Kornimate/medical-research-clean huggingface dataset:
bioimpedance-guided fluid management in chronic peritoneal dialysis patients.

Conditions: End Stage Renal Disease

Summary: peritoneal dialysis (pd) is one of established treatments in the end stage renal disease patients. volume overload is a predictor of mortality in pd patients. in this randomized controlled trial, the investigators use the body composition monitor (bcm), a multifrequency bioimpedance device, to measure the level of overhydration in pd patients and explore its value in fluid management in peritoneal dialysis patients as well as their prognosis.

optimal fluid management is one of the primary objectives of dialysis treatment, and there is significant concern that peritoneal dialysis (pd) patients can become progressively fluid-loaded with time on treatment, especially as residual kidney function declines. body composition monitor (bcm) has the potential to enable better management of fluid balance. the investigators undertake a prospective, randomized, open-label, controlled trial to determine whether availability of longitudinal bcm measures help clinicians maintain stable fluid status over 24 months in 300 peritoneal dialysis patients.

Eligibility criteria:
inclusion criteria: * patients 18 years or older but no older than 80 years. * who had been on chronic peritoneal dialysis for more than 3 months. * all of them have signed the informed consent. exclusion criteria: * were expected to stop pd treatment in 6 months; * were amputees; * had a cardiac pacemaker or metallic implants; * had peritonitis one month before recruitment; * treated together with hemodialysis; * were during pregnancy or lactation; * were positive with hiv; * had serious diseases, including cancer, infection and liver cirrhosis, which were not suitable for the study.

Keywords: peritoneal dialysis volume status body composition monitor
simultaneous study of the serum tryptase level of the mother and the child during childbirth (trypla)

Conditions: Newborn; Parturient

Summary: currently the neonatal serum level of severals proteins can be used as an indicator of subsequent risk. for example, we plan to explore the neonatal kinetics of tryptase and other immune proteins as potential markers for the risk of postnatal complications, particularly in premature babies. however, today no study has shown whether the tryptase level in the newborn is a reflection of fetal synthesis alone, or that of the mother by possible transplacental passage. there is also no database that has defined normal values for tryptase in cord blood. our main objective is to determine the correlation between the level of maternal tryptase and that of the newborn in cord blood immediately after birth in order to estimate the transplacental passage of this molecule.

* the protocole will be explain to the family in delivery room, an information note will be given, and we will let the time to think about it. * in a second time investigator will make the mother sign a consent, that participant could retract any time then. * a blood sample will be taken from the mother within 2 hours of delivery, using a standard blood test. * a sample will be taken from the infant by blood drawn from the umbilical cord (non-invasive and painless sample). * a final blood sample from your newborn will be collected at the time of the guthrie test (systematic screening for congenital diseases) already scheduled for the new born on the third day of life. * this blood sample will be sent to the immunology laboratory of the clermont-ferrand university hospital where specific biological assays will be carried out. * blood samples will be stored for future use in studies. * a collection of data concerning the child, childbirth and the results of biological analyzes will be carried out. all data will be coded. * a phone call will be made at 3 months of life, to review the state of the child's health during his first months of life.

Eligibility criteria:
inclusion criteria: * mother-child couple * childbirth at the clermont-ferrand university hospital. * affiliated to a social security system exclusion criteria: * newborns whose holders of parental authority are protected by law (under guardianship, placed under the protection of justice) * newborns whose holders of parental authority are under the age of 18 * fetal pathology, excluding prematurity. * emergency caesarean section, because o life threatening condition for the fetus or the mother.

Keywords: tryptase neonatal newborn transplacental passage mast cell inflammation biomarker
prospective sibling oocyte study of a new method to improve embryo development in ivf/icsi patients

Conditions: Infertility

Summary: prospective, multi-centric, split-sample, sibling oocyte study evaluating the safety and efficacy of a new method to prepare sperm samples for ivf (in vitro fertilization) / icsi (intracytoplasmic sperm injection) compared to standard procedures.


Eligibility criteria:
female: inclusion criteria: * with ovarian reserve of between 8 and 30 antral follicles counting both ovaries * treatment planned for embryo transfer at the blastocyst stage exclusion criteria: * any diagnosed sexually transmitted infection (sti) * diabetes or other metabolic disorders. * recurrent pregnancy loss (defined as \>2 clinical pregnancies without live birth). * previous failures in two or more ivf cycles male: inclusion criteria for ivf: * age: 20-55 years * fresh sample (not cryopreserved ) * sperm motility (total) ≥ 40% in spermogram * normal sperm morphology (kruger criteria) ≥ 4% in spermogram * sperm count after swim up ≥ 5x10\^6 * treatment planned for embryo transfer at the blastocyst stage inclusion criteria for icsi: * age: 20-55 years * fresh sample (not cryopreserved ) * sperm concentration ≥ 10x10\^6 /ml in spermogram * sperm motility (total) ≥ 20% in spermogram * normal sperm morphology (kruger criteria) ≥ 3% in spermogram * treatment planned for embryo transfer at the blastocyst stage exclusion criteria: * any diagnosed sexually transmitted infection (sti) * total failure of in vitro fertilization in previous cycles.
study of enzastaurin versus placebo in the treatment of patients with brain metastases of lung cancer, after whole brain radiation therapy

Conditions: Non Small Cell Lung Cancer; Small Cell Lung Cancer

Summary: this study is a multinational study to compare enzastaurin versus placebo in the treatment of patients with brain metastases of lung cancer. approximately 108 patients will be randomly assigned to receive either enzastaurin or placebo after having completed whole brain radiotherapy.


Eligibility criteria:
inclusion criteria: * having radiologically proven brain metastases of lung cancer * having received whole brain radiotherapy with either 30 grays in 2 weeks or 20 grays in one week. treatment with enzastaurin must start within 14 days after the last fraction of the whole brain radiotherapy * no other previous radiotherapy to the brain except for radiosurgery at one occasion * adequate organ function as measured by appropriate laboratory tests. * age 18 years or older. exclusion criteria: * inability to swallow tablets or show conditions which could interfere with oral medication intake (e.g. vomiting, partial bowel obstruction). * inability to discontinue use of certain anti-epileptic drugs such as, carbamazepine, phenobarbital or phenytoin. * concurrent administration of warfarin * hemophilia * having had any systemic anti-cancer treatment within the last 2 weeks prior to enrolment.
treatment of intracranial wide-neck aneurysms using stent-assisted coil embolization

Conditions: Intracranial Aneurysms

Summary: this device was designed to assist in the stent-assisted coil embolization of intracranial aneurysms, specifically those that have a wide neck that would not otherwise maintain the coil embolization material within the aneurysm because of the wide opening at the base of the aneurysm. this device was designed to treat aneurysms that are: unruptured, wide-necked, intracranial, saccular aneurysms arising from a parent vessel ≥ 2 mm and ≤ 4.5 mm. wide-necked was defined as having a neck \> 4mm or dome-to-neck ratio \< 2.

this is a prospective study to investigate the efficacy of using stent-assistance for embolization of intracranial aneurysms with a wide neck (defined as \> or = to 4mm, or with a dome to neck ratio of 2:1 or less). we plan to investigate successful embolization of intracranial aneurysms defined by angiographic occlusion of greater than or equal to 90% at 6 months. patients will be followed for a minimum period of 2 years from the date of the procedure, with a planned total duration of 4 years of the study, including follow up time. participants will be initially assessed and if included, will undergo procedure that includes use of the device. afterwards, they will be scheduled for regular follow up at 2 weeks for clinical assessment, then again at 3 months for clinical assessment and mra to investigate the stented region, then again at 6 months for clinical assessment and possible cerebral angiogram vs possible mra, and then again at 1 year post-procedure, and then again at 2 years post-procedure. patients may then follow up on an annual basis or every 2-3 years, depending on preference and any residual or recurrent aneurysm. a more specific timeline and treatment course is described below. patients will receive cerebral angiography for evaluation of their cerebral vasculature and aneurysm configuration to ensure that the parent vessel diameter is adequate and that the aneurysm is 4mm in size with a wide neck. in these cases, if it is determined that the patient will require additional vascular support in order to adequately embolize the aneurysm then the use of stent-assisted coil embolization may be offered to the patient. once enrolled, patients will undergo endovascular stent-assisted coil embolization of the aneurysm, and clinical outcomes will then be assessed. data will be collected for analysis according to the primary and secondary outcome measures in addition to any deviations from the protocol or safety concerns as well

Eligibility criteria:
inclusion criteria: * adult patients (18 years old or older) with intracranial aneurysms with a wide neck (defined as \> or = to 4mm, or with a dome to neck ratio of 2:1 or greater). exclusion criteria: * small-necked aneurysms, * inability to tolerate anti-platelet medication
trial of simvastatin and gemcitabine in pancreatic cancer patients

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.

randomized double-blinded, placebo-controlled phase ii trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. histologically or cytologically confirmed, metastatic or unresectable pancreatic adenocarcinoma (if repeated biopsy (\>3) fails or if biopsy is not feasible, the inclusion of the patient will be determined by the central pi) 3. ecog performance status of 0\~2 4. no radiotherapy within 1 month of the study entry 5. measurable or evaluable lesion according to recist criteria 6. no prior history of chemotherapy for pancreatic cancer (gemcitabine-based adjuvant chemotherapy ≥ 12 months from the study entry will be allowed) 7. adequate marrow, hepatic, renal and cardiac functions (absolute neutrophil count ≥ 1.5 x 109/l; platelet count ≥ 75 x 109/l, serum creatinine ≤ 1.5 x uln), serum aspartate aminotransferase/alanine aminotransferase ≤ 5 x uln or ≤ 10 x uln if liver abnormalities are due to underlying malignancy; total bilirubin ≤ 2.0 x uln 8. written informed consent must be provided exclusion criteria: 1. severe co-morbid illness and/or active infections 2. pregnant or lactating women 3. active cns metastases not controllable with radiotherapy or corticosteroids a.patients with symptoms suggestive of cns metastases must undergo radiologic evaluation to rule out metastases b.patients with known, asymptomatic cns lesions are permitted 4. known history of hypersensitivity to study drugs 5. patients who are currently on statin therapy or has taken statin as lipid lowering agents within 1 year of the study entry

Keywords: advanced pancreatic cancer gemcitabine simvastatin placebo
evaluation of the psychoeducation program given to behcet's patients in the context of the roy adaptation model

Conditions: Psychoeducation; Nursing Caries; Behcet Syndrome

Summary: the physical, social and psychological effects of behcet's disease necessitate the patient's adaptation in many areas. this study was conducted to examine the effect of psychoeducation given to behcet's patients in the context of the roy adaptation model on illness adjustment, dyadic adjustment, self-esteem, and psychiatric symptoms. the study is a control group quasi-experimental study with a pre-test, post-test and follow-up design. the study was conducted with 70 behcet's patients including 35 interventions and 35 controls. the data of the study were collected using the "patient information form", " adaptation to chronic illness scale", "dyadic adjustment scale", "rosenberg self-esteem scale" and "brief symptom inventory" in pre-test, post-test and follow-up measurements. a 7-session psychoeducation program was applied to the intervention group.

the research was carried out by using quantitative research methods, quasi-experimental (pre-test, post-test, follow-up, control group) research method.the study was conducted with patients followed-up in eye, dermatology and rheumatology clinics of 6 state-owned hospitals in ankara, turkey. the sample size of the study was calculated with the pass (power analysis and sample size) statistical package program. it was calculated that our study could be performed with 5% error and 90% power with 35 interventions and 35 control groups, with 70 patients in total. thus, the research was completed with 70 patients, 35 interventions and 35 control groups.the 7-session psychoeducation program prepared on the basis of the roy adaptation model was applied to the intervention group once a week for 90-120 minutes. psychoeducation was conducted in 3 groups of 10-12 people, and make-up sessions were held for those who did not attend two consecutive psychoeducation sessions or did not attend two sessions in total. the contents of the psychoeducation sessions were created by the researcher, based on the roy adaptation model, by examining the relevant literature. after the ethics committee report with the permission number go16 / 229-21 was obtained from the non-interventional clinical research ethics committee of hacettepe university, the application permission was obtained from the hospitals where the study will be conducted in order to be able to apply the study. before starting the intervention, the patients were informed about the purpose and scope of the study, and written informed consent was obtained from the patients who agreed to participate in the study. for the control group, after the necessary information was given to the patients, their written informed consent was obtained.

Eligibility criteria:
inclusion criteria: * married or had a partner life, * were 18 years old exclusion criteria: * hearing and speech impairment * a psychiatric diagnosis * neurological involvement
resistant maltodextrin supplementation: gastrointestinal health

Conditions: Healthy

Summary: resistant maltodextrin (rmd) is an indigestible water soluble fiber that increases fecal bulk by enhancing growth of specific microbial populations; however the effect of rmd on bifidobacteria and total fecal weight is not clear. the purpose of this research study is to determine whether incorporating about ¼ cup of a fiber supplement into the diet will induce beneficial changes in gastrointestinal function, the fecal microbiota profile (increased number of healthy bacteria in stool) and immune processes resulting in improved quality of life.

this is a randomized, double-blind, placebo-controlled study. after obtaining informed consent, participants will be randomized to either consume 0, 15 or 25 grams of resistant maltodextrin (rmd) during the first arm of the study. during the first intervention period, participants will consume the rmd everyday for 3 weeks. after a 2-week post intervention period, participants will be crossed to one of the other treatments for 3 weeks, followed by a 2-week post intervention and then receive the final intervention for 3 weeks. participants will complete daily questionnaires and weekly gastrointestinal symptom questionnaires during the intervention and post-intervention periods. stool samples will be collected at the baseline and final time points of each intervention. dietary intake will also be assessed weekly during each intervention period.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18.5 to \<30 kg/m2 * usual fiber intake of \<19 g/d for males and 13 g/d for females based on food frequency questionnaire (ffq) such as the nutritionquest fruit/vegetable/fiber screener. * willing to complete daily and weekly questionnaires, 20 dietary recalls, and 15 stool collection days over approximately 18 weeks * willing to drink the study supplements for 3 weeks for each of the three intervention periods * willing to discontinue any prebiotic, fiber, or probiotic supplements or foods containing probiotics (e.g., yogurts with live, active cultures) * internet access for the duration of the protocol to complete online questionnaires * on average you have 6 or more stools but fewer than 12 exclusion criteria: * does not meet above criteria * dietary fiber intake greater than half the adequate intake (ai) based on automated self-administered diet history (asa24) (http://riskfactor.cancer.gov/tools/instruments/asa24/) dietary intake data collected during run-in period: * females with a dietary fiber ≥13 g/d * males with a dietary fiber ≥19 g/d * antibiotic use within 2 months from providing the screening stool sample * physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, crohn's disease, gastroparesis, cancer, peptic ulcer disease, celiac disease, short bowel disease, ileostomy, colostomy) other than gastroesophageal reflux disease (gerd), constipation, or diverticular disease * purposeful strenuous exercise of \>300 minutes per week on average * women who are lactating or know they are pregnant

Keywords: gut microbiota fiber diet quality immunity
safety and effectiveness of wavefront-guided lasik corrections of myopic refractive errors

Conditions: Myopia

Summary: the purpose of this clinical trial is to demonstrate that wavefront-guided lasik is safe and effective for the correction of myopic refractive errors.


Eligibility criteria:
inclusion criteria: * 18 years of age or greater * best spectacle corrected visual acuity (bscva) of 20/20 or better * uncorrected visual acuity (ucva) of 20/40 or worse * less than 0.75d difference between cycloplegic and manifest refraction sphere. * demonstration of refractive stability * anticipated post-operative stromal bed thickness of at least 250 microns * willing and capable of returning for follow-up examinations for the duration of the study. exclusion criteria: * women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study * concurrent use of topical or systemic medications that may impair healing * history of any medical conditions that could affect wound healing * history of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality * evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s) * known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course

Keywords: refractive lasik
autologous stromal vascular fraction in the treatment of thumb basal joint osteoarthritis

Conditions: Thumb Osteoarthritis

Summary: trial purpose is to research the outcome after thumb carpometacarpal injection with stromal vascular fraction (svf) derived from adipose tissue. the study compares svf injection therapy with thumb splinting vs. splinting only. patients with radiologically and clinically confirmed eaton-glickel ii osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo svf injection and splinting vs. splinting only. baseline data is collected preoperatively and patients are followed at 1, 3 and 6 months after enrollment. the primary end-point is 6 months and the primary outcome is pain visual analogue scale and patient-rated wrist evaluation (prwe).


Eligibility criteria:
inclusion criteria: * age 40-70 years * eaton-glickel ii thumb cmc osteoarthrosis * symptom duration \> 3 months * pain visual analogue score \> 30 mm * \< 3 months of treatment with thumb splinting * american society of anaesthesiologists physical status (asa) i-iii * fluent in written and spoken finnish exclusion criteria: * age \ 70 years * eaton-glickel i, iii-iv * symptom duration \< 3 months * pain vas \< 30 mm * post-traumatic osteoarthrosis of thumb cmc i * rheumatoid arthritis or other inflammatory joint disease * the use of per oral corticosteroids or other immunomodulatory drugs * less than 6 months after another operation of the same upper limb * other condition of the same upper limb requiring surgery * malnutrition * neurological condition affecting upper limb function * heavy smoking (\> 20 cigarettes per day) * alcohol or drug abuse * previous history or active cancer * previous history of allergic reaction to local anaesthetic

Keywords: thumb osteoarthrosis stromal vascular fraction
genetic study of antithyroid drugs associated agranulocytosis

Conditions: Agranulocytosis

Summary: thionamides, the antithyroid drugs, have been widely used to treat hyperthyroidism1. side effects are found in 1% - 5% of the patients1. one of the most serious side effect is agranulocytosis, which occurs in 0.1% - 0.3 % of the patients1. this might lead to severe infection and sometimes mortality. the underlying mechanism is unclear. an immune phenomenon may be involved because the antigranulocyte antibodies or lymphocyte sensitized to antithyroid drugs are found in these patients6,7. the recognition of major histocompatibility complex class ii peptide complexes by t lymphocytes is central to the development of immune response. according to a report in 1996, the hla drb1\*08032 allele is strongly associated with susceptibility to methimazole-induced agranulocytosis20. recently, there are new techniques for genetics study. we aimed to identify the associated genetic change of the agranulocytosis side effect of antithyroid drugs. first, we will look at the classical human leukocyte antigen (hla) loci, such as hla-a, -b, -c, -dr, -dq and -dp. if no significant change is found in the above genes, we will consider whole exon sequencing with next-generation sequencing, statistic analysis will include appropriate linkage analysis, association study, variation data analysis, pathway analysis. if we can identify the genetic change and perform genetic examinations before prescription, we can avoid the happening of severe side effects.


Eligibility criteria:
inclusion criteria: * patients with absolute neutrophil count lower than 500/mm3 caused by anti-thyroid drugs exclusion criteria: * patients who is younger than 20 years old or older than 85 years old