Kornimate/medical-research-clean huggingface dataset:
joint status in subjects with severe hemophilia a in relation to different treatment regimens

Conditions: Hemophilia A

Summary: the joint status (knees, ankles) of patients suffering from severe hemophilia a (too little blood clotting factor viii in blood) is evaluated in a single magnetic resonance imaging session. no study medication is given.


Eligibility criteria:
inclusion criteria: * males aged 12 - 35 years * severe hemophilia a ( \< 1 % fviii:c) * no history of factor viii inhibitory antibody * for prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present. * complete documentation of joints bleeds and their locations prior to start of prophylaxis, * bleeding history and/or treatments received during the last 5 years documented in the subjects medical records. * for the on-demand subjects \> 12 bleeds/year in the last 5 years. * written informed consent by subject and parent/legal representative, if \< 18 years exclusion criteria: * individuals with other coagulopathies (e.g., von willebrand disease) * hiv seropositive subjects * individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee) * hcv seropositive individuals who underwent interferon therapy during the last 12 months * individuals for whom high-magnetic exposure is contraindicated (see section 7.1) * synovectomy performed within the six months prior to investigation enrollment or orthopedic surgery planned to be performed within the investigation period * joint replacement * for the on-demand treatment group, any period greater than 8 consecutive months having received \>/= 50 iu per kg per week factor viii for the prevention of bleeding

Keywords: hemophilia a joint status bleeds magnetic resonce imaging
is it necessary to set external peep in aecopd patients

Conditions: Acute Exacerbation Chronic Obstructive Pulmonary Disease

Summary: acute exacerbation of chronic obstructive pulmonary disease patients with intrinsic positive end-expiratory pressure (peepi), neurally adjusted ventilatory assist (nava) reduce work of breathing and trigger delay at any external positive end-expiratory pressure (peepe) level compared with pressure-support ventilation (psv)

all patients randomly underwent a 30 mins psv and nava crossover ventilation (15 mins each) at progressive peepe levels. progressive levels of peepe were applied stepwise in increments of 40% of baseline static peepi, every 30 mins, from zero to 160% of baseline static peepi during the protocol (0, 40%, 80%, 120% and 160% of static peepi, respectively). during psv, pressure support level was set to meet a vt 6ml/kg, i/e cycling was 30% of the maximum inspiratory peak flow, flow trigger was 1l/min, and inspired fraction of oxygen (fio2) was set to the similar level before the study protocol. during nava, nava level was set at 15 cmh2o / µv and a peak airway pressure limit was set in order to apply the same inspiratory pressure support at each peepe level during psv. the new setting of nava was defined as nava15. moreover the trigger was set at 0.5 µv and the i/e cycling fixed at 70% of the peak of eadi. during the entire protocol, fio2 and peak air way pressure were maintained the same levels at each peepe level between psv and nava. arterial blood gases were measured at the end of psv or nava15 ventilation at each peepe level.

Eligibility criteria:
inclusion criteria: 1. mechanical ventilation aecopd patients with static peepi measured by end-expiratory airway occlusion method ≥ of 5 cm h2o 2. hemodynamics stability (heart rate \< 140 beats/min, no vasopressors required, or \<5 μg/kg/min dopamine) without any evidence 3. no sedation or on minimal sedation with low dose of morphine (\<3mg/h, by continuous intravenous infusion 4. breathing spontaneously 5. awake and with positive cooperate exclusion criteria: 1. tracheostomy 2. treatment abandonment 3. history of esophageal varices 4. gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days 5. coagulation disorders (inr ratio\>1.5 and activated partial thromboplastin time \> 44 s) 6. history of acute central or peripheral nervous system disorder or severe neuromuscular disease

Keywords: aecopd work of breathing patient-ventilator synchrony
efficacy and safety of rivaroxaban in acute non-neoplastic portal vein thrombosis in hcv

Conditions: Portal Vein Thrombosis

Summary: portal vein thrombosis (pvt) in patients with liver cirrhosis may be due to neoplastic growth or non-neoplastic causes. * treating pvt with anticoagulation in liver cirrhosis is difficult to be established but may be of great benefit in acute symptomatic pvt. * the ultimate goal is complete recanalization of the portal vein without inducing major bleeding, abnormal liver function tests or increased mortality.

out of 220 patients with chronic hcv who had undergone splenectomy due to hypersplenism in the period extending from may 2014 until august 2016; 36 participants (16.4%) were selected. they were presented with acute pvt. also, the investigators enrolled 4 patients who were presented with pvt due to portal pyemia complicated infected thrombosed internal piles (n=1), appendicular abscess (n=1), ulcerative colitis (n=2). control group it included 30 patients who had acute non-neoplastic pvt with the same inclusion criteria and were given symptomatic therapy for ascites, abdominal pain and followed synchronously with the study group. laboratory investigations they included investigation preliminary to splenectomy as liver function tests, coagulation profile, renal function tests, complete blood count, reticulocyte count and bone marrow aspiration. for each patient, child-pugh (ctp) and meld scores were calculated. abdominal ultrasonography (usg) cirrhotic echo pattern, criteria of portal hypertension, ascites, hcc were excluded color doppler sonography to confirm the diagnosis of pvt. upper gi endoscopy all the patients before splenectomy were exposed to upper gi endoscopy to detect the presence and grading of gastro-esophageal varices. protocol of therapy enoxaparin was initiated at a dose of 1mg/kg every 12 hours subcutaneously for 3 days then treatment was continued with rivaroxaban 10mg/12 hr. rivaroxaban was started 2 hours before the next dose of enoxaparin. * follow up every week with a questionnaire about symptoms of bleeding (hematemesis, melena, epistaxis, gum bleeding, vaginal bleeding, subcutaneous bleeding), worsening or improvement of abdominal pain. * bedside ultrasonography for detection of thrombus resolution and presence or improvement of ascites every 2 weeks laboratory follow-up which included serum creatinine, complete blood count, and liver function tests to detect if there any side effects of the therapy every 2 weeks.

Eligibility criteria:
inclusion criteria: * acute non-neoplastic portal vein thrombosis * compensated cirrhosis (child class a-b) * the onset of pvt is within 1 week. exclusion criteria: * decompensated liver disease * bleeding tendency or recent bleeding event as bleeding peptic ulcer or oesophageal varices * neoplastic invasion of the portal vein * renal impairment with the creatinine clearance ≤ 30 ml/min * pregnancy and breastfeeding * hypersensitivity to rivaroxaban * concomitant treatment with another anticoagulant * concomitant use of clopidogrel.

Keywords: portal vein thrombosis acute rivaroxaban
rollover protocol continued access to tenofovir disoproxil fumarate (tdf) for subjects in taiwan

Conditions: Hepatitis B

Summary: the purpose of this study is to offer subjects from centers in taiwan who successfully complete 168 weeks of treatment in study gs us 174-0108 access to treatment with tenofovir df for up to three additional years (144 weeks). subjects will be followed per local standard of care. serious adverse events (saes), drug accountability and patient disposition will be recorded.


Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to be eligible for participation in this study. * complete all end of study visit procedures for the gs us 174-0108 study. * willing and able to provide written informed consent. * a negative pregnancy test is required for female subjects at the end of study visit (i.e., screening visit for study gs-us-174-0141) for gs us 174-0108 (unless surgically sterile or greater than two years post-menopausal) * all sexually active female subjects who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study. * male subjects who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion. exclusion criteria: • not applicable
early outcomes of arthroscopic versus open reduction for developmental dysplasia of the hip in children

Conditions: Developmental Dysplasia of the Hip (DDH)

Summary: this study was designed to determine whether arthroscopic-assisted reduction offers better early surgical outcomes than open reduction for treating developmental dysplasia of the hip in children. by comparing these two approaches, the researchers sought to find out if using an arthroscopic-assisted method could lower redislocation rates, shorten operative time, reduce blood loss, maintain acceptable acetabular alignment, and potentially decrease the risk of complications such as avascular necrosis, thereby improving the quality of care and long-term hip function for affected children.

this investigation evaluates two distinct surgical strategies for managing developmental dysplasia of the hip (ddh) in young children using a comparative, parallel-group design. the technical approach under consideration involves an arthroscopic-assisted procedure, which provides direct visualization of the hip joint structures through minimally invasive portals. by employing specialized instruments and an arthroscopic camera system, surgeons can assess ligamentous and capsular integrity, identify obstacles to proper femoral head positioning, and address intra-articular pathologies with potentially less disruption to the vascular supply and surrounding soft tissues than is typical in conventional open surgery. the surgical team implemented stringent measures to maintain uniformity in anesthesia protocols, operative setup, and postoperative immobilization strategies, ensuring that any observed differences would more likely be attributable to the surgical technique rather than confounding variables. additionally, advanced imaging modalities, including fluoroscopic guidance where appropriate, were used intraoperatively to confirm adequate reduction and optimize acetabular coverage. the study's procedural protocols were developed in consultation with senior pediatric orthopedic surgeons experienced in both techniques and piloted to establish feasibility before patient enrollment commenced. in this manner, the investigation aims to refine the understanding of arthroscopic-assisted hip reconstruction in the pediatric population, providing insights that may influence future surgical guidelines, training curricula, and patient care pathways.

Eligibility criteria:
inclusion criteria: * children diagnosed with ddh (tönnis grade ii-iv) * age range: 12 to 24 months at the time of the first surgical reduction * a documented failed attempt at conservative reduction (e.g., closed reduction) prior to enrollment exclusion criteria: * presence of neuromuscular disorders * teratologic hip dislocation * prior surgical intervention on the affected hip * incomplete radiographic documentation (missing radiographs at any of the required assessment intervals)

Keywords: arthroscopic-assisted reduction developmental dysplasia of the hip open surgical reduction pediatric orthopedic surgery avascular necrosis
radiographic stability of hip prosthesis prior to revision surgery

Conditions: Loosening, Prosthesis; Hip Arthropathy

Summary: the goal of this validation study is to compare the preoperative implant stability, assessed by implant movement analysis (ima), provocation dual ct scans, with the intraoperative stability evaluation in revision hip arthoplasty. the main question it aims to answer is: does ima reflect the intraoperative clinical evaluation of implant stability? participants scheduled for revision hip arthoplasty will undergo ima preoperativelly in addition to rutine clinical work up. during revision arthoplasty, a surgeon blinded to the ima results will assess clinically the stability of the hip prosthesis. ima will be compared with the intraoperative findings to assess imas sensitivity and specificity


Eligibility criteria:
inclusion criteria: 600 consecutive patients scheduled for revision tha due to aseptic loosening, in whom, one component has no convincing loosening signs, based on the preoperative plain radiographs and clinical assessment by the attending surgeon. the radiographs should be not older than 8 weeks prior to surgery. exclusion criteria: both cup and stem have been preoperatively evaluated as loose by the attending surgeon, based on the preoperative plain radiographs. instability with repeating dislocation of the tha non-aseptic revision surgery, based on preoperative work up. participants are excluded after inclusion if revision surgery is cancelled.

Keywords: implant stabilty tha radiographic evaluation ima implant movement analysis revision tha
leveraging adult protective service interaction to offer evidence-based treatment for depression in elder neglect/self neglect

Conditions: Depression in Old Age

Summary: the purpose of this study is to test the feasibility and acceptability of an evidence-based treatment for depression delivered over an ipad, computer, or smartphone can help adult protective services (aps) clients with their activities of daily living to evaluate whether reductions on measures of depression and apathy (a) mediate reduced elder neglect/self neglect (en/sn) behaviors; and (b) whether secondary posited mediating mechanisms are also active in impacting depression and apathy


Eligibility criteria:
inclusion criteria: * aps case in aps region vi- must have open case * phq 9 score- must have score of nine (9) or more exclusion criteria: * previous mental health diagnosis of bipolar disorder, psychotic disorders, and moderate to severe dementia * assessment of consent proxy- those who need assessment of consent proxy * suicidal intent (as indexed by phq-9 question 9)- those scoring 2 or 3 * current alcohol and drug dependency- as evidenced by cut down, annoyed, guilty, and eye-opener (cage) score of 3 or more

Keywords: elder neglect self neglect
the life after stopping tyrosine kinase inhibitors study (the last study)

Conditions: Leukemia, Myeloid, Chronic

Summary: this is a non-randomized, prospective, single-group longitudinal study. the purpose of this study is to improve the decision making process used by physicians and patients when they are considering stopping their tyrosine kinase inhibitor (tki) medication.

this is a non-randomized, prospective, single-group longitudinal study. the overall objective is to improve decision making for tki discontinuation in eligible chronic myelogenous leukemia (cml) patients. patients with cml on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their tki. confirmed deep (\> 4 log reduction) molecular response (\>mr4) defined as p210 (bcr-abl) fusion protein (bcr-abl) \< 0.01%, for at least two years. the study will closely monitor patients using standard real-time quantitative polymerase chain reaction (rq-pcr) testing for molecular recurrence, testing them monthly for six months, then every other month until 24 months, and then quarterly until 36 months. concurrently, the study will assess a wide range of patient-reported outcomes (pros) before stopping tkis and after discontinuation in conjunction with polymerase chain reaction (pcr) testing, though at fewer time points, utilizing online and/or phone questionnaires. patients who have molecular cml recurrence based on rq-pcr will restart imatinib, dasatinib, nilotinib, or bosutinib and will continue to be monitored for disease status and health status until the end of the study.

Eligibility criteria:
inclusion criteria: 1. age 18 or older at time of study entry 2. willing and able to give informed consent 3. diagnosed with cml in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 bcr-abl protein 4. currently taking imatinib, dasatinib, nilotinib or bosutinib 5. patient has been on tki therapy for at least 3 years 6. documented bcr-abl \ mr4 i.e. \>4 log reduction) or undetectable bcr-abl by pcr for at least 2 years according to the patient's local lab 7. documented bcr-abl \ mr4 i.e. \>4 log reduction) or undetectable bcr-abl at least 3 times prior to screening according to the patient's local lab 8. two (2) screening pcrs have been completed and both results are \ mr4 i.e \> 4 log reduction) by central lab 9. has been on any number of tkis, but has not been resistant to any tki (changes made for intolerance are allowed) 10. patient has been compliant with therapy per treating physician exclusion criteria: 1. prior hematopoietic stem cell transplantation 2. poor compliance with taking tki 3. unable to comply with lab appointments schedule and pro assessments 4. life expectancy less than 36 months 5. patients who have been resistant to previous tki therapy are not eligible 6. pregnant or lactating women
contrast-enhanced ultrasound for the prediction of bile duct cancer response to radioembolization treatment

Conditions: Intrahepatic Cholangiocarcinoma

Summary: this phase ii trial tests whether contrast-enhanced ultrasound can predict the response of bile duct cancer to targeted radiotherapy (radioembolization treatment). contrast-enhanced ultrasound uses gas microbubbles that may provide enhancement on ultrasound. it is also possible to pop these microbubbles using ultrasound imaging. tumors that experience popping of these microbubbles may be easier to kill with radiotherapies. therefore, this trial may also help doctors see if ultrasound-triggered microbubble popping can improve bile duct cancer response to radiotherapy. another purpose of this trial is to test if the pressure inside the tumor estimated through ultrasound can be used to predict the tumor response to radiotherapy.

primary objective: i. to determine the ability of quantitative volumetric contrast-enhanced ultrasound (ceus) to predict non-hepatocellular carcinoma (hcc) tumor response to transarterial radioembolization (tare) prior to therapy. secondary objectives: i. to characterize the safety and preliminary efficacy of using localized ultrasound contrast agent (uca) inertial cavitation to improve icc response to radioembolization. ii. to determine if ceus estimated tumor perfusion and residual vascularity 7-14 days post treatment can predict icc response to radioembolization. iii. to evaluate tumoral response using the patient's 1 month magnetic resonance imaging (mri) (obtained clinically) and determine the accuracy of mr or computed tomography (ct) tumor evaluation at this earlier time point. exploratory objective: i. to examine the utility of subharmonic aided pressure estimation (shape) to noninvasively monitor tumoral interstitial fluid pressure (ifp) and provide an early biomarker of radiotherapy response. outline: patients receive perflutren protein-type a microspheres intravenously (iv) over 10 minutes and undergo ultrasound at 1 month before tare, 1-4 hours, 1 week, and 2 weeks post-tare. after completion of study, patients are followed for 1 year.

Eligibility criteria:
inclusion criteria: * be scheduled for sub-lobar radioembolization therapy of a previously untreated intrahepatic cholangiocarcinoma greater than 1 cm but small enough to be fully visualized in the ultrasound three-dimensional (3d) volume (approximately 6 cm maximum diameter, but depth dependent) * be at least 18 years of age * be medically stable * if a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam * have signed informed consent to participate in the study exclusion criteria: * females who are pregnant or nursing * patients with recent cerebral hemorrhage * patients with known sensitivities to albumin, blood, or blood products * patients with known hypersensitivity to perflutren * patients with known congenital heart defects * patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli * patients with bilirubin levels \> 2 mg/dl
management of cerebral vascular spasm in posttraumatic subarachnoid hemorrhage using combination therapy

Conditions: Oral Nimodipine; Milrinone; Vascular Spasm After Traumatic Subarachnoidhaemorrhage

Summary: to evaluate the efficacy and safety of oral nimodipine and iv milrinone combination therapy for management of cerebral spasm after aneurysmal subarachnoid hemorrhage.

after being informed about the study and potential risks. all patients giving written consent will be randomized by double-blind manner into 2groups each one containing 15 patients. group 1(n =15 ):the patients will receive nimodipine (60 mg/4 hours) orally or via nasogastric tube in group 2(n =15 ): the patients will receive oral nimodipine (60 mg/4) will be given orally or in the gastric tube also from the first day of admission, then after the diagnosis of vasospasm is confirmed, start milrinone.

Eligibility criteria:
inclusion criteria: * adult patients admitted to our surgical icu * aged between (18-60) years old * world federation of neurological surgeons grades 1-3 grades exclusion criteria: * aneurysmal sah * sah with fisher grade i and iv, * world federation of neurological surgeons grade iv \& v * no informed consent, * peripheral vascular disease * cardiac disease (heart block, severe valvular stenosis, cardiomyopathothy , ejection fraction\<40%), renal impairment (serum creatinine ≥ 1.4 mg.l-1), hemodynamic instability

Keywords: milrinone oral nimodipine
harmonizing rct-duplicate emulations in a real world replication program (harrp)

Conditions: Type 2 Diabetes Mellitus

Summary: replication of three clinical trial emulations canvas, leader, and savor timi that form part of the rct-duplicate initiative, sponsored by the fda and delivered by the brigham and women's hospital and harvard medical school. astrazeneca will use the instant health data platform panalgos (ihd) for the analyses.

rct-duplicate (rct-d) is an initiative led by the brigham and women's hospital and harvard medical school, that selected 30 clinical trials as part of an empirical experiment where these trials would be emulated using rwd. astrazeneca will replicate three emulations canvas, leader, and savor timi from among the 30 plus clinical trials analyzed in rct-d. these clinical trials assess type 2 diabetes mellitus drugs. the replications will be conducted on the instant health data panalgos (ihd) platform to assess these studies in two claims databases optum and ibm watson market scan. the aim is to recreate these three emulations to investigate the reproducibility of the emulations, increase transparency and better understand the process of trial emulations; and where possible, contribute with potential improvements to the rct-d framework.

Eligibility criteria:
the eligibility criteria for canvas, leader and savor-timi are replicated please see the criteria for each under: * canvas: https://clinicaltrials.gov/ct2/show/nct03936010 * leader: https://clinicaltrials.gov/ct2/show/nct03936049 * savor-timi: https://clinicaltrials.gov/ct2/show/nct03936023

Keywords: clinical trial emulation epidemiology type 2 diabetes regulatory real world evidence real world data