Kornimate/medical-research-clean huggingface dataset:
clinical impact of enhanced risk assessments in women with a brca1/2 mutation, care study

Conditions: BRCA1/2-Associated Hereditary Breast and Ovarian Cancer Syndrome

Summary: this clinical trial evaluates the impact of enhanced risk assessments on knowledge, perceptions, and decisional conflict about cancer prevention in women with a brca1 or brca2 mutation. brca1/2 mutation carriers have a much higher risk of developing breast and ovarian cancer. due to the high risk of cancer, mutation carriers are provided guidelines on more intensive screening and preventative surgeries such as bilateral mastectomy and bilateral salpingo-oophorectomy. doctors want to learn if a more personalized risk assessment impacts the patients' risk perceptions and comfort with decision-making around cancer prevention behaviors.

primary objectives: i. to deploy tools for delivering enhanced genetic risk predictions based on brca1/2 genetic risk modifiers in a clinical setting and assess the impact of risk stratification on genetic knowledge, risk perceptions and decisional conflict regarding cancer prevention decision-making. ii. to perform long-term follow-up of individuals in the randomized controlled trial (rct) to determine if there are differences in satisfaction, decision-making and outcomes in individuals who received standard versus enhanced genetic risk predictions over time. outline: patients undergo collection of blood or mouthwash samples. patients are then randomized to 1 of 2 arms. arm i: patients undergo genotyping with enhanced risk assessment on study. 4 to 8 weeks later, patients receive a follow-up phone call for return of enhanced risk assessment results and tailored counseling. arm ii: 4-8 weeks later, patients receive a standard follow-up phone call. after completion of study intervention, patients are followed up for 2 years.

Eligibility criteria:
inclusion criteria: * have had genetic counseling and testing for mutations in brca1 and/or brca2 through a clinical laboratory improvement act (clia)-certified laboratory * were found to have a known pathogenic mutation upon testing * are within 3 weeks of results disclosure * have available medical records for ascertainment of clinical information * are able to provide a source of deoxyribonucleic acid (dna) (blood or mouthwash) for study * have access to a telephone and a computer or other internet-ready device * have not yet had a bilateral prophylactic mastectomy or bilateral salpingo oophorectomy
osteonecroses in pediatric patients with all

Conditions: Osteonecrosis; Acute Lymphoblastic Leukaemia; Lymphoblastic Lymphoma

Summary: nowadays approximately 80% of children and adolescents with acute lymphoblastic leukaemia (all) or lymphoblastic lymphoma (lbl) can be cured and become long-term survivors. avascular osteonecroses (on) appear as serious side-effect of antileukaemic treatment. frequently on are first diagnosed at higher and than irreversible stages (arco iii, iv). at these advanced stages curative treatment options are not available. hence on are associated with considerable morbidity concerning pain and immobility and go along with long-term impairment of quality of life. therefore early diagnosis of on in the follow-up of children and young adults with all or lbl is a pressing object. within the prospective multicentric observational opal-trial patients at risk (aged 10 years or older) treated according to the clinical trials all-bfm(berlin-frankfurt-muenster study group), coall or nhl (non hodgkin lymphoma)-bfm in germany should be examined with regard to the development of on. by using a treatment associated, risk orientated assessment and examination incidence, symptoms and the clinical course of on are investigated. the validity of mri screening in the early diagnosis of on in children and young adults is analysed. systematical investigation of patients under antileukaemic treatment is intended to contribute to risk adapted diagnostic strategies and to serve as data base for the subsequent evaluation of preventive and interventional approaches for the treatment of on. long-term objective is the reduction of on-associated morbidity.


Eligibility criteria:
inclusion criteria: * diagnosis of all or lbl * age at diagnosis of all or lbl ≥ 10 and \< 18 years * study patient of aieop( associazione italiana ematologia ed oncologia pediatrica)-bfm, coall or nhl-bfm in germany * treatment in a hospital participating in opal * written informed consent exclusion criteria: * relapse of all or lbl * every non evidence based treatment (pharmacological, orthopaedic-conservative, orthopaedic operative) aiming at the prevention of on during study participation * pacemaker, other mri prohibited devices * metal implants in the field of view, other mri prohibited implants * pregnancy * claustrophobia

Keywords: osteonecrosis children pediatric acute lymphoblastic leukaemia lymphoblastic lymphoma
rtms for orthopaedic trauma patients

Conditions: Orthopaedic Trauma

Summary: this study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for orthopaedic trauma patients. in this open label study, all participants will receive accelerated theta-burst stimulation. this study will examine whether symptoms of psychiatric distress and opioid use in orthopaedic trauma patients can be mitigated with rtms to improve post-injury recovery.

a large percentage of orthopaedic trauma patients suffer from psychiatric distress and chronic pain related to their injury and underlying psychosocial factors; this predicts poor post-injury recovery. repetitive transcranial magnetic stimulation (rtms) is a neuromodulation technique used to stimulate areas of the brain that may modulate symptoms of pain, depression, and post-traumatic stress. the fda-approved rtms protocol for treatment is 10hz stimulation for 40 minutes over the left dorsolateral prefrontal cortex (l-dlpfc) for the treatment of depression. this methodology has been very successful in real world situations, however poses some limitations, including the duration of the treatment session (approximately 40 minutes per treatment session). recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. this study will use modified parameters to create a more rapid form of treatment and look at outcome changes in pain and depression, commonly seen in orthopaedic trauma patients.

Eligibility criteria:
inclusion criteria: * male or female, 18 to 65 years of age. * able to provide informed consent. * present to stanford emergency department as a trauma with a major operative lower extremity injury * glasgow coma scale of 15 within 24 hours after admission or extubation * negative urinary toxicology screen for illicit substances; * negative pregnancy test if female and less then 60 y/o; * no suspicion for a head injury and/or negative head ct scan for intracranial hemorrhage or injury based on standard of care * no history of seizure disorder or other neurological disorders. * all patients included must screen positive for phq-9 score \>4 (positive symptoms of depression) and ces-t score \<36 (poor coping self-efficacy). exclusion criteria: * incarceration, * pregnant females, * prior psychotic disorder, * current use of anti-depressant or anti-psychotic medications, * prior-admission opioid use within 30 days (patients will be screened for recent prescription opioid use using the cures report), * heavy alcohol use, * lesional neurological disorder or brain implant or intracranial ferromagnetic material, * seizure disorder

Keywords: depression transcranial magnetic stimulation (tms) theta burst orthopaedic trauma pain
function and structure imaging in different retinal diseases: retinal leakage analyzer versus optical coherence tomography

Conditions: Diabetic Retinopathy; Age-Related Macular Degeneration; Macular Edema

Summary: the main objective of this observational study is to characterize and correlate functional and structural changes at the retinal level using the retinal leakage analyzer (rla) and the optical coherence tomograph (oct). to show if it is possible to use oct as an indirect measurement of leakage, this study will check, in a primary analysis, for oct changes between fluorescein leaking and non-leaking areas (identified by retinal leakage analyzer). as a secondary objective, changes in rla and oct over time (between two consecutive visits) will be analyzed and characterized. the results of this study will be used exclusively for scientific purposes.


Eligibility criteria:
inclusion criteria: * diagnosis of dr, armd or me * females or males * age over 18 years * signed informed consent form exclusion criteria: * cataract or other eye disease that may interfere with fundus examinations * vitreous syneresis or posterior vitreous detachment * dilatation of the pupil \< 5 mm
chemotherapy-induced symptoms in sarcoma patients and the impact of tumor burden

Conditions: Soft Tissue Sarcoma

Summary: assessments (survey data) in this study are designed to sample the symptom burden of patients undergoing adjuvant and neoadjuvant chemotherapy in the hospital. there will be no change in the treatment plan for these patients.


Eligibility criteria:
inclusion criteria: * patients who are receiving doxorubicin plus ifosfamide (ai) exclusion criteria: * there is no exclusion criteria

Keywords: sarcoma questionnaire doxorubicin plus ifosfamide (ai)
novel protection against potential brain, hearing and vision injury during blast wave exposure

Conditions: Concussion, Mild

Summary: the purpose of the study is to monitor changes in brain structure and function between the pre-training and post-training, in a population of tactical team members wearing the device and compared to a similar population not wearing the device. secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.

this study will investigate the effectiveness of this device in tactical team members exposed to blast waves during tactical training. subjects participating in this study will be randomly assigned to one of two groups: 1) device wearing during the tactical training or 2) non-device wearing during the tactical training. the helmets of all participants will be outfitted with an accelerometer which will measure the magnitude of every concussive blast wave sustained by the subject. effectiveness of the device will be determined via differences in brain mri and eeg, vision and hearing testing prior to and following standardized breaching and diversionary device scenario training.

Eligibility criteria:
inclusion criteria: * normal healthy volunteer * able to provide written consent exclusion criteria: * unable to provide written consent * history of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-tactical training screening: * medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis) * glaucoma (narrow angle or normal tension) * hydrocephalus * recent penetrating brain trauma (within 6 months) * known carotid hypersensitivity * known increased intracranial pressure * central vein thrombosis * any known airway obstruction * any known seizure disorder
relationship between constitutional varus knee and patellofemoral pain

Conditions: Patellofemoral Pain Syndrome

Summary: this study aims to research on the relationship between constitutional varus knee and patellofemoral pain. the standardized standing whole-lower-extremity radiographs, the knee lateral view and skyline view of the participants will be taken. the hip-knee-ankle angle will be obtained from the radiographs. according to the hip-knee-ankle angle, the knees will be labelled knee varus or knee nonvarus. the knee varus incidences of the two groups will be determined and compared.

the patellofemoral joint will be assessed in the skyline view and lateral view. the hip-knee-ankle angle will be obtained from the standing whole-lower-extremity radiographs. according to the hip-knee-ankle angle, the knees will be labelled knee varus or knee nonvarus. the knee varus incidences of the two groups will be determined and compared. it is hypothesized that constitutional varus knee is a risk factor for patellofemoral pain.

Eligibility criteria:
inclusion criteria: * patellofemoral pain during physical activities such as running, jumping, squatting, and going up or down stairs for at least 4 weeks. * the onset of pain is required to be atraumatic in nature. * exhibit two of the following clinical criteria on assessment: pain on direct compression of the patella against the femoral condyles with the knee in full extension, tenderness of the posterior surface of the patell on palpation, pain on resisted knee extension, and pain with isometric quadriceps muscle contraction against suprapatellar resistance with the knee in 15° of flexion. * negative findings in the examination of knee ligaments, menisci, bursae, synovial plicae, hoffa's fat pad, iliotibial band, and the hamstring, quadriceps, and patellar tendons and their insertions. exclusion criteria: * with patellofemoral instability, or with other knee diagnoses. * any previous surgery or severe trauma in the affected limb. * inflammatory joint disease or tumors in the affected limb.

Keywords: patellofemoral pain syndrome anterior knee pain knee varus
effect of feedings on caffeine in premature infants

Conditions: Apnea of Prematurity; Premature Newborn; Caffeine

Summary: almost all infants born \<29 weeks gestational age develop apnea of prematurity and are treated with caffeine. type of diet and disease states may be significant contributors of variability in caffeine metabolism and pharmacokinetics (pk) in this population. this prospective, observational, open-label, opportunistic pk study will compare the population pk of caffeine between infants fed formula and infants fed exclusively breast milk; compare the activities of caffeine metabolizing enzymes between infants fed formula and infants fed exclusively breast milk; and determine the effect of hypoxia, hypotension, and infection on caffeine pk and metabolism in premature infants.

this study will use a consecutive patient sampling approach. all eligible participants admitted at each site will be approached. caffeine and feedings will be administered per standard of care. manipulations of caffeine dosing or feeding regimens will not be a part of this protocol. to minimize the amount of blood sampling, the investigators will use a sparse sampling methodology. urine will be collected for analysis of caffeine and caffeine metabolite concentrations. caffeine pharmacokinetics will be described by population pharmacokinetic analysis. urinary concentrations of caffeine and its metabolites will be used to calculate metabolic ratios as markers of enzyme activity.

Eligibility criteria:
inclusion criteria: * written informed consent from parent(s) or legal guardian(s) * \<29 weeks birth gestational age * postnatal age ≤15 days * receiving caffeine (intravenous or oral) per standard of care for prevention or treatment of apnea of prematurity exclusion criteria: * known major congenital or chromosomal anomaly

Keywords: infant, premature caffeine pharmacokinetics metabolism
do lower spine injections improve outcomes for lower back pain patients

Conditions: Low Back Pain

Summary: the purpose of this project is to determine the effect of lower back injections on select biomechanical outcomes, walking patterns, lower back flexibility and balance.

the purpose of this project is to determine the effect of lumbar injections on select biomechanics parameters; walking pattern, lumbar flexibility and balance. the surveys will help assess the patient's sense of functional ability and feeling of wellness compared with low back pain scores. the long terms goals of this project will be to elucidate the mechanism of action of injections and to improve identification of patients that are likely to benefit from injection therapy

Eligibility criteria:
inclusion criteria: * diagnosis of lumbar spine stenosis * receiving lumbar epidural injection * age 18-90 years * bmi \<35kg/m2 * walking unaided exclusion criteria: * age \ 90 years * bmi \>35 kg/m2 * severely impaired intellectual capacity * medications that could impact balance * dementia, or other neurodegenerative diseases that would preclude appropriate cognitive or physical ability to perform study protocol

Keywords: low back pain lumbar injection lumbar pain
kidney involvement in covid-19 disease (covkid)

Conditions: COVID; Kidney Injury

Summary: novel coronavirus disease (covid-19) is a newly discovered contagious disease caused by sars-cov-2 virus, primarily manifesting as an acute respiratory illness with pneumonia, but can affect multiple organs such as kidney, heart, digestive tract, blood and nervous system. in previous reports of sars and mers-cov infections, acute kidney injury was described in 5 to 15% of patients and was associated with a high mortality rate (60-90%). recent reports showed renal abnormalities in covid-9 infected patients. a recent chinese study also reported that acute kidney injury was an independent risk factor for mortality. however, the exact mechanism of kidney involvement remains unclear: sepsis-related cytokine storm or direct cellular injury from the virus. also, kidney involvement has not yet been well characterized: heavy albuminuria, hematuria or interstitial nephropathy alone. a recent study identified viral rna in kidney tissue and another study succeeded isolating sars-cov-2 from the urine sample of an infected patient. these data suggest that the kidney might be a target of this novel coronarivus. the sponsor suggests characterizing kidney involvement in sars-cov-2 infection. study objectives are: * to give an accurate characterization of kidney involvement in covid-19 * to investigate the physiopathologic mechanism of kidney involvement in sars-cov-2 infection * to identify risk factors for kidney involvement in in sars-cov-2 infection * to evaluate the impact of kidney involvement in in sars-cov-2 infection * to assess the long-term health effect of kidney injury on survivors of in sars-cov-2 infection


Eligibility criteria:
inclusion criteria: * confirmed covid-19 disease * age \> 18 years-old exclusion criteria: * age \< 18 years-old * pregnancy * patient with tutor- or curatorship or in prison * patients who had undergone renal replacement therapy (rrt) before admission
effects of a lifestyle intervention on gestational diabetes management

Conditions: Gestational Diabetes; Type 2 Diabetes; Nutritional and Metabolic Disease

Summary: the purpose of this study is to investigate the effects of nutrition education focusing on colorful fruit and vegetable intake with after-meal physical activity guidance on glycemic control and complications in women with gestational diabetes and pre-gestational diabetes.

diabetes (high blood sugar) developed during pregnancy can be harmful to the mother as it can lead to delivery complications because of a large baby and increases risks of type 2 diabetes and heart disease in the mother and baby in later life. thus, pregnancy is a critical time during the human lifespan to make effective dietary changes that are safe for both mother and the fetus and reduce risks of developing diabetes and pregnancy complications. women at risk for gestational diabetes will be randomly assigned to the standard care or the nutrition education group. blood draws and other biomedical measures will be collected at baseline and at end of the study before delivery.

Eligibility criteria:
inclusion criteria: * high risk for gestational diabetes * willing to make lifestyle changes * history of diabetes exclusion criteria: * carrying more than one fetus * history of chronic conditions except diabetes and hypertension
sgm-101 in locally advanced and recurrent rectal cancer

Conditions: Rectal Cancer; Recurrent Rectal Cancer

Summary: near-infrared fluorescence-guided oncologic surgery (egos) with the use of a tumor specific tracer (sgm-101) developed by surgimab can provide valuable intra-operative information about tumor location and extensiveness, which can be difficult to detect with conventional visual and tactile feedback. hence, this information could aid in intra-operative decision making and therewith foster complete resection margins and less extensive surgery. subsequently, this may drastically improve patient care by improving oncologic outcome.


Eligibility criteria:
inclusion criteria: 1. patients aged over 18 years old; 2. all women of child bearing potential and all males must practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their last dose of study treatment. 3. patients should be scheduled and eligible for surgery because of a clinical diagnosis of t3 with a threatened crm or t4 rectal cancer (locally advanced) or recurrent rectal cancer. (uicc. tnm classification of diseases for oncology. 3rd ed. geneva: world health organization; 2000) 4. patients should be capable and willing to give signed informed consent before study specific procedures. exclusion criteria: 1. other malignancies, either currently or in the past five years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma. 2. patients with a history of, or recently diagnosed with, peritoneal metastases (even those diagnosed during surgery) 3. patients with a recent history (within the last 3 years) of other distant metastases (even those diagnosed during surgery) 4. patient with a history of a clinically significant allergy. 5. patients pregnant or breastfeeding lack of effective contraception in male or female patients with reproductive potential; 6. laboratory abnormalities defined as: 1. aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase) or alkaline phosphatase levels above 5 times the or; 2. total bilirubin above 2 times the uln or; 3. serum creatinine above 1.5 times the uln or; 4. platelet count below 100 x 109/l or; 5. hemoglobin below 4 mmol/l (females) or below 5 mmol/l (males); 6. known positive test for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibody or patients with untreated serious infections; 7. any condition that the investigator considers to be potentially jeopardizing the patients' well-being or the study objectives. 8. previous administration of sgm-101