Kornimate/medical-research-clean huggingface dataset:
analgesics in the pre-hospital setting: implications on hemorrhage tolerance - morphine

Conditions: Healthy

Summary: we are examining how morphine (a commonly used pain medication) will alter responses to simulated blood loss in humans. to simulate blood loss in our research laboratory, participants will complete a test with their lower body in a custom-designed vacuum chamber for a brief period of time.

pain management on the battlefield is critical for the wellbeing of the soldier. given that a hemorrhagic injury on the battlefield is virtually always associated with pain, it is paramount that the selected pain medication does not disrupt appropriate physiological mechanisms that are beneficial towards the maintenance of blood pressure and vital organ blood flow during that hemorrhagic insult. current guidelines for the selection of pain medications of a hemorrhaging soldier are based upon limited scientific evidence, with the vast majority of supporting studies being conducted on anesthetized animals. thus, the interaction between hemorrhagic shock and pain medications commonly employed on the battlefield is yet to be determined in the conscious humans. with this background, we will test the hypothesis that morphine will impair the capacity for a conscious human to tolerate a hemorrhagic insult. the obtained data will provide the necessary scientific evidence in humans to support the committee on tactical combat casualty care (cotccc) guidelines on the analgesic of choice for moderate to severe injuries where the casualty is in hemorrhagic shock. notably, such data will identify the analgesic that least compromises a human's ability to tolerate a hemorrhagic insult, ultimately providing critical information to the combat medic on which analgesic should be employed for such an injury.

Eligibility criteria:
inclusion criteria: * healthy * non-obese (body mass index less than 30 kg/m2) * body mass greater than or equal to 65 kg exclusion criteria: * subjects who have cardiac, respiratory, neurological and/or metabolic illnesses * any known history of renal or hepatic insufficiency/disease * pregnancy or breast feeding * current smokers, as well as individuals who regularly smoked within the past 3 years * positive urine drug screen * currently taking pain modifying medication(s)
diabetic ketoacidosis: brain morphology and cognition

Conditions: Diabetic Ketoacidosis

Summary: the purpose of this study is to assess brain and memory changes in patients with uncontrolled diabetes (a condition called diabetic ketoacidosis (dka))

diabetic ketoacidosis (dka) is a common and serious medical problem. most cases occur when patients forget or stop insulin injections. some patients require frequent admissions to the hospital with dka after stopping insulin. many patients do not know why they stop insulin therapy. the investigators will test if patients with one or more episodes of dka have poor memory and brain changes that may lead to poor management. in this study, the investigators will perform memory testing and brain images in subjects with initial dka episode and subjects with more than 3 episodes of dka. the results will be compared to subjects with diabetes and no history of dka and healthy (non-diabetic) subjects. each subject with dka will have an mri and cognitive testing done shortly after hospital discharge, 1 month, and 3 months after hospital discharge. diabetic subjects without dka and healthy controls will only come in for a single baseline visit and have a mri and cognitive testing done.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes with diabetic ketoacidosis (dka) * age 18-50 years * newly diagnosed or history of noncompliance with insulin therapy as precipitating cause of dka * no significant medical or surgical illness as precipitating cause of dka exclusion criteria: * significant medical/surgical illness as precipitating cause of dka (i.e. myocardial infarction, major surgery) * associated significant medical or surgical condition within 6 months history * history of hypoglycemia unawareness * history of seizures, ischemic stroke or hemorrhage, and severe head trauma * history of symptomatic stenosis of major intracranial vessels * dementia (mini-mental state examination (mmse) score (r ≤ 24) or inability to cooperate) * liver or renal failure or transplant * severe hypertension (systolic blood pressure (bp) \>160 mm hg and/or diastolic bp \>100 mm hg or subjects taking ≥ 2 antihypertensive medications) * malignancy * current recreational drug or alcohol abuse * magnetic resonance imaging (mri) exclusions: any metal and bio-implants not compatible with 3 tesla mri, claustrophobia
use of artificial intelligence for clinical assessment of assisted reproductive techniques and ivf outcomes

Conditions: Infertility; in Vitro Fertilization (IVF); ART

Summary: the use of machine learning techniques using an artificial intelligence tool is proposed to analyze clinical data to predict best possible ivf/art outcomes. this tool has been utilized to accurately predict embryo quality here at cornell. utilizing this tool to assess objective clinical findings and predict outcomes of assisted reproductive techniques is sought, with the ultimate goal of an automated tool to reduce implicit physician bias. within this goal, using this tool to objectively and accurately assess baseline ovarian reserve at the start of an art cycle is proposed, using 3d sonography to image the ovary and artificial intelligence tool to objectively identify baseline antral follicle counts.

this study will collect prospective data, specifically 3d transvaginal ultrasound of ovaries at time of baseline evaluation at beginning of an art cycle. all participants will be asked to give written consent to be included in the study. at the time of initial ultrasound that is routinely done on the first day of the art cycle, the physician performing the ultrasound will use a 3d ultrasound transvaginal probe to perform the ultrasound and capture both 2d and 3d images. 3d ultrasound is performed routinely for patients undergoing art and is not an investigative procedure, however is not uniformly performed at the time of the baseline ultrasound. as per standard practice, the baseline antral follicle count will be documented by the performing physician, as well as a 3d image saved to be analyzed later using ai. information about the medical history, treatment and outcomes will be collected as part of the study. data maintained in the medical record as a result of standard of care monitoring for ivf and iui will also be used for this study. this will include semen analysis (male partners if applicable) and pregnancy outcomes. for male partners, the semen analysis record will be part of the fertility history and semen analysis will be performed as standard of care with semen processing for fertilization. additional data related to the treatment and outcomes will be collected from the medical record from the time of consent through the end of the treatment (including pregnancy outcomes). the time commitment for subjects may take up to 1 month (time from consent signing to 3d ultrasound) and to the time of delivery if pregnant (up to 9 months). no further procedures will be performed in the study group.

Eligibility criteria:
inclusion criteria: * all patients undergoing ovarian stimulation (including oi and ivf cycles) * treatment for fresh embryo transfer and cryopreservation of oocytes or embryos upfront * healthy male partners of the female subjects who agree to be part of the study. exclusion criteria: * none

Keywords: artificial intelligence
development and validation of a deep learning-based myopia and myopic maculopathy detection and prediction system

Conditions: Myopia; Myopic Macular Degeneration

Summary: myopia has become a global public health issue. myopia affects the psychological health of children and adolescents and poses a financial burden. therefore, early detection and prediction of children at a high risk of myopia development and progression are critical for precise and effective interventions. in this study, we developed a deep learning system deepmyopia, based on fundus images with the following objectives: 1) to predict myopia onset and progression; 2) to detect myopic macular degeneration for ai-assisted diagnosis; 3) to predict the development of myopic macular degeneration; 4) evaluate its cost-effectiveness.

myopia has become a global public health issue. myopia affects the psychological health of children and adolescents and poses a financial burden. furthermore, as myopia progresses it increases the risk of ocular complications such as myopic macular degeneration, leading to irreversible visual impairment or even blindness. according to the world health organization , more than 1 billion people worldwide are living with vision impairment caused by myopia, hyperopia, and other problems due to late detection. therefore, early detection and prediction of children at a high risk of myopia development and progression are critical for precise and effective interventions. in this study, we developed a deep learning system deepmyopia, based on fundus images with the following objectives: 1) to predict myopia onset and progression; 2) to detect myopic macular degeneration for ai-assisted diagnosis; 3) to predict the development of myopic macular degeneration; 4) evaluate its cost-effectiveness.

Eligibility criteria:
inclusion criteria: 1. subjects with fundus images in the shanghai child and adolescent large-scale eye study (scale) ; 2. subjects with fundus images in the shanghai time outside to reduce myopia \[storm\] trial; 3. subjects with fundus images in the high myopia registration study \[scale-hm\] 4. subjects with fundus images in the shanghai myopia screening (sms) study; 5. subjects with fundus images in the beijing children eye study 6. subjects with fundus images in the first affiliated hospital of kunming medical university; 7. subjects with fundus images at the ophthalmology department of the first affiliated hospital of xinjiang medical university; 8. subjects with fundus images at the ophthalmology department of the affiliated hospital of inner mongolia medical university; 9. subjects with fundus images at zhongshan eye centre, sun yat-sen university; 10. subjects with fundus images in the hong kong children eye study; exclusion criteria: * participants with poor-quality fundus images
nalbuphine as adjuvant during bilateral suprazygomatic maxillary nerve block for pediatric cleft palate repair

Conditions: Complication Following Peripheral Nerve Block

Summary: the aim of this study is to evaluate the efficacy of adding nalbuphine to bupivacaine via suprazygomatic nerve block for postoperative pain control and emergence agitation management in pediatrics aged from to 1 to 7 years who were maintained on sevoflurane inhalational anesthesia and scheduled for cleft lip and palate operation.

cleft lip and cleft palate are the most common craniofacial abnormalities in children. cleft surgery results in a profound sympathetic stimulation leading to hypertension, tachycardia, and bleeding. postoperative pain can be severe, and many of these patients are at increased risk of opioid-induced respiratory depression. emergence agitation (ea) is another common problem in these children, with an incidence between 10% and 80% after sevoflurane anesthesia. inadequate postoperative analgesia combined with vigorous crying may lead to surgical complications including wound dehiscence, bleeding, and respiratory compromise. the anesthetic management of cleft surgery should ideally bound the intraoperative autonomic response and provide adequate analgesia without respiratory depression or ea. a combination of inhalation-based anesthesia and high-dose opioids has been described to block the autonomic response during surgical dissection; however, this technique may be associated with postoperative sedation and respiratory depression. surgical infiltration with a local anesthetic and a vasoconstrictor promotes hemostasis and reduces the autonomic response intraoperatively but does not provide extended postoperative pain relief. sensory innervation of the lip and palate is provided by branches of the maxillary nerve. suprazygomatic maxillary nerve blocks have been shown to be opioid-sparing after cleft lip and palate surgery. the addition of opioid analgesic might both prolong the analgesia after a regional nerve block and reduce the incidence of ea.

Eligibility criteria:
inclusion criteria: 1. age 1 to 7 years. 2. both genders. 3. american society of anesthesiologists (asa) physical state i-ii. 4. children undergoing palate surgeries. exclusion criteria: 1. guardians' refusal 2. history of developmental delay or mental retardation. 3. children with any co-morbidities. 4. skin infection at the site of injection. 5. bleeding diathesis. 6. known allergy to any drugs used in this study.
mhealth technology in people with parkinson's disease

Conditions: Parkinson Disease

Summary: the main objective of the study is to explore the feasibility and effectiveness of this type of mhalth technology in the treatment of motor symptoms in people with parkinson's disease.

parkinson's disease (pd) is a neurological disease whose motor symptoms drastically affect the quality of life of those who suffer from it. there is currently high scientific evidence of the positive effect of physical exercise on the motor function of people with pd. this effect seems to be more relevant when this physical exercise is implemented with external sensory signals (eg visual, auditory). however, the health and socioeconomic context of the patient conditions their access to treatments and physical exercise programs, associationism being common as a low-cost strategy to cover the different therapies. the development of telemedicine, electronic devices and mobile health applications could be an interesting option for those patients who find themselves in the situations mentioned above. however, there are several limitations regarding the use of mobile health apps, such as that less than 1% of them are grounded in research evidence and the digital barrier. therefore, the main objective of the study is to explore the feasibility and effectiveness of this type of mhalth technology in the treatment of motor symptoms in people with parkinson's disease.

Eligibility criteria:
inclusion criteria: * absence of treatment with psychotropic drugs or stable dose of the same (without drug or dose modifications in the last four weeks). in the case of subjects who are part of the intervention group, the following will also be inclusion criteria: * caregiver or family member who presents the appropriate skills for collaboration in the implementation of the exercises and in the management of the mobile application. * availability of the necessary time for the initial training in the handling of the devices, the development of the sessions and the communication with the researchers. exclusion criteria: * insufficient physical condition for participation. * sensory deficits that make participation difficult. * unstable clinical situation. * unstable mental disorder or not adequately controlled with medication (depression, agitation, etc.). * presence of associated pathology that involves treatment with drugs that alter cognitive abilities or interfere with the user's participation
intralesional injection of metronidazole for the management of cutaneous leishmaniasis

Conditions: Cutaneous Leishmaniasis

Summary: aim of the study to evaluate the effectiveness of intralesional metronidazole 0.5% solution as a local injection in treating cutaneous leishmaniasis. in an open-label single-arm clinical trial, all patients will be given intralesional levofloxacin injections; the patients had cutaneous leishmaniasis lesions. each lesion will be considered a case in the final analysis. each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured. intralesional metronidazole (5 mg/ml, 100 ml, flagyl®, sanofi, france) will be injected into each lesion based on its size (5 mg/cm2). the infiltration of intralesional dose will be given once weekly for up to 6 weeks. treatment will be stopped in patients cured before 6 weeks of treatment, and patients will be only asked to come for lesion assessment. a fine insulin needle will be used to infiltrate the lesion.


Eligibility criteria:
inclusion criteria: * patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis exclusion criteria: * immunocompromised * allergic reaction to treatment.
intravenous tranexamic acid versus iv carbetocin in abdominal myomectomy

Conditions: Myomectomy

Summary: the aim of the present study is to compare safety and efficacy of intravenous tranexamic acid versus iv carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial


Eligibility criteria:
inclusion criteria: * women with symptomatic fibroids candidate for abdominal myomectomy with staging of myoma from (3 to 6) according to figo staging exclusion criteria: * women with myoma figo staging (1,2,7 and 8) candidate for laparoscopic or hysteroscopic myomectomy, women with allergy or contraindications to carbetocin or tranexamic acid
study to assess the efficacy, safety and tolerability of secukinumab in japanese subjects with generalized pustular psoriasis (gpp)

Conditions: Psoriasis

Summary: the purpose of this study was to assess efficacy and safety data of secukinumab in japanese subjects with generalized pustular psoriasis (gpp). this study was expected to support the filing of secukinumab in the indication of pustular psoriasis in japan.


Eligibility criteria:
inclusion criteria: * at baseline, presence of gpp classified on the basis of the criteria for diagnosis of gpp by japanese dermatological association (jda) * at baseline, erythema area with pustule ≥ 10% exclusion criteria: * erythrodermic, guttate psoriasis, or subcorneal pustular dermatosis at screening. * at baseline, : total score of jda severity index for gpp ≥ 14 * drug-induced psoriasis * ongoing use of prohibited psoriasis treatments.

Keywords: generalized pustular psoriasis skin condition skin disease,
aspirin for the enhancement of trophoblastic invasion in women with abnormal uterine artery doppler at 11-14 weeks of gestation

Conditions: Placental Insufficiency

Summary: to establish wether a prophylactic intervention from first trimester with low-dose of aspirin improves trophoblastic invasion evaluated at third trimester in women defined as high-risk by abnormal uterine artery doppler at first trimester


Eligibility criteria:
inclusion criteria: * patients over 18 years old attending for routine ultrasound at first trimester of pregnancy between 11 and 14 weeks of gestation (crown-to rump length 45-48mm) * single gestation * mean pulsatility index of the uterine arteries above the 95th percentile for our population exclusion criteria: * pre-existing hypertension, renal or cardiovascular disease * previous history of pre-eclampsia * pregestational diabetes * systemic lupus erythematosus * gastric ulcer * acetylsalicylic acid or lactose hypersensitivity * bleeding disorders * fetal disorders (including chromosomal abnormalities) * administration of low molecular weight heparin * concomitant treatment with aspirin
impact of telehealth education in diabetes patients

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: the goal of this clinical trial is to to evaluate the effectiveness of continuity of in-hospital care with the application of a structured telemonitoring protocol in self-care activities in patients with type 1 or type 2 diabetes mellitus or those who have an hba1c level greater than or equal to 6.5% during hospitalization, regardless of the reason for hospitalization. the main question\[s\] it aims to answer are: • is telehealth education effective for improving self-care for type 1 or type 2 diabetes mellitus or those with an hba1c level greater than or equal to 6.5% during hospitalization will be included, regardless of the reason for hospitalization? participants will answer the diabetes self-care activity questionnaire researchers will compare patients in the intervention group, in addition to the hospital's standard hospital guidance, will receive an educational approach through structured telemonitoring, reinforcing and validating the points addressed in the face-to-face guidance, which are considered the foundations of self-care.

this study have two groups of patients. group 1 will be carried out at discharge, discharge orientation of the patient with diabetes and application of the diabetes self-care activity questionnaire (qad). for this group, a new contact will be made within 30 days after discharge, where the qad will be applied again. group 2 will be performed at the time of discharge, guidance for discharge of patients with diabetes. this group will receive 3 contacts, the first will be carried out within 72 hours after discharge, the second contact within 10 days after the first contact and the third within 30 days after discharge, where diabetes education guidelines will be given to the patient in all contacts. at the time of discharge, and in the third contact, 30 days, the qad will also be applied.

Eligibility criteria:
inclusion criteria: * patients who were hospitalized at hospital israelita albert einstein and included in the subcutaneous insulin protocol to control hyperglycemia * patients monitored by the diabetes program, an institutional program that manages glycemic changes that occur within the institution. * patients with type 1 or type 2 diabetes mellitus or those with an hba1c level greater than or equal to 6.5% during hospitalization. exclusion criteria: * patients not submitted to the first face-to-face educational approach required by protocol * patients discharged on the weekend or holidays

Keywords: self care
zoledronic acid in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: null hypotheses: zoledronic acid does not improve bone density in cystic fibrosis. low bone mineral density (osteoporosis) is prevalent in adults with cystic fibrosis (cf); they have an increased rate of bone fractures in comparison to the general population. cf patients start to lose bone density in adolescence/early adulthood due to an imbalance in bone breakdown and formation. predicted survival for patients with cf has increased from 16 years in 1970 to 36.5 years in 2009 which has resulted in an increase in comorbidities associated with increased longevity in cf e.g. decreased bone density. oral and intravenous bisphophosphonates are known to increase bone density in cf; the current licensed oral preparations require daily or weekly dosing which are difficult to maintain. zoledronate, which is licensed for use, is administered intravenously once a year which should be easier to administer. the current evidence relates to its use in other disease groups e.g. glucocorticoid induced osteoporosis and oncology. the purpose of this study is to ascertain its efficacy in cystic fibrosis.


Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis * aged at least 18 years * bone mineral density score of -1.5 or less at lumbar spine or total hip * able to give informed consent exclusion criteria: * previous solid organ transplant * on solid organ transplant waiting list * long trem oral glucocorticosteroids * crp \>20mg on day of randomisation * hypocalcaemia * poor dental hygiene

Keywords: cystic fibrosis bone density