Kornimate/medical-research-clean huggingface dataset:
reducing tobacco smoking: a transcranial direct current stimulation (tdcs) telehealth study

Conditions: Smoking Cessation

Summary: the study aims to evaluate the feasibility of using dorsolateral prefrontal cortex (dlpfc) transcranial direct current stimulation (tdcs) as a tool to decreasing distress and cigarette smoking. 46 participants currently smoking cigarettes, and seeking to decrease cigarette use will be recruited.


Eligibility criteria:
inclusion criteria: * 21-75 years old * smoke ≥5 cigarettes per day and express interest in quitting smoking in next 30 days * mild to moderate distress defined as k10 scores 10-35 * self reported previous diagnosis of cancer * psychotropic medication stable for ≥1 month prior to enrollment and throughout the trial, at the discretion of the study physician * access to a reliable internet connection, able to use mobile device, and complete online questionnaires, competent in instrumental activities of daily living * able to read and understand informed consent and questionnaires in english (wrat-4 score≥85) exclusion criteria: * inability to effectively use study-provided supplies * chronic non-compliance with study procedures * changes in health information over the course of enrollment in the study which place the participant at higher risk for an adverse event (as determined by study physician or principal investigator; e.g. medication changes, invasive procedures) * temporary or permanent obstructions to making contact between the electrodes and the scalp (e.g. wig that the participant is not willing to remove) * history of traumatic brain injury, brain metastases, seizure disorder, recent (\<5 years) seizure history, or a neurodegenerative disease or neurocognitive disorder associated with significant impairment (e.g. parkinson's, dementia) * current severe major depressive disorder, lifetime history of psychotic disorders or bipolar disorder type i, or current suicidal ideation * currently meets dsm-5 criteria for severe substance use disorder in the past 6 months for any psychoactive substance other than tobacco * current suicidal ideation (as determined by the mini) * current use of prescription or over the counter smoking cessation medication, or primary use of non-combustible forms of nicotine/tobacco * currently receiving intravenous chemotherapy or radiation treatments * presence of metal objects in the head/neck * any skin disorder or skin sensitive area near stimulation locations * self-reported pregnancy * enrolled in group or individual therapy for smoking cessation that would be concurrent to intervention

Keywords: cigarette smoking cancer anxiety stress tobacco mindfulness
most total pancreatectomies for ductal adenocarcinoma can be replaced by whipple over the splenic artery: a before and after study

Conditions: Ductal Adenocarcinoma of the Pancreas

Summary: recently, more and more total pancreatectomy (tp) has been performed for pancreatic ductal cell adenocarcinoma (pdca) which abuts or involves both gastroduodenal and splenic arteries. warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during whipple (wotsa). in that case, tp can be replaced by wotsa. this uncontrolled before and after study assesses the safety and efficacy of a new technique "whipple over the splenic artery (wotsa)" as a treatment for pdac which traditionally requires total pancreatectomy (tp).

recently, more and more total pancreatectomy (tp) has been performed for pancreatic ductal cell adenocarcinoma (pdca) which abuts or involves both gastroduodenal and splenic arteries. warshaw's procedure (spleen-preserving distal pancreatectomy with excision of splenic vessels) has been safely performed for years. likewise, both pancreatic tail and spleen can be preserved after excision of splenic vessels for leftward extension of pancreatic parenchyma transaction line during whipple (wotsa). in that case, tp can be replaced by wotsa. this uncontrolled before and after study assesses the safety and efficacy of a new technique "whipple over the splenic artery (wotsa)" as a treatment for pdac which traditionally requires total pancreatectomy (tp). methods: the study group comprised 40 consecutive patients who underwent wotsa for pdac. their clinicopathological characteristics and survival were compared with those of a historical control group comprising 30 consecutive patients who underwent tp between.

Eligibility criteria:
inclusion criteria: * pancreatic ductal cell adenocarcinoma (pdca) patients exclusion criteria: * patient undergoing palliative pancreatectomy, other malignancies with distant metastases * vulnerable groups

Keywords: ductal adenocarcinoma pancreatectomies whipple
intracoronary of nicorandil and verapamil to reduce the occurrence of periprocedural myocardial injury

Conditions: Coronary Artery Disease

Summary: percutaneous coronary intervention (pci) remains the major revascularization strategy for patients with obstructive coronary artery disease (cad).however,in a substantial number of pci cases for acute coronary syndrome (acs) and chronic coronary syndrome (ccs),periprocedural myocardial injury or myocardial infarction (mi) occurs,both these pci-related complications may be associated with an increased risk of future major adverse cardiovascular events (such as death, re-infarction, and revascularization).the incidence of periprocedural myocardial injury varies according to the different definition and cardiac biomarker .for 4th udmi criteria with hs-ctn, 78% to 85% patients who undergoing elective pci may suffer from periprocedural myocardial injury. experimental and clinical evidence highlight the abnormalities of the coronary microcirculation is one of the causes of myocardial ischemia.coronary microvascular disturbances (cmd) have been associated with early stages of atherosclerosis even prior to any angiographic evidence of epicardial coronary stenosis, as well as to other cardiac pathologies such as myocardial hypertrophy and heart failure. in this study, we try to conduct a double blinded, randomized, placebo-controlled trial，the aim of our trial is: (1) to observe whether the prophylactically intracoronary administration of nicorandil and verapamil could reduce the occurrence of periprocedural myocardial injury and infarction in cad patients undergoing elective pci.;(2) to observe whether the prophylactically intracoronary administration of nicorandil and verapamil has protective effect on coronary microcirculation after elective pci.

simple randomization in a 1:1 ratio will be made in blocks of variable size according to a random numbers generated by excel 2019 to divide the patients to treatment group (nicorandil and verapamil) and control group (saline). the primary end points are the incidence of periprocedural myocardial injury and 4a mi and the level of the imr,secondary end points include levels of hs-ctni, ck-mb ,nt-probnp and hs-crp before, and 24 hours following pci, and major adverse cardiovascular events at day 30. spss 26.0 will be used, and p-value \< .05 will be considered statistically signifificant.

Eligibility criteria:
inclusion criteria: * 1.diagnosis of chd with ffr\<0.8;2.elective pci; exclusion criteria: * patients with ami, lesion at the opening of the main coronary artery，kidney dysfunction, liver dysfunction，blood coagulation disorder ,nyha iii-iv,degree ii-iii atrioventricular block,and restenosis after pci，cabg will be excluded.

Keywords: periprocedural myocardial injury coronary microvascular disturbances percutaneous coronary intervention nicorandil verapamil
clinical trial robert® - project active training

Conditions: Apoplexy; Stroke; Spinal Cord Injuries; Safety; Usability

Summary: the overall purpose with this clinical trial is to, monitor and secure robert®'s clinical performance and safety in a clinical environment in the regional hospital north denmark, neuro unit north. the purpose of the study is to investigate if robert® has the ability to 1. perform guided active training. 2. perform resistance based active training. and validate the safety of robert® in a clinical environment.


Eligibility criteria:
inclusion criteria: * hospitalised patients at neuro unit north, during the trial period. * 18 years or older. * can read, understand and speak danish * reduced motor function in lower extremities. exclusion criteria: * no able to sign informed consent. * cannot read, understand or speak danish * patients with unstable fractures in columna, pelvis or lower extremities. * patients with the risk of ulcers, or with exceedingly sensitive skin. * the patient is refusing to train with robert®
folic acid vs 5-methyltetrahydrofolate (5mthf) in recurrent abortion

Conditions: Recurrent Abortion

Summary: recent data indicates that 5 methyltetrahydrofolate (5mthf) can reduce serum homocystein level more efficiently than folic acid. on the other hand, folic acid is currently an important part of treatment in idiopathic recurrent abortion. there is no study comparing the effectiveness of these supplements in the treatment of recurrent abortion. the aim of this study is to compare the efficiency of these two agents in the treatment of recurrent abortion. in this study, patients with idiopathic recurrent abortion, referring to avicenna clinic will be randomly allocated into two groups of those taking either folic acid (5 mg) or 5 mthf (5mg) from 8 weeks prior to conception until the 20th week of pregnancy. the serum level of folate, homocystein, and ongoing pregnancy will be analysed and compared in the two groups.


Eligibility criteria:
inclusion criteria: * willing to participate in the study and filling out the informed consent form, * history of 3 or more idiopathic abortion, * the last abortion should be more than 6 months ago, * no history of consumption of folate supplements or high folate containing foods during last 6 months, * all previous abortions should be idiopathic without any anatomic, cytologic, hormonal, septic pathologic finding, * no special diets exclusion criteria: * elective or induced abortion, molar or ectopic pregnancies, * presence of any malignancy, chromosomal abnormality, uterine abnormality, thyroid, kidney, or liver dysfunction, glucose intolerance, seizure, * alcohol or drug abuse, * taking any drug affecting homocystein metabolism, * not following the study protocol.
clinical trial of tqb2102 for injection versus trastuzumab emtansine for injection in her2-positive advanced breast cancer

Conditions: Metastatic Breast Cancer

Summary: this study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. the primary endpoint was pfs evaluated by the independent review committee (irc). eligible subjects were randomly assigned in a 1:1 ratio to receive either tqb2102 for injection or trastuzumab emtansine for injection.


Eligibility criteria:
inclusion criteria: * the subjects voluntarily participated in this study, signed the informed consent form, and had good compliance; * age: 18 - 75 years old (at the time of signing the informed consent form); eastern cooperative oncology group (ecog )score ≤ 1; expected survival period exceeds 3 months; * her2-positive, unresectable, locally advanced or metastatic invasive breast cancer confirmed by histopathological or cytological examination; * according to the 2018 version of the american society of clinical oncology (asco)/college of american pathologists (cap )humanepidermalgrowthfactorreceptor2 (her2) testing guidelines, her2 positive is defined as: immunohistochemical result of 3+ or fluorescence in situ hybridization (fish) dual probe positive; * the hormone receptor (hr) status has been clearly determined: a) according to the 2020 version of the asco/cap guidelines, hr positive includes er positive and/or pr positive, that is, the proportion of tumor cells with positive staining among all tumor cells is ≥ 1%. * received anti-her2 monoclonal antibody and taxane drugs during the recurrence/metastasis stage. * disease progression occurred during or after the most recent treatment or intolerance. * at least 1 line of treatment has been received in the recurrence/metastasis stage. * according to the response evaluation criteria in solid tumors (recist) 1.1 standard, at least one measurable lesion exists. exclusion criteria: * excluded are patients with known spinal cord compression or active central nervous system metastases . * patients with only skin and/or intracranial lesions as target lesions. * patients with adverse reactions from previous treatments that have not recovered to a ctcae v5.0 grade score of ≤1. * patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmhg or diastolic blood pressure ≥100 mmhg). * patients with major cardiovascular diseases * patients with a history of interstitial lung disease/pneumonia (non-infectious type) requiring steroid intervention treatment, or currently having interstitial lung disease/pneumonia, or those with suspected interstitial lung disease/pneumonia indicated by screening period imaging and cannot be excluded.
effect of local anesthetic emla (lidocaine 2.5% and prilocaine 2.5%) cream and reduction in dose, pain and intravenous analgesic during permanent pacemaker implantation

Conditions: Pacemaker Implantation; Pain

Summary: the investigators believe that the local anesthetic emla (lidocaine 2.5% and prilocaine 2.5%) cream will lessen pain and reduce the need for anesthesia and analgesia, when implanting a permanent pacemaker.


Eligibility criteria:
inclusion criteria: * all patients undergoing pacemaker implantation exclusion criteria: * dementia patients * psychiatric patients * unconscious patients * patients with sensitivity to emla
effect of ureteral stents length and location on related symptom

Conditions: Lower Urinary Tract Symptoms; Overactive Bladder Syndrome

Summary: this is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral placement of the stent's distal end versus the conventional stent placement on the postoperative luts and pain.

intravesical stent mass has been considered to cause stent-related symptoms, such as luts and pain. the current study hypothesized that the total intra-ureteral placement of the stent's distal end could decrease postoperative luts and pain. we proposed a prospective randomized trials, investigating the effect of intra-ureteral stent placement versus conventional stent placement. the primary end point was postoperative luts. the secondary end points were postoperative pain and quality of life. we used ussq questionnaire as the assessing tool.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of unilateral ureteral stone * plan to undergo unilateral urs lithotripsy * adult patients (\>18 years old) exclusion criteria: * pre-stented cases * distal ureteral stones * preoperative urinary tract infection * with medications known to influence stent-related symptoms, including alpha-blockers, antimuscarinics, beta3-agonist * pregnancy * other procedures required during the procedure of lithotripsy * a stent was expected to be indwelled for more than 10 days (ureteral stricture, ureteral tumors/polyps, ureteral trauma, and a large amount of stone fragments)

Keywords: ureteral stent oab
study to assess the safety and tolerability of the tor kinase inhibitor azd8055

Conditions: Cancer; Solid Tumors; Advanced Solid Malignancies

Summary: the primary objective is to assess the safety and tolerability of azd8055 in japanese patients with advanced solid tumours.


Eligibility criteria:
inclusion criteria: * japanese patients with advanced solid tumors for which suitable effective standard treatment does not exist or is no longer effective * relatively good overall health other than cancer exclusion criteria: * poor bone marrow function (not producing enough blood cells) * poor liver or kidney function * serious concomitant illness

Keywords: phase i, cancer solid tumors advanced solid malignancies dose escalation mtor kinase inhibitor japanese
evaluation of new flexible high-density intra-operative ecog electrodes for epilepsy surgery. ( epigrid )

Conditions: Focal Epilepsy; Intraoperative Monitoring

Summary: the objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density soft ecog electrode grids, manufactured by neurosoft bioelectronics sa (test device; td), in comparison to regular high-density electrode grids (adtech, ce-marked) (control device; cd) routinely used at the investigation site during epilepsy surgery. subjects will undergo ≥ 2 additional intracranial recordings pre- and post-resection with the td next to the standard recordings with the cd during ecog-tailored epilepsy surgery.


Eligibility criteria:
inclusion criteria: * age ≥18 years at the time of enrolment * lesional epilepsy (incl. mesial temporal sclerosis) that is considered a candidate for intra-operative high-density grid recordings (incl. patients who underwent stereoelectroencephalography (seeg) preceding resective surgery) * provided informed consent for study participation by the subject exclusion criteria: * prior brain surgery (excl. seeg) * occipital lesion * multiple epileptic foci or suspected dual pathology * surgeries involving a disconnection, or hemispherectomy. * planned awake surgery and/or functional recordings * use of anticoagulants that cannot be discontinued during the perioperative period, or a factor xiii deficiency or any other haematological disease * active participation in another investigational device study * any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study. * insufficient understanding of dutch language.

Keywords: intra-operative electrocorticography hfo epileptic biomarkers high frequency oscillations epilepsy surgery flexible ecog subdural electrode
2 courses of concurrent cisplatin chemoradiotherapy after surgery for high-risk head and neck squamous cell carcinoma

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: the main objective of this trial was to determine the value of 2 courses of cisplatin concurrent chemotherapy in postoperative adjuvant radiotherapy for high-risk head and neck squamous cell carcinoma.

the main objective of the trial was to evaluate whether the 3-year failure-free survival (ffs) rate in patients with high-risk head and neck squamous cell carcinoma treated with adjuvant radiotherapy and 2 courses of concurrent cisplatin chemotherapy after surgery was no less than 10% compared with 3 courses of concurrent cisplatin chemotherapy. the secondary objective was to evaluate efficacy and toxicity of 2 courses of concurrent cisplatin chemotherapy (100mg/m2, days 1 and 22) during adjuvant intensity-modulated radiation therapy will be compared with 3 courses of concurrent cisplatin chemotherapy (100mg/m2, days 1, 22 and 43).

Eligibility criteria:
inclusion criteria: a. the pathological type is head and neck squamous cell carcinoma * stages iii and iv b. radical surgery has been performed with high risk factors (one of below) * extracapsular invasion of cervical metastatic lymph nodes * positive incisional margin or inadequate incisional margin safety distance c. no evidence of distant metastasis (m0). d. functional status: karnofsky scale (kps) \> 70. e. normal bone marrow function: * white blood cell count \> 4×109/l * hemoglobin \> 120g/l in males, 110g/l in females * platelet count \> 100×109/l g. normal liver function: * alanine aminotransferase (alt), aspartate aminotransferase (ast) \< 1.5 times the upper limit of normal (uln) * alkaline phosphatase (alp) \< 2.5×uln * bilirubin \< uln. h. normal renal function: creatinine clearance \> 60 ml/min. i. patients must be informed of the basic contents of this study and sign informed consent. exclusion criteria: a. age \>70 years or \<18 years. b. treatment is palliative. c. previous chemotherapy (except induction chemotherapy prior to surgery). d. previous radiation therapy. e. women who are pregnant or breastfeeding f. previous history of malignant tumor. g. with other serious medical conditions that may pose a greater risk or affect compliance with the test. examples include: * unstable heart disease that requires treatment * kidney disease * chronic hepatitis * poorly controlled diabetes (fasting blood glucose \> 1.5×uln) * mental illness.

Keywords: concurrent chemoradiotherapy cisplatin postoperative head and neck squamous cell carcinoma
association between glycaemic control and morbi/mortality after 5 years of follow-up in type 2 diabetic patients

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to asses the link between glycaemic balance (summarised by hba1c level) and specific causes of death.

the gerodiab study is the first prospective, longitudinal follow-up cohort study, the main aim of which is to assess the link between glycaemic balance (evaluated on the basis of hba1c levels) and total mortality at 5 years in diabetic patients aged 70 and over, and suffering from type 2 diabetes. an extension to 10 years is considered given the innovative features of this cohort follow-up procedure. the secondary endpoints are as follows: * to assess the link between glycaemic balance and the mortality rate with specific causes. * to assess the link between glycaemic balance and the onset of or change in diabetes-related complications: cardiovascular diseases, change in renal function, diabetic retinopathy, peripheral neuropathy, perforating ulcer of the foot and acute metabolic complications. * to assess the link between glycaemic balance and nutritional status, the onset of or changes in cognitive disorders and a loss of autonomy. * to specify the role of other cardiovascular risk factors combined with glycaemic balance, in mortality, diabetes-related complications, cognitive disorders and loss of autonomy.

Eligibility criteria:
inclusion criteria: * patient with type 2 diabetes, aged 70 and over, * patient having received medicinal or non-medicinal treatment (in the case of diabetics treated with insulin, the length of time between diagnosis of diabetes and the onset of insulin therapy will be at least 2 years), * diabetes diagnosed for at least one year, * patient with autonomy defined by a score greater than or equal to 3/6 on the adl scale, * patient who can be monitored during hospital or private consultations over the next 10 years, * patient who did not refuse to take part in the study after receiving information on the study (patient information leaflet), patients are monitored in the hospital or private sector throughout france. exclusion criteria: * patient with type 1 diabetes, * patient with secondary diabetes (mainly corticosteroid-induced), * patient with a loss of autonomy defined by a score of less than 3/6 on the adl scale, * patient who cannot be monitored in the months or years to come, * patient in an acute situation (transient exclusion criterion), * patient expressing their refusal to participate in the study.

Keywords: hba1c diabetes-related complications glycaemic balance