Kornimate/medical-research-clean huggingface dataset:
evaluating therapeutic massage for chronic neck pain

Conditions: Neck Pain; Cervicalgia

Summary: this study will provide the basis for a full-scale trial to evaluate the effectiveness and safety of therapeutic massage for chronic neck pain (cnp).

neck pain is one of the most common problems affecting the health of americans and is a leading reason for using complementary or alternative medical (cam) therapies. therapeutic massage is one of the most popular cam treatments for neck pain, but little is known about its effectiveness. this study will lay the groundwork for a full-scale trial that evaluates the effectiveness of therapeutic massage for chronic neck pain. the study will involve two phases. during phase i, researchers will develop and pre-test key components for a randomized clinical trial. in phase ii, the safety and efficacy of massage for cnp will be evaluated. the changes in symptoms, function, and quality of life in massage and self care groups will be evaluated midway through treatment, at the end of treatment and at 6 months post randomization.

Eligibility criteria:
the inclusion and exclusion criteria will be developed through consultation with a medical expert on neck pain and several massage consultants

Keywords: neck pain cervicalgia massage
ketoacid analogues intradialytic effect on inflammation

Conditions: Hemodialysis Complication

Summary: this study tries to measure the effect of intradialytic ketoacid analogues on inflammatory parameters

this study will measure inflammation parameters: * interleukin 6 * malnutrition inflammation score * neutrophil lymphocyte ratio * monocyte lymphocyte ratio * thrombocyte lymphocyte ratio the duration of intervention is 12 weeks

Eligibility criteria:
inclusion criteria: * patient who undergo hemodialysis two times a week exclusion criteria: * travelling hemodialysis * acute conditions * hiv patient * acute infection * stroke and immobilized patient

Keywords: ketoacid analogues inflammation hemodialysis
endoscopic cyanoacrylate obliteration vs. nadolol treatment in the prevention of gastric variceal rebleeding

Conditions: Liver Cirrhosis and Hepatoma.; Gastric Variceal Bleeding

Summary: gastric variceal bleeding has a very high rebleeding rate even after endoscopic variceal injection of cyanoacrylate (gvo) which is considered the first choice of endoscopic treatment. beta-blocker (bb) is effective to lower portal pressure. we hypothesized combination of gvo and bb can further decrease the rebleeding rate.

gastric varies (gv) rarely rupture. however should it occur, the outcome would be worse than rupture of esophageal varies (ev). rupture of gv is characteristic of a higher rebleeding rate, a requirement for a larger amount of blood transfusion and a higher mortality. up to date, the treatment of gv bleeding (gvb) is still sub-optimal in contrast to the treatment of ev bleeding. the management of gv has been focused on treatment of acute gvb. various specific methods are used to control gvb and prevent rebleeding; however they were far from ideal. it is because gv are usually larger vessels formed in deeper submucosa and connect to the spontaneous gastrorenal shunt which creates a fast blood flow. therefore, voluminous blood in the larger diameter gv leads to exsanguine bleeding when ruptured. a variety of endoscopic methods, which include injection of sclerosants, tissue adhesive (cyanoacrylate), thrombin and ligation with rubber bands, detachable nylon loop and steel snares, are applied to control acute gv bleeding with variable successful rates (50\~100%) and rebleeding rates (20\~90%). the successful rate of endoscopic cyanoacrylate injection to arrest active gvb is more consistent around 90\~100% and rebleeding rate is around 30\~40%. the recent international consensus meeting endorsed that endoscopic cyanoacrylate injection is the first line treatment for acute gvb. the embolic complications, either septic \& aseptic, are not uncommon. expertise is also required to reduce the embolic complications and instrumental injuries. therefore, the efficacy of specific treatment for gvb is sub-optimal, consecutive innovation of new methods are required to improve the prognosis of gvb. non-selective beta-blocker is effective to reduce rebleeding from esophageal varices. however, its effect on gastric variceal hemorrhage has never been proven. this is an important issues prompted by current portal hypertension experts. we have much experience in the treatment of gastric variceal bleeding and published fruitful results in high ranking journal. therefore, we design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the secondary prevention of acute gastric variceal bleeding.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of liver cirrhosis and/or hcc, endoscopically proven gastric variceal bleeding exclusion criteria: * younger than 18 y/o or older than 80 y/o, terminal illness, other major systemic disease or malignancy
real-life use of transabdominal restorelle® meshes in apical prolapse repair

Conditions: Genital Prolapse

Summary: the purpose of this study is to prospectively follow patients after a sacrocolpopexy with restorelle® mesh for apical prolapse repair as part of routine care. it will help to describe the safety profile and to confirm the clinical benefits of restorelle mesh for at least 5 to 8 years post-surgery.

this study is a non-interventional, multicenter and post market clinical follow-up in adult women with apical prolapse under normal conditions of use (after a sacrocolpopexy with restorelle mesh for apical prolapse repair as part of routine care). the patient will be followed for 1 year (or less) by the investigator as per local usual practice. at the same time, the patient will be followed via pro (patient reported outcomes) over a period of 5 to 8 years.

Eligibility criteria:
inclusion criteria: * female patient of at least 18 years old * patient presenting apical pelvic organ prolapse and being eligible to surgical treatment * surgeon having decided to treat the patient with a restorelle mesh as per its ce mark indication and ifu, before patient inclusion * patient having received appropriate information and counselling before mesh implantation * patient has been provided written informed consent exclusion criteria: * patient currently pregnant or breastfeeding * patient being deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection

Keywords: apical prolapse transabdominal mesh pelvic organ prolapse sacrocolpopexy sacrocervicopexy sacrohysteropexy
nociceptors, neurotrophic factors and cytokine expression in gastroesophageal reflux disease

Conditions: Gastro-esophageal Reflux Disease

Summary: transient receptor potential vanilloid-1 (trpv1) receptor and proteinase-activated receptor 2 (par2) have been implicated in the mechanism of acid induced inflammation in gastroesophageal reflux disease (gerd). we aimed to evaluate trpv1 and par2 mrna expression levels in the gerd patients and their relationship with endoscopic findings and reflux symptoms.

all the subjects receive upper gi endoscopy and completed questionnaires about gerd symptoms under the supervision of a well-trained interviewer. subjects are excluded if there was a history of gastrointestinal surgery, barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and if he or she had any history of systemic disease requiring chronic medication (except for hypertension and diabetes mellitus). the subjects are classified into 3 groups after upper gi endoscopy and completing questionnaires about gerdsymptoms ; erd(erosive reflux disease), nerd(nonerosive reflux disease) and control group.

Eligibility criteria:
inclusion criteria: * subjects who completed upper gi endoscopy and questionnaires about gerd symptoms exclusion criteria: * a history of gastrointestinal surgery * barrett's esophagus * esophageal motility disorder * duodenal ulcer * benign gastric ulcer * gastroduodenal cancer * if he or she had any history of systemic disease requiring chronic medication (except for hypertension and diabetes mellitus).
efficacy of lateral kangaroo care in hemodynamic stabilization of premature infant.

Conditions: Kangaroo Care; Premature Infant; Body Temperature

Summary: the objetive of the study is to evaluate the non-inferiority or the equivalence of the kangaroo care position, in lateral versus traditional one in prone measuring the stability of several parameters in premature infants less than 28 weeks of gestational age during the first 5 days of life.

a non-inferiority clinical trial, controlled, randomized and not blinded has been designed. the non-equivalent, experimental group consist on neonates less than 28 weeks of gestational age who are placed in lateral position while they are on kangaroo care during the first 5 days of life. on the other hand, the control group include neonates less than 28 weeks of gestational age who are in traditional prone position during kangaroo care on the first 5 days of life. to define the sample size a power of 80% is assumed (β=0,20) and a 95% confidence interval (α=0,05) with a difference of 0,3ºc (sd 0,16) (9,10) in the axillary temperature. a non inferiority margin of 0.2ºc is established and a 10% sample size loss has been assumed. so a sample size of 35 premature in each group has been estimated. a non probabilistic and consecutive sampling has been defined. the allocation into the experimental (lateral position) or control group (prone position) is going to be randomized. the main outcome variable is the axillary temperature. however other clinical variables as pain, changes in the vital signs, hiv incidence rate are going to be measured as well.

Eligibility criteria:
inclusion criteria: * premature under 28 weeks of gestational age with mother / father who wants kangaroo care. exclusion criteria: * premature infants with mechanical ventilation in high frequency mode, * premature infants in the immediate postoperative period of major surgery, * premature infants with malformations of the abdominal wall * premature infants who require immobilization * premature infants who do not tolerate kangaroo care: hemodynamic, thermal instability or increased stress * premature infants with duration of kangaroo care of less than 60 minutes. * also excluded are those patients where the kangaroo care provider has an anatomical limitation for carrying out kangaroo care.

Keywords: patient positioning kangaroo-mother care method skin to skin extremely premature infant
study of plozasiran in adults with severe hypertriglyceridemia

Conditions: Severe Hypertriglyceridemia

Summary: this phase 3 study will evaluate the safety and efficacy of plozasiran injection (aro-apoc3) in adult participants with severe hypertriglyceridemia (shtg). after providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. after month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.


Eligibility criteria:
inclusion criteria: * established diagnosis of severe hypertriglyceridemia (shtg) and prior documented evidence (medical history) of fasting tg levels of ≥500 mg/dl (≥5.65 mmol/l) * mean fasting tg level ≥500 mg/dl (≥5.65 mmol/l) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period * fasting low density lipoprotein-cholesterol (ldl-c) ≤130 mg/dl (≤3.37 mmol/l) at screening * screening hba1c ≤8.5% * must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the investigator) exclusion criteria: * use of any hepatocyte-targeted small interfering ribonucleic acid (sirna) that targets lipids and/or triglycerides within 365 days before day 1 (except inclisiran, which is permitted). administration of investigational drug and inclisiran must be separated by at least 4 weeks * use of any other hepatocyte-targeted sirna or antisense oligonucleotide molecule within 60 days or within 5-half-lives before day 1 based on plasma pharmacokinetics (pk), whichever is longer (except inclisiran, which is permitted) * known diagnosis of familial chylomicronemia syndrome (fcs) (type 1 hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1- causing genes * body mass index \>45kg/m\^2 note: additional inclusion/exclusion criteria may apply per protocol
the effects of vibrotactile stimulation in patients with movement disorders

Conditions: Parkinson Disease; Essential Tremor; Dystonia

Summary: vibration applied to the skin has been anecdotally reported to potentially improve motor control in patients with movement disorders including parkinson's disease, however few devices have been studied formally. in this study, the investigators will test the effect of skin surface vibration applied non-invasively to patients with movement disorders to determine if there are any beneficial effects on common tasks of motor control and/or abnormal motor symptoms in patients with parkinson's disease (pd), essential tremor (et), and dystonia.

this study is to evaluate the feasibility, reliability, and clinical effects of non-invasive vibrotactile stimulation (vts) on basic tasks of motor control and on the motor symptoms of patients with movement disorders. vts settings will include continuous stimulation, intermittent stimulation during walking, and sham stimulation. the investigators will recruit 30 patients with pd who are between the ages of 18-80 years old and independently living in the community. the investigators will additionally recruit up to 5 patients with et and up to 5 patients with dystonia.

Eligibility criteria:
inclusion criteria: * age 18-80 and able to provide informed consent. * have a diagnosis of parkinson's disease, essential tremor, or cervical dystonia made by a movement disorders specialist. * medically optimized without planned medication changes for the duration of the study. * for patients with et, they will have a score of at least 2 on items 5 and 6 of the fahn-tolosa-marin (ftm) tremor rating scale. * for patients with dystonia, they will have abnormal dystonic postures of the head and not isolated head tremor exclusion criteria: * the presence of additional neurologic diseases, that might confound testing or the coexistence of pd and et together (action tremor that was present prior to the development of parkinsonism). * symptoms of peripheral neuropathy at the wrist (reduced vibratory, pinprick, or temperature sensation) * montreal cognitive assessment (moca) score \< 20 or previously documented dementia * unable to walk without a walking aid (e.g. cane, stick, walker)

Keywords: parkinson disease essential tremor dystonia vibrotactile stimulation
the effect of the serratus block on pain control after breast surgery

Conditions: Anesthesia

Summary: surgery for breast cancer is associated with significant pain. the serratus nerve block targets the interfascial plane either below or above the serratus muscle, blocking thereby the lateral cutaneous branches of the intercostal nerves. the purpose of this randomized controlled double-blinded study is to see whether the addition of a serratus nerve block to a general anesthesia results in a better postoperative pain control in patients undergoing surgery for breast cancer.

the prevalence of severe acute postoperative pain after breast surgery is high. regional anesthesia has the potential to provide superior pain relief with fewer side effects compared to standard systemic opioid therapy. the search for a regional anesthesia technique for breast surgery has been ongoing as this technique needs to be time efficient, relatively risk-free and also practicable in an out-patient setting. the serratus block is a promising technique that may combine these advantages.

Eligibility criteria:
inclusion criteria: * asa i to iii (american society of anesthesiologists physical status classification system) * undergoing unilateral primary or secondary breast surgery for cancer, specifically: lumpectomies with sentinel node biopsy or partial mastectomies or simple mastectomies, with or without sentinel node biopsy * day surgery procedures exclusion criteria: * inability to understand or to provide consent * inability or unwillingness to comply with required follow-up assessments * psychiatric disorder affecting patient assessment * contraindication to regional anesthesia, e.g., coagulopathy * allergy to local anesthestic * chronic pain and/or chronic use of opioids with a daily use of over 30mg oxycodone or equivalent per day * contraindication to a component of multimodal analgesia * preexisting neuropathy with motor or sensory deficits in the area of the anterolateral chest wall * infection near the injection site * pregnancy * bmi \>35 * complication or adverse events unrelated to the study intervention that precludes evaluation of the primary and secondary outcomes

Keywords: serratus block breast surgery
balloon aortic valvuloplasty during surgical aortic valve replacement

Conditions: Aortic Stenosis

Summary: prospective, two academic center, non-randomized pilot, acute in-patient study correlating pre-operative imaging studies, intra-operative measurements and intra-operative balloon aortic valvuloplasty (bav) in patients with degenerative aortic stenosis undergoing surgical aortic valve replacement (savr) to understand the requirements (device size and radial strength) of emerging percutaneous heart valve technologies in the treatment of aortic stenosis.


Eligibility criteria:
inclusion criteria: * age 18 years or older * any patient with severe, symptomatic calcific aortic stenosis (as) referred for elective surgical aortic valve replacement. * severe as: aortic valve area (ava) ≤ 1.0 cm2 * symptoms: dyspnea on exertion, heart failure, angina or syncope believed to be secondary to as exclusion criteria: * emergent surgical aortic valve replacement. * inability to undergo tte or tee intra-operatively. * currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.

Keywords: aortic valve replacement avr
dairy vs plant-based beverages for improving bone health during exercise

Conditions: Osteoporosis

Summary: this study will evaluate the effects of consuming dairy milk versus two plant-based beverages (pea-based, and almond-based) after resistance training sessions (3 times per week for 12 months) on bone properties (bone mineral density, bone geometry), body composition, strength, and functional performance in post-menopausal women and men 50y and older.

the purpose of the study is to compare consumption of dairy milk (1% chocolate milk) to plant-based beverages (protein-matched pea beverage and low-protein almond beverage) after resistance-training sessions on bone mineral density, bone geometric properties, lean tissue and fat mass, muscular strength, and functional performance. one-hundred and fifty postmenopausal women and men 50y or older will be randomized to one of three groups: 1) dairy milk; 2) pea-beverage; 3) almond beverage. the study will be double-blind, accomplished by chocolate flavoring of each beverage. participants will do supervised strength-training sessions three times per week for 12 months. after each strength-training session, participants will consume 375 ml of their beverage and then consume 375 ml of their beverage again one hour later.

Eligibility criteria:
inclusion criteria: * women need to be postmenopausal (no age limit) * men need to be 50y or older exclusion criteria: * taking medications that might affect bone * conditions that might preclude participating in a resistance-training program (determined by the "get active questionnaire"). * planning 6 weeks of travel during the 12 month intervention period * planning major surgery during the 12 month intervention period * already strength training greater than 2 days per week for 30 minutes or longer per session * allergies to ingredients in the beverages
integrative migraine pain alleviation through chiropractic therapy

Conditions: Migraine; Migraine Disorders; Migraine With Aura; Migraine Without Aura; Migraine, Classic

Summary: this pilot study evaluates the addition of chiropractic treatment to conventional neurological care in the treatment of migraine headaches in adult women. half of the participants will receive 10 chiropractic treatments in addition to their usual care over a 14 week period, while the other half will continue their usual medical care alone, as prescribed by their physician during that time period.

chiropractic care is a commonly used therapeutic intervention for the treatment of pain disorders, and some smaller studies have shown that it might be helpful for migraines. this pilot study will use a comprehensive model of chiropractic treatment which can include soft tissue mobilization, spinal manipulation, and postural and spinal stabilization and correctional exercises. specific aims: aim #1 - determine the feasibility of conducting a randomized control trial (rct) of chiropractic care in adult women with migraine. aim #2 - to provide preliminary data on the safety and effectiveness of chiropractic care on migraine frequency, severity, duration, and medication use in adult women with migraine. aim #3 - to provide preliminary estimates of the effects of chiropractic on disability, health-related quality of life, and psychosocial well-being.

Eligibility criteria:
inclusion criteria: * diagnosis of episodic migraine with or without aura (international classification of headache disorders-ii) * 4 to 13 days with migraines/month * more than one year of migraines * agreeable to participate, commit to all study procedures, and to be randomized to either group * fluent in english (required to complete self-report instruments) exclusion criteria: * currently, or having received chiropractic care in past 3 months for any condition * any major systemic illness or unstable medical or psychiatric condition (e.g. parkinson's disease, cancer) requiring immediate treatment or that could lead to difficulty complying with the protocol * history of stroke, carotid artery dissection, or vertebral artery dissection * head or neck trauma within the past year * diagnosis of medication overuse headache (international classification of headache disorders-ii) * began use of new prophylactic medication for migraine headaches within the last 3 months * currently taking prophylactic migraine medications other than propranolol and topiramate * failure to complete baseline diary recordings of migraine activity and medication use during run-in phase * currently, or having received botox treatment for migraine * current alcohol or substance abuse (self-reported) * diagnosis of ehlers-danlos syndrome

Keywords: migraine women adult feasibility safety pilot randomized trial randomized control trial chiropractic