Kornimate/medical-research-clean huggingface dataset:
mobile decision support system for nurse management of neuromodulation therapy

Conditions: Parkinson's Disease

Summary: the purpose of this study is to test the use of a clinical decision support tool for postoperative care of parkinson's disease patients who are treated using deep brain stimulation (dbs). the central hypothesis is that the use of a dbs clinical decision support system for individual patient management will enable considerable time savings and reduced burden on patients and caregivers.

the proposed study will evaluate outcomes for parkinson's disease (pd) patients who are treated with unilateral deep brain stimulation (dbs); patients who consent to the study will be randomized to standard care or the experimental group. the study will occur in two phases. phase i: both the standard care and experimental groups will be medically evaluated identically, but the programming will be different between the groups as the experimental group will be programmed using the ipad. patients in the control and experimental groups will be monitored with the same frequency at each participating clinic. data and safety monitoring is the responsibility of each participating pi and the lead pi as the protocol involves minimal risk or no more than a minor increase over minimal risk. we anticipate that a single nurse at each site will perform dbs programming. phase ii: patients in the experimental group will be evaluated and programmed by home health nurses in the patient's home setting. neurological exams in the clinic will be performed at the first post-operative dbs programming session and 6 months later (the proposed end of the experimental period for each patient). during the intervening period, dbs programming and patient evaluations will be performed by a home health nurse. during this phase, data and safety monitoring will be conducted by a dsmb, which will meet regularly to review all cases and ensure safety. all subjects will be recruited directly through the participating sites' clinic systems, and all subjects will have oral and written informed consent before participation in the study. we anticipate that up to two home health registered nurses (rns) will be performing dbs programming in phase 2.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease * planning to receive a dbs device at a participating site. * had a dbs device implanted, at a participating site, that hasn't been programmed yet exclusion criteria: * had a dbs device implanted at a non-participating site. * any previous dbs programming

Keywords: deep brain stimulation dbs stn gpi globus pallidus subthalamic nucleus neuromodulation
the effect of resistance training on proprotein subtilisin convertase kexin 9 level after coronary bypass surgery

Conditions: Coronary Artery Disease

Summary: this research add resistance training to patients who undergo cardiac rehabilitation program after coronary bypass surgery, comparing the level of pcsk9 level on that group to another group who receives conventional rehabilitation program (only aerobic exercise)

the pcsk9 level measured before and after cardiac rehabilitation program (around 3-4 weeks), and compared between two groups. elisa method will be used to measure plasma pcsk9 level. resistance training will be given by professional trainer in gymnasium of national cardiovascular center harapan kita supervised by cardiologists, following rules from american college of sports medicine guideline regarding to exercise after cardiac event.

Eligibility criteria:
inclusion criteria: * post elective coronary artery bypass surgery * \> 18 years old * sign informed consent exclusion criteria: * contraindications of resistance training (unstable angina, uncontrolled blood pressure (systolic \> 160 mmhg diastolic \> 100 mmhg), acute heart failure, pulmonary diseases, arrhythmia malignant) * musculoskeletal pain, visual analog scale \>3 * post congenital heart disease surgery * post elective coronary artery bypass surgery with malfunction valves (operated or not)

Keywords: resistance training, pcsk9, coronary artery bypass grafting
dental anxiety among children pre and post covid 19 pandemic

Conditions: Dental Anxiety

Summary: dental fear and anxiety is a significant issue that affects pediatric patients and creates challenges in oral health management. considering that the coronavirus disease 2019 (covid-19) pandemic, along with its associated sanitary regime, social distancing measures and nationwide quarantines, could itself induce public fears, including in children, it is of great interest to explore whether this situation and the necessity of reorganizing dental care could potentially affect the emotional state of pediatric patients facing a need for urgent dental intervention


Eligibility criteria:
inclusion criteria: * parental consent * no previous dental experience * medically free children exclusion criteria: * children with negative behavior according to frankl rating scale * children require general anesthesia
dlsct for breast cancer detection in women with dense breasts

Conditions: Breast Neoplasms; Breast Density; Radiographic Image Interpretation, Computer-Assisted

Summary: the main objective of this project is to demonstrate the feasibility of dlsct to detect breast cancer in women with dense breasts. patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. these patients have an indication for a positron emission tomography computed tomography (pet-ct) scan to search for distant metastases. in this study the participants will undergo an additional contrast enhanced dlsct scan to determine the feasibility of spectral ct to detect breast cancer in women with dense breasts.


Eligibility criteria:
inclusion criteria: * diagnosis of histopathologically proven locoregional advanced primary breast cancer: 1. tumors \> 5 cm (= t3) or 2. tumors with invasion of the skin or chest wall (= t4) or 3. any tumor with ≥ 4 axillary lymph nodes or ipsilateral internal mammary, infraclavicular or supraclavicular nodal involvement (= n2-3) * heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category c or d according to the acr bi-rads lexicon exclusion criteria: * history of allergic reactions to iodinated contrast agents * pregnancy or breast feeding * treatment of thyroid disease with radioactive iodine * use of metformin * creatinine clearance \< 45 ml/min * chronic or acutely worsening renal disease * patients who are declared incompetent
phosphodiesterase-5-inhibitors for right heart failure after left ventricular assist device implantation

Conditions: Phosphodiesterase Inhibitor Adverse Reaction; Right-Sided Heart Failure

Summary: refractory right heart failure is common during the postoperative period after left ventricular assist device implantation. oral phosphodiesterase-5 inhibitors are oft initiated in order to facilitate weaning from the intravenous inotropic substances. following this period many patients continue to receive the same medication in the long term, despite missing data on its therapeutic effect on right ventricular function.we hypothesise that beyond the acute postoperative period no additional benefit from the phosphodiesterase-5 inhibitors exists. the aim of the study is a detailed clinical and echocardiographic assessment of the right ventricular function after discontinuation of the medication in patients pretreated for at least one month after receiving left ventricular assist device.

the study aims to assess clinical and echocardiographic measures of right ventricular function before and after discontinuation of the oral phosphodiesterase-5 inhibitor in patients on left ventricular device support. at baseline and after discontinuation of the medication patients will receive a clinical examination and new york heart association classification, echocardiographic assessment of right ventricular function, cardiopulmonary exercise testing, 6 minute walking test and assessment of quality of life. the primary outcome is the change of the quantitative echocardiographic parameters of right ventricular function at follow-up. secondarily, we aim to assess the change in cardiopulmonary exercise capacity, the 6-minute walking distance and quality of life.

Eligibility criteria:
inclusion criteria: * age \>18 y.o. * clinically stable, ambulatory heart failure patients on left ventricular assist device support * implantation \> 1 month before inclusion in the study * uninterrupted therapy with an oral phosphodiesterase-5 inhibitor initiated during the early postoperativ period due to right heart failure exclusion criteria: * unable to provide written informed consent * refusal to provide written informed consent

Keywords: left ventricular assist device postoperative right heart failure
a study of patients receiving adjuvant nivolumab therapy for melanoma that has been removed

Conditions: Melanoma

Summary: an observational study of melanoma participants who are eligible for and who have initiated treatment with adjuvant nivolumab as part of routine clinical practice.

participants receiving adjuvant nivolumab therapy could be enrolled prospectively and retrospectively.

Eligibility criteria:
inclusion criteria: * patients with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease. * decision to treat with adjuvant nivolumab therapy has already been taken * at least 18 years of age at the time of treatment decision * patients who provide written informed consent to participate in the study (for retrospectively enrolled patients who are deceased at time of study start, a consent waiver will be sought) exclusion criteria: * any patient with a diagnosis of persisting advanced melanoma prior to first administration of nivolumab * any patient currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for overall survival (os)/ relapse free survival (rfs) can be enrolled. in case of a blinded study, the treatment arm needs to be known). other protocol defined inclusion/exclusion criteria could apply
an observational study of burden of upper gi-symptoms in cv risk patients

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to investigate the burden of upper gastrointestinal symptoms in patients with cardiovascular disease taking low dose aspirin


Eligibility criteria:
inclusion criteria: * provision of signed written inform consent. * physician prescribed or recommended daily intake of low dose aspirin (lda) (75-325 mg daily) for cardiovascular disease prevention within the past 12 months. * established cardiovascular disease, such as cad (coronaryartery disease), previous tia (transient ischemic attack), ischemic stroke or subjects with known risk factors for cardiovascular disease without having experienced cardiovascular events exclusion criteria: * need for concomitant treatment with a non-asa nsaid (nonsteroidal antiinflammatory drugs) including acyclooxygenase-2 (cox-2) selective nsaid. occasional use of up to 1 day/week is allowed.

Keywords: low dose aspirin (lda) cardiovascular disease low dose aspirin (lda) use in in subjects with cardiovascular risk or disease
lean body mass in head and neck cancer patients during cisplatin-based chemoradiation

Conditions: Head and Neck Cancer Patients; Lean Body Mass; Body Composition Changes

Summary: the goal of this clinical trial is to investigate the changes in body composition in head and neck cancer patients during treatment. the main questions it aims to answer are: what is the rate of lean body mass loss and how is it associated with changes in muscle strength and functional performance? is the lean body mass loss impacted by adding chemotherapy to the radiation treatment? participants will be asked to undergo five body composition scans during treatment and undergo tests for muscle strength and functional performance before and after treatment.

the primary aim of the present study is to investigate the rate of decline in body composition (lbm, body weight and fat mass) as well as changes in maximal muscle strength and functional performance during radiation treatment in hnscc patients and to investigate the association between the loss of lbm and impairments in maximal muscle strength and functional performance. secondly, the study investigates whether adding cisplatin during chemoradiation induces exacerbated lbm loss compared to radiation alone. 50 patients are expected to be included in the study. inclusion criteria are: (1) histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity, (2) prescribed to radical or post-operative radiotherapy of at least 60 gy with or without concomitant chemotherapy. exclusion criteria were palliative radiation or participation in competing research protocols. five times during treatment (biweekly), patients will be asked to undergo a dual energy x-ray absorptiometry scan to evaluate changes in lean body mass and fat mass. before and after treatment patients are asked to perform three test for maximal muscle strength (one repetition maximum knee extension, chest press and leg press) as well as three functional performance test (30 s arm curl, 30 s chair rise and stair climb).

Eligibility criteria:
inclusion criteria: * histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity * prescribed to radical or post-operative radiotherapy of at least 60 gy with or without concomitant chemotherapy exclusion criteria: * palliative radiation or participation in competing research protocols

Keywords: lean body mass body composition muscle strength functional performance cisplatin head and neck cancer
study of tace combined with lenvatinib to prevent postoperative recurrence in patients with mvi positive hcc

Conditions: Hepatocellular Carcinoma; Lenvatinib

Summary: single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (tace) combined with lenvatinib in preventing postoperative recurrence of microvascular invasion (mvi) positive hcc patients. explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.

focusing on the current status of clinical treatment of microvascular invasion (mvi) positive postoperative hepatocellular carcinoma (hcc) , single-center clinical trial studies have verified the safety and effectiveness of transcatheter arterial chemoembolization (tace) combined with lenvatinib in preventing postoperative recurrence of mvi-positive hcc patients. explore a new clinical first-line treatment plan for patients with liver cancer microvascular invasion after surgery.

Eligibility criteria:
inclusion criteria: * radical hepatocellular carcinoma was treated 4 weeks (±1 week) ago, and the pathological diagnosis was hcc after surgery, and mvi was positive * child-pugh score ≤9 points (child-pugh a-b), ps score 0-2 points, bclc stage a-b * the main portal vein is not completely obstructed, or although it is completely obstructed, the compensatory collateral branches of the portal vein are abundant or the portal vein blood flow can be restored by implanting the portal vein stent * with sufficient organ and bone marrow function, the laboratory test values within 7 days before enrollment meet the requirements * physical fitness score ecog 0～2 * expected survival\> 3 months * no other systemic malignancies * female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age must take effective contraceptive measures throughout the treatment period and 6 months after the treatment period * subjects have informed consent, understand and are willing to cooperate with the trial protocol, and sign relevant documents exclusion criteria: * histology includes fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc. * severe liver dysfunction (child-pugh c), including jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome, or a history of liver transplantation * the main portal vein is completely blocked, and the formation of collateral vessels is small

Keywords: tace hepatocellular carcinoma mvi prognosis lenvatinib
functional follow-up after endoscopic calcaneoplasty for haglund's deformity

Conditions: Haglund's Deformity

Summary: isokinetic muscle strength test implemented by the biodex system is a method used for evaluating muscle function that has been applied clinically in the field of sports and rehabilitation medicine. however, information on its application on haglund's deformity remain insufficient. therefore, the present study is designed to examine the effectiveness of the muscle strength test using the biodex system in evaluating the recovery of athletic capacity in patients with haglund's deformity following endoscopic surgery.

patients. a retrospective (medical records), level 3 evidence study was designed to evaluate the outcomes of patients who underwent endoscopic surgery for haglund's deformity. the present study was approved by the peking university third hospital's ethics committee. written informed consent was obtained from all patients, parents or guardians of the patients prior to the present study. the rights of the patients were protected. diagnosis. patients were designed to be diagnosed based on subjective complaints, combined with clinical and radiological examinations. radiological measurements for this disease include the fowler-phillip angle, calcaneal pith angle, parallel pitch lines, chauveaux-liet angle and the x/y ratio.

Eligibility criteria:
inclusion criteria: * patients who underwent endoscopic surgery for haglund's deformity exclusion criteria: * none

Keywords: haglund's deformity biodex system isokinetic muscle testing endoscopy
vitaflow liberty europe

Conditions: Aortic Valve Stenosis

Summary: this is a prospective, single-arm, multi-center, observational, post-market registry to document the clinical safety and performance of microport cardioflow vitaflow liberty™ transcatheter aortic valve system in the routine practice for the treatment of severe aortic valve stenosis. the primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months. patients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.


Eligibility criteria:
inclusion criteria: 1. subjects of age≥ 18 years 2. subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (avr). 3. subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements. exclusion criteria: 1. pre-existing mechanical heart valve in aortic position 2. a known hypersensitivity or contraindication to all anticoagulation /antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nickel or titanium, to nitinol, to dairy products, to polyethylene terephthalate (pet) or contrast media 3. ongoing sepsis, including active endocarditis 4. anatomically not suitable for the vitaflow liberty tav system 5. lvef\<20% 6. estimated life expectancy of less than 12 months 7. any medical, social or psychological condition that in the opinion of the heart team precludes the subject from receiving transcatheter aortic valve replacement 8. currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed 9. inability to comply with the clinical investigation follow-up or other clinical investigation requirements 10. patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)

Keywords: transcatheter aortic valve replacement
correlation between minimum inhibitory concentration and clinical outcome of invasive fusariosis

Conditions: Invasive Fusariosis

Summary: multi-centered, international, observational and retrospective study to analyze the correlation between mic and clinical outcome in patients with invasive fusariosis.


Eligibility criteria:
inclusion criteria: * invasive fusariosis diagnostic * proof of anti-fungic susceptibility according to eucast or clsi, for the medicine used in the treatment of invasive fusariosis. * available data about anti-fungic medicines used: name of medicine, start and end date of treatment. * available information about clinical outcome of illness after 30 days, 6 weeks and 90 days (dead or alive). * only cases of invasive fusariosis proven or possible will be included. exclusion criteria: * none

Keywords: invasive fusariosis minimum inhibitory concentration
laparoscopic tubal adhesiolysis versus ivf-icsi

Conditions: Tubal Factor Infertility

Summary: 2groups with peritoneal adhesions after cesarean delivery will be allocated to either laparoscopic tubal adhesiolysis or to ivf/icsi

this randomized clinical trial will be conducted at tanta university hospitals in fertility and mis units. two hundred and fifty 2ry infertility patients with confirmed post c.s adhesions will be included in the study and those patients will be divided randomly in two groups: group a: 125 patients will be undergoing laparoscopic tubal adhesiolysis and\\or tuboplasty then a widow of 12 months post operatively is given for natural conception. group b: 125 patients will undergo ivf-icsi procedures. the primary outcome measure of the study will be the rate of clinical pregnancy. inclusion criteria: * patient's age not exceeding 35 years old * confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video cds) as a solitary cause of their 2ry infertility. exclusion criteria: * patient's age \>35 years * other causes of infertility as male factor contribution, any ovulatory or endocrinological disorder, * diagnosed any degree of endometriosis * patients with history of recurrent pregnancy loss. * couples with prolonged sexual abstinence for any reason detailed explanation of the aims, procedures, steps and nature of the study for the participants will be done and a written consent will be signed by each patient before inclusion. after allocation laparoscopic tubal adhesions will be dissected and normal anatomy and function will be restored. in the other group ivf/icsi will be commenced the follow up with both groups will extend to 1year or till pregnancy is aggrieved the outcomes of the study were pregnancy rates and affordability

Eligibility criteria:
inclusion criteria: * age not exceeding 35 years old with confirmed post caesarean section tubal adhesions (by diagnostic laparoscopy report or video cds) as a solitary cause of their 2ry infertility. exclusion criteria: * patient's age \>35 years, male factor contribution, any ovulatory or endocrinological disorder, diagnosed any degree of endometriosis and patients with history of recurrent pregnancy loss. couples with prolonged sexual abstinence for any reason will be excluded from participation in the study.