Kornimate/medical-research-clean huggingface dataset:
fet-pet/mri for surgical assessment of pediatric brain tumors

Conditions: Pediatric Brain Tumors

Summary: the primary objectives of this study are: 1. determine the percentage of patients whose surgical plan would change with fet-pet/mri compared to mri alone. 2. determine the percentage of patients who have residual tumor after surgery detected with fet-pet/mri. a secondary objective of this study is: 1) perform preliminary correlations between the pre- and post-surgical metabolic tumor volumes measured with fet-pet/mri to progression free survival.


Eligibility criteria:
inclusion criteria: 1. patient must have a known or suspected primary brain tumor with a non-enhancing component with planned standard of care surgical resection. patients with newly diagnosed or recurrent brain tumors are eligible. 2. tumors with non-enhancing regions will be defined as t2/flair hyperintensity extending at least 0.5 cm beyond areas of enhancement as assessed by mri. 3. patient must be 18 years of age or younger at the time of study enrollment. 4. patient must have measurable disease defined as tumor measurable in two perpendicular dimensions on mri greater than 1 cm. 5. patient must have a life expectancy greater than 8 weeks. 6. patient must be able to undergo fet-pet/mri without sedation. 7. females with childbearing potential must have a negative urine β-hcg test on the day of procedure or a serum hcg test within 48 hours prior to the administration fet. females who have not reached menarche will not require pregnancy testing. exclusion criteria: 1. patient must not be receiving an investigational or standard of care anti-cancer drug within 6 months prior to the fet-pet/mri study. 2. patient must not have received radiation therapy within the past 6 months. 3. patient must not have a contraindication to contrast-enhanced mri (e.g. renal insufficiency, incompatible implant). 4. patient must not be pregnant or breast feeding. 5. patient must not have been treated for another cancer within 5 years with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma. 6. patients must not have a history of brain metastases.
p-gemox regimen as first-line chemotherapy in nk/t lymphoma patiens

Conditions: Lymphoma, Extranodal NK-T-Cell

Summary: this prospective study was conducted to evaluate the efficacy and safety profiles of first-line combined gemcitabine, oxaliplatin, and pegaspargase (p-gemox) in newly diagnosed, nasal type, extranodal natural killer/t-cell lymphoma.

treatment p-gemox dosages were as follows: days 1, 30 min intravenous infusion of 1250 mg/m2 gemcitabine; day 1, 2h intravenous infusion of 85 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2500 u/m2 peg-asp at three different sites. the regimen was repeated every 2 weeks for a maximum of six cycles. stage ie/iie patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got cr, pr or sd. three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (gy) per daily fraction with 5-6 weeks. the involved- field radiation (ifrt) dose was 50-56 gy. stage iiie/ive patients patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. primary tumor radiotherapy was recommended after they achieved cr.

Eligibility criteria:
inclusion criteria: * newly diagnosed enktl * age:18-80years * at lease one measurable lesion * receive no chemotherapy or radiotherapy before * eastern cooperativeoncology group performance status of 0 to 2. * adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/l, and platelet count≥ 100×10e9/l),renal function (eg, serum creatinine≤1.5 mg/dl and creatinine clearance ≥50 ml minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal) exclusion criteria: * mismatch the inclusion criteria * systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.

Keywords: nk/t-cell lymphoma induction chemotherapy survival
swog 8897-a dna analysis in predicting treatment outcome in women with breast cancer in swog 8897

Conditions: Breast Cancer

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict a patient's response to treatment. purpose: this laboratory study is looking at dna in tissue samples from women with breast cancer to see if it can predict treatment outcome.

objectives: * determine if polymorphisms resulting in greater activation of cyclophosphamide (cyp2b6, cyp3a4, and cyp3a5) are associated with disease-free survival and treatment toxicities in women with breast cancer. * determine if polymorphisms resulting in less production of quinone-related oxidative damage of doxorubicin hydrochloride (nqo1, nqo2, nos2, nos3, cbr3) are associated with disease-free survival and treatment toxicities in these patients. outline: this is a multicenter study. tissue samples archived on clinical trial swog-8897 are genotyped for polymorphisms in the cyp3a4, cyp3a5, cyp2b6, nqo1, nqo2, nos2, nos3, and cbr3 genes by matrix-assisted laser desorption ionization-time-of-flight mass spectrometry. variant alleles are correlated with patient outcome. projected accrual: a total of 1,577 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer * node-negative breast cancer * enrolled on clinical trial swog-8897 * archived tissue from patients with normal lymph nodes in the low-risk group receiving no treatment and those in the intermediate group receiving treatment * hormone receptor status known patient characteristics: * female * pre- or post-menopausal prior concurrent therapy: * not specified

Keywords: stage i breast cancer stage ii breast cancer
ovarian hyperstimulation syndrome (ohss) prevention with agonist

Conditions: Ovarian Hyperstimulation Syndrome

Summary: the aim of the study is to explore the concept of gnrh-agonist triggering in combination with elective cryopreservation of all 2pn oocytes at larger scale in a pragmatic clinical setting. the question asked is: "does gnrh-agonist triggering and cryopreservation work", in terms of efficacy and safety, when applied to a larger cohort of patients, and by a number of different centres with different clinical routines.


Eligibility criteria:
inclusion criteria: * indication for ivf with icsi * age \< 40 years * \< 4 failed previous ivf attempts with embryo transfer * ovarian stimulation with gnrh-antagonist and gonadotrophins * \>20 follicles \>11 mm in mean diameter or e2 \>4500 pg/ml on the day , on which it was planned to administer hcg * willing to participate and able to consent * patient has not previously received gnrh-agonist as a trigger of final oocyte maturation exclusion criteria: * none

Keywords: frozen-thawed embryo replacement gnrh agonist gnrh antagonist ovarian hyperstimulation
neuropsychiatric evaluation of healthy volunteers and adults with schizophrenia

Conditions: Brain Injury; Dementia; Healthy; Mental Disorder; Schizophrenia

Summary: the purpose of this study is to evaluate the cognitive processes of participants with schizophrenia, participants with nervous system and mental disorders, and healthy volunteers. participants in this study will undergo cognitive tests of attention, memory, attention. participants with attention deficit hyperactivity disorder (adhd), traumatic brain injury (tbi), bipolar disorder, and alzheimer's disease (ad) will be compared with participants with schizophrenia. a group of healthy adults and children will undergo cognitive tests to further delineate the degree of impairment in schizophrenia and neurological disorder participants.

in this study, we propose to administer cognitive tests to schizophrenic patients and to neurologic patients who will serve as contrast groups for neuropsychological studies of patients with schizophrenia. these include studies of alzheimers disease to dissociate size and organization of lexicon and adhd to understand error patterns on cpt-type tests of attention and vigilance. however, the majority of studies will examine schizophrenia in relation to normal controls. in addition, we propose to obtain test results from a local sample of normal subjects of varying ages and educational backgrounds to further delineate degree of impairment in these clinical groups. as well as assessing adults we wish to assess normal children. in particular, we wish to identify in children the size of their lexicon and their degree of semantic organization within their lexicon.

Eligibility criteria:
inclusion criteria english-speaking adults between ages 21 to 65, in good health and free from significant substance abuse. children between ages 4 to 20 must not have a history of special education, using psychotropic medication in long-term counseling or with a history of seizures, head injury or cns infections. normal controls will be recruited and screened for exclusionary morbidity by interview (e.g., no history of contact with mental health professionals, no history of diagnosable alcohol and/or substance abuse). normal controls will be recruited from building employees, local universities, from nimh rosters, and the general public. exclusion criteria excluded are adults with histories of dementing illness, movement disorder, affective disorders, developmental and/or acquired brain injury. diagnoses will be made by review of medical records, interview, examination, and in the case of psychiatric diagnoses, a structured interview by scid. advertisement will make clear that the subjects will be asked questions about family psychiatric history and their own history or psychiatric disorder, substance abuse, and neurological disease. only if the subject answers these negatively will he or she participate in this study.

Keywords: cognition neuropsychology neuropsychological tests neurological exam psychiatric attention schizophrenic schizoaffective working memory memory
surgery versus sclerotherapy for isolated accessory great saphenous vein varicosis

Conditions: Varicose Veins

Summary: the purpose of this study is to compare two therapeutic procedures in the treatment of isolated varicosis of the anterior accessory great saphenous vein (aagsv): crossectomy and avulsion of the varicose aagsv versus foam sclerotherapy of the aagsv.


Eligibility criteria:
inclusion criteria: * reflux in anterior accessory great saphenous vein (aagsv) \> 0,5 sek exclusion criteria: * concomitant reflux in great saphenous vein (gsv) * reflux in the deep venous system (postthrombotic syndrome) * acute thrombosis * hypercoagulability * allergy to aethoxysclerol or local anesthetics * immobility * open foramen ovale * bacterial infection of the skin * pregnancy and breast feeding * peripheral arterial occlusive disease iii, iv (paod)

Keywords: varicosis foam sclerotherapy surgery
rewards sensitivity after brain injury

Conditions: Acquired Brain Injury

Summary: a study measuring rewards sensitivity in individuals with acquired brain injury at an acute rehabilitation level.

individuals in acute rehabilitation following acquired brain injury journal (abi) and aged-matched, non-injured controls will be recruited for this study. testing sessions will take place in a private treatment room at the shirley ryan abilitylab and required 45 minutes to complete. upon entering the room, participants will be greeted, electrodes placed on the participant's fingers to record their electrodermal activity, and participants will provide demographic information. participants will then be instructed about how to respond on the cued reinforcement response time task (crrt, see description below), and complete the task on a laptop computer while their electrodermal activity is being recorded. in this task, they are instructed to respond as quickly and accurately as possible, and will be informed that they will receive a monetary reward based on their accuracy at the completion of the task. finally, participants will complete 3 self-report measures: (1) explicit level of motivation was measured in a post-study survey which included two items from the sensitivity to punishment and sensitivity to reward questionnaire, (spsrq); (2) reward sensitivity was evaluated using the reward responsiveness scale , and (3) depression was evaluated using the patient health questionnaire (phq-8) survey. at the end of the session, the electrodes will be removed, and participants will be debriefed and provided their monetary reward

Eligibility criteria:
inclusion criteria: * individuals with abi * diagnosis of traumatic brain injury or stroke, based on their medical records * age between 18-100 * able to follow directions in english (measured informally during screening) * able to use at least one upper extremity (demonstrated by holding a pen) * mild-moderate or lesser diagnosis in cognitive-communication area * score of 25 or higher on the orientation log assessment * able to consent for participation in study (identifies through chart review) * capable of understanding and cooperating with the experimental procedures. healthy participants * age of 18 to 100 years old * ability to follow directions in english * ability to use at least one upper extremity. exclusion criteria: * individuals with abi * additional diagnosis of a neurological disorder other than abi * additional diagnosis of aphasia. * having cognitive or behavioral impairments that preclude participation in the experimental procedures healthy participants • history of significant cerebrovascular or neurological disease including (but not limited to) meningitis, epilepsy and/or seizures, stroke, tumor, multiple sclerosis, meningitis, mental retardation, dementia.

Keywords: rewards sensitivity motivation acquired brain injury electrodermal activity
evaluation of the efficacy of vr on pain and anxiety when performing an ultrasound-controlled ankle block.

Conditions: Hallux Valgus; Surgery

Summary: the purpose of this study is to observe or not a reduction on pain and anxiety felt by the patient when performing an ultrasound-controlled ankle block in preparation for forefoot surgery, using a virtual reality device instead of drug sedation.

currently, in preparation for forefoot surgery, the realization of the ankle block is accompanied by drug sedation. the investigator's randomized study aims to compare the anxiety and pain experienced by patients who have benefited from drug sedation with those of patients who benefited from the virtual reality device at the time of the realization of the ankle block.

Eligibility criteria:
inclusion criteria: * patient with medical insurance * major patient requiring a hallux valgus surgery * patient who received information about study and signes a consent to participate in the study exclusion criteria: * minor patient * patient participating in another interventional study * patient refusing to sign the consent form * patient for whom it is impossible to give informed information * patient who had previously undergone forefoot surgery under locoregional anesthesia * patient with poor skin condition or infection at puncture sites * patient refusing locoregional anesthesia * patient under the protection of justice, under curatorship or under tutorship * patient undergoing anxiolytic or antidepressant treatment * photosensitive epileptic patient

Keywords: virtual reality pain anxiety
30-days post-operative complications in bariatric surgery

Conditions: Bariatric Surgery

Summary: comparison of 30-days post-operative outcomes of laparoscopic sleeve gastrectomy (lsg) and laparoscopic roux-en-y gastric bypass (lrygb)

obesity is one of the most challenging chronic diseases in the western world as well as in pakistan. half of the people in this world consider themselves overweight or obese. obesity is one of the most challenging chronic diseases in the western world as well as in pakistan . half of the people in this world consider themselves overweight or obese. obesity is challenging to control by medical therapy and drug treatment. the most effective way to treat obesity is bariatric surgery. laparoscopic roux-en-y gastric bypass (lrygb) is a "gold standard" bariatric surgical procedure. recently there is much attention gained by laparoscopic sleeve gastrectomy (lsg). therefore, we decided to conduct this comparative study to compare the early post-op complications of lsg with lrygb technique in patients undergoing bariatric surgery.

Eligibility criteria:
inclusion criteria: * patients of age 18 to 65 years * body mass index (bmi) \>35 kg/m2 (morbidly obese) * patients with failed conservative treatment of weight control exclusion criteria: * severe indicative gastroesophageal reflux disease (gerd) * conversion of another bariatric procedure * large hiatal hernia * patients with inflammatory bowel disease

Keywords: bariatric surgery laparoscopic roux-en-y gastric bypass laparoscopic sleeve gastrectomy
hepatic drug biotransformation in children with obstructive sleep apnea

Conditions: Sleep Apnea

Summary: the purpose of this research study is to determine the effect of chronic nighttime low oxygen saturations on selected body systems (liver) that break down drugs in children with obstructive sleep apnea syndrome (osas).

the purpose of this study is to determine the effect of chronic intermittent nocturnal hypoxia on selected hepatic drug-metabolizing enzyme systems in children with osas. the specific aims are to evaluate the activities of cytochrome p450 (cyp)1a2, n-acetyltransferase-2 (nat-2), xanthine oxidase (xo)and cyp2d6 in children with osas and to determine the effect of osas treatment on the activities of these enzyme systems.

Eligibility criteria:
inclusion criteria: * children ages 4 to 16 years with suspected uncomplicated osas exclusion criteria: * children with complicated osas (craniofacial abnormalities, neuromuscular disorders) * children who are receiving medications known to induce or inhibit hepatic cyp1a2, nat-2, xo, cyp2d6 or cyp3a4 activity * children who are exposed to second hand smoke for greater than 8 hours per day. * children with hypersensitivity to caffeine or dextromethorphan * children who are receiving corticosteroids or thyroid hormone

Keywords: sleep apnea phenotyping cytochrome p450 drug metabolism child
performance nutrition for residents and fellows

Conditions: Physician Well-being; Cognitive Function; Diet Modification; Diet Habit; Shift-Work Related Sleep Disturbance; Sleep Deprivation

Summary: currently, residents commonly experience dehydration and poor nutrition during nighttime duty hours as a result of heavy work load, lack of time to take nutrition and hydration breaks, or limited or no access to healthy food and drinks which may affect residents' work performance. the goal of this study is to compare the effects of two different meal compositions with no typical dietary practices (existing conditions) on work performance of the on-call residents during night shifts.

the purpose of this study is to determine the effects of dietary modifications on resident physicians' work performance during night shifts. specific objectives are: 1. to assess the effects of macronutrient composition of the test meals on cognitive performance, self-reported sleepiness and fatigue of resident physicians during night-time duty. 2. to compare to no intervention, the effects of providing meals before 22:00 hours, and only providing chewing gum, tea, coffee and water onwards to on-call residents, on cognitive performance, self-reported sleepiness and fatigue of resident physicians during night-time duty.

Eligibility criteria:
inclusion criteria: * all residents and fellows performing in hospital overnight work * must be able to eat plant source foods (e.g. soy, nuts, seeds) and animal source foods (e.g. meat, eggs, dairy products) exclusion criteria: * food allergies or sensitivities * prior anaphylactic reaction to food * strict dietary restrictions (e.g. vegan, gluten free)

Keywords: nutrition physician well-being cognitive performance sleepiness shift-work
study of efficacy and safety of csj117 in patients with severe uncontrolled asthma

Conditions: Asthma

Summary: the purpose of this study is to determine the efficacy and safety of multiple csj117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (soc) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in fev1 at the end of 12 weeks of treatment.

this was a randomized, multicenter, multi-national, double-blind, placebo-controlled, parallel-arm study evaluating the effect of 5 dose levels of csj117 in adult subjects with inadequately controlled asthma despite medium to high dose inhaled corticosteroid (ics) plus long-acting beta agonist (laba). subjects were assigned to one of the following six treatment arms/groups in a ratio of 2:1:1:1:2:2: * placebo inhaled once daily * csj117 0.5 mg inhaled once daily * csj117 1.0 mg inhaled once daily * csj117 2.0 mg inhaled once daily * csj117 4.0 mg inhaled once daily * csj117 8.0 mg inhaled once daily the study included: * a screening period of approximately 2 weeks * a single blinded placebo run-in period of 4 weeks (extended to 8 weeks for subjects experiencing an asthma exacerbation or respiratory tract infection during the run-in period) * a double blinded treatment period of 12 weeks * a follow-up period of up to 12 weeks, study drug free, following the last dose of study treatment. patients who successfully completed 12 weeks of treatment in this study could be offered participation in the safety extension study ccsj117a12201e1 (nct04946318).

Eligibility criteria:
inclusion criteria: * diagnosed asthma * male and female patients aged ≥18 and ≤75 years * patients who have been treated with medium or high dose ics plus laba with up to 2 additional controllers * morning pre-bd fev1 value of ≥ 40% and ≤ 85% of the predicted normal * a positive reversibility test * acq-5 score of ≥ 1.5 at screening and end of run-in visits. exclusion criteria: * patients who have a cigarette smoking history of greater than 10 pack years or current smokers * pregnant or nursing (lactating) women * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using specified methods of contraception during dosing of study drug and until 12 weeks after last study drug treatment * patients with a history of immunodeficiency disease or hepatitis b, untreated and not cured hepatitis c or hiv.

Keywords: csj117 uncontrolled asthma