Kornimate/medical-research-clean huggingface dataset:
prospective study on embolization of intracranial aneurysms with pipeline™ embolization device

Conditions: Intracranial Aneurysm

Summary: the purpose of this study is to assess the safety and effectiveness of the pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.


Eligibility criteria:
inclusion criteria: 1. subject has provided written informed consent using the irb/ec-approved consent form and agrees to comply with protocol requirements. 2. age 22-80 years. 3. subject has a target intracranial aneurysm (ia) located in the: 1. internal carotid artery (up to the carotid terminus) or 2. vertebral artery segment up to and including the posterior inferior cerebellar artery 4. subject has a target ia that is ≤ 12 mm. 5. subject has a target ia that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target ia. 6. subject has a target ia with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5. 7. subject has a pre-procedure pru value between 60-200. exclusion criteria: 1. subject has received an intracranial implant (e.g. coils) in the area of the target ia within the past 12 weeks. 2. subarachnoid hemorrhage in the past 30 days. 3. subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy. 4. major surgery in the last 30 days. 5. history of irreversible bleeding disorder and/or subject presents with signs of active bleeding. 6. any known contraindication to treatment with the pipeline™ device, including: 1. stent is in place in the parent artery at the target ia location 2. contraindication to dual antiplatelet therapy 3. relative contraindication to angiography (e.g., serum creatinine \>2.5 mg/dl, allergy to contrast that cannot be medically controlled). 4. known severe allergy to platinum or cobalt/chromium alloys. 5. evidence of active infection at the time of treatment (e.g., fever with temperature \>38°c and/or wbc \>1.5 109/l). 7. the investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment. 8. pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation. 9. participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation.

Keywords: intracranial aneurysm brain aneurysm
thermal imaging to identify distinct temperature patterns in various stages of pressure ulcers

Conditions: Decubitus Ulcer; Pressure Ulcer

Summary: 40 patients total with pressure ulcers with a decubitus pressure ulcer will be included in this study. ten patients with a stage i, ii, iii, and iv decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera. thermal imaging of the various stages of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal distribution can be identified which can then be applied to identify patients at risk of developing pressure ulcers at an earlier stage in their hospital course.

this study will be a single-center prospective phase i study in which the use of a thermal imaging camera will be used to obtain imaging data on decubitus ulcers of various stages. the data collected during this study will be used to determine if stage-specific thermal distribution patterns can be identified. this information will then be used to design future studies in which patients are risk for the development of pressure ulcers are screened for the presence of pressure ulcers not detectable upon physical examination so that preventative measures and treatments can be instituted. a total of 40 patients with pressure decubitus ulcers will be recruited for inclusion in this study. the investigators plan to enroll ten patients with each stage of pressure ulcer (i.e. stage i-iv), which will provide the investigators with a set of thermal imaging data from which the investigators will determine if thermal distribution patterns unique to each stage of pressure ulcer can be identified. it is anticipated that 40 patients who meet the inclusion criteria and distribution of pressure ulcer staging will be enrolled within one year of the start date of this study. the investigators are planning a study of a continuous response variable from independent control and experimental subjects with 1 control(s) per experimental subject. it is estimated that the response within each subject group will be normally distributed with standard deviation 25. if the true difference in the experimental and control means is 35, the investigators will need to study 9 experimental subjects and 9 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.8. the type i error probability associated with this test of this null hypothesis is 0.05.

Eligibility criteria:
inclusion criteria: * patients with sacral/heel pressure ulcers, admitted to university of arkansas for medical sciences (uams) inpatient services. * patients 18-years old or older. * patients have an expected survival of \> 48 hours exclusion criteria: * patients not compliant with obtaining thermal imaging. * patients not expected to survive for 48 hours.
behavioral activation, nutrition, and activity intervention

Conditions: HIV

Summary: this study will explore if a behavioral intervention program to assist people aged 50 and older with hiv is practical. the program includes a coach who talks with participants, encouraging them to be more active, reduce loneliness, and eat healthier.

this study aims to see if a 12-week program called behavioral activation (ba) can help people aged 50 and above with hiv by reducing loneliness and boosting social engagement. the program includes physical activity and nutrition guidance and is led by remote coaches. investigators will recruit participants from the university of maryland thrive program and other hiv centers in baltimore. investigators will test the program with 10 people aged 50 and above with hiv to see if it works. if it proves to be helpful and accepted, investigators might move on to a larger study to evaluate it more thoroughly.

Eligibility criteria:
inclusion criteria: 1. 50 years of age or older 2. hiv positive diagnosis 3. montreal cognitive assessment score \> 13 4. report minimal level of loneliness, isolation, and/or depression (phq9 \> 5) 5. able to consent 6. ability to read or speak english 7. attend the um thrive center or another hiv center in baltimore exclusion criteria: 1) no severe cognitive impairment

Keywords: aging hiv social engagement nutrition physical activity
the influence of the sound generator combined with conventional amplification for tinnitus control: blind randomized clinical trial

Conditions: Tinnitus; Hearing Loss

Summary: the university of sao paulo department of otorhinolaryngology developed prototypes for a digital new hearing aid with an integrated sound generator. these prototypes assist both hearing rehabilitation (about 10% of the population) and tinnitus sufferers (about 17% of the population). currently, the brazilian public heath care does not have any such hearing aids. so, the development of devices for the hearing rehabilitation as well as the treatment of tinnitus represents an advance in the implementation of public policies in brazil. the aim of this study is to compare the efficacy of the hearing aid with an integrated sound generator and amplification alone for tinnitus control in patients with tinnitus associated hearing loss.

this study, in the form of a blind randomized clinical trial, was approved by cappesq under protocol number: 0163/10. 49 adults with tinnitus and sensorineural hearing loss were randomly assigned into 2 groups. both groups received counseling about tinnitus. one group received hearing aids with only amplification and the other group received hearing aids with an integrated sound generator. after the fitting process, both groups were told to use the hearing devices 8 hours per day. the outcome measures as the tinnitus handicap inventory and psychoacoustics measurements were conducted by a blind audiologist that didn't know each group each patient belonged to.

Eligibility criteria:
inclusion criteria: * mild to moderate sensorineural hearing loss * tinnitus (thi \> 20) * first user exclusion criteria: * profound hearing loss * conductive hearing loss * thi \< 20

Keywords: tinnitus hearing loss hearing devices
efficacy study of ilaprazole to treat erosive esophgitis

Conditions: Erosive Esophagitis; GERD

Summary: this study compared ilaprazole 20mg with lansoprazole 30mg for the healing of erosive esophagitis and resolution of heartburn.


Eligibility criteria:
inclusion criteria: * subject must have endoscopically confirmed erosive esophagitis as defined by the los angeles (la) classification grading system (a-d) within 14 days prior to baseline. * episodes of heartburn or regurgitation has experienced during the last 7 days prior to baseline. exclusion criteria: * coexisting diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus. presence of a schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) or barrett's esophagus were not exclusionary. * current or a history of zollinger-ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer. * known hypersensitivity to any ppi (including lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of ilaprazole, or gelusil. * cancer (except basal cell carcinoma of the skin) within 5 years prior to screening.

Keywords: erosive esophagitis ilaprazole gerd
epidemiology of helicobacter pylori infection in children from slovenia

Conditions: Helicobacter Pylori Infection; Transmission

Summary: the epidemiology of h. pylori infection among children in slovenia has not been investigated. therefore, we are conducting a study to examine the epidemiology of h. pylori and associated risk factors among children in slovenia.

the population selection was from the three different geographic location in slovenia. the selection of the studied places was based on their social and economic characteristics and medical provision. we included children from three age groups at the same time we collected information from the parents which may be important for h. pylori transmission.

Eligibility criteria:
inclusion criteria: * age 6, 14 and 17 years living in three different regions in slovenia exclusion criteria: * none

Keywords: children infection
safety and efficacy of tanezumab in patients with chronic pancreatitis

Conditions: Chronic Pancreatitis

Summary: tanezumab is effective in reducing the pain associated with chronic pancreatitis.

on 23 dec 2010 the fda imposed a clinical halt for anti-ngf compounds due to safety reasons, ie, a case of osteonecrosis which occurred in relation to an anti-ngf compound of another company. all indications with the exception of cancer pain are affected resulting in termination of all studies in respective indications. recruitment of study a4091044 was stopped effective 27 dec 2010. two patients recruited so far did not receive further doses and were followed up for safety until lslv on 22 mar 2011.

Eligibility criteria:
inclusion criteria: * adult male or female * written informed consent * diagnosis of chronic pancreatitis based on imaging studies * persistent abdominal pain due to chronic pancreatitis * qualifying pain score during the pre-treatment period * willing to comply with study visit schedule and study requirements including for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control exclusion criteria: * pregnant women, lactating mothers, women suspected of being pregnant and women who wish to become pregnant during the course of the study * chronic pancreatitis as a complication of pancreatic cancer or acute pancreatic duct obstruction * pancreatic surgery, lithotripsy or endoscopist decompression within 3 months * history of alcoholism (within 1 year of screening) or concurrent alcohol abuse * history of cancer in the past years * significant cardiac disease within 6 months * history, diagnosis or signs and symptoms of significant neurologic disease * disqualifying laboratory values including hepatitis b or c, hiv and drug test * other medical condition that may interfere with study endpoints or safety of the patient as determined by the investigator * known history of rheumatoid arthritis * avascular necrosis of the bone * history of trauma to a major joint evidence of osteoarthritis
effective management of emotional response to generate well-being post-hf exacerbation

Conditions: Congestive Heart Failure

Summary: emerge is a pi-initiated feasibility study that aims to evaluate the accessibility, usability, effectiveness and relevance of an integrated psycho-behavioral intervention on heart failure patients in order to increase support, outreach and general well-being of these patients following hospitalization due to heart failure exacerbation.


Eligibility criteria:
inclusion criteria: * adult male and female patients, age ≥ 18 hospitalized at duke inpatient service because of heart failure * nyha class ≥ ii exclusion criteria: * significant cognitive impairment, indicated as a mini-mental state exam (mmse) total score of 23 or lower * lack of convenient internet access outside of hospital * alcohol or other drug dependence/abuse within past 90 days as evaluated by review of medical record and patient interview (scid) * severe physical disability (visual, sensory or motor) that may interfere with study participation (assessment, online interactive learning) * history or presence of psychoses, bipolar disorder, and/or severe personality disorders as evaluated by review of medical record and patient interview (scid) * life-threatening co-morbidity with the likelihood of 50% mortality in one year * active suicidal ideations * female patients of childbearing potential * treatment with electroconvulsive therapy or transcranial magnetic stimulation within past 90 days * uncorrected hypothyroidism or hyperthyroidism

Keywords: chf
change in the lower leg muscle stiffness following peroneal artery-based flap

Conditions: Donor Site Complication; Muscle; Ischemic

Summary: in the field of reconstructive microsurgery, donor site morbidity after free flap harvest is one of the key factors to consider when choosing among different options of free flap. peroneal artery-based free flap, such as fibula flap or peroneal flap, is one of the popular options of free flap. there are a plenty of literature using a variety of modalities to evaluate the donor site morbidity after free fibula harvest, such as gait analysis. elastography has been used to evaluate the stiffness change of soft tissue, such as skeletal muscle, or liver. the purpose of this study is to use elastography to evaluate the stiffness of lower leg muscle after peroneal artery-based free flap harvest.

a total of twenty-three patients will be recruited at national taiwan university hospital yunlin branch. all of them will receive fibula flap or peroneal flap harvest operations. at the time points of pre-operation, 1-month post-operation, 3-month post-operation, and 6-month post-operation, the muscles of both legs of each patient will be evaluated by elastography, and the function of both legs will be evaluated by american orthopedic foot and ankle score (aofas). paired t-test will be used to compare the results of each evaluations.

Eligibility criteria:
inclusion criteria: * no previous major operations over both legs * able to walk freely during daily life * going to receive peroneal artery-based free flap harvested from one leg exclusion criteria: * previous major operations over either leg * unable to walk freely during daily life

Keywords: elastography; donor site morbidity
cabenuva injection tracking in chorus

Conditions: HIV Infections

Summary: this is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. the purpose of this study is to assess if receiving alerts can help providers manage the scheduling of monthly cabotegravir + rilpivirine long-acting injections for the treatment of hiv.

a novel long-acting hiv antiretroviral therapy has recently been approved by the fda: cabotegravir and rilpivirine delivered through intramuscular injection. these injections should be administered monthly, on the same day of the month as the initiation injections, up to 7 days before or after the date of the scheduled monthly injection visit. this is a cluster randomized trial in which clinics will be randomized to the intervention or the control arm. providers in the intervention group will receive alerts to remind them when patients are due for their injections, or if they missed their treatment window. providers in the control group will not receive alerts and will manage injections as per their clinic's standard process. surveys will be administered to understand the utility of the alerts for the management of these injections.

Eligibility criteria:
inclusion criteria (patients): * as per label, routine clinical care inclusion criteria (clinics): * aids healthcare foundation (ahf) clinic * hiv primary care clinic * minimum of 100 people living with hiv in care with a viral load \<50 copies/ml at the time of randomization (satellites will be included in the count of their parent clinic).
efficacy of iodine complex against covid-19 patients

Conditions: Covid19; SARS-CoV-2; Corona Virus Infection

Summary: the objective of this study is to measure the effect of iodine complex in treating the covid-19 patients to clear viral load of sars-cov-2 along with reduction in severity of symptoms and length of hospitalization of patients with covid-19.

the proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. this is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation ratio and superiority framework.

Eligibility criteria:
inclusion criteria: * positive pcr with mild to moderate disease exclusion criteria: * allergic to iodine * any co-morbidity other than hypertension and dietetics

Keywords: sars-cov-2 covid-19 coronavirus iodine complex
botulinum toxin efficiency on spasticity of rectus femoris and semitendinosus muscles as functional agonist and antagonist muscles

Conditions: Cerebral Palsy

Summary: the aim of the study is to confirm the functional improvement obtained through treatment of spasticity on 2 agonist and antagonist muscles. the hypothesis is that treatment of both muscles gives a better and longer functional improvement than treatment of only one muscle. the target muscles are the rectus femoris and semitendinosus and the treatment is botulinum toxin. clinical assessment (passive range of motion of the lower limbs, spasticity level, functional scales and subjective feeling) and gait analysis data (kinematics and kinetics data) are collected. evaluations take place before treatment, 2 months and 6 months after treatment.


Eligibility criteria:
inclusion criteria: * patients between 7 to 17 years old * cerebral palsy children with walking ability (even with crutch or knee-walker) allowing gait analysis. * patients with functional status allowing the use of botulinum toxin on target muscles. exclusion criteria: * patients under 7 years old * patients up to 17 years old * patients in whom botulinum toxin is contra-indicated * patients who received botulinum toxin within a 6 month period before the beginning of the study

Keywords: cerebral palsy children botulinum toxin
germ-line mutations in blood and saliva samples from patients with cancer

Conditions: Malignant Neoplasm

Summary: this research trial studies germ-line mutations in blood and saliva samples from patients with cancer. studying samples of blood and saliva from patients with cancer in the laboratory may help doctors learn more about how inherited genetic mutations can affect cancer predisposition (an inherited increase in the risk of developing cancer), their impact on treatment response, and their role in cancer development.

primary objectives: i. to collect germ-line deoxyribonucleic acid (dna) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition. ii. to investigate the role of germ-line mutations in predicting cancer outcome and response to therapy. secondary objectives: i. to determine the effect of the identified variants on tumor micro-ribonucleic acid (mirna), protein and gene expression. ii. to study expression of dna, ribonucleic acid (rna) or protein in the blood of cancer patients with and without variants of interest to discover correlations between such levels and the presence of cancer and/or response to therapy in these patients. outline: patients undergo collection of blood and saliva samples 1-3 times at the discretion of the investigator for germ-line mutation analysis. after completion of study, patients are followed up for 5 years.

Eligibility criteria:
inclusion criteria: * pathologically or clinical confirmed tissue diagnosis of a cancer * ability to understand and the willingness to sign a written informed consent exclusion criteria: * patients will be excluded if their cancer cannot be confirmed * refusal to sign the informed consent
18f-fdg pet/ct-based prognostic model for predicting outcome in patients with diffuse large b-cell lymphoma

Conditions: Lymphoma, Large B-Cell, Diffuse

Summary: the purpose of this study is to evaluate whether 18f-fdg pet/ct-based prognostic model of diffuse large b-cell lymphoma can predict disease progression

in this study investigators develop a prognostic model based on 18f-fdg pet/ct and test its ability for prognostic value in patients with dlbcl. pet/ct scans evaluation using the liver suvmax as reference. positive lesions in pet were indicated as suvmax of residues higher than the threshold (1.6 fold of liver suvmax) or new 18f-fdg avid lesions. 18f-fdg pet/ct-based prognostic model includes pet/ct image, dominant clinical and pathological prognostic factors to predicting disease progression during chemotherapy or survival in dlbcl.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed dlbcl; 2. treated using an anthracycline-containing regimen with or without rituximab; 3. minimal follow-up at 6 months after the completion of first-line treatment; 4. complete medical history and clinicopathological data exclusion criteria: 1. secondary malignant disease; 2. serious infection or inflammation (e.g., hiv); 3. primary central nervous system lymphoma; 4. hepatic or renal dysfunction.

Keywords: positron-emission tomography prognosis