Kornimate/medical-research-clean huggingface dataset:
flowmet-r blood flow measurement for the diagnosis of peripheral artery disease and critical limb ischemia

Conditions: Peripheral Artery Disease

Summary: non-randomized, multi-center, longitudinal study of healthy subjects and subjects with pad who are scheduled for abi, tbi, and either duplex ultrasound or angiographic assessments in a vascular clinic.

patients scheduled for peripheral vascular examination and healthy controls will be measured with the flowmet-r, a noninvasive blood flow monitor, and compared to gold standard diagnostics - abi, tbi, and doppler ultrasound. sensitivity and specificity of the flowmet-r device output in diagnosing pad and cli will be assessed on initial visit, 3-month followup, and 6-month followup.

Eligibility criteria:
inclusion criteria: pad positive cohort * subject meets pad positive criteria * subject is willing and able to provide informed consent * subject is willing and able to comply with study procedures * subject is able to understand the study procedures * subject is scheduled for vascular examination that includes noninvasive assessments as standard of care: abi, tbi, and either a duplex ultrasound or angiogram healthy cohort * subject is willing and able to provide informed consent. * subject is willing and able to comply with the study procedures. * subject is able to understand the study procedures. * subject has no history of positive pad diagnosis, and is not currently suspected of having pad. exclusion criteria: pad positive cohort * subject is under 40 or unable to consent. * subject has any medical condition, which, in the judgment of the investigator and/or designee, makes the subject a poor candidate for the investigational study. * subject is excluded from analysis if no stenosis is found during doppler but tibial disease is suspected and tibial ultrasound is not able to be performed. * subject does not have a suitable finger to attach the flowmet-r probe. * subject does not have a suitable 1st or 2nd digit to attach flowmet-r probe on the limb of interest. * subject has undergone revascularization within the last 90 days * subject cannot lay safely in a supine position. healthy cohort * subject is under 40 or unable to consent. * subject has any medical condition, which, in the judgment of the investigator and/or designee, makes the subject a poor candidate for the investigational study. * one or more limbs has a prior or current diagnosis of pad, or is reasonably suspected of having a diagnosis of pad. * subject does not have a suitable finger to attach the flowmet-r probe. * subject does not have a suitable 1st or 2nd digit to attach flowmet-r probe. * subject has undergone revascularization within the last 90 days

Keywords: peripheral artery disease claudication critical limb ischemia
sch 727965 in patients with advanced breast and lung cancers (study p04716)

Conditions: Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Summary: to determine the activity of sch 727965 in participants with breast cancer and in participants with nonsmall-cell lung cancer (nsclc) compared to standard treatment. the standard treatment used is capecitabine for breast cancer and erlotinib for nsclc. the study will also determine the activity of sch 727965 treatment in participants who experience cancer progression after standard treatment.


Eligibility criteria:
inclusion criteria: * age \>=18 years, either sex, any race. * histologically or cytologically confirmed breast cancer or nsclc; and radiographic or clinically advanced disease. * breast cancer: * participant must have previously received both a taxane and an anthracycline (unless anthracycline therapy is contraindicated) in the adjuvant and/or metastatic setting, * participant with her2-positive disease must have progressed after trastuzumab and concomitant or subsequent lapatinib, * participant must have received at least one, but no more than two prior regimens for recurrent or metastatic disease (endocrine and biologic therapies do not count as chemotherapeutic regimens). * nsclc: at least one, but no more than two prior chemotherapeutic regimens for advanced disease. * measurable disease by the recist. * eastern cooperative oncology group performance status of 0, 1, or 2. * adequate hematologic, renal, and hepatic organ function and laboratory parameters. * ability to swallow tablets. exclusion criteria: * known brain metastases. for nsclc only, a participant with central nervous system metastasis is eligible provided the participant has received definitive local therapy (ie, radiation therapy or surgery), has stopped receiving treatment with corticosteroids, and is without symptoms for at least 4 weeks before randomization. * history of previous radiation therapy to \>25% of total bone marrow. * known hiv infection. * known active hepatitis b or hepatitis c. * previous treatment with sch 727965 or other cyclin-dependent-kinase inhibitors. * breast cancer: * known dihydropyrimidine dehydrogenase deficiency, * previous treatment with capecitabine. * nsclc: previous treatment with erlotinib.
clinical trial to evaluate the efficacy and safety of codivir® in addition to standard antiretroviral treatment for hiv infection in antiretroviral-naïve participants

Conditions: HIV; HIV Infection

Summary: the study will begin with a two-week lead-in period (w-2 and w-1), when participants randomized to codivir® will receive codivir® 2 ml, 1 subcutaneous injection every day. participants randomized to standard antiretroviral treatment will wait for the next step. at v0 (w0, d0) all participants will start the antiretroviral treatment described above. from v0 (w0, d0) to v6 (w12, d84) participants randomized to codivir® will receive codivir® as complementary therapy to the above antiretrovirals on alternate days (every other day). at v6 (w12, d84) treatment with codivir® will end. at v7 (w24, d168) participation in the study will end. viral load will be monitored during the study. in case of failure, participation in the study will be discontinued and the participant will be referred to receive the best treatment available for their case.


Eligibility criteria:
inclusion criteria: 1. male or female sex; 2. age ≥ 18 years; 3. hiv infection confirmed by serology (ab for hiv1/hiv2) and hiv1/hiv2 rna test; 4. naive for antiretroviral treatment; 5. viral load \&gt; 1,000 and \&lt; 50,000 copies/ml; 6. cd4 t lymphocyte (cd4) cell count \&gt;350 cells/mm3; 7. body weight at v -1 \&gt; 50 kg; 8. signature of the icf. exclusion criteria: 1. pregnancy, lactation or plan to become pregnant; 2. bmi \&lt; 18.5 kg/m2 at screening; 3. coinfection with hbv (hbsag +) or hcv; 4. any grade 3 or 4 clinically significant abnormality according to the division of aids (daids)\* rating scale; 5. any significant acute illness within 1 week before v0. 6. use of any immunomodulatory therapy (including interferon), systemic steroids, or systemic chemotherapy within 4 weeks of screening; 7. active malignancy or ongoing malignancy; 8. changes in safety tests: neutrophil count \&lt; 1000 u/l; hb \&lt; 9.0 gm/dl; platelet \&lt; 75,000 u/l; creatinine \&gt; 1.5 mg/dl, direct bilirubin \&gt; 85 μmol/l, ast or alt \&gt; 2.5 x uln; 9. potential allergy or hypersensitivity to components of the codivir® formulation. 10. participation in another clinical trial within 12 months of screening. 11. any medical condition that makes the participant unsuitable for the study or increases the risk of participation at the discretion of the investigator.

Keywords: hiv aids
a study to determine the performance of the press fit condylar (p.f.c.) sigma rp-f knee system

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate if the p.f.c. sigma rpf knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion does not compromise the longevity of the implant.

primary endpoint is to demonstrate that 90% of patients have a functionally stable knee that can achieve post operative range of motion of 125 degrees or greater. the secondary endpoint is to investigate the survivorship of the p.f.c. sigma rp-f knee at 1, 2, 3, 5, 10, 15 and 20 years

Eligibility criteria:
inclusion criteria: * male or female subjects, aged between 45 and 75 years inclusive. * subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. * subjects who are able to achieve a pre-operative passive range of motion of equal to or greater than 110º. * subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. * subjects who present with idiopathic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty. * subjects who in the opinion of the clinical investigator are considered to be suitable for treatment with the p.f.c.® sigma rpf knee, according to the indications specified in the package insert leaflet. exclusion criteria: * subjects who, in the opinion of the investigator, have an existing condition that would compromise their participation and follow-up in this study. * women who are pregnant. * subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. * subjects who have participated in a clinical study with an investigational product in the last month (30 days). * subjects who are currently involved in any personal injury litigation claims. * subjects with a known history of poor compliance to medical treatment. * subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis. * subjects who have morbid obesity i.e. bmi ≥40.

Keywords: arthroplasty knee replacement high flexion pfc sigma rp-f
optical detection of intravenous infiltration

Conditions: Intravenous Infiltration; Extravasation of Diagnostic and Therapeutic Materials

Summary: the purpose of this study is to investigate the safety and efficacy of an optical device designed and developed for monitoring the intravenous infusion site for infiltration. the hypothesis is that the changes in optical signals measured near the infusion site using the optical device can be used to monitor intravenous infusion for infiltration.


Eligibility criteria:
inclusion criteria: * subjects will have peripheral iv catheter with active infusions that are anticipated to be in place and functioning for 48-72 hours. the ivs and accompanying infusions are solely a part of the subject's medical care and are not started or terminated for the purposes of this study. the rationale for choosing this time frame is that the rate of infiltration is likely to be increased the longer the iv infusion is taking place. * subjects are admitted to one of the institution's intensive care or intermediate care units, including adult emergency department, pediatric emergency department, adult medical intensive care unit, pediatric intensive care unit, neonatal intensive care unity, surgical-trauma intensive care unit, cardiothoracic surgery intensive care unit, neuroscience intensive care unit, burn intensive care unit, transplant intensive care unit, coronary care intensive care unit, post-anesthesia recovery unit, pediatric intermediate care unity, surgical intermediate care unit, and medical intermediate care unit. exclusion criteria: * inability to consent * lack of a peripheral iv

Keywords: infiltration extravasation optical monitoring
study comparing tigecycline and vancomycin with aztreonam in complicated skin and skin structure infections

Conditions: Skin Diseases, Infectious

Summary: to compare the safety and the efficacy of tigecycline to vancomycin with aztreonam in treating hospitalized patients with complicated skin and/or skin structure infections.


Eligibility criteria:
inclusion criteria: * anticipated need for intravenous antibiotic therapy of 5 days or longer. * patients known or suspected to have a complicated skin and skin structure infection. complicated skin/skin structure infection includes infections either involving deeper soft tissue or requiring significant surgical intervention or a significant underlying disease state (such as diabetes mellitus, peripheral vascular disease, peripheral neuropathy, lower venous insufficiency) that complicates response to treatment. other inclusion applies exclusion criteria: * patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed. * patients with severely impaired arterial blood supply and insufficiency such that the likelihood of amputation of the infected anatomical site within one month is likely. * infected diabetic foot ulcers or decubitus ulcers where the infection is present for greater than one week's duration or chronically infected decubitus ulcers in patients who can not be compliant with measures necessary for chronic wound healing. * necrotizing fasciitis or gangrene. other exclusion applies.

Keywords: skin infections skin disease
sonographic venous doppler imaging in acute kidney injury

Conditions: Acute Kidney Injury

Summary: the first presentations of patients with acute kidney injury (aki) are usually to the emergency departments. while the mortality rate is 5-10% in uncomplicated aki, it is between 40-90% in patients hospitalized in the intensive care unit. therefore early diagnosis and treatment of aki in the emergency department is important in terms of morbidity and mortality. sonographic evaluation of the venous system (hepatic, portal and renal vein) may be useful for diagnosis. studies conducted so far have generally been based on predicting cardiorenal aki and renal poor outcomes and have been designed in general icu conditions. in this study, the investigators aimed to determine the diagnostic value of sonographic venous doppler imaging in terms of distinguishing subgroups of aki in patients presented to the emergency department with aki.


Eligibility criteria:
inclusion criteria: * aki diagnosis exclusion criteria: patients * with end-stage renal failure (stage 4), * who received 500 ml iv fluid or 40 mg diuretics, * who are pregnant, * with renal transplantation, * with cirrhosis and liver malignancy, * with postrenal aki, * who were referred from another center after starting treatment, * who do not give consent for the study.
a phase 3 multi-center study to assess pet imaging of flurpiridaz f 18 injection in patients with cad.

Conditions: Coronary Artery Disease

Summary: the primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz f18 injection pet myocardial perfusion imaging (mpi) compared to single photon emission computed tomography (spect) mpi in the detection of significant coronary artery disease (cad) as defined by invasive coronary angiography (ica) or a documented history of myocardial infarction (mi).

the study will assess the diagnostic efficacy (sensitivity and specificity) of flurpiridaz f18 injection mpi against spect mpi in patients screened for cad as determined by ica. six hundred and eighty evaluable patients will be enrolled and will undergo spect mpi and flurpiridaz f18 pet mpi. patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ica without intervention (being either positive or negative for cad).

Eligibility criteria:
inclusion criteria: invasive coronary angiography. men or women age 18 or older - see protocol for additional details. exclusion criteria: women who are pregnant, lactating, or of child bearing potential who are not practicing birth control. unstable cardiac status. history of coronary artery bypass graft. history of percutaneous coronary intervention within the past six months. see protocol for additional details.

Keywords: coronary artery disease. positron emission tomography myocardial perfusion imaging. single positron emission computed tomography. flurpiridaz f18 injection.
image-guided biopsies in identifying mechanisms of resistance in participants with metastatic castration resistant prostate cancer undergoing radioligand therapy

Conditions: Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IV Prostate Cancer

Summary: this trial studies image-guided biopsies work in identifying mechanisms of resistance in participants with castration resistant prostate cancer that has spread to other places in the body and who are undergoing radioligand therapy (rlt). tissue sample collected from a biopsy may help determine why response to rlt varies among patients, and this may help researchers to find better treatments for advanced prostate cancer.

primary objectives: i. proportion of metastatic castration resistant prostate cancer (mcrpc) patients with altered signaling pathways after radioligand therapy assessed by phospho-proteomics of biopsy samples. secondary objectives: i. generation of patient derived xenograft (pdx) models to determine if tumor levels of activity for individual adaptive pathways are related to the best prostate specific antigen (psa) response. ii. sequencing to identify frequently mutated genes such as tp53 and atm. outline: participants undergo image-guided biopsy over 45 minutes prior to first rlt course and 1-2 days after the third rlt course.

Eligibility criteria:
inclusion criteria: * volunteer patient * histologically confirmed prostate cancer * enrolled in lu-psma-617 treatment trial (institutional review board \[irb\]# 17-000330) * based on positron emission tomography (pet)/computed tomography (ct) images: evidence of lymph node or soft tissue metastatic disease amenable to image-guided biopsy * platelets \> 75,000/ul within 14 days prior to biopsy * prothrombin time (pt) or international normalized ratio (inr) and a partial thromboplastin time (ptt) \< 1.5 times the institutional upper limit of normal (uln) within 14 days prior to biopsy * patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for one week prior to the biopsy. conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the principal investigator (pi) exclusion criteria: * patients with significant congenital or acquired bleeding disorders (e.g. von wildebrand's disease, acquired bleeding factor inhibitors) are not eligible
the effect of trunk control on respiratory muscle strength

Conditions: Cerebral Palsy, Spastic; Posture; Respiratory Muscle Strength; Activities of Daily Living

Summary: cerebral palsy (cp) can be defined as a group of disorders of movement and posture, causing activity limitation that are attributed to nonprogressive deficits that take place in the immature brain. the motor disorders of cp are often accompanied by deficits in sensation, cognition, communication, perception, behavioral and respiratory system . children with cp have many primary motor impairments such as selective mobility, muscle weakness, abnormal muscle tone, impaired coordination between agonist-antagonist muscles and insufficient postural control. these motor impairments also lead to secondary problems such as contractures and bone deformities. whether primer or secondary, all these problems can reduce independence in activities of daily living (adl) by affecting cp children at different levels. there are several studies in children with cp that investigate the effects of trunk control and/or respiratory functions. however, there are very few studies examining the relationship of these functions which have direct effects on adl. in these studies, the functions of children who are more heavily affected and unable to move have been examined. however, there are no studies examining the effect of trunk control on respiratory muscle strength in children with cp with a better mobility level. there are many factors affecting both trunk control and respiratory functions in these children. therefore, in children with cp, who have better functional level and can move on their own, revealing the interaction between trunk control and respiratory functions may contribute significantly to the treatment process. for this reason, this study was planned to investigate the effect of trunk control on adl and respiratory muscle strength in children with cp having a gross motor functional classification system (gmfcs) levels of 1 and 2 and to compare them with healthy children.

trunk control was evaluated by trunk control measurement scale (tcms), adl was evaluated by pediatric evaluation of disability inventory (pedi) and respiratory muscle strength was evaluated by mouth pressure meter.

Eligibility criteria:
inclusion criteria: * diagnosis of cp by a pediatric neurologist * no significant scoliosis during postural evaluation * were having a level of 1 or 2 of gmfcs * no orthopedic surgery or not having botulinum toxin-a injection in the last 6 months exclusion criteria: * having speech or cooperative problems
tailoring varenicline to individual needs (tvin study)

Conditions: Tobacco Dependence; Smoking Cessation

Summary: varenicline is a partial nicotinic agonist which acts on alpha4 beta2 nicotinic receptors. it is presumed to alleviate withdrawal discomfort, but also to diminish rewarding effects of cigarettes. the standard varenicline dosing has been formulated to avoid adverse reactions (primarily nausea) in sensitive clients. the downside of this cautious approach is that a substantial proportion of clients may be under-dosed. a blanket dose increase would inevitably increase the incidence of side effects, but it is likely that tailoring varenicline dosing to clients' needs would be safe and may further increase varenicline's efficacy. this study will recruit 200 smokers who report little change to their enjoyment of cigarettes and no nausea, during the first week of varenicline use. these smokers will be randomised to receive the standard dose plus placebo or plus individualised varenicline dose up to 5mg, titrated over the next week prior to their target quit day. urges to smoke, and other withdrawal symptoms, experienced during the study period will be compared between groups to see if the tailored therapy may be useful.


Eligibility criteria:
inclusion criteria: * smoker seeking treatment * aged 18 and over * consenting to take part * report little or no change in enjoyment of cigarettes and/or nausea exclusion criteria: * pregnant or breastfeeding * have severe kidney disease * have severe heart problems * have a current psychiatric illness * are unable to fill in questionnaires in english * have an allergy to varenicline * are currently involved in another clinical trial

Keywords: tobacco dependence smoking cessation varenicline tailored dosing