Kornimate/medical-research-clean huggingface dataset:
early neurodivergent developmental trajectories in autism and in response to the esdm intervention

Conditions: Autism Spectrum Disorder

Summary: early support is thought to be key to ensure a better quality of life for young children on the autism spectrum. among early support, different evidence-based approaches have combined the principles of developmental and behavioral science within a naturalistic and interactive frame and grouped under the umbrella of naturalistic developmental behavioral interventions (ndbi). in the context of ndbis, the early start denver model is a manualized support that has reported evidence of efficacy for therapist-, group- and caregiver-implemented support, in multiple research as well as community based settings, different countries and languages (rogers \& dawson, 2010). understanding the effects of support characteristics and intensity on individual learning has a major impact on the delivery systems organization and policies, sustainability in low resources community settings and to provide the necessary support to the family. however, a direct comparison among different types and intensity of early support in community setting and relatively low access to standardized and intensive programs, have not been adequately explored. for this reason, the aim of this study is to investigate, in a community setting in the italian context, the impact of esdm and support intensity on individual developmental trajectories.


Eligibility criteria:
inclusion criteria: * unimpaired hand use * parent agreement to have a caregiver present during all home sessions * attendance at all intake sessions * permission to videotape evaluations and esdm treatment * italian as one primary language of the parent * unimpaired hearing and vision * developmental quotient of 35 or higher on the griffith scale * meets all of these autism spectrum disorder diagnostic criteria through the autism diagnostic observation schedule (ados; cutoff score of 12 if child produces no words or 10 if child produces some words) exclusion criteria: * serious parental substance abuse * parental self-report of bipolar disorder or psychosis * known genetic syndromes * serious medical conditions (e.g., encephalitis, concussion, seizure disorder) * significant sensory impairment * birth weight \<1600 grams and/or gestational age \< 34 weeks * history of intraventricular hemorrhage * known exposure to neurotoxins (including alcohol, drugs) * non-italian-speaking parents

Keywords: autism early support children esdm individual trajectories
an iron-containing food product for the prevention of diminished iron status in soldiers

Conditions: Iron Deficiency; Iron Deficiency Anemia

Summary: military personnel face intense physical and cognitive demands. diminished iron status affects physiologic responses to these challenges. both cross-sectional and longitudinal studies indicate a significant decrement in iron status in enlisted female military personnel immediately following basic combat training (bct). decrements in iron status are associated with diminished cognitive and physical performance, and may affect body composition. the primary objective of this randomized, placebo controlled study is to assess the utility of an iron-containing food product for maintaining iron status during bct. this study will provide insight into the utility and efficacy of an iron-containing food product for the maintenance of iron status during military training. furthermore, it will provide novel scientific data regarding the relationship between iron status and physical and cognitive performance in female soldiers.


Eligibility criteria:
inclusion criteria: * female us army recruit * participating in basic combat training exclusion criteria: * male * pregnancy * diagnosed hemochromatosis * diagnosed thalassemia * history of ulcerative colitis * allergy to chocolate

Keywords: iron iron status iron deficiency iron deficiency anemia
exploring virtual reality adventure training exergaming

Conditions: Physical Activity; Sedentary Behavior; Depression; Cognitive Function; Post Traumatic Stress Disorder; Quality of Life; Anxiety

Summary: the current project aims to design and implement an 8-week virtual reality adventure therapy exergaming (v-rate) intervention focused on women veterans. a randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed to examine effects on physical and mental health outcomes.

the current project aims to design and implement an 8-week virtual reality adventure therapy exergaming (v-rate) intervention focused on veterans. a randomized controlled trial using a repeated measure design with a 1-month follow-up assessment will be employed. the project addresses two specific aims: aim 1. to examine the effects of an 8-week v-rate intervention on physical health (i.e., bmi, physical activity, sedentary behavior) among veterans. we hypothesize that after controlling for socio-demographic variables and physical activity history, individuals in the v-rate group would exhibit more improvement in the physical health indicators after the intervention compared to individuals in the control group. we further hypothesize gains would be maintained or enhanced at 1-month follow-up measure. aim 2. to examine the effects of an 8-week v-rate intervention on mental health outcomes (i.e., depression, anxiety, posttraumatic stress, cognitive function, health-related quality of life), among veterans. we hypothesize that after controlling for socio-demographic variables and physical activity history, individuals in the v-rate group will exhibit more improvement in the mental health indicators after the intervention compared to individuals in the control group. we further hypothesize gains maintained or enhanced at 1-month follow-up measure.

Eligibility criteria:
inclusion criteria: 1. are between the ages of 18 and 45 2. identify as a u.s. military veteran 4. normal vision (no colorblindness) exclusion criteria: 1. unable to walk independently (e.g., use of any mobility assistive device such as brace, wheelchair, cane, crutch, walker, knee scooter) 2. self-reported joint problem that limits mobility (e.g., arthritis or other condition that would prevent participation) or ongoing orthopedic injury 3. self-reported pregnancy or suspicion of pregnancy 4. self-reported motor disorder or impaired sense of motion or balance (such as parkinsonism) 5. self-reported color blindness 6. self-reported neurological or cognitive disorder (e.g., tbi, history of seizure) 7. self-reported cardiac surgery or any ongoing cardiovascular issues preventing participation or physical activity.
mathematical coupling of data in transpulmonary thermodilution

Conditions: Critical Illness

Summary: the purpose of this study is to investigate whether cardiac output (co) and global end diastolic volume (gedv) determined from the same thermodilution curve by ev1000 are mathematically coupled during the infusion of fluid or inotropic agents in critically ill patients.

some fundamental questions remain unanswered about the mathematical analysis of the thermodilution curve and the physiological significance of the global end diastolic volume ( gedv ) . the mathematical derivation of the global end diastolic volume (gedv) is intimately linked with the cardiac output (co), because ev1000, to calculate the gedv, uses a formula in which the co is the term "flow " for both the calculations of volume thermal intra thoracic (ittv) and lung thermal volume (ptv) . the clinical validation of gedv as an index of preload has been substantially based on measuring changes in gedv and co in response to the fluid challenge only in patients "volume responsive". in this scenario, gedv and co may show a close correlation only on the basis of their mathematical derivation.

Eligibility criteria:
inclusion criteria: * patient admitted in the intensive care department * patient monitored by ev1000 trans pulmonary device * systolic blood pressure (sbp) less than 90 mm hg or sbp drop ≥ 40 mm hg of normal * decision by 1 expert intensivist physician to initiate fluid resuscitation hospital protocol or therapeutic infusion of vasopressor agent exclusion criteria: * pregnancy * age less than 18

Keywords: trans pulmonary thermodilution hemodynamic
randomized trial of prostate only or pelvic rt in high risk prostate cancer

Conditions: Prostate Cancer

Summary: evidence to justify the use of the pelvic field is lacking for men with high risk localized prostate cancer. an additional randomized study is needed in men with a potential risk of nodal involvement to test the hypothesis that the use of the pelvic field contributed to the benefit observed in those studies. this trial aims to compare the outcomes with whole pelvis rt and prostate alone rt in patients with high risk, non metastatic prostate cancer with a lymph nodal \>20% with primary 5 year biochemical failure free survival and secondary disease free survival, overall survival, acute toxicity, late toxicity and qol patients will be randomized to one of two arms arm 1 whole pelvis radiotherapy and arm 2 prostate only radiotherapy. the dose prescription will be 66 gy in 25 fractions will be prescribed for the prostate ptv in arm 2 an additional 50 gy in 25 fractions for nodal ptv in patients in arm 1. an overlap volume at rectal-prostate interface will receive 64 gy/25#. all patients will receive hormone therapy starting at least 8 weeks prior to the beginning of radiotherapy. they will continue the hormone therapy and later for a total duration of 2-3 years.


Eligibility criteria:
inclusion 1. any age according to the fitness estimated by the physician 2. physician estimated life expectancy \> 5 years 3. biopsy proven adenocarcinoma of prostate 4. high risk prostate cancer based on staging and risk of pelvic nodal metastases ≥ 20% as per the roach formula (2/3 psa) + \[(gs - 6) x 10\] if gleason score 8-10 - any psa, t1- t3a n0 m0 if gleason score 7 - psa \> 15, t1-t3a n0 m0 if gleason score 6 - psa \> 30, t1-t3a n0 m0 t3b-t4a n0 m0, any gleason score, any psa 5. ability to receive long term hormone therapy/ orchidectomy 6. kps ≥ 70 (see appendix) 7. estimated life expectancy \> 5 years 8. no previous history of malignancy ≤5 years 9. no prior history of therapeutic irradiation to pelvis 10. patient willing and reliable for follow-up and qol 11. no major co morbidities preventing radical treatment 12. signed study specific consent form exclusion 1. any histopathology other than adenocarcinoma 2. contraindication to pelvic radiotherapy like inflammatory bowel disorders 3. no prior history of pelvic surgery 4. uncontrolled diabetes 5. uncontrolled cardiac co morbidity 6. presence of nodal or distant metastatic disease
alternative gingival de-epithelialization techniques

Conditions: Recession, Gingival; Surgical Procedure, Unspecified; Graft Complication; Wound Heal

Summary: the goal of this clinical trial is to compare different de-epithelialization methods in patients undergoing soft tissue augmentation surgery. the main questions it aims to answer are: • which technique is superior for de-epithelialization in terms of remaining epithelium, wound healing of the donor site, and clinical outcomes?

participants will be randomly assigned to one of four surgical techniques during their surgical procedure and the wound site will be assessed on post-operative days 1, 7, 14, and 21. researchers will compare the use of mucotome, er:yag laser, surgical diamond bur, or blade to observe patterns of wound healing and assess if one method is superior in terms of removing the epithelium.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status classification i or ii * subjects undergoing periodontal surgical procedures that involve harvesting of soft tissue samples, who have a treatment plan including the use or removal of keratinized mucosa or subepithelial connective tissue that will not require additional anesthesia for sample collection * adequate physical and mental health to undergo routine dental treatment * ability and willingness to follow instructions related to the study procedures exclusion criteria: * poorly controlled diabetes, defined as hba1c \>/= 7.0 * autoimmune or inflammatory conditions such as systemic lupus erythematous, rheumatoid arthritis. * pregnant women or nursing mothers, or unsure of pregnancy status (self-reported) * severe hematologic disorders, such as leukemia or hemophilia * subjects on anticoagulant or antiplatelet therapy * local or systemic infection that may interfere with healing * hepatic or renal diseases * currently under cancer treatment or within 18 months from completion of radio- or chemotherapy * history of antibiotic or immunosuppressant use in the last 3 months * subjects on concomitant drug therapy for systemic conditions that may affect outcomes of the study * current smokers (cdc definition): heavy smokers: subjects who have smoked \>10 cigarettes per day within 6 months of study onset, and have smoked \>100 cigarettes in their lifetime
ultrasonographic measurements of the median nerve before and after splinting for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: a prospective cohort follow-up study design is undertaken. both males and females with mild to moderate carpal tunnel syndrome will receive standard-of-care wrist splint for 6 weeks and undergo follow up studies for data collection. controls will also be seen for a one time visit.


Eligibility criteria:
inclusion criteria: * 18 years or older and; * diagnosis of mild to moderate cts with median motor latency at 8 cm is greater than 4.5 milliseconds or combined sensory index \> 0.9 where first line therapy is indicated to include nocturnal wrist bracing * control subjects without symptoms of carpal tunnel syndrome. exclusion criteria: * evidence of severe cts as seen with electromyographic changes in the body of the muscle * untreated hypothyroidism, rheumatologic disorders * diagnosed severe cts or chronic symptoms of carpal tunnel, greater than 1 year, this includes wasting of the hand muscles * undergoing or previously treated for carpal tunnel on affected side. this includes surgery (carpal tunnel release), corticosteroid injections, bracing within the last 3 months while wearing the brace consistently every night, or any other intervention. * currently pregnant or \< 3 months post partum * history of wrist, hand fracture or severe trauma to affected hand and/or wrist * known tumor, mass or deformity of the hand/wrist * inflammatory articular disease of the joints or tendons existing cervical radiculopathy or previous surgeries to the neck for radicular symptoms * history of electrodiagnostic evidence of generalized polyneuropathy or evidence of denervation * diagnosed neuromuscular disorders which may complicate cts diagnosis * implanted electronic device (pacemaker, intrathecal pump/stimulator) * any illness that makes it unsafe for the patient to participate in the study * not fluent in english as neuroqol and other subjective information is limited to the english language interpretation
biomarker development in sturge-weber syndrome

Conditions: Sturge-Weber Syndrome

Summary: this is a study of 40 individuals with sturge-weber syndrome (sws) brain and/or eye involvement. it will examine the test-retest reliability of the following clinical tests: 1. quantitative eeg 2. transcranial doppler 3. medical rehabilitation scales 4. optical coherence tomography

sturge-weber syndrome (sws) is a rare disorder presenting at birth with a facial port-wine birthmark and later in infancy with seizures and strokes that result in weakness on one side of the body, cognitive disabilities, glaucoma, and visual field deficits. approximately 10-50% of infants born with a facial port-wine birthmark on the upper part of the face will also have sws brain and/or eye involvement. early detection and treatment of the disease is necessary to improve an sws patient's outcome, and early biological indicators need to be discovered to make this possible. we believe the following tests can serve as non-invasive biomarkers to improve early diagnosis, monitor response to treatment, and to predict outcome: 1. quantitative eeg 2. transcranial doppler 3. medical rehabilitation scales 4. optical coherence tomography the first step of this process is to determine how much the results of these tests vary between individual tests.

Eligibility criteria:
inclusion criteria: 1. individuals with sws and brain involvement (aims 1-3): for the purposes of this study sws brain involvement is defined as having shown on mri imaging evidence of the typical vascular malformation which includes the following: leptomeningeal angioma, choroid plexus glomus, and associated venous angioma/malformation. 2. individuals with sws and eye involvement (aim 4): for the purposes of this study sws eye involvement is defined as individuals with a port-wine birthmark in the v1 dermatomal distribution 3. able (or parents able) to provide informed consent 4. able to cooperate with tests 5. age 6 months to 21 years (aims 1-3 only) exclusion criteria: * subjects unable to cooperate with the studies will be excluded.

Keywords: sturge-weber syndrome biomarkers quantitative eeg transcranial doppler ultrasound medical rehabilitation scales optical coherence tomography
memory aid - working memory training in patients with mild cognitive impairment.

Conditions: Mild Cognitive Impairment

Summary: background: mild cognitive impairment (mci) is a condition characterized by memory problems more severe than normal cognitive changes due to old age, and less severe than dementia. reduced working memory (wm) is regarded as one of the core symptoms of an mci-condition. recent studies have indicated that wm can be improved trough computer based training. objectives: the objective of the study is to evaluate if working memory training is effective in improving working memory in elderly mci-patients. further, to evaluate if cognitive training relates to structural changes in the white and gray matter of the brain, assessed by structural magnetic resonance imaging. cognitive phenotypes related to memory impairment and progression to dementia will also be investigated. patients and methods: the proposed study is a blinded, randomized and controlled trail that will include 90 elderly patients from a memory clinic diagnosed with mci. the groups will be randomized to either training or a placebo version. the intervention is computerized working memory training performed for 45 minutes over 25 sessions. neuropsychological assessment and structural mri will be performed before, 6 and 12 months after training. relevance: currently there is no known treatment available for mild memory impairment/mci, and few studies on specific cognitive training in mci-patients have been performed. the proposed study has received funding from a norwegian health region. if computer based training results in positive changes to memory functions in mci patients this may represent a new, cost-effective treatment. secondly, evaluation of training induced structural changes to grey or white matter may improve our understanding of the mechanisms behind effective cognitive interventions in mci patients.


Eligibility criteria:
inclusion criteria: * patients who meet the peterson diagnostic criteria of mci: 1. memory complaints (preferably confirmed by an informant). 2. memory impairment according to age and education. 3. preserved general cognitive function. 4. intact activities of daily living, absence of dementia. exclusion criteria: * head trauma with post-traumatic loss of conscience for 30 minutes during lifespan. * loss of senses (blindness, deafness). * photo-sensitive epilepsy. * unsuitability for magnetic resonance imaging-examination due to metal foreign bodies or severe claustrophobia. * drug and/or alcohol abuse.

Keywords: mild cognitive impairment working memory training neuropsychological function in mci
lumbar plexus block for postoperative pain control after hip arthroscopy. a randomized controlled trial

Conditions: Postoperative Pain

Summary: the purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain. in addition, the study will examine whether lumbar plexus blocks reduce the total amount of pain medication needed, and therefore reduce the side effects of these medicines and increase patient satisfaction. it is hypothesized that addition of the lumbar plexus block will significantly reduce patients' postoperative pain.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) class 1-3 * patients aged 18 to 65 years * patients scheduled for primary, unilateral arthroscopic hip surgery by dr. kelly, dr. coleman, or dr. anil ranawat * planned use of neuraxial anesthesia * body mass index less than 35 * ability to follow study protocol exclusion criteria: * chronic opioid use (defined as daily or almost daily use of opioids for \>3 months) * contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities. * contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities. * infection at the injection site(s) * allergy to any of the study medications * contraindication to a short course of nsaids (renal failure, intolerance) * asa class 4-5 * patient refusal * patients younger than 18 years old and older than 65 * patients with any known indwelling hardware of the lumbar spine. * patients with a peripheral neuropathy of the surgical extremity * non-english speaking patients
nebulized ceftazidime and amikacin in ventilator associated pneumonia

Conditions: Pneumonia

Summary: pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated pneumonia often resistant to antibiotics. in experimental models, nebulization of antibiotics delivers high lung tissue concentrations of antibiotics in infected lungs and increases lung bacterial killing. the aim of the study is to assess the efficiency of nebulized ceftazidime and amikacin in the treatment of pneumonia caused by pseudomonas aeruginosa in ventilated patients.


Eligibility criteria:
inclusion criteria: * male or female \>18 years old, ventilator associated pneumonia caused by pseudomonas aeruginosa * written informed consent provided by the relatives exclusion criteria: * pseudomonas aeruginosa resistant to ceftazidime and amikacin * pseudomonas aeruginosa pneumonia associated with other infections requiring intravenous treatment * severe septic shock and severe hypoxemia * allergy to ceftazidime or amikacin

Keywords: nebulization ceftazidime amikacin pneumonia pseudomonas aeruginosa mechanical ventilation ventilator-associated pneumonia treatment