with pep-mask exclusion criteria: * pulmonary exacerbation within two last week * burkholderia cepacia infection * patients in lung transplantation waiting list * patients undergoing non invasive mechanical ventilation or oxygen therapy

Keywords: physiotherapy pulmonary function