Kornimate/medical-research-clean huggingface dataset:
breast cancer, sexuality and black cohosh

Conditions: Sexuality

Summary: the purpose of this study is to evaluate the cimicifuga racemosa effects on the sexuality of women with breast cancer using tamoxifen or aromatase inhibitor through questionnaires.

for the study will be recruited 60 women treated with breast cancer, using tamoxifen or aromatase inhibitor, are in menopause, hot flashes and has with or without sexual life. they will answer the questionnaires: kupperman, world health organization quality of life (whoqol) and those sexually active will have female sexual function index (fsfi). the control group will have 30 patients using tamoxifen alone or inhibitor. the other group will have 30 patients receiving tamoxifen or inhibitor and will start with 2 tablets per day of dry extract of cimicifuga racemosa. they will be followed for 6 months and answer questionnaires at the first visit, 3-month and 6-month follow-up.

Eligibility criteria:
inclusion criteria: * menopausal women with breast cancer treated and using tamoxifen or aromatase inhibitor. * with hot flashes and with or without active sexual life. exclusion criteria: * women did not have breast cancer * do not use tamoxifen or aromatase inhibitor * not in menopause and not have hot flashes
botox on vulvar vestibulitis

Conditions: Vulvar Vestibulitis; Vulvar Diseases

Summary: the study seeks to evaluate the effect of botulinum toxin on vulvar vestibulitis (vvs) after local injection with botox, a potential treatment to relieve patients of vulvar pain, reducing the need for painkillers, and improving the sexual quality of life of the patients.

vulvar vestibulitis (vvs) is characterized by pain confined to the vulvar vestibule that occurs upon touch and attempted introitus entry ( e.g. intercourse, tampon insertion), with minimal associated clinical findings. the aetiology of vvs is not well established and many variables have been associated with the condition, e.g. neuropathy secondary to inflammation. injection of botulinum toxin is tested as a therapeutic option for this condition. a temporary paralytic effect on the surrounding skeletal muscle hypertonicity is seen and earlier in cases described as a successful treatment of pelvic floor dysfunction, dyspareunia and interstitial cystitis.

Eligibility criteria:
inclusion criteria: * vulvar vestibulitis * safe birth control exclusion criteria: * treated earlier with botulinum toxin * ongoing vulvar infection * age\<18 * skin disease * pregnancy * myasthenia gravis * amyotrophic lateral sclerosis (als) * diabetes * using: * calcium antagonists; * aminoglycosides; * magnesium sulfate; * systemic steroid treatment
evaluation of cognitive-communication deficits following treatment of primary brain tumor patients

Conditions: Brain Tumor

Summary: this study is to evaluate which cognitive-linguistic symptoms are most commonly experienced following brain tumor treatment. cognitive surveys will be administered after treatment of primary brain tumor cancer.


Eligibility criteria:
inclusion criteria: * be between18 to 89 years old; * have undergone at least one cycle of a cancer treatment regimen (e.g., chemotherapy, radiotherapy, surgery) * have completed at least one cycle of a cancer treatment regimen within five years of enrollment in the study; * be native speakers of american english; * have obtained a minimum of a high school education; * self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the fact-br; and * must demonstrate capacity to sign informed consent based on informed consent for research: a guide to assessing a participant's understanding tool. exclusion criteria: * are younger than 18 years old or older than 89 years old; * have not undergone at least one cycle of a cancer treatment regimen following diagnosis (e.g., chemotherapy, radiotherapy, surgery) * have not undergone at least one cycle of a cancer treatment regimen in the five year period prior to enrollment; * are not native speakers of american english; * have not obtained a minimum of a high school education; * do not self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the fact-br; or * do not demonstrate the capacity to sign informed consent
evaluation of auto antibodies in oral sub mucous fibrosis

Conditions: Oral Submucous Fibrosis

Summary: the etiology of osmf is considered to be multifactorial. however, role of autoimmunity had been suggested as one of the factors but remains unproven. the present study is undertaken to evaluate the presence of auto antibodies in osmf patients to pave a way for new arena of treatment with the etiology of this persistent condition

oral submucous fibrosis (osmf) is a potentially malignant disorder affecting any part of the oral cavity, sometimes pharynx associated with juxta epithelial fibrosis causing progressive trismus leading to dysphagia. it is mainly seen in the asian countries with more prevalence in india. etiology of osmf is considered to be multifactorial. however, it is strongly associated with the use of arecanut in various forms and also in combination with other compounding factors. autoimmunity had been suggested as one of the factors yet unproven. few studies reveal that there is high incidence of autoantibodies including antinuclear (ana), anti smooth muscle (sma), anti thyroid microsomal (tma), and anti reticulin antibodies in osmf patients. these findings have not been consistent in further studies which needs further more research in this. a study concentrated on quantitation of circulating immune complexes (cic) levels which was established in patients with oral cancer and oral precancerous lesions. the levels were compared with that in normal controls and chronic chewers of betel quid with no signs of any disease. both patients with oral cancer and oral precancerous lesions had elevated cic when compared to both the control groups. the most interesting observations were (a) the cic levels in the chewing controls were significantly raised when compared to normal controls; and (b) the cic levels in the patients with premalignant lesions were elevated almost to the same levels as in the oral cancer patients. hla-typing was carried on areca nut chewers. however, it was unable to demonstrate a specific pattern of hla-antigen frequencies in chewers with or without the disease. it is not necessarily a hla-associated susceptibility in oral submucous fibrosis. due to less number of articles published on autoantibodies, this study is done to evaluate the presence of such auto antibodies in osmf patients thereby paving way for new arena of treatment on par with the etiology of this persistent condition.

Eligibility criteria:
inclusion criteria: * patients who are willing for the study. * a positive history of chewing arecanut, and/or smoking tobacco and alcohol. * patients with clinical and histopathological features of oral submucous fibrosis. * patients with osmf not under any treatment for the same exclusion criteria: * unwilling patients who do not want to be part of the study. * patients with known autoimmune disorders.

Keywords: autoantibodies, oral submucous fibrosis
cardiac arrhythmias in dravet syndrome

Conditions: Epilepsy

Summary: summary rationale: people with dravet syndrome (ds), a rare epilepsy syndrome, have a high risk of sudden unexpected death in epilepsy (sudep). mouse models indicated that the responsible sodium channel mutation (scn1a) not only alters cortical excitability but also increases the propensity to arrhythmias. little is known yet about the prevalence of seizure-induced arrhythmias in human ds subjects. objective: to assess the prevalence of cardiac arrhythmias in ds and to compare the prevalence of cardiac arrhythmias between ds subjects and subjects with other types of epilepsy. study design: observational study. study population: subjects with dravet syndrome and a known pathogenic scn1a mutation, seizure frequency ≥ 1/week (all seizure types except for absences or myoclonias), age ≥ 6 years and no signs of self-harm. each case will be matched to two historical controls (age +/- 5 years) from the eeg databases of the participating centres. only those controls with two or more recorded seizures will be matched to the cases. intervention: not applicable main study parameters/endpoints: ictal asystole ictal bradycardia ictal qt-shortening/lengthening nature and extent of the burden and risks associated with participation, benefit and group relatedness: participation does not carry risks. the sensor is wearable and miniaturised, thus minimising discomfort. if this nevertheless may occur, the study can be terminated. this study provides specific tools to investigate the seizure-related heart rate response. subjects may thus benefit from participation by identification of otherwise unknown arrhythmias. the rationale of the study (the high sudep risk and the evidence in animal studies for arrhythmic cause of sudden death) specifically applies to ds, a rare epileptic syndrome including minors and incapacitated persons. the investigators believe that the lack of risks, the potential diagnostic benefit, the minimal intervention with novel and wearable sensors and the possibility to terminate the study in case of discomfort, justifies the study in this patient group.


Eligibility criteria:
criteria: cases must meet all of the following criteria: 1. ds with a known pathogenic scn1a mutation 2. seizure frequency ≥ 1/week (all seizure types expect for absences or myoclonias) 3. no self-harm 4. age ≥ 6 years each case will be matched to two historical controls (age +/- 5 years). controls will meet the following criteria: 1. definite diagnosis of epilepsy 2. no clinical suspicion of ds 3. at least two seizures recorded (all seizure types expect for absences or myoclonias) during video-eeg registration. 4. age ≥ 6 years

Keywords: dravet syndrome sudden unexpected death in epilepsy (sudep) arrhythmias
snow disease surveillance system study

Conditions: Communicable Diseases

Summary: the study investigates whether shared online access to epidemiological data for general practitioners, disease prevention officers, emergency care services and microbiology laboratories changes clinical practice with regard to testing, diagnosing and treatment of communicable diseases. the main hypothesis is that "online access for general practitioner to epidemiological data about communicable diseases changes clinical practice for testing, diagnosing and treatment of communicable diseases".

we will collect data from general practitioners (gp) offices by installing local data extraction solutions. each installation will build a local anonymous database of gp consultations extracted from the local electronic patient record (epr) system. these anonymous data records will be used to produce local disease statistics before they are exported to a centralized server available in the norwegian health network. the centralized server will produce daily reports about the epidemiological situation in the patient population. we will combine the syndromic data from the gp offices with data from the microbiology laboratories on the hospitals that covers the study areas. the epidemiological data will be made available to the intervention areas in the study through web based and customized client applications. by using data extracted from the gp offices epr databases and the microbiology laboratories we will investigate the study hypothesis.

Eligibility criteria:
inclusion criteria: * volunteering general practitioner (gp) working in a gp office exclusion criteria: * the gp does not use a electronic patient record (epr) system

Keywords: communicable diseases epidemiology population surveillance computerized medical record data collection
a study of letrozole in the treatment of endometrial cancer

Conditions: Recurrent and Metastatic Endometrial Cancer

Summary: currently available treatments for endometrial cancer are associated with limited efficacy and significant toxicity. this study will assess the safety and efficacy of letrozole, an aromatase inhibitor, on endometrial cancer.


Eligibility criteria:
inclusion criteria * postmenopausal women with recurrent or metastatic adeno- or adenosquamous carcinoma of the endometrium * no adjuvant therapy * up to one prior hormonal (progestin) therapy for advanced/metastatic disease allowed * no chemotherapy for recurrence (adjuvant permitted) * unidimensionally measurable disease * good health status 0-2 (eastern cooperatitve oncology group) * no prior tamoxifen or aromatase inhibitor therapy * no other concurrent anti-cancer treatment * no metastases in the central nervous system exclusion criteria: additional protocol-defined inclusion/exclusion criteria may apply

Keywords: endometrial cancer aromatase inhibitor letrozole
predictor of clinical response to acthar in myositis

Conditions: Myositis; Dermatomyositis; Polymyositis

Summary: comparing the clinical effects of acthar gel before and after treatment and compare it to patients with inactive disease.

to compare the clinical impact of acthar gel at the cellular and molecular level before and after treatment and compare it to patients with inactive disease. the cohort of active myositis subjects are not actually enrolled in this study, but rather the data for those with active myositis will be obtained from a previously completed trial entitled "efficacy and safety of adenocorticotropic hormone gel in refractory dermatomyositis and polymyositis".

Eligibility criteria:
inclusion criteria: * healthy controls: * an individual will be eligible to be a control subject if his/her age is 18 years or greater. * myositis remission control group * definite or probable pm or dm by bohan and peter criteria. * pm patients must either possess a myositis-associated autoantibody or undergo adjudication for confirmation of the pm diagnosis by consensus of two experts (aggarwal or oddis) to ensure non-pm patients are not enrolled. this step is necessary since there are well known mimics of pm. * age is greater than or equal to 18 years * remission of myositis as defined by a myositis disease global activity score \<1 on the mdaat and no new immunosuppressive or glucocorticoid therapy or dose change within one year. exclusion criteria: * healthy controls: * an existing diagnosis of a ctd * a potential immune compromised state, for example, treatment with immunosuppressant or anti-rejection medication or a diagnosis of an immune deficiency disease * myositis remission control group: * juvenile dm or pm, myositis in overlap with another connective tissue disease, cancer associated myositis, inclusion body myositis, or any other non immune mediated myopathy. * severe muscle damage defined as a baseline global muscle damage score on the mdi (myositis damage index) of greater than or equal to five centimeters on a ten centimeter vas. * patients with malignancy within three years of screening (except basal cell cancer or squamous cell cancer of skin. * uncontrolled diabetes, hepatic or renal disease.

Keywords: pm dm
outcome of coronary high angulated bifurcation lesions treated with kissing ballooning or sequential ballooning techniques

Conditions: Stable Angina

Summary: coronary artery bifurcation lesions prone to occur with the worsening of atherosclerosis. their structural properties make angioplasty technique to increase the difficulty of implementation, but also increased the risks of the in-stent thrombosis and restenosis. standard treatment of coronary bifurcation lesions remains controversial manner, especially when the side branch (sb) was large combined with high angulated bifurcation lesions. complex procedures and certain types of lesions are associated with poor prognosis. there is no standard treatment for such lesions even with the development of drug-eluting stents solve partial problems. the investigators reviewed patients who received coronary intervention between 2009-2012 years and met the inclusion criteria, and then analyzed the prognostic relevance of these cases the use of different treatment modalities. we introduced a retrospective analysis for high angulated bifurcation lesions treated with either des or bms. primary endpoint: cardiovascular mortality, tlr, mace. secondary endpoint: procedure time, fluoroscopy time, procedure success, angiographic success.


Eligibility criteria:
inclusion criteria: * angulated bifurcation:mv(main branch) and sb(side branch) angle\>70 degree. mv diameter≥2.5mm and eligible for stenting. lesion stenotic severity\>70% by qca(quantitative coronary analysis). 1 stent strategy. syntax\>22 procedure success. de novo lesion exclusion criteria: * bifurcation lesions intervention without side br. ballooning after stents deployment or procedure incomplete. left main coronary artery bifurcational lesions. elective,provisional or bail-out stenting for side br.

Keywords: stable angina high angulated bifurcation syntax des bms
inflammatory response in myocardial infarction evaluated by mri and biomarkers

Conditions: Myocardial Infarction

Summary: an intense inflammatory reaction is triggered by the ischemic injury during myocardial infarction. the inflammatory processes involved are complex and haven't been explored in detail in human patients. this inflammatory response can increase myocardial damage following reperfusion, leading to adverse remodeling and adverse events (heart failure, sudden cardiac death). cardiac mri can assess the size of myocardial infarction and many other parameters associated with myocardial injury: edema, hemorrhage, micro-vascular obstruction. (however the association between biomarkers of inflammation and these imaging parameters is not known). there is very little data correlating imaging markers of myocardial injury to the biokinetics of inflammation biomarkers. in this study, the aim is to assess the relationship between the kinetics of specific inflammatory biomarkers (interleukin-1beta, interleukin 6, interleukin 17, tumor necrosis factor (tnf)-alpha, c reactive protein (crp), soluble toll-like receptor-2 (st2), neutrophils) and imaging markers of injury measured by cardiac mri at the acute phase in 20 acute mycardial infarction (ami) patients.


Eligibility criteria:
inclusion criteria: * all patients, aged over 18, without any legal protection measure, * having a health coverage, * presenting within 12 hours of the onset of chest pain, * who have st segment elevation ≥0.2 millivolt (mv) in two contiguous leads, * for whom the clinical decision was made to treat with percutaneous coronary intervention (pci). * he culprit coronary artery has to be the left anterior descending (lad) or the right coronary (rc) * the lad or rc artery has to be occluded (timi flow grade 0-1) at the time of admission coronary angiography. * preliminary oral informed consent followed by signed informed consent as soon as possible * final timi ≥ 2 exclusion criteria: * female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis). * patients with cardiogenic shock * patient in cardiac arrest * history of myocardial infarction * contre-indication to mri : claustrophobia, pacemaker or cardiac defibrillator , eye metal body allergy to gadolinium * patient with atrial fibrillation. * patients with loss of consciousness or (glasgow \<14) * known renal insufficiency (either known creatinin clearance \< 30 ml/min/1.73m² or current medical care for severe renal insufficiency) * patients with any disorder associated with immunological dysfunction * adult with legal protection measure

Keywords: myocardial infarction mri inflammatory biomarkers
safety and tolerability study of oral opc-34712 as maintenance treatment in adults with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to assess the long-term safety, tolerability and efficacy of oral opc-34712 as monotherapy in adults with schizophrenia.

schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. the first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as hyperprolactinemia and weight gain. in addition, the safety of these drugs vary considerably.

Eligibility criteria:
inclusion criteria: 1. male or female subjects between 18 and 65 years of age, with a diagnosis of schizophrenia, as defined by dsm-iv-tr criteria 2. outpatient status at last visit of trial 331-10-230 or trial 331-10-231 3. willing to discontinue all prohibitive psychotropic medications to meet protocol required washouts prior to and during the trial period. 4. other protocol specific inclusion criteria may apply. exclusion criteria: 1. females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug 2. subjects with a current dsm-iv-tr axis i diagnosis of: * schizoaffective disorder * mdd * bipolar disorder * delirium, dementia, amnestic or other cognitive disorder * borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder 3. subjects presenting with a first episode of schizophrenia 4. other protocol specific exclusion criteria may apply.
myofascial induction effects on stabilometry versus sham laser

Conditions: Foot Diseases; Myofascial Pain

Summary: the objective is to determine the effectiveness of myofascial induction effects on stabilometric variables. forty healthy subjects will be recruited for a single blind clinical trial. all subjects will be randomly distributed into two different groups: control group (simulated laser) and experimental group (myofascial induction). result measurements will be performed in the center of the pressure area (stabilometry) using a validated platform. two trials will be recorded for each condition (eyes closed and eyes open)


Eligibility criteria:
inclusion criteria: * healthy individuals without pain. exclusion criteria: * previous lower extremities surgery * history of lower extremities injury with residual symptoms within the last year * evidence of a leg-length discrepancy of more than 1 cm * evidence of balance deficits
the relationships between the noradrenergic, opioid and pain system

Conditions: Experimental Pain Perception

Summary: the role of alpha2 receptor agonist on pain perception and modulation will be examined. in addition whether this is mediated through the opioid system will be examined. pain perception and modulation will be examined before and after administration of clonidine or placebo together with naloxone or saline.


Eligibility criteria:
inclusion criteria: * healthy volunteers * age 18-40 * no chronic disease exclusion criteria: * subjects who suffer from chronic pain / pain syndrome * use of anti-depressant or anti-psychotic drugs * suffering from cardiovascular disease * breast feeding