Kornimate/medical-research-clean huggingface dataset:
neonatal seizure registry - developmental functional evaluation

Conditions: Neonatal Seizure; Hypoxic-Ischemic Encephalopathy; Stroke; Intracranial Hemorrhages; Epilepsy; Cerebral Palsy; Intellectual Disability

Summary: the nsr-dev study is a longitudinal cohort study of around 280 neonatal seizure registry participants that aims to evaluate childhood outcomes after acute symptomatic neonatal seizures, as well as examine risk factors for developmental disabilities and whether these are modified by parent well-being.

neonatal seizures due to brain injury (acute symptomatic seizures) are associated with high risk of neurodevelopmental disability in infancy. although prognosis in early childhood is a critical question for parents and providers, outcomes beyond infancy are largely unknown. further, parents of infants with neonatal seizures are at risk for mental health disorders, which can undermine their ability to care for a child with medical complexity and may contribute to impaired child development. the nsr-dev study is a longitudinal cohort study of around 280 neonatal seizure registry participants enrolled at one of nine sites across the usa. participants will be evaluated using developmental questionnaires and in-person neurodevelopmental testing. parent well-being will be assessed at each time point.

Eligibility criteria:
inclusion criteria: * enrolled in nsr-ii * alive at the start of the nsr-dev study period * parent(s) who are english or spanish literate (with assistance of interpreter) exclusion criteria: * neonates who were found to have exclusion criteria after nsr-ii enrollment * risk for adverse outcome independent of seizures and underlying brain injury (including but not limited to: inborn errors of metabolism, fetal infection, brain malformation) * transient cause for seizures (e.g., mild hypoglycemia, hyponatremia, hypocalcemia with normal neuroimaging) * neonatal-onset epilepsy syndromes

Keywords: family impact neurodevelopment
taste perception pre and post bariatric surgery

Conditions: Morbid Obesity

Summary: the investigators wish to study the effects of three forms of bariatric surgery, gastric bypass lap banding, and sleeve gastrectomy. the surgery is not part of the clinical trial. if your insurance does not cover the procedure, then the patient is responsible for payment of the surgical process. the investigators are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight-loss on taste perception.

bariatric surgery is the most effective weight loss therapy for obesity. however, the mechanisms responsible for decreased food intake are incompletely understood. one possible mechanism that could account for decreased food intake is changes in taste perception. therefore, the primary goal of this proposal is to provide a better understanding of the effects of bariatric surgery-induced weight-loss on taste perception.

Eligibility criteria:
inclusion criteria: * bmi \>=35 kg/m² * on stable dose of medication for at least 4 weeks before the pre-surgery studies * women exclusion criteria: * smokes \> 7 cigarettes per day * previous malabsorptive or restrictive intestinal surgery * pregnant or breastfeeding * recent history of neoplasia (\< 5 years ago) * have malabsorptive syndromes and inflammatory intestinal disease * diabetes mellitus * show signs of oral disease or xerostomia (i.e. dry mouth) * history of chronic rhinitis * on medication that might affect taste * severe organ disfunction

Keywords: obesity gastric bypass gastric banding sleeve gastrectomy weight loss taste perception
prospective study of the outcomes of the surgical treatment of deeply infiltrating endometriosis

Conditions: Endometriosis

Summary: the aim of this study is to examine the incidence of deeply infiltrating endometriotic lesions among surgically treated endometriosis patients, and examine the impact of endometriosis, and its surgical treatment, on severity of pain symptoms, quality of life, and sexual functioning.

patients scheduled for operation on suspected endometriosis in two study hospitals specialized in the surgical treatment of endometriosis between january 2005 - december 2007 (päijät-häme central hospital) and january 2008 - december 2008 (helsinki university hospital) were enrolled to the study. the diagnosis of endometriosis was histologically verified for all patients. background data was collected from patients' age, body mass index, previous deliveries, previous endometriosis surgery, and current hormonal treatment for endometriosis. from the beginning of january 2006 patients also completed preoperative questionnaires considering visual analogue scales (vas) for pain symptoms (dysmenorrhea, deep dyspareunia, pain with urination and defecation, chronic pelvic pain, pain with ovulation), functional bowel and urinary symptoms, and 15d quality of life questionnaire, mccoy sexual functioning questionnaire, ehp-5 short form endometriosis profile questionnaire. same questionnaires will also be completed six months, one year, two years, four years, and six years after the endometriosis operation. follow-up questionnaires also contain questions concerning complications related to surgery, endometriosis recurrence, pregnancies, and infertility treatments.

Eligibility criteria:
inclusion criteria: * finnish speaking patients scheduled for operation on suspected endometriosis exclusion criteria: * non-finnish speaking patients * previous hysterectomy. * previous bilateral salpingo-oophorectomy * any cancer * chronic inflammatory bowel or bladder disease * diabetes treated with insulin * rheumatoid arthritis.

Keywords: endometriosis deep endometriosis surgery laparoscopy chronic pain quality of life sexual function complications recurrence
phase ii study of dovitinib for fgfr1 amplified squamous non-small cell lung cancer

Conditions: Squamous NSCLC

Summary: efficacy of dovitinib for squamous nsclc.


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous nsclc * previously treated with one or two lines of chemotherapy * fgfr amplification (fish \> 5 copies of genes) * 20 years or older * ecog ps 0-2 exclusion criteria: * active infection * uncontrolled brain metastasis * unstable angina or mi

Keywords: efficacy dovitinib squamous nsclc
endoscopic fundoplication versus proton pump inhibitors for gerd treatment

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: the study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (tif) in gerd patients currently treated with daily proton pump inhibitors (ppis).


Eligibility criteria:
inclusion criteria: * age 18-75 years * proven gastroesophageal reflux (ph \ 4.3% time while off ppis for 7-14 days) * on daily ppis for \> 1 year * recurrence of gerd symptoms (gerd-hrql score difference of \> 10 between on and off ppis) * normal or hypotonic les resting pressure (5-40 mmhg) * patient willingness to cooperate with random group assignment, attend 4-5 office visits and comply with all tests in this protocol * signed informed consent exclusion criteria: * bmi \> 35 * hiatal hernia \> 2 cm * esophagitis grade d * barrett's esophagus * esophageal stricture * esophageal ulcer * esophageal motility disorder * gastric motility disorder * prior splenectomy * gastric paralysis * pregnancy (in females) * immunosuppression * asa \> 2 * portal hypertension * coagulation disorders * previous antireflux procedure * any other health condition, which the investigator believes would prevent the patient from completing the study * lack of fluency in english

Keywords: gerd endoscopic fundoplication proton pump inhibitors heartburn anti-reflux surgery
treatment of diabetes after gastric bypass with sitagliptin

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to assess whether januvia (sitagliptin phosphate 100mg) is safe and effective for the treatment of type 2 diabetes in patients who have had gastric bypass.

januvia (sitagliptin phosphate 100mg) is an fda approved medication for the treatment of type 2 diabetes. sitagliptin works by inhibiting the dipeptidyl peptidase-4 enzyme, resulting in increased active glucagon-like peptide-1 (glp-1) levels. glp-1 is an incretin which increases post-prandial insulin secretion. because gastric bypass has also been shown to increase glp-1 levels, this study seeks to determine the additional effect of ddp-4 inhibition on glucose control in patients who have elevated incretin levels post gastric bypass. the study will also assess if januvia (sitagliptin phosphate) is safe and well tolerated in patients after gastric bypass. recruitment and data collection for this study was started at st. luke's hospital in new york, ny and later moved to columbia university medical center in new york, ny.

Eligibility criteria:
inclusion criteria: * must be a resident of the nyc metropolitan area or be able to come for emergency unscheduled and regular weekly meetings in manhattan. * hba1c ≥ 6.5% and ≤ 8.5 % or a fasting glucose ≥ 126 mg/dl or a random glucose ≥ 200 mg/dl at least 12 months after gbp surgery confirmed by central laboratory. * subject is capable and willing to give informed consent. * subject is otherwise in good general health, based on medical history and physical examination. * subject is a non smoker for at least 6 months prior to study start * female subjects of child bearing potential must use oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the first administration of the challenge agent. subjects using hormonal contraception should use a barrier method in addition from the first administration of challenge agent until their next normal period following the end of the study. exclusion criteria: * history of type 1 diabetes * female subject is pregnant or breastfeeding. * recent (\< 30 days) or simultaneous participation in another clinical trial. * any situation that can compromise the study, including serious illness or a predictable lack of cooperation from the subject.

Keywords: januvia sitagliptin diabetes gastric-bypass
drug interactions and hip fracture risk in older adults

Conditions: Hip Fractures

Summary: older people are in great risk of hip fracture for multiple reasons. also they often are on medications for medical conditions. hip fracture risk increases in relation to some medications. when older peoples take 2 or more medications they are in increase risk of hip fracture.

in this study the investigators describe medication intake profile and identify older people risk of hip fracture in relation to their medication when they are taken together.

Eligibility criteria:
inclusion criteria: \* affiliated patients to the hmo plan de salud hospital italiano at least 6 months affiliated. older than 64 years old \* affiliated between 01/07/2014 al 31/12/2019. exclusion criteria: * pathological hip fracture * bilateral elective hip replacement previous study period
a prospective study on the comparison of postoperative pain according to the use of cocktail therapy in laminoplasty

Conditions: Adverse Effects in the Therapeutic Use of Analgesic, Antipyretic and Anti-Inflammatory Drug, Unspecified

Summary: this study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty

this study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty. through this study, we anticipate that the potential usefulness of multimodal cocktail analgesic injections in various aspects of spinal surgery will be demonstrated, offering valuable insights and possibilities.

Eligibility criteria:
inclusion criteria: * diagnosed with cervical myelopathy or radiculopathy and scheduled to undergo laminoplasty * recorded preoperative upper limb pain (visual analog scale \[- vas\] ), neck pain (vas), japanese orthopaedic association (joa) scores, and neck disability index (ndi) scores. * adults aged 20 years and above, but below 80 years capable of articulating their own pain or functional abnormalities * cognitive function at a level that enables them to comprehend and adhere to study procedures exclusion criteria: * previous surgical treatment of the cervical spine. * adolescents aged 20 years or below, pregnant individuals, or those with the potential for pregnancy. * hypersensitivity reactions to mixed medications used in cocktail therapy. (morphine 5 mg, ropiva 150 mg, tamceton 40 mg, epinephrine 1 mg, ketocin 60 mg, jetiam 1 g). * patients who lack the capacity for medical consent or are unable to communicate effectively in a medical context.
physical activity and nutrition to halt elevated risk in the pancreas interception center

Conditions: Pancreatic Ductal Adenocarcinoma; Intraductal Papillary Mucinous Neoplasm

Summary: the purpose of this study is to assist in implementing a practical, easy-to-adopt lifestyle intervention that optimizes patient outcomes and minimizes pancreatic ductal adenocarcinoma (pdac) risk.


Eligibility criteria:
inclusion criteria: * age 18 years or older * endoscopically, radiologically, or biopsy-proven pancreatic intraductal papillary mucinous neoplasm (ipmn) over 15 mm in size * eastern cooperative oncology group (ecog) performance status 0-2 * ability to sign informed consent * ability to read and speak english or spanish * body mass index (bmi) greater than or equal to 25 kg/m2 * visceral obesity based on mri quantification of visceral and subcutaneous fat; ratio of visceral to subcutaneous fat area greater than 0.4 and/or elevated cytokine, incretin or adipokine biomarkers exclusion criteria: * no diagnosis of an ipmn * ipmn with high grade dysplasia, cancer or other high-risk features * screen failure for exercise safety * underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease * recent fracture or acute musculoskeletal injury * numeric pain rating scale of 7 or more out of 10 * myopathic or rheumatologic disease that impacts physical function

Keywords: pancreatic ductal adenocarcinoma intraductal papillary mucinous neoplasm pancreatic cancer
effect of nigella sativa in the treatment of palmer arsenical keratosis

Conditions: Arsenical Keratosis

Summary: daily intake of nigella sativa for 12 weeks is effective in the treatment of palmer arsenical keratosis

depending on inclusion and exclusion criteria total 40 patients of palmer arsenical keratosis patients (both male and female; age range 18- 60 years) will be recruited from an arsenic affected area. study population will be divided randomly into two equal groups: one group will receive vitamin e capsules (200 mg) plus placebo and another group will receive vitamin e capsule plus n. sativa capsules (500 mg) twice daily for 12 weeks. drinking water (50 ml) and urine (50 ml) samples will be collected before starting the study and estimate the amount of total arsenic in order to confirm the diagnosis. nail (approx. 1 g) and blood (5 ml) samples will be collected both before and completion of the study to see the efficacy and safety of the drug. clinical examinations will be done at regular interval (two weeks). clinical features and adverse effects will be recorded using a structured data collection sheet. plasma cholesterol, vitamin e, and total antioxidant, serum transaminase, billirubin, creatinine levels and arsenic level in nail will be measured to evaluate the effectiveness of n. sativa on palmer arsenical keratosis patients

Eligibility criteria:
inclusion criteria: * moderate palmer arsenical keratosis * patient drinking arsenic contaminated water (more than 0.05 mg/l) for more than six months * subjects those voluntarily agree to participate exclusion criteria: * patient received treatment of arsenicosis for the last three months * pregnancy * lactating mother * eczema * psoriasis * contact dermatitis * tuberculosis * diabetes mellitus * patients with hepatic and renal impairment

Keywords: arsenic keratosis nigella sativa palm vitamin e
dexamethasone/ erector spinae plane block analgesia in laparoscopic cholecystectomy

Conditions: Post Operative Pain

Summary: although considered a minimally invasive procedure, laparoscopic cholecystectomy (lc) frequently results in moderate to severe immediate postoperative pain.

although considered a minimally invasive procedure, laparoscopic cholecystectomy (lc) frequently results in moderate to severe immediate postoperative pain. in addition to predominant visceral pain, nearly half of all patients suffer from shoulder pain in the early postoperative period. the most likely reason is sub-diaphragmatic irritation, which is transmitted by the phrenic nerve, causing referred pain in the c4 dermatome. due to multiple sources of pain, multimodal analgesia approaches have been used in the perioperative period following lc.

Eligibility criteria:
inclusion criteria: * patients undergoing elective lc under general anesthesia, asa status i-ii, aged from 18 to 65 years old of both sex exclusion criteria: * contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis) * altered conscious level * pregnancy * body mass index (bmi \> 35) * advanced hepatic or renal failure * chronic opioid consumption
comparison of two calorie restricted mediterrasian diet on weight loss in fto rs9939609 overweight carriers

Conditions: Obesity; Dietary Modification

Summary: background: obesity treatment should be individualized since some calorie restricted diet doesn't work for some individuals. objective: we assess the effect of two different calorie restriction with mediterrasian diet on weight loss of fto rs9939609 carriers with overweight. methods: we recruit 80 healthy overweight participants aged 20-45 years that randomly allocated in two interventional group \[group 1: mediterrasian diet according to adjusted ideal body weight with 500 calories restriction (rd) and group 2: without 500 calories restriction (nrd)+ moderate physical activity\]. anthropometric indices will be assesses for all participants weekly for two month. the criteria for weight loss is 250-500 grams weekly. metabolic indices, physical activity and psychologic aspects will be assesses at baseline and the end of the intervention. dietary adherence will be checked by 24hr recalls at day 0, 30 and 60. at the end of the study, we compare carriers with different alleles (aa+ta and tt) in two intervention groups to find out which calorie restriction is appropriate for each genotype. significant p-value is less than 0.05.

no data yet

Eligibility criteria:
minimum age: 20 years maximum age: 45 years gender: both accepts healthy volunteers?: yes criteria: inclusion criteria: * bmi range: 24.9-29.9 (overweight) * ethnicity: persian exclusion criteria: * history of any metabolic diseases like diabetes, cvd, thyroid problems and ... . * history of depression * pregnancy, trying to become pregnant or breast feeding * smoking * use of alcohol * significant weight loos during last two months (\>5 kilograms) * being on a diet during last two months * use of any drug or supplement

Keywords: overweight caloric restriction
clinical study to investigate the safety and pharmacokinetics of udenafil tablet in renal impaired male patients

Conditions: Renal Insufficiency; Kidney Diseases; Urologic Diseases

Summary: this study is designed to assess the effect of renal impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with renal impairment compared to healthy subjects.


Eligibility criteria:
inclusion criteria: * adult males aged 19 to 64 years at screening. * subjects with body weight ≥ 55 kg and within ±30% of the ideal body weight : ideal body weight = (height \[cm\] - 100)x0.9. * subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol. exclusion criteria: * subjects with the test results of qtc \> 430 ms or non-sinus cardiac rhythm by ecg analysis. * subjects with hypotension or hypertension. * subjects who have drunken habitually (exceeding 21 units/week, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the study period from 2 days prior to the first administration of investigational product and during this study. * subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Keywords: udenafil da-8159 renal impairment healthy volunteers
multi-center trial of anti-thymocyte globulin in treatment of aplastic anemia and other hematologic disorders

Conditions: Anemia, Aplastic; Hematologic Diseases; Pancytopenia; Blood Disease

Summary: to determine the therapeutic effects of anti-thymocyte globulin (atg) in patients with aplastic anemia and related bone marrow failure diseases.

background: aplastic anemia has been shown to respond to atg. an immunological basis for aplastic anemia has been suggested by previous observations although the precise mechanism of action of atg has not been defined. this serum, produced by immunization of horses with human thymocytes, may have broad reactivity with many human cells. design narrative: patients in group i with acute severe disease were randomized to receive atg in either ten day or twenty-eight day courses. patients in group ii with moderate or chronic disease were randomized to receive either atg for ten days or high doses of the androgen, nandrolone decanoate. patients in group iii with a variety of bone marrow diseases were also treated with atg. the study completion date listed in this record was inferred from the last publication listed in the citations section of this study record.

Eligibility criteria:
men and women with moderate or acute, severe, aplastic anemia.
boosting covid-19 vaccination uptake using wastewater surveillance

Conditions: Vaccine Uptake

Summary: vaccinations are among the most successful and critical public health interventions. despite the enormous protection that vaccines provide to public health, both delays and refusals of vaccines (vaccine hesitancy) are on the rise. given that low vaccination rates present both an individual and community risk, it is critical that measures are taken to increase vaccination uptake in both rural and urban counties in new york. wastewater surveillance of sars-cov-2 has been shown to be a leading indicator of pending surges. this study will examine whether a communications campaign based upon sars-cov-2 wastewater surveillance data can increase covid-19 vaccine uptake. forty counties have been selected for the communication campaign (20 in the treatment group and 20 in the control group). a difference-in-differences method will be applied to assess the impact of the communications campaign on vaccine uptake, which observes the outcomes between a control and treatment group over pre- and post-intervention time periods. the communications campaign will be evaluated using the change in vaccination status of residents of the treatment and control counties. outcomes will also be compared between demographic groups including race and ethnicity because of differences in vaccination rates that have been already observed. we hypothesize that information regarding covid-19 provided by wastewater surveillance that is geographically based and more local to communities will increase covid-19 vaccine uptake. this theory of local information having an impact on health behavior is a novel application of the health belief model to increase vaccine uptake.


Eligibility criteria:
inclusion criteria: * counties in new york state exclusion criteria: * counties outside of new york state

Keywords: covid-19 vaccine wastewater surveillance vaccine campaign communication campaign vaccine uptake vaccine hesitancy health belief model covid-19 sars-cov-2 coronavirus