Kornimate/medical-research-clean huggingface dataset:
project sueño: sleep & understanding early nutrition in obesity

Conditions: Infant Overweight; Infant Obesity; Infant Overnutrition; Infant Development; Metabolic Syndrome; Diabetes Mellitus Risk

Summary: the purpose of the study is to understand how mothers think and feel about feeding their babies and putting them to sleep, understand more about programs that can support mothers taking care of babies, and how professionals can be most helpful in helping mothers make decisions about their baby's feeding and sleeping. the overarching goal is to prevent early life obesity and progression to metabolic syndrome in high-risk populations, starting with healthy toddler weights by age 2 years.

this study seeks to intervene just in time for families at highest risk of early life obesity and obesity-related comorbidities (such as type 2 diabetes), to prevent intergenerational obesity and metabolic syndrome for hispanic families. for those children exposed to gestational diabetes (gdm) or maternal overweight/obesity in utero, there is a critical need for effective early life strategies for secondary prevention of obesity, to interrupt intergenerational transmission. this study will offer community-embedded coaching to families learn how to responsively feed their babies using 2 models: group visits and text-based. the investigators will also assess responsive sleep practices; i.e. paying attention to an infant's sleep cues as well as hunger cues, breaking the feeding to sleep association, and not overfeeding at night. infant and toddler sleep, both duration and quality, has not been well studied in this population for early life obesity prevention. this study is specifically exploring pathways from prenatal gestational diabetes and maternal overweight/obesity to dysregulated infant feeding and sleep. few interventions around infant sleep exist for the hispanic population, or resources in spanish-language around sleep coaching; let alone analyses on parents' self-efficacy and behavior change. in this study, the investigators aim to better understand the complex socioenvironmental drivers of infant sleep and feeding behaviors, and the prenatal risks related to infant rapid weight gain, in order to target modifiable factors in this population.

Eligibility criteria:
inclusion criteria: * mother to infant born full term \> 37 weeks, and are under 1 month of age * infant is singleton * infant has no identified health problems * infant is patient of communitycare * mother is 18 years of age * mother is latino/hispanic ethnicity * mother is willing to commit to study follow-up visits exclusion criteria: * mother smokes * mother works primarily at night * infant has metabolic or chromosomal disorders, chronic neurological or respiratory conditions, or developmental disability

Keywords: infant feeding infant sleep parenting practices rapid weight gain intergenerational obesity diabetes prevention
the efficacy and cost effectiveness of preoperative and postoperative cryotherapy in proximal tibia fractures

Conditions: Proximal Tibia Fracture

Summary: consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. time to discharge and complications will be monitored. primary outcome measure: cost of treatment (based on length of stay) secondary outcome measures: satisfaction/pain relief and narcotic requirement


Eligibility criteria:
inclusion criteria: * skeletally mature * trauma patients with single-system musculoskeletal injuries. * proximal tibia fractures treated with open reduction and internal fixation. * unilateral proximal tibial injuries. exclusion criteria: * previous ipsilateral knee surgery * upper extremity injuries impairing mobilization * pre-existing ipsilateral neurologic condition or acute ipsilateral neurologic injury * associated injuries impairing mobilization * suspected or confirmed compartment syndrome * open fractures * patients previously on narcotics * patients with impaired sensorium concurrent head injury intoxication

Keywords: tibial plateau fracture ao/ota 41
can vi-rads/adc accurately stage bladder cancer??

Conditions: MRI Contrast Media Adverse Reaction; Bladder Cancer; Bladder Disease; Bladder Neoplasm; Bladder Urothelial Carcinoma; Bladder Cancer Stage; Diagnoses Disease

Summary: vesical imaging-reporting and data system (vi-rads) is proposed for predicting muscle invasive bladder cancer (mibc) using multi-parametric mri. however, no validation study on vi-rads has been reported yet. apparent diffusion coefficient (adc) values on diffusion-weighted mri are reportedly significantly lower in mibc than those in non-mibc(nmibc).

vesical imaging-reporting and data system (vi-rads) is proposed for predicting muscle invasive bladder cancer (mibc) using multi-parametric mri. however, no validation study on vi-rads has been reported yet. apparent diffusion coefficient (adc) values on diffusion-weighted mri are reportedly significantly lower in mibc than those in non-mibc(nmibc). we aim to examine the accuracy of vi-rads for predicting mibc in final histopathology specimen. to assess whether incorporating adc into vi-rads improves the mibc predictive accuracy of vi-rads

Eligibility criteria:
inclusion criteria: * patients diagnosed at the out-patient cystoscopy with papillary or small nodular bladder tumour exclusion criteria: * fungating lesions * beyond the scope of enbloc resection

Keywords: vi-rads multiparametric mri non-muscle invasive bladder cancer (nmibc) muscle invasive bladder cancer (mibc)
post-market study on trhcross® in knee osteoarthritis after a single injection

Conditions: Knee Osteoarthritis

Summary: double-blind study assessing the safety and efficacy of trhcross® in knee osteoarthritis, compared to hyalone®, using scales such as womac, vas, and koos. the population includes 60 symptomatic patients with mild to moderate koa (kellgren-lawrence ii or iii) who have not responded adequately to non-pharmacological treatments or simple analgesics.


Eligibility criteria:
inclusion criteria: * men or women between 18 and 80 years of age. * body mass index \<40 kg/m². * diagnosis of knee osteoarthritis (koa). the stage must be radiographically confirmed (kellgren-lawrence grade ii or iii) within 6 months prior to study entry. * persistent pain reported during the 3 months prior to recruitment and moderate to severe pain when walking on inclines or stairs, or at rest (vas score ≥40) at baseline. * history of analgesic use (paracetamol and/or nsaids) related to the study condition. * willingness and ability to complete questionnaires and understand study instructions. * signed informed consent specific to the study. exclusion criteria: * x-rays showing grade iv changes on the kellgren-lawrence scale. * severe functional impairment in the knee. * bilateral involvement (simultaneous involvement of both knees). * associated hip osteoarthritis. * clinically significant pain in joints other than the knee. * psoriasis. * patients with confirmed rheumatic joint disease. * active infection. * known or suspected use of intra-articular steroids within the previous 3 months, or intra-articular ha or prp within the 9 months prior to treatment initiation, as well as the use of chondroprotective agents. * pregnant women.

Keywords: koa osteoarthritis knee sodium hyaluronate womac vas koos
investigation of rheumatic af treatment using vitamin k antagonists, rivaroxaban or aspirin studies, superiority

Conditions: Rheumatic Heart Disease

Summary: this program is a comprehensive evaluation of rheumatic valvular heart disease (rvhd), atrial fibrillation (af)/flutter and stroke. a prospective, randomized, open-label superiority trial comparing rivaroxaban to aspirin in high risk patients either with af and unsuitable for vka or without af and with high risk factors.


Eligibility criteria:
inclusion criteria: 1. rvhd diagnosed by echocardiography at any time prior to enrollment 2. age ≥18 3. increased risk of stroke by any of the following 1. cha2ds2-vasc score ≥ 2 or 2. moderate/severe mitral stenosis with valve area ≤2.0 cm2 or 3. left atrial spontaneous echo contrast or 4. left atrial thrombus 4. heart rhythm 1. af or flutter and unsuitable for vka therapy. (af or flutter should be documented on baseline 12-lead ecg, or on a previous 12-lead ecg, holter monitor, in-hospital ecg rhythm strip or pacemaker or icd electrogram). or 2. in the absence of af or flutter, patients would be eligible in the presence of any one of the following: 1. left atrial enlargement ≥5.5 cm or 2. left atrial spontaneous echo contrast or 3. left atrial thrombus or 4. frequent ectopic atrial activity (\>1000/24 hours) on holter monitoring exclusion criteria: 1. refusal to give informed consent 2. actively involved in any study that would compromise the protocol of invictus trial 3. severe co-morbid condition with life expectancy \< 1 year 4. other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region. 5. likely to have valve replacement surgery within 6 months 6. mechanical valve prosthesis or other condition requiring treatment with vkas. patients with deep vein thrombosis or recent pulmonary embolism can be enrolled where both vkas and rivaroxaban are approved. 7. contraindication to the study medication of the trial * allergy to rivaroxaban * allergy to vkas ( non-inferiority trial) * allergy to aspirin ( superiority trial) 8. severe renal insufficiency with an calculated creatinine clearance (cockcroft-gault) \<15 ml/min 9. serious bleeding in the past six months or at high risk for bleeding 10. moderate to severe hepatic impairment 11. ongoing need for dual antiplatelet therapy (patients with on-going aspirin therapy ≤100 mg per day are not excluded) 12. ongoing need for dual strong inhibitors of cyp-3a4 or p-glycoprotein inhibitor. 13. received an investigational drug in the past 30 days 14. patients considered unsuitable for trial inclusion because of unwillingness to attend follow up visits 15. women who are pregnant and/or breastfeeding 16. women of child bearing age who do not use an effective form of birth control.

Keywords: atrial fibrillation stroke
norspan efficacy and safety among elderly subjects

Conditions: Osteoarthritis Pain of the Hip and or Knee

Summary: an open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee.


Eligibility criteria:
summary criteria for inclusion: 1. males and females aged 50-60 or ≥ 75 years. 2. subjects with clinical diagnosis of osteoarthritis in knee and/or hip including fulfilment of acr-criteria and radiographic evidence not older than one year. 3. subjects with a moderate to severe pain, confirmed by a bs-11 score ≥ 4 for their pain on average during the last seven days of the screening phase in their primary oa-site at the baseline visit. summary criteria for exclusion: 1. subjects recording \< 4 on average during the screening phase on the bs-11 scale. 2. subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine) for their osteoarthritis pain. 3. subjects treated with a regular dose for \> 1 week of tramadol, codeine or dextropropoxyphene within 1 month before screening visit. 4. subjects who require nsaid treatment (except aspirin for cardiovascular indications) or cox-2-inhibitors during the study period. 5. subjects with history of, or ongoing, chronic condition(s), in addition to osteoarthritis, requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout, rheumatoid arthritis). 6. subjects scheduled for surgery that would fall within the study period. 7. subjects who currently abused substance or alcohol, or subjects who, in the opinion of the investigator, have demonstrated addictive or substance abuse behaviours. 8. subjects with cancer (except basal cell carcinoma) or history of cancer in the last 5 years (except treated basal cell carcinoma). 9. untreated depression or other psychiatric disorder in such way that participation in the study may, in the opinion of the investigator, pose an unacceptable risk to the subject. 10. subjects who are currently taking hypnotics, anxiolytics or other central nervous system depressants that, in the investigator's opinion, may pose a risk of additional cns depression with study medication. 11. subjects who are currently taking adjuvant analgesics such as antidepressants and anti-convulsants. 12. dermatological disorder or non-intact skin at any relevant patch application site that precludes proper placement and/or rotation of patch placement. 13. subjects who had received an intra-articular steroid injection within 6 weeks prior screening visit or subjects who require steroid treatment (oral, intra-muscular, intra-venous, intra-articular, epidural or other corticosteroid injections) during the study period. 14. subjects with joint evacuation 6 weeks prior screening visit and during the study. 15. subjects who are currently taking monoamine oxidase inhibitors (maoi's) or have taken maoi's within 2 weeks before screening visit.
the effect of use of breathing exercise device and reading aloud on vital signs

Conditions: Chronic Obstructive Pulmonary Disease; Breath Shortness

Summary: purpose of the research; to determine the effects of wearable technology follow-up, breathing exercises with a breathing exercise device and reading aloud on vital signs, fatigue and respiratory function parameters in individuals with copd. this research will be conducted using a randomized controlled trial model. "personal description form", "copd and asthma fatigue scale", visual analog scale and pulmonary function tests will be used in data collection.


Eligibility criteria:
inclusion criteria: * having been diagnosed with copd for at least 6 months or before * not having a respiratory system defect caused by diseases other than copd * not in the gold-4 copd stage * being able to read and write turkish * have no problems communicating or speaking * being able to use basic information technologies * using a smartphone * having an active internet connection exclusion criteria: * having non-copd pulmonary problems and diagnosed cardiovascular disease * not volunteering to participate in the study * having a psychiatric disorder such as schizophrenia or dementia that disrupts the thought process

Keywords: copd fatigue breath exercise reading aloud
national registry of surgical treatment and percutaneous cryoablation of parietal endometriosis

Conditions: Endometriosis; Cryotherapy Effect; Surgical; Radiology

Summary: national multicentric registry of a cohort of patient with suffering parietal endometriosis, carried out by a multidisciplinary radiosurgery team

patient who suffering of parietal endometriosis treat by cryoablation or chirurgical will be recorded in national registry. the patient will be follow during 3 years after treatement.

Eligibility criteria:
inclusion criteria: * presence of parietal endometriosis: with suggestive clinical and imaging criteria (mri and ultrasound) * symptomatic parietal endometriosis (vas \> 3 or bothersome bleeding or reported impact on quality of life) exclusion criteria: * endometriosis not affecting the anterior wall of the abdomen (as deep pelvic muscle: ilio-psoas, obturators, perineal, ischio-anal fossa) * minor patient (\< 18 years) * pregnant patient at any trimester * patient with hemostasis disorders (constitutional or acquired) * patient with systemic infection or localized scar infection upon inclusion. * patient with contraindications to mri * female patient with a planned medical or surgical procedure for the duration of the study that may interfere with the proper conduct of the study. * patient unable to understand the information provided * patient who is not affiliated to the social security system * patient under curatorship or tutorship * patient with a nodule of primary or secondary malignant tumor origin

Keywords: endometriosis cryo ablation surgical operation radiology
dry eye in women with turner syndrome and women with premature ovarian failure

Conditions: Turner Syndrome; Ovarian Failure, Premature; Sex Chromosome Aberrations; Menopause; Perimenopause

Summary: premature ovarian failure (pof) is known to be associated with an increased risk of ocular surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen in this condition. from preliminary data, we suspect that women with turners syndrome (45, xo), a genetic abnormality that affects sex hormone levels, are also at increased risk of ocular surface disease. comparing pof and ts women may allow us to distinguish different mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen and androgen) alterations posed by pof and ts.

premature ovarian failure (pof) is known to be associated with an increased risk of ocular surface disease (dry eye), likely due to the reduction of both estrogens and androgens seen in this condition. from preliminary data, we suspect that women with turners syndrome (45, xo), a genetic abnormality that affects sex hormone levels, are also at increased risk of ocular surface disease. comparing pof and ts women may allow us to distinguish different mechanisms for ocular surface disease, due to the different etiologies of hormonal (estrogen and androgen) alterations posed by pof and ts.

Eligibility criteria:
* inclusion criteria: 1. ability to understand and give informed consent. 2. meet the diagnostic criteria for ts (45, x0) or premature ovarian failure or age matched control for study participant with ts or pof. 3. for non turner syndrome subjects only - negative pregnancy test or post menopausal status for greater than or equal to 1 year. 4. karyotype of xo for ts subjects or xx for pof and age matched control subjects. exclusion criteria: 1. persons less than 18 years old. 2. persons with ophthalmic diseases associated with ocular surface disease. 3. hyperprolactinemia. 4. cushing s syndrome. 5. other endocrine disorders which impact sex steroid hormones. 6. aids 7. pregnancy or lactation. 8. for age matched control population only- complaints of dry eye. 9. for age matched control population only- oral contraceptives or menopausal hormone therapy or any medications which alter sex hormone levels in the blood or chronic usage of medications that induce dry eye.

Keywords: ocular surface disease imprinting eye abnormalities ovarian insufficiency women's eye health and disease turner syndrome ts premature ovarian failure pof healthy volunteer hv
characterizing subjective and physiological responses to stress and pain and cognitive learning and executive function

Conditions: Pain Response, Stress, Trauma

Summary: the study design is to assess the between groups factor (controls, chronic pain, addicted individuals) and repeated measures factor of pain/stress (pain vs no pain) along with a longitudinal component to assess stress, pain and addictive behaviors in daily life.

this proposal aims to systematically examine the physiologic, neuroendocrine and behavioral stress and pain responses to an adapted cold pressor test and also assess specific cognitive and executive function tests in community volunteers with a history of stress and trauma, social users of alcohol, cannabis and individuals with alcohol use disorder, cannabis use disorder, opioid use disorder, cocaine use disorder and chronic pain.

Eligibility criteria:
inclusion criteria: 1. between ages 18-50 years; 2. able to read and write english; 3. 50 individuals meeting dsm v criteria for binge heavy drinkers, using niaaa criteria for alcohol intake 50 individuals meeting dsm v criteria for cannabis use disorder 50 individuals meeting dsm v criteria for alcohol use disorder 50 individuals with moderate to severe pain 50 individuals meeting dsm v criteria for opioid use disorder who are initiating treatment 4. physically healthy as determined by physical exam, ekg and blood analyses 5. body mass index (bmi) in the 18-30 range; exclusion criteria: 1. any psychotic disorder or current psychiatric symptoms requiring specific attention, including active symptoms of psychosis or suicidal/homicidal ideation. 2. any current substance use disorder including alcohol, cannabis, cocaine, opioids, sedatives/hypnotics. for alcohol, cannabis, and opioid subjects, exclusion for the abused drug will not apply. 3. individuals taking any prescription medications or over-the counter medications regularly; 4. women with irregular menstrual cycles or who are nursing, dysmennorheic, amenorrheic, menopausal, or had premenstrual dysphoric disorder or those on birth control pills; 5. women who are pregnant as determined by the urine pregnancy test at each laboratory admission; 6. inability to give informed consent; 7. traumatic brain injury or loss of consciousness; 8. individuals with current or past history of seizure disorders
to quantify the impact of addition of the gaad score to imaging in patients with chronic liver disease eligible for hcc surveillance.

Conditions: Cancer, Hepatocellular

Summary: the goal of this prospective observational study is to test the impact of addition of the gaad score to imaging in patients with chronic liver disease eligible for hcc surveillance. the main questions it aims to answer are: * diagnostic accuracy of the gaad score (cut-off 2.57 (3)) for detection of hcc (overall and by bclc stage), expressed using sensitivity, specificity, negative predictive value and positive predictive value. * change in gaad score over time, and proportion of patients with a gaad score above the cut-off over time in relation to potential confounding factors (e.g. age, bilirubin levels, presence of hcc). 1000 participants with chronic liver disease eligible for hcc surveillance will be enrolled. data will be collected for 3 consecutive years after enrollment. as per clinical practice, patients will undergo standard bi-annual hcc surveillance comprising liver imaging with ultrasound (or ct or mri based on previous investigations) and gaad score assessment based on blood samples.


Eligibility criteria:
inclusion criteria: * all patients with cirrhosis * non-cirrhotic chronic hepatitis b patients meeting any of the following criteria: positive family history for hcc, intermediate-high amap and/or (m)page-b score (if non-caucasian) * non-cirrhotic chronic hepatitis c patients (with or without svr) with a history of f3 fibrosis (based on histology or liver stiffness assessment) * non-cirrhotic nash patients with a history of f3 fibrosis (based on histology or liver stiffness assessment) exclusion criteria: * diagnosis with any other cancer other than non-melanoma skin cancer * history of hcc * women who are pregnant or lactating * patient with glomerular filtration rate \<45 ml /min/1.73 m2 * unwillingness or inability to undergo both ct and mri imaging * life expectancy \<2 years * use of vitamin k antagonists

Keywords: gaad score early detection