Kornimate/medical-research-clean huggingface dataset:
evaluation of flt pet and mri as imaging biomarkers of early treatment response in patients with glioblastoma

Conditions: Glioblastoma

Summary: glioblastoma is the most common primary malignant neoplasm of the adult brain. even after multimodal therapy, outcomes remain poor, with a median survival of one year. although advanced imaging methods have been suggested as molecular markers of prognosis and therapeutic response, these methods have not been validated for clinical use. in this exploratory, imaging-based, trial, thirty patients with a pathological diagnosis of glioblastoma will be followed prospectively for two years. the study examines how pet and mr imaging signals change following administration of a standard radio-chemotherapy treatment regimen to determine whether these imaging modalities can provide early indicators of response to therapeutic intervention. the investigators hypothesize that decreases in uptake of an investigational 18f-flt pet tracer following treatment with radiation and chemotherapy will be a reliable predictor of glioblastoma response. in a more exploratory fashion, the investigators also will identify changes in diffusion and hypoxia mr imaging that may also correlate well with treatment response.

patients with glioblastoma will be imaged with flt pet/ct followed by mri. the flt uptake will be correlated with advanced mri markers of tumor progression to determine the ability of using flt pet and mri for predicting response to treatment.

Eligibility criteria:
inclusion criteria: * adult patients (\> 18 yo) with a pathological diagnosis of malignant glioma (who grades iii and iv, including all histological subtypes) * surgical intervention includes subtotal resection or biopsy with mri evidence of residual disease after resection * patients with plan to undergo standard chemotherapy and radiation protocols including a combination of fractionated radiation and temozolomide * preoperative karnofsky performance score (kps) of \> 60 * willingness of patient and his/her partner to use contraceptive measures for duration of trial that will include pet studies. exclusion criteria: * patient refuses adjunctive therapy * pregnancy * karnofsky scale \< 60 * inability to undergo mr imaging studies * estimated gfr ≤ 60 ml/min (using gfr = 0.85\*\[140 - age(y)\]\*\[bodyweight(kg)\]/\[72\*cr(mg/dl)\] for women and gfr = \[140 - age(y)\]\*\[bodyweight(kg)\]/\[72\*cr(mg/dl)\] for men). * inability or unwillingness to follow instructions for both pet and mr imaging sessions.

Keywords: positron emission tomography magnetic resonance imaging diffusion magnetic resonance imaging radionuclide imaging disease management radiation therapy
clinical benefit of cognitive behaviour therapy (cbt) for insomnia in cancer patients

Conditions: Insomnia; Cancer

Summary: the purpose of this study is to conduct a formal controlled evaluation of the potential benefits of cbt for insomnia in cancer patients.


Eligibility criteria:
inclusion criteria: * meets clinical criteria for insomnia. * diagnosis of breast, prostate, colorectal or gynaecological cancer. * in follow-up phase with no further anti-cancer therapy planned. exclusion criteria: * anti-cancer chemotherapy or radiotherapy within 4 weeks of trial entry. * evidence of sleep apnoea or other sleep disorder. * evidence of untreated major depressive disorder.
bisantrene for relapsed /refractory aml

Conditions: Acute Myelogenous Leukemia; Allogeneic Stem Cell Transplantation

Summary: induction of response in patients with aml that are either primary resistant (failed induction and or salvage therapy) or relapsed including post allogeneic stem cell transplantation and failed salvage therapy or cannot receive additional anthracycline .


Eligibility criteria:
inclusion criteria: * subjects must meet all of the following inclusion criteria to be eligible to enroll in this study. disease-related: 1. patients with rel/ref/aml 2. adequate birth control in fertile patients. 3. eastern cooperative oncology group (ecog) performance status 0-2 demographic: 1. age ≥ 18 years and willing and able to comply with the protocol requirements 2. life expectancy ≥ 3 months ethical/other 3. written informed consent in accordance with federal, local, and institutional guidelines. 4. females of childbearing potential (fcbp) must agree to ongoing pregnancy testing and to practice contraception. 5. male subjects must agree to practice contraception exclusion criteria: * disease-related 1. patients with other type of basic disease other than rel/ref aml. 2. patients with respiratory failure (dlco \< 30%). 3. patients with active congestive heart failure (new york heart association \[nyha\] class iii to iv), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. 4. patients with \> grade ii liver renal toxicity. 5. psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate 6. bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit 7. creatinine \> 2.0 mg/dl 8. ecog-performance status \> 2 9. cns disease involvement 10. severe pleural effusion and ascites. concurrent conditions 1. pregnant or lactating females 2. known human immunodeficiency virus infection 3. active hepatitis b or c infection 4. non hematologic malignancy within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of gleason grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas 5. contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment 6. any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent. 7. patients with relapse or disease progression \>3 months post hsct are allowed into the study unless they have severe (grade iii-iv) gvhd. patients with grade iii-iv gvhd will be excluded from the study.

Keywords: relapsed aml refractory aml
explore the short- and mid-term effects of fespixon in scar cosmesis following cervical or abdominal surgery

Conditions: Scar

Summary: the aim of this study is to evaluate the efficacy of the fespixon cream for prevention and/or appearance reduction of different types of linear scars during the 12-week treatment phase, which is assessed by the blinded independent evaluator.

methods: this study was designed as a prospective, double-blind, placebo-controlled trial involving 50 patients with linear scars. bounded by the midpoint of the scar, each patient received a topical scar formulation consisting of fespixon cream on one side of scar, and placebo cream on the other side of scar. treatment was given twice a day for 84 days. assessments of the scars were performed at visit 1, 2, 3 following the onset of topical application using three methods: a clinical assessment using the vancouver scar scale/ modified vancouver scar scale, a photographic assessment to establish before and after treatment improvements, and at the end of the study period, patients completed a final satisfaction questionnaire.

Eligibility criteria:
inclusion criteria: 1. male or female aged over 20 years old (inclusive). 2. subjects with linear scar in neck or abdomen following elective surgery, including thyroid and parathyroid surgery, excision of neck mass, caesarean section, trans-abdominal hysterectomy, trans-abdominal myomectomy or any neck or abdominal surgeries which can be managed by primary closure of clean surgical wounds. exclusion criteria: 1. subjects who have previous neck or abdominal trauma that will affect the surgical incision site. 2. after radiation therapy for cervical/abdominal cancer, or previous medical history with chemo-therapy or targeted therapy for any reason. 3. laboratory values at screening of: note: the investigator will decide which of the following laboratory tests should be performed considering the condition of the subject. 1. albumin \< 2.5 g/dl (for subjects with severe malnutrition) 2. hba1c \>12.0% (for subjects with severe diabetes) 3. liver function test \[ aspartate aminotransferase (ast) and alanine transaminase (alt)\] \> 3x the upper limit of normal 4. renal function test \[serum creatinine\] \> 2x the upper limit of normal 4. subject is currently receiving immunosuppressant or systemic corticosteroids. 5. has any other factor which may, in the opinion of the investigator, compromise participation in the study.(including subjects with medical history of keloid or hypertrophic scar).

Keywords: fespixon thyroidectomy caesarean section scar on101
infectious mediastinitis among the strasbourg universitary hospital

Conditions: Mediastinitis

Summary: mediastinitis are rare but serious infections, with mortality rates varying from 6 to 30% according to the literature. they are essentially linked to surgical management (cardio-thoracic in particular), but some forms can be spontaneous, after extension of an ent infectious focus, for example. despite their seriousness, there is no strong recommendations to define their management, especially concerning antibiotic therapy and its duration. the aim of this research is to make a descriptive analysis of the cases of mediastinitis at hus in recent years, and to study the therapeutic strategy used


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject diagnosed with mediastinitis between 01/01/2010 and 31/12/2020 * subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. exclusion criteria: * subject having expressed opposition to participate in the study * subject under guardianship, curatorship or safeguard of justice

Keywords: mediastinitis sternitis deep sternal wound infection
evaluation of novel noise reduction principles in hearing instruments

Conditions: Hearing Loss

Summary: in the study, the speech intelligibility in noise (outcome) between a novel noise reduction algorithm (intervention) versus the standard noise reduction (comparator) will be tested in adults with a n3-n4 hearing loss (population) using streamed signals via hearing aids.


Eligibility criteria:
inclusion criteria: * minimum age for men: 18 years, minimum age for wom-en: 64 years, hearing aid users, * written and spoken german, * hearing loss range: n3-n4 hearing loss (sensorineural) * healthy outer ear, * ability to understand and follow the instruction of the in-vestigator * informed consent as documented by signature. exclusion criteria: * clinical contraindications 1) hearing loss is not within the fitting range of the hearing aid, 2) acute tinnitus, 3) de-formity of the ear (closed ear canal or absence of pinna), and 4) neural hearing loss i.e., retro-cochlear pathologies such as absent / non-viable auditory nerve * pregnant or breastfeeding women * age \>85 years * known hypersensitivity or allergy, * limited mobility and not able to attend the appointments
response of united kingdom (uk) infants to a reduced primary schedule with meningococcal c and pneumococcal conjugate vaccines

Conditions: Pneumococcal Infections; Meningococcal Infections

Summary: the purpose of the study is to evaluate the immune responses of uk infants after one or two doses of pneumococcal conjugate vaccine or one or two doses of three different types of meningococcal conjugate vaccine given at either two and three or two and four months of age.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from parent or legal guardian of infant * age 7-11 weeks at first dose exclusion criteria: * any contraindications to vaccination as specified in the uk handbook "immunisation against infectious disease" (ed 1996) * \ 11 weeks at first dose

Keywords: streptococcus pneumoniae neisseria meningitidis
radiographic evaluation of secondary alveolar bone grafting in patients with alveolar cleft

Conditions: Alveolar Cleft

Summary: study about the comparison of post-operative results of secondary alveolar grafts according to two age groups: early secondary (4 to 7 years) versus late secondary (8 to 11 years) using a recently proposed score based on post-operative 3d ct analysis. comparison of the initial results of the graft in the two groups, with a reference 2d score and evaluation of the concordance between the results found with this score and those of the 3d score. finally, comparison of graft bone densities and nasal floor level (using 3d visualization) on post-operative tdms in the 2 groups. the aim of this study is to determine the optimal age for grafting using three-dimensional ct assessment.


Eligibility criteria:
inclusion criteria: - patients operated with an alveolar bone grafting for a single or bilateral labio-alveolar cleft in the pediatric plastic surgery department of the university hospital of montpellier between 1999 and 2021 and having had 3d imageries defined as: * group 1: o patients operated with an early secondary alveolar grafting between the ages of 4 to 7 years with a 3d imaging (ct, cbct or scan) performed between the ages of 8 to 11 years. * group 2: * patients operated with a late secondary alveolar graft between the ages of 8 to 11 years with a 3d imaging (ct, cbct or scan) performed at least 1 year after the operation. exclusion criteria: * patients operated with an alveolar bone grafting before 4 years or after 11 years * patients without post-operative ct

Keywords: secondary alveolar bone grafting 3d score navigation system 3d-reconstruction bone loss
effects of acute high intensity exercise training on cardiac function in type ii diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: it is known from research that long-term exercise exposure in type 2 diabetes had positive effects. however, the effect of acute exercise in a patient group with already reduced cardiac function is not known. in this study, the impact of acute exhaustive high intensity interval training on cardiac function will be investigated in type 2 diabetes patients. one single session of exhaustive high intensity interval exercise training is expected to lead to a greater cardiac stress in diabetics than in non-diabetics, and in addition the right ventricle of the heart is expected to be more affected than the left ventricle.


Eligibility criteria:
inclusion criteria: * type ii diabetes exclusion criteria: -

Keywords: exercise therapy heart function tests heart/physiology echocardiography
sc-004 alone or with abbv-181 in subjects with epithelial ovarian, fallopian tube, primary peritoneal and endometrial cancers

Conditions: Cancer

Summary: this is a two-part study consisting of part a (dose regimen finding) followed by part b (dose expansion). part a (dose regimen finding) will allow definition of the maximum tolerated dose (mtd) through dose escalation and possible dose interval modification. in part b (dose expansion), potential therapeutic doses may be studied with sc-004 as monotherapy and sc-004 in combination with abbv-181 in disease-specific cohorts.


Eligibility criteria:
inclusion criteria: * histologically confirmed advanced malignancy defined as any of the following tumors for which no further standard or curative therapy exists or is considered appropriate by the investigator: * epithelial ovarian cancer, including fallopian tube cancer or primary peritoneal cancer, of high-grade serous histology, with platinum refractory or resistant disease after prior treatment with at least one platinum-based chemotherapeutic regimen. in part b (dose expansion), subjects may have received no more than 3 lines of systemic cytotoxic chemotherapy. * note, the line of therapy limit does not apply to the biopsy substudy cohorts. * metastatic or advanced endometrial carcinoma previously treated with at least 1 platinum-based chemotherapeutic regimen. * eastern cooperative oncology group (ecog) 0-1. * adequate hematologic, hepatic, and renal function. exclusion criteria: * participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.

Keywords: ovarian cancer endometrial cancer sc-004 maximum tolerated dose (mtd) abbv-181
high on-treatment platelet reactivity identified by multiple platelet function assay

Conditions: Acute Coronary Syndrome

Summary: high on-treatment platelet reactivity to adenosine diphosphate was a important reason to cause ischemic events in antiplatelet therapy. using single testing to definite hpr may miss the "true hpr" or over estimate hpr, which may lead to randomized trials failed. it is not known whether combined multiple platelet function testing could assist to ensure"ture"hpr and improve clinical outcomes.

this was a single-center, randomized, prospective study. acs patients undergoing pci treated with clopidogrel and aspirin were included. in the 3-5th day after prescription of clopidogrel, platelet function were tested simultaneously by three methods: mpaadp by light transmittance aggregometry（lta）, maadp by thrombelastography (teg) ,and ctp2y by innovance pfa-200 . according to three result（two of three or all three results higher than cutoff value was identified as hpr, mpalta\>50%;maadp\>47mm;ctp2y\<106s）.patients was defined as hpr(n=125) or unhpr(n=232), hpr patients were divided into hpr-ticagrelor(hpr-t)and hpr-clopidogrel(hpr-c) randomized. hpr-t group(n=77) patients' antiplatelet agents changed to ticagrelor, both unhpr and hpr-c groups keep unchanged(clopidogrel). the major adverse cardiovascular events (mace) were recorded during 1 year follow-up.

Eligibility criteria:
inclusion criteria: * acs patients（uap;ustemi,stemi） * undergoing pci * oral antiplatelet therapy exclusion criteria: * stable cad

Keywords: clopidogrel；antiplatelet therapy
long-term intervention with weight loss in patients with concomitant obesity and knee osteoarthritis. the light study

Conditions: Osteoarthritis, Knee; Obesity

Summary: obesity and osteoarthritis (oa) co-exist in an increasing part of the population. the two diseases intertwine in several ways. the evolution in the population shows a tendency towards deterioration of both by increasing general age and weight. the two diseases share pathogenetic features and the development of one disease increases the risk of the other and may be the onset of a vicious circle. there is a link between treatments of these two diseases as well. there is now solid (gold) evidence that by treating effectively the obesity of patients with co-occurring oa, the functional status is dramatically ameliorated; the short-term results are equal to that of a joint replacement. the long-term efficacy of a weight loss remains to be shown. oa is definitely one of many diseases in which obesity must be taken seriously into account when planning a correct treatment of patients. this trial is an extension of the former carot trial nct00655941. the participants of this trial are recruited for a prolongation of the dietary intervention consisting of a group therapy with low-energy diet in a randomized, two group (each n = 75 patients) study of maintenance of weight loss by continuing with supplementary either 3 x 5 weeks dietary supplements only or once-daily supplement. the hypothesis is that maintenance of the already induced weight loss is most efficiently ensured by the once-daily program.

any patient with osteoarthritis (oa) of the knee was invited to participate in the preceding trial. eligible for this study will be patients, who have completed the one-year phase 2 of the carot. exclusion criteria are planned knee alloplasty of both knees.

Eligibility criteria:
inclusion criteria: former participant in the carot study ( nct00655941 ) - exclusion criteria: bilateral knee alloplasty -

Keywords: osteoarthritis obesity weight loss dietary instruction formula diet attention
pulsed electromagnetic fields (pemfs) - a highly selective breast cancer treatment platform (pascal)

Conditions: Breast Cancer

Summary: to assess the safety and tolerability of combined pemfs and anthracycline-based chemotherapy in subjects who are undergoing neoadjuvant chemotherapy for breast cancer treatment.

this is a single-center phase ib study to investigate the safety and tolerability of the combination of pemf with anthracycline-based chemotherapy. subjects will be enrolled on a 3+3 dose escalation design from dose level 1 with a target to reach dose level 4, where pemf can be administered prior to each cycle of anthracycline-based chemotherapy. in the first 2 dose levels, pemfs will first be administered to subjects who are planned for upfront surgical resection to ensure that pemfs is safe and tolerable for up to 0.5-hour. once the duration of each pemf treatment is established, pemfs will then be added to anthracycline-based chemotherapy to investigate the safety and tolerability of the combination treatment.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed breast carcinoma of any subtype (any estrogen receptor, progesterone receptor and her2 receptor status) 2. ecog 0-1. 3. non-metastatic disease for which surgery of curative intent is planned upfront or after completion of neoadjuvant chemotherapy 4. adequate organ function including the following: 1. bone marrow: 1. absolute neutrophil (segmented and bands) count (anc) \>= 1.5 x 10\^9/l 2. platelets \>= 100 x 10\^9/l 3. hemoglobin \>= 8 x 10\^9/l 2. hepatic: 1. bilirubin \<= 1.5 x upper limit of normal (uln), 2. alt or ast \<= 2.5x uln, (or \<=5 x with liver metastases) 3. renal: 1. creatinine \<= 1.5x uln 5. signed informed consent from subject or legal representative. 6. able to comply with study-related procedures. exclusion criteria: 1. pregnancy. 2. breast feeding. 3. presence of fungating breast tumor or open wound in breast planned for pemf. 4. active bleeding disorder or bleeding site. 5. second primary malignancy that is clinically detectable at the time of consideration for study enrollment. 6. major surgery within 28 days prior to study administration. 7. non-healing wound. 8. active infection that in the opinion of the investigator would compromise the subject's ability to tolerate therapy. 9. history of significant neurological or mental disorder, including seizures or dementia. 10. serious concomitant disorders that would compromise the safety of the subject or compromise the subject's ability to complete the study, at the discretion of the investigator.

Keywords: pulsed electromagnetic fields (pemfs)
the sleep-care study

Conditions: Sleep Disturbance

Summary: sleep disorder is common in icu patients, such as reduced sleep time, fragmentation, and abnormal sleep rhythm. in 2023, american thoracic society released a research statement on sleep and circadian disruption(scd) in icu, which considered scd is an important potential target for improving critical illness outcomes. although polysomnography(psg) is the gold standard of sleep measurement, subjective sleep evaluation tools are still used in most clinical studies related to sleep in icu. this makes the sleep quality of icu patients overestimated and difficult to reflect their true sleep conditions. and the answers to how and which outcomes different levels of sleep deprivation affect patient outcomes are still unclear and need to be further explored.


Eligibility criteria:
inclusion criteria: * adults (≥ 18-years old) * anticipated sicu stay for 24 hours or more exclusion criteria: * pregnancy * have a clear history of medication for sleep disorders * history of mental or psychological illness * treated with crrt or ecmo during monitoring

Keywords: polysomnography intensive care unit