Kornimate/medical-research-clean huggingface dataset:
effectiveness of percutaneous lumbar epidural adhesiolysis and neurolysis on low back pain

Conditions: Low Back Pain

Summary: clinically significant improvements in the percutaneous adhesiolysis patients with hypertonic neurolysis compared to those patients randomized to the control group who did not receive adhesiolysis and hypertonic saline neurolysis. improvement will be assessed in relation to the clinical outcome measures of pain and function. improvements among patients with adhesiolysis and hypertonic saline neurolysis and compare to control group. compare adverse event profile in both groups

patients with chronic low back pain and lower extremity pain secondary to spinal stenosis or post lumbar laminectomy syndrome, non responsive to conservative therapy with physical therapy or chiropractic and medical therapy and fluoroscopically directed epidural steroid injections. single-center, prospective, controlled, double blind, randomized study. if non-responsive or at patient's request, the patient may be unblinded anytime after 3 months, and will be offered adhesiolysis and hypertonic saline neurolysis if the patient was in the control group. all patients will be unblinded at 24 months.

Eligibility criteria:
inclusion criteria: * over 18 years of age * history of chronic, function limiting low back pain of at least 6 months in duration * able to give voluntary, written informed consent * able to understand investigational procedures and willing to return for follow-ups * no recent surgical procedures within last 3 months exclusion criteria: * large contained or sequestered herniation * cauda equina symptoms and/or compressive radiculopathy * narcotic use of no greater than 100mg/day hydrocodone, 60mg methadone, or 100mg morphine * uncontrolled major depression or psychiatric disorder * uncontrolled or acute medical illness * chronic sever conditions that could interfere with outcome assessments * women who are pregnant or lactating * subjects who have participated in a clinical study with an investigational product within 30 days of enrollment

Keywords: post-lumbar surgery syndrome percutaneous lumbar epidural adhesiolysis hypertonic saline neurolysis
percutaneous pinning versus plate and screws for surgical fixation of proximal humeral fractures

Conditions: Proximal Humeral Fractures

Summary: the aim of this multicenter nonrandomised study is to prospectively compare the clinical and radiographic results of two different techniques of surgical fixation of proximal humeral fractures: percutaneous pinning versus plate and screws.


Eligibility criteria:
inclusion criteria: * \&gt; 18 year old * proximal humeral fracture * both x-rays and ct scan available exclusion criteria: * dementia * psychiatric disease
effect of topical corticosteroids on dysphagia in anterior cervical discectomy and fusion

Conditions: Cervical Disc Herniation; Cervical Degenerative Disc Disease; Cervical Spondylotic Myelopathy; Dysphagia; Osteoarthritis of Cervical Spine

Summary: the purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following anterior cervical discectomy and fusion surgery.

background: dysphagia is a serious post-operative concern in patients following anterior cervical surgery. although many experts have acknowledged that dysphagia is often incompletely understood and defined, there is a significant amount of literature to support the significance of this clinical entity. this is the first randomized study to examine the use of topical steroids for the prevention of dysphagia postoperatively after anterior cervical discectomy and fusion. study design: this study is a single site, double blinded randomized control trial. all individuals undergoing 2-4 level acdf that meet the inclusion criteria will be randomized to either: 1. treatment arm or 2. control arm. both arms will undergo their planned surgeries and will receive the exact same procedure and standard of care as if they were not enrolled in a study. the only difference is that the treatment arm will receive 40 mg of methylprednisolone acetate delivered with one hemostatic matrix kit injectable delivery vehicle prior to closure in the prevertebral soft tissues. the control group will receive only hemostatic matrix kit prior to closure in the prevertebral soft tissues. outcomes: patients will be asked to fill out questionnaires that assess dysphagia, general swallowing difficulty, and how neck pain impacts their quality of life. additionally radiographic images will be obtained at set time points to evaluate soft tissue inflammation and bony fusion.

Eligibility criteria:
inclusion criteria: * any patient \> 18 years undergoing a 2-4 level anterior cervical discectomy and fusion exclusion criteria: * patients undergoing revision surgery * pediatric patients * trauma patients with cervical spine fractures * patients with cancer * patients with active infection * patients with a known allergy to methylprednisolone acetate * patients who refuse to participate * non english speakers

Keywords: anterior cervical discectomy and fusion dysphagia acdf
evaluation of cognitive and motor neurological disorders in the short and long term after surgery for the removal of a diffuse low-grade glioma of the supplementary motor area

Conditions: Cognitive Disorders; Motor Disorders; Low-grade Glioma

Summary: background : the supplementary motor area is the most common/preferential brain location of lgg. this area plays an important role in many motor and cognitive functions such as motor initiation, bimanual coordination and executive functions. many studies describe the supplementary motor area syndrome resulting from lesions in this area. news managements for lggs consisting in intraoperative mapping in awake patients reduce significantly neurological disorders and increase also the overall survival . however, the literature does not provide data concerning motor and cognitive functions in a long term and their consequences in the quality of life of patients. objective : the aim of our research project is to identify whether there are some motor or neurocognitive deficit in the short and the long term in a population of patients who have medical story of lgg resection in the supplementary motor area.

patients and methods : 20 patients who have medical story of lgg in the supplementary motor area and 20 patients who have medical story of lgg resection in other locations are recruited. firstly, patients have to complete a self-assessment questionnaire about their quality of life, sent by regular mail or e-mail. then, patients are admitted on the same day as their follow up visit and underwent motor and neurocognitive screening tests ( "bilan des 400 points", tests of attentional performances) for an hour. the investigators will analyse data and compare between the 2 groups.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * have a history of low-grade diffuse glioma resection * visiting the university hospital for a follow-up neurosurgical consultation * underwent awake surgery exclusion criteria: * presence of cognitive disorders that do not allow the proposed test battery to be performed * under guardianship or curatorship * opposition to the participation to the research

Keywords: glioma supplementary motor area neurological disorders
vitamin c and tyrosine kinase inhibitor in lung cancer patients with epidermal growth factor receptor mutations

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this trial was to explore whether intravenous vitamin c can prolong resistance time of tyrosine kinase inhibitor(tki) on lung adenocarcinoma patients with epidermal growth factor receptor(egfr) mutations, and can benefit nsclc patients.

the effects of vitamin c in combination with tyrosine kinase inhibitor on tumor size, tumor markers, inflammatory factor levels, quality of life, duration of resistance, progression-free survival, and overall survival time were evaluated. this trial is a low risk treatment, and has developed the appropriate safety measures and contingency plans to ensure patients' safety in the whole process. patients will be followed up after the end of the trial, and follow-up observations will be performed every month during the first year. followed every 3 months in the second year for 3 years.

Eligibility criteria:
inclusion criteria: * primary non-small cell lung cancer (adenocarcinoma) with egfr mutations on exons 19 and 21. * 18 years old to 75 years old. * during the trial, patients were prescribed tki drugs(received initial treatment within 2 months, or change medication within 2 months) and did not receive chemotherapy or radiotherapy at the same time. * eastern cooperative oncology group (ecog) performance status are 0 to 2. * expected survival over 3 months. * household registration is guangdong province. exclusion criteria: * co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), and uncontrolled blood sugars of greater than 300 mg/dl, known chronic active hepatitis or cirrhosis. * glucose-6-phosphate dehydrogenase deficiency (g6pd) (a relative contraindication). * patients who are allergic to vitamin c. * patients with hiv and other infectious diseases. * patients who are taking anticoagulants and have coagulopathy; * combine dysfunction of important organs such as heart, lung, liver and kidney; * patients with impaired renal function (serum creatinine content \> 1.2 mg/dl) * compromised liver function with evidence of serum total bilirubin content, serum alanine aminotransferase(alt) and aspartate transaminase(ast)\> 2 times normal reference value. * pregnant or lactating female. * smoking and alcohol abuse patients; * anti-infective treatment is required for systemic or localized serious infections; * patients with hyperuricacidemia (normal: 91-456 μmol / 24h (8-40mg / 24h)); * wilson's disease. * evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent. * any condition that impairs the patients' ability to swallow, which impairs drug absorption or drug kinetic parameters, including any kind of gastrointestinal resection or surgery; * history of surgery of visceral organs within 6 weeks before the study.

Keywords: tyrosine kinase inhibitor vitamin c non-small cell lung cancer progression-free survival overall survival
study evaluating a new ostomy appliance with regard to leakage, handling and comfort

Conditions: Colostomy

Summary: the objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to sensura.

peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems. to protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. coloplast has developed a new ostomy appliance to improve the feeling of security and increase comfort by the appliance characteristics. the objective of this investigation is to evaluate leakage, handling and comfort of a new ostomy appliance compared to sensura. the study is a randomised controlled cross-over intervention study, where all study participants will test two test products (new ostomy appliance and sensura). each test period will last 10 ± 2 days and the subjects will follow their usual wear and change pattern. the participants will visit the study investigator at study start and at cross-over. evaluation of the test products will occur via questionnaires the subjects fill in at home. 50 healthy subjects with a colostomy will be included in the study.

Eligibility criteria:
inclusion criteria: * have given written informed consent * be at least 18 years of age and have full legal capacity * be able to handle the bags themselves (application, removal) * have a colostomy with a diameter less than 45 mm * have had a colostomy for at least 3 months * currently use a 1-piece flat ostomy appliance with closed bag * is suitable for treatment with a standard adhesive, flat base plate (evaluated by nurse) * use minimum 1 product per day * be willing to test a new coloplast one-piece custom cut ostomy appliance size midi or maxi for 10 days and sensura (1- piece open ostomy bag custom cut ostomy appliance) size midi or maxi for 10 days * have the mental capacity to understand the study and questionnaires exclusion criteria: * use irrigation during the study (flush the stoma with water). * currently suffering from peristomal skin problems (i.e. bleeding or red and broken skin) * currently receiving or have within the last 2 months received chemotherapy or radiation therapy * currently receive or have within the past three weeks been receiving steroid medication in the peristomal area. * are pregnant or breastfeeding
renal sympathetic denervation as an a adjunct to catheter-based vt ablation

Conditions: Ventricular Tachycardia

Summary: despite significant advances in the management of ventricular arrhythmias through the use of icd therapy, aads, and catheter-based ablation strategies, considerable challenges remain. the optimal method for the prevention of recurrent vt following catheter ablation remains unclear. rsdn may be an effective tool for preventing ventricular arrhythmias, and associated icd therapies, by reducing central sympathetic tone, catecholamine levels, and the renin-angiotensin- aldosterone system and promoting ventricular remodeling. although rsdn has been shown to reduce the recurrence of vt in a case report of 2 patients suffering from electrical storm, to date no large prospective randomized study has evaluated the impact of rsdn in the prevention of recurrent vt in patients following catheter ablation of vt with ischemic or non-ischemic ventricular dysfunction. this study will specifically evaluate the safety and efficacy of adjunctive rsdn in the prevention of icd therapy in patients with ischemic or non-ischemic ventricular dysfunction who are to receive a catheter-based vt ablation.

the goal of this trial is to test the impact of catheter-based renal sympathetic denervation (rsdn) as an adjunctive treatment for patients with either ischemic or non-ischemic cardiomyopathy undergoing catheter ablation of ventricular tachycardia (vt). the proposed study is a prospective, multicenter, randomized control trial. patients undergoing vt ablation will be randomized to either vt ablation alone or vt ablation + rsdn.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * structural heart disease (post-mi, dilated cardiomyopathy, sarcoid myopathy, hypertrophic cardiomyopathy, chagas-related cardiomyopathy, etc.) * planned for catheter-based ablation of vt * all patients will have an existing icd * accessibility of renal vasculature (determined by renal angiography) * ability to understand the requirements of the study * willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements exclusion criteria: * mi or cva within 30 days * coronary artery bypass graft (cabg) within 30 days of this procedure * known renovascular abnormalities that would preclude rsdn (eg, renal artery stenosis) * gfr \<30 ml/min (unless receiving dialysis) * life expectancy \<1 year for any medical condition * any condition resulting in a contraindication to anticoagulation (e.g. gi bleeding) * inability to give informed consent * known pregnancy or positive -hcg within 7 days of procedure.

Keywords: tachycardia, renal sympathetic denervation catheter ablation cardioverter-defibrillator
study of the cleavage of the egg in relation to the stimulation treatment

Conditions: Female Infertility

Summary: this post-marketing, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.


Eligibility criteria:
inclusion criteria: 1. ivf/icsi treatment 2. regular cycles of 25-35 days 3. follicle stimulation with bravelle and/or menopur 4. women aged 38-35 years 5. long agonist or short antagonist treatment 6. willing and able to understand a danish, english or german patient information form 7. willing and able to provide written informed consent exclusion criteria: 1. bmi more than 35 2. presence of hydrosalpinx on ultrasound 3. fsh more than 13 or antral follicle count (afc) less than 4 at fertility investigation 4. known allergic reactions to the planned medications 5. use of testicular sperm
an integrated treatment for comorbid ptsd and substance abuse in adolescents

Conditions: Substance Abuse; Traumatic Stress

Summary: this study plans to develop an integrated treatment for comorbid post-traumatic stress disorder (ptsd) and substance abuse (sa) in adolescents. the investigators aim to develop a treatment approach that is community-friendly, well-tolerated, and deliverable by substance abuse counselors (sac) in outpatient settings. the proposed trauma-focused substance abuse treatment (tfsat) aims to reduce ptsd symptoms and substance use and build coping skills. the investigators propose to adapt an evidence-based trauma program, cognitive-behavioral intervention for trauma in schools (cbits), for adolescent substance abusers (asabusers); to assess the acceptability and feasibility of the integrated approach; and to pilot test the new program against standard care. the investigators hypothesize that the intervention group, compared to the control group, will reduce substance use and symptoms for traumatic stress.


Eligibility criteria:
inclusion criteria: youth * between ages of 13 \& 19; * meeting dsm iv criteria for substance abuse/dependence and ptsd; * previously enrolled at recruitment site for at least 2 weeks; * parent/guardian provides permission for minors to participate. exclusion criteria: youth * not within the specified age range; * presence of organic brain damage; * inability to understand enrollment forms (e.g. informed assent/consent form) inclusion criteria: parents/guardians * age 18 or above; * parents/guardians of youth who meets inclusion criteria. exclusion criteria: parents/guardians * presence of organic brain damage.

Keywords: substance abuse traumatic stress
a phase i clinical trial to evaluate the ebola adenovirus vector vaccine (ad5-ebov) in healthy adults.

Conditions: Ebola Virus Disease

Summary: since its first outbreak occurred in 1976, zaire ebola virus have been associated with 14 outbreaks reported up to 2014. the zaire ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with gp homology of the gene was only 97.6%, compared to the gp gene of the strain in 1976. this investigational ad5-ebov vaccine was developed according to the 2014 epidemic zaire strain and formulated as freeze-dry products which could be stored at 4℃. this is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. this study will determine the safety and side-effect profile, and immunogenicity of an investigational ad5-ebov vaccine.


Eligibility criteria:
inclusion criteria: * aged between 18 and 60 years. * able to understand the content of informed consent and willing to sign the informed consent * able and willing to complete all the secluded study process during the whole study follow-up period (about 6 months). * a body mass index (bmi) \<35 * hemoglobin 110-150g/l for female, and 120-160g/l for male. * white blood cells (wbc) 4.0-10.0×109 cells/l * total lymphocyte count 0.8-4.5×109 cells/l * platelets 100-300×109 cells/l * alanine aminotransferase (alt) 0-40u/l * serum creatinine 44-106μmol/l * partial thromboplastin time (ptt) 20-40 seconds * prothrombin time (pt) 10-14 seconds * negative in hiv diagnostic blood test * axillary temperature ≤37.0°c on the day of enrollment * general good health as established by medical history and physical examination. exclusion criteria: * family history of seizure, epilepsy, brain or mental disease * subject that has a medical history of any of the following: allergic history of any vaccination or drugs, or allergic to any ingredient of the ad5-ebov vaccine, such as mannitol * woman who is pregnant, breast-feeding or positive in β-hcg (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months * any acute fever disease or infections in last 7 days * major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease * hereditary angioneurotic edema or acquired angioneurotic edema * urticaria in last one year * asplenia or functional asplenia * platelet disorder or other bleeding disorder may cause injection contraindication * faint at the sight of blood or needles. * prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months * prior administration of blood products in last 4 months * prior administration of other research medicines in last 1 month * prior administration of attenuated vaccine in last 1 month * prior administration of inactivated vaccine in last 14 days * current anti-tuberculosis prophylaxis or therapy * any condition that in the opinion of the investigators may interfere with the evaluation of study objectives

Keywords: safety,immunogenicity,ebola
traditional vs. graft-augmented posterior colporrhaphy

Conditions: Pelvic Organ Prolapse; Posterior Vaginal Wall Defects

Summary: women who undergo posterior colporrhaphy with graft augmentation will have a lower recurrence of their posterior wall defect than women who undergo a traditional posterior colporrhaphy.

the traditional approach to surgical repair of posterior wall defect is the posterior colporrhaphy. although this technique has been successful in the anatomic correction of the defect, the functional outcomes have been disappointing. this fact suggests improvement in the functional and anatomic outcomes following a traditional posterior colporrhaphy. consequently, the idea of incorporating graft material into the repair to augment the patient's own tissue has been examined. placing a piece of graft material in between the vagina and rectum adds an extra layer of support and thus augments the strength of the repair. the purpose of this study is to evaluate the anatomic and functional outcomes of posterior compartment, graft-augmented traditional posterior colporrhaphy vs. traditional posterior colporrhaphy alone.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * posterior wall defect with point ap or bp at 0 or greater * desires surgical correction * willing to accept randomization to graft vs. no graft * competent to sign an informed consent * completed childbearing * non-pregnant exclusion criteria: * current anal sphincter disruption with planned incontinent surgical repairs * poor surgical candidate * history of rectal cancer or inflammatory bowel disease * current rectovaginal * history of vaginal cancer * history of vaginal/pelvic radiation * foreshortened vagina * previous adverse reaction to xenform matrix graft material

Keywords: pelvic organ prolapse posterior wall defects graft-augmented repair posterior colporrhaphy