Kornimate/medical-research-clean huggingface dataset:
next generation rocklatan

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this two-stage clinical trial is to assess the safety and hypotensive efficacy of ar-17043 and pg043 ophthalmic solutions in subjects with open-angle glaucoma (oag) or ocular hypertension (oht).

during stage 1, approximately 100 adult subjects with oag or oht will be randomized to 5 arms: 3 different concentrations of ar-17043, placebo comparator, or netarsudil 0.02% (rhopressa®) for a treatment duration of 7 days. during stage 2, approximately 350 adult subjects with oag or oht will be randomized to 5 arms: low and high concentrations of pg043 (ar-17043/latanoprost 0.005%), ar-17043 high concentration, latanoprost, or netarsudil 0.02%/latanoprost 0.005% (rocklatan®) for a treatment duration of 28 days.

Eligibility criteria:
stage 1 key inclusion criteria; * diagnosis of oag or oht in both eyes. * high unmedicated iop measurements in the study eye as specified in the protocol. * corrected visual acuity equal to or better than +1.0 logmar (snellen equivalent equal to or better than 20/200) in the study eye. * other protocol-specified inclusion criteria may apply. stage 2 key inclusion criteria: * diagnosis of oag or oht in both eyes. * high unmedicated iop measurements in the study eye as specified in the protocol. * corrected visual acuity equal to or better than +0.7 logmar (snellen equivalent equal to or better than 20/100) in the study eye. * other protocol-specified inclusion criteria may apply. stage 1 and stage 2 key exclusion criteria: * current use of more than 2 ocular hypotensive medications within 30 days (either eye). * intraocular pressure greater than 36 millimeters mercury (mmhg) at screening. * glaucoma other than oag. * previous glaucoma surgery. * any abnormality preventing reliable measurements. * unable to demonstrate proper eyedrop instillation. * other protocol-specified exclusion criteria may apply.

Keywords: glaucoma iop
fibrinogen and intraoperative bleeding in liver transplant

Conditions: End Stage Liver DIsease; Liver Transplant; Complications

Summary: liver transplantation is the only treatment for end-stage liver disease. it is a high-risk surgery that can cause heavy intraoperative bleeding. bleeding and transfusions of blood products are themselves associated with several postoperative complications. few data have suggested beneficial interventions that can decrease this bleeding. such interventions are necessary in order to improve these patients' outcomes. in order to better understand the potential therapeutic targets, a better comprehension of the variables associated with such bleeding is essential. several previous studies have demonstrated a weak association between usual clotting times and bleeding in this population. however, few studies have evaluated the association between the concentration of fibrinogen and bleeding in this population. the primary objective of this study is to assess the association between preoperative serum fibrinogen concentration and the volume of intraoperative bleeding. the secondary objective is to assess the association between preoperative serum fibrinogen concentration and the number of red blood cell units transfused during the intraoperative and immediate postoperative periods. the hypothesis of the study is that a low concentration of preoperative fibrinogen will be associated with an increase in intraoperative bleeding and red blood cell transfusions.

all patients who received a liver transplant between july 2008 and january 2021 at the centre hospitalier de l'université de montréal (chum) will be included. the effect of fibrinogen concentration, intraoperative bleeding, intraoperative and postoperative transfusions, as well as postoperative bleeding-related complications and mortality up to 1 year will be assessed. the analysis will be adjusted for several confounding factors, including other coagulation parameters. the main association model will be a multivariable linear regression. this study will be used to further explore the association between fibrinogen concentration and bleeding in liver transplantation. these results may help certain clinical decisions, without suggesting any potential effect of fibrinogen correction on clinical outcomes. if an association is found, the bases will be put in place to build a clinical trial evaluating the effects of a preemptive transfusion of blood products correcting this value on clinical outcomes.

Eligibility criteria:
inclusion criteria: * adult patients undergoing liver transplant. exclusion criteria: * use of cryoprecipitate or fresh frozen plasma after measurement of serum fibrinogen concentration prior to arrival in the operating room. * amyloid neuropathy or liver cancer * fulminant hepatitis * retransplantation
effectiveness of a short computer-based emotion recognition training in different patient groups

Conditions: Autism Spectrum Disorder; Conduct Disorder

Summary: emotion recognition and regulation are necessary skills for social interaction. disrupted development of these processes severely interferes with socio-emotional development. these difficulties are commonly reported in patients with autistic spectrum disorder (asd) or conduct disorder (cd), with the subsequent social/interpersonal difficulties. the available evidence suggest that impaired emotion regulation processes might underlie the aggressive behaviours frequently observed in both disorders. however, no study has yet investigated the presence of disorder-specific characteristics on emotion processing between these two disorders. different impaired emotion recognition difficulties may underlie the reported emotion dysregulation. a practical implication of this is that given that both disorders have shown difficulties during emotion recognition processes, a short, computer-based intervention to improve emotion recognition might benefit both cases, even though their aetiologies might differ.

for asd patients, studies training facial emotion recognition have focused on increasing the active attention to the eye region, re-directing attention to facial features to facilitate facial emotion recognition. evidence shows positive results using computer-based emotion recognition training programs with young children and adolescents with asd. it has also been recently suggested that emotion recognition training may be a suitable intervention for patients with cd. this would be supported by some preliminary evidence in patients with severe behavioural problems, young offenders and patients with cd + cu traits. the overall goal of this project is to investigate the compared impact of an emotion recognition training in patients with asd or cd. this goal can be subdivided into three separate subgoals: a) identify whether the training program is effective; b) identify whether the training program has differentiated or comparable effects between both patients groups and c) investigate individual characteristics that may help identify those individuals who would benefit most from the intervention. this information is crucial to inform the design of more efficient treatments to differentially address the specific deficits associated to the disorders.

Eligibility criteria:
inclusion criteria: * diagnosis: asd or cd * german speaking * iq \> 70 * age: 10-18 exclusion criteria: * comorbid anxiety or depressive disorder diagnosis * iq \< 70 * insufficient german language skills * severe developmental disorders

Keywords: autism spectrum disorder emotion recognition training
tipops (telemedicine vs in person oncology patient surveillance)

Conditions: Breast Cancer; Prostate Cancer; Patient Engagement; Patient Preference; Patient Satisfaction

Summary: this research study is comparing telemedicine and face-to-face visits to understand patients' experiences with telemedicine versus face to face visits and to understand when it is and is not appropriate to conduct visits remotely

this study is a prospective randomized trial of telemedicine (tm) versus face-to-face (f2f) visits for follow up care of patients with either early-stage breast or prostate cancer. this study does not involve investigational drugs or devices but does involve survey data collection from participants about their experiences of care. after an initial in-person routine visit, participants will be randomly assigned to either telemedicine or face-to-face care delivery for their next routine visit. it is anticipated participants will be in the study for about 6 months depending on the timing of their routine care appointments. it is expected that 360 people will take part in this research study

Eligibility criteria:
inclusion criteria: * for breast cancer participants: early-stage breast cancer defined as stages i-iiia at diagnosis or localized prostate cancer defined as stages i-iii * for breast cancer participants: participant has completed definitive treatment for early stage breast cancer including surgery, radiation, chemotherapy, anti-her2 antibody treatment. participant may or may not be taking oral anti-estrogen treatment such as tamoxifen or an aromatase inhibitor * for prostate cancer participants: participant is on active surveillance or has undergone definitive surgery for localized prostate cancer * participant is on a surveillance follow up visit schedule occurring at every three to seven month intervals * willingness and ability to use patient gateway portal * participant has access to an electronic device that can support a video and audio virtual visit platform (for example, laptop computer, desktop computer, smart phone) * participants can be women or men * age ≥ 18 years exclusion criteria: * patients whose next visit requires cytotoxic chemotherapy, radiation therapy, anti-her2 antibody therapy or investigational cancer agents are ineligible * patients with distant metastatic breast cancer * patients with locally advanced or metastatic prostate cancer * patients treated by radiation therapy for prostate cancer * patients whose next visit requires a prostate biopsy * prisoners * non-english speaking patients (non-english speaking patients will be excluded from the trial given the challenges of delivering telemedicine with the use of medical interpreters. there are also logistical challenges in obtaining the study endpoints, which are largely survey based, with non-english speakers as well as the possibility that study endpoints will be influenced by the presence of a medical interpreter during a visit).

Keywords: breast cancer prostate cancer patient engagement patient preference patient satisfaction
the study to evaluate patient outcome using distal protection combined with the bx velocity.

Conditions: Coronary Artery Disease

Summary: the primary objective is to evaluate the use of the angioguard™ device combined with the bx velocity™ on patient outcome at one month.

this is a prospective, non-randomized, multi-center trial. patients will be treated with the angioguard™ device and bx velocity™ stent and will be followed for six-months post-procedure.

Eligibility criteria:
inclusion criteria: * unstable angina pectoris (braunwald classification b \& c, i-ii-iii, native vessels) * or lesion located in the svg; * single de novo or restenotic lesion requiring treatment in a major native coronary artery or saphenous vein graft; * the vessel diameter to place the angioguard™ device in must be \> 3 and \< 5.5 mm (6.5 when the 7mm angioguard™ is available); * target lesion stenosis is \>50% and \<100% (timi 1). exclusion criteria: * a q-wave or non-q-wave myocardial infarction within the preceding 72 hours unless the ck and ck-mb enzymes are back to normal; * more than one coronary artery is 100% occluded; * patient has unprotected left main coronary disease with \> 50% stenosis; * patient has an ostial target lesion; * significant (\>50%) untreated stenosis proximal or distal to the target lesion that will be treated during the procedure, since this may require revascularization or impede runoff; * ejection fraction \<30%; * totally occluded vessel (timi 0 level).
comparison of microtrauma in urethra after usage of different catheters

Conditions: Hematuria

Summary: the study is undertaken to investigate if the urethral microtrauma, caused by intermittent catheterization, differs between three hydrophilic catheters for intermittent catheterization, lofric; speedicath (sc) and speedicath compact male (sccm). the study is a prospective, randomised, cross-over, single-centre study. each subject will be randomized to use three different catheter types. three catheterizations will be performed with each catheter type during one day, with at least two hours between each catheterization. the washout period between catheter switch will be at least one week. the primary objective is to evaluate urethral microtrauma for three hydrophilic catheters with regards to hematuria after intermittent catheterization. the secondary objectives are to evaluate urethral microtrauma for three hydrophilic catheters with regards to pyuria and subjective evaluation after intermittent catheterization. the safety of the three catheters will be evaluated in terms of adverse advents, non-serious and serious, rated for causality. the hypothesis that level of hematuria is equal after using different catheters will be tested using wilcoxon signed rank test. the hypothesis will be rejected if the p-value is less than 5%.


Eligibility criteria:
inclusion criteria: 1. provision of informed consent 2. healthy male volunteers aged 18 years and over (half of the included subjects shall be 18-50 years and the other half \>50 years old) 3. negative urine dipstick test (no blood in the urine) before randomization exclusion criteria: 1. intake of anticoagulants at enrolment and during the study period 2. intake of antibiotics at enrolment and during the study period 3. urinary tract infection (uti) at enrolment and during the study period 4. known abnormalities or diseases of the lower urinary tract with the exception of bph 5. kidney stones 6. tumour in the urinary tract 7. known sexually transferable diseases in the urinary tract during the study period 8. involvement in the planning and conduct of the study (applies to both astra tech staff or staff at the study site) 9. previous enrolment or randomisation of treatment in the present study 10. simultaneous participation in another clinical study that might interfere with the endpoints of the study, as deemed by the investigator 11. severe non-compliance to protocol as judged by the investigator and/or astra tech
a long-term extension trial from late phase ii of spm 962 in patients with restless legs syndrome

Conditions: Idiopathic Restless Legs Syndrome

Summary: the aims of the trial are to assess the safety and the efficacy of spm 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in japanese patients with restless legs syndrome (rls) in a multi-center, open-label trial. the maximum treatment period is 53 weeks. the trial is an extension trial from the precedent 6-week, double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003). the trial is also for an exploratory investigation of incidence of augmentation, the most problematic complications in dopaminergic treatment.


Eligibility criteria:
inclusion criteria: * subject completed the preceding trial 243-07-003 (nct00666965) exclusion criteria: * subject discontinued from the preceding trial 243-07-003 (nct00666965) * subject had a serious adverse event which association with the investigational drug is not ruled out during trial 243-07-003 * subject had a persistent serious adverse event at the baseline, which was observed and association with the investigational drug is ruled out during trial 243-07-003. * subject had persistent hallucination or delusion during trial 243-07-003. * subject had psychiatric conditions such as confusion, excitation, delirium, abnormal behaviour at the baseline. * subject had orthostatic hypotension or a systolic blood pressure (sbp) ≤ 100 mmhg and had a decrease of sbp from spine to standing position ≥ 30 mmhg at baseline. * subject had a history of epilepsy, convulsion etc. during trial 243-07-003. * subject developed serious ecg abnormality at the baseline. * subject had qtc-interval ≥ 500 msec at the baseline or subject had an increase of qtc-interval ≥ 60 msec from the baseline in the trial 243-07-003 and had a qtc-interval \> 470 msec in female or \> 450 msec in male at the baseline. * subject had a serum potassium level \< 3.5 meq/l at the end of the taper period in trial 243-07-003. * subject had a total bilirubin ≥ 3.0 mg/dl or ast(got) or alt(gpt) greater than 2.5 times of the upper limit of the reference range (or ≥ 100 iu/l) at the end of the period in trial 243-07-003. * subject had bun ≥ 30 mg/dl or serum creatinine ≥ 2.0 mg/dl at the end of the taper period in trial 243-07-003. * subject who planned pregnancy during the trial. * subject was judged to be inappropriate for this trial by the investigator for the reasons other than above.
trichotillomania: group cognitive-behavioral therapy

Conditions: Trichotillomania

Summary: objective: trichotillomania is a psychiatric condition characterized by chronic pulling and plucking of one's own hair. cognitive behavioral therapy shows promise as a treatment. however, there have been no randomized, controlled studies of the efficacy of group cognitive-behavioral therapy. methods: we evaluated 44 subjects, whom met the criteria for a diagnosis of trichotillomania. subjects were randomized to receive 22 sessions of either group cognitive-behavioral therapy or group supportive therapy (control).


Eligibility criteria:
inclusion criteria: * patients having been diagnosed with trichotillomania according to diagnostic and statistical manual of mental disorders iv (dsm-iv) criteria; being at least 18 years of age; and having had four or more years of schooling. exclusion criteria: * patients that having been diagnosed with trichotillomania according to dsm-iv criteria; having less of 18 years of age; and having less of four years of schooling. * patients with a history of suicidal ideation, * patients with any clinical pathology requiring emergency treatment at admission, * patients with mental retardation or any other central nervous system disorder that severely impairs cognitive function, * those with a psychotic disorder, * those currently being treated with psychotropic drugs, * those with any dsm-iv axis ii diagnosis, * those who scored ≤ 2 on the mgh-hps in an initial screening.
vaccine effectiveness of a bivalent rsv prefusion f protein-based vaccine for preventing rsv hospitalizations in older adults

Conditions: RSV

Summary: the purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of bivalent rsv prefusion f vaccine (rsv vaccine) in older adults. participants will be randomized 1:1 to either rsv vaccine or no rsv vaccine.

the study is a pragmatic, registry-based, open-label, individually randomized trial. the danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. the study aims to randomize 130,000 participants. participants will be individually randomized 1:1 to receive either a bivalent rsv prefusion f vaccine (rsv vaccine) or no rsv vaccine. the trial is designed to assess the vaccine effectiveness of the rsv vaccine vs. no rsv vaccine on rsv-related and all-cause cardio-respiratory outcomes.

Eligibility criteria:
inclusion criteria * age 60 years and above * informed consent form has been signed and dated exclusion criteria: * there are no specific exclusion criteria for this study

Keywords: rsv vaccination pragmatic registry lower respiratory tract disease respiratory tract disease respiratory cardiovascular
tailored messaging to reduce sodium intake

Conditions: Hypertension

Summary: the proposed study will determine the effectiveness of a mobile application location-based tailored notification message system in helping hypertensive patients reduce dietary sodium intake and feel more confident in following a low sodium diet.

people with high blood pressure often get advice to lower their salt or sodium intake. high dietary sodium intake is linked to high blood pressure, stroke, heart failure and kidney disease. u.s. federal guidelines advocate daily sodium intake of less than 2,300 milligrams (mg). the estimated average sodium intake for americans is 3,400 mg per day. in recent years, consumption of processed and restaurant foods has substantially increased. more than 75% of sodium in the average u.s. diet now comes from these sources. the mobile application will deliver tailored messages based on the user's location and previously identified high-sodium food items that they commonly consume. this 8-week research study at visit 1 or baseline will consent and randomize 50 eligible adults with high blood pressure to use the mobile application daily or to follow their usual eating pattern with no access to the application. all participants will be asked to complete four surveys at baseline and week 8: block food frequency questionnaire, block sodium screener, self-care confidence in following a low sodium diet and the automated self-administered 24-hour dietary recall survey. all participants will be asked to provide a baseline and end of study 24-hour urine collection, regularly provide home blood pressure measurements and urine dipstick tests every two weeks.

Eligibility criteria:
inclusion criteria: * \> 18 years of age * hypertension * use of anti-hypertensive therapy for at least 3 months, with stable anti-hypertensive therapy (medication type and dose) for at least 2 weeks * daily sodium intake of \>2,000 mg with sodium to kcal ratio \> 1, estimated via food frequency questionnaire * ownership and use of an apple iphone exclusion criteria: * chronic kidney disease * heart failure * systolic blood pressure \>180 mm hg * diastolic blood pressure \>110 mm hg * use of a loop diuretic or corticosteroid * insulin dependent diabetes mellitus

Keywords: sodium salt diet tailored messaging mobile application
robotic inflammatory bowel disease development, learning and efficacy study

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Summary: to determine if robotic surgery can be performed for inflammatory bowel disease (ibd) patients, to ascertain the optimal robotic set up for multi-quadrant ibd operations and evaluate clinical outcomes in robotic compared to laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * aged 18 years or over * undergoing ibd surgery using mis (minimally invasive surgery) techniques * histological/radiological evidence of inflammatory bowel disease exclusion criteria: * planned open surgical approach * lacks capacity to provide informed consent

Keywords: robotic ibd surgery laparoscopic ibd surgery