Kornimate/medical-research-clean huggingface dataset:
acute treatment of migraine with e-tns

Conditions: Migraine

Summary: the main objective of this study is to assess the efficacy of the cefaly® device as an acute treatment of migraine attack in adult patients. the patients will be applied either an active or placebo external neurostimulation for 1 hour during a migraine attack, and will report the pain on a visual analog scale before and after the treatment.


Eligibility criteria:
inclusion criteria: * history of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ichd-iii beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction) * having a migraine attack lasting at least 3 hours * migraine pain intensity stabilized for at least 1 hour * frontal, retro-, or peri- orbital headache. exclusion criteria: * pregnant women * patients having received botox treatment in the prior 4 months * patients having received supraorbital nerve blocks in the prior 4 months * diagnosis of other primary or secondary headache disorders, except of medication overuse headache * patients with only temporal or occipital headache * patients using opioid medication * patients having taken abortive migraine medication in the prior 3 hours * allodynia: intolerance to supraorbital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 5 minutes of neurostimulation). * implanted metal or electrical devices in the head * cardiac pacemaker or implanted or wearable defibrillator * patient having had a previous experience with cefaly®
efficacy study of tissucol/tisseel fibrin sealant to treat inguinal hernia

Conditions: Inguinal Hernia

Summary: the purpose of the study is to evaluate mid and long term postoperative pain and further disabling complications in open inguinal hernia repair by lichtenstein technique after mesh fixation with fibrin sealant (fs), compared to mesh fixation with sutures.

subjects in the fs group will be operated by lichtenstein technique, with mesh fixation by fibrin sealant. subjects in control group will be operated with conventional lichtenstein technique (mesh fixation by sutures). hernia repair will be performed according to standardized lichtenstein technique, a technique for tension free hernioplasty. a polypropylene, heavyweight, macroporous mesh will be used (8x15 cm) tailored to individual patients requirement. the different ways of mesh fixation will be randomly assigned within 24 hours before the operation. in the fs group, the two tails of the mesh will be fixed together in overlapping their edges and by surrounding the cord. the edges will be joined up to by 1 suture. no other sutures will be used. first the mesh will be put correctly in place. a small spot (0.5ml) of fs will be applied on the pubis under the mesh without spray then the remaining part (3,5ml) over the mesh on the entire surface in a thin uniform layer by spray. 2 ml tissucol-tisseel (4 ml of fibrin sealant) will be used per mesh. in the control group, the mesh will be fixed in a conventional manner. nerve resection (if occurred) will be recorded; it should be avoided.

Eligibility criteria:
inclusion criteria: * signed informed consent obtained from the subject prior to participation in the study * active males over the age of 18 years and below 80 years * experiencing an uncomplicated unilateral primary inguinal hernia or experiencing an uncomplicated bilateral hernia provided that only one hernia is operated during the 12 months of study follow-up * subjects eligible for elective inguinal hernia repair using lichtenstein technique. exclusion criteria: * recurrent, scrotal, incarcerated or femoral hernias * hernia types l3 and m3 according the ehs classification * bmi equal or more than 35 * concomitant abdominal surgery * ongoing long term analgesic or steroid treatment * patients under clopidogrel or warfarin (can be switched to lmw sub-cutaneous heparin) * known abuse of alcohol or drugs * liver cirrhosis (child c) * previous treatment or hypersensitivity to bovine aprotinin * known immunodeficiency * severely compromised physical or psychological health, that in the investigator's opinion will affect patient compliance * concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days

Keywords: tissucol tisseel lichtenstein hernia inguinal
reiki and reflexology massage diyabetik neuropathy pain

Conditions: Neuropathic Pain Diagnostic Questionnaire (DN4) ≥ 4

Summary: diabetes mellitus is a chronic endocrine and metabolic disease that occurs as a result of insufficiency, absence and/or deficiency of the insulin hormone secreted from the beta cells of the pancreas, and is characterized by hyperglycemia, disorders in carbohydrate, protein and fat metabolism, capillary membrane changes and accelerated atherosclerosis, and has a high risk of morbidity and early mortality, with the development of macrovascular and microvascular complications and a high cost of care. diabetic neuropathy is not always painful, but 12% of all diabetic patients are affected by symptomatic painful diabetic neuropathy, the most common chronic and earliest presenting complication. reflexology is a special pressure technique and energy balancing system that is performed by applying pressure to reflex points with rubbing, patting and squeezing movements to ensure healing. reflexology; it advocates that stimulating nerve points in the feet and hands with certain techniques produces electrochemical messages, which in turn stimulate the relevant organ with the help of neurons. feet are widely preferred for reflexology massage due to their features such as having many nerve endings, more sensitive reflexes, being easily accessible, having a large area, and the effectiveness and comfort of the application. reflexology massage is a supportive and complementary method, not an alternative to medical treatment. according to the reiki principle, everything in the universe, including the human body, consists of energy in the universe, and deviations in the energy field cause diseases. this study aims to investigate the effects of reiki and reflexology applications on the patient's quality of life and pain level in diabetic neuropathy pain.


Eligibility criteria:
inclusion criteria: people with neuropathy pain neuropathic pain is possible must have diabetes volunteering to participate in the study, * being able to understand and speak turkish and not having a hearing impairment, * not having any diagnosed psychiatric disorder that would reduce the ability to comprehend and understand, * agreeing to participate in the study. * having no communication problems,

Keywords: diabetic neuropathy
interest of learning self-hypnosis for patients awaiting lung transplantation

Conditions: Lung Diseases

Summary: patients benefitting from a lung transplantation are subject to long-lasting and often severe post-operative pain. self-hypnosis has been proven effective in the management of acute pain. the study hypothesis is that pre-operative training in self-hypnosis given to patients awaiting lung transplantation, will result in a reduction of post-operative pain one month after surgery.


Eligibility criteria:
inclusion criteria: * patients over 15 years of age * indication of lung transplantation exclusion criteria: * patient unable to receive training in self-hypnosis (for cognitive, linguistic or cultural reasons)

Keywords: all terminal leading indication lung transplantation
effects of theraplay on hand in cerebral palsy

Conditions: Hemiplegic Cerebral Palsy

Summary: among the neurological conditions known as cerebral palsy are those that impact muscle tone, mobility, and cooperation. cerebral palsy that affects only one side of the body is known as hemiplegic cerebral palsy. damage to one side of the brain causes this disorder, which usually manifests as before, in the middle of, or soon after birth. the ability to use one\&#39;s hands with coordination and expertise to accomplish tasks that call for control and accuracy is known as hand dexterity. for those who have cerebral palsy, hand dexterity can be a major issue. developing hand dexterity is crucial as it might augment an individual\&#39;s capacity to execute routine tasks and attain greater autonomy.convenient sampling will be used to carry out a randomized control study. twenty two subjects will be divided into two groups at random. the experimental group will receive theraplay therapy, which is a program that includes various play-based activities like playing with wooden puzzles, clay and blocks, making wraps, bubble tennis, and special handshakes, claps, and high fives, in addition to designed conventional therapy. the control group will receive designed conventional physical therapy exercises for the affected hand, such as hand weight-bearing exercises, stretching and strengthening exercises, and exercises using sponge balls. the course of treatment will run for eight weeks. as outcome measures, the gmfcs and macs scales, the box and block test, finger tapping, and the nine-hole peg test will be employed. data will be analyzed on spss version 25; the normality of the data will be checked and tests will be applied according to the normality of the data either it will be a parametric test or non parametric based on the normality.

group a: the control group will receive a designed conventional physical therapy program for the affected hand like stretching and strengthening exercises, sponge ball exercises to the hand, and hand weight bearing exercises. group b: the experimental group will receive theraplay therapy or a program and different play-based activities like playing with wooden puzzles and playing with clay and blocks, special handshake claps high fives, making wraps, and bubble tennis in addition to designed conventional therapy.

Eligibility criteria:
inclusion criteria: * ages of both boys and girls range from 6 to 12 years * based on the modified ashworth scale, the degree of spasticity is between 1 and 1+. * capable of grasping, releasing, and reaching with the afflicted hand * capable of comprehending and adhering to instructions exclusion criteria: * children with mixed c.p., ataxic, athetoid, and mental retardation * visual and auditory issues * upper limb congenital malformations, convulsions * youngsters who have recently sustained upper extremity trauma

Keywords: cp hand dexterity theraplay
prevention of parastomal hernias with a preformed three-dimensional, funnel-shaped mesh

Conditions: Parastomal Hernia

Summary: parastomal hernia (ph) remains a significant complication following stoma creation, boasting a considerable prevalence in the range of 30 to 50% within the first year post-surgery, a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms. a noteworthy one-third of these cases necessitate subsequent surgical interventions, yielding suboptimal outcomes both in the short and long term. the clinical manifestations of ph are diverse, ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction, hernia incarceration, and ischemia. various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes, although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies. keyhole and modified sugarbaker techniques dominate laparoscopic and robotic approaches, yet none offer ideal outcomes. the aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional, funnel-shaped mesh.


Eligibility criteria:
inclusion criteria: * patients undergoing a definitive colostomy confection * terminal colostomy confection * asa index iii or inferior * patients who have given legat authorization to participate in the study exclusion criteria: * lateral colostomy or a colostomy that will be removed posteriorly

Keywords: parastomal hernia end colostomy prophylactic mesh
v710 clinical study in healthy male japanese subjects (v710-006) (completed)

Conditions: Staphylococcal Infection

Summary: this study is to evaluate the safety and immunogenicity of v710 in japanese male subjects.


Eligibility criteria:
inclusion criteria: * generally good physical health exclusion criteria: * received v710 vaccine, any other investigational s. aureus vaccine, or investigational s. aureus antibodies before * temperature of equal/greater than 100.4 degrees f(38 degrees c) within the past 48 hours
a clinical research of qi deficiency and blood stasis syndrome (different disease with syndrome)

Conditions: Ischemic Heart Failure

Summary: the main purpose of this research is to reveal the curative effect mechanism of yiqihuoxue prescription which treat the disease of qi deficiency and blood stasis. and at the same time this study also try to confirm yiqi huoxue fang qi deficiency blood stasis treatment of coronary heart disease (chd) heart failure the curative effect and security.

modern research has shown that the main mechanism of the qi deficiency and blood stasis of coronary disease combined with cardiac failure is the disorder nerve-endocrine-immune network mechanism, disorder of energy metabolism, blood coagulation/anticoagulation imbalances, vascular endothelial injury and the expression of inflammatory factors and cytokines disorder, etc. some studies have identified that the chinese traditional medicine of supplementing qi and activating blood circulation drugs could adjust the nerve - endocrine - immune network, improve endothelial function, improve ventricular remodeling, ameliorate heart function, alleviate the clinical symptoms, enhance the quality of life, and so on. this study by comparing the curative effect of yi-qi formula, huoxue prescription and two prescription of yiqi huoxue (buyang huanwu decoction and qishen yiqi drop pill) on improving energy metabolism, ameliorating heart function, adjusting the blood coagulation and the expression of cell adhesion factor, improving endothelial function, to reveal the curative effect mechanism of yiqihuoxue prescription which treat the disease of qi deficiency and blood stasis, and confirm the tcm theory that "qi and blood are correlated.

Eligibility criteria:
inclusion criteria: 1. age 40 to 75; 2. patients with ischemic heart failure： lvef less than or equal to 45% measured by echocardiography in modified simpson method 3. qi deficiency and blood stasis syndrome; 4. new york heart association (nyha) class ii to ⅲ ; 5. submitted informed consent exclusion criteria: 1. combin the pulmonary embolism, or acute coronary syndrome (acs) ,or acute cerebrovascular disease; 2. combin other heart diseases: valvular heart disease, dilated cardiomyopathy, hypertension heart disease, pulmonary heart disease,congenital heart disease; 3. hypertension and diabetes patients treated with drugs but not controlled within standard limit; 4. severe hepatic and renal dysfunction, malnutrition, malignant tumour; 5. active tuberculosis or rheumatoid diseases; 6. nosohemia, organ transplantation,uremia; 7. psychosis and drug abuse; 8. allergic to the drugs or one component medicine of the drugs of this study ; 9. participated in other trials within 1 month ; 10. being pregnant, planning for pregnancy or breastfeeding;

Keywords: ischemic heart failure coronary artery disease qi deficiency and blood stasis
a study for post-marketing surveillance of niraparib in the treatment of adult participants for approved indications in south korea

Conditions: Ovarian Neoplasms

Summary: the purpose of this study is to estimate the cumulative incidence of all adverse events (aes), including serious adverse events (saes), adverse event of special interest (aesi), among participants who have been administered niraparib as per the approved indications.

this is a long-term prospective, observational post-marketing surveillance study of niraparib in participants with ovarian cancer (including fallopian tube, or primary peritoneal cancer) who are in complete or partial response to first-line platinum-based chemotherapy or who had complete or partial response to 2 or more lines of platinum-based chemotherapy or who have been treated with 3 or more prior chemotherapy regimens with either: brca mutation irrespective of platinum sensitivity; or platinum-sensitive hrd positive. the study will assess the safety and effectiveness of niraparib for its approved indication with real-world setting in south korea. the study will enroll approximately 600 participants. the data will be collected prospectively at the study sites will be recorded into electronic case report forms (e-crfs). all the participants will be assigned to a single observational cohort: • participants with ovarian cancer the multi-center study will be conducted in south korea. data collection will be based on routinely scheduled and emergency visits during a 24-month surveillance period or until end of the study whichever occurs first after drug administration. the overall duration of the study will be approximately 6 years.

Eligibility criteria:
inclusion criteria: 1. monotherapy for the maintenance treatment of adult participants with ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. 2. monotherapy for the maintenance treatment of adult participants with recurrent high-grade serous ovarian cancer (including fallopian tube, or primary peritoneal cancer) who are in a complete or partial response to 2 or more lines of platinum-based chemotherapy. 3. monotherapy treatment of adult participants with recurrent ovarian, fallopian tube or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens with either a) brca mutation (irrespective of platinum sensitivity) or b) platinum-sensitive hrd positive. exclusion criteria: 1. treated with niraparib outside of the locally approved label in korea. 2. niraparib is contraindicated as per product label. 3. participating in other clinical trials of cancer treatment.

Keywords: drug therapy
a trial comparing ferumoxytol with placebo for the treatment of iron deficiency anemia

Conditions: Iron Deficiency Anemia

Summary: to evaluate the efficacy and safety of intravenous (iv) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (ida).

this phase iii, randomized, double-blind, placebo-controlled, multicenter clinical study evaluated the safety and efficacy of ferumoxytol compared with placebo for the treatment of ida, specifically in adult patients with ida who have a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. the effect of ferumoxytol on hemoglobin, iron parameters and patient reported outcomes (pros) compared with placebo was evaluated. investigators were blinded to key laboratory parameters that could potentially unblind the treatment arms of the study, eg, hemoglobin \[hgb\], hematocrit \[hct\], iron, ferritin, total iron binding capacity \[tibc\], and transferrin saturation \[tsat\], and neither the investigators nor the subjects were aware of their treatment assignment, hemoglobin or other laboratory values.

Eligibility criteria:
key inclusion criteria include: 1. males and females ≥18 years of age 2. participants with ida defined as having: 1. hemoglobin \<10.0 g/deciliter (dl) 2. transferrin saturation \<20% 3. participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used 4. female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study key exclusion criteria include: 1. history of allergy to iv iron 2. allergy to two or more classes of drugs 3. participants on dialysis or with an estimated glomerular filtration rate \<30 ml/minute/1.73 m\^2 4. female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test 5. hemoglobin ≤7.0 g/dl 6. serum ferritin \>600 nanograms/ml

Keywords: iron deficiency anemia feraheme ferumoxytol ida
effect of tavns on abdominal pain and other symptoms in constipation-predominant irritable bowel syndrome

Conditions: Constipation-predominant Irritable Bowel Syndrome; Abdominal Pain

Summary: this study aims to investigate the effects and possible mechanisms of transcutaneous auricular vagal nerve stimulation (tavns) on abdominal pain and other symptoms in patients with ibs-c.

this study is designed as an early-feasibility, single-center, single-blinded, randomized controlled trial (rct), in which subjects are consented, undergo a baseline assessment, and receive tavns or sham-tavns treatment twice a day (8 a.m. and 8 p.m.) for 30 minutes each time for a period of 4 weeks. the tavns and sham-tavns treatment was applied using the commercially-available transcutaneous electrical applicator device (model snm-fdc01, ningbo medkinetic medical device co., ltd.) with the skin electrodes placed bilaterally on auricular concha. the patients are requested to score the abdominal pain (using vas) and complete bsfs, ibs-sss, ibs-qol, sas, and sds forms every week and fill out the bowel diary during tavns or sham-tavns. emergency medications (macrogol 4000 and pinaverium) are permitted for use when the patient cannot tolerate symptoms of constipation and abdominal pain.

Eligibility criteria:
inclusion criteria: 1. willing to sign a written informed consent form 2. met the rome iv diagnostic criteria for ibs-c exclusion criteria: 1. history of previous abdominal surgery (other than appendectomy) 2. presence of carcinoma 3. any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, parkinson's disease, or spinal cord injury 4. taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors 5. serious concomitant disease of the heart, liver, kidney, or diabetes 6. pregnancy or lactation 7. participating in another trial or enrolled in a trial during the past month 8. allergic reaction to surface electrodes