Kornimate/medical-research-clean huggingface dataset:
preliminary efficacy and safety study of oral nepadutant in infant colic

Conditions: Infantile Colic

Summary: this phase iia study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic.

infant colic is a functional gastrointestinal disorders which affects up to the 30% of the infant population; it is primarily characterised by excessive inconsolable crying starting without any apparent cause and lasting for several hours per day. current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs) are largely unsatisfactory. in animal models, nepadutant reverse the exaggerated intestinal motility and sensitivity, induced by different stimuli, without producing inhibitory effects on these functions at baseline, suggesting that nepadutant could have a therapeutic effect with no interference on physiological gastrointestinal transit. this phase iia study is designed to evaluate the efficacy of nepadutant paediatric oral solution given once daily at two doses in comparison to placebo. the experimental clinical phase encompasses the following periods: * screening period (no study medication) to be done 7 to 4 days prior to randomisation * treatment period, lasting seven days with once daily administration * post treatment period, lasting seven days a safety follow-up visit will be performed approximately 1 month after the first administered dose.

Eligibility criteria:
inclusion criteria: * healthy infants with diagnosis of infant colic according to the following modified wessel criterion "paroxysm of irritability, fussing or crying that start and stop without obvious cause for \>3h/day, \>3 days/week for one week" * age \> 4 weeks and \< 20 weeks * infants breast-fed mixed fed or formula fed with a stable dietary regimen * normal growth * history of no adequate response to conventional treatment alternatives which make the infants in need of medical treatment * willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period. exclusion criteria: * clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug. * suspect of gastroesophageal reflux disease (gerd) * suspect of cow milk allergy.

Keywords: infantile colic tachykinin antagonist nepadutant
erector spinae plane block for post-thoracotomy pain control

Conditions: Post-thoracotomy Pain Syndrome

Summary: the thoracic epidural block (teb) and thoracic paravertebral block (tpvb) are the most commonly used techniques for analgesia after thoracic surgery.recently, erector spinae plane block (espb) was reported as a treatment for thoracic neuropathic pain.dexmedetomidine has been primarily used for intra- venous sedation in intensive care settings. the unique analgesic properties of dexmedetomidine have encouraged the anesthesiologists to use it perineurally. this study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.

the thoracic epidural block (teb) and thoracic paravertebral block (tpvb) are the most commonly used techniques for analgesia after thoracic surgery. however, tea has several adverse effects, such as hypotension, motor blockade, hematoma, and abscess and tpvb has a chance of epidural spread and pneumothorax, and multiple injections are needed if more than 4 dermatome analgesia is required. recently, erector spinae plane block (espb) was reported as a treatment for thoracic neuropathic pain. espb is a relatively simple technique with easily identified sonographic landmarks, and a catheter is easily inserted into the plane after distention induced by the injection. additionally, the espb has the potential to provide both somatic and visceral sensory blockade. the selectivity of dexmedetomidine to the α2-receptors is eight times of its prototype, clonidine. accordingly, dexmedetomidine is a more powerful sedative and analgesic drug than clonidine with less hemodynamic derangements from the α1-receptor activation. dexmedetomidine has been primarily used for intra- venous sedation in intensive care settings. the unique analgesic properties of dexmedetomidine have encouraged the anesthesiologists to use it perineurally. previous studies have declared that dexmedetomidine potentiates local anesthetic effect when administered by neuroaxial route. this study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.

Eligibility criteria:
inclusion criteria: * physical status asa i and ii. * age ≥ 18 and ≤ 65 years. * body mass index (bmi): \> 20 kg/m2 and \< 40 kg/m2. * patient undergoing thoracotomy for cancer surgery (lobectomy, pneumonectomy, and decortication). exclusion criteria: * patient refusal * known sensitivity or contraindication to local anesthetics or dexmedetomidine. * history of psychological disorders. * localized infection at the site of block. * coagulopathies with platelet count below 50,000 or an inr\>1.5.
educational intervention - improving knowledge and screening rates for colorectal cancer

Conditions: Colorectal Carcinoma

Summary: this clinical trial studies how well educational intervention works in improving knowledge and screening rates of colorectal cancer. an educational intervention, such as viewing an inflatable colon, powerpoint presentation, or flip books/flipcharts, may help improve knowledge about colorectal cancer and how often people get checked for colorectal cancers.

primary objectives: i. to increase colorectal cancer (crc) knowledge, attitudes, positive behavior change, intent for screening, and screening among at-risk groups. outline: participants attend educational sessions comprising of an inflatable colon interactive exhibit that allows visitors to walk through a colon while seeing images, or a powerpoint presentation that contains messages that are tailored to meet the cultural and linguistic needs of black/african americans, appalachians, and hispanics/latinos, and flip books/flip charts. participants also receive a copy of the study information sheet which contains the basic elements of informed consent and a pre-education session knowledge survey.

Eligibility criteria:
inclusion criteria: * participants from franklin county or from appalachia ohio (depending on program location)
relative bioavailability of a fentanyl patch

Conditions: Pain

Summary: tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch transdermal delivery system.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on physical exam, medical history or clinical laboratory tests on screening. exclusion criteria: * negative test for hiv and hepatitis b and c * no history of drug or alcohol treatment * no allergies to opiates
retrospective study of immunoformulation for covid-19

Conditions: Covid19

Summary: multicentre, retrospective, observational study to describe the course of sars-cov-2 disease in patients treated or not with imuno tf ® and a combination of nutraceuticals and who have tested positive in a covid-19 diagnostic test based on the duration of symptoms.

sample size justification the primary objective of the study was to describe the course of sars-cov-2 disease in patients treated or not with imuno tf® and a combination of nutraceuticals and who have tested positive in a covid-19 diagnostic test based on the duration of symptoms. sample size calculation was established according to the ich guidelines, where it was specified that the number of patients should be sufficient to provide a safe response about the issues raised. the mean duration of mild/moderate symptoms of covid-19 was 11.5±5.7 days. a sample of 18 patients would be sufficient to estimate, with a 95% confidence and a precision of +/- 2.8 days, a mean duration of symptoms with a standard deviation of 5.7 days. assuming a loss of 10% of patients, the sample size was 20 patients. considering the two groups of patients (treated with imuno tf® / not treated with imuno tf®), the sample size was 40 patients, 20 patients per group. the calculations were performed with the help of the pass package, version 2011. data processing study data were collected in a crd and inserted the data in a database specifically designed for the study. the database included internal consistency ranges and rules to ensure data quality control.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 years or older. 2. patients who give written informed consent to participate in the study. 3. patients who have consulted their physician for symptoms associated with sars-cov-2 infection between march 2020 and may 2020. patients were included in one cohort or the other based on the treatment received for improvement of covid-19 symptoms: 1. imuno tf® cohort: patients treated\* with imuno tf® with a combination of nutraceuticals 2. control cohort: patients not treated\* with imuno tf® with a combination of nutraceuticals \*without restrictions on the adjuvant treatment received. 4. patients who have tested positive in a diagnostic test for sars-cov-2. 5. patients with onset of covid-19 symptoms ≥ 5 days prior to diagnosis of sars-cov-2. 6. patients with data in the medical record from the first visit due to disease symptoms until recovery, or at least 1 month of follow-up of symptoms, whichever occurs first. exclusion criteria: 1. any medical or psychological condition that, in the physician's opinion, could compromise the patient's ability to give informed consent. 2. patients requiring hospital admission due to the disease.
fibrin sealant for cholangiotomy closure study

Conditions: Common Bile Duct Gall Stones; Infection; Bile Leak

Summary: bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.

laparoscopic common bile duct exploration is a way of dealing with common bile duct stones that has gained increasing acceptance. following a cholangiotomy there is, however, the risk of bile leakage from the incision. a way of avoiding leakage following cholangiotomy may be to apply fibrin sealant on the cholangiotomy. the present study is based on patients undergoing laparoscopic cholecystectomy at the department of surgery, enköping hospital, sweden. the patients are informed about the study prior to the procedure. cholangiography is performed routinely. in case common bile duct stones are encountered on the cholangiography, an incision is made in the common bile duct and the stones are extracted. after the stone extraction, a t tube is introduced into the cholangiotomy and the incision is closed with running vicryl sutures. when the cholangiotomy has been closed, the randomisation is performed with a sealed envelope system. if the patient is randomised to fibrin sealant, this is applied on the cholangiotomy. a passive drain is introduced before the abdomen is closed. postoperatively, the amount of bile in the passive drain is measured by an observer randomised to the allocation. if the amount of bile in the drain does not exceed 100 ml three days postoperatively, a secondary cholangiography is performed through the t tube. if the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn. all postoperative complications are registered according to the clavien-dindo system.

Eligibility criteria:
inclusion criteria: * gallbladder disease exclusion criteria: * cancer/tumor
lactoferrin efficacy versus ferrous sulfate in treatment of patients with iron deficiency anemia

Conditions: Iron Deficiency Anemia Treatment

Summary: lactoferrin (lf) is a mammalian cationic iron binding glycoprotein belonging to the transferrin family which was discovered 70 years ago, and isolated simultaneously from human and bovine milks in 1960. it is widely distributed in all biological fluids and is also expressed by immune cells, which release it under stimulation by pathogens


Eligibility criteria:
inclusion criteria:all patients with iron deficiency anemia from 2 to 15 years old - exclusion criteria: * anemia rather than iron deficiency anemia. * family history of blood disease. * patients with thalassemia trait. * patients with chronic illness.

Keywords: iron deficiency anemia lactoferrin ferrous sulfate
prospective observatonal study for effect of duodenojejunal bypass and gastric bypass on t2dm patients

Conditions: Non Insulin Dependent Diabetes Mellitus

Summary: surgical treatment for type 2 diabetes has been taken note especially in less obese or non obese patients. in asian, the nuber of less obses or non obese patients with t2dm is greater than that of the obese. we are trying to do a prospective observational study for the evaluation of the effect of duidenojejunal bypass and gastric bypass on the glycemoc control in those patients. the selection criteria are type 2 diabetess, 20-60 years old, bmi 23-34 or 21-22 with viceral obesity, insulin use less than 10 years and the patients understanding the hypothesis of this study, risks, expecting effects and agreeing this study. we are checking oral gtt, insulin level, c-peptide level, hba1c, etc. with some anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month. we will compare the clinical factors at each time.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c \> 7.0% * bmi 23 - 34 or bmi 21-22 with viceral obesity * insulin use less than 10 years * uncerstanding the risks, hypothesis, expecting effects exclusion criteria: * type 1 diabetes * c-peptide \< 1.0ng/ml * bmi \< 21 * severe cardiovascular diseases or their history * malignancy or history * alcoholics, pituitary failrue * history of severe ketosis, diabetic coma or precoma * abnormal liver enzyme, over 3 fold of normal level * liver cirrhosis or hepatitis * serum creatinine \> 2.0mg/dl * glucocorticoids user * diabetes due to other endocrine diseases * pancreatic disease * anti-gad ab (+) * the incongruity for surgery

Keywords: metabolic surgery gastric bypass duodenojejunal bypass type 2 dm
using the digital eeg spectral analysis in assessing neuroelectrical processing abnormalities in autism

Conditions: Autistic Disorder; Autism, Early Infantile; Autism, Infantile; Asperger Syndrome

Summary: individuals with autism spectrum disorder will have abnormal desa® results. our objective is to use neuroelectrical measures to determine the degree of processing abnormalities in individuals with autism. the study will survey processing patterns and will locate and evaluate the degree(s) of abnormalities for further study. the abnormal results of comprehensive neuroelectrical evaluations of individuals with autism when compared to the normative database will provide objective, verifiable, neurophysiological information with which to form novel approaches to the disorder.

the research method will be: gathering, analyzing and utilizing data. we will observe research subjects through neuroelectrical instrumentation, then, compare results to retrospective information collected from research subjects and a normative database. a qualified neurologist thoroughly familiar with electrophysiology will interpret the data, and analyze it to explore the abnormalities. the hypothesis will be evaluated. we will, then, utilize the results to find data-based forms of treatment for those with the disorder.

Eligibility criteria:
inclusion criteria: * the study will include children between the ages of five and eighteen, adults from the age of nineteen to twenty-five, and those with the diagnosis of autism and autism spectrum disorders. exclusion criteria: * those with mental retardation * those with any other neurological disorder * those that cannot sit in a chair for one hundred and fifty minutes * those that have been previously diagnosed with a seizure disorder * those who are blind and/or deaf * those who are not ambulatory * those who cannot understand english * those that are not a resident of los angeles county

Keywords: evoked potentials evoked potentials, auditory evoked potentials, visual electroencephalography brain mapping
anti vitamin k therapeutic education

Conditions: Cardio-vascular Diseases

Summary: the purpose of this study is to measure the inr (international normalized ratio) time percentage in the target zone (ttr: time in therapeutic range) of children benefiting from the avk therapeutic education program.


Eligibility criteria:
inclusion criteria: * age from 0 to 18 years * avk prescription * to accept participating to avk therapeutic education program * informed consent form of parents or legal person exclusion criteria: * parents or legal person refusal to enter in the avk therapeutic education
reducing rate of falls in older people by means of vestibular rehabilitation: preliminary study

Conditions: Dizziness Chronic; Fall; Elderly

Summary: the aim of this study is to evaluate the effectiveness of vestibular rehabilitation to improve the balance in older people and reduce the number of falls, comparing three arms with different vestibular rehabilitation strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group.

vestibular rehabilitation has been shown to be effective in compensating patients with residual instability as a result of vestibular system disorders or parkinson's disease. it is also useful for treating lack of balance in the elderly (presbivertigo). however, there is no systematic, controlled and prospective analysis of whether vestibular rehabilitation is effective in reducing the number of falls in the elderly, or whether its effects in this age group are temporary or persist over time. this study compare vestibular rehabilitation with three different strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group, in people over 65 years. balance tests are performed before vestibular rehabilitation and three weeks, six months and one year after it. number of falls are quantified one year after vestibular rehabilitation.

Eligibility criteria:
inclusion criteria: persons with a high risk of falling shall meet at least one of the following requirements: * having fallen at least once in the last 12 months. * using more than 15 seconds or needing support in the tug test (normal limit calculated in previous studies). * obtaining a mean cdp sot balance score of \< 68% (normal limit calculated in previous studies). * having fallen at least once in the cdp sot. exclusion criteria: * cognitive decline that prevents the patient from understanding the examinations and vestibular rehabilitation exercises. * organic conditions that prevent standing on two feet, necessary for assessment of balance and performance of vestibular rehabilitation exercises. * balance disorders caused by conditions other than age (neurologic, vestibular...). * reduced cultural level that prevents the patient from understanding the examinations and from granting informed consent.

Keywords: vestibular rehabilitation falls in elderly computerized dynamic posturography optokinetic stimuli
impact of the "ten steps for healthy feeding of children younger than two years" in health centers

Conditions: Feeding and Eating Disorders of Childhood

Summary: a cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.

cluster randomized controlled trial targeting selected primary health care centers in porto alegre, south of brazil, a city of 1.4 million inhabitants. the trial included health centers that provide primary care services predominantly to low-income families.physicians, nurses and administrative staff of all intervention health centers participated in a training in january 2008 based on the "ten steps for healthy feeding for brazilian children from birth to two years of age" guideline. following staff training at the intervention sites, interviewers visited the intervention and control health centers from april to december 2008 to identify and enroll pregnant women who were in the last trimester of pregnancy. 98% of eligible pregnant women agreed to participate and answered a questionnaire about their socioeconomic status and expected due date. addresses and telephone numbers were obtained in order to schedule subsequent home visits. data collection: maternal interviews using structured questionnaires were conducted at baseline (during pregnancy - 2008) and at follow-up home-visits at mean child ages six months (2008/2009), 12 months (2009/2010) , three years (2011/2012) and six years (2014/2015) by field workers who were not involved in the intervention and who were unaware of the group allocations.

Eligibility criteria:
inclusion criteria: * all pregnant women in the last trimester of the gestation. exclusion criteria: * hiv-positive mothers * congenital malformation

Keywords: breast feeding child infant nutrition physiology public health morbidity health plan implementation