Kornimate/medical-research-clean huggingface dataset:
repeated-dose behavioral intervention to reduce opioid overdose

Conditions: Opioid-Related Disorders; Drug Overdose

Summary: reboot is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients with opioid use disorder. it includes an established overdose education curriculum within an informational-motivation-behavior (imb) model. this study will test the efficacy of reboot vs attention-control.


Eligibility criteria:
inclusion criteria: * age 18-65 years * characteristics of opioid use history * previously received take-home naloxone * no life-threatening illness likely to progress clinically during trial * able/willing to provide informed consent and locator information, communicate in english, and adhere to visit schedule exclusion criteria: * suicidal ideation * participating in another interventional study that could possibly impact the study's outcomes of interest * planning to leave san francisco/boston metro area during study * previously exposed to reboot counseling intervention * any condition that, in the principal investigator's judgment, interferes with safe study participation or adherence to study procedures
lower urinary tract dysfunction database

Conditions: Neurogenic Bladder; Diseases of the Lower Urinary Tract: General Conditions

Summary: patients with neurological disease/injury often suffer from lower urinary tract symptoms, which frequently have a negative impact on the patients' health related quality of life. the prevalence of lower urinary tract dysfunction is high and the treatment is a challenge because available treatments may fail. in this study data of patients with lower urinary tract dysfunction treated at the university of zürich, are prospectively and systematically collected in a database.

lower urinary tract dysfunction is characterized by detrusor overactivity, detrusor sphincter dyssynergia, voiding dysfunction, stress incontinence, or a combination of these and frequently has a negative impact on the patients' health related quality of life. in addition, the treatment of lower urinary tract dysfunction is a challenge because conventional therapies may fail. adequate treatment and long-term follow-up of lower urinary tract dysfunction is important to achieve/maintain continence and preserve renal function. thus, we aim to prospectively collect clinical, video-urodynamic and radiological data of patients with neurogenic lower urinary tract dysfunction treated at the university of zürich in a database.

Eligibility criteria:
inclusion criteria: * patient of balgrist university hospital * patient of university hospital zürich * urodynamic examination * written informed consent exclusion criteria: * no written informed consent

Keywords: urodynamics neurogenic lower urinary tract dysfunction neurological disease/injury
mediterranean diet intervention in adolescents with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the aim of the present randomized controlled study was to examine wether a clinical decision support stystem would increase the adherence to the mediterranean diet (md) of adolescent girls, aged 15-17 years, diagnosed with polycystic ovary syndrome. the intervention lasted for 3 months and in total, 40 girls were randomly assigned to either the md group (n=20) or a control group receiving general nutritional advice (n=20). anthropometry, nutritional intake, psychological well-being, and blood markers were analyzed at the begninning and the end of the trial.

the aim of the present randomised controlled trial was to investigate the effects of a mediterranean diet (md) intervention delivered through a clinical decision support system (cdss) on various dietary, health parameters and anxiety in adolescent females, aged 15-17 years, with pcos. a randomized controlled trial was conducted with 40 adolescent females diagnosed with pcos, randomly assigned to either an intervention group (ig) (n=20) or a control group (cg) (n=20). the ig received personalized dietary guidance based on the md principles, delivered through a cdss, while the cg received general nutritional advice. measurements of dietary intake, anthropometric indices, biochemical markers, and psychological well-being were collected at baseline and after a 3-month intervention period. after 3 months, significant improvements were observed in the ig compared to the cg. adherence to the md increased significantly in the ig, leading to decreased caloric intake, fat, saturated fatty acids, and dietary cholesterol, and increased intake of monounsaturated fatty acids. conversely, the cg experienced an increase in fat and dietary cholesterol intake. both groups exhibited an increase in fiber intake, with a more pronounced rise observed in the md group. psychological well-being showed a significant reduction in anxiety levels in the ig group, while no significant change was observed in the cg. the intervention led to improvements in dietary patterns, body composition, and psychological well-being. these results underscore the importance of dietary interventions tailored to the md principles in the management of pcos among adolescent females.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed with pcos females \<18 years of age. 2. females with guardians who provided signed participation consent. exclusion criteria: 1. females ≥18 years of age. 2. females suffering from severe illnesses (i.e., organ failure, autoimmune diseases, congenital metabolic disorders), psychiatric disease or with emerging health issues that could hinder the trial. 3. pregnant or lactating females. 4. females diagnosed with alcoholism or drug addiction. 5. females being under any drug treatment. 6. females followed a specific type of diet within the past 5 years or have used nutrient or non-nutrient supplements within the last 6 months. 7. females with guardians non able to read and understand the consent information.
moderate versus deep procedural sedation with propofol in the emergency department

Conditions: Pain

Summary: this study is a clinical trial of moderate sedation versus deep sedation with propofol for procedural sedation in the emergency department. the purpose of this study is to compare the rate of amnesia and respiratory depression rate in patients who receive moderate sedation to those that receive deep sedation.

purpose: for the pilot phase, if the visual memory assessment test developed in this study can adequately assess periods of amnesia during the procedure, then it can be used for the phase of the study that randomizes patients to moderate or deep sedation. the purpose of the randomized phase is to compare the rate of amnesia and respiratory depression in patients who receive moderate sedation to those that received deep sedation. the goal is to determine whether moderate sedation could provide a safer sedation while still resulting in adequate amnesia of the procedure. secondary goals would be to compare the duration of sedation, the success of the procedures for which the patient is sedated, procedural difficulty, the rate of hypotension and other adverse events, and the patient perception of the quality of the sedation (pain or recall of procedure). background: adequate pain control and alleviation of anxiety improves quality of care and patient satisfaction. numerous studies have found that procedural sedation (ps) in the ed is safe, and when properly administered, the incidence of reported complications, including clinically significant respiratory depression, is rare. procedural sedation is used for procedures such as fracture reduction, dislocation reduction, cardioversion, incision and drainage, and chest tube placement. propofol is an anesthetic agent frequently used for ps in the emergency department (ed) and produces sedation, hypnosis, and amnesia, but lacks analgesic properties. in studies conducted at hennepin county medical center (hcmc), we have found that patients are unable to recall whether or not they experienced pain during the procedure when sedated with propofol. however, there is the possibility that certain parts of the procedure can be later recalled by the patient. if extensive parts of the procedure can be recalled, then this is not an effective sedation. previous studies of memory during sedation at hcmc have used verbal prompts only, but research has shown that people can more readily remember images. images may provide a more sensitive way to determine the degree of amnesia during sedation.

Eligibility criteria:
inclusion criteria: * adults undergoing procedural sedation with propofol in the emergency department exclusion criteria: * \< 18 years old * pregnant * previous allergic reaction to propofol * prisoner * unable to provide informed consent

Keywords: propofol moderate procedural sedation deep procedural sedation memory emergency department
molecular and cellular mechanisms of lysosomal storage diseases

Conditions: Lysosomal Storage Disorders

Summary: the lysosome is a specialized part of the cell that functions to degrade metabolic wastes in the cell. defects in the functioning of the lysosome result in accumulation and subsequent storage of such metabolic wastes. these defects lead to conditions known as lysosomal storage diseases (lsd). lsds are caused by inherited genetic mutations and there are over 40 genetically distinct lysosomal storage diseases. within each specific lysosomal storage disease there are variances in severity of disease, age of onset, and clinical presentation. though the genetic mutations contributing to the disease have been largely clarified, the molecular and cellular mechanisms that contribute to variations in each distinct lsd remain unclear. with this study we intend to better understand at the cellular and molecular level how the accumulation and storage of metabolic wastes in the lysosome affect the clinical manifestation of lsds, to detect changes in these mechanisms upon treatment administration, and to correlate these results to genetic information. the knowledge obtained from this research study could lead to better ways to diagnose and treat lysosomal storage diseases.


Eligibility criteria:
inclusion criteria: * subject is greater than or equal to 1 day of age and less than or equal to 100 years of age * signed informed consent/assent * subject is able and willing to comply with study protocol requirements. * from clinical or blood laboratory findings subject has evidence of a lysosomal storage disease or a family member of a patient with lysosomal storage disease exclusion criteria: * pregnant woman

Keywords: gaucher disease fabry disease pompe disease niemann-pick disease
effect of implementing sleep care bundle on nurses' practice and patients' outcomes

Conditions: Respiratory Ilness; Respiratory Distress Syndrome, Adult

Summary: sleep is a fundamental physiological requirement for the human body to heal and overcome an illness or injury . good sleep is essential for patient recovery and restoration of normal daily functions . critically ill patients often experience poor sleep quality due to shortened sleep times, increased daytime sleep, and disrupted circadian rhythm . poor sleep quality is one of the most common complaints of patients who survive their critical illness. patients' complaints include trouble initiating and maintaining sleep and frequent awakenings with difficulty returning to sleep

sleep plays an important role in restoring the health of individuals who are ill or injured and essential for critical illness recovery. poor sleep quality during hospitalization may lead to post-hospital symptoms and increase readmission rates and mortality . sleep disruption is associated with immune system dysfunction, decreased resistance to infection, changes in nitrogen balance, and impaired wound healing. therefore, using a standardized non-pharmacological sleep promotion strategy as a sleep care bundle is proposed to reduce the incidence of delirium and improve sleep quality. internationally, investigations performed to evaluate the effect of implementing sleep care bundle on patients' outcomes had reported its effectiveness. however, studies that addressed the effectiveness of implementing sleep care bundle on critical care nurses' practice and patients' outcomes in egypt are scarce. moreover, from our empirical observations, investigators found that there are no available standards of sleep care in the study setting. furthermore, most nurses do not realize the importance of good sleep for critically ill patients. therefore, the present study will be carried out to address this issue. hopefully, the current investigation might generate attention and motivation for using this bundle and for conducting further research studies in this area.

Eligibility criteria:
inclusion criteria: inclusion criteria * adult patients of ≥ 18 years old. * fully consciousness (glasgow coma scale score 15; orientation to person, place, and time). * spent at least 3 full nights in the above-mentioned icus. exclusion criteria: history of sleep disorder as insomnia and sleep apnea. * history of mental disorders. * patients who are on sedative or narcotic drugs. * patients who have visual or hearing impairment. * history of skin diseases (e.g., contagious skin, eczema).

Keywords: sleep care bundle nursing practice patients outcomes
cpb versus sham treatment for pain management in small duct chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: this study assesses the pain response to endoscopic ultrasound (eus) guided celiac plexus block (cpb) treatment in comparison to eus without a pain block administered. all participants will receive medications for pain as needed.

the purpose of this study is to assess pain response to eus guided celiac plexus block treatment compared to no treatment. the visual analog scale (vas) is the primary measure. secondary aims include the comparison of quality of life scores, need for narcotics, to assess the effect of eus-cpb on overall mental state using the beck's depression index, and to assess the effect of eus-cbp on health care utilization and on employment.

Eligibility criteria:
inclusion criteria: * all patients referred to uab endoscopy unit for with known chronic pancreatitis * patients referred to the endoscopy unit with abdominal pain with suspicion of chronic pancreatitis meeting 5 of 9 parenchymal and ductal changes (i.e. lobulations, hyperechoic stranding, hyperechoic foci, cysts, calcification, irregular duct, hyperechoic walls, side branch dilations and ductal calculi). exclusion criteria: * age \<19 years * unable to safely undergo eus for any reason * coagulopathy (inr \>1.6, prothrombin time \>18secs, thrombocytopenia \<80,000 cells/ml) * unable to consent * non-english speaking patients. * previously undergone cpb * pregnancy and breast feeding * patients with ductal strictures, calcification, pancreatic ductal calculi, pseudocysts. * previous pancreatic surgery * previous pseudocyst drainage * other documented causes of abdominal pain.
assessment of the safety of sar342434 and humalog® when administered as continuous subcutaneous insulin infusion

Conditions: Type 1 Diabetes Mellitus

Summary: primary objective: * assess the safety of sar342434 and humalog when used in external pumps. secondary objectives: * intervals for infusion set changes. * incidence of insulin pump alarms for infusion set occlusion. * patient observation of infusion set occlusion. * adverse events including bruising at the infusion site and injection site reactions.

the study duration for each patient will be approximately 10 weeks.

Eligibility criteria:
inclusion criteria : * male and female subjects above the age of 18. * patients with type 1 diabetes mellitus for at least 1 year prior to the screening visit. * at least 1 year of insulin treatment with at least 6 months of continuous subcutaneous insulin infusion (csii) treatment with an external insulin pump. * signed written informed consent. exclusion criteria: * hba1c ≥8.5% at screening. * diabetes other than type 1 diabetes mellitus. * history of abscess at the infusion site within 3 months prior to the screening visit (visit 1). * use of oral glucose-lowering agents or any injectable glucose-lowering agents other than insulin during the 3 months before screening. * hospitalization for diabetic ketoacidosis (dka) in the last 6 months before screening visit. * hypoglycemic unawareness as judged by the investigator in the last 6 months before the screening visit. * history of severe hypoglycemia requiring treatment by emergency room admission or hospitalization in the last 6 months before screening visit. * any clinically significant abnormality identified on physical examination, laboratory tests, or vital signs at the time of screening that in the judgment of the investigator or any sub investigator would preclude safe completion of the study. * known history of drug or alcohol abuse within 6 months prior to the time of screening. * use of investigational drug(s) within 3 months or 5 half-lives, whichever is longer, prior to the screening visit. * patients who had previously received sar342434 in any other clinical trial. * pregnancy and lactation: women of child bearing potential (wocpb) (premenopausal, not surgically sterile for at least 3 months prior to the time of screening) not using highly effective (ie, with low failure rate \<1% per year) method(s) of birth control throughout the study and/or unwilling to be tested for pregnancy. * any contraindication to the use of humalog as defined in the national product labels; history of hypersensitivity to humalog or to any of the excipients. * patients is an employee or relative of an employee of the sponsor. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
mesalamine granules for irritable bowel syndrome (ibs) with diarrhea

Conditions: Irritable Bowel Syndrome With Diarrhea

Summary: the purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of ibs with diarrhea.


Eligibility criteria:
inclusion criteria: male or non-pregnant, non-lactating female subjects diagnosed with ibs confirmed by the rome iii criteria meet the following ibs symptom scores in all categories during the diary eligibility period: * an average daily score of greater than or equal to 3 for abdominal pain * an average daily score of greater than or equal to 3 for bloating * an average daily score of 5 or greater for stool consistency using the bristol stool scale * does not have adequate relief of ibs symptoms (weekly reported) over the past 7 days on the first day of screening and on the day of randomization exclusion criteria: * present with hard or lumpy stools (type 1 or type 2) on the bristol stool form scale during the diary eligibility period * history of inflammatory bowel disease * has type 1 or 2 diabetes * pregnant or lactating * history of hiv or hepatitis b or c

Keywords: ibs diarrhea ibs-d irritable bowel syndrome abdominal pain bloating
comparison of pfs and art in adhesive capsulitis in diabetic patients

Conditions: Adhesive Capsulitis

Summary: to determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques

there is a very limited literature available active release technique (art) and post facilitation stretch (pfs) in frozen shoulder. additionally there is a very limited literature on the evaluation of art in comparison with pfs in adhesive capsulitis of diabetic patient. disease such as rheumatoid arthritis (ra), osteoarthritis (oa) etc that cause stiffness of the shoulder joint also present with altered muscle activity, that in long run becomes one of the main causes of reduces joint range of motion. with this study, we will be able to determine the technique that will have better effects in realigning the muscle kinematics and to normalize the muscle activity along with reducing muscle stiffness with mobilizations techniques. this study will also fulfill that research gap and will provide clinicians with an alternative approach in treatment of adhesive capsulitis.

Eligibility criteria:
inclusion criteria: * controlled diabetic patients (random 200-250mg/dl /fasting 120-160mg/dl). * grade 2 \& 3 of adhesive capsulitis, * pain (nprs) ranging between 3-10 * reduced normal shoulder rom's i.e * flexion less than 160 degrees. * extension less than 50 degrees. * abduction less than 170 degrees. * external rotation less than 80 degrees. * internal rotation less than 70 degrees exclusion criteria: * trauma history of shoulder/surgery. * frozen shoulder accompanied with neurological involvement. * people with any injury or disability of elbow or hand

Keywords: shoulder pain fibrosis disability
simplified and easy detection of arterial disease in nursing homes

Conditions: Artery Disease, Peripheral

Summary: peripheral artery disease (pad) affects mainly elderly patients. the ankle brachial index (abi) and ultrasound imaging are the standard diagnostic tools in pad diagnostic and severity estimation. measurements are generally performed by a vascular physician. however, access to medical specialist is becoming increasingly difficult with long waiting times while the aging of the population increases, while most of these patients are seen by the general practitioner. to date, there is a lot of data in the literature on the value of using various ambulatory devices in the diagnosis and severity estimation of pad but studied one by one. the investigators propose to compare the measurements made by a series of simple non-invasive ambulatory tools with the measurements performed by the vascular specialist. the investigators wish to demonstrate that a series of simple and economical tools, available to paramedical health professionals can diagnose pad and evaluate ts severity the reducing the direct and indirect associated costs.

patients referred for an arterial vascular investigations of the lower limbs will be included. after signing the consent, all included patients will be assessed by the examination series, among which abi measurement and an arterial doppler ultrasound of the lower limbs +/- transcutaneous oxygen pressure recording in case of suspected critical limb ischemia. following the visit patients will be classified as have or not pad and in case of pad classified for the severity of pad on the basis of the investigation results. blinded to the results of the vascular laboratory test, a technician will: measure abi with an automatic sphygmomanometer. examination series: 1. skin temperature on the back of the foot with infra-red thermometry 2. toe saturometry 3. abi with an automatic sphygmomanometry 4. skin recoloration time at the foot

Eligibility criteria:
inclusion criteria: * patients referred for arterial assessment of the lower limbs as part of a screening or follow-up of pad * patients without contraindications for all non-invasive measures * age superior to 18 years * affiliated patients of a social security scheme * patients who have signed informed consent. exclusion criteria: * patients protected by law * patients unable to understand the objectives or instructions of the study * patients in an exclusion period relative to another biomedical study.