Kornimate/medical-research-clean huggingface dataset:
ai-powered portable mri abnormality detection

Conditions: Head Injury

Summary: this study aims to test a new ai-powered portable mri scanner that can quickly identify whether a brain scan is normal or abnormal. currently, standard mri scans are expensive and have long waiting times. our goal is to see if a smaller, cheaper, and more accessible mri scanner-combined with artificial intelligence (ai)-can help doctors identify abnormalities faster and improve patient care. we will invite patients from king's college hospital (kch) who are already having a standard mri scan. they will be asked to have an extra scan using the portable mri, which takes about 60 minutes. the ai tool will then analyse these scans and compare its results to those of expert radiologists. by the end of the study, we hope to prove whether portable mri with ai can be used in hospitals and gp clinics, making brain scans more accessible, reducing wait times, and helping doctors prioritise urgent cases. this study is funded by the medical research council (mrc) and has been approved by uk research ethics committees.


Eligibility criteria:
inclusion criteria: adults ≥18 years old. undergoing standard brain mri including t2-weighted sequences. exclusion criteria: contraindications to mri (e.g. pacemaker, pregnancy). poor quality mri scans without a neuroradiology report.
macrolide in pregnancy and adverse child outcomes

Conditions: Infection

Summary: over the last 20 years, concerns have been raised about rare but serious adverse outcomes associated with macrolide use during pregnancy. the strongest evidence comes from a large randomised controlled trial (rct, oracle child study ii) of women with spontaneous preterm labour (spl), which reported an increased risk of cerebral palsy in children whose mothers received erythromycin compared with no erythromycin. a recent systematic review on macrolides prescription during pregnancy showed consistent associations with miscarriage, and less consistent associations with adverse child outcomes such as congenital malformations, cerebral palsy and epilepsy. in this study, the investigators will evaluate associations between macrolide antibiotics prescription during pregnancy and a range of adverse child outcomes. the investigators compare children whose mothers were prescribed an only monotherapy of macrolides or penicillins during pregnancy (from 5 gestational week (gw) to delivery and by trimesters). the investigators estimate the risk ratios of major malformation (overall and five system-specific) and hazard ratios of four neurodevelopmental disorders (cerebral palsy, epilepsy, attention-deficit/hyperactivity disorder, and autism spectrum disorder) with control for potential confounders. the associations will also be examined by subtype of macrolides and treatment duration. mother-child pairs will be analysed in a cohort selected from the uk clinical practice research database (cprd) between 1990 and 2016.


Eligibility criteria:
inclusion criteria: * children whose mother was prescribed an only monotherapy of macrolides or penicillins during pregnancy (between 5 gw and delivery). * children born from jan 1st 1990 to june 30th 2016 in the cprd mother baby link. * children who registered with the gp within 6 months of birth * children whose mother was aged 14 to 50 years and had been registered with gp at least 50 weeks before estimated conception date until after delivery exclusion criteria: * children with known chromosomal abnormalities and pregnancies with exposure to known teratogenic medications (warfarin, angiotensin-converting enzyme (ace) inhibitors, antineoplastic agents, isotretinoin, misoprostol, and thalidomide)
long-term follow-up of a randomized comparison of percutaneous coronary intervention versus coronary artery bypass surgery

Conditions: Coronary Stenosis; Coronary Artery Disease

Summary: this is a long-term follow-up of a completed clinical trial which compared percutaneous coronary intervention (pci) using sirolimus-eluting stents and coronary artery bypass grafting (cabg) in patients with unprotected left main coronary artery disease. the purpose of the study is to obtain retrospective long-term data on clinical outcome of the study population.

the randomized multicenter, open-label trial "percutaneous coronary intervention (pci) with drug-eluting stents (des) versus coronary artery bypass graft (cabg) for patients with significant left main stenosis" was conducted at 4 tertiary care centers in germany. 201 patients with unprotected left main stem stenosis (≥50%) with or without additional multivessel coronary artery disease were enrolled in a 1:1 ratio from july 2003 through february 2009. results were published: https://pubmed.ncbi.nlm.nih.gov/21272743/ long-term follow-up will be performed by a structured telephone interview using a standardized questionnaire by an interviewer blinded to treatment allocation. wherever possible, data will be completed and verified by health care records. retrospective data of the underlying randomized study will be included in data analysis.

Eligibility criteria:
inclusion criteria: * alive participants of underlying study who give their consent to participate * deceased participants of underlying study exclusion criteria: * alive participants of underlying study who do not consent

Keywords: percutaneous coronary intervention sirolimus-eluting stent coronary artery bypass grafting
monitoring of scratch via accelerometry in children

Conditions: Atopic Dermatitis

Summary: sleep sensors, wrist worn accelerometers, polysomnography (psg), and associated data analysis platforms would provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic atopic dermatitis (ad) population. the overall aim of this research is to validate the use of sensor technology and digital measures to quantitatively and qualitatively evaluate scratch and sleep in ad patients, and specifically in this study in children ages 2 to 11 years. to evaluate this experimental paradigm, the investigators propose using wearable accelerometers, a sleep sensor, psg, videography and associated traditional patient-reported outcome measures/clinical outcome assessments (pro/coa) in patients/caregivers with ad in a well-controlled in-laboratory and at-home study.

to assess the feasibility of quantifying scratch and sleep in children with atopic dermatitis (ad), children, age 2 to 11 years, with ad will be recruited. the subjects will complete specific questionnaires related to itch, sleeping habits and ad and continuously wear two wrist worn accelerometry devices. the earlysense sleep monitor will also be placed underneath the mattress to measure additional sleep related activities. the study will be comprised of two overnight sleep laboratory site visits. the clinic visits will be followed by a continuous \~48 hour in-home environment assessment period (defined as the subject's daily routine environment). during the sleep lab site visit, the subject and accompanying parent(s)/guardian(s) will sleep overnight at the facility. the subject will be video-recorded during the in-sleep lab visit, wear the wrist accelerometry devices, use the sleep sensor and complete assessments (depending on age, parent/guardian may complete some assessments). upon the completion of sleep lab activities the subjects will then continue to wear the wrist accelerometry devices, utilize the sleep sensor and complete patient reported outcome/clinical outcome assessments (pro/coa) assessments during the 48 hour in-home assessment. at the conclusion of the in-home portion of the assessment, the subject will return the device/s and assessments to the facility and undergo brief assessments/interview.

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥2 years of age and \<12 years of age at day 1. 2. written informed consent from parent(s)/guardian(s) and assent from the subject (where assent is applicable). 3. native english speakers or demonstrated fluency in english (both subject and parent(s)/guardian(s)). 4. has a clinical diagnosis of atopic dermatitis (ad) according to the criteria of hanifin and rajka (concomitant ad treatments are permitted on study). exclusion criteria: 1. ad affected surface areas are in a location of device placement. 2. has unstable ad (total bsa\>40%). 3. has any planned surgical or medical procedure that would overlap with study participation.

Keywords: wearable devices scratch sleep
twelve-year follow-up on the treatment of obese pregnant women (top) study

Conditions: Obesity; Lifestyle, Healthy; Diet, Healthy; Follow-up; Physical Activity; Body Composition; Gestational Weight Gain

Summary: the participant (both mother and child) in the initial top study will be invited to a follow-up study to evaluate the effect of life style intervention during pregnancy on both mother and their offspring 12 years after the intervention. the study will contribute to understanding the transfer of obesity between generations and how to treat as well as prevent obesity.

the initial study (treatment of obese pregnant women (top) study) was performed at hvidovre hospital, university of copenhagen in 2009-12 and included 425 pregnant women with pre-gestational bmi ≥ 30kg/m2 in gestational week 11-14. they were randomized 1:1:1 into: 1) a low-calorie mediterranean-style diet and pedometer assisted physical activity (pa) intervention 2) a pedometer assisted pa intervention alone or 3) no intervention (control). primary outcome was gestational weight gain (gwg). 389 women completed the study. the participants (both mother and child in pair) who completed the initial top study will be invited to a 3-hour examination now 12 years after the intervention during pregnancy to evaluate the effect of the intervention on both mother and child long term.

Eligibility criteria:
inclusion criteria: * participants/mothers in the initial top study will be invited with their offspring born following the pregnancy during the initial study to the 12-year follow-up study exclusion criteria: * there are no exclusion criteria as the potential study population has already been selected at the baseline study in 2009-2012
sub-dissociative dose ketamine dosing study

Conditions: Acute Pain

Summary: goal is to determine if in adults presenting to the emergency department (ed) with moderate to severe acute pain, ketamine administered at 0.15 mg/kg will provide similar pain relief to ketamine administered at 0.3 mg/kg, with fewer adverse effects.

study investigators will enroll participants who present to the emergency department (ed) with moderate to severe acute pain, and require intravenous pain medication. participants will be double-blinded and randomized to one of the two treatment groups. investigators aim to determine if ketamine 0.15 mg/kg ivpb is non-inferior to ketamine 0.3 mg/kg ivbp for the treatment of acute moderate to severe pain in the emergency department (ed). study investigators hypothesize that in adults presenting to the ed with moderate to severe acute pain, sdk administered at 0.15 mg/kg will provide similar pain relief to sdk at 0.3 mg/kg, with reduced adverse effects.

Eligibility criteria:
inclusion criteria: * adults ages 18-59 * weight 45 - 115 kg * acute abdominal, flank, back, musculoskeletal pain, or a headache * onset of pain within 7 days * pain score of 5 or more * requiring intravenous analgesia * hasn't been enrolled in this study previously exclusion criteria: * pregnancy * breast-feeding * altered mental status rendering the patient unable to consent to the study * allergy to ketamine * unstable vital signs (systolic blood pressure \ 180 mm hg, pulse rate \ 150 beats/minute, and respiration rate \ 30 breaths/minute) * history of acute head or eye injury, seizure, intracranial hypertension * chronic pain * renal or hepatic insufficiency * known alcohol or drug use disorder * currently under influence of alcohol/opiates * acute psychiatric illness
diagnostic and prognostic value of serial procalcitonin (pct) measurements in critically ill patients

Conditions: Sepsis

Summary: in 2005, the food and drug administration (fda) approved procalcitonin in conjunction with other laboratory markers to aid in the risk assessment of critically ill patients with severe infection (sepsis). although considerable literature exists regarding the usefulness of procalcitonin (pct) as a marker of sepsis, there are still potential uses for pct measurements that are not yet explored and its value among the critically ill patients remains unclear. this study seeks to better understand the usefulness of measuring pct values in patients admitted to the medical icu for a variety of reasons and in particular with severe infection (sepsis).

procalcitonin (pct) is a 116 amino acid peptide that has an approximate mw of 14.5 kda and belongs to the calcitonin (ct) superfamily of peptides. transcription of the calc-1 gene for pct is usually suppressed in the non-neuroendocrine tissue, except in the c cells of the thyroid gland where its expression produces pct, the precursor of ct in healthy individuals and in the absence of infection. in the presence of microbial infection, circulating levels of calcitonin precursors (ctpr), including pct, increase up to several thousand-fold.1 in addition to being a marker of microbial infection, pct also acts as a modulator of the host inflammatory reaction. in an animal model of sepsis, administration of exogenous human pct worsened outcome, whereas neutralization of endogenous pct improved survival. there are several inflammatory laboratory markers, like tumor necrosis factor (tnf)-α, interleukin (il)-1, il-6 and c-reactive protein (crp), but they are non- specific for infection and can be caused by conditions like pancreatitis, burns, trauma or acute lung injury. the non-specific nature of clinical and laboratory parameters for microbial infection makes it difficult to evaluate patients with potential infection. in addition to the lack of specificity, traditional laboratory and clinical indicators of sepsis are not temporally concordant with the course of illness. as a result, these tests are not reliable to evaluate the response to therapeutic interventions in real time.

Eligibility criteria:
inclusion criteria: * all consecutive patients admitted to the medical intensive care unit of the cleveland clinic with an anticipated micu stay of ≥ 12hrs exclusion criteria: * age less than 18-years of age and/or an expected micu stay of less than 12-hrs

Keywords: sepsis septic shock procalcitonin pct
laparoscopic natural gastric banding for morbid obesity

Conditions: Obesity, Morbid

Summary: to do gastric banding using round ligament or omental flap instead of synesthetic band

the round ligament or omental flap is used for gastric band instead of synesthetic band which had many complications that led to its abandon

Eligibility criteria:
inclusion criteria: * obese patients with bmi more than 40 with or without co-morbidity or more than 35 with co-morbidity * patients fit for laparoscopic surgery * give approval to share in the study * previous restrictive bariatric procedure exclusion criteria: * patients unfit for surgery * patients aged less than 18 and older than 60 * patient with previous upper abdominal surgery either for obesity or other diseases
efficacy and results of endoscopic gastroplasty using overstitch in patients with class i and ii obesity

Conditions: Obesity

Summary: obesity is a chronic disease that has grown to epidemic proportions in brazil and throughout the world in recent years. bariatric surgery has been the most effective method for the treatment and prophylaxis of complications caused by morbid obesity, thereby increasing the longevity and quality of life of patients. the treatment of patients with class iii obesity or higher or class ii with comorbidities is already well established with bariatric surgery being the best option. however, there is no consensus as to the best treatment in cases of class i or ii obesity without comorbidities. the objective of this research will be to make a gastric tube similar to that obtained by surgical gastroplication but using endoscopic intragastric sutures.

the primary objective of this research will be to make a gastric tube similar to that obtained by surgical gastroplication but using endoscopic intragastric sutures. the secondary objective will be to correlate demographic, endoscopic and laboratory data with the outcomes. this study will be carried out in two institutions. the kaiser clinic and day hospital and the faculty of medicine of abc. sixty patients will be randomly selected for treatment by endospore endoscopy (esg) or as controls (only the endoscopist will know which group each patient belongs to). the draw will take place only after upper endoscopy has been carried out to avoid possible contraindications for the procedure due to injuries. once the criteria for endoscopic evaluation have been met, randomization will be carried out in loco with the patient still sedated. gastric endo sutures will be performed when the patient is randomized for group i; group ii will be the control group. all patients will be followed up for two years by a multidisciplinary team (endoscopist, surgeon, nutritionist and psychologist). the data will be obtained during the outpatient follow-up at the hospital mario covas and will include demographic (gender, age), clinical (height, weight, bmi, time after procedure, hypertension, diabetes, dyslipidemia, smoking, alcoholism) and operative data (complications). preparation to perform the examination/procedure: all exams will be performed with the patients within eight hours. the procedure will begin with the patient in left lateral decubitus position and under general anesthesia performed by an anesthesiologist. endoscopic suturing will be performed with 2-0 prolene stitches until a tubular-shaped stomach is formed similar to vertical gastrectomy. recovery after the procedure: after this procedure and recovery from the anesthesia, all patients will only be discharged in the company of a companion. all patients will be counseled to enter in touch with the physician to report any signs or symptoms.

Eligibility criteria:
inclusion criteria: * aged over 18 years, * bmi \> 30 and \< 36 kg/m2, with or without comorbidities, * bmi \> 36 and \< 40 without comorbidities exclusion criteria: * previous gastric surgery * taking anticoagulant drugs * psychiatric disorders * severe esophagitis
long-term krd in relapsed and/or refractory multiple myeloma

Conditions: Multiple Myeloma in Relapse; Multiple Myeloma, Refractory

Summary: research question: is krd therapy effective and safe in the real-world asian patients? primay objective: to evaluate the effectiveness of krd in rrmm patients secondary objectives: to evaluate the effectiveness of investigational treatment strategy by * pfs difference according to the high-risk disease subgroups and previous treatment * os * overall response rate and clinical benefit rate * duration of response to evaluate the safety and tolerability of krd in rrmm patients

key study variables: demographic data, iss, r-iss, cytogenetic abnormalities on fish and g-banding, previous treatment regimens, response to previous treatment regimens, existence of extramedullary plasmacytoma, mm-related symptoms, whether or not m protein has increased twice or more in 2-3 months at the time of krd commencement, response to krd therapy, duration of krd treatment, adverse events during krd therapy, disease progression and progression date, survival, and censored date or day of death

Eligibility criteria:
inclusion criteria 1. patients ≥ 19 years 2. relapsed and/or refractory multiple myeloma patients 3. patients who had received krd combination chemotherapy from february, 2018 to february, 2020. exclusion criteria 1. patient who had not been treated with krd combination therapy from the first cycle of treatment 2. patients who had received krd combination chemotherapy before february, 2018 and after february, 2020.
electrically evoked compound action potentials human observation medtronic system study (echo-mdt)

Conditions: Chronic Pain

Summary: this is a prospective, multi-center, non-significant risk ide study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.


Eligibility criteria:
inclusion criteria: 1. 22 years of age or older 2. candidate for or undergoing medtronic scs device trial for labeled indication\* 3. willing and able to provide signed and dated informed consent 4. capable of comprehending and consenting in english 5. willing and able to comply with all study procedures and visits \*candidate for or undergoing medtronic scs device trial for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo medtronic scs trialing to treat the patient's chronic pain. this decision is to be made prior to discussing with the patient whether to enroll in the study. exclusion criteria: 1. implanted electrical cardiac device (e.g., pacemaker, defibrillator) 2. currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the medtronic study manager or designee) 3. currently diagnosed with a disease that may confound ability to evoke compound action potentials, e.g. multiple sclerosis, as determined by the investigator 4. pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study 5. has untreated major psychiatric comorbidity, as determined by the investigator or designee 6. trialed with a permanent implant lead and extension ("buried lead trial")
one versus twice daily administration of multiple cardiovascular agents in patients with ischemic heart disease

Conditions: Ischemic Heart Disease

Summary: patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, angiotensin converting enzyme (ace) inhibitors or beta-blockers. uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists. the investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.

patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, angiotensin converting enzyme (ace) inhibitors or beta blockers. these drugs are usually given at different timetables. recent investigations, however, have demonstrated that adherence to medical treatment is significantly greater if a one daily strategy is adopted. uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists. the investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.

Eligibility criteria:
inclusion criteria: ischemic heart disease, willing to participate, compliance to medical therapy exclusion criteria: patients with acute coronary syndrome; pregnancy

Keywords: coronary artery disease