Kornimate/medical-research-clean huggingface dataset:
vascular closure with a device compared to manual compression after atrial fibrillation ablation: the locket ii study

Conditions: Atrial Fibrillation; Hemostasis

Summary: the locket ii study is a single center, prospective randomized study. it is intended to study the effectiveness of using locket device to gain hemostasis after venous procedures as compared to manual compression (mc). approximately 110 patients will be enrolled.

the volume of catheter ablation procedures for the treatment of atrial fibrillation and other arrhythmias are on the rise in the united states and worldwide. despite decrease in complication rates due to refinement in ablation tools and techniques, achieving vascular hemostasis following large-bore sheath femoral access remains a challenge. thus, mc remains the current standard of care. however, mc requires up to 8 hours of prolonged bedrest, which is associated with longer length of stay and complications from indwelling catheters. another method of vascular closure is the figure-of-eight (foe) stitch - a subcutaneous suture that has been evaluated to achieve homeostasis following major cardiovascular procedures. in recent years, invasive, vascular closure devices have become popular. however, results continue to suggest that the risk versus benefit has not been definitively demonstrated. instead, the locket is a new suture retention device designed to closely mimic manual compression by distributing the tension of a foe stitch over a larger surface area. in such a way, patients can have the benefits of mc without a healthcare professional to stand bedside.

Eligibility criteria:
inclusion criteria: * must be at least 18 years of age * be able to provide consent * presenting for planned procedures that require percutaneous venous punctures, such as atrial fibrillation radiofrequency ablation, and where the physician utilizes a locket device or mc to close the wound. exclusion criteria: * under the age of 18 * unable to or unwilling to provide consent * cannot comply with study requirements * not undergoing procedures that require a percutaneous venous puncture or planned access to the left atrium and/or ventricle * subjects whose physician does not use locket or mc to close the venous puncture. * patient is currently pregnant, as evidenced by positive urine beta-hcg. (urine beta human chorionic gonadotropin (hcg) will be checked in all females of the reproductive age group). * if the physician detects a formed hematoma prior to venous closure, that patient will be excluded from the study.
safety, tolerability and efficacy of disulfiram and copper gluconate in recurrent glioblastoma

Conditions: Recurrent Glioblastoma

Summary: this study of dsf-cu in combination with tmz for recurrent gbm will evaluate the antitumor effect in patients who have recurrent gbm. patients will take dsf-cu daily during their routine standard of care with tmz therapy for approximately 6 months. patients will be evaluated for response every 8 weeks. patients will be followed up 2 years after the last dose of dsf-cu.


Eligibility criteria:
inclusion criteria: * histologically confirmed gbm (who grade iv). * the subject must have completed rt with concurrent tmz at least 12 weeks prior to the planned start of treatment on this study unless there is pathological verification of recurrent tumor and at least 4 weeks have elapsed since the end of rt with concurrent tmz. * experienced first unequivocal progression of tumor by magnetic resonance imaging (mri) \[as assessed via radiologic assessment in neuro-oncology (rano) criteria within 3 months from the last dose of tmz. * karnofsky performance status (kps) of at least 60%. * willing to remain abstinent from consuming alcohol. * recovered from the toxic effects of prior therapy to \< grade 2 toxicity per nci ctcae prior to study registration (except lymphopenia). * meets laboratory criteria for the following parameters: anc, platelets, hemoglobin, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, bun and creatinine. * 11. females of childbearing potential must be willing to use an acceptable method of birth control (i.e., intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. exclusion criteria: * radiographic evidence of leptomeningeal dissemination, gliomatosis cerebri, infratentorial tumor, or disease at sites remote from the supratentorial brain. * enrolled in another clinical trial testing a novel therapy or drug within the past 4 weeks. * received more than one course of radiation therapy or more than a total dose of 75 gy. * history of allergic reaction/hypersensitivity to temozolomide, dacarbazine, dsf or cu. * treatment with the following medications are contraindicated with dsf: metronidazole, isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline, tindazole, tizanidine, atazanavir. * fever within 3 days prior to study enrollment. * active or severe hepatic or renal disease. * grade 2 or higher peripheral neuropathy or ataxia per nci ctcae * history of idiopathic seizure disorder schizophrenia, or psychosis unrelated to glioblastoma, corticosteroid, or anti-epileptic medications. * history of wilson's disease. * history of hemochromatosis. * pregnant or breastfeeding.
vitamin d in periodontal and cardiovascular disease progression

Conditions: Vitamin D Deficiency

Summary: vitamin d has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of periodontitis (cp) and coronary heart disease (chd). this study investigated the association between serum vitamin d levels and periodontitis in patients with cp and with chd. furthermore, the objective was to determine if periodontitis and chd had an impact on serum vitamin d levels.

using a cross-sectional design, a total of 39 patients with cp, 38 patients with chd, 38 patients with both cp and chd, and 37 healthy subjects will enrolled in the present study.

Eligibility criteria:
inclusion criteria: * presence of at least twenty teeth * cp with a minimum of 40% of sites with a clinical attachment level (cal) ≥2mm and probing depth (pd) ≥4mm; * presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs * presence of ≥40% sites with bleeding on probing (bop) exclusion criteria: * intake of contraceptives * intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study * status of pregnancy or lactation * previous history of excessive drinking * allergy to local anaesthetic * intake of drugs that may potentially determine gingival hyperplasia such as hydantoin, nifedipine, cyclosporin a or similar drugs.
air optix® night and day® aqua therapeutic wear

Conditions: Bullous Keratopathy; Corneal Erosion; Entropion; Corneal Edema; Corneal Dystrophy

Summary: the purpose of this study is to support the safety and performance assessment of air optix night and day aqua (aonda) soft contact lenses for therapeutic use in accordance with updated eu medical device regulation (mdr) requirements.

in this retrospective, real world evidence study, the subjects wore air optix night and day aqua (aonda) soft contact lenses or purevision 2 (pv2) soft contact lenses as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes as part of their eye care professional's treatment and management plan.

Eligibility criteria:
inclusion criteria: * diagnosis of a corneal condition with pain for which aonda or pv2 contact lenses were placed on one or both eye(s) as a therapeutic contact lens at baseline. * baseline and follow-up (up to 1 year from baseline) charts available. * other protocol-defined inclusion criteria may apply. exclusion criteria: * had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic cl wear or confounds study results during the data collection period. * used systemic or ocular medication that would confound study results during the data collection period. * other protocol-defined exclusion criteria may apply.

Keywords: bandage lens
combined segmentectomy versus lobectomy for stage ia lung adenocarcinoma with ground-glass component of prospective, randomized, controlled clinical study

Conditions: IA Lung Adenocarcinoma; Combined Segmentectomy

Summary: this project intends to include stage ia lung adenocarcinoma patients with ct imaging grboreal lesions; compare the results of lobectomy vs combined subsegmentectomy, and compare perioperative complications, differences in lung function and long-term outcomes between the two groups.


Eligibility criteria:
inclusion criteria: * (1)age: 20-80 years, (2)suspected non-small-cell lung carcinoma, mixed nodules with ggo in the middle and peripheral lung fields, (3) clinical stage (uicc stage 8) , stage ia (t1a-cn0m0) , (4) multiple ggo was considered to be multiple primary lung cancer, but the largest diameter of ggo was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of ggo was less than 3 cm, the largest diameter of compactness was less than 2 cm, the largest diameter of ggo was less than 3 cm, the largest diameter of compactness was less than 2 cm (5) without any induction therapy; (6) ps score of 0-1, without severe complications, and functional status tolerant to minimally invasive lobectomy. (7) fev1≥1l was assessed by pulmonary function test and was greater than 50% of the predicted value, (8) no hilar and mediastinal lymph node metastasis and no distant metastasis were found in the preoperative clinical evaluation, (9) voluntary participation and informed consent were obtained; exclusion criteria: * (1) pure dense nodules without ggo, or pure ggo ≤0.5 cm with ggo;(2) the lesion was located in 1/3 of the lung field, and combined segmental resection may not meet the requirement of resection margin (3) multiple ggo considered multiple primary lung cancer with the largest diameter ≥1cm, dense component ≥0.5 cm and a second primary lesion that may require surgical treatment in the next 5 years (4) high risk patients with severe other organ diseases, (5) history of other malignant tumors within 5 years, (6) history of ipsilateral thoracic surgery. (7) the lesion was located in the middle lobe of the right lung, (8) in pregnant or lactating women, (9) with severe mental disorders, (10) with a history of unstable angina or myocardial infarction within 6 months, and severe stenosis of the major branches of the coronary artery; (11) a history of cerebral infarction or cerebral hemorrhage within 6 months, (12) a history of continuous systemic corticosteroid therapy within 1 month, and (13) according to the judgment of the investigators, the patients were not suitable to be included in the trial.
tumor-directed radiation therapy for patients with the highest risk category of localized prostate cancer

Conditions: Prostate Cancer

Summary: hypo-rt-pc boost is is an open-label, multicentre, phase ii trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer.

hypo-rt-pc boost is is an open-label, multicentre, phase ii trial evaluating safety and efficacy of real-time image-guided tumor-directed ultra-hypofractionated radiation boost and lymph node irradiation for patients with node-negative high risk localized prostate cancer. 76 participants will be enrolled in the study. specific aims of the study are: * to study the feasibility of ultra-hypofractionation target lesion boost for node-negative very high-risk prostate cancer together with lymph node irradiation (primary outcome). * to study the effectiveness of ultra-hypofractionated target lesion boost for high-risk prostate cancer. * to study the feasibility of defining focal boost during concomitant androgen deprivation therapy with advanced functional imaging methods.

Eligibility criteria:
inclusion criteria: * life expectancy \>5 years * age ≥18 years * world health organization (who) performance status 0-2 * histological evidence of prostate cancer * classified as very high-risk according to national guidelines (2-3 of following high risk criteria: t3 / gleason grade 8 /prostate-specific antigen (psa) 20-49 μg/l or and/or gleason score 9-10 and/or psa ≥40 μg/l * at least one prostate imaging-reporting and data system (pi-rads) 4-5 lesion on diagnostic magnetic resonance imaging (mri) * patients must be able to comply with the protocol * signed informed consent * adequate laboratory findings: haemoglobin (hb) \>90 g/l, absolute neutrophil count \>1.0x10\^9/l, platelets \>75x10\^9/l, bilirubin \<2.0 x upper limit of normal (uln), alanine aminotransferase (alat) \<5x uln and creatinine \<2.0x uln) exclusion criteria: * regional or distant metastasis * any contraindications for mri * psa \>150 ng/ml * previous pelvic radiotherapy * prior prostate surgery including transurethral resection of the prostate (turp) * endocrine treatment (past or present) * other malignancies than prostate cancer and basalioma in the past five years * serious disease state that makes study inclusion and treatment unsuitable * severe lower urinary tract symptoms (international prostate symptom score (ipss) ≥20)

Keywords: very high risk prostate cancer radiotherapy localized prostate cancer treatment ultra-hypofractionated radiation boost
the effect of intravenous lidocaine on thbs2 and angiogenic factors expression in women undergoing cervical cancer surgery

Conditions: Cervical Cancer; Metastatic Cancer

Summary: the purpose of this study is to investigate the efficacy of intravenous lidocaine on thbs2, mmps and vegf-c in serum in cervical cancer patients undergoing radical hysterectomy under general anesthesia.

the surgical stress response to tumour removal causes bloodstream release of a variety of pro-inflammatory cytokines and other molecules which may affect perioperative immune response and other conditions conducive to residual tumour cell survival that could later emerge as clinical recurrences or metastasis. lidocaine has analgesic and anti-inflammatory effects, and may also have specific anticancer properties. blood serum expression of these molecules (metalloproteinases, vascular endothelial growth factor \[vegf\], epidermal growth factor）, play a important role in the metastatic process and tumor progression. lidocaine could affect the course and growth of metastatic tumors by changing the cancer cells, the tumor microenvironment, or both. we tested the hypothesis that women undergoing cervical cancer resection with these techniques (intravenous lidocaine) have reduced postoperative serum expression of metastasis biomarkers, and may change the outcomes of cancer patients.

Eligibility criteria:
inclusion criteria: * patients were scheduled by following cervical cancer surgery under general anesthesia * aged 18-65 years * asa physical status ⅱ-ⅲ exclusion criteria: * severe heart, pulmonary, hepatic and renal insufficiency * history of neurological diseases * autoimmune disorders * antiarrhythmic drugs (amiodarone, verapamil, propafenone) * patients' decision to withdraw anytime from the study, and refusal to participate before surgery and at postoperative follow-up * allergy to one of the used medications * psychiatric illness, psychological disorder, and drug or alcohol abuse * unwillingness to comply with the protocol or procedures * preoperative treatment of chemotherapy, radiation, nsaid and hormonal therapy * history of anesthesia and surgery in two weeks * coexisting other cancers and intraoperative presence of liver metastasis * perioperative treatment of blood transfusion

Keywords: cervical cancer tumor progression lidocaine metalloproteinases vascular endothelial growth factor epidermal growth factor thrombospondin2
dietary approaches for cardiovascular health study

Conditions: Cardiovascular Diseases

Summary: the primary purpose of this study is to examine the efficacy of family meal frequency as an intervention target in addressing the primary prevention of cvd.


Eligibility criteria:
inclusion criteria: * parents who have a male or female child aged 6-12 years-old with a bmi-for-sex and age \<95th percentile * parent age is ≥18 years-old * parent reports at least 2 of the following cvd risk factors: smoking, high cholesterol, high blood pressure, physical inactivity, overweight/obesity, diabetes * parent is able to read, speak and understand english exclusion criteria: * parents who live with their child \<5 days per week * parents who do not have access to the internet and/or are unable to attend intervention sessions * parents who report a medical condition that impacts growth or requires a specific eating plan for themselves or their child.
assessment of botulinum toxin injection for treatment of temporomandibular joint dislocation

Conditions: Dislocation of Temporomandibular Joint TMJ; Subluxation of Temporomandibular Joint

Summary: assessment of the effect of botulinum toxin injection on the frequency of luxation and tmj pain in patients with tmj dislocation either chronic recurrent dislocation or subluxation

diagnostic procedure: 1. patient questionnaire: a questionnaire will be recorded by the examiner including the chief complaint, personal data, and medical history. 2. consent: informed consent will be obtained from patients to participate in the study. 3. clinical examination: tmj examination with specific emphasis on the tmj regarding pain, clicking, maximum inter-incisal mouth opening, lateral excursions, and muscle examination is done (inspection and palpation). o operative procedures: • the surgical field will be scrubbed and prepared in a standard sterile fashion using alcohol and topical anesthesia is applied at point of needle insertion a-botulinum toxin type a injection: btx-a vial will be reconstituted with normal saline to obtain a 10 u/0.1 ml solution, 0.25 ml of this solution containing 25 u btx-a will be loaded in a 1-ml insulin syringe attached to a needle with 27 gauge and 31 mm length. b-the placebo comparator injection: patients in the placebo arm will receive equivalent volumes of placebo solution (normal saline). • procedure - with the patient sitting in an upright position on the dental chair, the lateral ptreygoid muscle will be approached extra orally through the space formed by the zygomatic arch and the sigmoid notch of the mandible below the center of the zygomatic arch. the needle will be advanced perpendicular to the skin with the mouth closed. the muscle is approximately 3 to 4 cm deep. aspiration will be carried out to avoid unintentional intravascular injection. according to the assigned group, the inferior head of lateral pterygoid muscle will be injected with btx-a or normal saline - the patient will be instructed to remain in an upright position for 6 h (to reduce diffusion into pharyngeal muscles which may cause dysphagia and nasal regurgitation). - patients will be recalled weekly during the first month, then monthly after 3 months * post-operative care: paracetamol 1000 mg will be prescribed as needed any excessive mouth opening should be avoided soft diets are advised in the first 48 hours after injection

Eligibility criteria:
inclusion criteria: 1. patients with tmj habitual or recurrent dislocation 2. age ≥ 18 years 3. the willingness of the patient to receive relative painful injections and to follow instructions exclusion criteria: 1. patients with neurogenic cause of tmj hypermobility. 2. drug-induced tmj hypermobility

Keywords: botulinum toxin tmj subluxation
methotrexate adherence in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: this study was conducted for assessment of adherence of rheumatoid arthritis patients to methotrexate as a gold standard drug for treatment of r.a. moreover, evaluating the effect of drug adherence to patient quality of life.

rheumatoid arthritis one of most common autoimmune diseases. characterized by numerous complications which may affect patient quality of life. hence, this review aim to search the relation between patient"s drug adherence and clinical health outcome. our review utilizing survey as a tool to collect needed data from rheumatoid patients. survey consisted of number of questions , participants were required to answer these questions. participation to this questionnaire was optional.

Eligibility criteria:
inclusion criteria: 1. the study was carried out among all ra patients (adults patients ≥ 18 years). 2. patients not suffering from severe mental disorders. 3. patients with a disease duration from (1-5) years. 4. patients on mtx treatment from (1-5) years. 5. patients taking mtx alone or in combination with other dmards. exclusion criteria: 1. patient who on mtx for more than 5 years 2. patient who have complications like:- * history of liver or kidney disease * diabetic patients * hypertensive patients * bone marrow hypoplasia * leukopenia or significant anemia * peptic ulcer or any git problems * hereditary alopecia.
supportive care for patients newly diagnosed with lung cancer

Conditions: Lung Cancer

Summary: the aims of this project are to assess the feasibility of recruiting patients and delivering a nurse-led telephone based palliative care intervention for patients with newly diagnosed lung cancer and to assess if among patients with newly diagnosed lung cancer, the investigators can estimate the effect of a nurse-led telephone based palliative care intervention on quality-of-life, symptom burden and patient satisfaction.

patients meeting entry criteria will be randomized to the intervention arm, palliative care plus usual care or the usual care arm. patients randomized to the intervention arm will receive usual oncologic care and phone calls from a nurse. outcomes measures will be collected at baseline, and 3 months. the study will be performed at the va puget sound health care system. the investigators will recruit individuals (n=40) with lung cancer over 1 year. the primary objective is to test the feasibility and acceptability of the intervention, and recruitment of subjects. the investigators will estimate the effect of a nurse-led telephone based palliative care intervention to improve quality-of-life, symptom burden and patient satisfaction. in addition, using validated instruments, the investigators will assess the potential effect size of the intervention on quality of provider communication and on clinician knowledge of patient preferences for life sustaining therapies. the results of this pilot study will inform a future randomized clinical trial to test the efficacy of the intervention on a larger scale.

Eligibility criteria:
inclusion criteria: * patients diagnosed at the puget sound health care system with a primary diagnosis of lung cancer, * any cell type or stage, * diagnosed within 8 weeks of study enrollment. * must have telephone access, * ability of understand english and * provide informed consent. exclusion criteria: * patients not eligible to participate in the study include those who are inpatients prior to randomization, * those who are under the care of palliative care or hospice at the time of randomization, * those who have severe mental health disorders, * those who are unable to speak directly with the nurse over the telephone, * or those that have the inability to provide informed consent. investigators will recruit individuals (n=40) with lung cancer over a 12 month period.

Keywords: palliative care