Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of paclitaxel coated ptca balloon catheter with a shellac plus vitamin e excipient (genoss® dcb) in patients with coronary in-stent restenosis (isr): a prospective, multi-center, observational study

Conditions: Coronary Artery Disease; In-stent Restenosis

Summary: the sfrgenista study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin e excipients (genoss® dcb) in patients with coronary in-stent restenosis (isr).

drug-coated balloon (dcb) treatment is a therapeutic strategy to overcome in-stent restenosis (isr) that occurs after drug-eluting stent (des) implantation. the 2018 european guidelines on myocardial revascularization recommend dcb treatment in patients with bare-metal stent (bms) or des isr lesions. the sequent please world wide registry has shown that dcb therapy is safe and exhibits a low target lesion revascularization (tlr) rate in a large population. the genoss® dcb is coated with 3µg/mm² of paclitaxel along with shellac, a hydrophilic excipient for rapid release and diffusion into the tissue. additionally, it incorporates vitamin e, an antioxidant known to directly prevent the accumulation of smooth muscle cells associated with neointimal hyperplasia that arises from the vessel wall being damaged by the balloon catheter. the catheter was designed to enhance trackability and pushability, minimize vascular damage with the application of a hydrophilic coating to the distal part, and use a soft yet durable end-tip for easier access to the target lesion. in a clinical trial comparing genoss® dcb to the sequent® please (b-braun) dcb, the in-segment late lumen loss at six months after dcb was comparable, and the rates of adverse clinical events were similar. given this background, this study intends to investigate the long-term efficacy and safety of the genoss® dcb in patients with coronary isr.

Eligibility criteria:
inclusion criteria: * patients with coronary in-stent restenosis (isr) who underwent percutaneous coronary intervention using the genoss® dcb. * participants who have agreed to the clinical trial protocol and the clinical follow-up study plan, voluntarily decided to participate in this clinical research, and have provided written consent on the research participant agreement form. exclusion criteria: * women of childbearing age who plan to become pregnant during the study duration. * patients scheduled for a surgery within 12 months of enrollment that requires discontinuation of antiplatelet agents. * patients for whom the expected remaining life span is less than one year. * patients who presented with cardiogenic shock at the time of their visit and, based on medical assessment, are predicted to have a low likelihood of survival. * patients currently involved in a randomized medical device study. * patients deemed by the researcher to be unsuitable for this study or whose participation might increase associated risks.

Keywords: coronary artery disease in-stent restenosis drug-coated balloon
a safety and immunogenicity study of a 13-valent pneumococcal conjugate vaccine in japanese subjects aged 6 to 64 years.

Conditions: Pneumococcal Infections

Summary: this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines.


Eligibility criteria:
inclusion criteria: * japanese males and females aged 6 to \<65 years at enrollment. * subjects with an increased risk of pneumococcal disease determined by documented medical history, physical examination, and clinical judgment of the investigator. exclusion criteria: * previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt during study participation. * end-stage disease including but not limited to metastatic malignancy, severe chronic obstructive pulmonary disease (copd) requiring supplemental oxygen, or end-stage renal disease with or without dialysis. * graft-versus-host disease (gvhd), history of solid organ transplant within 6 months before investigational product administration or history of hsct, or potential for solid organ transplant or hsct during study participation. * receipt of cytotoxic chemotherapy or blood products within 3 months before investigational product administration or anti-b-cell antibodies within 6 months before investigational product administration through completion of study participation. * any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components. * documented s pneumoniae infection within the past 5 years before investigational product administration.
high definition transcranial direct current stimulation motor cortex versus insula

Conditions: Pain

Summary: brain stimulation is a technique that can alter cortical function and thus be suitable for treating pain. this is especially when pain is chronic and associated with functional and even structural reorganization of the central nervous system. the idea of using invasive and noninvasive brain stimulation for pain relief is not new. studies from the 1950s have investigated the brain stimulation for therapeutic use. direct implantation of electrodes on the cerebral cortex has been carried out by tsubokawa and colleagues in japan. although reported to be effective, it is invasive and involves the implantation of a foreign body into the cranium. recent advancements in the techniques of non-invasive brain stimulation have improved and have measurable modulatory effects making this an attractive alternative for treating pain

repetitive transcranial magnetic stimulation and transcranial direct current stimulation are currently the two main methods of non-invasive brain stimulation under investigation. stimulation of the primary motor cortex has been reported to relieve neuropathic, musculoskeletal, visceral pain as well as headaches and migraine. other parameters of stimulation have shown encouraging results. for example, stimulation of the secondary somatosensory cortex was also reported to relieve chronic visceral pain. however, there are numerous unanswered questions regarding these techniques. this research project is an attempt to answer some of these questions: 1. which pain conditions can be alleviated by non-invasive brain stimulation? 2. what are the best parameters for stimulation- 1. method: transcranial direct current stimulation or repetitive transcranial magnetic stimulation transcranial or alternating current stimulation 2. high-definition transcranial direct current stimulation or conventional transcranial direct current stimulation? 3. which area to stimulate? primary motor cortex, insula? 3. will other forms of treatment such as pharmacotherapy, peripheral nerve stimulation or multi-disciplinary pain management enhance the effectiveness of non-invasive brain stimulation

Eligibility criteria:
inclusion criteria: * able to give informed consent to participate in the study. * male and female university undergraduate, postgraduate and staff in the department of psychology. * american society of anesthesiology scores i to ii patients. exclusion criteria: the participant who has any history of: * an adverse reaction to brain stimulation. * a seizure * an unexplained loss of consciousness * a stroke * serious head injury * surgery to their head * any brain related, neurological illnesses * any illness that may have caused brain injury * frequent or severe headaches * metal in your head (outside the mouth) such as shrapnel, surgical clips, or fragments from welding * any implanted medical devices such as cardiac pacemaker's or medical pumps * taking any analgesic medications in the past 24 hours * pregnancy * anyone in your family has epilepsy
efficacy and safety of saussurea involucrata liquid tonic in patient with postpartum rheumatism

Conditions: Postpartum Rheumatism

Summary: this study is a multi-center, randomized, double-blinded, controlled trial with two parallel arms. the study aims to evaluate the efficacy and safety of involucrata liquid tonic in patients with postpartum rheumatism.


Eligibility criteria:
inclusion criteria: * women experience joint and muscle pain, soreness, heaviness, numbness, etc. within 1 year after childbirth, miscarriage or induction of labor; with or without sensitivity to external stimuli such as wind, cold, moisture, etc., which may be induced or aggravated by emotional fluctuations * meets the diagnostic criteria for yang qi deficiency and cold-dampness syndrome. * age 18-50 * pain vas score ≥4cm exclusion criteria: * those in the puerperium (within 42 days after delivery). * those who have rheumatoid arthritis, ankylosing spondylitis, osteitis density, polymyalgia rheumatica, reactive arthritis, myofasciitis, fibromyalgia syndrome and other rheumatic immune diseases before pregnancy. * severe abnormalities in blood routine and electrocardiogram, active liver disease or abnormal liver function, ast, alt or ggt higher than 1.2 times the upper limit of normal value; abnormal renal function, serum creatinine (scr) higher than 1.2 times the upper limit of normal value. patients whose white blood cell count \< 3.0×109/l, or hemoglobin \< 90 g/l, or platelet count \< 100.0×109/l in routine blood examination * combined with serious underlying diseases, primary diseases and postpartum diseases, such as uncontrollable hypertension, heart disease, kidney disease, puerperal fever, mastitis, moderate to severe postpartum depression diagnosed by a psychiatric department, etc. * those who have a history of using glucocorticoids, immunosuppressants and other drugs within 4 weeks. * those who are allergic to the ingredients of the test drug or have a high-sensitivity constitution. * existing or past history of cancer. * those who have participated in other clinical drug studies in the past 2 months. * those who do not use the medication as prescribed, or who have incomplete information that affects the judgment of efficacy.

Keywords: saussurea involucrata liquid tonic traditional chinese medicine postpartum rheumatism
prophylaxis of venous thrombo-embolism in cancer patients under palliative care

Conditions: Cancer; Venous Thromboembolism

Summary: to determine the efficacy and to measure the complications of prophylactic anticoagulation using low-molecular weight heparin in adult cancer patients under palliative care


Eligibility criteria:
inclusion criteria: * cancer patients in palliative care * patients fully informed about their condition * signed informed consent * no exclusion criteria exclusion criteria: * absence of advanced cancer * cancer previously cured * venous thromboembolism diagnosed within 6 months prior to inclusion * absence of discerning capacity * active anti-thrombotic treatment with heparins or coumarines * thrombocytopenia \<50g/l * ptt \>45sec * tp\<35% * active bleeding * renal failure \<20ml/min * past history of heparin-induced thrombocytopenia
a multi-center open label prospective study on early initiation of targeted-release formulation of budesonide in patients with primary iga nephropathy

Conditions: IgA Nephropathy (IgAN); Early Initial Therapy

Summary: to observe of the efficacy and safety of early initiation of budesonide enteric coated capsules in the treatment of primary iga nephropathy.


Eligibility criteria:
inclusion criteria: 1. target patients aged 18-75, including those aged 18 and 75 2. primary iga nephropathy diagnosed by renal biopsy within 3 months 3. egfr≥30ml/min/1.73m2 4. 24-hour urine protein ≥ 1.0g/d, or upcr ≥ 0.8 g/g 5. sign informed consent exclusion criteria: 1. including but not limited to secondary igan caused by allergic purpura, systemic lupus erythematosus, cirrhosis, rheumatoid arthritis, and ankylosing spondylitis 2. patients who have received kidney transplantation or dialysis 3. patients with other glomerular diseases (such as c3 glomerular disease and/or diabetes nephropathy) and nephrotic syndrome (i.e. proteinuria\>3.5 g/d, serum albumin\<3.0 g/dl, with or without edema) 4. patients with acute, chronic, or potential infectious diseases, including hepatitis, tuberculosis, human immunodeficiency virus, and chronic urinary tract infections 5. patients with type 1 or type 2 diabetes diagnosed and poorly controlled (hba1c\>8%) 6. patients with a history of unstable angina, grade iii or iv congestive heart failure, and/or clinically significant arrhythmias 7. patients with poor blood pressure control (systolic blood pressure ≥ 140mmhg or diastolic blood pressure ≥ 90mmhg) 8. patients diagnosed with malignant tumors within the past 5 years 9. patients with known glaucoma, known cataracts, and/or a history of cataract surgery 10. gastrointestinal diseases that may interfere with the study of drug efficacy or release, such as peptic ulcer disease, inflammatory bowel disease, and chronic diarrhea 11. patients with severe adverse reactions to steroids in the past, including psychiatric symptoms 12. patients who have received systemic immunosuppressive drug treatment within 3 months prior to enrollment 13. patients who have received any systemic gcs treatment within the past 3 months prior to enrollment 14. patients taking potent cytochrome p450 3a4 inhibitors (cyp3a4) 15. current or previous (within the past 2 years) alcoholism or drug abuse; 16. expected lifespan\<5 years 17. during the study treatment period and 3-month follow-up period, women who are pregnant, breastfeeding, or unwilling to use highly effective contraception (contraception is only required for women with fertility potential) 18. researchers believe that patients who are not suitable for treatment with nefecon

Keywords: iga nephropathy (igan) nefecon multi-center early initial therapy
efficacy of nalbuphine and naloxone administered as nose sprays in the treatment of orofacial pain

Conditions: Temporomandibular Joint Dysfunction Syndrome; Burning Mouth Syndrome

Summary: patients with chronic masticatory muscle pain (i.e., pain greater than three months) or patients with burning mouth syndrome participate in this study. the aim of the study is to compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered with either placebo or naloxone, a drug used to treat opiate overdose. a second goal is to determine if there are sex differences in these two drug regimens. drugs will be administered with single-use intranasal spray devices. all participants will receive two sprays (one spray per nostril). one of the two sprays will be nalbuphine (5 mg). the other spray will be naloxone in half the participants and placebo in the other half.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of temporomandibular muscle pain or * clinical diagnosis of burning mouth syndrome * pain duration: at least 3 months * pain severity: 2 or greater on a 0 - 10 scale exclusion criteria: * no adverse reaction to study drugs * not currently using narcotic analgesic drugs

Keywords: bms tmd
the effect of mobile application-based information about before and after surgery

Conditions: Breast Cancer

Summary: aim and hypothesis: this study was conducted to evaluate the effect of mobile information given to women before and after breast cancer surgery on anxiety, distress, and quality of life. e-mobile information given to women before and after breast cancer surgery reduces the level of anxiety (i) and the level of distress (ii), and positively affects their quality of life (iii). methods: this randomized controlled study was conducted between april and august 2021 in the surgical oncology clinic-outpatient clinics of a university hospital. patients in the intervention group (n=42) used the mobile information application for one month with routine care. patients in the control group (n=40) received their routine care. data were collected with data collection forms one week before and three weeks after surgery.


Eligibility criteria:
inclusion criteria: * scheduled for elective surgery due to breast cancer, * over 18 years old, * read and understand turkish, * at least primary school graduates, * have internet access, * have a smartphone with an android operating system suitable for downloading the mobile application. exclusion criteria: * diagnosed with active psychiatric disease, * using antidepressant medication, * vision problems that prevented them from using the mobile application, * scheduled for reconstructive surgery using their own tissue

Keywords: breast cancer mobile application mobile health anxiety distress quality of life
instant total contact cast to heal diabetic foot ulcers

Conditions: Diabetic Foot Ulcers

Summary: aim 1. to compare the effectiveness of total contact casts (tcc), removable cast walkers (rcw) and instant total contact casts (itcc) to heal diabetic foot ulcers in a 20 week randomized clinical trial of 225 patients in community care in three university medical center diabetes clinics. aim 2. to compare the frequency of complications such as soft tissue and bone infections, iatrogenic wounds, falls and fall related injuries, and amputations among patients treated with tcc, itcc and rcw to heal diabetic foot ulcers. aim 3. to compare patient compliance and level of activity among tcc, itcc, rcw treatment groups. using computerized activity monitors which time-stamp each step, we will evaluate both degree and magnitude of activity between groups. aim 4. to evaluate the cost of diabetic foot ulcer-related treatment and complications during the course of therapy.

this is an investigator blinded randomized, controlled clinical trial with three parallel treatment groups of 75 adult outpatients with diabetes mellitus and a foot ulcer. the study will be conducted at five university affiliated medical centers in arizona and texas. the study participants and nurse coordinator will not be blinded to the treatment after randomization. investigators will be blinded to treatment group assignment.

Eligibility criteria:
inclusion criteria: * men or women 18 years old or older * one or more foot ulcers without clinical evidence of osteomyelitis * diagnosis of diabetes mellitus * university of texas grade 1a-b, 2a-b or 3a-b * abi \>0.5 * spanish-speaking subjects will be eligible to participate exclusion criteria: * active charcot arthropathy * abi \<0.5 * gangrene, active infection * unable to keep research appointments * wide spread malignancy or systemically immunocompromising disease * alcohol or substance abuse within 6 months * unreliable, unwilling or unable to comprehend informed consent

Keywords: diabetic foot ulcers casting wound care
comparative study of gene-activated bone substitute "histograft" for lumbar and cervical spinal fusion

Conditions: Cervical Disc Disorder With Radiculopathy; Spinal Stenosis; Lumbar and Other Intervertebral Disc Disorders With Radiculopathy; Biomechanical Lesion, Unspecified

Summary: the goal of this clinical trial is to evaluate the safety and efficacy of the combination product "histograft", a bone substitute based on octacalcium phosphate (ocp) and plasmid dna encoding vegfa gene, in spinal fusion prosedure in comparison with bone autografts and synthetic material based on β-tcp

an open-label non-randomized controlled clinical trial will be conducted with two groups of patients. following enrollment based on specific indication criteria, all patients will undergo surgical treatment (spinal fusion) using either bone substitute "histograft" (for spinal fusion of cervical and lumbar spine) or bone autograft (for spinal fusion of lumbar spine), or synthetic material based on β-tcp (for spinal fusion of cervical spine). the primary outcomes will involve the bone fusion rate evaluated with computer tomography (ct) at 6 and 12 months. for the safety assessment, the frequency of serious adverse events (saes) and adverse events (aes) will be monitored throughout the entire clinical trial.

Eligibility criteria:
inclusion criteria: * signing the informed consent * indications for spinal fusion: degenerative-dystrophic diseases of the cervical and lumbar spine. exclusion criteria: * refusal to sign ip * age less than 18 years * history of spinal surgery in the area of planned spinal fusion * decompensated forms of chronic diseases * oncological diseases with identified metastases or risk of metastasis * patient's refusal to participate in the study

Keywords: spinal fusion bone graft
internet-delivered strengths use intervention

Conditions: Burnout, Professional; Mental Health Wellness 1

Summary: the aim of the study will be to test the feasibility and acceptability of a novel online-delivered gamification-based intervention for the identification, development, and use of strengths in the organization. the program will be addressed to employees at the beginning of their careers and will have the aim of boosting their well-being and performance.


Eligibility criteria:
inclusion criteria: - participants should score 4.49 or lower (on a scale from 0 to 6) on work engagement; exclusion criteria: * workload which will impede following the intervention program (based on a filter yes/no question); * lack of internet access during the period of the implementation of the program (based on a filter yes/no question).

Keywords: work engagement burnout employee wellbeing
acupuncture and pain processing

Conditions: Fibromyalgia

Summary: the purpose of this study is to test the hypothesis that acupuncture will reduce fibromyalgia pain, via alterations in the processing of pain in the central nervous system.

patients and healthy controls will be enrolled in the study for a total of 6 weeks. this includes a screening and baseline visit, 8 acupuncture treatments (2 per week for 4 weeks), and a follow-up visit and treatment 1 week after completion of the study treatment sessions. to determine the effects of acupuncture on pain, patients and healthy controls will undergo psychophysical pain testing at four points throughout the study: baseline (appointment 1), post-treatment 1 (appointment2), post treatment 8 (appointment 9), and at the final follow-up session (1 week from last treatment - appointment 10).participants will also fill out a brief report on pain, sleep, and functioning on a palm pilot. this is expected to take less than 2 minutes per day and will occur throughout the 6 week study period.

Eligibility criteria:
inclusion criteria: 1. age 18-50 2. fibromyalgia patient or healthy control 3. no current opioid use 4. patients: must have had fibromyalgia for 6 months or longer exclusion criteria: 1. inflammatory disorder (lupus, rheumatoid arthritis) 2. current untreated depression 3. active infection 4. healthy controls: pain disorder or major medical condition that in the discretion of the investigator interfere with the validity of the study 5. heart disease or use of a cardiac pacemaker
epidemiology of merkel carcinomas in the bas-rhin

Conditions: Merkel Carcinoma

Summary: the aim of this work is to study demographic, clinical, management (diagnostic and therapeutic) and survival data concerning patients with merkel's carcinoma in the lower rhine, thus obtaining the first french data.


Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis of primary merkel carcinoma (topographic code c44 morphological code 8247/3) * diagnosis made between 1983 and 2011 * patient residing in the bas-rhin at the date of diagnosis * patient who has given his consent for the use of his data for research purposes exclusion criteria: - refusal to participate in research

Keywords: merkel carcinoma