Kornimate/medical-research-clean huggingface dataset:
a clinical study to evaluate the efficacy and safety of monopolar radiofrequency combined with skinceuticals a.g.e and skinceuticals ce ferulic for improving facial skin elasticity, tightening and fading fine lines

Conditions: Skin Aging

Summary: a prospective, single-center, single-blind, randomized split-face, controlled trial will be conducted. the goal of this clinical trial is to evaluate the efficacy and safety of monopolar radiofrequency combined with skinceuticals a.g.e and skinceuticals ce ferulic for improving facial skin elasticity, tightening and fading fine lines


Eligibility criteria:
inclusion criteria: * subjects must meet all of the following criteria to be enrolled in the study: 1. healthy women, skin quality is not limited, aged 25 \~ 65 years old face old \~ moderate aging group; 2. subjects facial skin rough, loose, lack of elasticity; 3. subjects with multiple facial fine lines, decree lines or puppet lines areas have static fine lines trend, the lower part showed signs of loosening; 4. subjects with consistent facial skin status on both sides and planning to receive monopolar radiofrequency treatment; 5. be able to cooperate well with the tester and maintain the regularity of life during the study; 6. be able to read and understand all contents of the informed consent form, and voluntarily sign the informed consent form (icf); 7. agreed not to use any cosmetics, drugs and health products that have an impact on the results during the trial; exclusion criteria: * subjects were not included in the study if they met any of the following exclusion criteria: 1. subjects with contraindications to monopolar radiofrequency treatment (such as malignant tumors, acute systemic infection, metal implants or active implants in the body such as cardiac pacemakers/defibrillators, etc.) or contraindications to a.g.e./ce use (or allergies to other skin care components); 2. subjects with facial skin diseases, infections, inflammation, etc. that may affect the judgment of the test results; 3. subjects with hypertrophic scar or scar constitution; 4. subjects who have experienced tightening medical treatment (gemma, fotona 4d, ultrasonic cannon, ultrasonic scalpel, gold microneedle, etc.) in the past 3 months; 5. subjects who have oral and topical cosmetic products that may affect the study results within 2 weeks; 6. subjects who participate in drug clinical trials or other trials within 30 days, or subjects who have systemic use of drugs that may affect the study results within the past 1 week; 7. pregnant or lactating women, or recent plans to prepare for pregnancy; 8. other subjects who are not suitable for participating in this study as assessed by the investigator.
a clinical evaluation of the pronova xr polymer free drug eluting coronary stent system

Conditions: Myocardial Ischemia

Summary: the objective of this study is the assessment of the performance, safety and efficacy of the pronova xr polymer free drug eluting stent system in the treatment of patients with de novo native coronary artery lesions.

this study is a prospective, single arm, multicenter registry of approximately 50 patients undergoing pci with the pronova drug eluting coronary stent system according to its instructions for use. the purpose of this registry is the evaluation of the performance, safety and efficacy of pronova xr des in real-world patients. following initial stent implantation, all patients will have clinical follow up at 30 days, at 6 and 12 months. additionally all patients will have a angiographic f/u at 6 months to assess the late luminal loss by qca measurements and the neointimal volume including stent apposition by intravascular ultrasound.

Eligibility criteria:
general inclusion criteria: * patient must be at least 18 years of age. * patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the pronova xr des and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate medical ethics committee of the respective clinical site. * patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ecg) consistent with ischemia) * patient must agree to undergo all required follow-up examinations. * patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment. angiographic inclusion criteria: * target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy) * target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate * target lesion ≤ 28 mm in length by visual estimate exclusion criteria: * patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year) * patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, cobalt, chromium, nickel, or contrast sensitivity that cannot be adequately pre-medicated * participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days * patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.

Keywords: pronova xr polymer free drug eluting coronary stent system des stent coronary artery lesions pronova stent implantation
feasibility of multi-energy digital radiography detector for lung lesions detection

Conditions: Lung Tumor; Solitary Pulmonary Nodule

Summary: a single-centre, industry sponsored, pilot study to assess the feasibility of single exposure dual energy subtraction with a multi-energy digital radiography detector as an imaging platform for lung lesion detection.

a feasibility study is proposed to investigate the imaging characteristics captured by a single exposure dual-energy subtraction digital radiography with ka imaging's multi-energy detector. the acquisition of dual-energy subtraction radiography will consist of using the multi-energy detector integrated into the x-ray system in grand river hospital. patient will receive a multi-energy chest radiography exam on the same day as their routine chest ct exam. each multi-energy radiography exam will consist of one chest pa image and one chest lat image. duration of each procedure is 60 minutes. the multi-energy detector will generate a general radiography image and dual-energy subtracted images. visualization of lung lesions by multi-energy detector will be compared to corresponding ct exam and general radiography results. imaging data will be evaluated qualitatively by radiologists on data collection form to describe the findings on the images. further comparison between general radiography, dual-energy subtraction radiography and ct will be analyzed to determine the differences of imaging characteristics such as description of image quality and visibility of relevant anatomical structures and anomalies.

Eligibility criteria:
inclusion criteria: * age 18 years and older. * patients with previously diagnosed carcinoma with lung metastases, or patients with previously detected lung nodule * subject is able to provide informed consent * study participant is scheduled to have a chest ct exam as part of their routine care. * study participant is able to stand and be still during the exams. exclusion criteria: * not able or willing to provide informed consent, or consent is withdrawn. * study participant is pregnant * study participant is unable to perform standard radiography exam and ct exam
pharmacokinetics of cftr modulators in pregnant individuals and in postpartum breastfeeding mothers

Conditions: Cystic Fibrosis; Pregnancy

Summary: this study aims to evaluate the pharmacokinetic changes during pregnancy, postpartum, and in breast milk in cystic fibrosis patients receiving a cystic fibrosis transmembrane conductance regulator (ctfr) modulator, including elexacaftor, tezacaftor, ivacaftor, or lumacaftor.

the advent of cystic fibrosis transmembrane conductance regulator (cftr) therapy has significantly increased the life expectancy for individuals with cystic fibrosis (cf). as a result, adults with cf are more likely to have families than they have in the past. although the overall pregnancy rate among women with cf age 18-44 is declining (mirroring trends in the general population), the overall number of pregnancies is increasing due to the increasing number of adults with cf. however, little is known about cftr modulator use in pregnant or breastfeeding mothers, as outlined in a recent review of cf-therapies in pregnant and breastfeeding women. presently, there is one report of an uncomplicated pregnancy during ivacaftor use, and one case of a successful pregnancy in a woman who was maintained on lumacaftor/ivacaftor with reported maternal and fetal drug levels. in this study, we aim to study the pharmacokinetics of cftr modulators in pregnancy as well as while breastfeeding. this information will hopefully improve counseling while offering them for cf patients given the tremendous improvements seen in non-pregnant adults.

Eligibility criteria:
inclusion criteria: * female 18 years of age and older * female who has a diagnosis of cystic fibrosis * female who is taking cystic fibrosis transmembrane conductance regulator (cftr) modulator medication during pregnancy and postpartum exclusion criteria: * female \< 18 years of age * female with cystic fibrosis who is not taking cystic fibrosis transmembrane conductance regulator (cftr) modulator medication during pregnancy and postpartum * participant has contraindication to breastfeeding or not planning to breastfeed
genetics of spina bifida and anencephaly

Conditions: Anencephaly; Acrania

Summary: the goal of this research study is to discover the genetic and environmental factors that contribute to the cause of neural tube defects such as spina bifida and anencephaly. ultimately, this type of research may result in improved diagnosis, improved treatment and possibly prevention.


Eligibility criteria:
not currently enrolling new participants.

Keywords: anencephaly acrania
endoscopic ultrasound staging of periampullary neoplasms: retrospective

Conditions: Periampullary Neoplasms

Summary: the purpose of this retrospective study is to determine the degree to which a biliary stent affects eus staging accuracy of ampullary tumors.


Eligibility criteria:
inclusion criteria: * patients will be identified retrospectively through an existing indiana university medical center eus database and pathology database. * patients with and without biliary stents will be included. exclusion criteria: * patients that were suspected to have ampullary tumors but who were ultimately found to have a normal ampulla will be excluded.

Keywords: eus periampullary neoplasms
iconquerfear program for the treatment of fear of cancer recurrence in patients with localized renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: this trial investigates whether an online intervention, iconquerfear, can reduce fear of cancer coming back (recurrence) and anxiety in patients with renal cell carcinoma that is restricted to the site of origin, without evidence of spread (localized). this intervention is an online adaptation of a highly effective face-to-face treatment for fear of recurrence that teaches strategies for: controlling worry and excessive threat monitoring, modifying unhelpful beliefs about worry, developing appropriate monitoring and screening behaviors, addressing cancer-related existential change, promoting values-based goal setting, and reducing uncertainty by providing information about cancer and treatment. the information learned may help others with renal cell carcinoma who also have a fear of cancer recurrence.

primary objectives: i. to assess feasibility and acceptability of the iconquerfear program for patients with renal cell carcinoma (rcc). ii. to assess preliminary effects of the program on fear of cancer recurrence-7 item scale (fcr-7), patient-reported outcomes measurement information system (promis)-anxiety, promis-depression, and functional assessment of chronic illness therapy-general (fact-g). iii. explore differences in feasibility and efficacy of iconquerfear by sociodemographic or clinical factors. outline: patients complete 5 sessions of iconquerfear program online over 5 weeks. patients also complete questionnaires at baseline, after the intervention, and 2 months later.

Eligibility criteria:
inclusion criteria: * sufficiently fluent in english * cytologically or pathologically verified diagnosis of rcc * undergone nephrectomy with negative margins (note: patients with other local definitive therapies, e.g., radiofrequency ablation or stereotactic ablative radiotherapy \[sabr\], would not be candidates for this protocol) * no evidence of metastatic disease (including at a minimum computed tomography \[ct\] of the chest, abdomen and pelvis for staging) * internet access and basic computer skills * moderate to severe fear of cancer recurrence (fcr)
collaborate and leverage evidence in african american rural network

Conditions: Cardiovascular Diseases

Summary: the goal of this non-randomized, propensity-matched-controlled study is to assess the effectiveness of the heart matters evidence-based program -- previously evaluated for feasibility and efficacy in nct02707432 -- in improving cardiovascular health outcomes (change in systolic and diastolic blood pressure, primary outcomes) when implemented by community-based facilitators.

the research team will use a non-randomized, propensity-matched-controlled design to evaluate the effectiveness of the heart matters evidence-based program -- previously evaluated for feasibility and efficacy under nct02707432 -- in improving cardiovascular health outcomes when scaled in multiple rural, eastern north carolina counties and implemented by community-based facilitators. this study aims to recruit 210 participants, 70 of whom will be propensity-score-matched with participants from nct02707432. propensity-score-matching will allow for flexibility in recruitment, statistical rigor, and resource efficiency. the research team hypothesizes that matched participants in the present study will show significant improvements in health outcomes (systolic blood pressure, diastolic blood pressure) compared to the matched nct02707432 controls.

Eligibility criteria:
inclusion criteria: * identify as black or african american * reside in rural, eastern north carolina * self-report at least one cardiovascular disease risk factor, such as pre-diabetes, pre-hypertension or stage one hypertension, obesity, or family history of early heart disease exclusion criteria: * evidence of active or unstable cardiovascular disease * cognitive impairment that limits informed consent

Keywords: heart health behavioral modification community-based participatory research
safety and efficacy of smithkline beecham (glaxosmithkline [gsk]) biologicals' candidate adjuvanted vaccines (287615)

Conditions: Hepatitis B Disease

Summary: this study was done to evaluate the effect of various adjuvants in combination with hbsag as a model antigen on the induction of immune responses, mainly cytotoxic t lymphocytes (ctl) in healthy volunteers. the study was also done to evaluate the safety and reactogenicity of the various adjuvanted vaccines.


Eligibility criteria:
inclusion criteria: * healthy volunteers between 18 and 40 years of age * written informed consent obtained from subject * female of non-childbearing potential exclusion criteria: * any hepatitis b vaccination. * positive hbv serological markers: anti-hbs, anti-hbc, and/ or hbsag * pregnancy or lactating female * use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is the longer) preceding the first vaccine administration

Keywords: adjuvants hbsag
heparin alone vs. heparin-aspirin combo in free flap survival

Conditions: Complication,Postoperative

Summary: this randomized clinical trial aims to compare the effectiveness of heparin alone versus combination therapy of heparin- aspirin in improving free flap survival in patients undergoing reconstructive surgery. participants will be randomly assigned to receive either heparin or a combination therapy, and the primary outcome measure will be the survival rate of the free flap at various time points post-surgery

the objective of this randomized clinical trial is to evaluate the efficacy of heparin alone vs compared to combination therapy of heparin-aspirin in enhancing free flap survival in patients undergoing reconstructive surgery. participants will be randomly assigned to one of two groups: one receiving standard heparin therapy and the other receiving a combination therapy that includes heparin and other agents. the primary outcome will be the survival rate of the free flap, assessed at multiple intervals after surgery. secondary outcomes will to assess the incidence of flap thrombosis, bleeding complications, re-operation in free flap surgeries and overall patient outcomes in both groups. ethical approval will be obtained, and informed consent will be required from all participants. this trial seeks to provide robust evidence on the potential benefits of combination therapy over heparin alone in free flap survival, potentially informing future clinical guidelines.

Eligibility criteria:
inclusion criteria: * patients undergoing free flap surgery * age between 18 and 70 years exclusion criteria: * known hypersensitivity to heparin or aspirin * history of bleeding disorders * concurrent use of other anticoagulant or antiplatelet medications * severe renal or hepatic impairment * preoperative use of aspirin that could not be stopped five days before surgery due to a higher risk of cardiac-related complications.

Keywords: ischemia thrombosis vascular complications surgical wound healing reconstructive surgery complications
acute microvascular changes with ldl apheresis

Conditions: Hyperlipidemia

Summary: severe hypercholesterolemia produced by conditions such as heterozygous familial hypercholesterolemia is associated with multiple complications including premature atherosclerotic disease. there is evidence that microvascular perfusion, particularly flow reserve, in critical organs is limited due to abnormalities in plasma viscosity, abnormal rbc deformability, and an imbalance between vasodilators and vasoconstrictors. there is little is currently known about acute changes in microvascular blood flow and microvascular rheology that occur in response to plasmapharesis which is used in some patients to lower critically elevated cholesterol levels. our research group has pioneered ceu methods for assessing myocardial and skeletal muscle perfusion, and has previously demonstrated in pre-clinical models that acute hyperlipidemia produces a reduction in microvascular rbc transit rate. in this study, the investigators will assess acute changes in microvascular perfusion in patients undergoing clinically-indicated plasmapharesis.

subjects who are scheduled to have planned apheresis treatment for severe hypercholesterolemia will be recruited into the study. they will undergo a screening evaluation, including a medical history, physical examination, ecg, and limited echocardiogram to evaluate for exclusion criteria. before the apheresis procedure, blood samples will be obtained for plasma markers of inflammation, erythrocyte deformability, and plasma viscosity. contrast enhanced ultrasound perfusion imaging will be performed to evaluate blood flow in the myocardium at rest, as well as in the forearm skeletal muscle before and after mild isometric exercise (50% maximal grip, 0.2 hz). flow mediated vasodilation will be performed. the subjects will then undergo their planned apheresis procedure. within 2 hours of completion of apheresis, blood collection and ceu will be repeated. plasma lipids will be available as part of the standard apharesis protocol.

Eligibility criteria:
inclusion criteria: * hypercholesterolemia (ldl \>200 mg/dl) * clinically-indicated aphersis for hyperlipidemia * age \>18 y.o. exclusion criteria: * pregnant or lactating females * hypersensitivity to ultrasound contrast agents * evidence for right to left or bidirectional shunt * on anticoagulants
efficacy and safety study to evaluate gadavist (gadobutrol) as contrast agent in magnetic resonance imaging (mri) of vascular diseases in chinese patients

Conditions: Vascular Diseases

Summary: the purpose of this study is to determine if the contrast agent is effective and safe in the magnetic resonance imaging (mri) of vascular diseases in patients of chinese origin.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer healthcare ag, germany. bayer healthcare ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * chinese origin * known or suspected blood vessel diseases exclusion criteria: * pregnancy * lactation * conditions interfering with mri * allergy to any contrast agent or any drugs * participation in other trial * require emergency treatment * severely impaired liver and kidney functions

Keywords: gadovist gadavist mri imaging vascular diseases chinese
follow up study of tear in the rotator culf

Conditions: Rotator Culf Tear

Summary: rotator culf tears are common in the aging population and are a significant morbidity source. the common knowledge is that the major tears do not heal and constantly expanding.still since the majority of the patients are old the acceptable therapy is conservative treatment. our objective is to estimate the accuracy of rotator culf tear utilizing an ultrasound.


Eligibility criteria:
inclusion criteria: * was diagnosed with shoulder tear * size of the tear till 2.5 cm * the opposite tendon-normal exclusion criteria: * systematic diseases . * injury to the shoulder after the previous us. * pregnancy
registry of adjuvant hormone-blockade breast cancer patients evaluated for bone mineral metabolism

Conditions: Breast Cancer

Summary: establishment of a registry by which to census all patients treated with adjuvant hormone blockade for previous breast cancer in order to evaluate in future studies the trend of bone mass and its relationship to laboratoristic indices inherent in calcium metabolism, and the prevalence and incidence of fractures.

establishment of a registry by which to census all patients treated with adjuvant hormone blockade for previous breast cancer in order to evaluate in future studies the trend of bone mass and its relationship to laboratoristic indices inherent in calcium metabolism, and the prevalence and incidence of fractures. inclusion in the registry will be proposed consecutively to every patient with adjuvant hormone-blockade breast cancer diagnosed and evaluated at the endocrinology operative unit for bone mineral metabolism as part of the 'diagnostic clinical-assistance pathway (pdta) of the patient with breast cancer' of irccs aou of bologna and referred/referred by zamagni oncology. the registry will include patients seen from 01/01/2015 for a duration of 15 years. a maximum follow-up duration for each patient is expected to be 10 years with an end date of enrollment on 12/31/2029 and a registry update deadline on 12/31/2039.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient undergoing adjuvant hormone blockade therapy (aromatase inhibitors, gnrh analogs, tamoxifen) for breast cancer referred by uo oncology zamagni * performed densitometry at uo radiology lovato and performed hematochemical tests inherent to mineral metabolism * informed consent obtained exclusion criteria: * none