Kornimate/medical-research-clean huggingface dataset:
advanced mr imaging as predictor of treatment response in newly diagnosed glioblastomas

Conditions: Adult Glioblastoma

Summary: this clinical trial studies advanced mr imaging techniques in measuring early response of standard treatment may become predictors of long-term treatment response in patients with newly diagnosed glioblastomas.

the standard care of patients with glioblastoma is concomitant chemoradiation and adjuvant temozolomide. allowing for assessment of tumor therapy prior to treatment completion is important to select patients most likely to benefit from alternative treatment option. multimodal advanced mr imaging- contrast-enhanced t1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging on 3t enables quantitative assessment of treatment response. quantifying changes in advanced mr imaging techniques would allow predict outcome for early and long-term treatment response and survival in glioblastomas.

Eligibility criteria:
inclusion criteria: * patients must have radiologically and histologically confirmed diagnosis of newly diagnosed glioblastoma * patients must have measurable disease, defined as evident tumors with gadolinium enhancement on mri that is measurable in at least one diameter * life expectancy of greater than 3 months * patients scheduled for standard therapy (6 weeks radiation treatment (rt) \~ 60 gy, plus temozolomide 75 mg/m\^2 during 6 week rt, and followed routine monthly temozolomide therapy) * ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and health insurance portability and accountability act (hipaa) authorization in accordance with institutional guidelines exclusion criteria: * patients who underwent complete resection * patients with no evidence of measurable disease after surgery * patients who have had chemotherapy or radiotherapy * patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction * patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential * for patients who have undergone surgical resection prior to joining the study, in whom baseline magnetic resonance (mr) images exhibit enough signal degradation (due to susceptibility artifact in the region of the surgical bed) such that the data are uninterpretable will be excluded

Keywords: glioblastoma mri standard treatment
safety study of imexon plus docetaxel in lung, breast or prostate cancer patients

Conditions: Non-small Cell Lung Cancer; Breast Cancer; Prostate Cancer

Summary: protocol amp-010 is a phase 1b study of imexon plus docetaxel for patients with previously treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer. docetaxel is approved by the food and drug administration (fda) as a second line therapy for these cancers. the imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle. the objective of the protocol is to determine the highest dose of imexon which can be given with a full dose of docetaxel, and to provide information to enable the design of a future study focused on one or more specific cancer types.


Eligibility criteria:
inclusion criteria: * be diagnosed with previously treated breast, lung, or prostate cancer where docetaxel is indicated. * prior treatment; at least one prior regimen required. * able to perform the activities of daily living. * off prior cancer therapy for at least 4 weeks. * if female neither pregnant nor nursing. * willing to use contraceptives to prevent pregnancy. * no other serious illnesses. * no other active malignancy. * no serious infections. * no other current drug therapy for the cancer. * blood counts and blood chemistries in or near normal range. * prior radiation is permitted. exclusion criteria: * active brain metastases.

Keywords: hormone refractory prostate cancer
study investigating repeat doses of a new medication (gsk159797) in asthmatic patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (gsk159797) following dosing for 14 days.


Eligibility criteria:
inclusion criteria: * subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of fp or equivalent corticosteroid * female subjects only using acceptable birth control method * non-smokers * fev1 between 60 and 90% predicted * increase in fev1 12% or greater and 300ml and greater after salbutamol use exclusion criteria: * past or present disease conditions * normal screening holter ecg * respiratory tract infection within 4 weeks of screening * history of life threatening asthma * previous use of coa

Keywords: safety asthmatic patients gsk159797 efficacy
evaluation of the contribution of lower limb and/or abdominal compression on orthostatic hypotension

Conditions: Orthostatic Hypotension

Summary: orthostatic hypotension (oh) is associated with an increased risk of myocardial infarction, stroke, heart failure and neurocognitive disorders. in the elderly, oh is an independent predictor of falls and mortality. non-drug treatments are used as the first-line treatments. among non-drug treatments, compression of the lower limbs and abdominal compression have been shown to help reduce oh and associated symptoms. as these studies were solely based on ankle-to-thigh bandages, the effectiveness of other medical devices developed, such as compression socks and tights, needs to be evaluated. in addition, data comparing the efficacy and tolerability of several approaches, single or combined, of several levels of compression, provided by socks, tights and an abdominal belt are scarce. the hypoflex study aims to provide new data to enable better management of oh.

patients will be recruited from a single center, over a 12-month inclusion period. the clinical investigation will focus on ce-marked class i medical devices, used for their intended purpose, as part of a post-market clinical follow-up with additional non-invasive, non-invasive procedures. randomization will be carried out to determine the order of the 5 conditions studied: * no compression, * class 2 compression socks, * class 3 compression socks, * class 2 compression tights, * dynabelt abdominal belt + class 2 compression socks. conditions will be tested over half a day.

Eligibility criteria:
inclusion criteria: * patient aged 60 or over, * patients hospitalized at broca hospital with orthostatic hypotension, * patient able to stand, * patient who has been medically stable for at least 48 hours, * patient whose measurements are compatible with thuasne compression device sizes, * patient having been informed, having received answers to his questions and having signed the informed consent form prior to his participation in the study, * patient affiliated or entitled to a social security number. exclusion criteria: * patients presenting, according to the investigator, a contraindication to lower limb and/or abdominal compression, * patients presenting any contraindication mentioned in the instructions for use of the medical devices under investigation. * patient presenting, according to the investigator, a major cognitive impairment incompatible with participation in a clinical trial, * patient taking part in another clinical investigation conducted to establish the conformity of a medical device having an impact on the outcomes, * vulnerable patient according to article l1121-6 of the public health code, subject to a judicial protection measure or incapable of consenting to a clinical trial or incapable of giving informed consent.

Keywords: orthostatic hypotention abdominal compression lower limb compression
drug-screening in aml at relapse for targeted treatment

Conditions: AML

Summary: this is a non-randomised clinical study investigating subsequent patients with specific aml treatment started between january 1, 2022 until december 31, 2022. patients with relapsing disease are planned to be analyzed in this study

the standard treatment for young fit patients with acute myeloid leukemia (aml) is intensive chemotherapy followed by consolidation treatment with curative intent. usually, two cycles of intensive chemotherapy are given, with subsequent consolidation treatment depending on the genetic risk-assessment of the patients as well as on the response to the induction treatment. for elderly or unfit patients, such an intensive approach is not feasible, and palliative treatment must be considered. the standard first-line-treatment for such patients since more than a decade comprises repetitive cycles of a hypomethylating agent (either azacitidine or decitabine). the median progression free survival following these approaches in this population is between 4 and 8 months, with an overall-survival of up to 12 months. more recently, the addition of the bcl-2 inhibitor venetoclax to hypomethylating agents has led to a modest improvement both of progression-free and overall survival. however, overall survival in such patients usually does not exceed 14-16 months. the laboratory of prof. berend snijder, institute of molecular systems biology, at the eth (eidgenössische technische hochschule) zurich has developed an image-based ex-vivo drug screening platform for patients with aggressive haematological malignancies, also called pharmacoscopy. using such a technique, leukemic cells from a patient at relapse can be rapidly screened for sensitivity to single compounds. a drug score is calculated for each compound. starting in q2/2021, the investigator at the department of medical oncology, university hospital inselspital in bern, collected experiences using such an approach. having received information from the laboratory on top sensitivity of leukemic cells of a given patient to a specific drug, a process is initiated to try to obtain access to such off-label drugs.

Eligibility criteria:
inclusion criteria: * included are patients with aml at relapse treated at the department of medical oncology at the university hospital inselspital in bern. * patients are not planned to undergo intensive reinduction treatment with subsequent allogeneic hematopoietic transplantation in a curative intent. * patients have exhausted all standard therapeutic options and they must have no available licensed standard treatment for relapsed aml. * written informed consent exclusion criteria: * patients able to undergo intensive reinduction treatment with subsequent allogeneic hematopoietic transplantation in a curative intent * patients have available standard therapeutic options

Keywords: aml relapse drug-screening pharmacoscopy
influence of oxygen target range on intermittent hypoxemia in preterm infants

Conditions: Intermittent Hypoxemia; Apnea of Prematurity

Summary: in this randomized crossover trial, preterm infants with intermittent hypoxemia and need for supplemental oxygen will be randomized to either sequence of two different oxygen target ranges (low: 85-89%; high: 91-95%) for a total duration of 19 hours. cerebral oxygenation, cardiac output, arterial oxygenation and heart rate will be measured continuously. primary outcome is time with arterial oxygen saturation \< 80%.


Eligibility criteria:
inclusion criteria: * preterm infant \< 29 weeks gestation * at least 8 hypoxemic events during 8 hours * requires supplemental oxygen to achieve high spo2 target range * parental consent given exclusion criteria: * congenital life-threatening malformation * fatal outcome expected * airway malformation * higher grade intraventricular bleeding (grade iii or iv according to la papile) * posthaemorrhagic hydrocephalus * life-threatening disease at the time of study entry

Keywords: cerebral oxygenation nirs near-infrared spectroscopy bradycardia hypoxemia cerebral perfusion cardiac output apnea desaturation oxygen saturation target range
a study of the safety, blood levels and biological effects of gbt440 in healthy subjects and subjects with sickle cell disease

Conditions: Healthy Subjects; Sickle Cell Disease

Summary: the purpose of this study is to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of gbt440 compared with placebo in healthy subjects and subjects with sickle cell disease (scd).


Eligibility criteria:
inclusion criteria: * healthy male or female of non-child bearing potential; 18 to 55 years old; are non-smokers and have not used nicotine products within 3 months prior to screening. * male or female, 18 to 60 years old, with sickle cell disease (hemoglobin ss, hbs/β0thalassemia, hbs/β+thalassemia, or hbsc) not requiring chronic blood transfusion therapy; without hospitalization in 30 days before screening or receiving blood transfusion within 30 days before screening; subjects are allowed concomitant use of hydroxyurea if the dose has been stable for the 3 months prior to screening. exclusion criteria: * subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders. * subjects who consume more than 14 (female subjects) or 21 (male subjects) units of alcohol a week. * subjects who have used any investigational product in any clinical trial within 30 days of screening * subjects with sickle cell disease who smoke \>10 cigarettes per day; have hemoglobin level \ 10.4 g/dl (\> uln (appropriately corrected for gender) for cohort 15) at screening; have aspartate aminotransferase (ast) \>4x upper limit of normal or alanine aminotransferase (alt), or alkaline phosphatase (alk) \>3x upper limit of normal reference range (uln) at screening; have moderate or severe renal dysfunction
diet quality before and after metabolic bariatric surgery (eetscore study)

Conditions: Obesity and Overweight; Bariatric Surgery; Nutrition Assessment; Diet Quality

Summary: the aim of this study was to learn more about the use of a short screener for diet quality (eetscore ffq) in bariatric patients and about changes in diet quality before and after the bariatric procedure.


Eligibility criteria:
inclusion criteria: * approved for (primary) bariatric surgery * aged 18-65 years * following the standard care pathway exclusion criteria: * previous bariatric procedure other than adjustable gastric banding * non-dutch eating pattern * active eating disorders * inability to fill in questionnaires or food records

Keywords: screener diet quality obesity metabolic bariatric surgery weight loss surgery validity
comparison of the efficacy between transurethral coagulation and transurethral resection of ulcer in bladder pain syndrome patients

Conditions: Bladder Pain Syndrome

Summary: on the eau (european association of urology) guidelines, the ulcer type bladder pain syndrome (bps) should be treated with transurethral resection (tur) or coagulation (tuc) of ulcer. but, up to date, there was no study to compare the therapeutic efficacy of tur with tuc in ulcer type bps patients. we assume tur have a more therapeutic effect than tuc.


Eligibility criteria:
inclusion criteria: 1. male and female aged 18 yrs or greater 2. patients diagnosed with bps(bladder pain syndrome) 3. symptom persisted more than 6 months 4. pain vas ≥4 5. o'leary-sant interstitial cystitis questionnaire (ic-q) scores 12 or greater with pain and nocturia domain scores \> 2. 6. pelvic pain and urgency/frequency patient symptom scale(puf) \>13 7. no history of cystoscopy within 2yrs. exclusion criteria: 1. history of augmentation cystoplasty or previous transurethral coagulation/resection due to bps 2. child-bearing potential, pregnant or nursing women. 3. mean voided volume lesser than 40ml or over than 400ml. 4. hematuria exceeds 1+ in the urinary dipstick (dipstick) examination. 5. urinary tract infection during run-in periods. 6. genitourinary tuberculosis or bladder,urethral and prostate cancer 7. recurrent urinary tract infection 8. history of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or cesarean section,prostate operation or treatment etc within 6months. 9. neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.

Keywords: bladder pain syndrome transurethral resection of ulcer transurethral coagulation of ulcer
sas-j compared to oagb and lsg as a treatment for morbid obesity

Conditions: Morbid Obesity

Summary: 150 morbidly obese patients divided into to equal groups, group a underwent single anastomosis sleeve jejunal bypass and group b underwent mini gastric bypass, group c underwent sleeve gastrectomy. all patients were followed for at least one year. all cases were evaluated as regard bmi, complications, nutritional status and obesity-related comorbidities.

150 morbidly obese patients divided into to equal groups, group a underwent single anastomosis sleeve jejunal bypass and group b underwent mini gastric bypass, group c underwent sleeve gastrectomy. all patients were followed for at least one year. all cases were evaluated as regard bmi, complications, nutritional status and obesity-related comorbidities. the minimal follow up period is one year

Eligibility criteria:
inclusion criteria: * obese patients with bmi more than 40 with or without co-morbidity or more than 35 with co-morbidity * patients fit for laparoscopic surgery * give approval to share in the study exclusion criteria: * patients refused to share in the study * patients unfit for surgery * patients aged less than 18 and older than 60 * patient with previous upper abdominal surgery either for obesity or other diseases * revisional bariatric procedures
usage of the home macular perimeter (hmp)

Conditions: Age Related Macular Degeneration

Summary: demonstrate the ability of the current interactive tutorial and 1-800 support to teach an amd patient to use the hmp device.

the pilot study purpose is to demonstrate that the tutorial which is part of the device software, is giving sufficient training for the intended users.

Eligibility criteria:
inclusion criteria: * capable and willing to sign a consent form and participate in the study * subjects diagnosed as intermediate amd in at least one eye * age \>50 years * va with habitual correction \>20/60 in the study eye * ability to speak, read and understand instructions in hebrew * familiar with computer usage exclusion criteria: * evidence of macular disease other than amd or glaucoma in the study eye * presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, cfp. * any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye * participation in another study with the exclusion of areds study * patients diagnosed with geographic atrophy (ga)

Keywords: hmp, amd, cnv, php, hphp
efficacy and tolerance of high flow nasal cannula for respiratory distress syndrom in late preterms (34-36 weeks)

Conditions: Respiratory Distress Syndrom; High Flow Nasal Cannula

Summary: the main objective of the study is to gather preliminary data on the effectiveness of high flow nasal canula (hfnc), provided since the delivery room, for ventilatory support in newborns of 34-36 weeks with moderate respiratory distress syndrome (rds). the secondary objective is to evaluate the safety of hfnc in this indication.

treatment with hfnc will start maximum 30 minutes after birth at an initial flow rate of 2l/kg/min. according to retraction signs, flow may be increased by gradual increments of 1l/min to reach a maximum flow rate of 5l/kg/minute. patients not improving after 2 hours of support with hfbnc will be hospitalized in the neonatal intensive care unit (nicu), and hfnc maintained as long as necessary, with regular attempts of weaning. at any moment during the study, aggravation will lead to stop hfnc trial, and the infant management decided by the physician involved in the patient's care. aggravation is definined by one of the following conditions: silverman-anderson score \> 6, and / or fio2 \> 0.5 and / or severe apneas and / or hemodynamic instability.

Eligibility criteria:
inclusion criteria: * newborn premature between 34 and 36 weeks of gestational age * moderate rds after 30 minutes of life while treated with + 5cm h2o positive airway pressure * presence of a dedicated pediatric nurse and pediatrician * parental consent exclusion criteria: * need for early intubation * severe rds, defined by one of the following: silverman-anderson score \> 6, severe hypoxia (fio2 \> 0.5), hemodynamic disorders (hr\> 180 / min, mabp \ 5s, pallor), and severe apneas (\> 5s and / or with bradycardia \<80 /min) * 1 minute apgar score \< 3 and / or five minutes apgar score \< 7 * birth weight \< 1800g and / or iugr \<-2 sd * congenital heart, pulmonary, facial, or digestive malformation * subject not affiliated to social security system * legal representatives unable to understand the terms of the study

Keywords: 34 to 36 weeks preterm neonates respiratory distress syndrom high flow nasal cannula
antimicrobial photodynamic therapy as an adjunct treatment for periodontal disease in down's syndrome patients

Conditions: Periodontal Diseases

Summary: the aim of this study was to evaluate the effectiveness of antimicrobial photodynamic therapy as an adjuvant of scaling and root planning for treatment of periodontal disease in patients with down's syndrome. after scaling and root planning, half of patients received antimicrobial photodynamic therapy with methylene blue dye and laser and the sessions were repeated after 3, 7 and 14 days. the other half received only scaling and root planning. .

antimicrobial photodynamic therapy (apdt) has been widely used in periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. therefore, a good adjuvant alternative for periodontal disease treatment arises, especially for patients with down syndrome (ds) who present greater severity and high prevalence of periodontal disease. usually apdt is used as an adjunct therapy to scaling and root planning.

Eligibility criteria:
inclusion criteria: down's syndrome diagnose characterized by the whole chromosomal aneuploidy 15 to 52 years absence of severe hearing loss could impair the comprehension about the dental treatment absence of severe visual loss that could impair the comprehension about the dental treatment presence of at least four teeth being one for hemiarch. diagnose of gingivitis and periodontitis absence of acute periodontal disease and necrotizing periodontal disease exclusion criteria: smokers use of alcohol menopause pregnancy absence of all teeth uncontrolled diabetes mellitus uncontrolled hyperthyroidism angina uncontrolled hypertension coagulopathy use of illicit drugs head and neck radiotherapy chemotherapy non-cooperative patients or patients with other diseases as autism.

Keywords: periodontal diseases down syndrome