Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of the citop™ guidewire for crossing chronic total occlusions in coronary arteries

Conditions: Coronary Occlusion

Summary: the citop™ guidewire coronary study is a feasibility open label study, to evaluate the safety and efficacy of the citop™ guidewire for crossing chronic total occlusion in coronary arteries.


Eligibility criteria:
inclusion criteria: 1. informed consent obtained prior to any trial activities. 2. patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria). 3. patient has an angiographic documented chronic total occlusion showing distal timi flow 0 to 1. exclusion criteria: 1. patient unable to give informed consent. 2. current participation in another study with any investigational drug or device. 3. factors making follow-up and/or repeat angiography difficult or unlikely. 4. contra-indication to emergency artery by pass surgery. 5. lack of surgical backup. 6. contra-indication to treatment with aspirin, or clopidogrel and/or heparin. 7. lesion \> 40mm in length (both calcified lesion and adjacent thrombus). 8. treated vessel referenced diameter less than 2.5 mm. 9. visualization of the distal lumen less than the rentrop classification grade 2 collateralization. 10. non-visible entry point of target lesion. 11. totally occluded bypass graft as target vessel. 12. acute mi less than 1 week before procedure. 13. patient has significant lv dysfunction, 35% lvef or less. 14. patient with cancer or other sever chronic disease with life expectance of 2 years. 15. patient has chronic renal failure with serum creatinine ≥2. 16. hemoglobin ≤11. 17. patient is known or suspected not to tolerate the contrast agent. 18. morbid obesity (bmi \> 40). 19. drug abuse or alcoholism. 20. patients under custodial care. 21. pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.

Keywords: cto chronic total occlusion revascularization
low intensity shock wave therapy in the rehabilitation treatment of erectile dysfunction after robotic radical prostatectomy.

Conditions: Erectile Dysfunction

Summary: the study deals with the hypothesis that lieswt in addition to the administration of pde5i can improve sexuality rehabilitation with faster recovery of a valid erection and higher iief-5 scores in the short and medium-term follow-up.

prospective randomized controlled trial (rct) designed to provide high level evidences describing the role of low-intensity extracorporeal shock wave therapy lieswt plus early introduction of pde5i vs early pde5i alone on penile rehabilitation of erectile dysfunction ed after treatment of post-robot-assisted (ra) radical prostatectomy (rp) rarp

Eligibility criteria:
inclusion criteria: * patients aged ≤75 yrs; * low-risk pca (psa \<10 ng/ml and gs \<7, isup grade 1, and ct1-2a) undergoing nerve sparing rarp; * preoperative iief-5 score ≥ 17; * first psa (45d after surgery) \<0.2 * compliants patients able to follow the study protocol and fill in iief-5 scores and eortc quality of life questionnaires; * patients able to provide a written informed consent for the trial. exclusion criteria: * anaesthesiologic contraindications to robotic surgery; * patients submitted to pelvic radiotherapy or androgen deprivation; * patients reporting major postoperative complications (cd≥3); * cardiovascular contraindications to pde5i medical treatment.
bortezomib (velcade) in patients with untreated multiple myeloma

Conditions: Multiple Myeloma

Summary: bortezomib (velcade) has just recently been approved by the fda for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy. this study will determine if velcade is effective in treating patients with multiple myeloma that have had no prior treatment for the disease. we will also use whole-genome scanning to identify drug response biomarkers in bone marrow samples as well as nerve fiber studies to compare nerves prior to the use of velcade and after treatment with velcade.

primary objective • to evaluate the objective response rate (cr + pr) to bortezomib alone in patients with newly diagnosed multiple myeloma. secondary objectives * to evaluate the tolerability and toxicity. * to evaluate time to progression. * to assess the frequency and severity of peripheral neuropathy. * to evaluate the impact of early intervention with dose modification and explore symptomatic treatment of peripheral neuropathy. exploratory objectives • to perform pharmacogenomic analysis of molecular markers associated with response or non-response. statistical design a one stage design is used to evaluate orr. with 60 evaluable participants, if at least 27 objective responses are observed then bortezomib will be considered promising. the probability of concluding the treatment promising is \>0.95 with a true orr of 55% and \<0.07 with a true orr of 35%.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma based upon standard criteria * measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of \> 1 g/dl and/or urine monoclonal immunoglobulin spike of \> 200mg/24 hours. * karnofsky performance status of \> 60 * hemoglobin \> 8.0 g/dl * ast (sgot) \< 3 x uln * alt \< 3 x uln * total bilirubin \< 2 x uln * is infertile or is practicing an adequate form of contraception * 18 years of age or older exclusion criteria: * prior treatment with systemic chemotherapy * plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes * plasma cell leukemia * calculated or measured creatinine clearance \< 30 ml/minute within 14 days of enrollment * grade 2 or greater peripheral neuropathy * hypersensitivity to bortezomib, boron or mannitol * severe hypercalcemia * hiv positive * known active hepatitis b or c * new york hospital association class iii or iv heart failure * second malignancy requiring concurrent treatment * other serious medical or psychiatric illness * pregnant women * dialysis dependent patients

Keywords: multiple myeloma velcade bortezomib
efficacy and safety of deferiprone in patients with chronic kidney disease undergoing a cardiac catheterization and receiving contrast agent

Conditions: Acute Kidney Injury

Summary: this trial will evaluate whether treatment with crmd001 (unique formulations of the iron chelator, deferiprone) will reduce morbidity and mortality in subjects with chronic kidney disease (ckd) and additional risk factors. adult subjects with moderate to severe ckd who are undergoing diagnostic or interventional coronary angiography will be randomized to either placebo or crmd001 and followed for 90 days. subjects will receive 8 days of randomized therapy starting 1-3 hours prior to angiography. the primary endpoint of the trial will be the difference in a composite of specified renal and cardiovascular clinical events occurring through day 90.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. egfr between 15 ml/min/1.73 m2 and \< 60 ml/min/1.73 m2 3. presence of at least one additional risk factor: * diabetes mellitus type 1 or 2 * age ≥ 75 years * left ventricular ejection fraction ≤ 40% exclusion criteria: 1. end-stage renal disease 2. primary pci for stemi 3. currently receiving mechanical ventilation 4. known active liver disease or liver failure 5. evidence of hemodynamic instability, such as a requirement for pressor agents 6. exposure to contrast media within prior 10 days 7. currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, or ascorbic acid (\> 2 g/day) 8. absolute neutrophil count \< 1500

Keywords: acute kidney injury contrast-induced nephropathy labile iron iron chelation deferiprone
evaluation of tc 99m tilmanocept localization in primary cutaneous kaposi's sarcoma and lymphatic drainage by spect/ct

Conditions: Kaposi's Sarcoma

Summary: the purpose of this study (nav3-12) is to determine the dissemination and localization of tc 99m tilmanocept by spect and spect/ct imaging in subjects with confirmed cutaneous ks. this is a single center, open-label, within-subject study.


Eligibility criteria:
inclusion criteria: 1. the subject has provided written informed consent with health insurance portability and accountability act (hipaa) authorization before the initiation of any study-related procedures. 2. the subject is at least 18 years of age at the time of consent. 3. the subject has an eastern cooperative oncology group (ecog) performance status of grade 0 to 2. 4. the subject has a ks stage of t(0), i(0), s(0). 5. the subject has a marker lesion with a confirmed diagnosis of ks (cd 206-expressing cutaneous ks) via punch biopsy. the location of the marker ks lesion will be limited to locations on the extremities: from the shoulder to the metacarpal region or from the groin to the metatarsal region. 6. the subject has a marker ks lesion that is ≥ 1cm in diameter. exclusion criteria: 1. the subject is pregnant or lactating. 2. the subject has had prior chemotherapy, immunotherapy, or radiation therapy to the local ks site or regional lymphatic system within one year of enrollment. 3. the subject has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the marker ks lesion. 4. the subject has known sensitivity to dextran.
pediatric pet/mr image registry

Conditions: Soft Tissue; Lymphoma; Osteosarcoma

Summary: the purpose of this study is to compare whole body magnetic resonance (mr) imaging, whole body positron emission tomography (pet)/mr imaging, and (if available) pet/computed tomography (ct) imaging for the diagnosis of tumors in children and young adults. sensitivities, specificities and diagnostic accuracies of the different imaging modalities will be compared for significant differences.


Eligibility criteria:
inclusion criteria: * patients with proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor. * we might also include some patients with leukemia if there is concern for a focal lesion in any of their organs. * participant's parents (if participant is under 18) or the participant (if participant is 18 years or older) must willingly give written informed consent prior to any image transfer to the image registry. exclusion criteria: * patient has contraindications for mri or pet/mr. this includes patients with cardiac pacemakers or intracranial vascular clips as well as patients with a blood glucose level \> 200 mg/dl. * lack of parental permission (if participant is younger than 18) or lack of informed consent (if participant is at least 18 years of age). * patient has a cns primary tumor. * pregnant women and fetuses
trivalent chromium treatment for rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: trivalent chromium has shown good results in abolishing inflammation and had a successful result in treating animal model of rheumatoid arthritis. in addition to that, trivalent chromium lacks many side effects which are related to the already known medications of the disease. so this study aims to evaluate the efficacy of trivalent chromium supplementation in rheumatoid arthritis treatment and measuring the outcomes of that in rheumatoid arthritis patients.

rheumatoid arthritis is a debilitating autoimmune disease which is treated by medications that have many side effects. trivalent chromium, a naturally occurring element with regulatory effects on blood sugar, has shown anti-inflammatory properties in many studies and has shown a good response at alleviation of rheumatoid arthritis in the disease animal model. for these reasons trivalent chromium should be tried in rheumatoid arthritis patients.

Eligibility criteria:
inclusion criteria: * rheumatoid arthritis exclusion criteria: * other autoimmune diseases
a phone intervention for family dementia caregivers in vietnam

Conditions: Dementia

Summary: this is a cluster randomized controlled trial to examine the feasibility, acceptability, and preliminary efficacy of the phone version of reach vn, a psychosocial culturally adapted alzheimer's family caregiving intervention, to support family caregivers of persons living with dementia in vietnam.

the objective of this study is to conduct a cluster randomized controlled trial (rct) to examine the feasibility, acceptability, and preliminary efficacy of the phone version of reach vn (resources for enhancing alzheimer's caregiver health in vietnam), a psychosocial culturally adapted alzheimer's family caregiving intervention that will be delivered over the phone with an enhanced control as the comparison. the pilot cluster rct will test the hypothesis that family caregivers who receive the intervention will show lower caregiver burden (primary outcome) and lower depressive/anxiety symptoms (secondary outcome) compared with those in the control group.

Eligibility criteria:
inclusion criteria: * to be eligible to participate, a family member will need to be the identified adult (i.e., age 18 and above) who is the primary informal (i.e., unpaid family member) caregiver (i.e., the person who provides the most time day-to-day care) to an older adult (i.e., age 60 and above) with dementia living in the community. if the primary caregiver is not available to participate, an alternate family member who provides substantial care (i.e., at least 4 h/day) to an older adult with dementia will be eligible to participate. * in addition, caregivers will need to score ≥ 6 on the zarit burden interview-4 (zbi-4). * all participants will be living in clusters in thach that district, a semi-rural area in hanoi. clusters will have a minimum of 3 participants and a maximum of 15 participants. exclusion criteria: * caregivers with difficulties in the consent process due to cognitive impairment or severe sensory impairment (i.e., visual, hearing) * caregivers don't have access to phone * individuals who are not yet adults (i.e., infants, children, teenagers) * prisoners

Keywords: dementia family caregiving phone intervention non-pharmacological intervention dementia caregivers
dermacyd ph_detinback (lactic acid) sweet flower - photo avaluation

Conditions: Hygiene

Summary: the purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product dermacyd phdetinback sweet flower.


Eligibility criteria:
inclusion criteria: * phototype skin ii and iii; * integral skin test in the region; * willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; exclusion criteria: * lactation or gestation * use of antiinflammatory and/or immunosuppression drugs 15 days before the selection; * diseases which can cause immunity decrease, such as hiv, diabetes; * use of drug photosensitizer; * history of sensitivity or irritation for topic products; * active cutaneous disease which can change the study results; * history of photodermatosis active; * family or personal antecedent of cutaneous photoinduced neoplasias; * presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium; * intense solar exposure in the study area; * use of new drugs or cosmetics during the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
comparative study between photodynamic therapy with led associated with probiotics in the treatment of halitosis

Conditions: Halitosis

Summary: halitosis is a term that defines any odor or bad smell coming from the oral cavity, which can have a local or systemic origin. this project aims to verify if there is a difference in the effectiveness of treatment with antimicrobial photodynamic therapy (apdt) with led associated with treatment using probiotics in reducing halitosis. 92 participants, aged 18 to 60 years, diagnosed with halitosis, presenting sulfhydride (sh2) ≥ 112 ppb in gas chromatography will be selected. participants will be randomly divided into 4 groups (n=23), which will receive different treatments: group 1 (control): brushing, dental floss and tongue scraper; group 2: brushing, dental floss, tongue scraper and apdt with blue led and annatto; group 3: brushing, dental flossing, tongue scraper and apdt with blue led, annatto and probiotic lozenges containing streptococcus salivarius k12 (blis k12®); group 4: brushing, dental flossing, tongue scraper and probiotic lozenges containing streptococcus salivarius k12 (blis k12®). the results of the halimetry will be compared before, immediately after the treatments, thirty days after and sixty days after. the microbiological analysis will be performed by counting the colony forming unit of viable bacteria in the tongue coating at these same times. the microbiome analysis will be performed before, thirty days after and sixty days after the treatments after dna extraction. all groups will be treated with oral hygiene instructions with a toothbrush, toothpaste and dental floss as well as receiving material for this practice. the normality of the data will be measured by the shapiro-wilk test, and in the case of normality the analysis of variance (anova) test will be applied, and in the case of non-parametric data, the kruskal-wallis test will be used. the wilcoxon test will be used to analyze the results of each treatment in the two study periods.


Eligibility criteria:
inclusion criteria: * diagnosis of halitosis showing sulfhydride (sh2) ≥ 112 ppb in gas chromatography. exclusion criteria: * individuals with dentofacial anomalies (such as cleft lip, cleft palate and nasopalatine); * undergoing orthodontic and/or orthopedic treatment; * undergoing oncological treatment; * with systemic alterations (gastrointestinal, renal, hepatic) * undergoing antibiotic treatment up to 1 month before the research; * pregnant women.
pelvic and acetabular fracture in old people

Conditions: Fracture Dislocation

Summary: it was reported that satisfactory postoperative outcome was difficult to obtain for the pelvic or acetabular fracture in old people. the less invasive surgical method was conducted in this study. then, the clinical results were compared with the patients treated using traditional methods to assess the less invasive method.

pelvic or acetabular fractures were caused by high energy trauma, which may lead to poor prognosis for the old. the patients over 60 years were included in this study. the surgical procedure was conducted in two weeks. the less invasive methods involved stoppa approach and novel plate. the data including surgical time, blood loss and results of follow-up were recorded. the clinical results were compared with the patients treated using traditional methods. thus, the clinical outcome of pelvic or acetabular fractures in old man was assessed.

Eligibility criteria:
inclusion criteria: over 60 years old fracture involving pelvis or acetabulum operation was conducted within 14 days sign the consent form exclusion criteria: presented with a pathologic acetabular fracture refused to participate follow-up insufficient 12 months

Keywords: fracture outcome pelvic acetabular
bevacizumab in combination with temozolomide in patients with neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: the purpose of this study is to determine what effects (good and bad) bevacizumab and temozolomide have on patients with neuroendocrine tumors.

patients will receive temozolomide orally once daily for one week, followed by a one-week rest period. this one-week on/one week off schedule will continue for the duration of treatment unless significant side effects develop. bevacizumab will be administered intravenously every other week. after eight weeks (two cycles), a ct scan will be performed to see how treatment affected tumor growth. bactrim, an antibiotic, and acyclovir, an antiviral medicine, will be given in order to help prevent infection. blood tests will be done every other week to evaluate any side effects. once the study has been completed, a physical exam, vital signs, blood tests, and ct scan will be performed. patients will remain on the study as long as they continue to receive benefit from the treatment and there are no serious side effects.

Eligibility criteria:
inclusion criteria: * histologically documented locally unresectable or metastatic neuroendocrine tumor excluding small cell carcinoma * measurable disease \> 1cm by spiral computed tomography (ct) or \> 2cm by other radiographic technique * ecog performance status of 0-2 * life expectancy of \> 12 weeks * prior treatment with chemotherapy is allowed * total bilirubin \< 2.0mg/dl * ast \< 5x upper limit of normal (uln) * serum creatinine \< 2.0mg/dl * absolute neutrophil count \> 1,000/mm3 * platelets \> 100,000/mm3 * international normalized ratio (inr) \< 1.5 exclusion criteria: * prior treatment with temozolomide, decarbazine or bevacizumab * clinically apparent central nervous system metastases or carcinomatous meningitis * clinically significant cardiovascular disease * major surgery, open biopsy, or significant traumatic injury within 28 days * pregnant or breast-feeding women * chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medication * serious, nonhealing wound, ulcer or bone fracture * evidence of bleeding diathesis or coagulopathy * history of other disease or metabolic dysfunction

Keywords: metastatic neuroendocrine tumor advanced neuroendocrine tumor bevacizumab temozolomide
reiterative development and evaluation study of osa therapy system

Conditions: Obstructive Sleep Apnea

Summary: the purpose of this study is to evaluate new iterations/generations of the apnicure sleep therapy device.


Eligibility criteria:
inclusion criteria: 1. subject is between the ages of 18 and 80. 2. subject is fluent in english and understands the study protocol and is willing and able to comply with study requirements and sign the informed consent form. 3. subject has a least one molar in each of the four quadrants of the mouth (right upper, right lower, left upper, and left lower). exclusion criteria: 1. poor nasal patency as evidenced by the inability to breathe through the nose with the mouth closed. 2. oral cavity infection or any other oral or dental condition or problem that would limit subject use of the apnicure system (e.g. dentures, loose tooth/teeth, temporomandibular joint (tmj) conditions, or any oral or dental condition that the investigator believes could be exacerbated by the attune sleep apnea system. 3. history of any osa surgical treatment including uvulopalatopharyngoplasty surgery (uppp), maxillomandibular advancement surgery (mma), radio frequency (rf) ablation treatment, palatal stent devices, etc. 4. any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than osa, including insomnia, and central sleep apnea. 5. currently working nights, or rotating night shifts. 6. current disease state, use of medication or other treatment which, in the investigator's opinion, may pose additional risk to the subject or confound the results of the study. 7. female subjects of child bearing age who are pregnant or intend to become pregnant during the study period.