Kornimate/medical-research-clean huggingface dataset:
metal ion serum concentrations in patients with total hip replacements

Conditions: Osteoarthritis

Summary: other research studies have shown that the levels of metals in the blood are slightly increased after patients receive a total hip replacement. we want to learn whether these elevated levels are associated with any adverse effects. we hope this study will help us identify which type of patients have elevated levels of metal in their blood.

it is suspected that the concentration of the metals chromium, cobalt and titanium in the blood will be higher in people with an all metal total hip prosthesis than in those with a plastic and metal prosthesis. to find out if this is true, we will test blood samples for the levels of metal in the blood and compare the values from 3 groups of people: 1. people with metal on metal hip replacements 2. loosening of a plastic and metal prosthesis and 3. evidence of osteoarthritis and are awaiting a total hip replacement.

Eligibility criteria:
inclusion criteria: group 1 - unilateral hip replacement with metal on metal prosthesis, well functioning. group 2 - loosening of plastic and metal prosthesis group 3 - osteoarthritis of the hip and awaiting total hip replacement exclusion criteria: * renal dysfunction * other types of metal implants or dental prostheses * rheumatoid arthritis * hip infection

Keywords: metal ion concentration
the use of nmes as a home-based therapy following total knee arthroplasty

Conditions: Venous Thrombosis

Summary: the use of neuromuscular electrical stimulation (nmes) as a home-based therapy following total knee arthroplasty. measures of interest: lower limb venous hemodynamics, joint range of motion, lower limb swelling, walking speed, quality of life, activities of daily living, device usability, device compliance, activity levels, and pain (vas).

the use of neuromuscular electrical stimulation (nmes) as a home-based therapy following total knee arthroplasty. all participants receive and use a research stimulator for approximately 5 weeks following total knee arthroplasty. participants randomised to either a stimulation group or placebo-controlled group. stimulation of the soleus muscle to investigate the effects on lower limb venous hemodynamics, joint range of motion, lower limb swelling, walking speed, quality of life, activities of daily living, device usability, device compliance, activity levels, and pain (vas) in both groups.

Eligibility criteria:
inclusion criteria: * any patient undergoing knee arthroplasty in the galway clinic with an ability to understand the nature of the study * ability to give informed consent * not excluded based on exclusion criteria exclusion criteria: * history of symptomatic heart disease or severe arterial disease * pregnancy * presence of a pacemaker * history of neurological disorder * presence of cognitive difficulties which may prevent the patient or his/her carer from using the stimulator properly
smoking cessation intervention for thoracic patients

Conditions: Lung Cancer

Summary: the primary aim of the proposed study is to develop and assess the feasibility of delivering a smoking cessation intervention to patients undergoing lung surgery that begins before surgery and continues up to 3 months post-discharge. the secondary aim is to assess smoking cessation rates 3 months following surgery.

this is a pilot study evaluating the feasibility of a cognitive-behavioral smoking cessation plus varenicline program, designed specifically for early stage lung cancer patients and patients with a potential lung cancer diagnosis pre and post-surgery. the study population will be approximately 80 smokers who have upcoming lung resection surgery scheduled at massachusetts general hospital (mgh) in boston. a patient will be considered eligible for the intervention or control group if he or she 1) is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis, and 2) had a cigarette in the past 2 weeks, 3) is willing to make a pre-surgical quit attempt. patients will be excluded from the control group if they are 1) non-english speaking, 2) determined medically ineligible by their surgeon/oncologist, 3) suffering from psychosis or dementia 4) is currently on varenicline has been on varenicline for more than 3 weeks, or 5) is otherwise unable to participate in the intervention. patients will be excluded from the intervention group if they are 1) non-english speaking, 2) determined medically ineligible by their surgeon, 3) suffering from psychosis or dementia 4) have been taking varenicline for longer than three weeks 5) have been taking bupropion (for smoking cessation purposes) for more than three weeks, 6) is otherwise unable to participate in the intervention.

Eligibility criteria:
inclusion criteria: a patient is eligible if he/she: 1. is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis 2. smoked a cigarette in the past 2 weeks 3. is willing to make a pre-surgical quit attempt exclusion criteria: patients will be excluded from the intervention group if they are: 1. non-english speaking 2. determined medically ineligible by their surgeon 3. suffering from psychosis or dementia 4. have been taking varenicline for longer than three weeks 5. have been taking bupropion (for smoking cessation purposes) for more than three weeks 6. is otherwise unable to participate in the intervention.
effect of dexamethasone and methylprednisolone on pain, swelling and trismus after third molar surgery

Conditions: Pain,; Edema,; Trismus

Summary: the main aim of the present study was to investigate the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.

third molar surgery is often associated with significant post-surgical sequelae. the trauma caused to soft and bony tissue can result in considerable pain, swelling and trismus. symptoms begin gradually having a peak 2 days after extraction. the use of corticosteroids such as dexamethasone and methylprednisolone can be a valuable tool when performing moderate to moderately severe oral surgical procedures. no clear consensus have emerged yet regarding patient selection, dosage, timing and type of administration of steroid. in this light, this clinical trial aim to compare the effect of preemptive dexamethasone and methylprednisolone to prevent pain, swelling and limitation in mouth opening following third molar extraction.

Eligibility criteria:
inclusion criteria: * patients with indication of asymptomatic bilateral extractions of lower third molars * aged 18 years or older; * have a good health and no disease; exclusion criteria: * patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation

Keywords: pain measurement, edema, trismus
interleukin-12 gene in treating patients with liver metastases secondary to colorectal cancer

Conditions: Colorectal Cancer; Metastatic Cancer

Summary: rationale: inserting the interleukin-12 gene into a person's cancer cells may make the body build an immune response to kill tumor cells. purpose: this phase i trial is studying the side effects and best dose of interleukin-12 gene when injected into the tumors of patients with liver metastases secondary to colorectal cancer.

objectives: * determine the toxicity and maximum tolerated dose of intratumoral adenoviral vector-delivered interleukin-12 gene in patients with liver metastases secondary to colorectal cancer . * determine the tumor response in patients treated with this regimen. * determine the immune response in patients treated with this regimen.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed\* colorectal adenocarcinoma metastatic to the liver * solitary or multiple metastatic tumors in the liver * metastatic involvement of the liver no greater than 40% of estimated liver volume note: \*must be from the hepatic tumor designated for study injection * metastatic liver tumors must be bidimensionally measurable by ct scan or mri * at least 1 metastatic liver tumor measuring at least 2.0 cm must be visualized by ultrasound (us) and accessible for us-guided percutaneous injection * extrahepatic metastases allowed * no prior or current ascites * ineligible for hepatic resection patient characteristics: age * adult performance status * karnofsky 70-100% life expectancy * at least 16 weeks hematopoietic * granulocyte count at least 1,500/mm\^3 * hemoglobin at least 9.0 g/dl * platelet count at least 100,000/mm\^3 hepatic * no clinical evidence of other severe liver disease (e.g., portosystemic encephalopathy) * pt no greater than 14 seconds * bilirubin no greater than 2.0 times upper limit of normal (uln) * transaminases no greater than 2.5 times uln renal * creatinine no greater than 1.5 mg/dl or * creatinine clearance at least 45 ml/min other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective nonhormonal contraception during and for at least 2 months after study participation * hiv negative * no active infection * no other concurrent serious medical illness * no other malignancy within the past 5 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or grade 1 papillary bladder cancer * oriented and rational * weight at least 30 kg prior concurrent therapy: biologic therapy * not specified chemotherapy * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) endocrine therapy * at least 2 months since prior corticosteroids radiotherapy * not specified surgery * not specified other * at least 2 months since prior systemic immunosuppressive drugs * no concurrent immunosuppressive drugs * no concurrent anticoagulant therapy with heparin or warfarin

Keywords: stage iv colon cancer stage iv rectal cancer liver metastases recurrent rectal cancer recurrent colon cancer
isar-dapt (a comparative evaluation of efficacy and safety in the 3-months dapt group vs. the 6-months dapt group of patients treated with the coroflex isar stent; a prospective, multicenter, randomized, open-label clinical trial)

Conditions: Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease

Summary: this clinical trial studies patients treated with the coroflex isar stent for coronary artery disease in order for the objective of verifying the non-inferiority of results that among patients who were administered dapt for 3 months compared to patients who were administered dapt for 6 months, in terms of the efficacy and safety of dapt.


Eligibility criteria:
inclusion criteria: 1. patients aged 19 or older 2. patients who have submitted a written consent to participate in the clinical trial 3. de novo lesion 4. patients scheduled for elective intervention to treat ischemic cardiovascular disease exclusion criteria: 1. patients with any contraindications or hypersensitivity related to antiplatelet therapy 2. patients with acute myocardial infarction (st elevation myocardial infarction, non st elevation myocardial infarction) 3. patients who are anticipated to receive treatment or surgery that may require desisting the administration of antiplatelet therapy for 2 weeks or longer during the period of the clinical trial 4. chronic total occlusion (cto) lesions, in-stent restenosis (isr) 5. patients experiencing cardiogenic shock 6. women who are breastfeeding, pregnant, or desiring pregnancy 7. patients with findings of hemorrhage 8. patients with a life expectancy of less than 1 year 9. patients who have received a drug-eluting stent (des) procedure within the past 6 months 10. any other patients judged by the investigator to be unsuitable for the trial

Keywords: stent polymer-free antiplatelet therapy clopidogrel des dapt
efficacy of afl-assisted pdt with short incubation time in actinic keratosis

Conditions: Actinic Keratosis

Summary: photodynamic therapy (pdt) using methyl aminolevulinate (mal) is an effective first-line treatment for actinic keratosis (ak). erbium: yttrium-aluminium-garnet (er:yag) ablative fractional laser-assisted mal-pdt (afl-pdt) has shown significant benefit for the treatment of ak. however, knowledge on the optimal photosensitizer incubation time for afl-pdt is limited

photodynamic therapy (pdt) is widely used in the treatment of superficial skin cancer. it has an excellent cosmetic outcome, and it could be considered the first-line therapy for actinic keratosis (ak). in pdt incubation time is required so that the photosensitizer can be converted to ppix. the recommended treatment regimen of pdt requires a relatively long incubation time with ala (4 hours) and mal (3 hours) before illumination. theoretically, ablative fractional laser (afl) pre-treatment may facilitate the penetration and distribution of topically applied drugs, since the ablated laser holes extend into the dermis, thereby possibly acting as channels for drug uptake. however, knowledge on the optimal photosensitizer incubation time for afl-pdt is limited. the objectives of this study were to compare the efficacy, recurrence rate, cosmetic outcome, and safety between afl-pdt with 2 and 3hours of incubation vs. conventional mal-pdt in patients with facial and scalp ak.

Eligibility criteria:
inclusion criteria: * age \>18 years * the presence of 2-10 facial ak lesions exclusion criteria: * lactating or pregnant women * patients with porphyria * a known allergy to any of the constituents of the mal cream and lidocaine * patients with systemic disease * history of malignant melanoma * tendency for melasma development or keloid formation * any ak treatment of the area in the previous 4 weeks * any conditions associated with a risk of poor protocol compliance * patients on immunosuppressive treatment

Keywords: ablative fractional laser actinic keratosis efficacy photodynamic therapy short incubation time
emotional awareness and expression therapy (eaet) for migraine

Conditions: Migraine Disorders

Summary: the goal of this feasibility study is to test the effect of a new behavioral intervention, emotional awareness and expression therapy (eaet), as a possible new treatment for people living with migraine. the main questions it aims to answer are: * can eaet lower the frequency and severity of migraine attacks? * what are the elements that can explain eaet's effect? requirements from participants: * participants will engage in 8 weekly online sessions via zoom (sessions are 2 hours long). each session has a lecture, in-class exercises, discussion, and weekly assignments. * each participant is required to fill out questionnaires before the first session, after the last session of the treatment, and at a 3-month follow-up after treatment. participants will benefit from a new and promising intervention that can significantly help with their migraines at no cost.

migraine is a debilitating disorder that affects many people worldwide. despite the new migraine medications and the recommended complementary interventions for migraine, most people living with migraine are not migraine-free and continue to experience debilitating headaches. chronic stress and past traumatic experiences are known to contribute to the development of migraine and to the transition from episodic to chronic migraine. although current behavioral interventions focus on "calming down" the body and mind, a different approach is to help individuals identify and express difficult emotions, release emotionally difficult experiences, and acquire new skills to help manage interpersonal relationships. emotional awareness and expression therapy (eaet) is a new intervention that focuses on this approach and has shown promising results in patients with different chronic pain conditions. in this research, the investigators will test how effective eaet is in people living with migraine.

Eligibility criteria:
inclusion criteria: * adults of all genders, ages 18-80. * a diagnosis of either episodic or chronic migraine (with or without aura) by a licensed neurologist. * a migraine disability assessment scores higher than 6. * a stable medication regimen for a minimum of 3 months. * must have had migraines for at least 1 year. * must have a minimum of 4 migraine days per month. exclusion criteria: * serious psychiatric disorders (e.g., schizophrenia or bipolar disorder) uncontrolled with medications. * active suicidal ideation. * risk of violent behavior. * untreated alcohol or substance use disorder. * substantial cognitive impairment. * a diagnosis of medication overuse headaches. * changes in migraine medication in the past 3 months. * enrollment in another treatment study. * current involvement in health-related litigation or disability application. * inability to use a computer and/or smartphone. * limited access to the internet. * inability to communicate in english. * failure to complete at least 80% of the daily diaries during the baseline 30-day diary assessment.
a study of bbi503 in advanced solid tumors, or bbi503/ sorafenib in advanced hepatocellular carcinoma

Conditions: Advanced Solid Tumors; Hepatocellular Carcinoma

Summary: this is an open-label, multicenter, phase 1 dose escalation study of bbi503 monotherapy, or bbi503 in combination with sorafenib. this study population is adult patients with advanced solid tumors in monotherapy, or adult patients with advanced hepatocellular carcinoma in combination therapy.


Eligibility criteria:
inclusion criteria: * provision of written informed consent. * ≥ 20 years of age * measurable disease as defined by response evaluation criteria in solid tumors (recist) 1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last bbi503 dose * females of childbearing potential must have a negative serum pregnancy test * adequate organ function * life expectancy ≥ 3 months exclusion criteria: * any known symptomatic or untreated brain metastases * pregnant or breastfeeding * crohn's disease, ulcerative colitis extensive gastric and small intestine resection * unable or unwilling to swallow bbi503 daily * uncontrolled concurrent disease * received other investigational drugs within 4 weeks prior to first dose * prior treatment with bbi503
intravascular ultrasound-derived assessment of hemodynamically negative lesions in nsteacs patients

Conditions: Non-ST-segment Acute Coronary Syndrome

Summary: this is an observational and prospective cohort study to examine whether the addition of ivus plaque morphological evaluation to ffr haemodynamic assessment of non-culprit lesions in nsteacs patients will better predict maces.

impact-nsteacs is a prospective, single-centre and dynamic observational study. the study population consists of nsteacs patients who undergo ffr in lesions with intermediate to severe angiographic stenosis. then, ffr-guided pci is performed, followed by morphological assessment based on ivus in all ffr-negative lesions (fnls). after discharge all patients receive optimal medication treatment and are followed up clinically. on the basis of follow-up angiography, maces are further adjudicated as occurring at fnls or not.

Eligibility criteria:
clinical inclusion criteria: 1. moderate to high risk nsteacs requiring invasive strategy based on current guidelines and local clinical practice. 2. patient agrees and is able to follow all protocol procedures. clinical exclusion criteria: 1. stemi or scad. 2. hemodynamic instability (e.g. cardiogenic shock, refractory ventricular arrhythmias, acute and severe conduction system disease and left ventricular ejection fraction ≤30%). 3. contraindication for ffr, pci, ivus and omt (e.g. severe allergy to antiplatelet drug or contrast, significant bleed within the past 6 months, bleeding diathesis and serum creatinine ≥2.5 mg/dl). 4. pci within 6 months or any prior cabg. 5. anticipated life expectancy \<3 year. 6. pregnancy 7. unwilling or unable to provide informed consent imaging inclusion criteria 1. patients must have at least \> 1 de novo lesion in a native coronary segment with a visually estimated diameter stenosis of between 40 and 90 %. 2. successful ffr-guided pci performed in all major epicardial coronary arteries (including their branches): pci for all lesions a) with 40%-90% diameter stenosis and ffr\<0.8 and b) with ≥90% diameter stenosis. 3. the ffr-negative lesions must be available for assessment of ivus. imaging exclusion criteria: 1. target lesion reference diameter \<2.0 mm. 2. anatomic conditions precluding ffr and ivus (e.g. marked calcification or tortuosity, chronic total occlusion or thrombus). 3. after successful ffr-guided pci, no fnl is left. 4. any remaining lesion with diameter stenosis ≥90% or ffr\<0.8 after pci. 5. left main coronary artery lesion. 6. cabg planned by the investigators according to extent and severity of coronary artery disease.

Keywords: fractional flow reserve intravascular ultrasound major adverse cardiovascular events non-st-segment acute coronary syndrome percutaneous coronary intervention
effectiveness of sulfamethoxazole-trimethoprim in the treatment of chronic otitis media

Conditions: Chronic Otitis Media

Summary: chronic suppurative otitis media is one of the most common chronic infections in children worldwide. symptoms include otorrhea, otalgia and hearing loss. in many countries, it is treated primarily with antibiotics; in other countries such as the netherlands a surgical approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes or a tympanomastoidectomy is preferred. there is however, no agreement on the management of this disease. the purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim for 6-12 weeks in children suffering from chronic otitis media and otorrhea.

chronic suppurative otitis media is one of the most common chronic infections in children worldwide. symptoms include otorrhea, otalgia and hearing loss. in many countries it is treated primarily with antibiotics; in other countries such as the netherlands a surgical approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes or a tympanomastoidectomy is preferred. there is however, no agreement on the management of this disease. co-trimoxazole is an inexpensive antibiotic and tolerated well by children, also when long treatment regimens or prophylaxis is necessary. a previously performed retrospective study of 48 children who were referred to the pediatric department of otorhinolaryngology in the umc utrecht because of "therapeutic resistant" otorrhea showed promising results; after 3 months follow-up, 52% of the patients were otorrhea free, 25% had otorrhea incidentally and 23% showed no signs of improvement. therefore, the treatment of chronic otitis media with sulfamethoxazole-trimethoprim for a minimum of six weeks is promising and might be a good alternative to surgical treatment. the purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim during 6-12 weeks in children with chronic otitis media and otorrhea for more than 12 weeks.

Eligibility criteria:
inclusion criteria: * age between 1 and 12 years * otorrhea for more than 3 months exclusion criteria: * cholesteatoma * known immune deficiency other than iga or igg2 * down's syndrome * craniofacial anomalies * cystic fibrosis * immotile cilia syndrome * allergy to sulfamethoxazole-trimethoprim * continuous use of sulfamethoxazole-trimethoprim for more than six weeks in the past six months