Kornimate/medical-research-clean huggingface dataset:
high intensity focused ultrasound (hifu) ablation system study

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine if the hifu pulmonary vein ablation system is effective in the treatment of paroxysmal atrial fibrillation compared to the control of best medical therapy with fda approved antiarrhythmic drugs.

atrial fibrillation (af) is the most common sustained cardiac arrhythmia affecting an estimated 2.2 million persons in the united states (us). in addition to being debilitating, af has been identified as a leading risk factor for stroke. af is often associated with structural heart disease, but a substantial number of af patients have little or no detectable structural heart disease. a patient with af is up to 5 times more likely to have a stroke than the general population. recently, it has been demonstrated that for a significant portion of af patients (80% - 95 %) the arrhythmia originates in one of the four pulmonary veins (pv's). furthermore, it has been shown that isolation of this arrhythmia by ablation can, in the majority of patients (50-70%), eliminate or markedly reduce episodes of af. currently, there are a number of modalities being investigated to treat af. they include radiofrequency, laser, thermal, cryo, microwave, and ultrasound ablation of targeted areas in the atrium and/or pvs. comparison(s): clinical success of high intensity focused ultrasound (hifu) ablation for pulmonary vein isolation in the treatment of atrial fibrillation, compared to medical therapy with anti-arrhythmic drugs (aads).

Eligibility criteria:
inclusion criteria: * documented atrial fibrillation * failed or intolerant to at least 1 anti-arrhythmic drug * able to take anti-coagulant therapy * able to complete screening tests required for inclusion/exclusion criteria * able to take at least 1 approved anti-arrhythmic drug * not pregnant * available for follow-up for at least 12 months exclusion criteria: * persistent or permanent atrial fibrillation * mitral disease * prior surgical treatment for atrial fibrillation * ablation for treatment of atrial fibrillation within 6 months * severe left ventricular hypertrophy * known untreated coagulopathy * unstable angina * prior stroke * uncontrolled heart failure * secondary causes of atrial fibrillation * uncorrected hyperthyroidism within 12 months * pulmonary embolism within 6 months * pneumonia or acute pulmonary disease within 3 months * pacemaker/icd * high risk for esophageal disease * currently enrolled in investigational drug or device study

Keywords: atrial fibrillation arrhythmia af ablation antiarrhythmic agent catheter ablation pulmonary veins
effect of sitagliptin on endothelial progenitor cells

Conditions: Type 2 Diabetes Mellitus

Summary: endothelial progenitor cells (epcs) are involved in cardiovascular homeostasis, through angiogenesis and endothelial healing. diabetic patients have a high risk of cardiovascular events and low levels of circulating epcs. sitagliptin is an oral dpp-iv antagonist, approved for the treatment of type 2 diabetes. it increases the bioavailability of endogenous incretins, thus improving insulin and glucagon secretion. sdf-1, one of the major epc regulators, is also a substrate of dpp-iv. this study tests the hypothesis that sitagliptin increases the levels of circulating epcs in type 2 diabetic patients.

diabetic patients suffer an elevated wirk of cardiovascular events, which strongly impact on morbidity and mortality. the mechanisms that lead to cardiovascular disease in diabetes include alterations in the endothelial layer, due to hyperglycemia, oxidative stress and other associated abnormalities. endothelial progenitor cells (epcs) are bone marrow-derived cells involved in endothelial repair after injury, and they have been found to be reduced in diabetic patients. thus, reduced epcs in diabetes may be another mechanism of vascular disease induction. reduction of epcs in diabetes is attributable at least in part to the impairment of bone marrow mobilization, which is regulated by the chemokine sdf-1alpha, among others. the oral hypoglycemia agent sitagliptin is a dipeptidyl dipeptidase-iv inhibitor, which prevents degradation of endogenous incretins (gip and glp-1), thus re-equilibrating insulin and glucagon secretion. sitagliptin may also increase the concentrations of sdf-1alpha, which is another substrate of dpp-iv. the hypothesis is that sitagliptin may increase circulating epc levels, through sdf-alpha. this is going to be a pilot, non-randomized controlled 4-week trial of 100 mg oral sitagliptin therapy added to metformin/sulphonylureas in poorly controlled type 2 diabetic patients. at baseline and 4 weeks after the initiation of therapy blood samples will be drawn for the determination of circulating epc levels, and concentrations of sdf-1alpha. epcs will be defined as cd34+kdr+ cells and measured by flow cytometry as previously described in detail. sdf-1alpha will be measured using elisa kits according to the manufacturer's instructions. changes between baseline and 4 weeks will be evaluated using two-tailed paired student's t test and statistical significance accepted at p\<0.05.

Eligibility criteria:
inclusion criteria: * type 2 diabetes; * both genders * age 40-80 * fasting c-peptide \>=1.0 ng/l * therapy with metformin or sulphonylureas * hba1c \>7.0% * no contraindications to sitagliptin use exclusion criteria: * type 1 diabetes * age \ 80 * fasting c-peptide \<1.0 ng/l * therapy with tzd * hba1c \<=7.0% * acute concomitant diseases * immunological disorders * recent (within 3 months) cardiovascular events or surgery * pregnancy and lactation * inability to provide informed consent

Keywords: diabetes endothelium stem cells
the role of auditory feedback in guiding upper extremity movements

Conditions: Stroke

Summary: stroke is one of the leading causes of disability, with an estimated prevalence of 50,000 cases per year in canada. less than half of stroke patients regain use of their arm and hand. there is currently no intervention regime that is the gold standard, despite the variety of therapeutic techniques used to treat the upper extremity post-stroke. the use of external feedback to improve motor learning is a technique that has been less studied but shows promise. therefore, the purpose of this proof of principle study it to test whether different auditory feedback frequencies can facilitate reaching ability in people with stroke. in addition brain scans will be collected that will enable us to determine how stroke severity may impact on one's ability to improve with this technique. we hypothesize that patients who receive less feedback (50% alternate) will have enhanced learning relative to the patients who receive more feedback (100%).


Eligibility criteria:
inclusion criteria: * unilateral first time mca ischemic stroke * stroke patients should have some movement of shoulder/elbow (no movement of hand - e.g. hand, fingers - is ok) * \> 2 months post * between 30-85 years exclusion criteria: * prior stroke * severe comprehension (or cognitive) deficit that compromises informed consent or understanding of instructions * contraindications to mri (e.g. claustrophobia, metal implants) * neurodegenerative or psychiatric disease * apraxia * auditory deficits that would impair testing * prior musculoskeletal injury to back or upper extremity (including shoulder subluxation from stroke) * skin conditions that would preclude taping of goniometers
cryotherapy versus radiofrequency ablation for treatment of para-hisian accessory pathways

Conditions: Cardiac Arrhythmias; Accessory Pathway; Wolf Parkinson White Syndrome

Summary: a randomized pilot study to evaluate safety and efficacy endpoints for treatment of para-hisian accessory pathways according to two different strategies of lesion formation. these patients will be divided into 2 groups with different strategies of treatment: group 1 treated with radiofrequency (rf) ablation, group 2 with cryotherapy (cryo). the primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. secondary endpoints will be immediate success and rate of permanent atrioventricular (av) block.

this is a randomized study on the safety and efficacy for percutaneous ablation of para-hisian accessory pathways according to two different modalities: radiofrequency (rf) or cryotherapy. thirty patients with symptomatic or high-risk para-hisian accessory pathways, documented by previous electrophysiological study (eps), referred to percutaneous catheter ablation, will be enrolled in this trial. after informed consent, these patients will be randomized in 2 groups with different current established strategies of invasive treatment. group i: electrophysiological mapping and ablation with radiofrequency (rf) focal lesion formation. group ii: electrophysiological mapping and ablation with cryotherapy (cryo) focal lesion formation. the primary outcome will be the recurrence rate of accessory pathway conduction after one year of follow-up. secondary endpoints will be immediate success and rate of permanent atrioventricular (av) block.

Eligibility criteria:
inclusion criteria: * patients with para-hisian accessory pathways, diagnosed by electrophysiological study (eps), with indication of invasive treatment according to current guidelines. patients should be willing and able to sign an informed consent form, and to undergo all procedures described in both the study protocol and the consent form. exclusion criteria: * previous cryotherapy ablation; * previous extensive radiofrequency ablation (including aortic cusp mapping); * age below twelve years; * severe coagulation disorder; * pregnancy; * refusal to participate in the study.

Keywords: para-hisian radiofrequency cryoablation accessory pathway electrophysiology
a randomized, phase 2/3 study to investigate the efficacy and safety of rp2 in combination with nivolumab in immune checkpoint inhibitor-naïve adult patients with metastatic uveal melanoma

Conditions: Metastatic Uveal Melanoma

Summary: the purpose of this study is to measure the clinical benefits of the combination of rp2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.


Eligibility criteria:
key inclusion criteria: * patients who are 18 years of age or older at the time of signed informed consent. * patients with confirmed diagnosis of metastatic uveal melanoma not amenable to surgical resection. * has at least 1 measurable and injectable tumor of ≥ 1 cm in longest diameter (≥ 1.5 cm in the shortest axis for a lymph node \[ln\]) that is amenable to serial rp2 injections. * must be willing to provide tumor biopsy samples. * ldh ≤ 2 × upper limit of normal (uln). * has adequate hematologic, hepatic and renal function * prothrombin time (pt) ≤ 1.5 × uln (or international normalization ratio \[inr\] ≤ 1.3) and partial thromboplastin time (ptt) or activated partial thromboplastin time (aptt) ≤ 1.5 × uln. * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1. * life expectancy of \> 6 months as estimated by the investigator. key exclusion criteria: * any exposure to immune checkpoint inhibitor (icis) since the time of first being diagnosed with uveal melanoma. * known acute or chronic hepatitis b or c infection or human immunodeficiency virus (hiv) infection or any other uncontrolled infection. * current active significant herpetic infections or prior complications of hsv-1 infection. * any central nervous system (cns) involvement of melanoma, including carcinomatous meningitis. * major surgery ≤ 2 weeks prior to the first dose of study intervention. * any bleeding, thrombotic and/or other event that places the patient at an unacceptable risk of complications of intratumoral therapy. * active, known, or suspected autoimmune disease requiring systemic treatment. * prior treatment with an oncolytic virus. * requires intermittent or chronic use of systemic (oral or iv) antivirals with known antiherpetic activity (eg, acyclovir). * systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose. * has received investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose. * conditions requiring treatment with immunosuppressive doses (\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment. additional inclusion/ exclusion criteria are outlined in the study protocol

Keywords: metastatic uveal melanoma nivolumab ipilimumab randomized immune checkpoint inhibitor-naïve rp2 oncolytic viruses hsv-1
characterization of mechanical tissue properties in patients with pancreatic, liver, or colon cancer

Conditions: Colon Carcinoma; Liver and Intrahepatic Bile Duct Carcinoma; Pancreatic Carcinoma

Summary: this pilot research trial studies characterization of mechanical tissue properties in patients with pancreatic, liver, or colon cancer. mechanical properties and stiffness of the cancerous tissue may be correlated with the standard pathology report that describes the stage of the disease.

primary objectives: i. to determine if our optical polarimeter device is able to measure tissue stiffness across several human cancer types ex vivo. secondary objectives: i. to describe the inter- and intra-tumor heterogeneity of tissue stiffness. ii. to determine if the measurements made by the optical polarimeter device are non-destructive. tertiary objectives: i. perform multi-variable cross-correlation statistical analysis to determine relationships between: tissue stiffness characteristics, molecular level signatures, and cellular level properties, and if numbers permit, response to treatment. outline: patients undergo fresh tumor tissue collection at the time of surgery. the fresh tumor tissue samples are analyzed for tissue stiffness measurements using an optical polarimeter device and cell viability using an automated cell counter.

Eligibility criteria:
inclusion criteria: * scheduled for surgery to remove primary tumors in the pancreas, liver or colon and have not undergone any prior treatment * ability to understand and the willingness to sign a written informed consent exclusion criteria: * pregnant women will not be consented * patients that are unable to consent for surgery * primary liver tumors with cirrhosis will be excluded from this study
"acrylic vs. metal palatal coverage in complete dentures: patient-reported outcomes"

Conditions: Complete Edentulism; Satisfaction, Patient; Quality of Life

Summary: conventional dentures can be uncomfortable and limit oral functionality due to the polished surfaces covering the palate and rugae areas. a randomized crossover clinical trial was conducted to compare patients' satisfaction and oral health-related quality of life when using dentures with an acrylic or metal palate. the study aimed to determine whether an acrylic palate would provide better sensory feedback and improved oral function. participants wore each denture and completed a questionnaire. the study's results have implications for the design of complete dentures, as they highlight the importance of considering patient experiences and feedback when selecting materials. by prioritizing patient satisfaction and oral health-related quality of life, dental professionals can enhance denture treatments' effectiveness and improve patients' quality of life.

conventional dentures have long been criticized for their discomfort and limitations in oral functionality, primarily attributed to the polished surfaces covering the palate and rugae areas. to address these concerns, a rigorous randomized crossover clinical trial was meticulously conducted to compare the subjective experiences of patients wearing dentures with either an acrylic or metal palate. the primary objective of this study was to evaluate patients' satisfaction and oral health-related quality of life while wearing dentures with different palate materials. specifically, researchers sought to ascertain whether the use of an acrylic palate could offer superior sensory feedback and enhance overall oral function compared to traditional metal palates. participants enrolled in the study were required to wear both types of dentures consecutively and subsequently complete a comprehensive questionnaire designed to capture their subjective experiences and perceptions. the questionnaire encompassed various aspects, including comfort, ease of speech, ability to chew and swallow, and overall satisfaction with the dentures.

Eligibility criteria:
eligibility minimum age: 45 years maximum age: 80 years sex: all gender-based inclusion: no accepts healthy volunteers: yes (if completely edentolous) inclusion criteria: * patients seeking a set of conventional maxillary and mandibular complete dentures at the university of jordan hospital, either for the first time or as a replacement for previous dentures * patients aged between 45 and 80 years old * completely edentulous for at least 3 months * patients who approved and consented to participation exclusion criteria: - patients with severe underlying medical conditions, including: neuromuscular dysfunction, auditory problems, mental conditions, oral pathology, xerostomia, tied tongue condition - patients who met the inclusion criteria but failed to sign a consent form
circumferential pulmonary vein isolation plus transition zone modification in atrial fibrillation patients without low-voltage areas

Conditions: Atrial Fibrillation (AF)

Summary: this study investigates two treatments for atrial fibrillation (af) patients without low-voltage-areas (lvas). it aims to determine whether adding transition zone modification (tzm) to the pulmonary vein isolation (pvi) improves long-term outcomes compared to pvi alone.


Eligibility criteria:
inclusion criteria: aged 18 to 80 years af referring for ablation no prior history of af absence of low-voltage areas during substrate mapping presence of transition zone during substrate mapping sign informed consent exclusion criteria: presence of left atrial thrombus acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within three months prior to enrollment previous cardiac transplantation, complex congenital heart disease, rheumatic heart disease untreated hypothyroidism or hyperthyroidism dialysis-dependent terminal renal failure life expectancy \<12 months due to non-cardiovascular causes. any conditions that, in the opinion of the investigator, may render the patient unable to complete the study female under pregnancy or breast-feeding involved in other studies

Keywords: pulmonary vein isolation transition zone modification atrial fibrillation
endovascular exclusion of thoracoabdominal and/or paravisceral abdominal aortic aneurysm

Conditions: Thoracoabdominal Aortic Aneurysm; Paravisceral Abdominal Aortic Aneurysm

Summary: this is a study to assess the safety and effectiveness of endovascular treatment of thoracoabdominal (taaa) and paravisceral abdominal (pvaaa) aortic aneurysms. the investigational operation involves placing a stent-graft over the aortic aneurysm.

a taaa or pvaaa is an abnormal enlargement of the aorta, the main artery in the chest and abdomen. the standard operation for taaa of pvaaa is performed through a long incision extending down the side of the chest and the front of the abdomen. in the standard operation, the weak area of the aorta is replaced with a fabric sleeve (graft). the investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents). the combination of a stent and a graft is known as a stent-graft. compared with standard operation, the potential advantages of endovascular taaa/pvaaa repair include less pain, less disturbance of intestinal function, a lower risk of pulmonary or cardiac complications and shorter hospital stay. the main disadvantage of endovascular taaa/pvaaa is an unknown success rate.

Eligibility criteria:
inclusion criteria 1. aortic aneurysms: * greater than or equal to 6 cm in diameter in men, * greater than or equal to 5.5 cm in diameter in women, * and/or larger than 5 cm in diameter and enlarging at a rate of more than 5 mm/year, * and/or iliac aneurysms larger than 4 cm in diameter. 2. anticipated mortality comparable to published rates with conventional surgical treatment. 3. life expectancy more than 2 years. 4. ability to give informed consent. 5. willingness to comply with follow-up schedule. 6. suitable arterial anatomy for endovascular repair. exclusion criteria 1. free rupture of the aneurysm. 2. pregnancy. 3. known allergy to nitinol, stainless steel, or polyester. 4. unwillingness or inability to comply with the follow up schedule. 5. serious systemic or groin infection. 6. uncorrectable coagulopathy.

Keywords: thoracoabdominal paravisceral aneurysm endovascular stent-graft aorta
effectiveness of mindfulness based cognitive therapy (mbct) on for insomnia and mental health of prisoners

Conditions: Insomnia

Summary: insomnia is highly prevalent in prisoners and is a risk factor for poor mental well-being, depression, suicidality and aggression, all common concerns in this vulnerable population. improving sleep management options in prison offers the potential to impact positively on a number of these common risk factors. the study aim is to asses psychological intervention for insomnia in prisons.


Eligibility criteria:
inclusion criteria: * are at least 18 years of age * clinical level of insomnia (more than 10 on isi) * meets criteria for insomnia according to dsm-5 insomnia disorder * can speak, understand, and write in persian * male exclusion criteria: * currently receiving psychological treatment for insomnia * presence of a rapidly progressing neurological or medical disorder
motivational strategies in batterer intervention programs for offenders with alcohol/drug abuse problems (imp-adaps)

Conditions: Intimate Partner Violence Against Women; Alcohol Abuse; Drug Abuse

Summary: alcohol and/or drug abuse problems (adaps) have been consistently identified in the scientific literature as a risk factor of intimate partner violence against women (ipvaw). around 50% of ipvaw offenders referred to batterer intervention programs (bips) have adaps. adaps are also one of the main predictors of bips dropout. in spain, the majority of bips do not fit the intervention to specific needs or characteristics of ipvaw offenders, such as those with adaps. the aim of this research is to assess the effectiveness of a new motivational strategy adapted to ipvaw offenders with adaps, aiming to increase treatment adherence and to improve bips outcomes. the motivational strategy will include an individualized motivational plan (imp) developed for each participant with adaps (imp-adaps). in these imps one of the main aims will be to reduce alcohol and/or drug consumption. the current study will use a randomized control trial. participants with adaps will be allocated to one of two treatment conditions: experimental condition: standard batterer intervention program (sbip) plus individualized motivational plan focused in adaps (sbip+ adaps-imp), and control condition: standard batterer intervention program plus individualized motivational plan (sbip+imp). primary/final outcomes will be recidivism and adaps reduction. secondary/proximal outcomes will include treatment adherence related variables, violence related attitudes and attributions, self-control and psychological adjustment. outcome variables will be assessed at baseline, at the end of the intervention, and at six months after the intervention will be finished.


Eligibility criteria:
inclusion criteria: * males convicted of ipv against their partner or ex-partner * alcohol and/or drugs abuse problems exclusion criteria: * no current severe psychological disorders

Keywords: intimate partner violence alcohol drug batterer intervention programs