Kornimate/medical-research-clean huggingface dataset:
internet-based behavior therapy for adults with tourette syndrome

Conditions: Tourette Syndrome; Chronic Tic Disorder

Summary: this study protocol outlines a parallel-group, randomized controlled trial (rct) designed to evaluate the effectiveness of internet-delivered behavior therapy (bt) based on exposure with response prevention (erp) for adults with tourette syndrome (ts) or chronic tic disorder (ctd). the primary aim is to evaluate the effects of internet-delivered erp-based bt on tic severity compared to a control condition offering general psychological support at week 11 counting from the treatment start. the primary outcome measure is the yale global tic severity scale - total tic severity subscale (ygtss-tts). secondary outcomes include measures of tics-related impairment, work and social adjustment, rates of responders, self-rated tic severity, symptoms of depression, and quality of life. long-term maintenance of results will be assessed at week 23 and 14 months after the treatment start. participants will be recruited nationwide. the intervention group will receive 10 weeks of erp-based therapy delivered through an online platform, with therapist support. the control group will receive psychoeducational content and general psychological support. adherence to treatment, adverse events, and patient safety will be closely monitored throughout the trial. the study population will be intent-to-treat and the between-group differences at the primary endpoint will be assessed using an analysis of covariance (ancova) with pre-score of the measure as covariate. a health-economic evaluation will assess the cost-effectiveness of the intervention.


Eligibility criteria:
inclusion criteria: ≥ 18 years of age. primary diagnosis of ts/ctd, according to criteria in diagnostic and statistical manual of mental disorders 5th edition. provided digital informed consent. have a total tic severity score (tts) of \>15, or \>10 for individuals with motor or vocal tics only, in the past week, as measured by the yale global tic severity scale (ygtss). being willing and able to follow the study procedures and participate in the 10-week treatment program. being fluent in swedish. have regular access to a computer connected to the internet, sufficient technical skills to use the treatment platform, as well as a mobile phone to receive text messages. exclusion criteria: ongoing or planned psychological treatment for ts/ctd. previous bt for tics of a minimum of 8 sessions with a qualified therapist within 12 months prior to assessment. adjustment of medication for tics within the last two months prior to assessment. severe psychiatric comorbidities such as organic brain disorders, bipolar disorder, ongoing psychosis, anorexia nervosa or substance use disorders that can interfere with the treatment for ts/ctd. acute psychiatric problems such as severe depression or suicidal risk needing immediate psychiatric care. severe tics causing immediate risk to the participants themselves or to others and requiring urgent medical attention.
glycogen storage disease type ia (gsdia) disease monitoring program

Conditions: Glycogen Storage Disease Type Ia

Summary: the main objective of this observational study is to evaluate the long-term safety and effectiveness of dtx401 for at least 10 years after dtx401 administration.

the dtx401-cl401 disease monitoring program (dmp) is a prospective, multicenter, long-term observational study to follow up participants with gsdia for at least 10 years after the administration of dtx401.

Eligibility criteria:
inclusion criteria: * patient who had: * dtx401 (full or partial dose) administered in a parent clinical study (group 1) or * prescribed dtx401(full or partial dose) administered in a post-marketing setting (group 2) * patient is willing and able to provide informed consent after the nature of the study has been explained, and prior to any research-related assessments or procedures. if a minor or an adult with cognitive limitations, the patient is willing and able (if possible) to provide assent and have a legally authorized representative provide informed consent after the nature of the study has been explained, and prior to any research-related assessments or procedures. exclusion criteria: * presence of any condition that would interfere with study participation, interpretation of results or affect patient's safety in the opinion of the investigator

Keywords: glycogen storage disorder ia aav gene therapy von gierke disease glucose metabolism disorder gsd1 gsdia
decentralization of hepatitis b care in sub-saharan africa: a pilot program in ethiopia

Conditions: Hepatitis B

Summary: the goal of this observational study is to study models of care for decentralized hepatitis b treatment in ethiopia. three different models of decentralized hbv care (standard model, simplified model, test-and-treat model) will be implemented at primary hospitals or health clinics in ethiopia. treatment will be given for free to patients who meet the treatment criteria. we will compare clinical outcome, laboratory outcomes and programmatic outcome measures between the 3 models.

chronic hepatitis b (chb) is a major health problem globally, and in ethiopia 5-10 % of the general population are infected with hepatitis b. in the absence of treatment, 15-40 % of these will die from its complications. antiviral therapy effectively prevents disease progression and death in chb. however, in low-income countries antiviral treatment is rarely available due to complex treatment guidelines, poor laboratory capacity, restrictions on antiviral treatment and lack of public funding. in 2015, we set up a pilot treatment program for chb at a tertiary hospital in addis ababa, ethiopia. in 2021/22, this program was extended to four regional secondary hospitals to study simplified chb care in a low-income country. with the present study we aim to decentralize chb therapy to rural settings, which will be essential to achieve universal access to antiviral therapy in africa. we will study different treatment models, each of which has its theoretical pros and cons: i) standard model ("treat only if..."), ii) inclusive model ("treat all except..."), and iii) test-and-treat ("treat all"). the primary endpoint will be death or liver decompensation, and secondary endpoints will be programmatic and laboratory success indicators. moreover, we will study the cost-effectiveness of these decentralized models and compare with the tertiary/secondary hospital-based model. implementation research, such as our study, is of vital importance to respond to the research gaps identified by the world health organization in hepatitis b care. our study is expected to directly inform international hepatitis b guidelines and will be a major contribution to the efforts to eliminate viral hepatitis as a public health threat by 2030.

Eligibility criteria:
inclusion criteria: * adult (at least 18 years of age) who is hbsag positive. exclusion criteria: * below 18 years of age. * negative hbsag rapid test at screening visit. * other disease with short life expectancy (disseminated cancer etc.)

Keywords: liver cirrhosis antiviral agents liver disease resource-limited settings
e-diary in heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to determine the efficacy and feasibility of using a smartphone application to monitor symptoms and weight in patients with advanced heart failure.

attention to symptoms of heart failure and weight gain are central tenets in heart failure patient education and self-care. a key self-care skill for heart failure patients is the early detection of subtle changes in symptoms. daily diary use can be one method for patients to acknowledge and attend to their symptoms. this study is examining if the use of a diary in the form of an app on a mobile phone will improve patient outcomes. participants will be randomized to one of two groups-- usual care or the movn mobile application. participants randomized to the mobile app will be asked to record their weight and any symptoms every day over the course of two months.

Eligibility criteria:
inclusion criteria: * at least 18 years old * history of symptomatic heart failure (class iii or iv) * owns a smartphone or tablet compatible with the movn mobile application exclusion criteria: * cognitive impairment * lack of english proficiency/literacy * clinically unstable (decompensated heart failure nyha class 3-4; unstable arrhythmias, aortic stenosis, thrombophlebitis, dissecting aneurysm, or symptomatic anemia; active infection; uncontrolled blood pressure: resting diastolic higher than 100 mmhg, systolic greater than 180 mmhg; unstable angina, 2nd or 3rd degree heart block; or uncontrolled high grade exercise-induced ventricular ectopy or hemodynamically unstable)
pediatric supracondylar humerus fracture nirs study

Conditions: Supracondylar Humerus Fracture

Summary: the purpose of this study is to use a device to compare the blood flow in the patient's injured arm to the patient's uninjured arm. this will help us determine 'normal' readings for this device for a child's forearm and may in the future help us detect children that have injured the blood vessels that go to the forearm when they have an elbow fracture. the patient will be one of approximately 100 people involved in this research project at carolinas medical center, and the patient's participation will last until the patient is discharged from the hospital. it is hypothesized that if the blood vessel is uninjured, the readings on the nirs device on the injured arm will be equal to the uninjured arm. it is also hypothesized that if the blood vessel of the injured arm is injured, the readings on the nirs device will be different than on the uninjured arm.

supracondylar humerus fractures (fracture just above the elbow) are common in children. supracondylar humerus fractures account for 60% of the elbow fractures in children. some supracondylar fractures injure the brachial artery and a small percentage of children present with an absent radial pulse after supracondylar humerus fracture, and these injuries may result in insufficient blood flow to the ipsilateral forearm. this can lead to compartment syndrome and/or ischemic contracture of the forearm muscles, and may result in permanent disability. currently, physicians do not have objective data to determine whether or not the forearm muscles below a supracondylar humerus fracture are receiving adequate blood flow and must rely on the clinical exam of the wrist and hand distally. the purpose of this study is to use near infrared spectroscopy (nirs) to compare the blood flow in the forearm muscle compartments of an injured arm compared to an uninjured arm. this will provide data to establish normal readings for this device for a child's forearm, and may then help clinicians detect children with insufficient perfusion of the forearm muscles after supracondylar humerus fracture.

Eligibility criteria:
inclusion criteria: * supracondylar humerus fracture needing operative treatment * ages 2-17 exclusion criteria: * bilateral (both sides) arm injuries * other injuries to the same arm * open fractures * previous vascular (blood vessels) injury to the upper extremity (arm) * vascular disease or insufficiency * not willing to consent to participate * only having one arm

Keywords: supracondylar pediatric humerus nirs near infrared spectroscopy compartment perfusion
histologic comparison of ablative techniques for endometriosis

Conditions: Endometriosis; Endometriosis-related Pain; Endometriosis Pelvic; Endometriosis; Peritoneum

Summary: to our knowledge, no other human studies directly compare the effectiveness of the various ablative technologies. we set out to design a study to directly compare ablative energy sources and evaluate their ability to destroy native endometriosis tissue in humans.


Eligibility criteria:
inclusion criteria: * adult women 18 years of age or older * already planning to undergo scheduled robotic assisted or laparoscopic excision of lesions for pelvic pain symptoms (pelvic pain, dysmenorrhea, dyspareunia, dysuria, dyschezia, ovarian pain) or endometriosis of any kind (endometriosis of any location, or endometrioma) exclusion criteria: * known pregnancy at enrollment or at the time of the excision surgery
long term safety study of plecanatide

Conditions: Irritable Bowel Syndrome

Summary: multi-center, open-label, long-term safety study

this is a phase 3, multicenter, open-label, long-term safety and tolerability study of 6 mg daily dose of plecanatide administered orally. patients who are study completers or eligible screen failures whose eligibility is confirmed at the end of their participation in the double-blind plecanatide studies sp304203-04 or sp304203-05 will be enrolled. beginning on day 1, patients will take one (1) plecanatide 6.0 mg tablet in the clinic and thereafter every morning with approximately 240 ml (8 ounces) of liquid, with or without meals. safety and tolerability assessments and patients' self-assessment of disease severity will be performed according to the schedule of assessments. patients who discontinue early from the study will undergo an early withdrawal (ew) visit within 5 days after stopping study drug.

Eligibility criteria:
inclusion criteria: patients with documented diagnosis of ibs-c who: * completed plecanatide study sp304203-04 or sp304203-05, were compliant with the previous study's requirements, and did not experience any serious adverse event (sae) deemed related to study drug during the course of the previous study, or * failed screening in study sp304203-04 or sp304203-05 due to diary noncompliance (an exclusion in the core study) or due to an administrative reason and is allowed to enter this study by notification from sponsor or delegate. key exclusion criteria: * patient is unwilling or unable to: participate in the study for the required duration, understand and sign the informed consent form (icf) and undergo all protocol related tests and procedures throughout the study. * female patient of childbearing potential with a positive urine pregnancy test on day 1. * male and female patients of childbearing potential who do not agree to continue to use the method of birth control used in the core double-blind plecanatide study for the duration of this clinical trial. * patient has experienced a significant negative change in health status during the course of participation in the core double-blind plecanatide study or after completion of the study. * in the opinion of the investigator or medical monitor, it is not in the patient's best interest to participate in the study. the reason(s) for the patient's exclusion must be specified.
mobilemedminder: a networked aide for medication compliances

Conditions: Heart Failure, Congestive

Summary: the main aim of this study is to conduct a randomized control trial to compare mobilemedminder, a mobile phone based medication reminder software product, with currently accepted and empirically supported methods for increasing medication compliance through reminders and tracking.


Eligibility criteria:
inclusion criteria: * taking beta blockers, ace or arb, and hydralazine for treatment of hf. exclusion criteria: * inability to understand informed consent * inability to read and understand english
analysis of volatile organic compounds in exhaled air and in sweat in the context of suspicion of covid-19 infection

Conditions: Covid19

Summary: in the context of the actual pandemia of the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) which requires a better diagnostic strategy for the management of patients. the study of volatile organic compounds (voc) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. the analysis of voc can be done either by the technique of the mass spectrometry which allows the identification of each voc in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the voc without identifying them. the voc have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases. moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of sars-cov-2 infection with a specificity greater than 90%; this olfactory signature corresponds to vocs detectable by the flair of dogs (nosaïs-covid19 study). validation of the diagnostic value of voc analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a sars-cov-2 infection warrants the performance of this clinical study.


Eligibility criteria:
inclusion criteria: 1. patients * patents anaged at the foch hospital for suspected covid-19 and any other patient whose management requires diagnosis of sars-cov-2 infection * patients aged 18 or over; * patients fluent in french ; * patients with a signed consent form; * patients with a health insurance plan. 2. healthy volunteers * foch hospital staff asymptomatic for sars-cov-2 infection; * aged 18 yor over; * fluent in french; * with a signed consent form; * with a health insurance plan. exclusion criteria: * pregnant woman * patient deprived of liberty by judicial or administrative decision
the use of medicinal cannabinoids as adjunctive treatment for medically refractory epilepsy

Conditions: Epilepsy, Unspecified, Refractory (Medically)

Summary: many families of children with medically refractory epilepsy are choosing to use medicinal cannabinoids (mcbd) as an adjunctive alternative treatment option. the safety, tolerability and efficacy of these products are not known. the primary objective of this study is to determine how the use of mcbd affects children with medically refractory epilepsy in an observational study. measures of evaluation to be used will include: laboratory values, developmental measures, seizure diaries and serial electroencephalographic (eeg) recordings.

this is an observational study of a family's choice to use mcbd and the effect of this substance on medically refractory epilepsy in children. the risks associated with this use are not well known. there have recently been reports of stroke, liver dysfunction and altered anticonvulsant levels. in addition, there have been long term risks reported of decreased memory function, cognitive problems and executive function abnormalities. this study does not condone or advocate the use of the substance but merely seeks to document the short term effects of the use in this population. it should be noted that providers at children's hospital colorado are not registered providers for medicinal cannabis; therefore, this will be an observational study of effects of this substance as prescribed by other physicians outside of our institution.

Eligibility criteria:
inclusion criteria: 1. male or female \>1 month of age 2. documentation of a diagnosis of medically refractory epilepsy as evidenced by medical records, genetic testing and/or the following clinical features: * failure to control seizures despite an appropriate trial of two anticonvulsant medications at therapeutic doses 3. baseline seizure frequency of at least 2 per week of the any of the following types: * generalized tonic-clonic * clonic * tonic * hemiconvulsive * drop attacks * focal motor * epileptic spasms 4. 1-3 baseline anti-seizure medications at stable doses for a minimum of 4 weeks prior to enrollment. 5. written informed consent obtained from the patient or the patient's legal representative. exclusion criteria: 1. epilepsies associated with rapidly progressing neurodegenerative diseases ex: rasmussen encephalitis, and tumors. 2. epilepsies associated with treatable inborn errors of metabolism 3. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. 4. non-epileptic events. 5. current use of mcbd products (note: patient is eligible if currently using mcbd but will be switching to a different product).

Keywords: epilepsy marijuana
remote electrical stimulation for pain and depression treatment in cirrhosis

Conditions: Cirrhosis

Summary: this study is being done to better understand how the study team can treat pain for people with cirrhosis and depression. enrolled participants on this feasibility study will be randomized to transcutaneous electrical acustimulation (tea) or sham tea.


Eligibility criteria:
inclusion criteria: * diagnosis of cirrhosis - must meet the criteria as outlined in the protocol * chronic pain (patient self-reports ≥ 4 on the 0-10 scale for \>50% of days within 3- months) * depression (in at least half of participants) - must meet the criteria as outlined in the protocol * english speaking * willing to use a transcutaneous electrical acustimulation device exclusion criteria: * dementia and/or severe cognitive impairment * unable or unwilling to provide consent * expected to undergo liver transplant in next 24 weeks * no email address * deemed unsuitable by the study investigator

Keywords: transcutaneous electrical acustimulation chronic pain depression
tricuspid regurgitation in the elderly

Conditions: Tricuspid Regurgitation

Summary: tricuspid regurgitation (tr) is the second most common vhd after mr. its prevalence also increases with age, with an estimated incidence of up to 6% in elderly population. when adjusted to age (among other confounders), survival is worse for patients with moderate and severe tr. we aim to explore the prevalence, mechanisms, and clinical implications of tricuspid valve regurgitation in elderly subjects screened at a tertiary center in cairo, egypt.


Eligibility criteria:
inclusion criteria: * all comer patients ≥60-year-old presenting to the echocardiography clinic exclusion criteria: * poor acoustic window.

Keywords: valvular heart disease tricuspid regurgitation elderly geriatric echocardiography