Kornimate/medical-research-clean huggingface dataset:
a dose escalation and cohort-expansion study of oral eft508 in subjects with advanced solid tumors

Conditions: Cancer

Summary: this clinical trial is a phase 1-2, open-label, sequential-group, dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of daily oral administration of eft508.

eft508 is an oral, potent and highly selective inhibitor of mitogen-activated protein kinase interacting kinase (mnk) 1 and 2. dysregulated translation of messenger rna (mrna) plays a role in the pathogenesis of multiple solid tumors and hematological malignancies. mnk1 and mnk2 integrate signals from several oncogenic and immune signaling pathways (including ras, p38 and toll-like receptors) by phosphorylating eukaryotic initiation of factor 4e (eif4e) and key effector proteins. phosphorylation of these regulatory proteins by mnk1 and mnk2 selectively regulates the stability and translation of a subset of cellular mrna that control tumor growth, the tumor microenvironment and immune signaling. nonclinical studies indicate that eft508 shows activity against various types of solid tumors. these nonclinical studies support initiation of clinical development of eft508 in patients with cancer.

Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status of 0 or 1. 2. pathologically documented diagnosis of advanced solid tumor malignancy that progressed after appropriate prior therapy or has no potential for cure with currently available treatments. 3. measurable disease defined by response evaluation criteria in solid tumors (recist) outside of any prior radiation field. 4. at least 3 weeks post any treatments/therapies at the time of first dose. 5. adequate bone marrow function. 6. adequate hepatic function. 7. adequate renal function. 8. normal coagulation panel. 9. negative antiviral serology. 10. willingness to use effective contraception. exclusion criteria: 1. known central nervous system malignancy. 2. gastrointestinal disease that may interfere with drug absorption. 3. significant cardiovascular disease. 4. significant ecg abnormalities. 5. ongoing risk of bleeding due to active peptic ulcer disease, bleeding diathesis, or requirement for systemic anticoagulants. use of heparin or thrombolytic agents for local maintenance or clearance of a central venous catheter is permitted. 6. ongoing systemic bacterial, fungal or viral infection (with the exception of fungal infections of the skin or nails). 7. pregnancy or breastfeeding. 8. major surgery within 4 weeks before the start of study therapy. 9. prior solid organ or bone marrow progenitor cell transplantation. 10. prior therapy with any known inhibitor of mnk1 or mnk2. 11. ongoing immunosuppressive therapy, including systemic or enteric corticosteroids (can be using topical or inhaled corticosteroids). 12. use of drugs that might pose a risk of a drug-drug interaction within 4-7 days before the start of study therapy.

Keywords: cancer neoplasm solid tumor breast head and neck lung pancreatic hepatic melanoma colon renal thyroid prostate ovarian mnk1 mnk2 eif4e
an explorative study of treatment of contact dermatitis due to diabetesdevices

Conditions: Contact Dermatitis Irritant; Type 1 Diabetes

Summary: a feasibility study of treatment with a occlusive medical device or patch in pediatric patients with type 1 diabetes suffering from irritative contact dermatitis due to diabetes devices.


Eligibility criteria:
inclusion criteria: * signed informed consent, and for patients under the legal age consent by a legal guardian * clinically confirmed, active and evaluable irritant contact dermatitis (icd) * age 6-20 at the time of signing the informed consent form (icf) * ability to answer study questionnaires exclusion criteria: * any type of skin irritation other than icd * use of occlusive therapy for the treatment of their icd, or unwilling to refrain from this treatment for duration of study * for any other reason considered unsuitable by the investigator * pregnant or of child-bearing potential unwilling to use acceptable effective contraception
functional magnetic resonance imaging (fmri) for the study of response inhibition, and face and linguistic processing in autism

Conditions: Autism; Asperger's Syndrome

Summary: this study investigates face processing, response inhibition and phoneme processing in autistic adults by fmri.

fifteen adult outpatients with high functioning autism or asperger's syndrome will be recruited. fifteen healthy volunteers matched for age and iq will also be recruited. participants will undergo an fmri scan. during the scan they will perform a task. the paradigm is designed to test control inhibition, face processing and language. therefore, it includes a go-no go test, a face emotion discrimination test and a linguistic sound. the subjects are shown a series of faces with happy or sad expressions in random order. each face presentation is accompanied by either a standard or variant sound. the sound stimulus is the english phoneme /oe/. the variant sound was created by raising the frequency of the standard sound by 20%. the task consists of four blocks. during each block the subjects are asked to press a button when they see a happy or sad face depending on the block. each block consists of 96 trials lasting 2 seconds and an initial and final fixation period of 40 sec. for each trial the target image is projected for 500 ms. there is 1250 ms fixation time allowed for response and 250 ms for jitter. twenty-four of the 96 trials are no go trials and 16/96 are sound oddball trials. the oddball is at least two trials apart (between two variant sounds there are at least two standard sounds). there are 24 faces displayed in total, 12 female and 12 male. faces switch every 16 trials. face genders are balanced. the faces were selected with over 80% congruency except for two faces with congruency of over 72%. the correlation between sound (2 conditions: standard versus variant) and target condition (go-no go) is zero. the task was piloted on healthy controls and autistic adults. all subjects performed well.

Eligibility criteria:
inclusion criteria: * age range of 18-50 years old * diagnosis: autism spectrum disorder by diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) and autism diagnostic interview - revised (adi-r) * intelligence quotient (iq) \> 80 * outpatients exclusion criteria: * subjects with epilepsy * subjects with history of schizophrenia, schizoaffective disorder or other axis 1 mental disorders, such as bipolar disorder * subjects reporting history of encephalitis, phenylketonuria, tuberous sclerosis, fragile x syndrome, anoxia during birth, neurofibromatosis, hypomelanosis of ito, hypothyroidism, duchenne muscular dystrophy, and maternal rubella * subjects who have received depot neuroleptic medication, or other psychoactive drugs within the past 5 weeks.

Keywords: autism fmri response inhibition face processing linguistic processing
evaluation of the relationship between dental caries and growth parameters in preschool children

Conditions: Dental Caries in Children

Summary: untreated dental caries are very common in preschool children. pain and inflammation due to dental caries have been reported to affect eating and sleeping disorders, affecting growth and development. the aim of this study was to compare the changes in serum igf-1 and igfbp-3 levels, height and weight gain before and after treatment in patients with dental caries-related inflammation and pain in preschool children and to compare these children with children without dental caries. thirty children aged between 3-6 years with dental caries with pulp were identified using icdas ii and dmft index as the study group.30 children dental caries including pulp, will be included using the same indices as the control group. in the study group, serum igf-1 and igfbp-3 levels and anthropometric measurements will be determined before and at the 6th month after treatment. in the control group, serum igf-1 and igfbp-3 levels and anthropometric measurements will be determined at the 6th month following the first dental examination. igf-1, igfbp-3 and anthropometric measurements will be compared between first dental examination and 6th month values in the study and control groups, and between first dental examination and 6th month time points between the groups.

in addition to growth parameters, the children's sleeping habits questionnaire and the early childhood oral health impact scale will be compared before the 6th month of dental treatment and compared

Eligibility criteria:
inclusion criteria: for study group 1. (3-6 years) preschool children 2. children whose dental treatments are indicated under general anesthesia 3. children with primary dentition 4. children with early childhood caries (dmft index d≥ 3) 5. children with symptoms of pulpitis or periapical infection in at least one tooth 6. children with dental problems at least in the last 6 months 7. volunteering to participate in the study. for the control group, 1- (3-6 years) preschool children 2-children with primary dentition 3- children without pulpitis symptoms or periapical infection during dental examination 4-volunteering to participate in the study. exclusion criteria: 1. children who do not show adequate compliance during blood sampling 2. consent form is not signed 3. children with chronic and systemic diseases that may affect growth and development 4. children using anti-inflammatory 5. patients with physical and mental disabilities 6. patients using corticosteroids in the last 6 months 7. if a child is diagnosed with any of the these diseases during the study

Keywords: dental caries igf-1 igfbp-3 anthropometry sleeping
exploratory study on link between dynamic hyperinflation and lung clearance index in cystic fibrosis

Conditions: Cystic Fibrosis; Lung Clearance Index

Summary: recent improvements in cystic fibrosis management have enabled an important subset of patients to maintain normal spirometry. nevertheless, even in these patients with normal spirometry, chest computed tomography (ct) might identify structural lung abnormalities such as bronchiectasis, mucus plugging, bronchiolitis and air trapping. lung clearance index (lci) has been shown to correlate well with structural pulmonary alterations seen on ct even in cf patients with well-preserved spirometry. in cystic fibrosis, a high lci is associated with a worse feeling of illness assessed by the cystic fibrosis questionnaire-revised (cfq-r). school-aged cf patients with normal spirometry also have normal aerobic function as assessed by peak oxygen uptake (v̇o2) measured during symptom-limited incremental cardiopulmonary exercise test. however, the ability of lci to predict ventilatory abnormalities appearing at exercise in cf patients has not been investigated. the investigators therefore aimed to compare physiological parameters at exercise between cf patients with elevated lci (i.e., lci above the upper limit of normal \[uln\]) and patients with normal lci, all with preserved spirometry.


Eligibility criteria:
inclusion criteria: * children between 10 to 17 years old with a diagnosis of cystic fibrosis confirmed by sweat test and genetic test * pulmonary function test and incremental cardiopulmonary exercise test included in their follow-up * lung function preserved (fev1 greater than the lower limit of normal) * affiliation to the french social security * children and their legal guardians informed of the use of anonymised data exclusion criteria: * recent respiratory infection * association with another obstructive respiratory disease, especially with asthma
a health intervention to prevent depression hepatitis c patients

Conditions: Hepatitis C; Major Depressive Disorder

Summary: interferon-alpha (ifn-α) is an efficacious treatment for hepatitis c (hpc); however, ifn-α treatment results in a significant increase in depressive symptoms. the aim of this project is to compare two health interventions (exercise vs. health education) to prevent depression in hpc patients receiving ifn-α. participants will be recruited from the clinical center for liver diseases at ut-southwestern and randomized to 26 weeks of either: aerobic exercise or a health education control group.


Eligibility criteria:
inclusion criteria: * diagnosed with hepatitis c and prescribed ifn-α * ability to understand and willingness to provide written informed consent. * willing to provide contact information. * medical clearance with protocol-defined stress testing (in accordance with american college of sports medicine (acsm) guidelines) from protocol approved medical personnel. details of guidelines and related testing protocol are provided in the study manual of procedures. * able to comprehend and communicate in english. exclusion criteria: * have a medical condition contraindicating exercise participation * are currently physically active - defined as moderate intensity physical activity on 3 or more days per week for the last month * have been diagnosed with current major depressive disorder or are currently receiving antidepressant medication treatment (including ssris and snris) * currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site pi, medical personnel, or designee. * pregnancy. * current psychotic disorder. other comorbid psychiatric diagnosis that, in the investigator's judgment, will pose a safety issue or make it difficult for the participant to understand or complete the intervention. * anticipated circumstances over the 6-month course of the trial that would render the participant unlikely to complete the study in the judgment of the pi or designee. * any reason not listed herein yet, determined by the pi, medical personnel, or designee that constitutes good clinical practice and that would in the opinion of the pi, medical personnel, or designee make participation in the study hazardous. * are currently enrolled in another research study, and participation in that study contraindicates participation in the current study

Keywords: hepatitis c interferon-alpha depression major depressive disorder exercise physical activity
preliminary testing of the md anderson symptom inventory (adolescent version)

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this study investigates how the md anderson symptom inventory questionnaire modified for use with adolescents performs in adolescent patients with cancer. conducting interviews with adolescents about the md anderson symptom inventory may help researchers improve the questionnaire to better understand the symptoms experienced by 13-17 year old patients with cancer.

primary objective: i. to examine how the md anderson symptom inventory (mdasi) modified for use with adolescents (adolescent version) performs in adolescent patients who have various cancer types, who have undergone various treatments, and who have varying levels of symptom burden. secondary objectives: i. to explore the feasibility of various methods for collecting mdasi (adolescent version) data (for example, paper-and-pencil forms, face-to-face and telephone interviews, electronic data capture methods such as electronic tablets or automated telephone systems. ii. to evaluate the mdasi (adolescent version) as an estimate of functional status and quality of life in adolescent cancer patients. outline: part 1: patients complete the mdasi questionnaire and then complete a cognitive debriefing interview regarding its comprehensibility, the acceptability of each item, and whether any important symptoms are missing from the questionnaire. part 2: patients complete the mdasi questionnaire twice (1-7 days apart). approximately 1 week after beginning standard of care treatment, patients complete the mdasi questionnaire at 4 additional time points, each 1 week apart. patients may also complete a cognitive debriefing interview regarding its comprehensibility, the acceptability of each item, and whether any important symptoms are missing from the questionnaire.

Eligibility criteria:
inclusion criteria: * ability to speak and read english * diagnosis of cancer, confirmed pathologically or clinically * being seen by a healthcare provider at md anderson cancer center * written assent by subject and written consent by parent/guardian for participation * starting a cycle of chemotherapy, starting radiation therapy, or starting preparative regimen for stem cell transplantation (part 2 only) exclusion criteria: * medical condition, as determined by the attending physician, that would preclude participation in the study * diagnosis of active psychosis, developmental delay, or severe cognitive impairment documented by primary physician in medical record
the use of lifup in chronic disorders of consciousness

Conditions: Disorder of Consciousness; Vegetative State; Minimally Conscious State; Minimally Conscious State Plus; Minimally Conscious State Minus; Traumatic Brain Injury; CVA (Cerebrovascular Accident); Anoxia, Brain; Thalamic Infarction; Coma; Prolonged

Summary: when patients survive a severe brain injury but fail to fully recover, they often enter a disorder of consciousness (doc) --that is, a set of related conditions of decreased awareness and arousal including the vegetative state (vs) and the minimally conscious state (mcs). when these conditions become chronic, there are no approved treatments to help bolster any further recovery. in prior work, we have shown the clinical feasibility and potential of low intensity focused ultrasound pulsation (lifup) as a remarkably safe form of non-invasive brain stimulation in these conditions.

in the present study, we propose taking the "next step" to assess whether lifup can affect objective and validated markers of doc patient impairment (in the direction of lesser impairment). specifically, patients will be admitted at casa colina hospital for a 10-day (in-patient) protocol, and two follow-up sessions, conducted remotely (e.g., over the phone) at 7 and 30-days post-discharge. the full length of the study is 40 days from admission. over the admission period, patients will undergo multiple measurements of validated biomarkers, including behavioral testing, brain metabolism (using positron emission tomography), and electroencephalography, before and after one session of lifup to thalamus.

Eligibility criteria:
inclusion criteria: 1. diagnosis of vs or mcs based on the crs-r . 2. chronic status: * 3 months post-injury for non-traumatic etiologies * 12 months post-injury for traumatic etiology 3. 18 years of age or older. 4. if on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and the patient will be willing to remain on a stable regimen during the protocol. exclusion criteria: 1. history of neurological disorder (other than the brain injury). 2. unsuitability to undergo magnetic resonance (mr) assessment (e.g., non-mr compatible implants). 3. unsuitability to undergo lifup neuromodulation (e.g., presence of non-bone implant or absence of bone under the expected positioning of the device by the left temporal bone window). 4. manifest continuous spontaneous movement (which would prevent imaging) 5. participation in another concurrent clinical trial. 6. having undergone pet, ct, or other exam involving the use of ionizing radiation in the 12 months prior to the date of scheduled admission to casa colina. 7. dependence on ventilator.
seroquel long-term nis for schizophrenia patients

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: to assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or schizoaffective disorder


Eligibility criteria:
inclusion criteria: * the patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent * the patient suffers from schizophrenia or schizoaffective disorder according to dsm-iv-tr * the patient is between 18 and 65 years old(extremes included) * on the basis of physical and neurological examination, medical history, the patient is, in the investigator's opinion, otherwise healthy * if the subject is a female of childbearing potential, she must be not pregnant or breast-feeding and be using a reliable method of contraception. reliable methods may include abstinence, hormonal contraceptives (eg,oral contraceptives or long-term injectable or implantable hormonal contraceptives), double-barrier methods (eg, condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation exclusion criteria: * the patients who have known hypersensitivity to quetiapine

Keywords: schizophrenia schizoaffective quetiapine long-term efficacy naturalistic observational
using emr data and ai to develop a passive digital marker to predict postoperative delirium

Conditions: Delirium in Old Age

Summary: this study will be a pilot randomized controlled trial that will determine the effect of an indicator of delirium risk, which will be delivered either via a paper form or via the electronic medical record, on (1)postoperative delirium incidence; and (2)the development of long term cognitive decline and dementia.

patients will be recruited from a large general, minimally invasive, colorectal, and oncologic, university-based surgical practice. english speaking individuals over the age of 65 with planned major abdominal surgery (encompassing abdominal wall, gastrointestinal and hepatobiliary procedures for benign and malignant diseases) will be screened for eligibility following an initial visit with their surgeon. inclusion criteria will include a required inpatient stay for ≥ 24 hours following surgery and a scheduled preadmission testing and medical risk stratification visit with an internal medicine provider. patients will be excluded if they have severe mental illness, hearing and visual impairment, alcohol intoxication or related delirium, central nervous disorder (e.g., stroke, traumatic brain injury), and pregnant or nursing status. once enrolled, subjects will be randomized using a computer-generated scheme (permuted blocks of four and six) to the pdm or usual care, stratified according to type of surgery (hepatobiliary, gastrointestinal, abdominal wall).

Eligibility criteria:
inclusion criteria: 65 years old planned inpatient major surgery requiring inpatient stay ≥ 1 day exclusion criteria: * baseline cognitive impairment or a diagnosis of alzheimer's disease/alzheimer's disease and related dementias (ad/adrd) * alcohol or drug withdrawal * prisoner status * unable to communicate with research staff due to sensory impairments * not fluent in english * currently has a personal safety attendant
lymphocyte count as a sign of immunoparalysis and its correlation with nutritional status in septic pediatric patients

Conditions: Lymphopenia

Summary: participants were classified as normal or malnourished according to anthropometric measures. serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. lymphocyte count was also recorded on the 1st and 7th days.

the investigators enrolled 14 consecutive patients with sepsis. patients were classified as normal or malnourished according to anthropometric measures. as an additional evaluation of nutritional status, serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. lymphocyte count was also recorded on the 1st and 7th days. investigators correlated nutritional status with lymphocyte count and zinc dosage.

Eligibility criteria:
inclusion criteria: * septic patients exclusion criteria: -

Keywords: nutrition lymphocyte count immunoparalysis nutritional status of septic patients