Kornimate/medical-research-clean huggingface dataset:
radiofrequency ablation using octopus electrodes for treatment of focal liver malignancies

Conditions: Hepatocellular Carcinoma; Metastasis; Cholangiocarcinoma

Summary: the purpose of this study is to evaluate the clinical feasibility and short-term outcome of switching monopolar rfa using a separable cluster electrode in patients with primary and secondary liver malignancies.

radiofrequency ablation (rfa) is one of minimal invasive treatment methods and it has been showing comparable overall survival with surgery in early or small hepatocellular carcinomas (hccs) and better cost-effectiveness. however, it is suffering from high local tumor progression (ltp) rate. to reduce ltp rate, creation of large ablative zone has been attempted in various strategies. a separable cluster electrode is a new type of rfa electrode. it consists of three individual applicators and the applicators can be incorporated as a single handle such as a cluster electrode, and can be separated as three electrodes, depending on operators' needs. it allows high flexibility to operators and the preclinical results were promising. herein, we want to evaluate the clinical feasibility of the electrodes by observing major complication rates, technical success rate and 12-months ltp rate.

Eligibility criteria:
inclusion criteria: * hepatic malignancies diagnosed on biopsy or * typical imaging features of hepatocellular carcinoma (hcc) on computed tomography (ct) or magnetic resonance imaging (mri) according to aasld guideline * typical imaging feature of metastasis on ct or mri and * 1\~5 tumors equal to or smaller than 5cm in the liver * no direct contact with or invasion into the hepatic hilar structures or inferior vena cava (ivc) * eastern cooperative oncology group performance status of 0 * patients who signed informed consent exclusion criteria: patients with any of followings are excluded. * patients with uncontrolled coagulopathy * patients with child-pugh classification c * patients with tumor invasion in major portal vein or hepatic vein branch * extrahepatic metastasis

Keywords: rfa
a study to compare pregabalin/pf-00489791 combination versus pregabalin alone in post-herpetic neuralgia

Conditions: Postherpetic Neuralgia

Summary: pregabalin is an alpha-2 delta ligand approved for the treatment of neuropathic pain, however, not all patients will respond to this drug. this study will compare the efficacy of pregabalin when administered with an experimental drug pf-00489791, in patients with post-herpetic neuralgia. the efficacy of this combination will be compared to pregabalin alone.


Eligibility criteria:
inclusion criteria: * male or female of non-childbearing potential * pain present for more than 3 months after healing of herpes zoster skin rash * vas score of \>=40mm at screening and baseline visits exclusion criteria: * patients with pain conditions which might impair the assessment of postherpetic neuralgia * skin conditions in the affected dermatome that could alter sensation other than postherpetic neuralgia * history or diagnosis of dsm iv major depressive disorder
advancing cervical cancer screening through the emergency department - iis

Conditions: Cervical Cancers; HPV

Summary: cervical cancer screening in the emergency department

this will be an effort to deploy hpv self-sampling among emergency department patients. emergency department patients, in the us and worldwide, are disproportionally under-screened for cervical cancer relative to the general population.

Eligibility criteria:
inclusion criteria: * cisgender women and transgender/non-binary individuals with a cervix, * age 25-65, * able to demonstrate decisional capacity to participate. exclusion criteria: * past hysterectomy with cervical removal, * known infection with hiv (as screening recommendations for people with hiv differ from the general population), * non-english speaking.

Keywords: hpv cervical cancer cancer screening
development of a health promotion nursing intervention for post-traumatic stress women based on swanson's theory of caring

Conditions: Women Who Have Experienced Trauma

Summary: objectives: we aimed to (1) develop a caring program for health promotion among women who experienced trauma and (2) evaluate its effect on post-traumatic stress, depression, health-promoting behaviors, and self-esteem. methods: we conducted a quasi-experimental study using a group pre-test/post-test design. data were collected from 14 women recruited from a self-sufficiency support center for sexually exploited women who experienced trauma, during december 2019-may 2020. participants were assessed at pre-test, post-test, and at a one-month follow-up. we analyzed changes in outcome variables over time using repeated-measures analysis of variance and paired t-tests.


Eligibility criteria:
inclusion criteria: 1. women aged over 18 years who had experienced a traumatic event, and 2. a pts score of 64 or lower on the ptsd checklist for dsm-5 (pcl-5) developed by weathers et al. (1993), revised by weathers et al. (2013), and translated into korean by kim et al. (2017). exclusion criteria: 1. presence of psychiatric conditions with hallucinations and delusions, and 2. diagnosis of an intellectual disability that would make understanding the intervention procedure difficult. although a standard cut-off was not present in the pcl-5, women who exceeded 80% (64 points) of the total score were excluded to rule out high-risk women with severe trauma.
deep dry needling for the management of post-stroke spasticity

Conditions: Stroke

Summary: stroke is the leading cause of physical disability, particularly due to the presence of spasticity. different needling techniques, including the use of botulinum toxin a are proposed for the management of spasticity. the presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. no study has investigated the effects of deep dry needling inserted into the targeted spastic musculature in patients with stroke. the investigators will conduct a randomized controlled trial investigating the effects of a single session of deep dry needling over the musculature of the leg on spasticity, widespread pressure pain sensitivity and plantar pressures (baropodometry) in individuals with chronic stroke. the investigators hypothesize that patients receiving a single session of dry needling would exhibit a greater reduction in spasticity and pressure sensitivity than those who will not receive the intervention.


Eligibility criteria:
inclusion criteria: * first-ever unilateral stroke; * hemiplegia resulting from stroke; * unilateral equinovarus gait with independent walk; * able to ambulate without supporting devices. exclusion criteria: * recurrent stroke; * previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time, or with btx-a in the previous 6 months * not independent in the basic activities of daily living * severe cognitive deficits; * progressive or severe neurologic diseases; * fear to needles; * any contraindication for dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.
study in nsclc: is timely analysis of egfr-mutation status feasible in region antwerp, belgium.

Conditions: Non Small Cell Lung Cancer

Summary: this is an observational study to evaluate the feasibility of the implementation of a personalized treatment strategy based on specific tumor marker (f.i. egfr-mutation) in the routine clinical care setting in the antwerp region (belgium).

the favourable results of a number of phase iii-trials with gefitinib in nsclc patients with activating egfr-mutations, have resulted in the licensing of gefitinib in this indication. this offers the prospect of a true personalized treatment of patients with nsclc. implementation of such a personalized treatment strategy is dependent both on the availability of adequate tumor samples for the egfr-mutation analysis and on the timely reporting of the mutation analysis results. ideally the results should be available in all patients within 2 weeks of the analysis request.

Eligibility criteria:
inclusion criteria: * age 18 years or above * newly diagnosed nsclc * written informed consent * tumor sample available exclusion criteria: * mixed histology of small cell and nsclc

Keywords: non small cell lung cancer observational study egfr mutation analysis egfr mutation status testing turn around time
biomarkers in pulsed field ablation versus cryoballoon ablation

Conditions: Atrial Fibrillation

Summary: our study will include consecutive patients undergoing pulsed field ablation (pfa) or cryoballoon (cba) ablation. tissue injury and inflammation markers will be measured before and after the procedure.

study population: the participants with symptomatic atrial fibrillation scheduled for pfa or cba procedures biomarkers of interest: high-sensitive troponin, crp, nt-probnp data collection: blood samples will be collected at baseline, immediately after the procedure, 24 hours after, and three months after. statistical analysis: comparisons of biomarker levels between pfa and cba groups. results: comparison of biomarker levels between pfa and cba groups at each time point. changes in biomarker levels over time within each group. correlation analysis between biomarker levels and clinical outcomes, such as af recurrence, la stiffness, complications, and hospitalization.

Eligibility criteria:
inclusion criteria: * symptomatic paroxysmal or persistent atrial fibrillation. * age between 18 and 75 years. exclusion criteria: * prior atrial fibrillation ablation. * history of significant bleeding or thromboembolic events within the last 6 months. * history of severe renal or liver disease. * history of malignancy within the last 5 years. * history of autoimmune disease or immunodeficiency. * significant mitral stenosis or other significant valvular heart disease. * pregnancy or breastfeeding.
effect of lifestyle modification on pregnancy outcome for gdm

Conditions: GDM; Lifestyle; Pregnancy Outcome

Summary: effect of lifestyle modification on pregnancy outcome for pregnant women with gdm

evaluate the effect of lifestyle modification on pregnancy outcome among gdm women. primary outcomes: excessive gestational weight gain, uncontrolled blood glucose level, pih, polyhydromnios, oligohydrominos, recurrent monilia infection and urinary tract infection , intra uterine fetal death (iufd), intra uterine growth restriction (iugr), premature preterm rupture of membrane and diabetic ketoacidosis. secondary outcomes: preterm labor, caesarian section, neonatal hypoglycemia, stillbirth, respiratory distress syndrome, small for gestational age (sga), large for gestational age (lga) ,neonatal intensive care unit (nicu) and failure to initiate or maintain breast feeding.

Eligibility criteria:
inclusion criteria: * women diagnosed with gdm exclusion criteria: * pre-gestational diabetes type 1 or type 2 diabetes mellitus, diagnosed as pregnancy induced hypertension before gdm
jawline improvement using patient-specific angle implants with virtual planning in orthognathic surgery

Conditions: Malocclusion

Summary: background: jawline improvement is nowadays a strong patients' demand. among patients undergoing orthognathic surgery, it remains sometimes a challenge to manage angle definition due to the classic mandibular osteotomy trait which mostly allows sagittal mandibular movements but can't modify the ramus height. a few types of osteotomies can be used to improve jawline's shape while correcting malocclusion, but they remain technically difficult and often imply the necessity for bone grafting and/or the use of a specific saw and screwdriver. the advent of computer-assisted surgical planning and computer-aided design/ computer-aided manufacturing (cad-cam) techniques for patient-specific implant (psi) fabrication has enabled new methods for managing the jawline in orthognathic surgery. the aim of this study was to assess jawline improvement with patient-specific angle implants in patients undergoing orthognathic surgery with standard osteotomies.methods: a virtual simulation of a le fort i osteotomy (if needed), a sagittal split ramus osteotomy with patient-specific titanium angle implants, and a genioplasty (if needed) was conducted on a preoperative three-dimensional (3d) model of each patient's skull using proplan cmf software (materialise, leuven, belgium). computer-assisted osteotomy saw-and-drill guides and patient-specific implants (psis, titanium plates and angle implants) were produced and used during the surgery. the investigators chose to focus on jawline improvement by comparing the preoperative and the post-operative 3d-photographs using the vectra h2 3d imagine system (canfield scientific, \*\*).


Eligibility criteria:
* inclusion criteria: patients undergoing orthognathic surgery and jawline correction with patient-specific angle implants at head and neck institute, nice, france * exclusion criteria: none
paper applicator acceptability study

Conditions: HIV Prevention

Summary: to assess the acceptability of a user-filled, paper, applicator for delivery of tenofovir (tfv) gel among women at high risk of acquiring human immunodeficiency virus (hiv) in rural kwazulu-natal, south africa.

caprisa 070 is designed to enroll rural women who exit from caprisa 008 - an ongoing trial assessing implementation, effectiveness and safety of tfv gel in kwazulu-natal, south africa. all study participants in caprisa 008 have also participated in caprisa 004 and thus have several years of experience using tfv gel with the prefilled, plastic applicator. caprisa 070 will allow us to assess acceptability of the user-filled, paper applicator among women who have had extensive experience with the pre-filled, plastic applicator and are well-positioned to provide feedback and comparisons on a new gel delivery method.

Eligibility criteria:
inclusion criteria: * age 18 years and older * women who previously participated in caprisa 008 * able and willing to provide first person informed consent to be screened for, and to enroll in, the study * allow access to their caprisa 008 data, including study exit data * able and willing to provide adequate locator information for study retention purposes * sexually active (at least one coital act in the last 3 months prior to screening) * hiv negative * negative pregnancy test \* * agree to use a non-barrier form of contraceptive * agree to adhere to study visits and procedures * breastfeeding is not exclusionary but participants must be informed of the presence of tfv in breast milk in negligible amounts exclusion criteria: * has creatinine clearance ,\<50ml/min, as estimated using the method of cockcroft and gault * has any other condition, that based on the opinion of the investigator or designee would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of the study outcome data, or otherwise interfere with achieving the study objectives
endoscopic third ventriculostomy versus ventriculo-peritoneal shunting in idiopathic normal pressure hydrocephalus

Conditions: Normal Pressure Hydrocephalus

Summary: an endoscopic third ventriculostomy is considered to be successful in idiopathic normal pressure hydrocephalus (inph) in some literature reports, but there is a lack of high quality data. the aim of the present study is to compare the treatment options of inph (endoscopic third ventriculostomy versus ventriculo-peritoneal shunt) in a randomized, controlled, multicenter study.

the traditional treatment for communicating hydrocephalus is a ventriculo-peritoneal shunt insertion and the endoscopic third ventriculostomy (etv) is reserved for patients with obstructive hydrocephalus. however, in the last decade several reports highlighted an success of an etv in communicating hydrocephalus as well. thus, the aim of the present study is to compare ventriculo-peritoneal shunting against etv in patients with an idiopathic normal pressure hydrocephalus, an subset of communicating hydrocephalus, in a randomized, controlled multicenter study.

Eligibility criteria:
inclusion criteria: * age over 50 years * gait disturbances typical for inph * symptoms duration less than 36months * exclusion of obstructive hydrocephalus * positive spinal tap-test exclusion criteria: * no informed consent * malignant disease * other diseases of the cns (parkinson, dementia) * secondary communicating hydrocephalus

Keywords: endoscopic third ventriculostomy ventricular peritoneal shunt communicating hydrocephalus
quality and outcome measurements of urological patients

Conditions: Urologic Diseases

Summary: prospectively, all available parameters of urologic patients treated at the study sites will be acquired and stored in multilayered databases. upon a given samples size, neuronal networks will be trained to define clinical endpoints. beside uro-oncological patients also patients with other urological diseases will be enrolled.


Eligibility criteria:
inclusion criteria: * all patients treated at the study sites, signed informed consent exclusion criteria: * no consent to record medical history
mode of ventilation and bleeding during transsphenoidal surgery

Conditions: Surgery

Summary: the risk of bleeding is important during transsphenoidal surgery. this study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding.

the risk of bleeding is important during transsphenoidal surgery. this study aims to find if the ventilation mode, controlled pressure and controlled volume, modifies the risk of bleeding. * group volume controlled ventilation: tidal volume of 7 ml/kg ideal body weight, frequency of 12 cycles/minute, i/e ratio of 1:2, no positive end expiratory pressure. ventilatory frequency is changed if necessary to maintain end-expiratory pressure of co2 between 35 and 40 mmhg. * group pressure-controlled ventilation: initial pressure of 15 cm h2o, frequency of 12 cycles/minute, i/e ratio of 1:2, no positive end expiratory pressure. pressure is modified to maintain a tidal volume of 7 ml/kg of ideal body weight and frequency ventilation is modified to maintain end-expiratory pressure of co2 between 35 and 40 mmhg. * in both groups, the fraction of inspired oxygen is 50%. a recruitment maneuver is performed if the blood oxygen saturation became less than 92%.

Eligibility criteria:
inclusion criteria: * aged \> 18 years * patients scheduled for transsphenoidal surgery for pituitary adenomas exclusion criteria: * pregnancy * obesity (bmi\> 35) * known respiratory disease * redo surgery * preoperative problem with hemostasis (antiplatelet or anticoagulant treatment; constitutional disorder).

Keywords: surgery transsphenoidal surgery pituitary adenoma mechanical ventilation bleeding
effectiveness of a short, intensive and standardised spa therapy for low back pain on sick leave duration

Conditions: Low Back Pain

Summary: the purpose of this study is to determine whether an intensive 5 days long multidisciplinary program (including spa therapy, exercises and patients'education) is more effective regarding return to work than usual care in subacute and chronic low back pain for people in sick leave from 4 to 24 weeks duration, and for which an extension of sick leave is considered

sick leave due to low back pain (lbp) is costly and compromises workforce productivity. sick leave itself, fears and believes regarding return to work, and a low self-esteem have been identified as independent predictors of extended sick leave. previous data suggested that multidisciplinary rehabilitation programs, including physical activities and psychobehavioral management, should decrease sick leave duration in chronic lbp. however these programs are heavy (at least 4 weeks long), and are often proposed to patients at the end of the management (over 6 months after the beginning of symptoms). another approach could be to propose a shorter multidisciplinary program (for example 5 days long), earlier in the history of lbp to break the vicious circle as soon as possible. the target population could be people suffering from subacute lbp with sick leave duration between 4 and 24 weeks.

Eligibility criteria:
inclusion criteria: * male or female aged from 18 to 60 years (included) * low back pain (or back and radicular pain with back pain the most painful) * sick leave between 4 and 24 weeks duration, without expected return to work * a prior medical evaluation is made and the results will be communicated to the patient * patient giving his informed consent to participate in the study * patient affiliated to or beneficiary of social insurance exclusion criteria: * cognition or behavioral disorders making it impossible to assess * inability to speak and write french * contra-indication to perform a short spa therapy

Keywords: subacute low back pain chronic low back pain low back pain disability education exercise spa therapy physiotherapy multidisciplinary cost-effectiveness sick leave
high-resolution intra-operative psma pet-ct in prostate cancer

Conditions: Prostate Cancer

Summary: this is a single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by prostate cancer (pca) with a risk of lymph node invasion (lni) higher than 5% and candidates for a robot-assisted radical prostatectomy (rarp) with an extended pelvic lymph node dissection (eplnd) . the aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative pet-ct-scan for intraoperative margin and lymph node invasion assessment, after 18f-psma injection, using histopathology as the gold standard.


Eligibility criteria:
inclusion criteria: 1. male patient, 18 years of age or older. 2. patient is confirmed with high risk prostate cancer. 3. patient is indicated to undergo radical prostatectomy and eplnd. 4. patient is estimated compliant for study participation by the investigator. 5. patient has freely given his/her informed consent to participate in this study. exclusion criteria: 1. patient has general or local contra-indications for radical prostatectomy. 2. patient has active viral or fungal infection. 3. patient previously received radiotherapy of the prostate. 4. patient participated in other clinical studies with radiation exposure of more than 1 msv in the past year.
acupuncture as treatment of post-herpetic neuralgia: a rct a double-blinded randomized clinical trial.

Conditions: Post Herpetic Neuralgia

Summary: the aim of this study is to perform the first rct investigating the possible effect of superficial dry-needling (sdn) - a special kind of acupuncture used for phn. the participants will be divided into two groups. group a, the intervention group will receive sdn in the area of pain. group b, the control group will receive a sham procedure.

the aim of this study is to investigate the possible effect of sdn on phn. the study population consists of patients with chronic pain after herpes zoster. the study is a controlled double-blinded randomized study. the participants will be divided into two groups, group a, the intervention group, will receive sdn in the area of pain. group b, the control group will receive a sham procedure. the procedure will take place at the out-patient clinic at odense university hospital. the plan is to include 40 patients (20 in each group).

Eligibility criteria:
inclusion criteria: * age between 50-75 years. * pain in the dermatomal area of the previous outbreak of hz. * pain located to a dermatome originating from the thoracic or lumbar spine. * at least six months since the outbreak. * understands the purpose of the study and is able to give consent. exclusion criteria: * a psychiatric illness affecting participation in the study. * active cancer * pregnancy

Keywords: post-herpetic neuralgia pain post herpetic neuralgia shingles autologous fat grafting autologous fat transplant