Kornimate/medical-research-clean huggingface dataset:
intra-articular 0.5 % lidocaine injection for osteoarthritis

Conditions: Chronic Pain

Summary: in this study, investigators compared the efficacy of intra-articular 0.5% lidocaine and saline injection on pain, stiffness and physical function in patients with osteoarthritis.

patients with osteoarthritis were randomly allocated into two groups. group i (n=26) received intra-articular injection of 7 ml 0.5% lidocaine and group ii (n=26) received 7 ml saline into painful knee for 3 times with one week intervals under usg guidance. vas and womac scale including pain, stiffness and physical function was used for the assessment of patients with osteoarthritis. analgesic requirements were also recorded. the primary outcome parameter of this study was the pain scores. the sample size for the primary variable was calculated based on a standard deviation of 20 mm estimated from a previous study. a power analysis with a type ii error of 20% at a two-sided 5% significance level estimated 22 patients per group to be included. investigators included 26 patients per groups for possible missing date. χ2 test for categorical data and independent samples t-test for the comparison of vas and womac scores between groups were used for statistical analysis.

Eligibility criteria:
inclusion criteria: * knee pain for more than 25 of the past 30 days, morning stiffness or less than 30 minutes, crepitation in the knee * pain for more than 25 of the past 30 days and osteophytes on x-ray examination of the knees indicating knee oa exclusion criteria: * the knees with a history of mechanical derangement, fibromyalgia, skin lesions and other risk factors of infection, therapy with anticoagulants and trauma/surgery

Keywords: osteoarthritis lidocaine pain ultrasound
host-pathogen interactions in meningococcal disease: finding the key that fits the lock

Conditions: Meningitis

Summary: at any time, around 10% of people carry meningococcal bacteria in the nose and throat, which can cause meningitis, blood poisoning and other serious illnesses. most people carry these bacteria and never become ill, yet a very small proportion go on to develop these illnesses which can result in life long disabilities or death. the mechanism by which this happens is poorly understood and has been studied in various ways, usually focussing on the bacteria or on the individual, but none has given a definitive answer. this study will be the first of its kind and will assess the interaction between the host and the bacteria at the genetic level, through genetic mapping, helping us to understand what makes some people susceptible to this infection.

at any time, around 10% of people carry meningococcal bacteria in the nose and throat, which can cause meningitis, blood poisoning and other serious illnesses. most people carry these bacteria and never become ill, yet a very small proportion go on to develop these illnesses which can result in life long disabilities or death. the mechanism by which this happens is poorly understood and has been studied in various ways, usually focussing on the bacteria or on the individual, but none has given a definitive answer. this study will be the first of its kind and will assess the interaction between the host and the bacteria at the genetic level, through genetic mapping, helping us to understand what makes some people susceptible to this infection.

Eligibility criteria:
inclusion criteria: * any individual with culture-confirmed imd in england from 01 september 2015 to 31 august 2019 * written informed consent from the individual, the parent (for children aged \<16 years) or next-of-kin (for non-survivors) exclusion criteria: * any individual who does not fulfil the inclusion criteria temporary exclusion criteria: * critically-ill patients and/or their family member will be only approached when the patient starts recovering from their illness or after they are deceased, on the advice of their clinical team.
checkpoint blockade immunotherapy combined with stereotactic body radiation in advanced metastatic disease

Conditions: Metastatic Cancer

Summary: the purpose of this study is to determine whether stereotactic body radiation therapy (sbrt) combined with checkpoint blockaded immunotherapy (cbi) will improve the response to the anticancer treatment compared to cbi alone in patients with advanced metastatic cancer.

patients who will receive anti-pd-1/pd-l1 immunotherapy with at least 1 site of measurable metastatic disease which will not be irradiated will be candidates for the study. patients will be randomized (1:1) to cbi combined with sbrt or cbi alone. sbrt at 9.5gy x3 fractions will be delivered within 1-21 days of the start of first cycle of cbi. the first six patients will be treated and observed for toxicity in the safety run-in phase for 30 days after radiation before continuing with further accrual. radiation dose reduction is allowed if necessary to meet tissue constraints (6gyx3 minimum dose). response rates will be determined from the non-irradiated lesion/lesions. blood draws will be obtained to analyze anti-tumor immune responses.

Eligibility criteria:
inclusion criteria: * patient has one lesion that is treatable with sbrt. * patient has at least 1 site of measurable disease by response evaluation criteria in solid tumors (recist) 1.1 criteria on computed tomography (ct) or magnetic resonance imaging (mri) which will not be irradiated. * histological confirmation of malignancy (primary or metastatic tumor). * patient may have any prior therapy allowed aside from having had prior radiotherapy to the treatment site. * eastern cooperative oncology group (ecog) performance status ≤ 2. * patient's screening laboratory values must meet protocol limits. * patient must have the ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patient has had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * patient receiving any investigational or experimental agents other than immunotherapy. * patient who has had any prior radiotherapy to the treatment site(s). * patient is a pregnant woman (pregnant women are excluded from this study because radiation treatment has known potential for teratogenic or abortifacient effects). * patient refuses to sign informed consent.

Keywords: stereotactic body radiation therapy checkpoint blockade immunotherapy
characterizing the cross-sectional approach to investigate the prevalence of tissue brca1/2 mutations in newly diagnosed advanced ovarian cancer patients

Conditions: Ovarian Neoplasms

Summary: this is a multi-center, observational study in japan. patients with newly diagnosed figo stage iii - iv advanced oc will be enrolled sequentially. in this study, data of 200 subjects will be collected at approximately 20 sites in japan. to reduce regional bias of study sites, the number of enrolled patients per site will be capped

study design:this is a multi-center, observational study in japan. patients with newly diagnosed figo stage iii - iv advanced oc will be enrolled sequentially. in this study, data of 200 subjects will be collected at approximately 20 sites in japan. to reduce regional bias of study sites, the number of enrolled patients per site will be capped. study population:patients with figo stage iii - iv epithelial ovarian cancer drug exposure:not applicable planned study sites and sample size:the objective number of patients will be 200 from approximately 20 hospitals.

Eligibility criteria:
inclusion criteria: * aged 20 years or older of japanese women at the time of consent (the age of death, in case of dead patient) * newly diagnosed as advanced oc (figo stage iii - iv) with epithelial ovarian cancer, primary peritoneal cancer or fallopian-tube cancer \[or a combination of these cancers\] after january 1, 2019 * patients who have archived formalin-fixed paraffin-embedded (ffpe) samples of primary or peritoneal metastatic tumor collected after january 1, 2019 * patients who have undergone or are scheduled to undergo bracanalysis * patients who give their written informed consent to participate in this study (however, the cases of death should be handled in accordance with the instructions of the ethical review board of each site.) exclusion criteria: * patients who are not recommended enrolling this study decided by physician

Keywords: advanced ovarian cancer, brca1/2
predictability of ani (analgesia nociception index) for spinal hypotension

Conditions: Cesarean Section; Spinal Anesthesia

Summary: spinal anesthesia is widely accepted as the anesthetic method of choice for cesarean section. however, the incidence of spinal hypotension is 50-70%, and the decrease in blood pressure is often rapid and severe. heart rate variability is influenced by various factors such as the sympathetic nervous system, parasympathetic nervous system, temperature regulation, baroreflex, and endocrine regulation, but high frequency heart rate variability above 0.15 hz very specifically reflects the parasympathetic nervous system. the ani monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system. this study aims to determine whether ani monitor can predict hypotension in patients undergoing a caesarean section under spinal anaesthesia while applying the preemptive vasopressor phenylephrine infusion protocol.


Eligibility criteria:
inclusion criteria: * full-term parturients undergoing cesarean delivery exclusion criteria: * emergent surgery, placenta previa, morbid obesity with a bmi ≥ 40 kg/m2, gestational age \< 36 or ≥ 41 weeks, contraindications to spinal anesthesia, cardiac arrhythmia, implantable pacemaker, diseases affecting the autoimmune system (such as immune disease or diabetic neuropathy), use of medications affecting ani monitoring (antimuscarinics, alpha-agonists, beta blockers), illiteracy, or foreigners
3-year follow-up study in patients previously treated with tmc435-containing regimen for the treatment of hepatitis c virus infection

Conditions: Hepatitis C

Summary: the purpose of this study is to investigate durability of svr in chronic hcv patients who achieved svr in the previous study with tmc435-containing regimen and time for resistance associated mutations to return to baseline in chronic hcv patients who did not achieve svr in the previous study with tmc435-containing regimen.

this is a 3-year follow-up study in patients who completed the last post-therapy follow-up visit of the previous phase iib \[nct00882908, nct00980330\] or phase iii \[nct01289782, nct01290679, nct01281839\] study in which they received tmc435, in combination with pegylated interferon and ribavirin, for the treatment of hepatitis c infection. the entire study duration for each patients will be approximately 36 months. the medical follow-up of the patients will be performed according to the local standard of care. this study will evaluate the levels of hepatitis c virus in the blood circulation, as well as safety and alpha-fetoprotein testing and the change in sequence of hcv ns3/4a region over time in patients with confirmed detectable hcv rna at last post-therapy follow-up visit of the previous tmc435 study. in this study the development of liver disease progression will also be assessed. no medication will be administered in this study.

Eligibility criteria:
inclusion criteria: * have previously participated in a phase iib or phase iii study * must have received at least one dose of tmc435 in that study * has completed the last post-therapy follow-up visit of the previous (lpvps) study exclusion criteria: * must be currently enrolled or plan to enroll in another study with an investigational drug or invasive investigational medical device * have received antiviral or immunomodulating treatment, including therapeutic vaccines, for hepatitis c virus (hcv) between lpvps and the screening visit of present study

Keywords: hepatitis c hepatitis tmc435 liver disease virus infection
peripheral transcutaneous neuromodulation of the post-tibial nerve for solifenacin 10 mg. hyperactive bladder syndrome

Conditions: Urinary Incontinence

Summary: * to determine if the t-ptns is not inferior in the short term (3 months) to one of the usual pharmacological treatments (solifenacin) in the treatment of hyperactive bladder syndrome and with respect to the percentage of patients that improve 50% any of the 3 signs (urinary frequency, diurnal / nocturnal frequency, urgency and urinary incontinence). * to determine prognostic factors associated with insufficient improvement (less than 50% in the 3 main signs of hyperactive bladder syndrome (urinary frequency, urgency and urinary incontinence frequency) after treatment with t-ptns and solifenacin.

patients will be randomized to receive the usual standard treatment with solifenacin or treatment based on peripheral unilateral transcutaneous neuromodulation of the posterior tibial nerve .

Eligibility criteria:
inclusion criteria: * women\> 18 years, diagnosed with hyperactive bladder syndrome for at least 6 months of evolution and who have taken beta 3 agonists exclusion criteria: * patients who can contribute biased information: have previously consumed and abandoned anticholinergic drugs due to lack of efficacy or side effects; suffering from hyperactive bladder of neurogenic origin (multiple sclerosis, parkinson's, spinal cord injury); present cystocele or any pelvic organ prolapse\> 2 according to pelvic organ prolapse-q classification * patients who may become worse with the interventions envisaged in the study: being a implantable automatic defibrillators; with cutaneous alterations in lower extremities that prevent the placement of electrodes on the surface; women who are pregnant or who may be pregnant during the duration of the clinical trial (prior and at each evaluation visit urine bhcg will be requested to rule out pregnancy) or patients who are not able to manage transcutaneous electrical neurostimulation on an outpatient basis ) or patients in whom solifenacin is contraindicated: urinary retention, severe gastrointestinal disorders (including toxic megacolon), myasthenia gravis, or narrow-angle glaucoma, and in patients at risk of these conditions as hypersensitive at first active or to any of the excipients, undergoing hemodialysis, with moderate hepatic insufficiency or severe renal insufficiency or in simultaneous treatment with a potent inhibitor of cyp3a4, eg ketoconazole.

Keywords: hyperactive bladder syndrome
physiological pacing for av block to prevent pacemaker-induced cardiomyopathy

Conditions: Conduction System Pacing; Conventional Ventricular Pacing

Summary: the implantation of a pacemaker and conventional cardiac pacing from the right ventricle (apex or septum) is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia.

pacemaker implantation and conventional cardiac stimulation from the right ventricle is an effective and safe therapy for the treatment of patients with atrioventricular block and bradycardia. but it can cause worsening of heart function, with a significant drop in lv ejection fraction, known as pacemaker-induced cardiomyopathy (picm). conduction system pacing (either by his or left bundle branch pacing) causes a physiological left ventricular activation through the normal conduction system thus correcting the electrical and mechanical asynchrony caused by conventional pacing. conduction system pacing may prevent the appareance of picm. clinical, electrocardiographic, echocardiographic follow-up will be performed for 1 year.

Eligibility criteria:
inclusion criteria: * the patient must be ≥ 18 years of age. * the patient must indicate their acceptance to participate in the study by signing an informed consent document. * patients with ef\> 50% and indication for pacemaker implantation due to atrial-ventricular block according to current clinical guidelines. exclusion criteria: * inability to understand and sign the informed consent. * patients with severe comorbidities and life expectancy \<1 year. * patients with severe cognitive impairment or other comorbidities resulting in dependence for basic activities of daily life. * patients who cannot come to our center to carry out the follow-up of the study.

Keywords: pacemaker-induced cardiomyopathy
assessment of potential interactions between intravenous cocaine and atomoxetine - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to assess potential interactions between intravenous (i.v.) cocaine and atomoxetine (strattera) administered orally in four escalating doses.


Eligibility criteria:
inclusion criteria: * 18-45 years of age who are not seeking treatment at the time of the study * must be able to provide written informed consent * must be within 20 percent of ideal body weight and weigh at least 45 kg * must meet dsm0iv diagnostic criteria for cocaine abuse or dependence * must currently be using cocaine as confirmed by a positive be * if female and of child bearing potential, must agree to the use of birth control exclusion criteria: - please contact the site directly for more information

Keywords: cocaine dependence
role of anti-trek-1 autoantibodies in scvf

Conditions: Short-coupled Ventricular Fibrillation; Idiopathic Ventricular Fibrillation

Summary: short-coupled ventricular fibrillation (scvf) is a lethal, primary electrical disorder and an important cause of unexplained cardiac arrest.1 recent work from our group suggests that a substantial proportion of scvf cases is associated to circulating autoantibodies targeting trek-1, a cardiac potassium channel, resulting in an abnormal gain-of-function which is the prerequisite for the scvf phenotype.2 this proposal is a translational multicenter study to validate anti-trek-1 autoantibodies as a diagnostic and prognostic biomarker in a large, diversified cohort of scvf patients (figure 1). functional, cellular experiments in patient-derived hipsc cardiomyocytes and purkinje cells will be performed to explore the cell type-specific role of trek-1 in arrhythmogenesis, while single-nuclear rna sequencing (snrna-seq) will allow us to establish the transcriptomic profile (figure 1). these results will identify the cellular substrate for scvf.

please refer to the uploaded study protocol

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of scvf as per current criteria * willingness to provide written informed consent exclusion criteria: - scvf patients \< age 18

Keywords: scvf anti-trek-1
a clinical trial about treatment of mild to moderate persistent alergic rhinnitis with test or reference mometasone (puma)

Conditions: Mild to Moderate Persistent Allergic Rhinitis

Summary: the primary objective will be to compare the impact of the study formulations on alergic rhinitis carriers.


Eligibility criteria:
inclusion criteria: * sign and date the informed consent form or, in case of subjects younger than 18 years, the document must also be signed by a legal guardian; * ≥ 12 years old; * suffer from mild to moderated persistent alergic rhinitis; * total nis scale score ≥ 4 points at the screening visit and within at least 4 of the 7 days before the randomization visit; * indication for use nasal corticosteroid; * present with alergic rhinitis symptoms for at least 2 years; * may undergo a washout period of at least 2 weeks exclusion criteria: * patients with severe alergic rhinitis; * patients with severe co-morbidities (at the investigator's criteria); * patients with mild to severe persistent asthma; * clinical history of infection of the airways 30 days before the study entry; * patients with structural changes causing nasal obstruction, such as pronounced nasal septum deviation, nasal polyps or any other type of nasal malformation; * for female subjects, be pregnant or breastfeeding or planning to become pregnant or unwilling to use safe birth control methods during the study; * subjects in need of other drugs to treat alergic rhinitis, such as anti-immunoglobulin e, immunotherapy, anti-leukotrienes, oral corticosteroids, inhalant corticosteroids, or any administration route other than cutaneous; * active smokers (use of cigarette, pipe, cigar or any other form of tobacco in any amount within the past 3 months before the study entry); * participation in another clinical study within the past 12 months;
aetiology of children with bronchiectasis in china

Conditions: Bronchiectasis

Summary: this multicenter retrospective observation study is designed to investigate the etiology of children with bronchiectasis by review the medical records.

this study is divided into two parts. part i. retrospective review the 10 years medical records of the children with bronchiectasis from every center, and investigate the etiology of the cases by the standard diagnostic process. part ii. all new cases of bronchiectasis which was confirmed diagnosed at every center from the beginning of the study are made the investigation of the etiology by the standard diagnostic process.

Eligibility criteria:
inclusion criteria:a included patient must be coincident at least one point of the four items of hrct manifestations. * internal bronchial diameter greater than the accompanying pulmonary artery. * lack of bronchial tapering * bronchi visible in the peripheral 1cm of lung * bronchial diameter greater than adjacent segmental bronchi exclusion criteria:subject will be excluded if she or he has one of the following * it is unable to provide complete medical records or the current condition can not accept the diagnosis process * it does not agree to participate in the test

Keywords: etiology children
human immune globulin in treating patients with primary amyloidosis that is causing heart dysfunction

Conditions: Multiple Myeloma; Plasma Cell Neoplasm

Summary: rationale: antibodies, such as human immune globulin, can block the growth of abnormal cells in different ways. some block the ability of abnormal cells to grow and spread. others find abnormal cells and help kill them or carry cell-killing substances to them. giving human immune globulin may be effective in treating patients with primary amyloidosis that is causing heart dysfunction. purpose: this phase i/ii trial is studying the side effects and best dose of human immune globulin and to see how well it works in treating patients with primary amyloidosis that is causing heart dysfunction.

objectives: * establish the maximum tolerated dose of human immune globulin intravenous (igiv) given weekly for the first 3 months and then bi-weekly for 9 additional months in patients with cardiac-associated primary light chain-associated (al) amyloidosis. * determine the safety, pharmokinetics, and therapeutic efficacy as evidenced by titers of serum fibril-reactive immunoglobulin g (igg) antibodies pre- and post-igiv infusions. * demonstrate stable or improved organ function. outline: patients receive human immune globulin iv (igiv) once weekly for 3 months and then once biweekly for 9 months, for a total of 12 months in the absence of disease progression or unacceptable toxicity. patients undergo blood sample collection to measure serum anti-fibril antibody titers pre- and post- igiv infusion for assessing safety and response to treatment.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cardiac-associated primary (al) amyloidosis based on accepted clinical and laboratory criteria * patients must have heart involvement as evidenced by elevated serum brain natriuretic peptide (bnp), troponin levels, and/or 2d echocardiography evidence of a thickened intraventricular septum (ivs). * life expectancy \> 3 months * prior or concurrent chemotherapy or other drug-based anti-al regimes allowed exclusion criteria: * non-al amyloidosis * new york heart association (nyh) class iv heart disease * significant comorbidity (e.g., uncontrolled infection, diabetes, or other serious illnesses)

Keywords: primary systemic amyloidosis