Kornimate/medical-research-clean huggingface dataset:
vibrotactile coordinated reset for parkinsons patients who are on dopaminergic medication

Conditions: Parkinson Disease, Idiopathic

Summary: the purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with parkinsons disease who take dopaminergic medication and are unable to withhold this medication. participants will be followed for five years and make a total of five study visits.


Eligibility criteria:
inclusion criteria: * age at the time of enrollment: adults 18 and older * idiopathic parkinson's symptoms between hoehn and yahr stages 2 to 4 * fluent in english * comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes. * lives in the united states exclusion criteria: * any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies. * any current drug or alcohol abuse. * participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. any other trial participation should be approved by the principal investigators. * pregnancy, breast-feeding or wanting to become pregnant. * patient is unable to communicate properly with staff (i.e., severe speech problems). * excessive drooling

Keywords: vibrotactile vibrotactile coordinated reset parkinsons disease
the ssri/nie recombinant antigen elisa for the follow up of patients infected by strongyloides stercoralis

Conditions: Strongyloides Stercoralis Infection

Summary: this is a single-center interventional study with an ivd medical device. the main objective of this study is to evaluate the elisa ssir/nie test for the post-treatment follow-up of patients suffering from strongyloidosis, using well-characterized sera from a previous study. all sera available in the tropica biobank and coming from the strong treat study, for which serum samples collected at baseline and at 12-month follow-up are available, will be eligible for the study. the test the inbios strongy detect tm igg elisa detects specific igg antibodies against recombinant strongyloides nie and ssir antigens in serum. it consists of an enzymatically amplified sandwich immunoassay. positive and negative control samples are provided in the kit. the test will be performed and interpreted according to the manufacturer's instructions. the results are expressed as od and nod. clinical interpretation of the results will be performed by receiver operating characteristic (roc) curve analysis generated using data from confirmed positive and confirmed negative samples. the laboratory technicians will receive from the pi of the study a list of pseudo-anonymized sera to be tested with ssir/nie elisa, they will check their availability and proceed with the test according to the manufacturer's instructions. laboratory personnel performing and reading the tests will be blinded to the results of any previously performed tests (and the classification of the sample in the strong treat study). a single run will be performed for each sample, unless the test needs to be repeated due to any technical problem. both baseline and follow-up sera will be tested. the resulting od and nod will be reported in an excel file by the laboratory technicians performing the tests.


Eligibility criteria:
inclusion criteria: * all sera available in our biobank and originating from the strong treat trial * availability of the baseline and the 12-month follow up serum of each included case exclusion criteria: * unavailability of the baseline or of the 12-month follow up serum of each included case
photodynamic therapy and periodontal therapy. a clinical, microbiological and immunoenzymatic analysis

Conditions: Periodontal Disease

Summary: residual pockets and furcation defects are challenging sites that require additional periodontal therapy. the aim of this study is evaluate 1)the effect of a single photodynamic therapy (pdt) as monotherapy residual pockets in single rooted teeth and 2) the effect of pdt in association with scaling and root planing (srp) in class ii furcation lesions with probing pocket depth (ppd) \>5mm and bleeding on probing (bop). a blind randomized controlled clinical trial was conducted in subjects presenting at least three residual pockets in single root teeth and subjects with at least one molar presenting class ii furcation defect. to evaluate the effect of a single pdt as monotherapy in residual pockets, the selected sites were assigned to receive: pdt alone, photosensitizer alone or srp alone. to evaluate the effect of pdt in association with srp in class ii furcation lesions, the selected sites were assigned to pdt+srp or srp alone. clinical, microbiological and immunoenzymatic analyses were assessed at baseline, 3 and 6 months post-therapies.

residual pockets and class ii furcation lesions are challenging sites that require additional periodontal therapy. the aims of this study were to evaluate: 1) the effect of a single pdt as monotherapy residual pockets in single rooted teeth and 2) the effect of pdt in association with srp in class ii furcation lesions. a blind randomized controlled clinical trial was conducted in subjects presenting at least three residual pockets in single root teeth and subjects with at least one molar presenting class ii furcation involvement. to evaluate the effect of a single pdt as monotherapy in residual pockets, the selected sites were assigned to receive one of following therapies: pdt alone, photosensitizer alone or srp alone. to evaluate the effect of pdt in association with srp in class ii furcation lesions, the selected sites were assigned to receive pdt+srp or srp alone. microbiological, immunoenzymatic analyses and clinical parameters: probing pocket depth (ppd), position of the gingival margin (pgm), relative clinical attachment level (rcal), full mouth plaque (fmps) and bleeding score (fmbs), will be assessed at baseline,3 and 6 months post-therapies.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic periodontitis (according to the criteria of the 1999 international classification) * at least three contralateral single rooted teeth with residual ppd \> 5mm with bleeding on probing (bop) in supportive periodontal therapy or with at least one molar presenting class ii furcation defect. exclusion criteria: * pregnancy * lactation * current smoking and smoking within the past 10 years * antibiotic therapies in the previous 6 months * use of mouth rinses containing antimicrobials in the preceding 2 months * systemic conditions that could affect the progression of periodontitis * orthodontic appliances * use of long-term administration of anti-inflammatory and immunosuppressive medications
the efficacy of permethrin 5%, fusidic acid 1% and synthomycine 5% for demodex - blepharitis

Conditions: Inflammation of the Eyelids

Summary: the study aims to investigate the effect of permethrin 5% treatment on signs and symptoms of demodex-blepharitis in comparison to synthomycine 5% and fucithalmic (fusidic acid 1%) .

3 arms study. 75 patient total, 25 patients in each group. group a (study group) patients will apply facially permethrin 5% every night for 3 months. group b patients will apply on the eyelids fusidic acid 1% every night for 3 months. group c patients will apply on the eyelids synthomycine 5% every night for 3 months follow up evaluation will be made after one week, one month, two months, three months, 4 months and half a year.

Eligibility criteria:
inclusion criteria: - adult (age ≥18y) individuals clinically diagnosed with demodex- blepharitis. exclusion criteria: - known sensitivity to all study medications or components. pregnant women and individuals deemed unfit to provide informed consent. systemic steroid use.
registry for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is an observational, prospective and retrospective registry of patients with pancreatic cancer treated in duke university health system, which will examine patient and treatment effects on cancer outcomes.


Eligibility criteria:
inclusion criteria: * pancreatic cancer exclusion criteria: * younger than 18 years of age
the medacta international amistem-p post-marketing surveillance study

Conditions: Arthrosis; Traumatic Arthritis; Rheumatoid Polyarthritis; Congenital Hip Dysplasia; Avascular Necrosis of the Femoral Head

Summary: this is a post-market surveillance study of amistem-p femoral stem prosthesis


Eligibility criteria:
inclusion criteria: * patients with a disease (primary coxarthrosis, inflammatory arthritis of the hip, necrosis of the femoral head, etc.) requiring a total hip replacement * patient eligible to receive an uncemented amistem-p femoral stem * patient agreeing to comply with the study requirements * patient willing to provide written informed consent * patient affiliated to a social security system * patients between 18 and 85 years old exclusion criteria: * participation in biomedical research * patients younger than 18 years old * vulnerable adult patients according to article l1121-6 of the french public health code * pregnant or breastfeeding women * patients unable to provide written informed consent
evaluation of a non-invasive sensory feedback system in hand prostheses

Conditions: Amputation, Traumatic; Prosthesis User

Summary: implication and evaluation of a non-invasive sensory feedback system in hand prostheses in everyday life.

a non invasive sensory feedback system in embedded in the prosthetic socket will be tested on forearm amputees in their everday life. pretests and follow up will contain objective outcome assessments and semi-structured interviews.

Eligibility criteria:
inclusion criteria: * acquired forearm amputation exclusion criteria: * psychiatric disorders

Keywords: hand prosthesis sensory feedback amputation upper limb
clinical trial to investigate the pharmacokinetics drug interaction between metformin and rosuvastatin

Conditions: Hyperlipidemia; Diabetes

Summary: the purpose of this study is to investigate the pharmacokinetic drug interaction between metformin and rosuvastatin in healthy male volunteers.

drug-drug interaction following co-administration of metformin and rosuvastatin in healthy male volunteers

Eligibility criteria:
inclusion criteria: * 19\~55 years healthy male * bmi measurement 19.0kg/m\^2\~ 28.0kg/m\^2 * signed informed consent form from to participate voluntarily and to comply with the trial requirements. exclusion criteria: * history of clinically significant kidney, liver, gastro-intestinal system, cardiovascular system, respiratory system, tumor or blood disorders, nervous system, immune system, endocrine disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.) * sbp\>140mmhg or \ 90mmhg or \<60mmhg. * an impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason. * history of drug abuse * a alcohol consumer(alcohol\>140g/week) or smoker(cigarette\>10 cigarettes/day) hypersensitivity reaction in history of investigational drugs or specific drugs(aspirin, antibiotics) * administrated investigational product in a previous clinical trial within 60 days of the screening day in this study. * administrated drugs which can inhibit or induce oct2, oatp1b1 transporter within 30 days of the screening day in this study.(ex: proton pump inhibitor, rifampicin) * glomerular filtration rate\<60ml/min * donated blood within 60 days prior to the screening day or apheresis blood within 30 days prior to the screening day .
defibrotide as prevention and treatment of respiratory distress and cytokine release syndrome of covid 19.

Conditions: COVID19

Summary: protection of endothelial dysfunction by intravenous infusion of defibrotide (defitelio), expected to decrease inflammation and expression of adhesion molecules in the endothelium, leukocyte tissue infiltration and epithelial destruction, and to promote immune tolerance through a change in the cytokine balance, which is decisive in preventing multiorgan failure and death in patients with sars-cov-2 infection with clinical status grade 4 or 5 according to the who classification

protection of endothelial dysfunction by intravenous infusion of defibrotide (defitelio), expected to decrease inflammation and expression of adhesion molecules in the endothelium, leukocyte tissue infiltration and epithelial destruction, and to promote immune tolerance through a change in the cytokine balance, which is decisive in preventing multiorgan failure and death in patients with sars-cov-2 infection with clinical status grade 4 or 5 according to the who classification

Eligibility criteria:
inclusion criteria: 1. acceptance of participation in the study by the patient or legal representative. 2. patients of any gender, 18 years or older. 3. confirmed diagnosis by pcr+ of sars-cov-2 infection. 4. covid-19 positive patients who grades 4, 5 or 6. * grade 4: hospitalized requiring oxygen therapy. * grade 5: hospitalized requiring high-flow oxygen therapy, noninvasive mechanical ventilation, or both. 5. levels of il-6 ≥ 3 times the upper limit of normality exclusion criteria: 1. acute bleeding. 2. thrombolytic treatment and anticoagulant treatment at therapeutic doses. 3. pregnancy or lactation. 4. patients with active malignant tumour, other serious systemic or neuropsychiatric diseases. 5. patients participating in other clinical trials in the last month. 6. inability to give informed consent or to accomplish the requirements of the diagnostic tests. 7. patients with hypersensitivity to defibrotide.
effect of nicorandil for the patients of acute st segment elevation myocardial infarction

Conditions: Coronary Heart Disease

Summary: to evaluate whether nicorandil as an adjunctive therapy for acute myocardial infarction (ami) reduces reperfusion injury.

reperfusion injury might occur in patients with acute st segment elevation myocardial infarction undergoing the primary percutaneous coronary intervention(p-pci),characterized by myocardial stunning, reperfusion-induced arrhythmia, microvascular dysfunction and myocardial cellular apoptosis, etc. nicorandil is an antianginal agent with a dual mechanism of action: nitrate and k+atp channel opener. the nitrate action causes vasodilation of systemic veins and epicardial coronary arteries, while the adenosine triphosphate (atp)-sensitive potassium channel opener action causes vasodilation of peripheral and coronary resistance arterioles. nicorandil not only decreases preload and afterload but also increases coronary blood flow. the study will compare the effectiveness between nicorandil and placebo of preventing the reperfusion injury and left ventricle remodeling in patients with acute st segment elevation myocardial infarction undergoing the p-pci.it is intended that before reperfusion injury ,nicorandil which was early used by intracoronary injection could prevent and release the microcirculatory spasm, release the coronary microvascular endothelial swelling,decrease embolism of atherosclerotic debris and thrombus formation.so,it could decrease the phenomenon of no-reflow/slow reflow,reperfusion-induced arrhythmia and worsening of chest pain.

Eligibility criteria:
inclusion criteria: * acute st segment elevation myocardial infarction (astemi) defined as typical chest pain lasting \>30min within the previous 12 h, with a clear st-segment elevation of \>0.1millivolt(mv) in ≥2 contiguous electrocardiographic leads, and the value of troponin i(tni) above the maximum peak in the normal range. * age20-80,all genders * the first myocardial infarction, and there is no history of pci therapy and coronary artery bypass grafting * the infarct-related artery(ira) is totally occlusive * blood pressure is higher than 90/60 millimeters of mercury（mmhg） * the time from myocardial infarction onset to reach the hospital is less than 12 hs * successful interventional treatment, the residual stenosis of ira is less than 30% , * timi flow grade 3 exclusion criteria: * kidney dysfunction (creatinine \>2 mg/dl), * history of previous liver disease, * cardiogenic shock, * history of myocardial infarction (mi) * history of coronary artery bypass grafting * history of allergic response to drugs * right ventricular infarction * severe hypovolemia

Keywords: nicorandil primary percutaneous coronary intervention acute st segment elevation myocardial infarction thrombus aspiration
phase ii study for robot assisted distal gastrectomy

Conditions: Early Gastric Cancer

Summary: the aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph node dissection in patients with stage ia early gastric cancer.


Eligibility criteria:
inclusion criteria: 1. biopsy specimen from the primary lesion shows adenocarcinoma 2. diagnosed as stage ia early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography 3. endoscopic submucosal dissection is not indicated 4. tumor was located within lower two thirds of stomach 5. not having duodenal invasion 6. eastern clinical oncology group performance status is 0 or 1 7. body mass index is lower than 30 8. no prior laparotomy 9. no prior chemotherapy or radiation including those for other cancers 10. fulfil all following conditions wbc \> 3,000/mm3 plt \> 100,000/mm3 ast \< 100 iu/l alt \< 100iu/l t.bil \< 2.0 g/dl cre \< 1.5mg/dl exclusion criteria: 1. having other active cancers 2. possibly pregnant, or breast feeding woman 3. with psychiatric disorder 4. receiving steroids 5. with acute myocardial infarction in 6 months or with unstable angina 6. with uncontrolled hypertension 7. with uncontrolled diabetes mellitus 8. with pulmonary disease which require continuous oxygen therapy

Keywords: davinci robot assisted surgery gastrectomy safety gastric cancer
regional anaesthesia and substance p in head and neck cancer

Conditions: Head and Neck Cancer

Summary: in the clinical trial the investigators will observe the impact of regional anesthesia in addition to a general anesthesia on the expression of substance p in patients with unilateral head or neck cancer undergoing unilateral neck dissection. the investigators will perform an unilateral regional cervical plexus block on the tumor side. the tissue of the tumor side will be analysed by immunohistology, measuring the expression of the substance p.

several investigations show that anesthetic procedures, and especially the perioperative regional anesthesia, can have a benefit for patients undergoing tumor surgery.the perioperative regional anesthesia might reduce the immunological response and therefore lower the risk of tumor relapse. factors that might play a role in tumor relapse are various, so more prospective and randomised trials are necessary to investigate the underlying mechanisms. in a retrospective analysis by merquiol et al. it was shown that an cervical epidural anesthesia was associated with an extended tumorfree timeline of larynx and hypopharynx carcinoma. supporting results could be seen in a study by munoz et al. performing regional anaesthesia in breast cancer patients. taking all these facts into consideration the investigators believe that performing regional aneasthesia could reduce the relapse of larynx carcinoma. the relapse of carcinoma is believed to be linked to substance p and the neurokinin 1 (nk-1) receptor . it is accepted that an additional regional anesthesia could reduce the impact of substance p to gain a normal immune response in the perioperative setting and to reduce the rate of tumor relapse.

Eligibility criteria:
inclusion criteria: * patients at charité - universitaetsmedizin berlin, campus charité mitte * primary diagnosis of unilateral head or neck cancer * resection of tumor is planned with unilateral neck dissection * patient did not underwent any therapeutic treatment of the cancer before start of study * surgical therapy is planned with curative intent exclusion criteria: * allergy to local anesthetics * coagulation disorders, which can lead to complications in regional anesthesia * insulin-dependent diabetes mellitus, polyneuropathy * severe psychiatric disorders * dementia * alcohol abuse, korsakoff syndrome * medication with immunosuppressants or immune modulantia * patient under special care * refusal of study participation * pregnancy and breast feeding period. * participation in a clinical intervention study, parallel with the study or participation up to 30 days before inclusion * lack of consent that pseudonomized data of the study may be saved and distributed
ideal anatomic location for saphenous nerve blocks: a prospective clinical evaluation

Conditions: Foot Injury; Ankle Injury

Summary: this research is being done to compare two different saphenous nerve block locations and will help to determine which site best maintains knee strength and pain control.

this is a prospective, randomized, observer blinded clinical trial comparing motor strength in knee extension between two sets of patients, one receiving a proximal thigh block of the saphenous nerve and one receiving a distal thigh block of the saphenous nerve. the secondary objectives are to compare the pain relief and quality of life of participants in these two groups.

Eligibility criteria:
inclusion criteria: * age 18-65 * upcoming elective foot or ankle surgery exclusion criteria: * preoperative weakness in knee extension * documented neuropathy * previous knee surgery * inability to provide informed consent

Keywords: adult nerve blocks in foot and ankle surgery saphenous
a study of insulin lispro mix in type 2 diabetic asian patients

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose is to evaluate the proportion of subjects achieving a hemoglobin a1c (hba1c) level below 6.5%, when lispro mix 50/50 is introduced in a stepwise manner from every day (qd) administration to type 2 diabetic patients who have failed to achieve adequate glycemic control on oral antidiabetic drugs (oads).

a multicenter, non-randomized, open-label, post-marketing clinical study. the target population of the study is type 2 diabetic patients who have failed to achieve adequate glycemic control on oads. the study consists of 4 periods: lead-in period (2 to 4 weeks), study period i (16 weeks), study period ii (16 weeks), and study period iii (16 weeks). the regimen of lispro mix 50/50 injection will be changed every 16 weeks based on the hba1c level. during study period i, all the subjects will be given a once daily (qd) injection of lispro mix 50/50. during study period ii, the regimen of lispro mix 50/50 injection will be changed to twice daily (bid) if the hba1c level at week 16 is 6.5% or above, and qd injection will be continued if the value is below 6.5%. during study period iii, if the hba1c level at week 32 is 6.5% or above, the subjects on bid treatment during the previous period (study period ii) will receive three times daily (tid) injections of insulin.

Eligibility criteria:
inclusion criteria: * patients diagnosed as having type 2 diabetes. * patients who have not been on insulin treatment within 6 months. * patients who have been taking oads for at least 90 days. * patients with an hba1c level in the range of 7.5% to 11.0%. * patients with a body-mass index (bmi) of 35 kg/m² or below. exclusion criteria: * patients having pre-proliferative or proliferative retinopathy (except for old retinopathy with no need for treatment). * patients having or suspected of having malignancy * patients having serious complications of the heart, liver, or kidney. * patients hypersensitive or allergic to insulin or insulin analog preparations or a history of it. * patients receiving systemic steroids. * are currently enrolled in a clinical trial of a non-approved drug. or patients who participated in other clinical trials including post-marketing clinical trials within 90 days prior to informed consent being obtained. * patients of child-bearing potential. breastfeeding patients. patients with a positive result in a pregnancy test performed for women of child-bearing potential.