Kornimate/medical-research-clean huggingface dataset:
postmarketing immunogenicity study in hae subjects treated with berinert

Conditions: Hereditary Angioedema Types I and II

Summary: this is a prospective, international, multi-center, non-randomized, single arm, open-label, postmarketing study to investigate the formation of inhibitory anti-c1-inh antibodies in hae subjects treated intravenously with berinert. individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. all subjects will receive 20 iu berinert/kg body weight per attack.


Eligibility criteria:
inclusion criteria: * diagnosis of congenital c1-inh deficiency (hae type i or ii) and assessed by the investigator to likely require intravenous (iv) berinert treatment during the study period. * male or female, ≥ 12 years of age at the time of signing informed consent. * written informed consent for study participation obtained before undergoing any study specific procedures. exclusion criteria: * incurable malignancies in the last 6 months prior to study entry. * acquired angioedema due to c1-inh deficiency. * all other types of angioedema not associated with c1-inh deficiency. * use of any c1-inh products other than berinert within 30 days before the study, or planned use during the study. * immunization within 30 days prior to study entry. * autoimmune conditions requiring use of immunosuppressants during the study. * known or suspected hypersensitivity to c1-inh. * participation in any of the previous berinert studies from which anti-c1-inh antibody results were submitted to the food and drug administration.
paxil cr bioequivalence study brazil - fed administration

Conditions: Depressive Disorder

Summary: the study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the test drug and the reference drug (two periods of drug administration after standardized meals).

title: relative bioavailability study between the formulations: paroxetine hydrochloride 25 mg tablet with controlled release (paxil cr) manufactured by glaxosmithkline inc. - mississauga - canada (test formulation) and paroxetine hydrochloride 25 mg tablets with controlled release (paxil cr) manufactured by smithkline beecham (cork) limited - cidra - puerto rico (reference formulation), fed administration in healthy volunteers of both genders. the study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the drug test and reference (two periods of drug administration). the population is composed of 60 healthy volunteers, adult of both gender, with age between 18 and 40 years, with a body mass index (bmi) between 18.5 and 27. volunteers have weight above than 50 kg. 50% of the volunteers recruited are female and 50% male. there are no restrictions regarding the ethnic group. the relative bioavailability of the formulations after oral administration in steady state will be evaluated based on statistical comparisons of relevant pharmacokinetic parameters obtained from data of drug concentration in blood. the concentration of paroxetine hydrochloride (controlled release) will be measured by an appropriate analytical method and valid after the drug administration.the pharmacokinetic samples will be collected at steady state in each period after standardized meals. the safety assessment will include evaluation and clinical monitoring, vital signs monitoring, ecg, and laboratory tests. adverse events will be monitored throughout the study.

Eligibility criteria:
exclusion criteria: * hypersensitivity to the study drug or to compounds chemically related; * history of serious adverse events; * concurrent or recent use of other antidepressives, schizophrenia, anticonvulsant; * history of liver, heart, gastrointestinal or renal illness; * ecg findings not recommended according to the investigator judgement; * the volunteer ingests more than 5 cups of coffee or tea a day. inclusion criteria: * man and woman (since they are not pregnant or breastfeeding); * age between 18 and 40 years; * non-smoker and not addict; * mass index between 18,5 and 27; * good health conditions or without significant illness, by judgement of a legally qualified professional; * sign the informed consent.

Keywords: bioequivalence paroxetine reference/test healthy volunteers fed condition
myo-inositol versus metformin in obese women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the aim of this study is to compare the effects of six months treatment of two insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women affected by polycystic ovary syndrome. the study group includes 40 patients, randomly allocated to subgroup a (metformin 1500 mg/day) and subgroup b (myo-inositol 1500 mg/day). the investigations include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline and after six months of treatment.


Eligibility criteria:
inclusion criteria: * women with polycystic ovary syndrome, diagnosed in accordance with rotterdam consensus conference criteria 2003; * bmi\>25 kg/m2; * age 18-35 years. exclusion criteria: * pregnancy; * significant liver or renal impairment; * other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs); * neoplasms; * unstable mental illness; * diagnosis of diabetes mellitus or impaired glucose tolerance; * use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study.

Keywords: polycystic ovary syndrome myoinositol metformin glucose-insulinemic metabolism menstrual pattern insulin-lowering therapies
the effect of pomegranate peel, german chamomile or their combination on gingivitis

Conditions: Gingivitis

Summary: the aim of this study is to compare clinically and biochemically the effect of herbal mouthwashes containing german chamomile and pomegranate peel extracts individually and as a mixture to chlorohexidine mouthwash in the treatment of gingivitis. the response will be assessed clinically and by suitable biochemical parameters.

1. ethical committee approval has been obtained from ethics committee of faculty of medicine and faculty of dentistry, alexandria university 2. all participants should agree to take part in this clinical study and will provide informed consent. 3. sixty plaque induced gingivitis patients ,will be recruited from faculty of dentistry, alexandria university. 4. the 60 participants will be randomly assigned into 5 groups. group 1: patients will be managed by scaling. group 2: patients will be managed by scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily. group 3: patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily. group 4: patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily. group 5: patients will be managed by scaling and will use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily. 5. all patients will be submitted to: * full patient history and clinical examination. * gingival index will be measured * saliva samples will be obtained in order to conduct elisa for the selected biomarkers. * different mouthwashes will be provided to patients. 6. statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 7. results, conclusion, discussion and recommendations will be given.

Eligibility criteria:
inclusion criteria: * age: 25-50 * patients with plaque induced gingivitis. exclusion criteria: * patients with systemic diseases (diabetes, leukemia, anemia) * smokers * pregnant females * patients receiving orthodontic treatment

Keywords: pomegranate peel german chamomile tnf-α il-1β
seamless follow up and support system for frail elderly living at home

Conditions: Elderly

Summary: the object of the present project is to promote the prevention of disability by providing 1) a feedback and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. the technical solution will contain wearable (e.g. smart insole) and ambient unobtrusive devices (e.g. weigh scale including balance analysis), and analysis and diagnosis assistance software. the devices transmit wirelessly the collected data to a remote server through a tablet. data will then be available remotely for consultations by users (i.e. patients or physicians). the clinical evaluation will be a multi-phased design with a first living lab evaluation followed by a real life home trial to finalize the evaluation. comprehensive assessments will be conducted to highlight the feasibility and acceptability.

functional decline challenges the sustainability of healthcare systems. there are difficulties in implementing effective interventions to prevent disability, to promote adherence to lifestyle recommendations and to perform seamless follow-up at home. a technological solution addressing this challenge and improving individual participation would be welcome. our aim is to evaluate an instrument for supporting physical activity and monitoring multiple parameters of frailty (a pre-disability condition) in frail elderly persons. the investigator and collaborator are therefore developing a solution to monitor key parameters of frailty during subject daily life and to promote walking. this tools are : 1. connected soles to evaluate different parameters of the volunteer walking 2. connected weighing machine to evaluate the volunteer weight and equilibrate 3. machine to measure gripping force because gripping force is correlated to physical condition. the primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficiency of the solution to prevent disability.

Eligibility criteria:
inclusion criteria: * patient living at home; * pre-frail or frail volunteers; * informed and written consent by the patient or the legal representative or the reliable person when appropriate. exclusion criteria: * patient's life expectancy less than 12 months; patient presenting disability with an activity of daily living score \< 4/6 ant/or a mini - mental state \<20/30, not walking or walking with a technical support; * non agreement of study participation of patients or legal representative or the reliable person when appropriate.

Keywords: frailty tele-monitoring self-management
pharmacogenomics study on treatment of psoriasis vulgaris by methotrexate

Conditions: Psoriasis Vulgaris

Summary: to investigate the influence of genetic factors on the curative effect , to find the relationships between genetic variants and the response of methotrexate to treatment of psoriasis vulgaris.

previous studies have indicated that the gene mutations of absorption distribution metabolism and drug target may affect the efficacy of methotrexate in vivo.to investigate the influence of genetic factors on the curative effect , to find the relationships between genetic variants and the response of methotrexate to treatment of psoriasis vulgaris.investigators analyzed the various levels of genetic factors, including: 1.to analysis the key gene variants which associated with adme(absorption, distribution, metabolism and excretion) affect the efficacy of methotrexate; 2.direct full genetic sequencing of mhc genes, to explore the genetic variations of efficacy and side effects; 3. direct sequencing of all exons in the gene in the patients of the response of serious and effectively, to explores the rare genetic variation may cause deterioration of treatment by methotrexate.

Eligibility criteria:
inclusion criteria: 1. diagnosed according to classification criteria for psoriasis vulgaris 2. patients aged 18 to 70 years (to the date of screening) 3. not treatment in the topical corticosteroids, biologicals agents or tretinoin cream 4. phototherapy nearly one months before enrolled 5. total bilirubin \< 1.5 x uln, ast(sgot)/alt(sgpt) \<2.5 x uln, if not liver metastases \< 5 x uln, if known liver metastases, creatinine clearance \<1.5 x uln 6. understanding the whole process of the study, voluntary participation and signed the informed consent exclusion criteria: 1. pregnant women, ready to pregnant or lactating women 2. have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history 3. patients is liver function abnormal persons (alt above the center laboratory normal limit) or hepatitis b patient grain carriers 4. patients with chronic diarrhea, or peptic ulcer nearly 1 year 5. patients suffering from malignant tumor 6. patients suffering from acute and chronic infectious diseases 7. mental disorders, history of alcohol abuse, drug or other substance abuse 8. other cases which researchers believe that can not enroll

Keywords: psoriasis vulgaris methotrexate
"solana™ trichomonas assay field study"

Conditions: Trichomonas Vaginalis

Summary: the solana® trichomonas assay is an in vitro qualitative nucleic acid amplification test for the detection of trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the helicase-dependent amplification (hda) technology and the solana instrument.

this study is to establish the clinical performance of the solana® trichomonas assay for the detection of trichomonas vaginalis in vaginal swabs and urine samples as compared to a combined reference method of direct wet mount microscopy and a fda-cleared device.

Eligibility criteria:
inclusion criteria: * female subjects will be recruited from the general population as they present to the clinical facility. subjects will be categorized by the clinician as either asymptomatic or symptomatic for trichomonas vaginalis infection. symptoms in women can include: * greenish-yellow, frothy vaginal discharge with a strong odor * painful urination * vaginal itching and irritation * discomfort during intercourse * lower abdominal pain (rare) exclusion criteria: 1. the study is limited to females. male subjects are not accepted. 2. at clinical sites informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
visual and functional assessment in low vision patients

Conditions: Retinitis Pigmentosa; Age-related Macular Degeneration; Optic Nerve Pathology; Inherited Retinal Dystrophies

Summary: vision testing is a fundamental part of every optometry and ophthalmology assessment. traditional vision testing charts are not able to measure vision below a certain level. vision in this range is classified as counting fingers (cf), hand movements (hm) and light perception (lp). these measures are not very accurate or easily quantifiable. they are also poorly understood in terms of impact on quality of life. this study aims to assess new methods for measuring the vision of patients with very low vision.

assessing very low vision accurately is becoming increasingly important with the increase in research in this area, such as using retinal implants to restore vision. without being able to accurately measure the change in vision before and after treatment, it is not possible to fully assess the effect of treatment. the freiburg vision test (fract) is a computer based test developed to assess patients down to the lp level. it has been used in research in recent years. the fract is suitable for research but is not suitable for a clinical setting. the berkeley rudimentary vision test (brvt) works on a similar principal as the fract but consists of hand held cards shown to the patient. little work has been completed on how well the brvt test works. results from fract and brvt will be compared in a group of patients with very low vision. this is important to establish how easily research results can be applied to a clinical setting. patients will also be asked to complete a daily living survey to better understand the impact of such poor vision on the ability to carry out day to day tasks. this understanding will help guide low vision services for patients as well as help direct low vision research to achieve a useful level of functional vision.

Eligibility criteria:
inclusion criteria: * snellen va or equivalent ≤ 6/60 in both eyes * patient has capacity to give consent and to undertake vision tests exclusion criteria: * diagnosis of functional vision loss * unwilling and/or unable to sign informed consent and complete the vision tests

Keywords: low vision vision testing retinitis pigmentosa amd visual acuity poor vision quantification
the health effect of diet rich in nordic berries

Conditions: Metabolic Syndrome; Impaired Glucose Tolerance; Low-grade Inflammation; Dyslipidemia

Summary: dietary polyphenols might have beneficial effects on glucose and lipid metabolism based on the studies made in animals or cell cultures. the findings regarding the possible decrease of low-grade inflammation are existing also in humans. low-grade inflammation has been suggested to be a mechanistic link between obesity and its consequences on cardiometabolic health. the aim of the present study is to examine the effect of diet rich in berries on glucose and lipid metabolism and inflammatory markers.

berries are traditionally an important part of the nordic diet. about 50 different berries are grown in the northern region, and about half of them are edible. phenolic compounds are one of the most diverse group of secondary metabolites present in edible plants, and berries are especially rich in them. flavonoids, phenolic acids, lignans and complex phenolic polymers (polymeric tannins) are typical for berries. phenolic compounds are reported to have a variety of beneficial biological properties. they are potent antioxidants, and exhibit various other physiological activities including anti-inflammatory, antimicrobial, antiallergic, anticarcinogenic and antihypertensive activities. epidemiological studies indicate that diet rich in phenolic compound correlates with lower risk of cancer and cardiovascular disease. the aim of the present study is to examine the effect of diet rich in berries on glucose and lipid metabolism and inflammatory markers and gene expression profile in peripheral blood mononuclear cells (pbmcs) in subjects with features of metabolic syndrome. randomized, controlled clinical intervention including 4 wk run-in period, 8 wk dietary intervention and 4 wk recovery period was conducted.

Eligibility criteria:
inclusion criteria: * overweight (bmi 26-39 kg/m2), and two of the following: * elevated fasting plasma glucose in the absence of diabetes (5.6-6.9 mmol/l) * abnormal serum lipid concentration: fasting serum triglyceride concentration \>1.7 mmol/l, fasting serum hdl cholesterol \<1.0 mmol/l (males) or \<1.3 mmol/l (females)) * waist circumference \>102 cm (males) or \>88 cm (females) * blood pressure \>130/85 mmhg exclusion criteria: * chronic diseases * use of lipid lowering medication

Keywords: bilberry vaccinium myrtillus metabolic syndrome glucose metabolism lipid metabolism inflammation gene expression
effect of shock waves therapy on chronic anal fissure

Conditions: Chronic Anal Fissure

Summary: the study conducted to assess if there is an effect of extracorporeal shock wave treatment on anal fissure

design of the study: a prospective, randomized, blind, paired (right/left) comparison. materials: measurement tool: * healing of anal fissure, * wexner constipation scoring system * anal pain intensity by means of a 10-point visual analogue scale (vas) therapeutic instruments: •. shock waves • topical application of 0.4% glyceryl trinitrate (gtn) ointment methods: • testing procedures: the assessment will be performed before commencing treatment, after 4 and 8 weeks of the treatment. • treatment procedures: patients will be assigned randomly into two groups equal in number: shock waves group: twenty patients will receive the shockwaves on perianal area of for 4 weeks (3 sessions /week). control group: twenty patients will receive the recommended routine medical treatment include topical application of 0.4% glyceryl trinitrate (gtn) ointment only..

Eligibility criteria:
inclusion criteria: * patient with chronic anal fissure * symptomatic for at least 6 months * failed conservative measures exclusion criteria: * pregnant women, * cardiac patients, * patients with a pacemaker, * low molecular heparin or warfarin treatment, * neurological disease,
effects of wearing a powered ankle-foot prosthesis on amputee walking

Conditions: Traumatic Amputation of Lower Extremity

Summary: amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at the same speeds as non-amputees and this discrepancy is more apparent at faster walking speeds. amputees choose to walk at speeds 30-40% slower than non-amputees. preferred walking speed is likely influenced by elevated metabolic energy, but the underlying reason for slower preferred walking speeds is not fully understood. unilateral amputees exhibit highly asymmetrical gait patterns that likely require more metabolic energy and impair functional mobility, increasing the risk of degenerative joint disease, osteo-arthritis and lower back pain. improvements in prosthetic devices could enhance mobility in amputees, thus positively effecting rehabilitation and ambulation in veterans. a prosthesis that allows amputees to reduce metabolic energy would be especially useful for rehabilitation in older, ill individuals with reduced exercise capacities and could literally restore walking ability in people that are currently non-ambulatory. hypotheses. amputees wearing the massachusetts institute of technology (mit) powered ankle-foot (paf) prosthesis will have a lower metabolic cost, faster preferred walking speed, and improved gait symmetry during walking than amputees wearing a conventional prosthesis and will have nearly the same metabolic cost, preferred walking speed, and gait symmetry during walking as age, gender, height, and weight matched non-amputees.


Eligibility criteria:
inclusion criteria: * 20 healthy adult volunteers, 10 unilateral trans-tibial amputees and 10 matched non-amputees, will be recruited and screened * amputees must be at least 1 year post-amputation, high-functioning (at least a k3 level of ambulation), and whose cause of amputation is either traumatic or vascular. medicare defines a k3 level amputee as an ambulator who has the ability or potential for prosthetic ambulation with variable cadence, who has the ability to traverse most environmental barriers and who may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion exclusion criteria: * none

Keywords: unilateral below the knee amputation