Kornimate/medical-research-clean huggingface dataset:
pain modulatory profiles in massage for individuals with neck pain

Conditions: Musculoskeletal Pain; Neck Pain

Summary: one in ten adults experience widespread pain. neck pain, for example, is a prevalent condition with a high rate of recurrence that affects between 10.4% and 21.3% of the population annually. massage is a common manual therapy intervention for individuals with musculoskeletal pain. however, the mechanisms of massage are not well established. also, the conditioned pain modulation (cpm) paradigm is a dynamic quantitative sensory testing measure of a pain inhibitory process in which pain sensitivity is lessened in response to a remotely applied painful stimulus. this study will evaluate the association between pain inducing massage and the conditioned pain modulation paradigm in participants with a history of neck pain.

conditioned pain modulation (cpm) is the physical manifestation of the diffuse noxious inhibitory control (dnic), an endogenous pain inhibitory pathway in which pain inhibits pain. conditioned pain modulation is less efficient in individuals with chronic pain conditions and it is a predictor for the development of chronic pain. massage is a common manual therapy intervention for individuals with musculoskeletal pain. greater changes in pain sensitivity occur following pain inducing massage suggesting a mechanism dependent upon the efficiency of the conditioned pain modulation response. previous research has indicated pain inducing massage is more effective than pain free massage suggesting a mechanism dependent upon conditioned pain modulation. the study team will evaluate the association between pain inducing massage and the conditioned pain modulation paradigm. participants with neck pain will be randomly assigned to receive a pain inducing massage, pain free massage, or a coldpressor task. pre-and post intervention pain will be assessed. the study team will determine if analgesia induced by pain inducing massage is similar to the conditioned pain modulation paradigm and if baseline conditioned pain modulation predicts responders to pain inducing massage and short term clinical outcomes in patients with a history of neck pain.

Eligibility criteria:
inclusion criteria: * currently experiencing neck pain with or without arm pain * neck pain symptom intensity rated as 4/10 or higher during the last 24 hours * neck pain for greater than or equal to 3 months exclusion criteria: * non-english speaking * systemic medical conditions known to affect sensation (e.g. diabetes, hypertension) * history of neck surgery or fracture within the past 6 months * current history of chronic pain condition other than neck pain * diagnosis of cervical radiculopathy or cervical myelopathy * history of whiplash; g) currently using blood thinning medication * any blood clotting disorder such as hemophilia * any contraindication to application of ice, such as: uncontrolled hypertension, cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, and circulatory compromise.

Keywords: conditioned pain modulation (cpm) diffuse noxious inhibitory control (dnic) massage hypoalgesia
psycho-biological substrates of therapeutic benefit of thermal cure on generalized anxiety disorders

Conditions: Generalized Anxious Disorders

Summary: multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of generalised anxiety disorders

multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of generalised anxiety disorders main objective is to quantify the therapeutic benefit of a thermal cure on generalized anxiety disorders and to understand the psycho-biological substrates of this improvement. secondary objectives: * a decrease of insula activity at rest during the answers to aversive pictures and during the task of subjective measurement of heartbeat. * a decrease of sensibility to emotional interference by subliminal presentation of emotional words thanks to a lexical task and a color recognition task associated to simultaneous measurement of physiological indicator of emotional activity ( dermal resistance)

Eligibility criteria:
inclusion criteria: * diagnostic of generalized anxiety disorder according to the diagnostic and statistical manual of mental disorders (dsm iv) * no treatment by antidepressant for at least 2 months * no treatment by anxiolytic/neuroleptic/bete blockers/antipsychotic for at least 3 weeks * global score of hamilton anxiety scale (ham-a) is greater or equal to 20 * score of ham-a symptoms greater or equal to 8 * score of hamilton depressive scale (ham-d) lower or equal to 7 * age: participants will be males and females, 18-75 years of age included. * for women, no ongoing pregnancy/ negative pregnancy test * no wounds * affiliation to a social security system (recipient or assignee) * signed written inform consent form exclusion criteria: * treatment by antidepressant for at least 2 months or a treatment by anxiolytic, neuroleptic for at least 3 weeks * psychotropic treatment (antidepressant, anxiolytic and neuroleptic) between the preinclusion and inclusion * psychotherapy during the 3 months prior to the inclusion * thermal cure during the 6 months prior to the inclusion * treatment by paroxetine for at least 1 month with dose equal or superior to 20 mg per day during the 12 months prior to the inclusion * contraindication to paroxetine * enhanced protection (minors, pregnancies women, nursing women,people deprived of liberty by administrative or judicial decision, ...) * blood donation during the 3 months prior to the inclusion

Keywords: generalized anxious disorders thermal cure paroxetine
effects of vibration training on exercise capacity in copd-patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to investigate the exercise capacity in copd-patients performing a vibration training additional to a standard three-week rehabilitation program in comparison to patients performing merely a rehabilitation program.


Eligibility criteria:
inclusion criteria: * chronic obstructive pulmonary disease iii/iv exclusion criteria: * severe exacerbations in the last 4 weeks prior to begin of study (definition of exacerbation: symptoms on more than 3 days with a relevant change in drug therapy (cortisone, antibiotics)) * severe disease other than copd, that could influence the results of the study * abuse of alcohol or drugs * simultaneously participation in another study * tachypnea (\>30/min) * severe exacerbation during rehabilitation * cardiac insufficiency (nyha iv) * myocardial infarction during the last 6 weeks * mental-health problem * pregnancy * known hiv-infection * slipped disk * acute discopathy * acute thrombosis * implants in trained regions of the body (lower extremities) * acute inflammation of the locomotor system, active arthrosis or rheumatoid arthritis * acute tendinopathy in trained regions of the body * acute hernia * fresh fractures, wounds or scars in trained regions of the body * gallstones or stones in the urinary tract collection system

Keywords: copd iii/iv 6-minutes-walking-distance vibration training galileo pulmonary rehabilitation
characterization of left atrial substrate in patients with ventricular arrhythmias

Conditions: Atrial Remodeling

Summary: the goal of this observational study is to analyze the characteristics of left atrial electroanatomical maps in patients without a history of atrial fibrillation but with a high clinical risk of developing it, as indicated by the presence of structural heart disease or a cha2ds2-vasc score ≥ 2 points. the study cohort will be compared to a historical cohort of patients with diagnosed atrial fibrillation in a propensity-matched fashion. the main questions it aims to answer are: * are the left atrial electroanatomical changes a consequence or a precursor to the development of atrial fibrillation? * are the left atrial electroanatomical findings different between patients with atrial fibrillation and those at high risk of developing it? * what is the prognostic impact of left atrial pathologic changes in patients without diagnosed atrial fibrillation in terms of cardiovascular outcomes?


Eligibility criteria:
inclusion criteria: * absence of a prior history of atrial fibrillation or flutter. * patients presenting for ablation of any ventricular tachycardia related to structural heart disease or any ventricular arrhythmia with a cha2ds2-vasc score ≥ 2. exclusion criteria: * presence of thrombus in the left atrial appendage. * complications related to the index procedure. * insufficient quality of the left atrial electroanatomical map.
comparative study of safety and efficacy of heavyweight and partially absorbable mesh in inguinal hernia repair

Conditions: Hernia, Inguinal

Summary: proflex® mesh (partially absorbable mesh, korea) and marlex® mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up.


Eligibility criteria:
inclusion criteria: 1. male patients \>=20 years =\<85 years old 2. patients with unilateral hernia 3. patients without previous operations in lower part of abdomen 4. patients capable to understand the explanation about purpose and method of the trial, and write an informed concent form 5. patients capable to participate during the period of the trial exclusion criteria: 1. previous hernia repair at the same site 2. incarcerated hernia 3. strangulated hernia 4. patients to whom and open surgery cannot be indicated 5. previous urological surgery 6. immune incompetence of patient: aids, vesical fibrosis, etc. 7. patients with aihd or patients who take immunosuppressive drugs 8. patients with liver disease (asl, ast ≥ normal value by more than 3 times) 9. patients with kidney disease (creatinine\>2.0mg/dl) 10. patients on anti-coagulants 11. patients with severe systematic disease 12. patients with malignant tumor 13. patients with infection or with the predicted problem of surgery site healing 14. participation in another clinical study within the last 30 days 15. patients whose participation is considered inappropriate according to other except above mentioned clinical condition
tachosil® versus surgicel® original for the secondary treatment of local bleeding in adult and pediatric patients undergoing hepatic resection surgery

Conditions: Hemorrhage

Summary: the efficacy and safety of tachosil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard usa licensed hemostatic agent, surgicel® original. hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment.


Eligibility criteria:
inclusion criteria: * resection of at least the equivalent tissue volume of 1 anatomical segment of the liver * minor to moderate (oozing/diffuse) bleeding from the resection area persisting after conventional resection procedure and primary control of arterial pulsating bleeding or major venous hemorrhage by sutures, ligations, clips, vascular stapler, point electrocautery or focal radiofrequency ablation * need for additional supportive hemostatic treatment * expected ability to lightly press the trial treatment to the liver resection wound for 3 minutes exclusion criteria: * indication for emergency surgery * known coagulopathy (as judged relevant by the investigator) * known or suspected hypersensitivity to any ingredient of the investigational medicinal products (e.g. human fibrinogen, human thrombin and/or collagen of any origin) * patient unwilling to receive blood products * known current alcohol or drug abuse * pregnancy, breastfeeding, no use of acceptable contraceptive method in females of childbearing potential * dry surgical field of the targeted application area * occurrence of any serious surgical complication * disseminated intravascular coagulopathy (dic), i.e. microvascular bleeding * application of topical hemostatic material on the liver resection wound * radiofrequency precoagulation of the liver resection wound except focal radiofrequency ablation of vessels as primary hemostatic treatment

Keywords: liver resection liver transplantation liver surgery secondary hemostasis
providing standardized consented proms (patient reported outcome measures) for improving pain treatment

Conditions: Pain, Postoperative

Summary: prompt aims at improving management of acute and chronic pain by identifying a core set of proms (patient reported outcome measures) that are predictive indicators of treatment success in clinical practice and controlled trials. these will not only address pain intensities as well as the functional consequences of pain for individuals but also identify patients at risk of experiencing chronification of acute post-operative pain. results will help health care professionals to individualize pain management, and thus improve the quality of life of pain patients.

in order to reach this objective, a non-interventional prospective data collection aiming at reaching a consensus on a core set of proms which reliably predict and/or measure success in acute and chronic pain treatments in real life conditions and identifying predictors for chronification of postoperative pain will be conducted (prompt nit-1). aim of the data collection is to evaluate the abilities of certain proms in assessing acute post-surgical pain outcomes in daily routine care of patients after four different surgical procedures: (total knee replacement, breast surgery, sternotomy and surgery related to endometriosis), and to validate selected risk factors for chronification prospectively.

Eligibility criteria:
inclusion criteria: * patient is of consenting age (\>18 years old) * elective surgery * planned stay in hospital for the surgery * first contact with the patient before surgery * patient agrees to participate exclusion criteria: * patient is unable to give consent * cognitive impairment * questionnaire is not available in a language the patient is fluent in * patient not willing to answer the follow-up questionnaire

Keywords: acute pain chronification of pain pain treatment pain management postoperative pain
cervical cord compression and hypertension

Conditions: Hypertension

Summary: myelopathy from cervical cord compression may induce hypertension and sympathetic hyperactivity. anesthesia may suppress sympathetic activity and lead to hypotension that require vasopressor treatment. we aim to elucidate the causative factors for severe hypotension during anesthesia by prospective observational study.

it had been reported the cervical spondylotic myelopathy may lead to the development of hypertension. decompression surgeries ameliorated neurological symptoms as well as the blood pressure. the cause may be the abnormality of autonomic dysfunction developed after myelopathy. however, the evidence was weak. we have noticed a tendency of hypotension during anesthesia in patients undergroing cervical spine surgeries, especially in surgeries of long levels and hypertensive patients. thus we postulate the autonomic activity is abnormal in patients with cervical myelopathy. sympathetic hyperactivity developed in order to maintain adequate perfusion to the cervical cord. when patients are under anesthesia, the sympathetic tone is suppressed, thus leading to severe hypotension that require the treatment of inotropic treatment. heart rate variability (hrv) is a good index of autonomic activity. thus we plan to therefore we will measure the hrv (analysis of ecg) and baroreflex activity (analysis of arterial line during the anesthesia) in patients undergoing cervical spine surgeries for decompression of cord compression perioperatively. the primary end-point is the comparison of severity of cord compression between normotensive and hypertensive patients with cervical myelopathy. the secondary end-point is to compare blood pressure and hrv pre- and postoperatively. the third end-point is to elucidate the causative factors for severe hypotension during anesthesia.

Eligibility criteria:
inclusion criteria: * cervical spine surgery for cord compression exclusion criteria: * spinal cord injury * asa class \>3 * chronic kidney disease * congestive heart failure * bmi\>30 * atrial fibrillation/ flutter * obstructive sleep apnea

Keywords: heart rate variability cervical myelopathy blood pressure decompression
thymoglobulin induction therapy in kidney transplantation (6mg/kg vs 4mg/kg)

Conditions: Kidney Failure

Summary: this is a prospective randomized controlled study to evaluate feasibility and safety of early steroid withdrawal after 6mg/kg vs 4.5mg/kg thymoglobulin induction therapy in kidney transplantation. patients are enrolled from june, 2015 for 24 months. they are randomized to either 6mg/kg or 4.5mg/kg thymoglobulin induction group. steroid withdrawal is done within one week after kidney transplantation for all the patients. maintenance immunosuppressants are tacrolimus and mycophenolate mofetil (or myfortic). primary outcome is a composite of biopsy-proven acute rejection, delayed graft function, graft loss or death within one year post transplant.


Eligibility criteria:
inclusion criteria: * male or female patients with renal failure from 18 to 70 years of age * candidates for cadaveric or living donor kidney transplantation * patients who are able and willing to consent the protocol of the study exclusion criteria: * patients who have been receiving immunosuppressive therapy before transplantation * patients who have received an investigational medication within the past 30 days * patients who have a known contraindication to the administration of antithymocyte globulin * patients who are suspected or known to have an infection or were seropositive for hepatitis b surface antigen (hbsag), antibody against hepatitis b core antigen (anti-hbcag), hepatitis c virus (hcv), or human immunodeficiency virus (hiv) * patients who have had cancer (except non melanoma skin cancer) within the previous 2 years * pregnant women, nursing mothers, and women of childbearing potential who were not using condoms or oral contraceptives
autologous slings with vesico-vaginal fistula repair

Conditions: Vesicovaginal Fistula

Summary: it is clear from multiple accounts in the literature that patients with a vesico-vaginal fistula (vvf) involving the bladder neck and/or proximal urethra have a high likelihood of residual incontinence. performing subsequent surgeries after the initial vvf repair risks additional complications. therefore, placement of an autologous sling at the time of initial vvf repair would not only assist in covering the fistula, but would also imitate the physiologic support that would theoretically improve urethral function. a rectus fascia sling would most naturally provide this support and warrants testing against the success of the pc sling. using the goh scoring criteria, goh class 3 and 4 vvf's are the type most involving the urethra. therefore, this group of patients is the target population for this study. as there is currently no standard of care for repairing large urethral defects, this procedural technique combined with otherwise standardized fistula repair would not introduce any foreseeable harm to patients.


Eligibility criteria:
inclusion criteria: * women with vesico-vaginal fistulas classified as goh 3 or 4 at the time of surgery * patients who have consented for an autologous sling * patients who have not previously undergone repair attempt exclusion criteria: * patients who require an abdominal approach to the vvf repair * patients found at surgery not to have a goh 3 or 4 class vvf * patients requiring a complete urethral reconstruction * patients who have undergone previous attempt at repair * patients who require an alternative tissue grafting other than the rectus fascia or pubbococcygeus decided by the surgeon at the time of surgery

Keywords: obstetric fistula, anti-incontinence techniques
dotatate petmri aaa study

Conditions: Abdominal Aortic Aneurysm

Summary: abdominal aortic aneurysm (aaa) screening and an aging population have increased the prevalence of aaa diagnoses. small aaas (\<5.5cm) are monitored with ultrasound. large aaas may rupture and this is usually fatal. surgery is considered at a crude size threshold of 5.5cm when the annual rupture risk reaches 5%. aaa size is the only predictor of growth and rupture available but growth is non-linear and some small aaas rupture. thus, only 1 in 20 patients treated at 5.5cm will have benefited from rupture prevention in the year following surgery, and others may miss out on life-saving surgery. this study will develop an imaging tool petmri with radiotracer ga- dotatate with high clinical utility, to improve prediction of aneurysm growth and risk.

the prevalence of abdominal aortic aneurysm (aaa) in those over 65 years is 4-8% and rising. currently, aaa size is the only metric to determine risk of growth/rupture; we are unable to image the underlying disease process. using size alone is problematic. for small aaas there is no consensus between surgical societies on appropriate surveillance intervals. aaa growth is non-linear and thus some small aaas may rupture between screening intervals. macrophage mediated inflammation leads to weakening of the aortic wall. our own laboratory work indicates macrophages correlate with aaa severity in mice. in humans, activated macrophages express somatostatin receptor 2 (sstr2). for the first time ever, using a radiotracer probe specific for sstr 2 (gallium-dotatate), we will detect activated macrophages in aaas using positron emission tomography- magnetic resonance imaging (pet-mri). patients attending the university health network (uhn) vascular clinic undergoing ultrasound surveillance of small aaas of differing sizes will be imaged with ga-dotatate pet-mri. we will correlate aneurysm size and anatomical information with in-vivo imaging of aortic macrophages detected with ga-dotatate, to determine the risk of aneurysm growth.

Eligibility criteria:
inclusion criteria: 1. diagnosis of asymptomatic abdominal aortic aneurysm aaa \>3cm in maximum diameter; 2. minimum 2 years prior ultrasound or ct imaging of their aaa; 3. no prior treatment for aaa; 4. age \>50 years; 5. no contraindications to pet/mri, such as claustrophobia; exclusion criteria: 1. pregnant females. all women of child-bearing potential must receive a negative urine pregnancy test prior to administration of 68ga-dotatate; 2. allergy and/or hypersensitivity to mri contrast agents (gadolinium) or components of 68ga-dotatate drug product (as listed in ib); 3. presence of pacemaker or implanted cardioverter defibrillator (icd); 4. history of alcohol or substance abuse.