Kornimate/medical-research-clean huggingface dataset:
occupational gaps after mild stroke: a single-center observational study

Conditions: Stroke; Occupational Problems

Summary: the goal of this observational study is to investigate participation restrictions and their determinants in people after a mild stroke. the main questions it aims to answer are: do mrs score, time since stroke onset, cognitive disorders, mood disorders and fatigue negatively impact occupations after mild stroke? does an increased prevalence of occupational gaps correlate with a diminished quality of life following mild stroke?


Eligibility criteria:
inclusion criteria: * over 18 years old, * a diagnosis of stroke confirmed by cerebral imaging, * an mrs score \<3 at the post-stroke consultation, * informed about the study * not opposed to participation exclusion criteria: * cognitive dysfunction making participation in the study impossible, * phasic disorders preventing comprehension of the questionnaires, * neurological deficits prior to the stroke, a history of psychiatric disorders * being under legal protection.
feasibility study of the treatment of acute ischemic stroke using the novis transcarotid neuroprotection system

Conditions: Acute Ischemic Stroke

Summary: study objective is to establish the feasibility and safety of the novis transcarotid neuroprotection system when used for the transcarotid intervention of patients that have a failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions.

this is a prospective, multi-center, single arm feasibility study for the endovascular treatment of patients with acute ischemic anterior circulation strokes due to large vessel embolic occlusions using the transcarotid approach with flow reversal. patients enrolled into the nite 1 study will have failed transfemoral therapy and will be followed immediately from post-op to 90 days.

Eligibility criteria:
inclusion criteria summary: * 1. patients presenting with acute ischemic stroke of the anterior circulation with large vessel occlusions who are eligible for revascularization using endovascular therapies (stentrievers and/or aspiration devices) 2. occlusion of the intracranial ica, mca m1, proximal mca m2, single-vessel mca m2, dominant mca m2, or co-dominant mca m2 segments 3. patient has failed transfemoral therapy (see appendix 4 for definition), and at least 15 minutes have elapsed from groin puncture exclusion criteria summary: * 1. significant disease of the ipsilateral common carotid artery on routine cta 2. presence of a cervical ica loop or other high-risk anatomical features of the ica on routine cta, that may preclude the use of the novis nps 3. any active or recent hemorrhage within the past 30 days 4. embolectomy contraindications a. pre-stroke mrs ≥2 b. nihss ≤ 5 c. aspects ≤ 5 5. iv tpa has been or is being administered 6. last known well \> 24 hours ago

Keywords: mechanical thrombectomy stroke treatment embolic protection transcarotid
virtual reality to improve patient experience during endoscopic mucosal and submucosal resection

Conditions: VR; Virtual Reality Pain Distraction; Endoscopic Submucosal Dissection; Endoscopic Mucosal Resection

Summary: this study explores the feasibility of using virtual reality (vr) to manage pain and anxiety during endoscopic mucosal (emr) and submucosal dissection (esd). emr and esd often requires sedation or analgesia, which can cause side effects like respiratory or cardiac suppression. vr, by immersing patients in a calming virtual environment, has shown potential in reducing pain and anxiety in medical settings. this study aims to evaluate its application in improving pain management and reducing sedation use during emr and esd.

this study utilizes a prospective randomized controlled trial (rct) design to evaluate the feasibility of incorporating virtual reality (vr) as a method for pain management during endoscopic mucosal and (emr) submucosal dissection (esd). participants will be randomized into two groups: one receiving vr sedation with on-demand analgesia and sedation, and the other following standard sedation protocols. the primary endpoint is to assess the feasibility of integrating vr for pain management during emr or esd procedures. eligibility criteria ensure that participants are suitable for the study. patients must be 18 years or older, scheduled for emr esd, able to provide informed consent, and proficient in english. those with contraindications for emr, esd, severe impairments affecting vr use, or conditions contraindicating vr are excluded. endoscopists must be experienced in emr and esd, willing to participate, and fluent in english, with non-esd practitioners or those unwilling to participate excluded. the study aims to enroll 40 patients (20 per group) and involve five experienced endoscopists from the unit, all of whom will be consented. secondary endpoints include the proportion of emr and esd procedures completed using vr, reductions in sedation and analgesia usage, differences in pain scores between the two groups, and satisfaction levels of both patients and endoscopists. follow-up will consist of immediate post-procedure feedback and questionnaires to gather insights on vr's impact. this trial will provide critical data on the potential for vr to enhance patient experience, optimize sedation use, and improve procedural outcomes during emr and esd, informing future research and clinical applications.

Eligibility criteria:
inclusion criteria: * age ≥18 years * able to consent. * fit to use virtual reality. * patients allocated to appropriate emr/ esd lists. exclusion criteria: * patients who are unable to consent. * contraindication to use vr including, epilepsy and photosensitivity. * planned other interventional colonoscopy (polypectomy, stenting). * visually impaired. * pregnancy.

Keywords: vresd virtual reality and esd vr and endoscopic submucosal dissection virtual reeality and endoscopic submucosal dissection vrwmr vremresd
aliskiren and the calcium channel blocker amlodipine combination as an initial treatment strategy for hypertension

Conditions: Hypertension

Summary: this study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.

this study was designed to evaluate if patients with hypertension treated early with a combination therapy would achieve better blood pressure (bp) control, than patients being treated with a classical sequential add-on therapy. the study compared the effects of the two treatment strategies: treatment initiation on a single compound, either with aliskiren or amlodipine, and then continuation with the combination of both versus treatment initiation with the combination of aliskiren/amlodipine and then continuation with the combination. the study also evaluated if the overall mean sitting systolic blood pressure (mssbp)-lowering effect during the study, as well as the change from baseline to study end in mssbp, are superior in the group having received combination therapy from the beginning. the study further evaluated the bp-lowering efficacy and tolerability of both treatment strategies.

Eligibility criteria:
inclusion criteria: * male or female outpatients ≥ 18 years of age * participants with essential hypertension: * naive participants must have a mean sitting systolic blood pressure (mssbp) ≥ 150 mmhg and \< 180 mmhg at visit 1 and visit 2. (participants are considered 'naïve' if they have never been treated with any antihypertensive medication.) * all participants must have a mssbp ≥ 150 mmhg and \< 180 mmhg at visit 2 * written informed consent to participate in this study prior to any study procedures exclusion criteria: * severe hypertension * pregnant or nursing (lactating) women * pre-menopausal women not taking accepted form of birth control * serum potassium ≥ 5.5 meq/l (mmol/l) at visit 1 * history of cardiovascular conditions * uncontrolled type 1 or type 2 diabetes mellitus * hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures other protocol-defined inclusion/exclusion criteria may apply.

Keywords: aliskiren amlodipine hypertension spa1000 norvasc
phase 3 study to evaluate the efficacy and safety of co-administrated ad-2021 and ad-2022

Conditions: Hypertension, Essential; Primary Hypercholesterolemia

Summary: the purpose of this study is to evaluate the efficacy and safety of co-administrated ad-2021 and ad-2022

condition or disease : primary hypercholesterolemia and essential hypertension intervention/treatment drug : ad-2021 drug : ad-2022 drug : ad-2021 placebo drug : ad-2022 placebo phase : phase 3

Eligibility criteria:
inclusion criteria: * signed informed consent * subjects with hypertension and hyperlipidemia exclusion criteria: * patient with known or suspected secondary hypertension * other exclusions applied
facilitating implementation of cognitive behavioral therapy in primary care and community clinics

Conditions: Depression

Summary: the investigators propose to test the effect of external facilitation on the extent that brief cognitive behavioral therapy (cbt) for depression is incorporated into routine practice in primary care and community based clinics in the va. the investigators will provide training in brief cbt to mental health providers in participating clinics. to the investigators' knowledge, this will be the first study of the effect of external facilitation on outcomes of a training intervention.

we will test the effect of external facilitation on the extent that brief cbt for depression is incorporated into routine practice in primary care and community based clinics in the va. we will provide training in brief cbt to mental health providers in participating clinics. to our knowledge, this will be the first study of the effect of external facilitation on outcomes of a training intervention.

Eligibility criteria:
inclusion criteria: * mental health clinicians in selected clinics who do or are willing to do psychotherapy. exclusion criteria: * clinicians who do not do psychotherapy in eligible clinics.

Keywords: implementation facilitation psychotherapy training
fmt for postop crohn's disease

Conditions: Crohn Disease

Summary: people with crohn's disease often need surgery. the gut bacteria of people with crohn's is associated with crohn's disease coming back after surgery. fecal microbiota transplant (fmt) after surgery might be a way to prevent crohn's disease from coming back after surgery. this study aims to determine if fecal microbiota transplant (fmt) taken by capsules results in the same amount of good bacteria in the guts as fmt by colonoscopy in people with crohn's disease who have had surgery. participants will be randomized to get fmt by capsules or colonoscopy. colonoscopy with biopsies 8-weeks after the fmt will be used to assess the good bacteria in the gut.


Eligibility criteria:
inclusion criteria: * able and willing to sign informed consent form * age 18 or older * english speaking * established cd for at least 6-months based on typical clinical, endoscopic, and histopathic evidence. * prior ileocecal resection for cd * stable medications for 30 days * women of reproductive age: agree to remain abstinent or use effective birth control * able and willing to comply with all study procedures exclusion criteria: * antibiotic therapy within 15 days * probiotic therapy within 15 days * adenomatous polyps that have not been removed * anticipated antibiotic use over the study period * subtotal or total colectomy * current ostomy (ileostomy or colonoscopy) * anticipated surgical procedure over study period * pregnancy * severe food allergy * diagnosis of end stage liver disease or cirrhosis * absolute neutrophil count \< 500 cell / ul * life expectancy \< 6 months

Keywords: crohn's disease ileocecal resection fecal microbiota transplant intestinal microbiota transplant
rhizomelic chondrodysplasia punctata registry

Conditions: RCDP - Rhizomelic Chondrodysplasia Punctata; RCDP1; RCDP2; RCDP3; RCDP4; RCDP5

Summary: the goal of this registry is to collect medical information on individuals with rhizomelic chondrodysplasia punctata and closely related conditions. the study team hopes to learn more about these conditions and improve the care of people with it by establishing this registry.

the goal of this registry is to collect information on individuals with rhizomelic chondrodysplasia punctata (also called rcdp). this registry will enable detailed natural history studies of rcdp, with the hopes that identification of risk factors will allow for preventative treatments and thus a better quality of life for individuals with these diagnoses. this study is limited to chart review, after signed informed consent obtained. there will be no additional visits or time in clinic because of participation in this registry. this study involves only the collection and storage of data extracted from the medical record. records that may be requested and reviewed as a part of this study include but may not be limited to: specialist evaluations, surgical reports, results of blood and urine tests, genetic testing, x-rays, ct/mri imaging. there are no special procedures, visits, or expectations of the individual as a result of participation in this registry. no one will be asked to have any specific testing for the sole purposes of this research.

Eligibility criteria:
inclusion criteria: * diagnosed with rcdp or closely related conditions by metabolic and/or genetic testing exclusion criteria: * not meeting diagnosis of rcdp or closely related conditions by study team physician review of prior metabolic and/or genetic testing
treatment patterns among patients with venous thromboembolism in the united states

Conditions: Venous Thromboembolism

Summary: the purpose of this study is to assess outpatient treatment patterns following hospitalization for venous thromboembolism (vte). vte is a condition that occurs when blood clot forms in the vein. this is a retrospective study (assessments on events that have already occurred) of healthcare claims from databases. the study sponsors will assess healthcare claim records of patients treated with either apixaban or warfarin. assessment includes treatment persistence, switch, and stopping therapy, along with recurrent vte and bleeding.


Eligibility criteria:
inclusion criteria: * inpatient hospitalization with primary discharge diagnosis of venous thromboembolism (vte) (this is the index hospitalization) * treatment with apixaban or warfarin during the hospitalization * at least 18 years of age exclusion criteria: * hospitalization for vte within 6 months prior to the index hospitalization * diagnosis of atrial fibrillation/flutter or procedure for mechanical heart valve in the 6 months prior to the index hospitalization * procedure for inferior vena cava filter or diagnosis of pregnancy during the study period * prior use of oral anticoagulants or parenteral anticoagulants
an eight-week study to evaluate the efficacy and safety of sr58611a in patients with generalized anxiety disorder

Conditions: Anxiety Disorders

Summary: the purpose of the study is to evaluate the efficacy and safety of sr58611a in patients with generalized anxiety disorder. the primary objective is to evaluate the efficacy of a 350 mg and 700 mg dose of sr58611a compared to placebo in patients with generalized anxiety disorder (gad). the secondary objectives are to evaluate the efficacy of sr58611a on disability and quality of life in patients with gad and to evaluate safety of sr58611a


Eligibility criteria:
inclusion criteria: * patients suffering from generalized anxiety disorder (gad) as defined by dsm-iv-tr criteria and confirmed by the mini international neuropsychiatric interview (mini) plus gad module * total score on the 14-item hamilton anxiety rating scale (ham-a) equal or above 20. exclusion criteria: * patients with a diagnosis of major depressive disorder as defined by dsm-iv-tr within 6 months of study entry. * patients with a montgomery-asberg depression rating scale (madrs) total score of 18 or higher at screening or baseline visits. * patients having a moderate to high current risk for suicide. * patients with other current anxiety disorder assessed with the mini: agoraphobia, social phobia, panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, acute stress disorder. * patients with a lifetime history according to the mini of: bipolar disorders, psychotic disorders, antisocial personality disorder. * patients with severe or unstable concomitant medical conditions according to the investigator's judgment. * females who are pregnant or lactating. * female patients of childbearing potential must use an effective method of birth control during the entire study period. * patients with positive test for any illicit drug included in the urine drug screen. * participation in a clinical trial of an experimental therapy within 3 months prior to screening

Keywords: anxiety anti-anxiety agents controlled clinical trials
open versus percutaneous insertion of capd catheters

Conditions: Renal Failure

Summary: healthy kidneys clean your blood by removing excess fluid, minerals, and wastes. when your kidneys fail, harmful wastes build up in your body and your body may retain excess fluid. when this happens, you need treatment to replace the work of your failed kidneys. this may be with a dialysis machine using haemodialysis or with fluid in the abdomen or peritoneal dialysis. in peritoneal dialysis, a tube called a catheter is put in the abdomen wall and used to fill your abdomen with a cleansing liquid called dialysis solution. the walls of your abdominal cavity are lined with a membrane called the peritoneum, which allows waste products and extra fluid to pass from your blood into the dialysis solution. these wastes and fluid are removed from the body when the dialysis fluid is drained and replaced with a fresh solution. the tubes or catheters used to exchange the fluid are currently positioned using a general anaesthetic (with the patient awake) and an operation with a cut under the belly button. newer techniques using local anaesthetic (with the patient awake and the area numbed) and requiring only a small cut in the skin have been used. no one has ever directly compared the two techniques. the investigators aim is to perform a direct comparison between the two techniques to look at the complications and time required for surgery and length of hospital stay required. the investigators will also look at the patients satisfaction and pain scores with each technique to help gather evidence as to which is likely to be the best technique to use from now on.


Eligibility criteria:
potential participating patients will be identified by referral to the vascular surgery department for insertion of capd catheter for peritoneal access. specific inclusion criteria necessary for invitation to study participation; * patients referred to vascular consultants for capd catheter insertion general inclusion criteria: * ability to give informed written consent specific exclusion criteria: * previous abdominal surgery via midline incision * unfit for general anaesthetic * aged under 18 at time of referral general exclusion criteria: * inability to give informed written consent * inability to attend follow up appointments withdrawal criteria: * patient request * patient non compliance with study protocol

Keywords: dialysis peritoneal catheter surgery
neonatal hyperbilirubinaemia in the democratic republic of congo

Conditions: Neonatal Hyperbilirubinemia

Summary: neonatal hyperbilirubinaemia (nh) is common among healthy neonates and normally resolves within a week. untreated pathological hyperbilirubinaemia, however, can result in long-term neurological sequelae, which compromise childhood development, or may result in perinatal death. true population-based data from middle to low-income countries are scarce and nh contribution to morbidity and mortality remains unclear. with this study the investigators aim at assessing the prevalence of neonatal hyperbilirubinaemia in a cohort of newborns in a maternity hospital in kinshasa, the democratic republic of congo, and at evaluating the possible risk factors for nh in the mother and the baby.

neonatal hyperbilirubinaemia is common among healthy neonates and normally resolves within a week. untreated pathological hyperbilirubinaemia, however, can result in long-term neurological sequelae, which compromise childhood development, or may result in perinatal death. worldwide, this condition aﬀects at least 481,000 term or near term newborn babies annually, causing 114,000 deaths and more than 63,000 cases of moderate or severe disability. in high-income settings, early diagnosis and treatment in neonatal intensive care units have dramatically improved the outcome for babies at risk. however, true population-based data from middle to low-income countries are scarce and nh contribution to morbidity and mortality remains unclear. the democratic republic of congo is one of the 5 countries with the highest neonatal mortality rate: 29 per 1000 live births, with an estimated 96,963 annual deaths. nh diagnosis is mostly performed by visual inspection, which is not very reliable, and it is not systematically reported in maternity records. the primary objective is to evaluate the prevalence of neonatal hyperbilirubinaemia in a cohort of in-hospital consecutive live births. the secondary objective is to evaluate the possible risk factors for nh in the mother and the baby. the results of this survey will provide essential baseline data for the community. if the frequency of the nh and severe nh in the area is higher than routinely reported, prompt and appropriate management guidelines can be put in place to improve treatment to decrease neonatal mortality and neurological disabilities.

Eligibility criteria:
inclusion criteria: * all live male or female new-borns * mothers of any age, willing and able to give informed consent for participation in the survey and agree to stay 72 hours in hospital after giving birth exclusion criteria: * newborn health conditions which makes difficult to drawn a blood sample * newborn health conditions requiring specific care not compatible with the survey procedures
diclofenac sodium topical gel to reduce injection site discomfort in patients taking glatiramer acetate

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to assess the effect of diclofenac sodium topical gel (dstg) on injection site reaction following self-administer glatiramer acetate in people with multiple sclerosis.

a 4 week study with active or placebo medication at randomization and switch treatment at 2-week crossover visit (2 weeks on each arm). there will be a total of 3 visits to the clinic. subjects will receive instruction on how to apply the dstg/placebo at the injection site and keep a daily injection site reaction diary.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis (ms) made at least 3 months prior based on mcdonald or poser criteria. * age 18 or more * ongoing treatment with glatiramer acetate (copaxone) for three months or more. * no ms exacerbation for 60 days prior to screening. * mean score of greater than or equal to 1.0 on screening local injection site reaction scale of last 3 days. * written informed consent. exclusion criteria: * regular use of any non-steroidal anti-inflammatory drug (ndaid), except asprin (\<325 mg daily), between screening and end of study. * any contraindication to diclofenac sodium topical gel (dstg) * allergy to dstg or any nsaid. * history of asthma, urticaria, or other allergic reaction after taking any nsaid. * females who are breast feeding, pregnant or have potential to become pregnant during the course of the study(fertile and unwilling/unable to use effective contraceptive measures). * cognitive deficits that would interfere with the subject's ability to give informed consent or preform study testing. * any other serious and/or unstable medical condition.

Keywords: multiple sclerosis diclofenac subcutaneous injection glatiramer acetate copaxone