Kornimate/medical-research-clean huggingface dataset:
study of aro-ang3 in participants with homozygous familial hypercholesterolemia (hofh)

Conditions: Homozygous Familial Hypercholesterolemia

Summary: participants with documented homozygous familial hypercholesterolemia (hofh) who have provided informed consent will receive 2 open-label doses of aro-ang3 and be evaluated for safety and efficacy parameters through 36 weeks. participants who complete the first 36 week treatment period may opt to continue in an additional 24-month extension period during which they will receive up to 8 doses open-label doses of aro-ang3.


Eligibility criteria:
inclusion criteria: * fasting ldl-c \>100 mg/dl at screening * weight of ≥ 40 kg and body mass index ≥ 18.5 and ≤ 40 kg/m2 * diagnosis of hofh based on a supportive genetic test or clinical diagnosis * on stable maximally tolerated lipid lowering therapy * willing to abide by stable low-fat, low-cholesterol, heart-healthy diet for at least 4 weeks prior to day 1 * participants of childbearing potential (males \& females) must agree to use highly-effective contraception during the study and for at least 24 weeks from the last dose of study medication. * women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding * women of childbearing potential on hormonal contraceptives must be stable on the medications for \> 2 menstrual cycles prior to day 1 * willing to provide written informed consent and to comply with study requirements exclusion criteria: * current use or use within 365 days from day 1 of any hepatocyte targeted small interfering rna oligonucleotides (sirna) or antisense oligonucleoside molecule * use of evinacumab (some exceptions apply) * fasting tg \> 300 mg/dl at screening * presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins * newly diagnosed (within 3 months prior to informed consent) or poorly controlled diabetes (hemoglobin a1c \> 9%) * use of systemic corticosteroids (some exceptions apply) * symptoms of myocardial ischemia or severe left ventricular dysfunction * history of metastatic malignancy within 3 years of day 1 (some exceptions apply) * planned cardiac procedure/surgery such as coronary artery bypass graft (cabg) surgery, percutaneous coronary intervention (pci), carotid surgery or stenting, or carotid revascularization note: additional inclusion/exclusion criteria may apply per protocol
diagnosis of acute rejection in renal transplant patients by urine mass spectrometry

Conditions: Rejection of Renal Transplant

Summary: reliable and timely detection of acute rejections in renal transplant patients is important to preserve the graft function and to prevent premature graft failure. the current gold standard for the rejection diagnosis is a renal biopsy which is usually performed upon an unexplained decline in the graft function (determined by serum creatinine or clearance). because of the insensitivity of creatinine determinations and the invasiveness of renal biopsies, non-invasive tests have been suggested to diagnose acute rejection including mass spectrometry (ms) analysis of urine samples. the ability of ms analysis to detect acute rejection has been demonstrated in small studies on selected patients but evidence is lacking that this test is efficacious in the routine setting of the post-transplant patient care. based on our previous work that established urine peptide sets for acute rejection by ms, a prospective, multicentre diagnostic phase iii study will be executed. the aim of the study is to prove that this test is as equally effective as the allograft biopsy to detect acute rejection in patients that undergo a biopsy for unexplained renal dysfunction. the perspective of this approach is that the test could be used either in place of the biopsy or as decision guidance whether a biopsy is necessary to confirm the presence of rejection. another perspective is that the ms test (respectively, a simplified test system derived from this method) could be used in the regular post-transplant surveillance for acute rejection, in place of the relatively insensitive procedure with periodic monitoring of the graft function by creatinine determinations.


Eligibility criteria:
inclusion criteria: * adult patients with a kidney or combined kidney/pancreas transplantation * unexplained renal allograft dysfunction within the first year of transplantation * renal allograft biopsy, which is clinically indicated to verify or exclude an acute rejection exclusion criteria: * lacking consent of the patient to participate in the study

Keywords: kidney transplantation acute rejection diagnosis urine analysis urinary peptides mass spectrometry allograft biopsy pathology diagnostic study
a study for evaluation of the efficacy and safety of si-614 ophthalmic solution in patient with dry eye

Conditions: Dry Eye Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of si-614 ophthalmic solution compared with placebo in patients with dry eye

this is a phase 3, multicenter, randomized, double-masked study designed to evaluate the efficacy and safety of si-614 ophthalmic solution compared to placebo in patients with dry eye. approximately 230 male and female patients at least 18 years of age with dry eye in both eyes will be randomized to receive treatment with si-614 or placebo in a 1:1 ratio.

Eligibility criteria:
inclusion criteria: * have history of dry eye in both eyes for at least 6 months prior to visit 1. * have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to visit 1. * if a female of childbearing potential, have a negative urine pregnancy test at visit 1 and will be using an adequate method of birth control throughout the study period. exclusion criteria: * have any clinically significant slit lamp findings at visit 1 or visit 2, including active blepharitis, meibomian gland dysfunction, lid margin inflammation or ocular allergies that requires therapeutic treatment and/or, in the opinion of the investigator, may interfere with the study parameters. * be diagnosed with an ongoing ocular infection (bacterial, viral or fungal), or active ocular inflammation (eg, follicular conjunctivitis) at visit 1 or visit 2. * have had any ocular surgical procedure within 12 months prior to visit 1, or have any scheduled ocular surgical procedure during the study period. * be a female who is pregnant, nursing an infant, or planning a pregnancy. * have a known allergy and/or sensitivity to the study drug or its components. * have a condition or is in a situation that, in the opinion of the investigator, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patients' participation in the study.
a study to evaluate the safety and tolerability of abbv-951 in subjects with parkinson's disease (pd)

Conditions: Parkinson's Disease (PD)

Summary: the purpose of this study was to assess the safety and tolerability of abbv-951 (foslevodopa/foscarbidopa) in participants with parkinson's disease (pd). this was a single-arm study with preplanned analyses conducted by dose subgroup (low dose or high dose) based on the modal total daily dose (most frequent dose) over the treatment period.


Eligibility criteria:
inclusion criteria: * participants with diagnosis of idiopathic parkinson's disease (pd) that is levodopa-responsive * participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "off" and "on" states (motor fluctuations), and have a minimum of 2.5 hours of "off" time per day exclusion criteria: * participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study * participant is considered by the investigator to be an unsuitable candidate to receive abbv-951 for any reason

Keywords: parkinson's disease (pd) abbv-951 levodopa/carbidopa
renal denervation therapy for resistant hypertension in type 2 diabetes mellitus

Conditions: Hypertension, Resistant; Diabetes Mellitus; Renal Denervation Therapy

Summary: to demonstrate the efficacy of renal denervation therapy in treating resistant hypertension and its effect on glucose metabolism in patients with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * age ranges from 18 to 70 years inclusive * essential hypertension * office systolic bp (sbp) ≥ 150 mmhg or diastolic bp (dbp) ≥ 90mmhg * 3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications * type 2 diabetes mellitus on oral hypoglycaemic agent (oha) * 2 functional kidneys; egfr ≥ 45 ml/min/1.73m² (mdrd formula) * suitable renal anatomy compatible with the endovascular denervation procedure exclusion criteria: * individual has renal artery anatomy that is ineligible for treatment including: * patients with secondary hypertension * myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months * patient with type 1 diabetes mellitus * patient on insulin due to oral drug failure * renovascular abnormalities (including severe renal artery stenosis, previous renal stenting or angioplasty, or known dual renal arteries) * pregnancy * patient with any implantable device incompatible with radiofrequency energy delivery * hemodynamically significant valvular heart disease for which reduction of bp would be considered hazardous * any serious medical condition, which in the opinion of the investigator, may limit the life expectancy of patients or adversely

Keywords: hypertension diabetes mellitus
effect of a prehabilitation mobile application versus standard of care before colon cancer surgery.

Conditions: Prehabilitation; mHealth; Usability

Summary: pilot study to evaluate the effect of prehabilitation programme through a mobile application prehapp in colon cancer surgery. the objectives of this pilot study were to evaluate the usability of the prehapp for people undergoing colon cancer surgery, estimate the effect of the app on functional recovery after surgery and to evaluate complications during the postoperative period after 4 weeks of follow-up.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years. * diagnosis of resectable colon cancer with elective surgery. * participants have at least 2 weeks to their operation date. * agree to collaborate in the study and sign the informed consent exclusion criteria: * diagnosis of unresectable colon cancer. * inability to follow the prehabilitation programme. * participants be able to understand written and spoken spanish. * subjects with previous nutritional supplements. * pre-anesthetic evaluation with results, according to the classification of the american society of anesthesiologists (asa) iv or v.
reconstructive management of peri-implantitis

Conditions: Resolution of Pathologic Process

Summary: with the growing burden of peri-implantitis around the globe, interest has flourished on the management of this pathology. nevertheless, lack of consensus exists in the pursuit of a predictable therapy. different therapeutic modalities have been advocated. non-surgical therapy as a sole modality is often insufficient to resolve inflammation. surgical interventions have demonstrated more favorable outcomes. amongst these, evidence supported the application of resective, reconstructive, or combined approaches to limit progressive bone loss and achieve soft tissue health. nevertheless, up to date, the most suitable modality remains unknown and the decision-making process derives from the understanding acquired from the management of periodontitis. one critical element regarded to successfully resolve peri-implantitis is to efficiently detoxify the contaminated implant surface. mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. however, evidence has not demonstrated superiority of a given detoxification agent/strategy. in this sense, the significance of barrier membranes is not yet well understood. roos-jansaker in 2014 showed that the additional use of barrier membranes did not improve the outcome. nevertheless, since then this subject has not been a matter of research.

the effect of barrier membrane in the reconstructive management of peri-implantitis will be tested at 12-month follow-up

Eligibility criteria:
inclusion criteria: * non-smokers * no use of antibiotics recently * no metabolic disorder * infra-osseous or combined peri-implantitis defect exclusion criteria: * smokers * pregnant * metabolic disorders that affect bone healing * supra-crestal defects
enhanced, ehr-facilitated cancer symptom control pragmatic clinical trial

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this early phase i trial investigates enhanced, electronic health record (ehr)-facilitated cancer system control. cancer and its treatment are often associated with severe, disabling symptoms that have been causally linked to diminished survival, increased healthcare utilization, degraded quality of life, unemployment, and non-adherence to recommended cancer treatments. collaborative case management for control of moderate or worse sleep disturbance, pain, anxiety, depression, fatigue (spade symptoms), and physical dysfunction among cancer survivors and patients with cancer may improve quality of life, symptom severity, and adherence to cancer treatment, and may also reduce need for acute care.

primary objectives: i. conduct a cluster randomized pragmatic trial with a stepped wedge design to test the hypothesis that a symptom control-focused enhanced, electronic health record (ehr)-facilitated cancer symptom control (e2c2) intervention will significantly reduce sleep disturbance, pain, anxiety, depression, fatigue (spade) symptom and physical dysfunction scores, reduce unplanned hospitalizations and emergency department visits, improve adherence to cancer therapies, and improve self-reported quality of life. ii. evaluate the hypothesis that use of a multifaceted, evidence-based implementation strategy to support adoption and use of the e2c2 system will result in improvements in implementation and clinical outcomes. iii. conduct a mixed methods evaluation to detect, understand and reduce disparities in the adoption and implementation of the e2c2 intervention among elderly and rural-dwelling patients with cancer. outline: patients randomized to e2c2 intervention participate in an interview over 30-45 minutes. providers and stakeholders also participate in an interview over 15-30 minutes.

Eligibility criteria:
inclusion criteria: * being seen for a solid or liquid cancer at a midwest mayo clinic midwest mayo clinic health systems (mchs) site or for a solid tumor at mayo clinic rochester exclusion criteria: * no minors (under age 18) will receive the questionnaires but no further exclusions can be made based on the standard of care for questionnaire assignment
chemoprevention trial for uremia-associated urothelial carcinoma

Conditions: Carcinoma, Transitional Cell

Summary: primary objective: to study if lycopene can improve the biomarker status of urothelial cells in patients with uremia-associated urothelial carcinoma. secondary objective: to evaluate the general safety and tolerability of oral lycopene 30 mg per day for 12 weeks in uremic patients.

this is a renal function-stratified phase ii chemoprevention trial. after 8 weeks of a run-in and washout period, participants will take lycopene, 30 mg per day for 12 weeks. the expression of intermediate biomarkers will be determined upon study entry after 8 weeks of run-in/washout, and after 6 and 12 weeks of lycopene supplementation. it takes at least 20 weeks to complete the course.

Eligibility criteria:
inclusion criteria: * patients have pathologically-proven urothelial carcinoma (uc) with a clinical stage \<= t3n0m0 * patients have no visible or identifiable residual uc after treatment with a life expectancy of \> 6 months * patients have remaining urothelium at risk of recurrence (transplanted renal unit excluded) * no other active malignancy. patients who have other primary malignancies should be treated successfully prior to the study entry and should be in a cure or remission state for at least one year. * patients are able to take lycopene capsules orally. * patients who sign and give informed consents and are willing to conform to the scheduled sampling of the blood, urine and/or tissue exclusion criteria: * patients who have clinical stage \> t3n0m0 or metastatic disease * positive urine cytology. patients who have positive cytology should be subjected to a serial diagnostic workup which may include renal echo, cystoscopy and ureterorenoscopy, and image studies (intravenous urography, computed tomography, magnetic resonance urography, retrograde or antegrade pyelography). if no recurrent or residual tumors are found, patients are still eligible for the study. * patients who have ever received systemic chemotherapy within 12 months * patients who have gastrointestinal malabsorption regardless of the etiology * have known allergic reaction to tomato or lycopene * patients who are participating or will participate in other clinical trials * patients who have active urinary tract infection can not be accrued until infection is effectively controlled * patient's age is less than 18 years

Keywords: urothelial carcinoma lycopene uremia prevention biomarker progression anti-oxidant
step-covid: a program for pregnant women during the sars-cov-2 pandemic

Conditions: Psychological; Mental Health Issue; Prenatal Stress; Maternal Distress; COVID-19 Pandemic

Summary: step-covid (supporting the transition to and engagement in parenthood during the covid-19 pandemic) is a manualized group intervention for pregnant women during the covid-19 pandemic designed to foster emotion regulation and reflective capacities in participants.

the program aims to (a) support mentalization in relation to oneself, motherhood and the relationship with the child to be born, (b) reduce isolation by allowing participants to exchange about the positive aspects and the challenges of pregnancy and motherhood with other women, (c) explore what pregnant women are going through in the context of the pandemic, (d) allow participants to repossess their experience of pregnancy in the current context of insecurity and fear, and (e) consider new ways of coping with stress and unpleasant emotions. the program is manualized and uses structured activities based on theoretical grounds and empirical research during which facilitators share information, animate reflective activities, and facilitate exchanges.

Eligibility criteria:
inclusion criteria: * pregnant women ages 18+ years * interested in reflecting about their experience of pregnancy and willing to attend weekly sessions in group setting. * must speak french as their first language exclusion criteria: * severe psychiatric disorders (schizophrenia, bipolar disorder) * severe emotional dysregulation * current self-harm * not sure to keep the child * high level of hostility

Keywords: mentalization well-being pregnancy
prct002 prostate cancer treatment with the aquabeam robotic system

Conditions: Localized Prostate Cancer

Summary: the goal of this clinical trial is to evaluate the safety of the aquabeam robotic system in treating patients with localized prostate cancer. participants will go through baseline and follow up assessments up to 12 months.


Eligibility criteria:
inclusion criteria: * clinical stage ≤ t2c * psa ≤ 20 ng/ml * prostate volume ≥ 30 ml * grade group (gg) 1 or 2: if gg 1: ≥ 3 cores positive for cancer. note, multiple positive from any mri targeted lesion will be considered as a single positive core. exclusion criteria: * any prior or current treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation or chemotherapy. * patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 12 months. * radiographically suspicious lymph node involvement confirmed with biopsy or pet scan. * evidence of bone metastasis. * evidence of extracapsular involvement. * evidence of seminal vesicle invasion on dre or mri read as "definite", "probable" or "consistent with" * any condition or history of illness or surgery that may pose an additional risk to men undergoing the aquablation procedure.

Keywords: aquabeam aquablation aquablation therapy robotic waterjet treatment rwt prostate cancer
the effects of virtual reality and music on pain, anxiety, itching, and vital signs

Conditions: Allergy; Anxiety; Pain; Itching; Vital Signs

Summary: aim: this study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation. background:virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes. methods: this randomised controlled trial was divided into three groups: virtual reality (n=30), music (n=30), and control (n=30). anxiety was assessed before and after the skin prick test using the "state-trait anxiety inventory for children"; pain was assessed during and after the skin prick test using the "wong-baker faces pain rating scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "visual analogue score" was assessed at 5, 10, and fifteen minutes after the skin prick test. the study followed the concort guideline.

the effects of virtual reality and music on pain, anxiety, itching, and vital signs during skin prick testing: a randomized controlled trial abstract aim: this study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation. background:virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes. methods: this randomised controlled trial was divided into three groups: virtual reality (n=30), music (n=30), and control (n=30). anxiety was assessed before and after the skin prick test using the "state-trait anxiety inventory for children"; pain was assessed during and after the skin prick test using the "wong-baker faces pain rating scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "visual analogue score" was assessed at 5, 10, and fifteen minutes after the skin prick test. the study followed the concort guideline. key words: allergy skin test, children, pain, anxiety, itching, virtual reality glasses, music.

Eligibility criteria:
inclusion criteria: * children aged 9-12 undergoing their initial skin test * with no cognitive, visual, or auditory impairments * no recent medical encounters involving pain or anxiety within the past 3 months * parents who volunteered for participation in this study. exclusion criteria: * those who are not between the ages of 9 and 12 and have had a skin prick test before * with cognitive, visual, or auditory impairments, * recent medical encounters involving pain or anxiety within the past 3 months, * parents who volunteered no for participation in this study.

Keywords: allergy skin test children itching musictherapy pain anxiety virtual reality