Kornimate/medical-research-clean huggingface dataset:
effect of ma versus tens for primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the trial aims to evaluate the effect of manual acupuncture versus transcutaneous electric nerve stimulation in treating primary dysmenorrhea.

according to systematic reviews,manual acupuncture(ma) and high frequency transcutaneous electric nerve stimulation(tens) had certain therapeutic effects on primary dysmenorrhea respectively. in this trial, 84 patients with primary dysmenorrhea will be recruited and randomly allocated into ma group and tens group. patients in ma group will receive treatment at acupoints of shiqizhui(ex-b8), ciliao(bl 32),diji(sp 8) and sanyinjiao(sp 6) and those in tens group will receive treatment at the area along the lower borders of the ribs and the upper borders of the hip crests on both sides. all patients, both in ea group and tens group, will be treated in their first day of dysmenorrhea, once a day for three consecutive days. and the treatments will last for three consecutive menstrual cycles.

Eligibility criteria:
inclusion criteria: 1. female; 2. aged of 18 to 40 years; 3. conforming to the criteria for the diagnosis of primary dysmenorrhea in the guideline developed by society of obstetricians and gynaecologists of canada（sogc）in 2017. 4. with normal menstrual cycle(28±7 days) and normal menstrual period（3-7days）； 5. menstrual mean pain score ≥4 on the numerical rating scale (nrs)； 6. to sign the informed consent and participate in the study voluntarily. exclusion criteria: 1. secondary dysmenorrhea; 2. pregnant patients,lactating patients or patients preparing pregnancy. 3. subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment; 4. subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time; 5. subjects installed with the cardiac pacemaker; 6. those who have received relevant acupuncture, transcutaneous electric nerve stimulation and other treatment (except pain medication) the last three months; 7. patients who may be allergic to electrodes.

Keywords: primary dysmenorrhea manual acupuncture transcutaneous electric nerve stimulation randomized controlled trial
a long-term extension study of roactemra/actemra (tocilizumab) in patients with juvenile idiopathic arthritis from france who completed wa19977 core study

Conditions: Juvenile Idiopathic Arthritis

Summary: this long-term, open-label extension study will evaluate the safety of roactemra/actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the wa19977 core study. patients will continue to receive roactemra/actemra 8 mg/kg intravenously every 4 weeks. anticipated time on study treatment is 104 weeks.


Eligibility criteria:
inclusion criteria: * patients who completed visit 33 (week 104) of wa19977 study and who may benefit from study drug treatment according to the investigator's assessment * patients have to receive the first roactemra/actemra infusion in this study at the week 8 visit at the latest * females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol exclusion criteria: * patients with, according to investigator judgment, not satisfactory benefit from roactemra/actemra therapy within wa19977 * treatment with any investigational agent since the last administration of study drug in the core study wa19977 * patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course juvenile idiopathic arthritis (jia) subsets: rheumatoid factor positive or negative jia or extended oligoarticular jia * patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug * any significant concomitant disease or medical or surgical condition * history of significant allergic or infusion reactions to prior biologic therapy * currently active primary or secondary immunodeficiency * any infections with contraindications to roactemra/actemra therapy according to investigator judgment * inadequate hepatic, renal or bone marrow function
the role of probiotics in periodontal disease

Conditions: Periodontal Diseases

Summary: in this randomized controlled trial, it was aimed to evaluate the effect of probiotics (chewable tablets) and kefir consumption in the initial periodontal treatment of periodontitis patients on the change of oral microbiota and treatment. in this clinical trial, 36 systemically healthy volunteers who were diagnosed with periodontitis who were admitted to gazi university faculty of dentistry, department of periodontology were included. besides the inclusion criteria, the nutritional habits of the patients were evaluated by questionnaire. for diagnosis, plaque index, gingival index, bleeding on probing, periodontal probing depth and clinical attachment level were examined. patients were randomly divided into 3 groups; probiotic, kefir and control group. following the periodontal diagnosis, clinical index records of the patients and subgingival microbial samples were obtained. the supragingival plaque sample was removed and the subgingival microbial dental plaque sample was gently taken with a sterile gracey curette. in the same session, periodontal initial treatment was started. according to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements. periodontal indexes were repeated in the 1st and 3rd months. subgingival plaque samples were taken at baseline and at 3 months and dna sequencing was performed for tanneralla forsythia (t. forsythia), porphyromonas gingivalis (p. gingivalis), and treponema denticola (t. denticola).


Eligibility criteria:
inclusion criteria: 1. systemically healthy 2. individuals over 18 3. periodontitis (4-6 mm pockets) patients with 3 teeth in each half of the jaws except wisdom tooth 4. non-smoker 5. not using probiotic tablets/capsules and consuming no more than 3-4 probiotic food. exclusion criteria: 1. antibiotic use within 6 months. 2. breastfeeding or pregnancy. 3. acute oral lesions or necrotizing ulcerative periodontitis 4. diabetes, rheumatic fever, lung, kidney disease history and drug use that will affect periodontal tissues 5. patients who smoke or who did not stop until last year 6. use of probiotics tablets or capsules 7. probiotic food consumption not more than 3-4 times a week

Keywords: periodontal disease probiotics prebiotics
serum exosomal long noncoding rnas as potential biomarkers for lung cancer diagnosis

Conditions: Lung Cancer (Diagnosis)

Summary: the study is to investigate the sensitivity and specificity of serum exosome noncoding rna as a biomarker for the diagnosis of lung cancer

conventional tumor markers for non-invasive diagnosis of lung cancer (lc) exhibit insufficient sensitivity and specificity to facilitate detection of early lung cancer (elc). the investigators aimed to identify elc-specific exosomal lncrna biomarkers that are highly sensitive and stable for the non-invasive diagnosis of elc.hence, in the present study, exosomes from the plasma of five healthy individuals and 30 lc patients and from culture media of four human bronchial epithelial cells and four cancer cells were isolated. exosomal rna profiling was performed using rna sequencing to identify lc specific exosomal lncrnas.

Eligibility criteria:
inclusion criteria: * subjects are willing to sign the informed consent form; * normal subjects have no evidence of any disease; * lung cancer patients are 18 to 75 years old, diagnosed as lung cancer by histopathology or cytopathology exclusion criteria: * people are unwilling to sign the informed consent form; * patients with heart disease, rheumatic disease, allergic disease, copd, pulmonary fibrosis, diabetes, thyroid disease, liver, kidney, brain disease and hematopoietic system disease; * pregnant or lactating women; * patients did not cooperate or participate in other clinical trials

Keywords: exosomes；lncrna； lung cancer；
treatment of breast fibroadenoma with high intensity focused ultrasound (hifu)

Conditions: Breast Fibroadenoma

Summary: this is a monocenter, open-label, uncontrolled study in accordance with §23b mpg to evaluate the efficacy of the hifu-treatment of fibroadenoma using the th-one device objectives primary objective: to evaluate the efficacy of hifu in the treatment of the breast fibroadenoma using the th-one device secondary objective: to evaluate the tolerability of the hifu using the th-one device


Eligibility criteria:
inclusion criteria: * female patients 18 years or older with at least one diagnosed breast fibroadenoma. * diagnosis of fibroadenoma must be based on: * clinical examination, * women ≤ 40 years of age: ultrasound image alone; women \> 40 years of age: ultrasound image and mammogram, * histological confirmation of fibroadenoma of the breast. * patient's fibroadenoma size as determined by ultrasound imaging: the longest diameter is limited to 25 mm. * women of childbearing potential must have a negative urine pregnancy test within 72 hours prior to hifu treatment. * patient must be able to understand the nature and the extent of the study and the procédures required and be willing and able to complete the screening and study procedures. * patient must give written informed consent (personally signed and dated) before completing any study-related procedure. exclusion criteria: * patient who is pregnant or breast-feeding. * patient with history of ipsilateral breast cancer within 5 years prior to study inclusion or radio therapy to the target breast within 5 years prior to study inclusion. * patient with implant on the treated breast. * patient with target fibroadenoma pre-treated by cryoablation or interstitial laser therapy within 12 month before recruiting for hifu. * patient's fibroadenoma not clearly visible on the ultrasound images (in b mode) at the inclusion visit. * patient participating in other studies using drugs or medical devices within 3 months prior to study inclusion or during study participation including the follow-up period.
spinchip hs-ctni clinical diagnostic performance

Conditions: Acute Myocardial Infarction

Summary: during a heart attack, the protein troponin i is released from the heart muscle into the bloodstream. measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack. the spinchip hs-ctni test is a new high-sensitive test for measuring the amount of cardiac troponin i in the bloodstream as an aid in the diagnosis of heart attack. the purpose of this study is to evaluate the diagnostic accuracy and safety of the spinchip hs-ctni test relative to a clinically validated hs-ctni method.

cardiac troponins are widely used as a biomarker to aid in the diagnosis of acute myocardial infarction (ami). these structural proteins are essential in regulating contraction in cardiac muscle cells, and they are sensitive and specific biochemical markers of myocardial damage. during a heart attack, cardiac muscle cells are injured and release the cardiac marker troponin i (ctni) into the bloodstream. high-sensitive troponin tests may detect the increase of cardiac troponin in blood within hours after the symptoms of a heart attack has started. the spinchip high-sensitivity cardiac troponin i (hs-ctni) test is a new high-sensitive test for measuring troponin i in blood samples, and the analysis may be performed close to the patient (near-patient test). the results may be obtained within 10 minutes, compared to approximately 1 hour for normal laboratory analysis. the spinchip platform consists of the spinchip hs-ctni test and the spinchip analyzer and may be used at the emergency department to evaluate patients presenting with symptoms of acute myocardial infarction (chest pain). the test can use blood from finger prick or venous blood samples, either as whole blood or separated into plasma this study is a multicentre, prospective, observational, non-randomised, open clinical performance study for evaluation of the diagnostic accuracy and safety of the spinchip hs-ctni test as an aid in the diagnosis of ami. subjects presenting with acute chest discomfort or other symptoms suggestive of ami will be recruited at the emergency departments (eds).

Eligibility criteria:
inclusion criteria: * able and willing to provide signed written informed consent * subjects ≥ 18 years old * subjects presenting at the ed with acute chest discomfort including "pain", "pressure", "tightness", "burning", or "stabbing" and/or other symptoms suggestive of ami such as upper abdominal pain, left shoulder/arm pain, pain in the jaw, or pain between the scapulae. exclusion criteria: * subjects experiencing shock * self-reported pregnancy * previously included in the study (e.g., in case of a second presentation) * patient incapable of judgement, for example due to severe pain

Keywords: acute myocardial infarction high-sensitive point of care troponin i near-patient test heart attack diagnostic accuracy
proton beam therapy for chordoma patients

Conditions: Chordoma

Summary: the goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chordoma. the safety of this treatment will also be studied.

proton therapy is a kind of external beam radiation therapy where protons are directed to a tumor site. researchers are trying to determine what level of proton therapy gives the most benefit without causing toxic side effects. researchers will also be testing the treatment's effect. if your doctor feels it is necessary, the proton beam therapy may be combined with standard photon therapy. if you are eligible to take part in this study, you will receive proton beam therapy at the university of texas (ut) md anderson cancer center (mdacc), and possibly photon beam, no sooner than 2 weeks after the last surgery to remove the tumor. you will receive proton beam therapy once a day for about 35 treatments (7 weeks). treatment will be given for 5 days in a row each week (except for saturdays, sundays and holidays) at the mdacc proton center in houston. the whole process should take up to 1 hour each day. this is an investigational study. the proton beam machine used to deliver treatment is approved by the fda for patient use. the doses being studied are experimental. about 15 participants will take part in this study. all will be enrolled at mdacc.

Eligibility criteria:
inclusion criteria: 1. pathologically confirmed chordoma of the skull base 2. contrast enhanced postoperative mri (ct in case mri is contraindicated) of the skull base obtained within 90 days of study registration 3. mdacc surgeons have determined that optimal debulking of disease has been performed. 4. karnofsky performance status greater than or equal to 60 5. signed informed consent exclusion criteria: 1. previous irradiation of the skull base 2. documented evidence of disseminated metastatic disease 3. any concurrent malignancy (other than non-melanoma skin cancers) in the last 3 years

Keywords: proton beam therapy skull base chordoma chordoma of the skull base chordoma
a randomized double blind study evaluating duloxetine in outpatients with mdd and pain

Conditions: Depressive Disorder, Major

Summary: to determine the efficacy of duloxetine vs. placebo on pain as determined by change in the brief pain inventory (bpi) from baseline over 8 weeks of treatment


Eligibility criteria:
inclusion criteria: * major depressive disorder according to dsm-iv criteria with at least one previous depressive episode in the patient's medical history * painful physical symptoms as measured by the brief pain inventory-short form exclusion criteria: * any anxiety disorder as a primary diagnosis within the past 6 months (including panic disorder, ocd, ptsd, generalized anxiety disorder and social phobia) * any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
evaluation of brain damage resulting from carotid endarterectomy with xenon anesthesia

Conditions: Carotid Endarterectomy

Summary: the objective of this study is to show that, in patients undergoing carotid endarterectomy, brain damage, assessed by the determination of s100b before removing the clamp, is less severe with a balanced anesthesia consisting of remifentanil combined with xenon (experimental arm) compared with remifentanil anesthesia associated with propofol (reference arm).


Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * patients with american society of anesthesiology (asa) scores of 1 to 4 * patient schelduled for carotid endarterectomy exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant * the patient is breastfeeding * the patient has a contra-indication for a treatment necessary for this study * the endarterectomy does not require a shunt * asa score of 5 * patient presenting with symptomatic gastric-oesophagien reflux * patient has neuro-endocrine cancer * patient has hypersensivity to one of the following substances: propofol, remifentanil, celocurine, cisatracurium, rocuronium, senon, paracetamol, tramadol * patient suffering from obstructive respiratory insufficiency (chronic obstructive pulmonary disease, asthma) * patient with coronary disease with severely altered cardiac function * high intracranial pressure * patient requiring high concentrations of oxygen (spo2 \< 92% normal air) * patient with neuro-sensorial deficit that, in the absence of a prothesis, prevents reading, writing, or responding to simple orders * patient suffering from myopathy or recent rhabdomyolysis * patient with psychiatric pathology or chronic alcohol consumption or consumption of another substance that interferes with understanding * lack of contraception for women of child-bearing age * history of or suspected malignant hyperthermia * patients with liver damage, jaundice, unexplained fever or eosinophilia after administration of a halogenated anesthetic * patient has undergone a recent multiple trauma (\<1 month) * patient who received general anesthesia within the past 7 days
l-arginine and sickle cell disease

Conditions: Sickle Cell Disease

Summary: one of the main problems in sickle cell disease is the decreased bioavailability of nitric oxide and arginine. this study was designed to assess if treating sickle cell disease patients with l-arginine would improve pulmonary arterial pressure and other aspects.

this is a phase iii, randomized, double-blind, placebo-controlled clinical trial with sickle cell disease patients older than 1 year of age. the patients were randomly assigned to take 0.1 g/kg/day of either l-arginine or placebo orally. adverse events were monitored by a safety committee. the variables were assessed while patients were in remission, as part of their routine care: weight, blood pressure, full blood cell count, creatinine and dosage of methemoglobin at baseline and at each follow-up visit. peripheral oxygen saturation (spo2), fetal hemoglobin, lactate dehydrogenase and tricuspid regurgitant jet velocity were measured through transthoracic doppler echocardiogram before and after treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of sickle cell disease confirmed through hemoglobin electrophoresis * genotypes ss, sc and sβ thalassemia * age \> 1 year exclusion criteria: * liver dysfunction (alanine aminotransferase alt \> 3 times the normal levels * renal dysfunction (creatinine \> twice the normal levels) * increase in methemoglobin levels (\> 5 times the normal levels) * history of recent stroke (\< 1 month) and priapism * pregnancy * allergy to l-arginine * use of sildenafil, calcium channel blockers, nitroglycerin or other nitrates

Keywords: sickle cell disease l-arginine hemolysis nitric oxide pulmonary arterial hypertension
evaluation of point-of-care tests for the diagnosis of cutaneous leishmaniasis in afghanistan

Conditions: Cutaneous Leishmaniases

Summary: new point-of-care (poc) tests are needed and assessing the performance of these tests for cutaneous leishmaniasis (cl) in afghanistan may help increasing the number of cl patients with access to accurate diagnosis, and enable prompt treatment. simpler tests could improve treatment access and benefit patients and communities, by reducing the risk of sequelae and the risk of disease transmission. cleishpocafg aims to advance the diagnosis of cl by using more accurate and field-amenable methods.

the investigators enrolled 274 cl suspects in the study to determine the diagnostic performance of loopamptm leishmania detection kit and cl detecttm rapid test for cl diagnosis in afghanistan. the study was conducted at the national malaria \& leishmaniasis control program (nmlcp) leishmaniasis clinic in kabul, afghanistan.

Eligibility criteria:
inclusion criteria: * clinical signs compatible with cutaneous leishmaniasis * age ≥ than two years old. * informed consent obtained and documented. * clinical samples can be obtained. exclusion criteria: * age less than two years old. * failure to obtain and document informed consent. * cutaneous leishmaniasis suspects from whom, for any reason, the required clinical samples needed for the study cannot be obtained. * patients already receiving cl treatment at the time of enrolment.

Keywords: cutaneous leishmaniasis rdt lamp pcr
mesh and mesh fixation in laparoscopic groin hernia surgery

Conditions: Hernia, Inguinal; Surgical Mesh; Laparoscopy; Hernia; Hernia, Femoral; Surgical Procedures, Minimally Invasive; Surgical Staplers; Recurrence; Fixation Device; Complications

Summary: the study attempts to quantify the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type. for this purpose the investigators will analyze data from the swedish hernia registry (shr).

this is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in the swedish hernia registry (shr), which covers \> 95% of all groin hernia repairs in sweden. the very large cohort of more than 38,000 tep (totally extraperitoneal) and tapp (transabdominal preperitoneal) repairs enables assessment of the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type, with fulfilling statistical power. each participant was entered at the date of surgery, when demographic and intraoperative data were registered. reoperations were registered in the shr in the same manner as index repairs, and were used as endpoints.

Eligibility criteria:
inclusion criteria: * all laparoscopic (mainly tep and tapp) repairs that have been registered in the shr from january 1, 2005 until december 31, 2018. exclusion criteria: * open repairs. * hernioplasties that were converted from laparoscopic to open surgery. * age \< 15 years. * patients not having a 10-digit state-assigned patient identification number.

Keywords: totally extraperitoneal transabdominal preperitoneal fibrin glue fibrin sealant mesh fixation fixation devices