Kornimate/medical-research-clean huggingface dataset:
comparative evaluation of three anxiety control protocols in third molar extraction

Conditions: Anxiety Disease

Summary: the surgery for the extraction of the third molars is a procedure in dentistry that generates a large picture of anxiety in the patient. one of the ways to try to soften this picture, are the professionals to use sedation. thus, the objective of this study was to evaluate three sedation protocols, and to compare them with vital signs values, in order to obtain the sedation method with greater patients stability.

the surgery for the extraction of third molars is one of the procedures in dentistry that generates a great picture of anxiety in the patients, due to the expectation of pain and discomfort in the postoperative period, but mainly in the trans-operative period. one of the ways to try to minimize this situation is to use sedation, which is a relatively safe procedure performed by trained professionals and with an accurate indication for anxious patients. there are several protocols in the literature, but few comparative studies. thus, the objective of this study was to evaluate three sedation protocols. for this purpose, 120 patients who required surgical treatment for extraction of third molars, aged between 18 and 30 years, and whose anxiety was moderate to severe according to the corah anxiety scale from the school of dentistry of são josé dos campos (unesp). these patients were randomly divided into three groups: group i - oral sedation with diazempam 5 mg; group ii - oral sedation with midazolam 7.5 mg and group iii - inhalation sedation with 40% of nitrous oxide . prior to sedation, anxiety was quantified through the corah anxiety scale. vital signs (blood pressure, heart rate and oxygen saturation) were measured before sedation, after sedation, in the trans-operative period and 15 minutes after the end of sedation. the results will be submitted to descriptive statistics and compared using the statistical analysis of variance (anova) and tukey test with significance level of 5%.

Eligibility criteria:
inclusion criteria: * healthy patients (asa1), without surgical contra indications, requiring avulsion of the included third and / or semi-molar third molars, * between the ages of 18 and 30, * patients who agreed to voluntarily participate in the research, after knowing the risks and benefits, and signing the informed consent form (tcle). * patients who presented moderate to high anxiety level in the questionnaire proposed by corah in 1969. exclusion criteria: * patients with any systemic or local change that contra indicated the procedure, * use of anti-inflammatories in the last 15 days, * pericoronitis, * patients who did not accept the informed consent form (tcle)

Keywords: exodontia sedation nitrous oxide benzodiazepines
optimized single-breath helium lung volume in obstructive lung disease

Conditions: Obstructive Lung Disease

Summary: whole-body plethysmography (wbp) is the gold standard for measuring lung volume, but its clinical application is limited because it requires expensive equipment and is complicated to use. studies have shown that the single-breath helium dilution (sbhd) method, which is commonly used in clinical practice, significantly underestimates lung volume in patients with obstructive lung disease (old). therefore, by comparing the differences in lung volume measured by the sbhd method and wbp in patients with different severities of obstructive lung disease, we aim to establish a correction equation for the sbhd method to determine the total lung volume in obstructive lung disease patients.


Eligibility criteria:
inclusion criteria: (1) age 18-80 years and (2) in line with the ats/ers definition of obstructive lung disease. exclusion criteria: (1) contraindications for spirometry, pulmonary diffusion function test, and wbp and (2) history of lung surgery and recent history of chest trauma.

Keywords: obstructive lung disease total lung capacity the single-breath helium dilution whole-body plethysmography correction equation
mavacamten pregnancy surveillance program

Conditions: Breastfeeding; Hypertrophic Cardiomyopathy; Pregnancy Related

Summary: the purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.


Eligibility criteria:
inclusion criteria: * exposure to at least 1 dose of mavacamten at any time during pregnancy (from 4 months prior to conception to pregnancy outcome) and/or at any time during breastfeeding (up to 12 months of infant age or weaning, whichever comes first) * at least 15 years of age or older at the time of enrollment * informed consent or institutional review board/ethics committee-approved waiver of informed consent exclusion criteria: - none
the effects of flaxseed supplement on biochemical factors and hepatic fibrosis in patients with nonalcoholic fatty liver disease

Conditions: Non Alcoholic Steatohepatitis

Summary: to study the effects of flaxseed supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with nonalcoholic steatohepatitis (nash), 50 patients who referred to gastrointestinal (gi) clinic with steatosis grade 2 and 3 will be randomly allocated to receive placebos or 30 grams flaxseed powder for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. at the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria:
inclusion criteria: * age of 18 to 70 years * body mass index (bmi) between 25-40 * serum alaninaminotransferase more than 1.5 fold of upper limit of normal range * sonographic findings compatible with hepatic steatosis (degree 2 or more) exclusion criteria: * diabetes * taking any kind of antibiotics two weeks before recruitment * history of alcohol consumption * pregnancy or lactation * professional athletes * other liver disease (viral/etc) * use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin e * a history of hypertension, cardiovascular disease, pulmonary disease, renal disease \& celiac disease; cirrhosis * history of upper gi surgery / prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty * following program to lose weight in recent 3 mo * a history of hypothyroidism or cushing's syndrome
collection of biological samples from patients treated with car-t cells for hematological malignancies

Conditions: Lymphoma and Acute Lymphoblastic Leukemia

Summary: development of car-t cell against cd19 b lymphoma and acute lymphoblastic leukemia leaded to 2 authorized medication: yescarta and kymriah. despite impressive outcomes in 3 phase ii studies, never met in relapsed or refractory diseases, half of the patients don't respond to this treatment.this can be explained by a low expansion, functional alteration or short persistence of infused cells. determination of reasons for treatment failure is the first step for optimization of this therapeutics. this project aims to bank blood samples from a cohort of patients treated with car-t cell for hematological malignancies in montpellier university hospital. clinical data related to samples will be collected. this samples will be used to determine factors influencing efficacy of car-t cells treatments.

development of car-t cell against cd19 b lymphoma and acute lymphoblastic leukema leaded to 2 authorized medication: yescarta and kymriah. despite impressive outcomes in 3 phase ii studies, never met in relapsed or refractory diseases, half of the patients don't respond to this treatment.this can be explained by a low expansion, functional alteration or short persistance of infused cells. determination of reasons for treatment failure is the first step for optimization of this therapeutics. this project aims to bank blood samples from a cohort of patients treated with car-t cell for hematological malignancies in montpellier university hospital. clinical data related to samples will be collected. this samples will be used to determine factors influencing efficacy of car-t cells treatments.

Eligibility criteria:
inclusion criteria: * patient treated by car-t cell at the university hospital of montpellier exclusion criteria: * refusal to sign consent form * pregnant woman * major protected

Keywords: car t-cell lymphoma acute lymphoblastic leukemia
prevent/delay development of type 2 diabetes in subjects with impaired glucose homeostasis treated with acarbose in primary care

Conditions: Diabetes Mellitus

Summary: the purpose of the study is to determine if the administration of small doses of acarbose can prevent or delay the appearance of type 2 diabetes mellitus in a population of subjects with prediabetes.


Eligibility criteria:
inclusion criteria: * age \> 40 and \< 75 years old * men and women * able to give voluntary informed consent * existence of one or more of the following risk factors: * body mass index (bmi) \> 27 mg/kg2 * one or more family members with diabetes determined by anamnesis. * personal antecedents of previous blood glucose anomalies (gestational diabetes reverted after the lactation time, before-during surgical stress, fasting glycaemia \> 110 mg/dl (6,1 mm) and \< 126 mg/dl (7 mm) registered in the clinical history during the last 3 years, etc.) * previous consumption of drugs with hyperglycaemic capacity for a period of 3 months continuously or more than 6 months discontinuously exclusion criteria: * type 2 dm * pregnancy during the study * nursing women * major debilitating (e.g. collagen vascular diseases, failure of major organ, psychosis, severe infections, neutropenia, bmi \< 20 mg/kg2) * subjects taking a prohibited drug (see protocol) * subjects taking drugs that can impair intestinal motility and/or carbohydrate absorption (i.e. cholestyramine, neomycin) * recent cardiovascular events (within last 6 months) such as myocardial infarction, cerebrovascular accident, congestive heart failure * serum creatinine \> 2 mg/dl * fasting triglycerides \> 10 mm/l (\> 885 mg/dl) * ast elevation \> 2.5 times above the upper limit of normal * subjects with hyper/hypothyroidism non compensated * subjects with documented gastrointestinal diseases that are likely to be associated with abnormal intestinal motility or altered absorption of nutrients (e.g. gastroparesia, malabsorption syndrome, chronic diarrhoea states, enteropathies, inflammatory bowel diseases, partial intestinal obstruction, large hernias) * subjects with any emotional disorder or substance abuse (e.g. severe depression, alcohol or drug abuse) * hypersensitivity to acarbose

Keywords: metabolic disease igt impaired glucose tolerance
effects of hernia repair on men's sexual functions

Conditions: Hernia, Inguinal; Men; Sexual Dysfunction

Summary: in the literature, there are several studies that compare laparoscopic totally extraperitoneal hernia repair (tep) with lichtenstein hernia (lh) repair. there are no studies that compare sexual functions on men's health and quality of life. our aim was to study the sexual functions of men, who underwent tep or lh repair according to health survey scoring demonstration (sf36) and the international index of erectile function (iief).

176 men with unilateral inguinal hernia were randomized into two groups. group t (n=88) underwent tep and group l(n:88) underwent lh repair. patients demografigs, perioperative findings were recorded. for all patients preoperative, postoperative 7th,30th and 90th day sf 36 and iief were filled up.

Eligibility criteria:
inclusion criteria: * having male gender * patients diagnosed on unilateral inguinal hernia * patients aged between 18 and 65 years * asa i and ii patients exclusion criteria: * having female gender * patients diagnosed on bilateral or recurrence inguinal hernia, * patients suffering erectile dysfunction
a clinical trial to evaluate efficacy and safety of xeomin® injections for preventing episodic migraine

Conditions: Episodic Migraine

Summary: in this clinical trial, participants with episodic migraine will receive injections with xeomin or placebo into muscles of the head and neck. the purpose is to measure the change in monthly migraine days with xeomin injections compared to placebo injections. trial details include: * trial duration: 52 to 55 weeks; * screening period: 4 to 5 weeks; * treatment duration: 4 treatments, each about 12 weeks apart; and * visit frequency: about every 4 weeks, 14 visits in total. the first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call.


Eligibility criteria:
inclusion criteria: * participant has a diagnosis of em with or without aura according to current international classification of headache disorders (edition 3 and edition 4 alpha) criteria for ≥ 12 months and is able to distinguish migraine headaches from all other types of headaches; * participant age \< 50 years at the time of migraine onset; * participant meeting the following headache and migraine day criteria in each of the 3 months prior to screening: history of ≤ 14 headache days per month and history of 6 to 14 migraine days per month; and * during the last 28 days of the screening period, participant experiencing: ≤ 14 headache days and 6 to 14 migraine days that qualify as such per the headache diary. exclusion criteria: * diagnosis of chronic migraine; * diagnosis of other primary headache types, except tension-type headache, which is permitted; * diagnosis of aura without headache, migraine with brainstem aura, hemicrania continua, hypnic headache, hemiplegic migraine, retinal migraine, persistent aura without infarction, migraine aura-triggered seizure, or previous migrainous infarction; * diagnosis of secondary headache types, except medication overuse headache, which is permitted; * currently taking \> 1 prescribed drug for the preventive treatment of migraine; * discontinuation of anti-calcitonin gene-related peptide (cgrp) / anti-cgrp receptor monoclonal antibody treatment less than 5 months prior to screening.
the effect of feedback on physical activity surveillance using wearable device-smartphone application for resolution of metabolic syndrome in aged 60 or older

Conditions: Metabolic Syndrome; Physical Activity; Wearable Device

Summary: the effect of feedback on physical activity surveillance using wearable device-smartphone application for resolution of metabolic syndrome in aged 60 or older; a 12-week randomized control study

research on whether wearable device interventions can effectively prevent metabolic syndrome remains insufficient. this study aimed to evaluate the effect of feedback on clinical indicators in patients with metabolic syndrome aged 60 or older on activities measured using wearable devices, such as smartphone apps. patients aged 60 or older diagnosed with metabolic syndrome were recruited and prescribed to survive for 12 weeks using wrist-worn devices (b.band, b life inc, korea). the block randomization method was used to distribute the participants between an intervention group (n=20) and control group (n=20). in the intervention group, an experienced study coordinator provided feedback on physical activity to individuals through telephone counseling every other week.

Eligibility criteria:
inclusion criteria: * diagnosed with metabolic syndrome by a doctor. * aged 60 or older. * a person who understands the clinical trial process and signs the consent form * possession of a smartphone and a daily mobile phone user for the past 3. months and expected to use for more than 3 months. * a person who agrees to provide the data on the amount of physical activity measured and collected by a wearable device. * a person who can exercise at an intensity more than walking for 12 weeks. exclusion criteria: * under the aged 60. * a person who does not agree to provide data on physical activity. * those who who are judged to have difficulty in exercising such as walking due to uncontrolled diabetes, high blood pressure or serious cardiovascular disease. * a person who is not used to or is reluctant to use a smartphone app. * those who have difficulty wearing wearable devices due to skin diseases around their wrists. * a person who is expected to have an unintended change in weight over the next three months due to current pregnancy and planning, thyroid disease, cancer, etc.
intra-abdominal hypertension in neonatal intensive care patients

Conditions: Intra-Abdominal Hypertension

Summary: the observational study is designed to determine the feasibility of performing intra-abdominal pressure (iap) via bladder pressure measurements and of tracking iap in neonates who require bladder catheterization. correlation of iap measurements with clinical status of the neonatal abdomen will help determine threshold values for intra-abdominal hypertension (iah) in the neonate.

an increasingly common cause of multiple organ dysfunction syndrome (mods) is mechanical injury/ischemia caused by elevated pressures within the abdominal cavity. this phenomenon has been termed intra-abdominal hypertension (iah) with the final pathway of multiple organ dysfunction and failure termed abdominal compartment syndrome (acs). in the neonate, iah is known to accompany omphalocele, gastroschisis and diaphragmatic hernia repair. iah has also been found to cause a need for neonatal extra corporeal membrane oxygenation (ecmo) and/or a subsequent failure of ecmo treatment. while abdominal compartment syndrome is the final physiologic and clinically apparent expression of severe elevations of intra-abdominal pressure, earlier in the course of this process, significant organ dysfunction occurs at a sub-clinical level. if mild to moderately elevated abdominal pressure can be detected early, it may allow clinicians to intervene early and reverse the process, preventing progression to acs and possibly reducing morbidity and mortality. to date no study has investigated the correlation between bladder pressure (a surrogate measure of iap) in neonates who may or may not have acs. thus, the ranges of normal and elevated iap are not determined. there is suggestion from pediatric icu patients that the threshold for iah in children is less than that in adults. likewise, the threshold for iah in neonates may be expected to be even lower, but this remains to be determined. in this study, iap (via bladder pressure measurements) will be measured with a commercially available and fda approved system which utilizes an electronic pressure transducer, tubing, and any bedside patient monitor with pressure measurement inputs. these types of monitors are standard in the nicu. the pressure transducer is attached to the bladder catheter via a two-way valve, allowing urine drainage in-between taking bladder pressure measurements. a small amount of sterile saline is infused into the bladder in order to make the iap measurement. while there is an indwelling urinary catheter, bladder pressure measurements will be taken every 2-4 hours.

Eligibility criteria:
inclusion criteria: * any nicu patient is eligible for enrollment in this study if his/her medical condition has required the placement of a bladder catheter for urine drainage and who does not meet any of the following exclusion criteria. exclusion criteria: * bladder trauma * history of recent bladder surgery * neurogenic bladder

Keywords: iap measurements abdominal compartment syndrome nicu patients intra-abdominal hypertension
effectiveness of endocuff vision in improving adr

Conditions: Colorectal Neoplasms

Summary: the goal of distal attachment devices is to enhance an endoscopist's adenoma detection rate (adr). a device called endocuff vision (ecv) has been introduced that employs a single row of flexible arms to evert colonic folds, thus optimizing mucosal visualization and enhancing adr. ecv has been shown to be efficacious in improving adr within the context of randomized trials. however, no 'real-world' studies have been published assessing the effectiveness of ecv in non-trial settings. the primary objective of this study is to assess the effect of ecv use on adr in a routine screening-related population.


Eligibility criteria:
inclusion criteria: adult patients undergoing colonoscopy. exclusion criteria: * single balloon- or double balloon-assisted colonoscopy; * planned advanced polypectomy or endoscopic mucosal resection (emr); * planned endoscopic post-polypectomy or post-emr surveillance; * known active diverticulitis; * known colonic stricture.
trial testing the effect of strategies on performance of brief intervention programmes for harmful alcohol consumption

Conditions: Alcoholism

Summary: the overall objective is to study if training and support, financial reimbursement and referral to an internet based brief intervention programme, singly or in combination, may increase implementation of evidence based methods of identification and brief intervention for excessive alcohol consumption in routine primary health care.

the study will be a stepped cluster rct in 5 countries and the endpoint of the study is the number of interventions delivered during a certain time period. more specifically, the rct will examine: * the effect of continuous medical education (cme) to phc providers * the effect of financial reimbursement to phc providers as a pay-for-performance of brief alcohol interventions * whether an alternative internet based method of delivering brief intervention can increase the proportion of patients reached * if one implementation strategy will give an added value to one already enforced.

Eligibility criteria:
inclusion criteria: * primary health care units (phcu) of approximate size of 5.000-20.000 registered patients * primary health care units (phcu) located in spain, poland, sweden, england or the netherlands * providers must be physicians or nurses exclusion criteria: * primary health care units with less than 5.000 registered patients or over 20.000 registered patients

Keywords: primary health care identification and brief intervention programmes hazardous and harmful alcohol consumption
electrocautery versus scalpel for surgical skin incisions in cesarean section.

Conditions: Surgical Wound Infection

Summary: to determine the risk of surgical site infection after surgical skin incision, comparing electrocautery vs. scalpel.


Eligibility criteria:
inclusion criteria: * elective cesarean section, regardless of gestational age. exclusion criteria: * skin infection in the cesarean section area. * emergency cesarean section. * presence of a maternal pathology that increases the risk of infection (immunocompromised state).

Keywords: surgical wound infection electrocautery scalpel