Kornimate/medical-research-clean huggingface dataset:
evaluation of response to biosimilar erythropoietin alfa therapy in anemic patients with myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes (MDS)

Summary: the primary objective of this study is to describe the response to treatment with biosimilar epo alpha in mds patients who had already been treated with "originator" epo alpha and were responsive, and in patients who started treatment with biosimilar epo alpha

to date, therapy with erythropoiesis-stimulating agents (esas) has been shown to be effective in the treatment of symptomatic anemia in patients with myelodysplastic syndrome ( mds) at low to intermediate risk, with the percentage of responsive patients ranging from 15 to 63%, depending on the characteristics of the patients treated, and averaging 45%. significant improvement in survival and quality of life was observed in treatment-responsive patients compared with non-responsive patients. recently, biosimilar esas have been introduced into clinical practice, and in patients with renal failure anemia and anemia associated with antineoplastic chemotherapy, their efficacy and safety have been demonstrated. however, data on the efficacy and safety of biosimilar esas in patients with mds are scarce to date, and efficacy and safety data for the purpose of their approval have been mainly extrapolated from studies conducted in patients with anemia from renal failure and anemia from antineoplastic chemotherapy. in these conditions bone marrow erythropoiesis is reduced but not qualitatively impaired as in mds. these considerations may justify a retrospective study examining the efficacy and safety of biosimilar epo alpha in a real-life setting in anemic mds patients.

Eligibility criteria:
inclusion criteria: mds patients with symptomatic anemia (pre-treatment hemoglobin \< 10g/dl) who started treatment with biosimilar epo alpha, diagnosed according to the who 2016 classification, and characterized by very low, low, or intermediate ipss-r risk and a pre-treatment serum epo level \< 500 u/l, who started treatment with biosimilar epo alpha at the u. o. of hematology of irccs aoubo during the period from 01/06/2018 to 31/12/2021. * age ≥ 18 years at the time of enrollment * acquisition of informed consent to study participation and data processing exclusion criteria: * - presence of other possible contributory causes of anemia (e.g., anemia from chronic inflammatory disease, hemolysis, hemorrhage) * poor compliance with treatment * very impaired general clinical condition (ecog performance status \> 3) * concomitant treatment with antineoplastic cytotoxic drugs
antihypertensive effect of fermented milk with lactococcus lactis on prehypertensive subjects

Conditions: Hypertension

Summary: the objective of the present work was to evaluate the antihypertensive effect associated with the consumption of fermented milk with lactococcus lactis nrrl-b50571 on prehypertensive subjects.

a double-blind randomized controlled clinical study of an 8-week intervention with 36 hypertensive subjects was carried out to evaluate the antihypertensive effect of fermented milk with lactococcus lactis nrrl-b50571. once obtained the informed consent; volunteers were randomized into two groups (n=18) to either receive 150 ml daily: fermented milk with lactococcus lactis nrrl-b50571 (intervention group) or artificially acidified milk as control (placebo). both drinks were consumed daily. participants were asked not to change their diet or lifestyle during the intervention. we applied intention to treat for those participants who did not have good adherence and those who withdraw the study. the outcomes between groups were analyzed using an independent sample student t test, with a p value of 0.05 or less (two sided) when there was statistical significance; using statistical software.

Eligibility criteria:
inclusion criteria: * systolic blood pressure \>130 mmhg * diastolic blood pressure \> 85 mmhg exclusion criteria: * pregnant women * cardiovascular diseases * diabetes * cancer * dairy allergy * lactose intolerance * patients receiving angiotensin converting enzyme inhibitors as pharmacological therapy

Keywords: hypertension fermented milk clinical study randomized double-blind
evaluation of the prevalence of functional digestive disorders during primary sjögren gougerot syndrome

Conditions: Sjogren's Syndrome; Digestive System Abnormalities

Summary: the investigators propose to carry out a prospective study consisting of a systematic research of digestive symptoms in patients with sgsp with the validated global symptom score (gss) questionnaire, which allowed to grades severity of 10 digestive symptoms (absent, mild, moderate, or severe), asthenia and fever.

primary sjögren syndrome (sgsp) is an autoimmune disease defined by the association of sicca syndrome in the absence of other connective tissues (ie rheumatoid arthritis, systemic lupus erythematosus, scleroderma, dermatopolymyositis). sgsp is complicated by several visceral involvements (pulmonary, renal, neurological, systemic vasculitis ...) and by a chronic alteration of the quality of life related to asthenia, chronic pain and sicca syndrome. two european-validated scales are currently used in daily clinical practice to assess these two facets of the disease, respectively eussar sjogren's syndrome patient reported index (esspri) and essdai (eular sjögren's syndrome disease activity index). neither of these two scores evaluate the digestive impairment. indeed, digestive complaints have been evaluated in a few studies, with a prevalence of 30 to 65%. the precise etiopathogeny of such digestive involvements remains unknown.

Eligibility criteria:
inclusion criteria: * patients with sgsp according to revised american-european criteria * patients 18 years of age or older * patients affiliated to the french social security care system. exclusion criteria: * patients under measure of maintenance of justice. * patients unable to understand or to participate to the study. * child and major patients making the object of a measure of lawful protection. * patients deprived of freedom. * concomitant interventional clinical trial

Keywords: primary sjögren syndrome - digestive symptoms
non-invasive plasma treatment for cervical infections: targeting high- and low-risk hpv variants

Conditions: HPV Infection; Cervical Cancer

Summary: this is a prospective, single-center, observational proof-of-principle clinical trial at the department of women's health of the university hospital tübingen.

the aim of this study is to investigate the hpv (human papillomavirus)-eradicating efficacy of nipp (non-invasive physical plasma) in patients with confirmed hpv infection but without cervical dysplasia. another objective is to examine cellular/molecular/immunological effects of nipp on the cervix through molecular biological methods following in-vivo treatment. tissue samples will be obtained at defined intervals via minibiopsy, and analyses will be conducted using molecular biological, histological, and microscopic methods, potentially in collaboration with other research institutes.

Eligibility criteria:
inclusion criteria: * inclusion criteria for nipp treatment * age ≥ 18 years * mrna or dna-based virus detection by smear (also external findings) * clearly visible transformation zone of the cervix and margins of the lesions corresponding to t1/t2 * written informed consent to participate in the study * inclusion criteria for control group * age ≥ 18 years * swab-based mrna or dna-based virus detection (also external findings) * clearly visible transformation zone of the cervix corresponding to t1/t2 * written informed consent to participate in the study exclusion criteria: the following exclusion criteria apply to both groups of patients (nipp treatment and control group). * transformation zone not fully visible * evidence of invasive disease * serious cardiovascular diseases
human papillomavirus (hpv) infection in pregnancy

Conditions: Papillomavirus Infections; Pregnancy Complications

Summary: the purpose of this study is to determine if maternal infection with human papillomavirus (hpv) is associated with pregnancy complications including spontaneous preterm delivery (sptd), severe preeclampsia (pe), and poor fetal growth.


Eligibility criteria:
inclusion criteria: * all women presenting for prenatal care at the hospital of the university of pennsylvania or affiliated clinics exclusion criteria: * multiple gestations * medical conditions such as diabetes, chronic hypertension, renal disease * fetal malformations or chromosomal anomalies * fetal death

Keywords: hpv pregnancy
a study to evaluate the safety, tolerability, and blood levels of pf-03654746 in subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is a study to evaluate the safety, tolerability and blood levels of pf-03654746 in subjects will mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * probable alzheimer's disease * mini mental state examination score 18-26 inclusive * aged 55-85 exclusion criteria: * dementia other than alzheimer's disease * clinically significant cardiovascular disease in the past 6 months prior to screening * creatinine clearance \<30 ml/min

Keywords: phase 1 alzheimer's disease safety tolerability pharmacokinetics
t regulatory and childhood asthma

Conditions: Childhood Asthma

Summary: this is an epidemiologic study, examining environmental exposures and affect on immune development.

this is an epidemiologic study, examining environmental exposures and affect on immune development. the study has completed enrollment

Eligibility criteria:
inclusion criteria: * moderate to severe asthma exclusion criteria: -
a phase 2 exploratory study of cs-3150 in japanese hypertensive patients with moderate renal impairment

Conditions: Hypertension

Summary: this study is a multi-center, open label, dose titration, exploratory study to evaluate efficacy and safety of cs-3150 in japanese hypertensive patients with moderate renal impairment. primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.


Eligibility criteria:
inclusion criteria: * men and women aged 20 years or older and 80 years or younger at informed consent * subjects with hypertension (sitting systolic blood pressure sbp \>= 140 mmhg and \ = 80 mmhg and \< 110 mmhg) * estimated glomerular filtration rate egfr \>= 30 ml/min/1.73 m2 and \< 60 ml/min/1.73 m2 exclusion criteria: * secondary hypertension or malignant hypertension * diabetes mellitus with albuminuria * serum potassium level \ = 5.1 meq/l * subjects under insulin treatment * subjects under or pre-planned for hemodialysis

Keywords: hypertension moderate renal impairment mineralocorticoid receptor antagonist cs-3150 japanese
effect on anxiety in pediatric patients; successful randomized controlled trial

Conditions: Anxiety

Summary: preoperative anxiety is characterized by subjective emotions such as irritability, irritability, sadness, and unhappiness. studies have shown that preoperative anxiety negatively affects children both psychologically and physiologically. preoperative anxiety occurs in 60-80% of children undergoing anesthesia and surgery and is associated with undesirable consequences such as nightmares, separation anxiety, eating disorders, negative behavioral changes such as increased fear of doctors, increased need for analgesics. the aim of this study is to evaluate the preoperative and pre-sedation anxiety levels in pediatric patients by explaining the peroperative process to the patients with drawings.


Eligibility criteria:
inclusion criteria: * asa i patients without any comorbidities who were operated on by the ent, * patients between the ages of 5-12, * and patients who could be contacted and did not have any anxiety problems were included. exclusion criteria: * patients with liver and/or kidney failure, trauma patients, asaii-iii-iv patients, patients with bleeding disorders, * those using medications that would affect the coagulation system, patients with local anesthetic allergy, patients with immobility and malnutrition, .and patients who did not want to participate in the study were excluded from the study.

Keywords: perioperative anxiety pediatric general anhesthesia
study of botulinum toxin type a (botox®) to treat urinary incontinence from neurogenic detrusor overactivity in belgium

Conditions: Urinary Incontinence

Summary: this study will evaluate the impact of botox® treatment on anticholinergic drug use in patients with urinary incontinence from neurogenic detrusor overactivity (ndo) due to spinal injury or multiple sclerosis (ms) who are prescribed botox® as standard of care in clinical practice.


Eligibility criteria:
inclusion criteria: * patients prescribed botox® for urine incontinence from ndo due to spinal injury or ms as standard of care in clinical practice in belgium * previous treatment with anticholinergic drugs ineffective * last botox® treatment ≥18 months. exclusion criteria: * diagnosis of urinary incontinence less than 9 months. * no anticholinergic drug use in the last 9 months.
carmustine in treating patients with recurrent malignant glioma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma.

objectives: * determine the safety of polifeprosan 20 with carmustine implant (gliadel) in patients undergoing surgery for recurrent malignant glioma. outline: this is a dose escalation study. all patients undergo maximal tumor resection. at the time of surgery, groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity. patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation, and are removed from study. patients are followed 3, 6, and 12 months after implantation. projected accrual: a total of 52 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * pathologically confirmed recurrent malignant glioma for which surgery is indicated * unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced ct or mri patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * at least 8 weeks hematopoietic: * wbc at least 3,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin, ast, alt, and alkaline phosphatase less than 2.5 times normal renal: * creatinine less than 1.5 times normal * bun less than 2.5 times normal * protein no greater than 3 g/dl * no gross hematuria other: * no hypersensitivity to nitrosoureas * not pregnant * fertile patients must use effective contraception * no concurrent life threatening disease prior concurrent therapy: biologic therapy: * no concurrent immunotherapy during first 8 weeks of study chemotherapy: * at least 4 weeks since chemotherapy (6 weeks since nitrosoureas) * no concurrent chemotherapy during first 8 weeks of study endocrine therapy: * not specified radiotherapy: * prior definitive external-beam radiotherapy (i.e., at least 5,000 cgy) required * no concurrent radiotherapy or brachytherapy during first 4 weeks of study surgery: * prior cytoreductive surgery for supratentorial brain tumor required * biopsy alone not sufficient other: * no concurrent investigational therapy during first 8 weeks of study

Keywords: recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult anaplastic ependymoma adult anaplastic oligodendroglioma adult mixed glioma adult ependymoblastoma adult giant cell glioblastoma adult gliosarcoma
"living together with dementia"_creation and validation of a training program for family caregivers of people with dementia to live at home

Conditions: Dementia

Summary: this study aims to experimentally evaluate the training program for family caregivers of people with dementia_"living together with dementia."

this study will begin in march 2016, with the initial assessment of family caregivers of people with dementia. these were recruited through hospital neurology clinic and must comply with a set of pre-established criteria. it is expected a total of 20 participants in the study (10 in the experimental group and 10 in control group). interventions will take place over the months of march and april. the final evaluation is scheduled for late april and the follow up to july 2016. an evaluation document itself for this study was built.

Eligibility criteria:
inclusion criteria: * be primary caregiver of the person with dementia * be able to read and write * carers of peolpe with dementia in initial or moderate stage exclusion criteria: * the person with dementia have severe mental pathologies associated

Keywords: family caregivers training programme dementia
the effects of ultrasonic noise exposure on human hearing

Conditions: Hearing Loss

Summary: the aim of this research is to investigate the effects of ultrasonic noise exposure on the human auditory system (how it effects hearing). current international regulations concerning ultrasound exposure differs significantly and are based on scarce and outdated scientific data; hence the motivation for this research. a cohort of 20 audiometrically healthy volunteers will undergo pure tone audiometry (pta); a standard test for hearing sensitivity, at both pre and post exposure to ultrasonic noise (40khz for 15 min at 120 db spl). a subgroup of 10 subjects will be used as a control group. the resulting audiograms will establish the extent of any recoverable loss in hearing sensitivity known as temporary threshold shifts (tts).


Eligibility criteria:
inclusion criteria: * adult, audiometrically healthy exclusion criteria: * underlying/pre-existing hearing impairment

Keywords: ultrasound, hearing
a study to assess the safety, tolerability, and efficacy of long-term sobi003 treatment in pediatric mps iiia patients

Conditions: Sanfilippo Syndrome Type A (MPS IIIA)

Summary: mps iiia, also known as sanfilippo a, is an inherited lysosomal storage disease (lsd). mps iiia is caused by a deficiency in sulfamidase, one of the enzymes involved in the lysosomal degradation of the glycosaminoglycan (gag) heparan sulfate (hs). the natural course of mps iiia is characterized by devastating neurodegeneration with initially mild somatic involvement. the aim of the present study is to assess the safety, tolerability and efficacy of long-term sobi003 treatment. sobi003 is a chemically modified recombinant human (rh) sulfamidase developed as an enzyme replacement therapy (ert).

this is an open, single-arm, multicenter extension study to assess the safety, tolerability and efficacy of long-term sobi003 treatment in pediatric mps iiia patients. the study is an extension of the first in human (fih) sobi003-001 study, allowing continuous treatment of sobi003 for up to 2 years. study patients who complete week 24 of the fih study (sobi003-001) will be invited to continue to week 25 in the extension study. when entering the extension study, these patients will receive the highest dose that has been declared safe in the ongoing fih study (sobi003-001). upon completion of the fih study, an analysis aimed at selecting the dose for forthcoming studies will take place. once the dose has been selected, this dose will be applied to all patients enrolled in the extension study. the total duration of the extension study for an individual patient is 80 weeks, resulting in a total of 104 weeks (2 years) of sobi003 treatment.

Eligibility criteria:
inclusion criteria: * completion of study sobi003-001 * informed consent obtained from the patient´s legally authorized representative exclusion criteria: * if, in the opinion of the investigator, there are patient specific safety concerns that contraindicates further treatment with sobi003
a study of a-101 topical solution administered twice a week in subjects with common warts

Conditions: Common Wart

Summary: the primary objective of this study is to evaluate the effectiveness of a-101 compared to vehicle when applied to 1 target common wart on the trunk or extremities twice a week.

the primary objective of this study is to evaluate the effectiveness of a-101 compared to vehicle when applied to 1 target common wart on the trunk or extremities twice a week. the secondary objectives of this study are to evaluate the clinical effect of a-101 when applied to all treated warts (target warts plus non-target warts) twice a week, duration of response in all treated warts (target warts plus non-target warts), and safety of a-101.

Eligibility criteria:
inclusion criteria: * subject is able to comprehend and is willing to sign an informed consent/assent for participation in this study. * male or female ≥ 8 years old. * subject chemistry and complete blood count results are within normal limits. if any of the laboratory values are outside normal range, the treating investigator must assess the value/s as not clinically significant and document this in the subject's medical chart in order for the subject to be eligible for randomization. * woman of childbearing potential (wocbp) must have a negative urine pregnancy test within 14 days of the first application of study drug and agree to use an active method of birth control for the duration of the study. * subject is non-pregnant and non-lactating. * subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any target and non-target warts or which exposes the subject to an unacceptable risk by study participation. * subject is willing and able to follow all study instructions and to attend all study visits. exclusion criteria: * subject has clinically atypical warts on the trunk or extremities. * subject is immunocompromised (e.g., due to chemotherapy, systemic steroids, genetic immunodeficiency, transplant status, etc.) * subject has a history of human immunodeficiency virus (hiv) infection * subject has had any human papilloma virus (hpv) vaccine within 1 year prior to visit 1 * subject has a history of sensitivity to any of the ingredients in the study medications. * subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations. * participation in another therapeutic investigational drug trial in which administration of an investigational study medication occurred with 30 days prior to visit 1.
pain and placebo analgesia. does extended information about dental procedures reduce pain induced by dental treatment?

Conditions: Anxiety; Odontophobia

Summary: information about the effectiveness of treatment has been found to reduce pain, termed placebo analgesia. in this study it will be investigated whether this finding translates to the dental clinic. it will be investigated whether information that suggested that minimal pain will be experienced during filling therapy, can reduce the pain associated with that procedure compared to a group that receives standard information. all patients will receive the same amount of anesthesia and similar procedures during filling therapy. it is predicted that extended information should reduce pain, and that the reduction in pain should be associated with a reduction in stress.


Eligibility criteria:
inclusion criteria: * patients to be treated for dental caries * patients should be able to read and communicate in norwegian exclusion criteria: * patients with life threatening diseases * patients taking pain killers for other reasons on the day of treatment

Keywords: information pain stress fear placebo analgesia