Kornimate/medical-research-clean huggingface dataset:
biomarkers in blood samples from patients with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: studying samples of blood from patients with cancer in the laboratory may help doctors identify and lean more about biomarkers related to cancer. purpose: this research study is studying biomarkers in blood samples from patients with acute myeloid leukemia.

objectives: primary * to determine if serum 2-hydroxyglutarate (2hg) is only detected in acute myeloid leukemia (aml) patients with isocitrate dehydrogenase (idh) mutations. secondary * to determine if the level of serum 2hg impacts leukemia-free survival (lfs). * to determine if the level of serum 2hg impacts overall survival (os). * to determine if serum 2hg is undetectable at the time of documented clinical remission (cr) in idh-mutated patients. outline: archived serum samples are analyzed for 2-hydroxyglutarate expression by reverse-phase liquid chromatography coupled to mass spectrometry. results are then compared with presence or absence of an idh mutation, patients' clinical outcome, as well as age, sex, white blood cell count at diagnosis, platelet count, bone marrow blast percentage at diagnosis, circulating (serum) percentage at diagnosis, cytogenetic risk group, presence of flt3, npmn1, and/or tet2 mutations, specific idh mutation, and randomization treatment group allocation.

Eligibility criteria:
disease characteristics: * morphologically confirmed acute myeloid leukemia (aml) * newly diagnosed with aml * serum samples from patients enrolled on the ecog-1900 clinical trial between 2002 and 2008 * patients with or without isocitrate dehydrogenase (idh) mutations patient characteristics: * not specified prior concurrent therapy: * received 2 different doses of standard induction chemotherapy on ecog-1900

Keywords: adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) untreated adult acute myeloid leukemia adult acute basophilic leukemia adult acute eosinophilic leukemia adult erythroleukemia (m6a) adult pure erythroid leukemia (m6b) adult acute minimally differentiated myeloid leukemia (m0) adult acute monoblastic leukemia (m5a) adult acute monocytic leukemia (m5b) adult acute myeloblastic leukemia with maturation (m2) adult acute myeloblastic leukemia without maturation (m1) adult acute myelomonocytic leukemia (m4)
a phase 4 pharmacokinetic study of hectorol injection and zemplar injection in ckd subjects on hemodialysis

Conditions: Secondary Hyperparathyroidism

Summary: this study will measure serum levels of the active vitamin d compound that circulates in hemodialysis subjects treated with either doxercalciferol injection (hectorol®) or zemplar® (paricalcitol injection).


Eligibility criteria:
inclusion criteria: * the subject must be receiving hemodialysis three times per week for a minimum of three months. * the subject must be receiving intravenous doxercalciferol or paricalcitol at each dialysis session (three times weekly) for a minimum of 12 weeks prior to screening. * at screening visit the subject's laboratory measurements must be within the following ranges: serum ipth measurement between 150-800 pg/ml; corrected calcium measurement ≤ 10.5 mg/dl; serum phosphorus measurement ≤ 7 mg/dl exclusion criteria: * any ongoing use of over the counter or prescription vitamin d preparations except doxercalciferol or paricalcitol injection or multivitamins. * history of heparin-induced thrombocytopenia.

Keywords: hectorol (doxercalciferol injection) zemplar (paricalcitol injection)
evaluation of the effect of cognitive behavioral therapy in individuals exposed to earthquakes

Conditions: Earthquake Victim

Summary: earthquake is a process that affects the lives of many people. it is very important to evaluate the psychological state of individuals after the earthquake and take appropriate action. when studies conducted after the earthquake were examined, no study was found that evaluated the effect of cognitive behavioral therapy on ruminative thoughts and cognitive distortions in individuals exposed to earthquakes. for this reason, this thesis was conducted to evaluate the effect of cognitive behavioral therapy on ruminative thoughts and cognitive distortions in individuals exposed to earthquakes.

earthquake is a process that affects the lives of many people. it is very important to evaluate the psychological state of individuals after the earthquake and take appropriate action. when studies conducted after the earthquake were examined, no study was found that evaluated the effect of cognitive behavioral therapy on ruminative thoughts and cognitive distortions in individuals exposed to earthquakes. for this reason, this thesis was conducted to evaluate the effect of cognitive behavioral therapy on ruminative thoughts and cognitive distortions in individuals exposed to earthquakes. in this thesis, a mixed design will be used in which quantitative and qualitative research methods will be used together. * the quantitative dimension of the research will be carried out in an experimental design with pre-test, post-test control group and repeated measurement, and the qualitative dimension will be carried out with semi-structured questions that have a certain contact with individuals. * the population of the research will be individuals in the container city in osmaniye. * the sample size will be determined by power analysis, and equal numbers of individuals will be included in the intervention and control groups. * there will be 8-10 sessions for each individual, each session lasting 45-60 minutes. * sessions will be held between november 2023 and december 2023. the 3rd month follow-up will be done in march 2024. * in this thesis, quantitative data, socio-demographic data form, ruminative thought style scale and cognitive distortions scale will be used. * qualitative data were collected through semi-structured questions and therapy interviews. will be collected. * spss statistics 20 program will be used in the analysis of qualitative data. maxqda analytics pro 2020 program will be used. * informed consent will be obtained.

Eligibility criteria:
inclusion criteria: being over 18 years old exposure to earthquake living in a container ability to communicate exclusion criteria: not being able to communicate

Keywords: earthquakes cognitive behavioral therapy rumination, cognitive
assessment of early-detection based on liquid biopsy in biliary tract cancer (ascend-btc)

Conditions: Biliary Tract Cancer

Summary: ascend-btc is a prospective, multi-center, observational study aimed at detecting early biliary tract cancer by combined assays of serum protein and cell-free dna (cfdna) methylation. the study will enroll approximately 492 participants diagnosed with biliary tract cancer and benign diseases.


Eligibility criteria:
inclusion criteria for cancer arm participants: * age 40-75 years at the day of consenting to the study. * able to provide a written informed consent * pathologically confirmed biliary tract cancers. * no prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw. exclusion criteria for cancer arm participants: * pregnancy or lactating women. * recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant. * recipients of blood transfusion within 7 days prior to study blood draw. * recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers. * with other known malignant tumors or multiple primary tumors. inclusion criteria for benign arm participants: * age 40-75 years at the day of consenting to the study. * able to provide a written informed consent. * confirmed diagnosis of benign biliary tract diseases. * no prior radical treatment of the benign diseases prior to study blood draw. exclusion criteria for benign arm participants: * pregnancy or lactating women. * recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant. * recipients of blood transfusion within 7 days prior to study blood draw. * recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancers. * confirmed diagnosis of malignancies or precancerous lesion. * a history of malignant tumors.
a study to evaluate safety and tolerability of different doses and efficacy of pq912 in subjects with mci and mild ad

Conditions: Early Alzheimers Disease; Mild Cognitive Impairment Due to AD

Summary: this is a phase 2b multicenter, randomized, double-blind, placebo-controlled, parallel group dose finding study to evaluate the safety, tolerability and efficacy of pq912, an inhibitor of the glutaminyl cyclase enzyme, in 250 subjects with mild cognitive impairment and mild dementia due to alzheimer 's disease.

in the parallel group dose finding part of the study the first 90 subjects will be randomized 1:1:1 between pq912 300 mg bid, 600 mg bid, and placebo. when the 90th patient has completed the week 24 treatment visit, the dsmb will decide on the dose of pq912 to be continued. the decision is based on safety findings only, no efficacy data will be considered. after the dsmb has reached a decision on the dose to be continued, all subjects randomized to receive pq912 will be reallocated to this dose (1:1). the duration of subjects participation in the study is either 48, 60, 72, 84 or 96 weeks of treatment (depending on time of randomization). subjects recruited early into the study will be kept on treatment for 96 weeks or until the regular, scheduled study visit which is closest to the scheduled week 48 visit of the last subject recruited in the study, whichever comes first.

Eligibility criteria:
main inclusion criteria: * positive csf ad biomarker signature according to the aa-nia criteria * clinical syndrome of mci or mild dementia according to the aa-nia research framework * a cognitive impairment in the wais iv coding test of at least 0.5 standard deviation below the normative data * adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the investigator * meeting the completion and performance criteria for the cogstate ntb * outpatient with study partner capable of accompanying the subject on all applicable clinic visits main exclusion criteria: * significant neurological or psychiatric disorders, other than ad, that may affect cognition. * atypical clinical presentations of mci due to ad or mild dementia due to ad, such as the visual variant of ad (including posterior cortical atrophy), frontal variant or the language variant (including logopenic aphasia). * moderate and severe dementia with a mini-mental state examination score (mmse) below 20. * current presence of a clinically important major psychiatric disorder (e.g. major depressive disorder) as defined by dsm-5 criteria, or symptom(s) (e.g. hallucinations) that could affect the subject's ability to complete the study. * history of clinically evident stroke. * history of seizures within the last two years prior to the screening visit. * myocardial infarction within the last six months prior to screening. * history of uncontrolled hypertension (in the opinion of the investigator) within six months prior to screening. * contraindication to lumbar puncture and mri
a retrospective review of outcomes following laparoscopic myomectomy

Conditions: Laparoscopic Myomectomy

Summary: this will be a retrospective review of approximately 900 patients who have undergone laparoscopic myomectomy since 1999. patients will be contacted by phone and surveyed. all patients who have had laparoscopic myomectomy will be included. only those not wishing to take part in the survey will be excluded. the data will then be compiled for statistical analysis , looking at pain, bleeding and subsequent fertility.

patients will be called and surveyed using a survey tool. they will be asked about what factors lead them to have surgery and then was their issue resolved after surgery.

Eligibility criteria:
inclusion criteria: * all patients who are willing to be surveyed exclusion criteria: * those patients who are not willing to answer the survey will be excluded * those patients who are unable to be contacted( ie; moved) will be excluded

Keywords: laparoscopic myomectomy menorrhagia pelvic pain
t-prf provides advantages on periodontal healing: a split mouth clinical study

Conditions: Periodontitis; Periodontal Attachment Loss

Summary: it was aimed to evaluate the contributions of t-prf treatment combined with open flap debridement on biological markers in gcf and periodontal outcomes in chronic periodontitis patients. 29 patients (58 sites) with chronic periodontitis were treated either with autologous t-prf with ofd or ofd alone. gcf growth factor levels and relative rankl/opg ratio at baseline and 2, 4 and 6 weeks postoperatively were analyzed, and clinical parameters such as probing depth (pd), relative attachment level (ral) and gingival margin level (gml) at baseline and 9 months after surgery were compromised.

a total of 29 medically healthy patients (12 females and 17 males; age range 28-49 years, mean±sd: 38.22±8.21) with chronic periodontitis at the outpatient ataturk university, department of periodontology, faculty of dentistry, erzurum, turkey, were selected for the study. the study, conducted from november 2015 to june 2016, was planned as a randomized, double-blinded, controlled clinical trial that used a split-mouth design. this study was proved by the ethics committee of ataturk university faculty of dentistry, and all patients received verbal information regarding participation and provided written informed consent for including to the study. bone loss characteristics of the patients were diagnosed with full-mouth radiographs and cone-beam computed tomography. this study included the patients with moderate-to-severe chronic periodontitis with a probing depth of 5 mm or deeper and horizontal bone loss (one- or two-wall shallow interproximal defects) of at least two quadrants of the jaws after phase-i periodontal therapy. after re-evaluating the results of phase-i therapy, patients with any of the following were excluded from the study: 1) smoking or tobacco use in any form; 2) medications known to affect periodontal treatment and blood coagulation; 3) systemic conditions known to affect periodontal status; 4) pregnancy/lactation; and 5) poor oral hygiene (plaque index \[pi\] \>1.5) (sillness and loe; 1964). patients with teeth with 3-wall intrabony defects, gingival recession, endodontic lesion, or furcation involvement were also excluded.

Eligibility criteria:
inclusion criteria: * patients with cp who had pocket depth ≤ 5 mm and at least two area (grouped as control and prf) with horizontal bone loss after initial treatment exclusion criteria: * the subjects excluded in the study had history of systemic disease, were smokers, had allergy to any drug, had need for prophylaxis of antibiotic and had taken antibiotics at least 6 months

Keywords: periodontitis growth factors periodontal healing
noise-induced hearing loss-acute exposure treatment (ua)

Conditions: Hearing Loss, Noise-Induced

Summary: the purpose of this study is to assess the safety and efficacy of zonisamide (zns) for the treatment of noise-induced hearing loss in adults.

this is a randomized, double-blind, and placebo-controlled study is to test whether zonisamide (zns) can treat noise-induced hearing loss in police officers on the range following training and certifications sessions. participants who meet the eligibility requirements will be randomized to receive either zns 100 milligrams (mg) or placebo. study participants will be recruited from the akron police department, summit county police department, and other local surrounding police departments. police officers will be offered participation if they are training for firearm certification as part of their standard occupational requirements. these are officers that would be recommended and/or required to complete these trainings/certifications despite this investigation and this investigation will have no influence on audiologic recommendations. after being informed about the study expectations and potential risks, all individuals providing written informed consent will undergo screening to determine eligibility for study entry.

Eligibility criteria:
screening inclusion criteria: * police officers who are scheduled for firearm training and/or certification on the range. * at least 18 years of age. * air conduction thresholds are to be no worse than 25 db hl from 0.5 khz to 3 khz, no worse than 30 db hl at 4 khz, and no worse than 45 db hl at 6 and 8 khz prior to shooting range exposure. * ability to understand and willingness to sign an irb approved written informed consent document. enrollment inclusion criteria: * observed audiometric tts ≥ 10 db hl at 2, 3, 4 and/or 6 khz * observed air-bone gap \< 10 db hl at .5, 1, 2 and 4 khz, with normal tympanometry exclusion criteria: * history of known sulfa allergy or hypersensitivity to carbonic anhydrase inhibitors. * history of moderate-to-severe kidney or liver disease. * acute viral, bacterial, fungal or parasitic infection. * history of seizures. * currently pregnant or breast-feeding. * any current or history of otologic disorder. * history of ototoxic drug use. * current use of strong/moderate 3a4 inhibitor/inducer and grapefruit juice. * for secondary outcomes, exclusion criteria is as follows: 1. dpoae data will be used as a secondary outcome measure of tts, and participants will be excluded if their dpoae is absent at more than 3/7 frequencies. criteria for a present response is any response that is \> 5 db spl above the noise floor and replicable within ±5 db spl. 2. ecochg: participants will be excluded if the ecochg/abr wave i response is absent. 3. win test: participants with win scores greater than moderate difficulty or 14.9 db snr will be excluded.
zushima plaster for treating knee osteoarthritis

Conditions: Osteoarthritis

Summary: the purpose of this study is to further evaluate the clinical efficacy and safety of zushima plaster for patients in knee osteoarthrosis post-marketing.


Eligibility criteria:
inclusion criteria: * ages 40-75; * unilateral or bilateral knee oa, confirmed radiographically; * patients taking oral nsaids prior to the breakthrough period will be permitted; * vas pain score is or above 20mm. exclusion criteria: * knee is swollen and hot; * allergic to any ingredient in girald daphne bark plaster (girald daphne bark, lithargite, linseed oil, red lead) ; * congestive heart failure and edema; * advanced renal disease; * knee joint skin is burst or skin disease or allergies.

Keywords: knee osteoarthritis
observational study on the weight effect of insulin detemir (levemir®) in type 2 diabetics

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. observational study evaluating the body weight progress during the treatment with insulin detemir (levemir®) in type 2 patients, previously treated with other basal insulins


Eligibility criteria:
inclusion criteria: * type 2 diabetes * current treatment with insulin nph or glargine * the selection of the subjects will be at the discretion of the individual physician exclusion criteria: * current treatment with insulin detemir * previous enrolment in this study * hypersensitivity to insulin detemir or to any of the excipients. * women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months
transitionchf systolic dysfunction to congestive heart failure cohort study

Conditions: Systolic Dysfunction, Transition, Heart Failure, Biobank

Summary: transitionchf aims to recruit a unique cohort of patients with asymptomatic left ventricular dysfunction (nyha i) to study the progression to symptomatic (\>nyha i) hf and to identify parameters/ biomarkers promoting and predicting the individual risk of transition. results from transitionchf cohort study will inform and refine current treatment guidelines. the implementation of common patient data sets and biobanking standards will enable data and biomaterial sharing with other study groups of the german center for cardiovascular research (dzhk). this study will set the standard for a unique dzhk heart failure database and biobank for innovative preclinical and clinical trials.


Eligibility criteria:
inclusion criteria: * asymptomatic systolic dysfunction (defined as: ejection fraction \< 40% by echocardiography or mri; documented within the last 3 months prior to baseline visit) * a maximum of one hospitalization for heart failure (defined as hospitalization with signs and symptoms of heart failure requiring intravenous loop diuretic therapy within 48 hours after hospital admission) at least 2 years prior to the baseline visit * no heart failure symptoms (nyha ii, iii or iv) upon inclusion * 6mwd ≥ 80% of reference values * written informed consent * age ≥ 18 years exclusion criteria: * symptomatic heart failure (nyha\>i) at baseline visit * any significant valvular disease (\> 2nd degree) * severe pulmonary disease (e.g. fev1/fvc \<0.7 and fev1\<50%) * severe renal disease (gfr \< 15 ml/min) * ejection fraction at baseline visit ≥ 50% by echocardiography or mri * life expectancy \< 1 year * pericardial disease * hypertrophic cardiomyopathy * myocardial infarction within the last 3 months * planned cardiac surgical intervention within 3 months after inclusion * geographical reasons (e. g. patients living outside germany or planning to move abroad) * inability to give informed consent (e. g. mental disorders) * therapy with loop diuretics (e.g. torasemide, furosemide, piretanide) within 4 weeks prior to inclusion/baseline visit